vvEPA United States Environmental Protection Agency Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) - Contaminant Information Sheets ------- Office of Water (4607M) EPA 815-R-22-003 October 2022 www, epa. gov/ safewater ------- EPA-Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA815-R-22-003 October 2022 Contents Abbreviations and Acronyms ii Chapter 1 Introduction 1 Chapter 2 Overview of the Final CCL 5 CISs 3 Chapter 3 CIS Key 8 Appendix A Contaminant Information Sheets A-l Appendix B Contaminant Information Sheet References B-l ------- EPA-Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA815-R-22-003 October 2022 Abbreviations and Acronyms CASRN Chemical Abstract Services Registry Number CCL Contaminant Candidate List CCL 1 EPA's First Contaminant Candidate List CCL 2 EPA's Second Contaminant Candidate List CCL 3 EPA's Third Contaminant Candidate List CCL 4 EPA's Fourth Contaminant Candidate List CCL 5 EPA's Fifth Contaminant Candidate List CERCLA Comprehensive Environmental Response, Compensation, and Liability Act CIS Contaminant Information Sheet CSF Cancer Slope Factor DSSTox Distributed Structure-Searchable Toxicity Public Database Network DTXSID Distributed Structure-Searchable Toxicity Substance Identifier FIFRA Federal Insecticide, Fungicide, and Rodenticide Act EEC Estimated environmental concentrations EDWC Estimated drinking water concentrations fHQ Final Hazard Quotient HRL Health Reference Level KH Henry's Law Constant Kow Octanol-Water Partition Coefficient lbs/year Pounds per year LOAEL Lowest Observed Adverse Effect Level NPDWR National Primary Drinking Water Regulation NHANES National Health and Nutrition Examination Survey NOAEL No Observed Adverse Effect Level OPP Office of Pesticide Programs OW Office of Water PWS Public Water System PCCL Preliminary Contaminant Candidate List QSAR Quantitative Structure-activity Relationship SDWA Safe Drinking Water Act SL Screening Level EPA United States Environmental Protection Agency ------- EPA - Office of Water Technical Support Document for the EPA 815-R-22-003 Final Fifth Contaminant Candidate List (CCL 5) October 2022 Contaminant Information Sheets Chapter 1 Introduction Section 1412(b)(l)(B)(i) of the Safe Drinking Water Act (SDWA), as amended in 1996, requires the United States Environmental Protection Agency (EPA) to publish every five years a list of drinking water contaminants which are not subject to any proposed or promulgated National Primary Drinking Water Regulations (NPDWRs), are known or anticipated to occur in public water systems (PWSs), and may require regulation under the SDWA. This list is known as the Contaminant Candidate List, or CCL. The SDWA directs the agency to consider health effects and occurrence information for unregulated contaminants to identify those that present the greatest public health concern related to exposure from drinking water. EPA uses this list of unregulated contaminants to help identify priority contaminants for regulatory decision making and to prioritize research and data collection efforts. EPA published the Draft CCL 5 on July 19, 2021 (86 FR 37948). EPA followed a 3-step process to identify chemicals for inclusion on the Final CCL 5. These steps included: Step 1. Building a broad universe of potential drinking water contaminants (called the CCL 5 Chemical Universe). EPA evaluated 134 data sources and identified 43 that were related to potential drinking water chemical contaminants and met established CCL assessment factors. From these data sources, EPA identified and extracted occurrence and health effects data for the 21,894 chemicals that form the CCL 5 Chemical Universe. Step 2. Screening the CCL 5 Chemical Universe to identify a list of chemicals that should be further evaluated (called the Preliminary CCL 5 (PCCL 5)). EPA established and applied a data- driven screening points system to identify and prioritize a subset of chemicals with the greatest potential for public health concern. The agency also incorporated publicly nominated chemicals to the PCCL 5. Step 3. Classifying PCCL 5 chemicals to select the Final CCL 5 chemicals. EPA compiled occurrence and health effects information and imported it into a standardized document format, called the Contaminant Information Sheet (CIS). The agency provided the CISs for use by two evaluation teams of EPA scientists. The evaluation teams reviewed this information for each chemical before reaching a group decision on whether to list a chemical on the CCL 5. A more detailed description of the 3-step process used to develop the Final CCL 5 of chemicals can be found in the Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) - Chemical Contaminants,1 referred to hereafter as the Final CCL 5 Chemical Technical Support Document. The purpose of this document is to present the CISs and relevant information that helps readers understand the data provided in the CISs. The remainder of this document is organized as follows: Chapter 2 presents an overview of the Final CCL 5 CISs; Chapter 3 provides a graphic illustration, also known as the CIS Key, to assist with interpretation of the data on the CIS. In this document, Appendix A provides CISs for 214 chemicals evaluated by the evaluation teams; 1 USEPA. 2022. Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) - Chemical Contaminants. EPA 815-R-22-002. October 2022. 1 ------- EPA - Office of Water Technical Support Document for the EPA 815-R-22-003 Final Fifth Contaminant Candidate List (CCL 5) October 2022 Contaminant Information Sheets and Appendix B provides the references for bracketed citations on the CISs. The remaining references for data sources on the CISs are included in Appendix N of the Final CCL 5 Chemical Technical SupportDocument (USEPA, 2022). 2 ------- EPA - Office of Water Technical Support Document for the EPA 815-R-22-003 Final Fifth Contaminant Candidate List (CCL 5) October 2022 Contaminant Information Sheets Chapter 2 Overview of the Final CCL 5 CISs This chapter presents an overview of the CISs with a brief description of the data elements presented and how they were used in the CCL 5 process. The CIS for each chemical is a concise, four-page profile that was provided to the chemical evaluators to assist them in making listing recommendations for the Final CCL 5. For select contaminants that have synonyms or other forms but that use the same DTXSID, additional data was added for completeness and transparency. Data that was added to the CIS between the Draft CCL 5 and Final CCL 5 are highlighted in green. The first page of each CIS includes a summary of the chemical's attribute scores, final hazard quotient, health effects and occurrence information used to calculate the final hazard quotient, chemical use information, and the chemical's status on the CCL. The second and third pages include detailed health effects and occurrence data, respectively. The derivation and use of these data are explained in detail in the Final CCL 5 Chemical Technical Support Document (USEPA, 2022). The fourth page lists the references that are cited in the CISs. Some chemical contaminants have five-page CISs. Page 1 - Summary and Decision The first page of each chemical CIS contains six sections of information including contaminant identifiers and use characteristics, the CCL 5 listing decision and final hazard quotient (fHQ), attribute scores, health effects and occurrence information, and the status of the contaminant with respect to nomination for the CCL 5 and decisions from previous CCL and regulatory determination cycles. From left to right, the six sections are described as follows: 1) Contaminant Identification - presents the contaminant name, a unique DSSTox Substance Identifier (DTXSID), the contaminant's Chemical Abstract Services Registry Number (CASRN), use information, synonyms or other contaminant forms, and other notes. The DTXSID field also contains a hyperlink to the chemical's profile on EPA's CompTox Chemicals Dashboard. A second table indicates if the contaminant is on any health or occurrence-related lists (e.g., FIFRA and CERCLA lists). 2) Contaminant Summary and Decision - indicates whether the contaminant was listed on the CCL 5 and presents the chemical's final hazard quotient (concentration in water divided by the health concentration). 3) Contaminant Status - indicates the status of the contaminant with respect to public nomination for the CCL 5, previous listing on CCLs 1-4, and previous negative regulatory determinations and the basis for that determination, if applicable. 4) Attribute Scores - presents assigned values/categories for each of the four CCL attributes derived from the health effects and occurrence data presented on the CISs, which are defined as follows: a. Potency quantifies the potential for a chemical to cause adverse health effects based on the dose required to elicit the most sensitive adverse effect as identified 3 ------- EPA - Office of Water Technical Support Document for the EPA 815-R-22-003 Final Fifth Contaminant Candidate List (CCL 5) October 2022 Contaminant Information Sheets in a single study or assessment. Potency for chemicals is reflected in several standard toxicological parameters, including reference dose (RfD) or its equivalent, cancer slope factor (CSF) or its equivalent, no observed adverse effect level (NOAEL), or lowest observed adverse effect level (LOAEL). b. Severity is a descriptive measure of the adverse health effect associated with the toxicity value that is used as the measure of potency and corresponds with the type of adverse outcome expected to occur at the LOAEL of a chemical. c. Prevalence provides a measure of how widespread the occurrence of the chemical is in the environment in the United States. The data used to develop the prevalence score may include the percent of PWSs or monitoring sites with detections of the contaminant, the number of states where pesticides are applied or releases to the environment are reported or chemicals are produced in pounds per year (lbs/year). d. Magnitude refers to the quantity of a chemical that is or may be in the environment. This was measured using the median value concentration of detections (if available) in drinking water or ambient water or the total pounds of a chemical released to the environment. In cases where magnitude data are not available, persistence and mobility data (i.e., chemical property/environmental fate parameters) were used as surrogates for water occurrence or release data (see the Final CCL 5 Chemical Technical Support Document (USEPA, 2022) for discussion). If a median was not available, the maximum was used. 5) Health Effects Information - presents the health effects information used to calculate the fHQ. If available, a health concentration (i.e., health reference level (HRL) or CCL Screening Level (CCL SL) was calculated from information provided by the cited assessment source. Health concentrations can be calculated for non-cancer and cancer endpoints and various target populations. The critical effect and target population from the selected assessment are also presented in this section. Health concentrations are expressed as a concentration of a chemical in drinking water (expressed in |ig/L). To determine the health concentration for a chemical, the agency considered adverse health effects that may pose a greater risk to specific life stages and other sensitive groups which represent a meaningful portion of the population. Although an HRL or SL was calculated for every qualifying or non-qualifying data element presented on the health effects page, a single health concentration was chosen to calculate the fHQ that is presented on the Summary and Decision page. More details on this process is provided in Section 4.3.1 of the Final CCL 5 Chemical Technical Support Document (USEPA, 2022). The assessment used as the source of the health concentration is the same assessment used as the source of the potency and severity attribute scores. This assessment is highlighted in yellow on the health effects page. 6) Occurrence Information - presents occurrence data used to calculate the fHQ - the 90th percentile concentration occurrence value, if available, or the next highest percentile value or the maximum concentration of detections (expressed in |ig/L). This section also indicates the data source, the type of water source monitored (e.g., finished or ambient water), and the monitoring date range. If measured data were unavailable, modeled 4 ------- EPA - Office of Water Technical Support Document for the EPA 815-R-22-003 Final Fifth Contaminant Candidate List (CCL 5) October 2022 Contaminant Information Sheets concentrations were used. A description of the selection process for the water concentration used to calculate the fHQ is provided in Section 4.3.2 and Appendix Hof the Final CCL 5 Chemical Technical Support Document (USEPA, 2022). Page 2 - Health Effects Data The second page of the CISs presents the available health effects data for each chemical. Thepage is split into three distinct sections: 1. Qualifying and Non-Qualifying Health Effects Data - presents data elements extractedfrom qualifying health assessments first followed by data elements extracted from non- qualifying health assessments. Differences between these two types of assessments are described in Section 4.3.1 of the Final CCL 5 Chemical Technical Support Document (USEPA, 2022). The column headings indicate the data element, the numerical or qualitative value, associated units, and assessment source and year associated with the data element. Typically, the year is the date of publication of the data, although given the variability of the formatting of the data sources, it may represent a toxicological study date or the date when the data source website was last updated or accessed. If available, the critical study and effect are noted alongside the target population and exposure factor used to derive the HRL or CCL SL; a reference to the full citation is provided on page 4 of the CIS. A notes field is filled in if other pertinent information for a particular data element or a specific data source is available. The row for the data element used to develop the potency and severity attribute scores and to calculate the final hazard quotientis shaded yellow. 2. Literature Search Summary - summarizes results from the rapid systematic review conducted for relevant health effects information, as further described in Section 4.2.2 of the Final CCL 5 Chemical Technical Support Document (USEPA, 2022). Search start andend dates, based on the date of the most recent published health assessment for the chemical of interest, are listed. The number of unique references identified for each chemical and deemed relevant after title-abstract screening and full-text review is also provided. If available, lowest LOAEL and highest NOAEL health effects information from animal toxicity studies are presented with the corresponding study references. Additional supplementary materials and rapid systematic review results for each chemicalare accessible via the CCL 5 docket (EPA-HQ-OW-2018-0594). 3. Other Health Data - at the bottom of the health effects data page of the CIS are other supporting qualitative and quantitative data. These data represent measured and modeledhealth effects information collected from primary data sources and the CompTox Chemicals Dashboard. Examples include cancer classifications from non- EPA sources, toxicity or benchmark values for multiple exposure durations (e.g., acute) and routes (e.g., inhalation), and quantitative structure-activity relationship (QSAR) results. Data thathave been modeled are provided in a separate table from the measured data. 5 ------- EPA - Office of Water Technical Support Document for the EPA 815-R-22-003 Final Fifth Contaminant Candidate List (CCL 5) October 2022 Contaminant Information Sheets Page 3 - Occurrence Data The third page of the CISs provides the available occurrence data for each chemical. Data used to develop the occurrence attribute scores, also known as "scoring data," are presented at the top of the page, followed by "non-scoring data". Scoring data associated with a higher attribute score (i.e., higher prevalence or higher magnitude) is presented first. The page is split into six distinct sections: 1. Nationally Representative Water Data - nationally representative finished water data represent the best estimation of the potential for human exposure; therefore, they are listed first in this section, followed by ambient water data. The column headers for the water data include the data source; number of total PWSs, sampling sites, or samples; number of positive results (referred to as "detects"); an indication as to whether these values correspond to PWSs, sampling sites, or samples; percent of PWSs, sites, or samples with detects; and where available, minimum, maximum, median, 90th percentile;units; sampling year(s); and a notes field. The row with the occurrence data element usedto develop the prevalence and magnitude attribute scores is shaded yellow on the CIS. 2. Application, Release, and Production Data - if water data were not available, then application, release, and production data were used to develop attribute scores to estimatethe potential occurrence of chemicals in water. These include pesticide application data, toxic release data, and chemical production data, all measured in lbs/year, for the most recent year for which data were available at the time of CCL 5 data collection. In addition, the pesticide application and toxic release data provide counts for how many states a chemical was applied or released in the data collection year. 3. Non-Nationally Representative Water Data - non-nationally representative water data are presented in the following order: finished water data, ambient water data, and waste water effluent data. These data were not used to develop attribute scores since they are not nationally representative; therefore, they are listed as "non-scoring data." This section includes data from both primary and supplemental data sources. Similar to the Nationally Representative Water Data section, the data in this section includes column headers for the water occurrence data, including the data source; number of total PWSs, sampling sites, samples; number of detects, number of PWSs, sampling sites, or samples; percent ofdetects; and where available, minimum, maximum, median, 90th percentile; units; sampling year(s); and a notes field. 4. Estimated Concentration in Water - estimated occurrence concentrations for pesticidesthat lacked nationally representative finished and/or nationally representative ambient water data. The data sources of presented modeled occurrence concentrations are EPA's Office of Pesticide Programs (OPP) risk assessments. This section provides modeled concentrations, known as estimated environmental concentrations (EECs) or estimated drinking water concentrations (EDWCs), accompanied by information on the assessment source, publication date, model used, and any other relevant notes. A description of the estimated occurrence 6 ------- EPA - Office of Water Technical Support Document for the EPA 815-R-22-003 Final Fifth Contaminant Candidate List (CCL 5) October 2022 Contaminant Information Sheets concentrations used in CCL 5 is provided in Section 4.2.1.2 of the Final CCL 5 Chemical Technical Support Document (USEPA, 2022). 5. Predicted Exposure and Biomonitoring Data - predicted exposure data from the EPA CompTox Dashboard provide results from qualitative structure-activity relationship (QSAR) and ExpoCast models that have been developed to predict chemical identifications such as toxicity endpoints, physical properties, exposure and environmental fate parameters. This information is presented in addition to the biomonitoring data collected by CDC's National Health and Nutrition Examination Survey (NHANES), which provides data for detections at the 90th percentile in human tissues and fluids such as serum, blood, and urine. This information is included because the data suggest there is exposure in the U.S. population; there are serious known or suspected health effects associated with different levels of exposure; and there may be limited availability and adequacy of analytical methods, and other logistical and cost considerations that resulted in limited finished or ambient water data. 6. Modeled Environmental Fate Parameters - includes any available data on environmental fate parameters. These modeled parameters from the EPA CompToxDashboard provide measures of a chemical's persistence and mobility in the environment. These measures include half-life (ti/2), boiling point, vapor pressure, solubility in water, bioconcentration factor, Henry's Law constant (Kh), and octanol-water partition coefficient (Kow). Page 4 - References The fourth page presents the references for the bracketed citations on the first three pages. References for all primary data sources are provided in Appendix N of the Final CCL 5 Chemical Technical Support Document (USEPA, 2022). 7 ------- EPA - Office of Water Technical Support Document for the EPA 815-R-22-003 Final Fifth Contaminant Candidate List (CCL 5) October 2022 Contaminant Information Sheets Chapter 3 CIS Key The following four pages provide an annotated graphic illustration, known as the CIS Key, to assist with interpretation of the data on the CIS. ------- EPA-Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Contaminant Identification: Presents the contaminant name, DSSTox Substance ID (DTXSID) and Chemical Abstract Services Registry Number (CASRN), use, notes, and its status on health or occurrence related lists. Propiconazole CCL 5 Contaminant Information Sheet CONTAMINANT IDENTIFYING INFORMATION Name: Propiconazole CASRN: 60207-90-1 DTXSID: DTXSID8024280 Use: Fungicide Chemical Notes: This CIS also contains some data for the following: -Cis-propiconazole -Trans-propiconazole Is the oA Btet on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neurotoxicants Neurodev. Disruptors Androgen Receptors in vitro Compounds with neurodev effe< 1undy etal 2015 Green shading indicates data updated between publication of Draft and Final CCL 5. Contaminant Summary and Decision: Indicates the contaminant's status on the CCL 5 and presents the final hazard quotient (concentration in water divided by the Health Reference Level (HRL) or CCL Screening Level (SL)). EPA-OGWDWand OST Contaminant Status: Indicates if the contaminant was publicly nominated for CCL 5, its status on previous CCL cycles, and past negative regulatory determinations and the basis for that determination. If the contaminant does not have a negative regulatory determination, "Not Applicable" is recorded. CONTAMINANT SUMMARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) Not List 0.000065 ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 4 non-cancer effects 9 2 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Source Assessment Pub. Date HRL 600 Liver toxicity; increased liver weight in males, and increase in liver lesions (masses/raised areas/swellings/nodular areas) general population OPP 2019 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished or Ambient (FW, SW, GW, WW) Source Date 0.039 90th Percentile All Ambient Water NAWQA 1991-2017 Attribute Scores: Presents assigned values/ categories for each of the four CCL attributes derived from the health effects and occurrence data presented on the CISs. Attribute scores allow EPA to compare relative toxicity and occurrence of CCL 5 chemicals. „ Occurrence information: Presents occurrence data used to calculate the final hazard quotient - the 90th percentile concentration occurrence value, if available, or the next highest percentile value or the maximum concentration of detections. If measured data were unavailable, modeled concentrations were used. Also, indicates water type, data source, and monitoring date(s). I PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Health Effects Information: Presents data elements used to calculate the final hazard quotient, including the Health Reference Level (HRL) or CCL Screening Level (SL), the assessment from which the HRL or CCL SL was derived, and the corresponding critical effect and target population. The assessment listed here was also used as a source for the potency and severity attribute scores. „ ------- EPA-Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Propiconazo^B CCL 5 Contc . Information S HEALTH EFFeI^DATA Qualifying Assessments, Exposur Qualifying and Non-Qualifying Health Effects Data: Presents data elements from qualifying health assessments first, followed by those from non-qualifying health assessments. The column headings summarize the data element, the numerical value (or qualitative, for cancer classifications), units and assessment source and year associated with the data element. If available, the critical study and effect are noted along with the target population, exposure factor, HRL or CCL SL, and a reference to the full citation on the references page. A notes field is filled in if other pertinent information for a particular data element is available. Data Element Reference Dose (RfD) or Equivalent mg/kg/day Source OPP 2019 Study Ciba Geigy Corporation 1982 Liver toxicity; increased liver weight in males, and increase in liver lesions (masses/raised areas/ swellings/nodular areas) Yellow shading indicates the data used to populate the potency and severity attribute scores, health effects information, and final hazard quotient sections on the Summary + Decision page. general population Exposure Factor (mL/kg-day) 33.8 HRL (ug/L) ~\~t 592 Assessment Full Citation [425] Cancer Classification (CC) [425] Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Assessment Source Critical Study Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Stt Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Acute Human Health Benchmark 2 mg/L EPAHHBP Acute PAD 0.3 mg/kg/day EPAHHBP Chronic Human Health Benchmark 0.6 mg/L EPAHHBP Health-Based Screening Level 0.6 mg/L Health-based screening levels from USGS propiconazole Health-Based Screening Level 0.6 mg/L Health-based screening levels from USGS cis-propiconazole Health-Based Screening Level 0.6 mg/L Health-based screening levels from USGS trans-propiconazole Population-Adjusted Dose (PAD) 0.1 mg/kg/day EPAHHBP Literature Search Summary: Summarizes the rapid systematic review results for relevant health effects information. If available, the lowest LOAEL and highest NOAEL health effects information from animal toxicology studies are presented with references. Search date ranges based on the publication date of the most recent health assessment are listed. The numbers of unique references identified and deemed relevant after title-abstract screen and full-text review are also provided. Notes: Yellow highlighted data indicate value was used in attribute scoring. Green highlighted data indicates a change made between the draft and final CCL 5. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. LD50 1490 mg/kg NIH HSDB min LD50 1517 mg/kg NIH HSDB max LOAEL 300 mg/kg/day EPA Toxicity Reference Database max LOAEL 8.39999962 mg/kg/day EPA Toxicity Reference Database min NOAEL 1.9 mg/kg/day EPA Toxicity Reference Database min NOAEL 100 mg/kg/day EPA Toxicity Reference Database max Percent of active toxcast in vitro assays tested 19.93 percent EPA Chemistry Dashboard Subchronic LOAEL 6.25 mg/kg/day EPA Toxicity Reference Database min Subchronic LOAEL 77.5899963 mg/kg/day EPA Toxicity Reference Database max Subchronic NOAEL 1.25 mg/kg/day EPA Toxicity Reference Database min Subchronic NOAEL 16.82 mg/kg/day EPA Toxicity Reference Database max Data Element Value Units Source Notes Modeled Data LD50 0.00405509 mo l/kg TEST QSAR Ames mutagenicity test 0.333 no units TEST QSAR Developmental toxin test 0.484 no units TEST QSAR Other Health Data: Presents supporting qualitative and quantitative health effects data. These data represent measured and modeled health effects information collected from primary data sources and the CompTox Chemicals Dashboard. Modeled data is provided in a separate table from measured data. 10 ------- EPA-Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Propiconazole CCL 5 Contaminant Informatii OCCURRENCE DATA Scoring Data Nationally Representative Water Data Finished Water Nationally Representative Water Data: Scoring data presented in order of the hierarchical attribute scoring protocol established for prevalence and magnitude. Finished water data from the most recent UCMR cycle are shown first, followed by the preceding UCMR cycles, then UCM and finally NIRS. Lastly, national ambient water data from NAWQA. Unregulated Contaminant Monitoring Rule (UCMR) 4 Unregulated Contaminant Monitoring Rule (UCMR) 3 Unregulated Contaminant Monitoring Rule (UCMR) 2 Unregulated Contaminant Monitoring Rule (UCMR) 1 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 National Inorganics and Radionuclides Survey (NIRS) Ambient Water National Water Quality Assessment (USGS NAWQA) (All Water) National Water Quality Assessment (USGS NAWQA) (SurfaceWatetJ National Water Qualitv Assessment (USGS NAWQA) (Grounll Pesticide Application Data Estimated Annual Agricultural Pesticide Use (USGS) Non-Scoring Data Non-Nationally Representative Water Data Finished Water Non-Nationally Representative Water Data: Non-scoring data from primary and supplemental sources that are presented in order of hierarchy, separated into three categories: finished water data, ambient water data, and waste water effluent data. Yellow shading indicates the data used to calculate the prevalence and magnitude attribute scores on the Summary + Decision Page. Application, Release, and Production Data: Additional scoring data for Prevalence and Magnitude used to estimate potential occurrence in water in the absence of measured water data. They include application rate data for pesticides, toxic release data, and chemical production data. 90th Percentile Maximum Cone. (Detects) (Detects) Magnitude USDA Pesticide Data Program (PDP) (Finished) ug/L USDA Pesticide Data Program (PDP) (Finished) USDA Pesticide Data Program (PDP) (Finished) Bradley et al. 2018 (Finished) [53] ug/L Ambient Water Magnitude National Water Information System (USGS NWIS) (Surface Water) ug/L National Water Information System (USGS NWIS) (Groundwater) ug/L National Water Information System (USGS NWIS) (All Water) ug/L USDA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) ug/L USDA Pesticide Data Program (PDP) (Groundwater) ug/L USDA Pesticide Data Program (PDP) (Untreated) ug/L Surface Water Database (SURF) California Dept. of Pestifide Regulation fAmhientl 14511 Bradley et al. 2017 (Ambient) [52] Bradley et al. 2017 (Ambient) [52] Bradley et al. 2017 (Ambient) [52] J22LML 124 Sites g.7 Arnold et al. 2016 (Filtered) [7] USGS, McKenzie River, Oregon, 201 USGS, McKenzie River, Oregon, 201 Waste Water Effluent Estimated Concentration in Water Estimated Concentration in Water: Pesticide modeled concentrations used in instances when no finished or ambient water data were available. The modeled value and units are included in this section, accompanied by information on the source, publication date, model used, and relevant notes. ug/L ug/L cis-propiconazole ug/L Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 1.63E-08 Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Biodegradation half-life Boiling point Modeled Environmental Fate Parameters: Available environmental fate parameters for a chemical extracted from EPA's CompTox Dashboard. For persistence, this includes the chemical's half-life. The remaining properties relate to a chemical's mobility in the environment. days Biomonitoring Data NHANES biomonitoring detection in se NHANES biomonitoring detection in bl NHANES biomonitoring detection in ur Notes: Highlighted Blank fields indicate "All Water" data froi Monitoring dates for non-scoring datal State Drinking Water Monitoring Data UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Predicted Exposure and Biomonitoring Data: Predicted daily exposure (ExpoCast) data extracted from EPA's CompTox Dashboard are presented above biomonitoring data from the National Health and Nutrition Examination Survey (NHANES) Biospecimen Program. Biomonitoring values presented are the 90th percentile concentrations of compounds in serum, blood and/oinurine. degree C 0.000000409 mol/L 0.000192309 mol/L atm-mA3/mol (log Kow) ------- EPA-Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Propiconazole CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water- Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W.T., ... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 53 Bradley, P. M., Kolpin, D. W., Romanok, K. M., Smalling, K. L., Focazio, M. J., Brown, J. B.,... & Dietze, J. E. (2018). Reconnaissance of mixed organic and inorganic chemicals in private and public supply tapwaters at selected residential and workplace sites in the United States. Environmental science & technology, 52(23), 13972-13985. 158 Reconnaissance of Land-Use Sources of Pesticides in Drinking Water, McKenzie River, Oregon. U.S. Geological Survey Scientific Investigations Report 2012-5091, 46 p. plus appendixes. 425 USEPA. 2019. Propiconazole Human Health Risk Assessment for the New Use of Propiconazole on Avocado, along with Conversion to Brassica, leafy greens, subgroup 4-16B, except watercress, Leaf petiole vegetable subgroup 22B, Celtuce, Florence fennel, Swiss chard, and the expansion to Vegetable, root, except sugar beet, subgroup IB. EPA-HQ-OPP-2018-0127-0007. DP No. D446376. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D., ... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticides in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. I References: This page presents the full references for the bracketed citations on the CISs. 12 ------- EPA - Office of Water Technical Support Document for the EPA 815-R-22-003 Final Fifth Contaminant Candidate List (CCL 5) October 2022 Contaminant Information Sheets Appendix A Contaminant Information Sheets This appendix contains CISs for the 214 chemicals reviewed by the evaluation teams for the CCL 5. These chemicals are listed in alphabetic order in a table, followed by 859 pages of CISs in a tabular format containing background, health effects, and occurrence information. Due to the technical limitations of this section, for further assistance with reasonable accommodation please contact Brynne Storsved at storsved.brynne@epa.gov or 202-564-4004. Chemical Name DTXSID 1,1,2,2-Tetrachloroethane DTXSID7021318 1,2,3-Trichloropropane DTXSID9021390 1,3-Butadiene DTXSID3 020203 1,3 -Di chl oropropene DTXSID 1022057 1,4-Dioxane DTXSID4020533 17-alpha-ethynyl estradiol DTXSID5020576 17-beta estradiol DTXSID0020573 1-Butanol DTXSID 1021740 lH-Benzotriazole, 4(or 5)-methyl- DTXSID0026171 2-(2-Methyl-4-chlorophenoxy)propionic acid (MCPP) DTXSID9024194 2,4-Dichlorophenol DTXSID 102043 9 2,4-Dichlorophenoxybutyric acid DTXSID7024035 2,4-Dinitrophenol DTXSID0020523 2,4-Dinitrotoluene DTXSID0020529 2,6-Dinitrotoluene DTXSID5020528 2-Aminotoluene DTXSID 1026164 2-Hydroxyatrazine DTXSID6037807 2-Methyl-4-chlorophenoxyacetic acid (MCPA) DTXSID4024195 2-Methylnaphthalene DTXSID4020878 4-Androstene-3,17-dione DTXSID8024523 4-Nonylphenol (all isomers) DTXSID3021857 4-tert-Octylphenol DTXSID90223 60 6-Chloro-l,3,5-triazine-2,4-diamine DTXSID 1037806 Acephate DTXSID8023 846 Acetamiprid DTXSID0034300 Acetochlor ethanesulfonic acid DTXSID6037483 Acetochlor oxanilic acid (OA) DTXSID 103 7484 Acetophenone DTXSID6021828 Acrolein DTXSID5020023 Acyclovir DTXSID 1022556 Alachlor ethanesulfonic acid (ESA) DTXSID6037485 A-1 ------- EPA - Office of Water Technical Support Document for the EPA 815-R-22-003 Final Fifth Contaminant Candidate List (CCL 5) October 2022 Contaminant Information Sheets Chemical Name DTXSID Alachlor OA DTXSID1037486 Aldrin DTXSID8020040 alpha-Hexachlorocyclohexane (alpha-HCH) DTXSID2020684 Ametryn DTXSID 1023 869 Ammonia DTXSID0023 872 Anthraquinone DTXSID3020095 Atenolol DTXSID2022628 Azoxystrobin DTXSID0032520 Benfluralin DTXSID3023899 Bensulide DTXSID9032329 Bentazon DTXSID0023 901 Benzophenone DTXSID0021961 Bifenthrin DTXSID9020160 Bisphenol A DTXSID7020182 Boron DTXSID3 023 922 Boscalid DTXSID6034392 Bromacil DTXSID4022020 Bromochloromethane DTXSID4021503 Bromoxynil DTXSID3 022162 Bupropion DTXSID7022706 Butyl benzyl phthalate DTXSID3 020205 Caffeine DTXSID0020232 Calcium DTXSID9050484 Camphor DTXSID5030955 Carbamazepine DTXSID4022731 Carbaryl DTXSID9020247 Carbendazim (MBC) DTXSID4024729 Carbon disulfide DTXSID6023 947 Chlordecone (Kepone) DTXSID 1020770 Chiorodifluoromethane (HCFC-22) DTXSID60203 01 Chloromethane DTXSID0021541 Chlorothalonil DTXSID0020319 Chlorpyrifos DTXSID402045 8 Clomazone DTXSID1032355 Clopyralid DTXSID9029221 Clothianidin DTXSID2034465 Cobalt DTXSID 1031040 Cotinine DTXSID 1047576 A-2 ------- EPA - Office of Water Technical Support Document for the EPA 815-R-22-003 Final Fifth Contaminant Candidate List (CCL 5) October 2022 Contaminant Information Sheets Chemical Name DTXSID Cycloate DTXSID6032356 Cyfluthrin DTXSID5035957 Cyhalothrin DTXSID6023 997 Cypermethrin DTXSID 1023 998 Cyprodinil DTXSID 10323 59 Deethylatrazine DTXSID5037494 Desisopropyl atrazine DTXSID0037495 Desvenlafaxine DTXSID40869118 Diazepam DTXSID4020406 Diazinon DTXSID9020407 Dicamba DTXSID4024018 Dichlorvos DTXSID5020449 Dicrotophos DTXSID9023 914 Dieldrin DTXSID9020453 Diethyl phthalate DTXSID7021780 Difenoconazole DTXSID4032372 Dimethenamid DTXSID4032376 Dimethenamid oxanilic acid degradate (OXA) DTXSID4037530 Dimethoate DTXSID7020479 Di-n-butyl phthalate DTXSID2021781 Diuron DTXSID0020446 Esfenvalerate DTXSID4032667 Ethalfluralin DTXSID8032386 Ethion DTXSID2024086 Ethoprop DTXSID4032611 Ethyl dipropylthiocarbamate (EPTC) DTXSID 1024091 Famoxadone DTXSID8034588 Fenbuconazole DTXSID8032548 Fenitrothion DTXSID4032613 Fenpropathrin DTXSID0024002 Fenthion DTXSID8020620 Fexofenadine DTXSID00861411 Fipronil DTXSID4034609 Fluconazole DTXSID3 020627 Flufenacet DTXSID2032552 Fluometuron DTXSID8020628 Fluoranthene DTXSID3 024104 Fluoxetine DTXSID7023067 A-3 ------- EPA - Office of Water Technical Support Document for the EPA 815-R-22-003 Final Fifth Contaminant Candidate List (CCL 5) October 2022 Contaminant Information Sheets Chemical Name DTXSID Galaxolide DTXSID8027373 Gemfibrozil DTXSID0020652 Heroin DTXSID6046761 Hexazinone DTXSID4024145 Imazalil DTXSID8024151 Imazapyr DTXSID8034665 Imazaquin DTXSID3024152 Imazethapyr DTXSID3 024287 Imidacloprid DTXSID5032442 Indoxacarb DTXSID 1032690 Iprodione DTXSID3024154 Isophorone DTXSID8020759 Isopropylbenzene (Cumene) DTXSID 1021827 Isoxaflutole DTXSID5034723 Lactofen DTXSID7024160 lambda-Cyhalothrin DTXSID7032559 Lidocaine DTXSID 1045166 Linuron DTXSID2024163 Lithium DTXSID5036761 Loratadine DTXSID2023224 Magnesium DTXSID0049658 Malathion DTXSID4020791 Manganese DTXSID2024169 Meprobamate DTXSID3023261 Metal axyl DTXSID6024175 Metformin DTXSID2023270 Methocarbamol DTXSID6023286 Methomyl DTXSID 1022267 Methyl tert-butyl ether (MTBE) DTXSID3020833 Methylmercury DTXSID9024198 Metolachlor ESA DTXSID 1037567 Metolachlor OA DTXSID6037568 Metoprolol DTXSID2023 309 Metribuzin DTXSID6024204 Molybdenum DTXSID 1024207 Morphine DTXSID9023 336 Morphine-3 -glucuronide DTXSID80174157 Myclobutanil DTXSID8024315 A-4 ------- EPA - Office of Water Technical Support Document for the EPA 815-R-22-003 Final Fifth Contaminant Candidate List (CCL 5) October 2022 Contaminant Information Sheets Chemical Name DTXSID N,N-Diethyl-m-toluamide (DEET) DTXSID2021995 Naled DTXSID 1024209 Naphthalene DTXSID8020913 Nicotine DTXSID 1020930 Norflurazon DTXSID8024234 Oxadiazon DTXSID3 02423 9 Oxyfluorfen DTXSID7024241 p,p'-DDE DTXSID9020374 p-Cresol DTXSID7021869 Pendimethalin DTXSID7024245 Permethrin DTXSID8022292 Phenanthrene DTXSID6024254 Phenol DTXSID5021124 Phorate DTXSID4032459 Phosmet DTXSID5024261 Phosphorus DTXSID 10243 82 Phostebupirim DTXSID 1032482 Piperonyl butoxide DTXSID 1021166 Potassium DTXSID9049748 Profenofos DTXSID3032464 Prometon DTXSID6022341 Prometryn DTXSID4024272 Pronamide DTXSID2020420 Propachlor DTXSID4024274 Propanil DTXSID8022111 Propargite DTXSID4024276 Propazine DTXSID3021196 Propiconazole DTXSID8024280 Propoxur DTXSID7021948 Prosulfuron DTXSID9034868 Pymetrozine DTXSID2032637 Pyraclostrobin DTXSID7032638 Pyrene DTXSID3 024289 Pyridaben DTXSID5032573 Quinoline DTXSID 1021798 Silicon DTXSID0051441 Sitagliptin DTXSID70197572 Sodium DTXSID 1049774 A-5 ------- EPA - Office of Water Technical Support Document for the EPA 815-R-22-003 Final Fifth Contaminant Candidate List (CCL 5) October 2022 Contaminant Information Sheets Chemical Name DTXSID Sulfamethoxazole DTXSID8026064 Sulfentrazone DTXSID6032645 Sulfomethuron-methyl DTXSID0034936 Tamoxifen DTXSID 1034187 Tebuconazole DTXSID9032113 Tebuthiuron DTXSID3 024316 Tefluthrin DTXSID5032577 Terbacil DTXSID8024317 Terbufos DTXSID2022254 Testosterone DTXSID8022371 Tetraconazole DTXSID8034956 Thiabendazole DTXSID0021337 Thiamethoxam DTXSID2034962 Thiobencarb DTXSID60243 3 7 Thiram DTXSID5021332 Tin DTXSID 1049801 Tri-allate DTXSID5024344 Tribufos DTXSID 1024174 Tributyl phosphate DTXSID3021986 Triclopyr DTXSID0032497 Triclosan DTXSID5032498 Tri ethyl citrate DTXSID0040701 Trifloxystrobin DTXSID4032580 Trifluralin DTXSID4021395 Trimethylbenzene (1,2,4-) DTXSID6021402 Tris(l,3-dichloro-2-propyl) phosphate (TDCP) DTXSID9026261 Tris(2-butoxylethyl) phosphate (TBEP) DTXSID5021758 Tris(2-chloroethyl) phosphate (TCEP) DTXSID5021411 Tungsten DTXSID8052481 Vanadium DTXSID2040282 Verapamil DTXSID9041152 A-6 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 1,1,2,2-Tetrachloroethane CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: 1,1,2,2 -Tet ra ch lo roet ha ne CASRN: 79-34-5 DTXSID: DTXSID7021318 Use: Industrial solvent; former pesticide; in manufacture of paints, varnish, rust removers; in soil sterilization and weed killer, insecticide formulations; chemical intermediate Chemical Notes: Is the contaminant on any lists? CERCLA X FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT IN FORMATION Potency Severity Prevalence Magnitude 5 carcinogen with linear MOA 5 6 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 0.1 hepatocellular carcinomas general population IRIS 2010 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 2.684 90th Percentile Finished Water UCM1 1988-1992 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS 1,1,2,2-tetrachloroethane is not expected to occur in many PWSs today. While 1,1,2,2-tetrachloroethane was detected in both the UCM Round 1 and the UCM Round 2 surveys, the percentage of detections had decreased by the time the UCM Round 2 survey was performed in the mid-1990's [a]. In addition, USGS did not detect 1,1,2,2- tetrachloroethane in two subsequent monitoring surveys of source jrsthat supply community water systems, using a reporting limit that is less than the 1,1,2,2-tetrachloroethane HRLof 0.4 pg/L [b,c]. EPA believes that this decrease in detections occurred because mercial production of 1,1,2,2-tetrachloroethane ceased in the mid- 1980's [d]. USE PA, 2008 [297]; [b] Grady, 2003 [87]; [c] Delzer & lvahn« 2003 [68]; [d] ATSDR, 1996 [4]; as cited in US EPA, 2008 [296] iko, Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-7 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 1,1,2,2-Tetrachloroethane CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.0011 mg/kg/day CALEPA 2003 Schmidt et al. 1972 transient weight gain depression and increased liver fat content general population 33.8 6.51 [57] Reference Dose (RfD) or Equivalent 0.0107 mg/kg/day OW 2008 NTP 2004 increase in relative liver weight general population 33.8 63.3 [287] Reference Dose (RfD) or Equivalent 0.01071 mg/kg/day OW 2008 NTP 2004 increase in relative liver weight general population 33.8 63.4 [291] Reference Dose (RfD) or Equivalent 0.02 mg/kg/day IRIS 2010 NTP 2004 increased relative liver weights general population 33.8 118 [307] Cancer Slope Factor (CSF) 0.15 (mg/kg/day) A-1 CALEPA 2003 NCI 1978 hepatocellular carcinoma general population 33.8 0.197 [57] Cancer Slope Factor (CSF) 0.085 (mg/kg/day) A-1 OW 2008 NCI 1978 hepatocellular carc nomas general population 33.8 0.348 [287] Cancer Slope Factor (CSF) 0.085 (mg/kg/day) A-1 OW 2008 NCI 1978 hepatocellular carc nomas general population 33.8 0.348 [291] Cancer Slope Factor (CSF) 0.2 (mg/kg/day) A-1 IRIS 2010 NCI 1978 hepatocellular carc nomas general population 33.8 0.148 [307] Cancer Classification (CC) L OW 2008 [287] Cancer Classification (CC) L OW 2008 [291] Cancer Classification (CC) L IRIS 2010 [307] ATSDR 2008 [271 Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (ml/kg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review 2009-09-01 2020-04-07 45 0 1 Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results 10-day Health Advisory 3 mg/L EPA DWSHA2018 Cancer Slope Factor (CSF) 0.2 (mg/kg/day)A-l CalEPA OEH HA Chemical Database Chronic Health-Based Guidance Value 0.0002 mg/L MN DOH Human Health Ambient Water Quality Criteria 0.0002 mg/L EPA Human Health Criteria forCWA Inhalation Unit Risk (IUR) 0.000058 ug/mA3 CalEPA OEH HA Chemical Database Intermediate Minimal Risk Level (MRL) 0.5 mg/kg/day CDC ATSDR Lifetime Health Advisory 0.0004 mg/L EPA DWSHA 2018 Public Health Goal 0.0001 mg/L CalEPA OEHHA Public Health Goals Cancer Classification (CC) 2B no units WHO IARC Cancer Classification (CC) Female.Mice P no units HHSNTP Cancer Classification (CC) Female.Rats N no units HHSNTP Cancer Classification (CC) Male.Mice P no units HHSNTP Cancer Classification (CC) Male.Rats E no units HHSNTP Data Element Value Units Source Notes Measured Data and Assessment Results LD50 250 mg/kg NIH HSDB Percent of active toxcast in 2.55 percent EPA Chemistry Dashboard vitro assays tested TD50 1910 mg/kg/day NIH CPDB max TD50 35.4 mg/kg/day NIH CPDB min Data Element Value Units Source Notes Modeled Data LD50 0.0108893 mo l/kg TEST QSAR Ames mutagenicity test 0.148 no units TEST QSAR Developmental toxin test 0.374 no units TEST QSAR Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. A-8 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 1,1,2,2-Tetrachloroetiiane CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 OCCURRENCE DATA Scoring_Data_ Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 24,800 19 Sites 0.08 0.1 0.5 1.5 2 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 20.407 91 Sites 0.45 0.05 0.5 2.68 200 National Inorganics and Radionuclides Survev (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Qualitv Assessment (USGS NAWQA) (All Water) 1991-2017 6.771 4 Sites 0.06 0.02 0.08 0.29 0.38 National Water Qua litv Assessment (USGS NAWQA) (Surface Water) 1991-2017 225 2 Sites 0.89 0.02 0.08 0.164 0.2 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 6.546 2 Sites 0.03 0.06 0.22 0.316 0.38 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) 9 5,936 Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Finished) 2006 - 2020 466 0 Sites 0 Drinking Water Monitoring Data - MA (Finished) 2006 - 2020 885 0 Sites 0 Drinking Water Monitoring Data - WA (Finished) 2006-2011 1,098 0 Sites 0 Ambient Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Source) 2006 - 2020 4,714 4 Sites 0.08 0.8 1.2 3.36 4.28 ug/L Drinking Water Monitoring Data - FL (Source) 2006-2011 3 0 Sites 0 Drinking Water Monitoring Data - MA (Source) 2006 - 2020 130 0 Sites 0 Drinking Water Monitoring Data - PA (Source) 2006-2011 13 0 Sites 0 Drinking Water Monitoring Data - WA (Source) 2006-2011 1,521 0 Sites 0 Drinking Water Monitoring Data - Wl (Source) 2012-2019 112 0 Sites 0 National Water Information System (USGS NWIS) (Surface Water) 2008-2017 237 0 Sites 0 National Water Information System (USGS NWIS) (Groundwater) 2008-2017 2,806 2 Sites 0.07 2.1 4 13.8 18 ug/L National Water Information System (USGS NWIS) (All Water) 2008 - 2017 3,039 2 Sites 0.07 2.1 4 13.8 18 ug/L Arnold et al. 2016 (Unfiltered) [7] 2012 - 2013 158 0 Sites 0 Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 0.0000368 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) < LOD ng/ml NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 14.5265 days Boiling point OPERA QSAR 147.582 degree C Boiling point TEST QSAR 132.363 degree C Vapor pressure OPERA QSAR 7.28977 mmHg Vapor pressure TEST QSAR 5.3827 mmHg Solubility in water OPERA QSAR 0.0176084 mol/L Solubility in water TEST QSAR 0.0107647 mol/L Bioconcentration factor OPERA QSAR 11.7866 no units Bioconcentration factor TEST QSAR 15.5239 no units Henry's Law constant OPERA QSAR 0.000500707 o E E Octanol/water partitioning coeff. (log Kow) OPERA QSAR 2.35016 no units A-9 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 1,1,2,2-Tetrachloroethane CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 4 Agency for Toxic Substances and Disease Registry (ATSDR). 1996. Toxicological Profile for 1,1,2,2-Tetrachloroethane. Atlanta, GA: Agency for Toxic Substances and Disease Registry, Public Health Service U.S. Department of Health and Human Services. Available on the Internet at: http://www.atsdr.cdc.gov/toxprofiles/tp93.html. 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 27 ATSDR. 2008. Toxicological Profile for 1,1,2,2-Tetrachloroethane. U.S. Department of Health and Human Services, Public Health Service, Agency for Toxic Substances and Disease Registry (ATSDR), Atlanta, GA. 57 CalEPA. 2003. Public Health Goal for 1,1,2,2-Tetrachloroethane in Drinking Water. California Environmental Protection Agency (Ca IE PA), Office of Environmental Health Hazard Assessment, Sacramento, CA. 68 Delzer, G.C. and T. Ivahnenko. 2003. Occurrence and Temporal Variability of Methyl tertButyl Ether (MTBE) and Other Volatile Organic Compounds in Select Sources of Drinking Water: Results of the Focused Survey. U.S. Geological Survey WaterResources Investigations Report 02-4084. 65 pp. Available on the Internet at: http://sd.water.usgs.gov/nawqa/pubs/wrir/wrir02_4084.pdf. 87 Grady, S.J. 2003. A National Survey of Methyl tert-Butyl Ether and Other Volatile Organic Compounds in Drinking-Water Sources: Results of the Random Survey. U.S. Geological Survey Water-Resources Investigations Report 02-4079. 85 pp. Available on the Internet at: http://sd.water.usgs.gov/nawqa/pubs/wrir/wrir02 4079.pdf. 287 USEPA. 2008. Drinking Water Health Advisory for 1,1,2,2-Tetrachloroethane. U.S. Environmental Protection Agency, Office of Water, Office of Science and Technology, Health and Ecological Criteria Division, Washington, D.C. 291 USEPA. 2008. Health Effects Support Document for 1,1,2,2-Tetrachloroethane. U.S. Environmental Protection Agency, Office of Water, Health and Ecological Criteria Division, Washington, D.C. 296 USEPA. 2008. Regulatory Determinations Support Document for Selected Contaminants from the Second Drinking Water Contaminant Candidate List (CCL 2). EPA Report 815-R-08-012. June 2008. 297 USEPA. 2008. The Analysis of Occurrence Data from the First Unregulated Contaminant Monitoring Regulation (UCMR 1) in Support of Regulatory Determinations for the Second Drinking Water Contaminant Candidate List. EPA 815-R-08-013. June. 307 USEPA. 2010. Chemical Assessment Summary, 1,1,2,2-Tetrachloroethane. U.S. Environmental Protection Agency, National Center for Environmental Assessment, Integrated Risk Information System (IRIS), Washington, D.C. A-10 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 1,2,3-Trichloropropane CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 CONTAMINANT IDENTIFYING INFORMATION Name: 1,2,3-Tric hlo ro p ro pa ne CASRN: 96-18-4 DTXSID: DTXSID9021390 Use: Paint ingredient Chemical Notes: Is the contaminant on any lists? CERCLA X FIFRA Human Neurotoxicants PubMed Neurotoxicants Neurodev. Disruptors Androgen Receptors in vitro Compounds with neurodev effects, Mundy et al 2015 CONTAMINANT SUM MARY& DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 7 carcinogen with mutagenic MOA 8 4 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value ("g/L) Critical Effect Target Pop. Assessment Source Assessment Pub. Date HRL 0.002 forestomach neoplasms general population IRIS 2009 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished or Ambient (F W, SW, GW, WW) Source Date 0.28 90th Percentile Finished Water UCMR3 2013-2015 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS RD 1 RD 2 RD 3 Not Applicable Not Applicable Not Applicable Basis Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-11 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 1,2,3-Trichloropropane CCL5ContaminantlnformationSheet E PA-OG WDW a n d OST Octo be r 2022 HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.006 mg/kg/day OW1989 NTP1983 a and b effects on body and organ weights, hematological effects, changes in clinical chemistry and histopathological effects general population 33.8 35.5 [201] Reference Dose (RfD) or Equivalent 0.0057 mg/kg/day CALEPA 2009 NTP1993 effects on erythrocytes general population 33.8 33.7 [59] Reference Dose (RfD) or Equivalent 0.004 mg/kg/day IRIS 2009 NTP1993 increased absolute liver weight general population 33.8 23.7 [299] Cancer Slope Factor (CSF) 25 (mg/kg/day) A-1 CALEPA 2009 NTP1993 fore stomach neoplasms general population 33.8 0.00118 [59] Cancer Slope Factor (CSF) 30 (mg/kg/day) A-1 IRIS 2009 NTP1993 fore stomach neoplasms general population 33.8 0.00230 [299] Cancer Classification (CC) L IRIS 2009 [299] ATSDR1992 [8] Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Titie-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results 10-day Health Advisory 0.6 mg/L EPA DWSHA 2018 Acute Health-Based Guidance Value 0.007 mg/L MNDOH Acute Health-Based Guidance Value 0.007 mg/L MNDOH Acute inhalation Minimal Risk Level (MRL) 0.0003 ppm CDC ATSDR Benchmark 0.000005 mg/L CalEPAOEHHA Chemical Database Chronic Health-Based Guidance Value 0.0000003 mg/L MNDOH Chronic Health-Based Guidance Value 0.007 mg/L MNDOH Intermediate Minimal Risk Level (MRL) 0.06 mg/kg/day CDC ATSDR Public Health Goal 0.0000007 mg/L CalEPA OEHHA Public Health Goals Reference Concentration (RfC) 0.0003 mg/mA3 EPA IRIS Short-Term/Subchronic Health-Based Guidance Value 0.007 mg/L MNDOH Cancer Classification (CC) 2A no units WHO IARC Cancer Classification (CC) Female.Mice P no units HHS NTP Cancer Classification (CC) Female.Rats P no units HHS NTP Cancer Classification (CC) Male.Mice P no units HHS NTP Cancer Classification (CC) Male.Rats P no units HHS NTP Data Element Value Units Source Notes Modeled Data LD50 0.00803526 mo l/kg TEST QSAR Ames mutagenicity test 0.673 no units TEST QSAR Developmental toxin test 0.462 no units TEST QSAR Data Element Value Units Source Notes Measured Data and Assessment Results LD50 320 mg/kg NIH HSDB min LD50 505 mg/kg NIH HSDB max Percent of active toxcast in 1.65 percent EPA Chemistry Dashboard vitro assays tested TD50 0.806 mg/kg/day NIHCPDB min TD50 454 mg/kg/day NIHCPDB max Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. A-12 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 1,2,3-Trichloropropane CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 OCCURRENCE DATA Scorin£Data_ Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018 - 2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013 - 2015 4,916 67 Sites 1.36 0.03 0.073 0.28 1.02 ug/L Unregulated Contaminant Monitoring Rule (UCMR) 2 2008 - 2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 24,088 19 Sites 0.08 0.03 0.5 16.6 3000 ug/L Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 17,392 44 Sites 0.25 0.1 0.915 6 112 ug/L National Inorganics and Radionuclides Survey (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991 - 2017 7,695 83 Sites 1.08 0.002 0.2 0.839 2.92 ug/L National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991 - 2017 265 1 Sites 0.38 0.12 0.16 0.179 0.179 ug/L National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991 - 2017 7,430 82 Sites 1.1 0.002 0.206 0.851 2.92 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) 2 5,040 Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Finished) 2006 - 2020 502 69 Sites 14 0.001 0.014 0.6 29 ug/L Drinking Water Monitoring Data - MA (Finished) 2006 - 2020 885 0 Sites 0 Drinking Water Monitoring Data - WA (Finished) 2006 - 2011 1,204 0 Sites 0 Community Water System Survey (CWSS) (Finished) [178] 2006 1 NA Sites 400 400 ug/L Ambient Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Source) 2006 - 2020 4,640 373 Sites 8.04 0.0018 0.032 0.31 270 ug/L Drinking Water Monitoring Data - FL (Source) 2006 - 2011 3 1 Sites 33 1.9 1.9 1.9 1.9 ug/L Drinking Water Monitoring Data - MA (Source) 2006 - 2020 130 0 Sites 0 Drinking Water Monitoring Data - PA (Source) 2006 - 2011 14 0 Sites 0 Drinking Water Monitoring Data - WA (Source) 2006 - 2011 1,690 1 Sites 0.06 0.0322 0.0335 0.0345 0.0348 ug/L Drinking Water Monitoring Data - Wl (Source) 2012-2019 112 1 Sites 0.89 0.33 0.33 0.33 0.33 ug/L National Water Information System (USGS NWIS) (Surface Water) 2008 - 2017 222 0 Sites 0 National Water Information System (USGS NWIS) (Groundwater) 2008 - 2017 3,422 51 Sites 1.49 0.002 0.0157 0.161 1.16 ug/L National Water Information System (USGS NWIS) (All Water) 2008 - 2017 3,640 51 Sites 1.4 0.002 0.0157 0.161 1.16 ug/L Arnold et al. 2016 (Unfiltered) [7] 2012 - 2013 685 12 Sites 1.75 0.005 0.0215 0.132 0.526 ug/L Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 1.33 E-08 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES bio monitoring detect ion in blood (1999-2016) < LOD ng/ml NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA a re not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 4.59332 days Boiling point OPERA QSAR 147.27 degree C Boiling point TEST QSAR 145.101 degree C Vapor pressure OPERA QSAR 6.2604 mmHg Vapor pressure TEST QSAR 6.56145 mmHg Solubility in water OPERA QSAR 0.0143205 mol/L Solubility in water TEST QSAR 0.0117761 mol/L Bioconcentration factor OPERA QSAR 11.92 no units Bioconcentration factor TEST QSAR 16.1808 no units Henry's Law constant OPERA QSAR 0.000365755 atm-mA3/mol Octanol/water partitioning coeff. (log Kow) OPERA QSAR 2.27667 no units A-13 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 1,2,3-Trichloropropane CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water- Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 8 ATSDR. 1992. Toxicological Profile for 1,2,3-Trichloropropane. U.S. Department of Health and Human Services, Public Health Service, Agency for Toxic Substances and Disease Registry (ATSDR), Atlanta, GA. 59 CalEPA. 2009. Public Health Goals for Chemicals in Drinking Water, 1,2,3-Trichloropropane. California Environmental Protection Agency (CalEPA), Office of Environmental Health Hazard Assessment, Pesticide and Environmental Toxicology Branch, Sacramento, CA. 178 USEPA (US Environmental Protection Agency). (2009). 2006 Community Water System Survey. Overview, 57. 201 USEPA. 1989. 1,2,3-Trichloropropane Drinking Water Health Adivsory. U.S. Environmental Protection Agency, Office of Water, Washington, D.C. 299 USEPA. 2009. Chemical Assessment Summary, 1,2,3-Trichloropropane. U.S. Environmental Protection Agency, National Center for Environmental Assessment, Integrated Risk Information System (IRIS), Washington, D.C. A-14 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 1,2,4-Trimethylbenzene CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: 1,2,4-Tiri methyl be n ze n e CASRN: 95-63-6 DTXSID: DTXSID6021402 Use: Chemical intermediate; vermifuge Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANTSUMMARY& DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 5 non-cancer effects 6 6 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 60 decreased pain sensitivity general population IRIS 2016 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 10 90th Percentile Finished Water UCM1 1988-1992 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-15 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 1,2,4-Trimethylbenzene CCL 5 Contaminant Information Sheet EPA-OGWDWand OST October 2022 HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.01 mg/kg/day IRIS 2016 Korsak and Rydzynski 1996 decreased pain sensitivity general population 33.8 59.2 [373] NOTE: IRIS utilized PBPK modeling to extrapolate an oral RfD from an inhalation study Cancer Classification (CC) D OW1987 [194] Cancer Classification (CC) D PPRTV 2007 [278] Cancer Classification (CC) 1 IRIS 2016 [373] NOTE: IRIS utilized PBPK modeling to extrapolate an oral RfD from an inhalation study Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (ml/kg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review 2015-09-01 2020-04-06 17 0 0 Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Acute Health-Based Guidance Value 0.1 mg/L MN DOH Benchmark 0.33 mg/L CalEPA OEHHA Chemical Database Chronic Health-Based Guidance Value 0.1 mg/L MN DOH Reference Concentration (RfC) 0.06 mg/mA3 EPA IRIS Reference Concentration (RfC) 0.08 mg/mA3 EPA IRIS Reference Concentration (RfC) 0.2 mg/mA3 EPA IRIS Reference Concentration (RfC) 3 mg/mA3 EPA IRIS Reference Concentration (RfC) 4 mg/mA3 EPA IRIS Short-Term/Subchronic Health-Based Guidance Value 0.1 mg/L MN DOH Subchronic Provisional RfD 0.04 mg/mA3 EPA IRIS Subchronic Provisional RfD 0.04 mg/mA3 EPA IRIS Data Element Value Units Source Notes Measured Data and Assessment Results LD50 3280 mg/kg NIH HSDB min LD50 6000 mg/kg NIH HSDB max Percent of active toxcast in 0.9 percent EPA Chemistry Dashboard vitro assays tested Data Element Value Units Source Notes Modeled Data LD50 0.0282488 mo l/kg TEST QSAR Ames mutagenicity test TEST QSAR Developmental toxin test 0.482 no units TEST QSAR Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. A-16 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 1,2,4-Tri methyl benzene CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 22.965 174 Sites 0.76 0.1 0.8 5.42 137 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 12.755 106 Sites 0.83 0.02 1 10 77 National Inorganics and Radionuclides Survev(NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 7.705 695 Sites 9.02 0.004 0.03 0.199 260 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 265 76 Sites 29 0.005 0.0255 0.21 3.6 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 7.440 619 Sites 8.32 0.004 0.033 0.196 260 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) 50 6,616,209 Chemical Data Reporting (CDR) Results (EPA) (2016) 250M-500M Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Finished) 2006 - 2020 405 5 Sites 1.23 0.039 1.15 8.02 22.3 ug/L Drinking Water Monitoring Data - MA (Finished) 2006 - 2020 884 11 Sites 1.24 0.5 0.68 2.1 2.4 ug/L Drinking Water Monitoring Data - WA (Finished) 2006-2011 1,188 1 Sites 0.08 1.4 1.4 1.4 1.4 ug/L Ambient Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Source) 2006 - 2020 4,250 14 Sites 0.33 0.034 0.645 2.45 3.5 ug/L Drinking Water Monitoring Data - MA (Source) 2006 - 2020 130 2 Sites 1.54 0.6 0.79 0.798 0.8 ug/L Drinking Water Monitoring Data - PA (Source) 2006-2011 13 0 Sites 0 Drinking Water Monitoring Data - WA (Source) 2006-2011 1,665 0 Sites 0 Drinking Water Monitoring Data - Wl (Source) 2012-2019 101 0 Sites 0 National Water Information System (USGS NWIS) (Surface Water) 2008-2017 219 13 Sites 5.94 0.011 0.033 0.0545 0.072 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008-2017 3,487 204 Sites 5.85 0.01 0.0525 0.304 180 ug/L National Water Information System (USGS NWIS) (All Water) 2008-2017 3,703 217 Sites 5.86 0.01 0.047 0.299 180 ug/L Arnold et al. 2016 (Unfiltered) [7] 2012-2013 685 18 Sites 2.63 0.012 0.039 0.161 0.274 ug/L Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/ day) Notes Expocast exposure 0.0000518 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicatethere were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 4.62726 days Boiling point OPERA QSAR 169.007 degree C Boiling point TEST QSAR 178.053 degree C Vapor pressure OPERA QSAR 1.87805 mmHg Vapor pressure TEST QSAR 1.49279 mmHg Solubility in water OPERA QSAR 0.000492809 mol/L Solubility in water TEST QSAR 0.00155239 mol/L Bioconcentration factor OPERA QSAR 144.739 no units Bioconcentration factor TEST QSAR 218.776 no units Henry's Law constant OPERA QSAR 0.00706473 atm-mA3/mol 0 eta no 1/water partitioning coeff. (log Kow) OPERA QSAR 3.61901 no units A-17 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 1,2,4-Trimethylbenzene CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 194 USEPA. 1987. Drinking Water Health Advisory for 1,2,4-trimethylbenzene. U.S. Environmental Protection Agency, Office of Health and Environmental Assessment, Environmental Criteria and Assessmen Office, Cincinnati, OH. 278 USEPA. 2007. Provisional Peer-Reviewed Toxicity Values for 1,2,4-Trimethylbenzene. U.S. Environmental Protection Agency, Office of Research and Development, National Center for Environmental Assessment, Superfund Health Risk Technical Support Center, Cincinnati, OH. 373 USEPA. 2016. Toxicological Review of Trimethylbenzenes. U.S. Environmental Protection Agency, Office of Research and Development, National Center for Environmental Assessment, Integrated Risk Information System (IRIS), Washington, D.C. A-18 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 1,3-Butadiene CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: 1,3-Butadiene CASRN: 106-99-0 DTXSID: DTXSID3020203 Use: Rubber chemical Chemical Notes: Is the contaminant on any lists? CERCLA X FIFRA Human Neurotoxicants PubMed Neu rotoxica nts X Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 1 6 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date IRIS 2002 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.518 90th Percentile Finished Water UCMR3 2013-2015 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-19 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 1,3-Butadiene CCL 5 Contaminant Information Sheet EPA-OGWDWand OST October 2022 HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Cancer Classification (CC) B2 IRIS 2002 1249] NOTE: according to IRIS: "Oral RfD not calculated because 1,3-butadiene is a gas, is poorly soluble in water, and causes hazard by inhalation only" ATSDR2012 [291 Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Cancer Slope Factor (CSF) 0.6 (mg/kg/day)A-l CALEPA 2009 Melnicket al. 1990 lung alveolar and bronchiolar neoplasms general population 33.8 0.0493 [60] Literature Search Summary Lowest LOAEL Health Effects Lowest LOAE L Lowest LOAEL Study Highest NOAEL Health Highest NOAEL Highest NOAEL Study Start Date of End Date of No. Unique References No. Animal Studies No. Human No. PECO Relevant Studies (mg/kg Effects (mg/kg bw/day) Search Search identified in lit search passed Title-abstract Studies passed passed full-text review bw/day) Screen Title-abstract Screen 2001-11-01 2020-02-13 1334 0 45 Other Health Data Data Element Value Units Source Notes Data Element Value Units Source Notes Measured Data and Assessment Results Measured Data and Assessment Results Cancer Classification (CC) 1 no units WHO IARC LD50 5480 mg/kg NIH HSDB Cancer Slope Factor (CSF) 0.6 (mg/kg/day)A-l CalEPAOEHHA Chemical Database Inhalation Unit Risk (IUR) 0.00017 ug/mA3 CalEPA OEH HA Chemical Database Inhalation Unit Risk (IUR) 0.00003 (ug/m3)A-l EPA IRIS Data Element Value Units Source Notes Reference Concentration (RfC) 2 ug/mA3 CalEPAOEHHA Chemical Database Modeled Data Reference Concentration (RfC) 0.002 mg/mA3 EPA IRIS LD50 0.0291072 mo l/kg TEST QSAR Cancer Classification (CC) Female.Mice P no units HHSNTP Ames mutagenicity test TEST QSAR Cancer Classification (CC) Female.Mice P no units HHSNTP Developmental toxin test 0.572 no units TEST QSAR Cancer Classification (CC) Female.Rats NT no units HHSNTP Cancer Classification (CC) Female.Rats NT no units HHSNTP Cancer Classification (CC) Male.Mice P no units HHSNTP Cancer Classification (CC) Male.Mice P no units HHSNTP Cancer Classification (CC) Male.Rats NT no units HHSNTP Cancer Classification (CC) Male.Rats NT no units HHSNTP Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. A-20 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 1,3-Butadiene CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 OCCURRENCE DATA Scoring_Data_ Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contam nant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contam nant Monitoring Rule (UCMR) 3 2013-2015 4,916 2 Sites 0.04 0.32 0.43 0.518 0.54 Unregulated Contam nant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contam nant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contam nant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contam nant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 1.411 1 Sites 0.07 0.649 0.649 0.649 0.649 National Water Qua lity Assessment (USGS NAWQA) (Surface Water) 1991-2017 51 1 Sites 1.96 0.649 0.649 0.649 0.649 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 1.360 0 Sites 0 Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) 33 1,241,320 Chemical Data Reporting (CDR) Results (EPA) (2016) 1B-5B Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Ambient Water Prevalence Magnitude National Water Information System (USGS NWIS) (Surface Water) 2008-2017 47 0 Sites 0 National Water Information System (USGS NWIS) (Groundwater) 2008-2017 824 1 Sites 0.12 0.81 0.81 0.81 0.81 ug/L National Water Information System (USGS NWIS) (All Water) 2008-2017 871 1 Sites 0.11 0.81 0.81 0.81 0.81 ug/L Arnold et al. 2016 (Unfiltered) [7] 2012-2013 527 0 Sites 0 Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/ day) Notes Expocast exposure Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 7.4766 days Boiling point OPERA QSAR 2.82833 degree C Boiling point TEST QSAR 18.339 degree C Vapor pressure OPERA QSAR 1266.91 mmHg Vapor pressure TEST QSAR 1213.39 mmHg Solubility in water OPERA QSAR 0.0170752 mol/L Solubility in water TEST QSAR 0.021727 mol/L Bioconcentration factor OPERA QSAR 11.0376 no units Bioconcentration factor TEST QSAR 7.31139 no units Henry's Law constant OPERA QSAR 0.0679036 atm-mA3/mol 0 eta no l/water partitioning coeff. (log Kow) OPERA QSAR 1.92103 no units A-21 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 1,3-Butadiene CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 29 ATSDR. 2012. Toxicological Profile for 1,3-Butadiene. U.S. Department of Health and Human Services, Agency for Toxic Substances and Disease Registry (ATSDR), Atlanta, GA. 60 CalEPA. 2009. Technical Support Document for Cancer Potency Factors, Appendix B. California Environmental Protection Agency (CalEPA), Office of Environmental Health Hazard Assessment, Air Toxicology and Epidemiology Branch, Sacramento, CA. 249 USEPA. 2002. Chemical Assessment Summary, 1,3-Butadiene. U.S. Environmental Protection Agency, National Center for Environmental Assessment, Integrated Risk Information System (IRIS), Washington, D.C. A-22 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 1,3-Dichloropropene CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 CONTAMINANT IDENTIFYING INFORMATION Name: 1,3- Die hlo ro p ro pe ne CASRN: 542-75-6 DTXSID: DTXSID1022057 Use: pesticide; in organic synthesis Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants X PubMed Neurotoxicants Neurodev. Disruptors Androgen Receptors in vitro Compounds with neurodev effects, Mundy et al 2015 CONTAMINANT SUM MARY& DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 5 carcinogen with linear MOA 1 1 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value ("g/L) Critical Effect Target Pop. Assessment Source Assessment Pub. Date HRL 0.2 forestomach, liver, adrenal, and thyroid tumors found in male rats general population OPP 2008 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished or Ambient (F W, SW, GW, WW) Source Date 1.63 90th Percentile Finished Water UCM1 1988-1992 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS RD 1 RD 2 RD 3 Not Applicable X Not Applicable Basis 1,3-DCP appears to occur infrequently at health levels of concern in PWSs. While 1,3-DCP was detected in the UCM Round 1 (late 1980's) and the UCM Round 2 (mid 1990's) surveys [a], it was not detected in a subsequent evaluation of 796 small systems from the UCMR 1 survey [b]. addition, the USGS did not detect 1,3-DCP in two occurrence studies performed between 1999 and 2001 using monitoring levels that were lower than the HRL[c,d]. EPA believes the 1999 pesticide labeling requirements, which are intended to mitigate risks to drinking water, may be one reason for the lack of occurrence of 1,3-DCP at levels of concern in subsequent monitoring surveys. [a] USE PA, 2008 [298]; [b] USEPA, 2008 [297]; [c] Grady, 2003 [87]; [d] Delzer & Ivahnenko, 2003 [68]; as cited in USEPA, 2008 [296] Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-23 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 1,3-Dichloropropene CCL5ContaminantlnformationSheet E PA-OG WDW a n d OST Octo be r 2022 HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Qtation Notes Reference Dose (RfD) or Equivalent 0.025 mg/kg/day OPP 2008 Stott et al. 1995 decreased body weight gain, increased incidence of basal cell hyperplasia of nonglandular stomach mucosa general population 33.8 148 [285] Cancer Slope Factor (CSF) 0.122 (mg/kg/day)A-l OPP 2008 NTP 1985; Stott et al. 1995 forestomach, liver, adrenal, and thyroid tumors found in male rats general population 33.8 0.243 [285] Cancer Classification (CC) L OPP 2008 [285] Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Titie-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results 10-day Health Advisory 0.03 mg/L EPA DWSHA 2018 Cancer Slope Factor (CSF) 0.091 (mg/kg/day)A-l CalEPAOEHHA Chemical Database Chronic Health-Based Guidance Value 0.0002 mg/L MNDOH Chronic inhalation Minimal Risk Level (MRL) 0.007 ppm CDC ATSDR Drinking Water Guideline Value 0.02 mg/L WHO Drinking Water Quality Guidelines Human Health Ambient Water Quality Criteria 0.00027 mg/L EPA Human Health Criteria for CWA Inhalation Unit Risk (IUR) 0.000004 (ug/m3)A-l EPA IRIS Intermediate Inhalation Minimal Risk Level (MRL) 0.008 ppm CDC ATSDR Intermediate Minimal Risk Level (MRL) 0.04 mg/kg/day CDC ATSDR Lifetime Health Advisory 0.0004 mg/L EPA DWSHA 2018 Public Health Goal 0.0002 mg/L CalEPA OEHHA Public Health Goals Reference Concentration (RfC) 0.02 mg/mA3 EPA IRIS Cancer Classification (CC) 2B no units WHO IARC Cancer Classification (CC) Female.Mice P no units HHS NTP Cancer Classification (CC) Female. Rats SE no units HHS NTP Cancer Classification (CC) Male.Mice IS no units HHS NTP Cancer Classification (CC) Male.Rats P no units HHS NTP Data Element Value Units Source Notes Modeled Data LD50 0.00398107 mo l/kg TEST QSAR Ames mutagenicity test 1.133 no units TEST QSAR Developmental toxin test 0.342 no units TEST QSAR Data Element Value Units Source Notes Measured Data and Assessment Results LD50 713 mg/kg NIH HSDB max LD50 94 mg/kg NIH HSDB min LOAEL 12.5 mg/kg/day EPA Toxicity Reference Database NOAEL 2.5 mg/kg/day EPA Toxicity Reference Database Percent of active toxcast in 0 percent EPA Chemistry Dashboard vitro assays tested TD50 1930 mg/kg/day NIHCPDB max TD50 33.2 mg/kg/day NIHCPDB min Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. A-24 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 1,3-Dichloropropene CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 OCCURRENCE DATA Scoring_Data_ Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 796 0 Sites 0 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 16.787 58 Sites 0.35 0.2 0.5 0.99 39 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 9.164 15 Sites 0.16 0.5 1 1.63 2 National Inorganics and Radionuclides Survev(NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 National Water Qua lity Assessment (USGS NAWQA) (Surface Water) 1991-2017 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) 24 59,344,846 2016 Toxic Release Inventory (TRI) Program (EPA) (2016) 10 7,907 Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Finished) 2006 - 2020 464 2 Sites 0.43 0.5 1 1 1 ug/L Drinking Water Monitoring Data - MA (Finished) 2006 - 2020 879 1 Sites 0.11 1.3 1.3 1.3 1.3 ug/L Ambient Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Source) 2006 - 2020 4,667 5 Sites 0.11 0.52 0.605 0.75 10 ug/L Drinking Water Monitoring Data - FL (Source) 2006-2011 2 0 Sites 0 Drinking Water Monitoring Data - MA (Source) 2006 - 2020 129 0 Sites 0 Drinking Water Monitoring Data - PA (Source) 2006-2011 13 0 Sites 0 Drinking Water Monitoring Data - Wl (Source) 2012-2019 112 0 Sites 0 Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990 - 2018 94 0 Sites 0 Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/ day) Notes Expocast exposure 3.56E-08 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 5.3718 days Boiling point OPERA QSAR 97.6161 degree C Boiling point TEST QSAR 97.43 degree C Vapor pressure OPERA QSAR 31.8587 mmHg Vapor pressure TEST QSAR 41.9759 mmHg Solubility in water OPERA QSAR 0.0196733 mol/L Solubility in water TEST QSAR 0.0229087 mol/L Bioconcentration factor OPERA QSAR 7.94771 no units Bioconcentration factor TEST QSAR 12.3027 no units Henry's Law constant OPERA QSAR 0.00202678 o E E Octanol/water partitioning coeff. (log Kow) OPERA QSAR 2.02743 no units A-25 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 1,3-Dichloropropene CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 68 Delzer, G.C. and T. Ivahnenko. 2003. Occurrence and Temporal Variability of Methyl tertButyl Ether (MTBE) and Other Volatile Organic Compounds in Select Sources of Drinking Water: Results of the Focused Survey. U.S. Geological Survey WaterResources Investigations Report 02-4084. 65 pp. Available on the Internet at: http://sd.water.usgs.gov/nawqa/pubs/wrir/wrir02_4084.pdf. 87 Grady, S.J. 2003. A National Survey of Methyl tert-Butyl Ether and Other Volatile Organic Compounds in Drinking-Water Sources: Results of the Random Survey. U.S. Geological Survey Water-Resources Investigations Report 02-4079. 85 pp. Available on the Internet at: http://sd.water.usgs.gov/nawqa/pubs/wrir/wrir02 4079.pdf. 285 USEPA. 2008. 1,3-Dichloropropene: Proposed New Use for Drip Irrigation in Vineyards: Revised HED Human Health Risk Assessment. EPA-HQ-OPP-2013-0154-0006. DP No. D347789. U.S. Environmental Protection Agency, Office of Prevention, Pesticides and Toxic Substances, Washington, D.C. 296 USEPA. 2008. Regulatory Determinations Support Document for Selected Contaminants from the Second Drinking Water Contaminant Candidate List (CCL 2). EPA Report 815-R-08-012. June 2008. 297 USEPA. 2008. The Analysis of Occurrence Data from the First Unregulated Contaminant Monitoring Regulation (UCMR 1) in Support of Regulatory Determinations for the Second Drinking Water Contaminant Candidate List. EPA 815-R-08-013. June. 298 USEPA. 2008. The Analysis of Occurrence Data from the Unregulated Contaminant Monitoring (UCM) Program and National Inorganics and Radionuclides Survey (NIRS) in Support of Regulatory Determinations for the Second Drinking Water Contaminant Candidate List. EPA 815-D-08-014. June. 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticides in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. A-26 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 1,4-Dioxane CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: 1,4-Dioxane CASRN: 123-91-1 DTXSID: DTXSID4020533 Use: Solvent; solvent stabilizer Chemical Notes: Is the contaminant on any lists? CERCLA X FIFRA Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 5 carcinogen with linear MOA 10 5 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 0.3 hepatocellular adenomas and carcinomas in general population IRIS 2010 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.93 90th Percentile Finished Water UCMR3 2013 - 2015 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-27 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 1,4-Dioxane CCL 5 Contaminant Information Sheet EPA-OGWDWand OST October 2022 HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.1 mg/kg/day ATSDR2012 Kociba et al. 1974 liver effects in male rats general population 33.8 592 [30] Reference Dose (RfD) or Equivalent 0.03 mg/kg/day IRIS 2010 Kociba et al. 1974 liver and kidney toxicity general population 33.8 178 [308] Reference Dose (RfD) or Equivalent 0.096 mg/kg/day WHO 2005 Kociba et al. 1974 renal tubular epithelial and hepatocellular degeneration and necrosis general population 33.8 568 [439] Reference Dose (RfD) or Equivalent 0.0054 mg/kg/day HC 2018 Kociba et al. 1974; Dourson et al. 2014 hepatocellular necrosis general population 33.8 32.0 [95] Cancer Slope Factor (CSF) 0.1 (mg/kg/day) A-1 IRIS 2010 Kano et al. 2009 hepatocellular adenomas and carcinomas in female mice general population 33.8 0.296 [308] Cancer Classification (CC) L IRIS 2010 [308] Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Hepatic, Systemic 440 Gi, 2018 Hepatic 562 Gi, 2018 1 Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results 10-day Health Advisory 0.4 mg/L EPA DWSHA2018 Acute inhalation Minimal Risk Level (MRL) 2 ppm CDC ATSDR Benchmark 0.001 mg/L CalEPA OEH HA Chemical Database Cancer Slope Factor (CSF) 0.027 (mg/kg/day) A-1 CalEPA OEH HA Chemical Database Chronic Health-Based Guidance Value 0.1 mg/L MN DOH Chronic Health-Based Guidance Value 0.0001 mg/L MN DOH Chronic inhalation Minimal Risk Level (MRL) 0.03 ppm CDC ATSDR Drinking Water Guideline Value 0.05 mg/L WHO Drinking Water Quality Guidelines Inhalation Unit Risk (IUR) 0.000005 (ug/m3)A-l EPA IRIS Inhalation Unit Risk (IUR) 0.0000077 ug/mA3 CalEPA OEH HA Chemical Database Intermediate Inhalation Minimal Risk Level (MRL) 0.2 ppm CDC ATSDR Intermediate Minimal Risk Level (MRL) 0.5 mg/kg/day CDC ATSDR Lifetime Health Advisory 0.2 mg/L EPA DWSHA 2018 Lifetime Health Advisory 0.00035 mg/L EPA DWSHA 2018 Reference Concentration (RfC) 0.03 mg/mA3 EPA IRIS Reference Concentration (RfC) 3000 ug/mA3 CalEPA OEH HA Chemical Database Short-Term/Subchronic Health-Based Guidance Value 0.3 mg/L MN DOH Cancer Classificat on (CC) 2B no units WHO IARC Cancer Classificat on (CC) Female.Mice P no units HHSNTP Cancer Classificat on (CC) Female.Rats P no units HHSNTP Cancer Classificat on (CC) Male.Mice P no units HHSNTP Cancer Classificat on (CC) Male.Rats P no units HHSNTP Data Element Value Units Source Notes Modeled Data LD50 0.0335738 mo l/kg TEST QSAR Ames mutagenicity test 0.069 no units TEST QSAR Developmental toxin test 0.408 no units TEST QSAR Data Element Value Units Source Notes Measured Data and Assessment Results LD50 2000 mg/kg NIH HSDB min LD50 5700 mg/kg NIH HSDB max Percent of active toxcast in 0.85 percent EPA Chemistry Dashboard vitro assays tested TD50 40.5 mg/kg/day NIH CPDB min TD50 71900 mg/kg/day NIH CPDB max Notes: Highlighted data indicate value was used in attribute scoring. Blan k fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. A-28 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 1,4-Dioxane CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 4,915 1.077 Sites 22 0.07 0.17 0.93 34 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 1.406 8 Sites 0.57 0.568 1.83 16.5 18.9 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 51 5 Sites 9.8 0.568 2.06 17.6 18.9 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 1.355 3 Sites 0.22 0.9 1.83 3.06 3.58 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) 24 617,134 Chemical Data Reporting (CDR) Results (EPA) (2016) 1M - 10M Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Finished) 2006 - 2020 42 18 Sites 43 0.5 1.5 3.2 9.1 ug/L Drinking Water Monitoring Data - MA (Finished) 2006 - 2020 10 8 Sites 80 0.0081 0.2 0.51 1.1 ug/L Community Water System Survey (CWSS) (Finished) [178] 2006 1 NA Sites 0.8 1.4 ug/L Ambient Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Source) 2006 - 2020 274 67 Sites 24 0.27 2 5.9 36 ug/L Drinking Water Monitoring Data - MA (Source) 2006 - 2020 6 5 Sites 83 0.0272 0.24 1.3 3.5 ug/L National Water Information System (USGS NWIS) (Surface Water) 2008-2017 114 16 Sites 14 0.124 1.32 6.94 15.9 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008-2017 955 105 Sites 11 0.083 3.3 7.6 36 ug/L National Water Information System (USGS NWIS) (All Water) 2008-2017 1,068 121 Sites 11 0.083 3.2 7.6 36 ug/L Community Water System Survey (CWSS) (Ambient) [178] 2006 1 NA Sites 0.9 1.3 ug/L Bradley etal. 2017 (Ambient) [52] 2012-2014 38 4 Sites 11 0.7226 0.987 2.77 3.537 ug/L Arnold et al. 2016 (Unfiltered) [7] 2012-2013 527 2 Sites 0.38 1 1.5 1.9 2 ug/L Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 0.0000011 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) < LOD ng/ml NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 10.227 days Boiling point OPERA QSAR 101.678 degree C Boiling point TEST QSAR 99.984 degree C Vapor pressure OPERA QSAR 41.0426 mmHg Vapor pressure TEST QSAR 46.9894 mmHg Solubility in water OPERA QSAR 11.2319 mol/L Solubility in water TEST QSAR 4.7863 mol/L Bioconcentration factor OPERA QSAR 0.779115 no units Bioconcentration factor TEST QSAR 1.49968 no units Henry's Law constant OPERA QSAR 0.0000147 o E E 0 eta no l/water partitioning coeff. (log Kow) OPERA QSAR -0.200282 no units A-29 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 1,4-Dioxane CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 30 ATSDR. 2012. Toxicological Profile for 1,4-Dioxane. U.S. Department of Health and Human Services, Public Health Service, Agency for Toxic Substances and Disease Registry (ATSDR), Atlanta, GA. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 95 HC. 2018. Guideline Technical Document for Public Consultation, 1,4-Dioxane in Drinking Water. Health Canada (HC), Ottawa, Ontario, Canada. 178 USEPA (US Environmental Protection Agency). (2009). 2006 Community Water System Survey. Overview, 57. 308 USEPA. 2010. Chemical Assessment Summary, 1,4-Dioxane. U.S. Environmental Protection Agency, National Center for Environmental Assessment, Integrated Risk Information System (IRIS), Washingtor D.C. 439 WHO. 2005. 1,4-Dioxane in Drinking-water. WHO Guidelines for Drinking-water Quality. World Health Organization (WHO), Geneva, Switzerland. A-30 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 1-Butanol CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: 1-Butanol CASRN: 71-36-3 DTXSID: DTXSID1021740 Use: Paint solvent; chemical intermediate; food additive Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANTSUMMARY& DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT IN FORMATION Potency Severity Prevalence Magnitude 4 non-cancer effects 9 8 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 600 ataxia and hypoactivity general population IRIS 1987 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 9.64712 90th Percentile Finished Water UCMR4 2018-2019 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-31 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 1-Butanol CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.1 mg/kg/day IRIS 1987 USE PA 1986 hypoactivity and ataxia general population 33.8 592 [193] Cancer Classification (CC) D IRIS 1987 [1931 Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Developmental 300 Sitarek, 1994 Reproductive 5654 Ema, 2005 1986-03-01 2020-03-16 4072 2 8 2 Other Health Data Data Element I Value Units 1 Source I Notes Measured Data and Assessment Results Chronic Health-Based Guidance Value 1 0.7 mg/L Imn doh l Data Element Value Units Source Notes Measured Data and Assessment Results LD50 790 mg/kg NIH HSDB Percent of active toxcast in 1.23 percent EPA Chemistry Dashboard vitro assays tested Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Modeled Data LD50 0.0105439 mo l/kg TEST QSAR Ames mutagenicity test 0.112 no units TEST QSAR Developmental toxin test 0.677 no units TEST QSAR A-32 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 1-Butanol CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 OCCURRENCE DATA Scoring_Data_ Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contam nant Monitoring Rule (UCMR) 4 2018-2019 3.689 145 Sites 3.93 2 3.5 9.65 101.5552 Unregulated Contam nant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contam nant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contam nant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contam nant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contam nant Monito ring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survey (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 1.406 0 Sites 0 National Water Qua lity Assessment (USGS NAWQA) (Surface Water) 1991-2017 51 0 Sites 0 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 1.355 0 Sites 0 Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) 46 9,818,559 Chemical Data Reporting (CDR) Results (EPA) (2016) 1B-5B Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Ambient Water Prevalence Magnitude National Water Information System (USGS NWIS) (Surface Water) 2008-2017 43 0 Sites 0 National Water Information System (USGS NWIS) (Groundwater) 2008-2017 1,104 0 Sites 0 National Water Information System (USGS NWIS) (All Water) 2008-2017 1,147 0 Sites 0 Bradley etal. 2017 (Ambient) [52] 2012-2014 38 1 Sites 2.63 5.743 5.74 5.74 5.743 ug/L Arnold et al. 2016 (Unfiltered) [7] 2012-2013 527 0 Sites 0 Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 0.0000587 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR4 data used in the CCL5 is a partial datasetand will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 4.44861 days Boiling point OPERA QSAR 111.366 degree C Boiling point TEST QSAR 118.364 degree C Vapor pressure OPERA QSAR 7.55899 mmHg Vapor pressure TEST QSAR 5.29663 mmHg Solubility in water OPERA QSAR 1.20266 mol/L Solubility in water TEST QSAR 0.626614 mol/L Bioconcentration factor OPERA QSAR 4.82083 no units Bioconcentration factor TEST QSAR 3.34965 no units Henry's Law constant OPERA QSAR 0.00000978 atm-mA3/mol 0 eta no l/water partitioning coeff. (log Kow) OPERA QSAR 0.850878 no units A-33 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 1-Butanol CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 193 USEPA. 1987. Chemical Assessment Summary, n-Butanol. U.S. Environmental Protection Agency, National Center for Environmental Assessment, Integrated Risk Information System (IRIS), Washington, D.C. A-34 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 lH-Benzotriazole, 4(or 5)-methyl- CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: lH-Benzotriazole, 4(or5)-methyl- CASRN: 29385-43-1 DTXSID: DTXSID0026171 Use: In water treatment, corrosion inhibitor for copper and its alloys Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUM MARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT IN FORMATION Potency Severity Prevalence Magnitude 5 non-cancer effects 10 5 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date SL 100 renal proximal tubule regeneration general population MDH 2019 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.9104 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-35 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 lH-Benzotriazole, 4(or 5)-methyl- CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.017 mg/kg/day MDH 2019 JBRC 2007 renal proximal tubule regeneration general population 33.8 101 [148] NOTE: the toxicity value was derived from a surrogate chemical (lH-benzotriazole) Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review 2020-03-13 86 1 2 0 Other Health Data Measured Data and Assessment Results Data Element Value Units Source Notes Measured Data and Assessment Results LD50 800 mg/kg NIH HSDB Percent of active toxcast in 5.14 percent EPA Chemistry Dashboard vitro assays tested Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. Data Element Value Units Source Notes PECO = Population, Exposure, Comparator, Outcome. Modeled Data LD50 TEST QSAR Ames mutagenicity test TEST QSAR Developmental toxin test TEST QSAR A-36 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 lH-Benzotriazole, 4(or 5)-methyi- CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev(NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 557 62 Sites 11 0.00672 0.242 0.91 4.17 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 75 51 Sites 68 0.00672 0.256 0.912 4.17 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 482 11 Sites 2.28 0.0284 0.0506 0.366 2.98 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) 1M - 10M Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Bradley et al. 2018 (Finished) [53] 2016 26 3 Sites 12 0.0130716 0.0333 0.0352 0.0357109 ug/L Ambient Water Prevalence Magnitude Bradley etal. 2017 (Ambient) [52] 2012-2014 38 20 Sites 53 0.0213052 0.664 2.33 4.6612843 ug/L Waste Water Effluent Prevalence Magnitude Scott et al. 2018 (Wastewater) [161] 2011-2017 21 20 Sites 95 0.1313613 1.36 9.3 27.69201 ug/L Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/ day) Notes Expocast exposure 0.000000337 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR4 data used in the CCL5 is a partial datasetand will be complete in Dec. 2020. A-37 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 lH-Benzotriazole, 4(or 5)-methyl- CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 53 Bradley, P. M., Kolpin, D. W., Romanok, K. M., Smalling, K. L., Focazio, M. J., Brown, J. B.,... & Dietze, J. E. (2018). Reconnaissance of mixed organic and inorganic chemicals in private and public supply tapwaters at selected residential and workplace sites in the United States. Environmental science & technology, 52(23), 13972-13985. 148 MDH. 2019. Toxicological Summary for: Tolyltriazole and 5-Methyl-lH-Benzotriazole. Health Based Guidance for Water. Minnesota Department of Health (MDH), Environmental Health Division, Health Risk Assessment Unit, St Paul, MN. 161 Scott, T. M., Phillips, P. J., Kolpin, D. W., Colella, K. M., Furlong, E. T., Foreman, W. T., & Gray, J. L. (2018). Pharmaceutical manufacturing facility discharges can substantially increase the pharmaceutical load to US wastewaters. Science of the Total Environment, 636, 69-79. A-38 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 17-alpha-Ethynyl estradiol CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: 17-alpha-Ethynyl estradiol CASRN: 57-63-6 DTXSID: DTXSID5020576 Use: Pharmaceutical, hormone Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro X Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANTSUMMARY& DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT IN FORMATION Potency Severity Prevalence Magnitude 10 reproductive and developmental effects 4 1 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value («"gA) Critical Effect Target Pop. Assessment Assessment Pub. Date SL 0.00007 lowest therapeutic dose: synthetic estrogen for birth control bottle-fed infants FDA; NIH 2018; 2018 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.001452 90th Percentile Finished Water UCMR3 2013-2015 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-39 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 17-alpha-Ethynyl estradiol CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDW and OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg- HRL (ug/L) Assessment Full Citation Notes Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg- CCL Screening Level (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 1.04167E-08 mg/kg/day FDA 2018; NIH 2018 Allergan, Inc. 2017 lowest theraputic dose: synthetic estrogen for birth control bottle-fed infants 151 6.94e-05 [77] [150] NOTE: (LowestTherapeutic Dose/3000x UF) is used in place of an RfD; LTDs were obtained from FDA-approved Reference Dose (RfD) or Equivalent 1.04167E-08 mg/kg/day FDA 2018; NIH 2018 Allergan, Inc. 2017 lowest theraputic dose: synthetic estrogen for birth control general population 33.8 0.000245 [77] [150] NOTE: (LowestTherapeutic Dose/3000x UF) is used in place of an RfD; LTDs were obtained from FDA-aooroved Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title- abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Acute Health-Based Guidance Value 0.0000005 mg/L MN DOH Chronic Health-Based Guidance Value 0.0000002 mg/L MN DOH Maximum Recommended Daily Dose 0.0005 mg/kg/day FDA Screening level for pharmaceutical - general population 0.000000245 mg/L EPA Office of Water Screening level for pharmaceutical - infants 6.94E-08 mg/L EPA Office of Water Sh ort-T erm/SubchronicHealth-Based Guidance Value 0.0000002 mg/L MN DOH Cancer Classification (CC) Female.Rats no units HHS NTP Cancer Classification (CC) Male.Rats EE no units HHS NTP Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Measured Data and Assessment Results LD50 1200 mg/kg NIH HSDB min LD50 5000 mg/kg NIH HSDB max Percent of active toxcast in vitro assavs tested 28 percent EPA Chemistry Dashboard Data Element Value Units Source Notes Modeled Data LD50 0.00798 mol/kg TEST QSAR Ames mutagenicity test 0 no units TEST QSAR Developmental toxin test 1 no units TEST QSAR A-40 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 17-alpha-Ethynyl estradiol CCL5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDWand OST Nationally Representative Water Data Date Number of Number of PWS/Sites/ Percent with Minimum Cone. Median Cone. 90th Percentile Maximum Cone. Cone. Units Notes PWS/ Sites/ Samples Detects Samples Detects (Detects) (Detects) (Detects) (Detects) Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018 - 2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013 - 2015 1,201 4 Sites 0.33 0.0011 0.0012 0.00145 0.00156 ug/L Unregulated Contaminant Monitoring Rule (UCMR) 2 2008 - 2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monito ring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survey (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991 - 2017 581 2 Sites 0.34 0.00066 0.000705 0.000732 0.00075 ug/L National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991 - 2017 33 1 Sites 3.03 0.00075 0.00075 0.00075 0.00075 ug/L National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991 - 2017 548 1 Sites 0.18 0.00066 0.00066 0.00066 0.00066 us/L PesticideApplication Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Drinking Water Monitoring Data -CA (Finished) 2006 - 2020 1 0 Sites 0 Furlong et al 2017 (Finished) [83] 2007 - 2012 NA NA Sites 0 ug/L Glassmeyer et al 2017 (Finished) [86] 2007 - 2012 25 NA Sites 0 ug/L USGS, Sioux Falls Area, 2012 (Finished) [153] 2009 - 2010 1 0 Sites 0 Ambient Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Source) 2006 - 2020 1 0 Sites 0 National Water Information System (USGS NWIS) (Surface Water) 2008 - 2017 255 5 Sites 1.96 0.00056 0.00121 0.00164 0.0017 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008 - 2017 353 1 Sites 0.28 0.00647 0.00647 0.00647 0.00647 ug/L National Water Information System (USGS NWIS) (All Water) 2008 - 2017 608 6 Sites 0.99 0.00056 0.00139 0.00361 0.00647 ug/L Furlong et a 12017 (Ambient) [83] 2007 - 2012 NA NA Sites 0 ug/L Glassmeyer et a 12017 (Ambient) [86] 2007 - 2012 25 NA Sites 0 ug/L Bradley et a 1. 2017 (Ambient) [52] 2012 - 2014 38 1 Sites 2.63 0.000884 0.000884 0.000884 0.000884 ug/L Bexfield et al. 2019 (Groundwater) [49] 2013 - 2015 1,091 0 Sites 0 USGS, Sioux Falls Area, 2012 (Ambient) [153] 2009 - 2010 2 0 Sites 0 Benotti et al. (2009) via Kostich et al. 2010 (Ambient) [127] 2010 NA NA 0.0014 ug/L Huang et al. (2001) via Kostich et al. 2010 (Ambient) [127] 2010 NA NA 7e-05 ug/L Kolpin et al. (2002) via Kostich et al. 2010 (Ambient) [127] 2010 NA NA 0.273 ug/L Zuo et al. (2006) via Kostich et al. 2010 (Ambient) [127] 2010 NA NA 0.0047 ug/L Waste Water Effluent Prevalence Magnitude Scott et al. 2018 (Wastewater) [161] 2011 - 2017 21 5 Sites 24 0.00053 0.00145 0.0018 0.00182 ug/L Auriol et al. (2008) via Kostich et al. 2010 (Wastewater) [127] 2010 NA NA 0.006 ug/L Chimchirian et al. (2007) via Kostich et al. 2010 (Wastewater) [127] 2010 NA NA 0.0012 ug/L Huang et al. (2001) via Kostich et al. 2010 (Wastewater) [127] 2010 NA NA 0.0024 ug/L Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 3.38E-08 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR4 data used in the CCL5 is a partial data set and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Value Units Notes Biodegradation half-life OPERA QSAR 58.463 days Boiling point OPERA QSAR 390.506 degree C Boiling point TEST QSAR 383.097 degree C Vapor pressure OPERA QSAR 7.41E-10 mmHg Vapor pressure TEST QSAR 1.27E-08 mmHg Solubility in water OPERA QSAR 0.0000399 mol/L Solubility in water TEST QSAR 0.0000126 mol/L Bioconeentration factor OPERA QSAR 120.559 no units Bioconeentration factor TEST QSAR Henry's Law constant OPERA QSAR 9.14E-08 atm-mA3/mol Qctanol/water partitioning coeff. (log Kow) OPERA QSAR 3.66688 no units A-41 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 17-alpha-Ethynyl estradiol CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 49 Bexfield, L.M., P.L. Toccalino, K. Belitz, W.T. Foreman, and E.T. Furlong. 2019. Hormones and pharmaceuticals in groundwater used as a source of drinking water across the United States. Environmental Science and Technology 53: 2950-2960. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 77 FDA. 2018. Drugs @ FDA: FDA Approved Drug Products. U.S. Food and Drug Administration (FDA), https://www.accessdata.fda.gov/scripts/cder/daf/. 83 Furlong, E.T., Batt, A.L., Glassmeyer, S.T., Noriega, M.C., Kolpin, D.W., Mash, H., Schenck, K.M. (2017). Nationwide reconnaissance of contaminants of emerging concern in source and treated drinking waters of the United States: Pharmaceuticals. Science of The Total Environment. 579 (1629-1642). 86 Glassmeyer, S.T., Furlong, E.T., Kolpin, D.W., Batt, A.L., Benson, R., Boone, J.S.,... & Wilson, V.S. (2017). Nationwide reconnaissance of contaminants of emerging concern in source and treated drinking waters of the United States. Science of The Total Environment. v581-582, (909-922). 127 Kostich, MS, etal., 2010. Predicting variability of aquatic concentrations of human pharmaceuticals. Sci. Total Environ. 408 (20), 4504e4510. 150 NIH. 2018. DailyMed Database. U.S. National Library of Medicine, National Institutes of Health (NIH). https://dailymed.nlm.nih.gov/dailymed/. 153 Occurrence of anthropogenic organic compounds and nutrients in source and finished water in the Sioux Falls area, South Dakota, 2009-10: U.S. Geological Survey Scientific Investigations Report 2012-5098, 21 p. plus appendixes. 161 Scott, T. M., Phillips, P. J., Kolpin, D. W., Colella, K. M., Furlong, E. T., Foreman, W. T., & Gray, J. L. (2018). Pharmaceutical manufacturing facility discharges can substantially increase the pharmaceutical load to US wastewaters. Science of the Total Environment, 636, 69-79. A-42 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 17-beta-Estradiol CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: 17-beta-Estradiol CASRN: 50-28-2 DTXSID: DTXSID0020573 Use: Pharmaceutical, hormone Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro X Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 9 non-cancer effects 3 1 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date SL 0.03 lowest therapeutic dose: hormone therapy; hy poest roge n is m, t reatme nt of va somoto r symptoms associated with menopause, etc bottle-fed infants FDA; NIH 2018; 2018 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.000886 90th Percentile Finished Water UCMR3 2013-2015 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-43 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 17-beta-Estradiol CCL 5 Contaminant Information Sheet EPA-OGWDWand OST October 2022 HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 4.16667E-06 mg/kg-day FDA 2018; NIH 2018 Epic Pharma, LLC lowest therapeutic dose: hormone therapy, treatment of symptoms associated with menopause, hypoestrogenism, etc bottle-fed infants 151 0.03 [77] [150] NOTE: (Lowest Therapeutic Dose/3000x UF) is used in place of an RfD; LTDs were obtained from FDA-approved drug labels Reference Dose (RfD) or Equivalent 4.16667 E-06 mg/kg-day FDA 2018; NIH 2018 Epic Pharma, LLC lowest therapeutic dose: hormone therapy, treatment of symptoms associated with menopause, hypoestrogenism, etc general population 33.8 0.1 [77] [150] NOTE: (Lowest Therapeutic Dose/3000x UF) is used in place of an RfD; LTDs were obtained from FDA-approved drug labels Cancer Slope Factor (CSF) 39 (mg/kg/day)A-l CALEPA 1992 High man et al. 1980 mammary gland adenocarcinomas general population 33.8 0.0007 [55] Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Cancer Slope Factor (CSF) 39 (mg/kg/day)A-l CalEPA OEHHA Chemical Database Inhalation Unit Risk (IUR) 0.011 ug/mA3 CalEPA OEHHA Chemical Database Maximum Recommended Daily Dose 0.5 mg/kg/day FDA Screening level for pharmaceutical - general population 0.000098 mg/L EPA Office of Water Screening level for pharmaceutical - infants 0.0000278 mg/L EPA Office of Water Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Measured Data and Assessment Results Percent of active toxcast in 22.84 percent EPA Chemistry Dashboard vitro assays tested Data Element Value Units Source Notes Modeled Data LD50 0.0057943 mo l/kg TEST QSAR Ames mutagenicity test 0.33 no units TEST QSAR Developmental toxin test 0.889 no units TEST QSAR A-44 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 17-beta-Estradiol CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 1.201 2 Sites 0.17 4.00E - 04 0.00076 0.000886 0.00091 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 580 2 Sites 0.34 0.00048 0.00051 0.000528 0.00054 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 32 2 Sites 6.25 0.00048 0.00051 0.000528 0.00054 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 548 0 Sites 0 Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Finished) 2006 - 2020 1 0 Sites 0 Glassmeyer et al 2017 (Finished) [86] 2007-2012 25 NA Sites 0 ug/L USGS, Sioux Falls Area, 2012 (Finished) [153] 2009-2010 1 0 Sites 0 Ambient Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Source) 2006 - 2020 2 0 Sites 0 National Water information System (USGS NWIS) (Surface Water) 2008-2017 255 14 Sites 5.49 9.00E - 05 0.00094 0.00242 0.00388 ug/L National Water information System (USGS NWIS) (Groundwater) 2008-2017 382 4 Sites 1.05 0.00179 0.00439 0.0063 0.0065 ug/L National Water information System (USGS NWIS) (All Water) 2008-2017 637 18 Sites 2.83 9.00E - 05 0.00148 0.0043 0.0065 ug/L Glassmeyer et a 1 2017 (Ambient) [86] 2007-2012 25 NA Sites 0 ug/L Bradley et al. 2017 (Ambient) [52] 2012-2014 38 5 Sites 13 0.000325 0.000616 0.00202 0.002354 ug/L Bradley et al. 2017 (Ambient) [52] 2012-2014 38 3 Sites 7.89 0.00071 0.00086 0.00153 0.0017 ug/L Bexfield et al. 2019 (Groundwater) [49] 2013-2015 1,091 0 Sites 0 USGS, Sioux Falls Area, 2012 (Ambient) [153] 2009-2010 2 0 Sites 0 Waste Water Effluent Prevalence Magnitude Scott et al. 2018 (Wastewater) [161] 2011-2017 21 5 Sites 24 0.000707 0.00119 0.0088 0.008934 ug/L Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 0.000000032 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 58.4157 days Boiling point OPERA QSAR 372.709 degree C Boiling point TEST QSAR 378.806 degree C Vapor pressure OPERA QSAR 3.41E-10 mmHg Vapor pressure TEST QSAR 2.03E-08 mmHg Solubility in water OPERA QSAR 0.0000158 mol/L Solubility in water TEST QSAR 0.000047 mol/L Bioconcentration factor OPERA QSAR 33.8438 no units Bioconcentration factor TEST QSAR 160.694 no units Henry's Law constant OPERA QSAR 0.00000853 atm-mA3/mol 0 eta no l/water partitioning coeff. (log Kow) OPERA QSAR 3.90759 no units A-45 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 17-beta-Estradiol CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 49 Bexfield, L.M., P.L. Toccalino, K. Belitz, W.T. Foreman, and E.T. Furlong. 2019. Hormones and pharmaceuticals in groundwater used as a source of drinking water across the United States. Environmental Science and Technology 53: 2950-2960. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 55 CalEPA. 1992. Expedited Cancer Potency Values and Proposed Regulatory Levels for Certain Proposition 65 Carcinogens. California Environmental Protection Agency (CalEPA), Office of Environmental Health Hazard Assessment, Reproductive and Cancer Hazard Assessment Section, Sacramento, CA. 77 FDA. 2018. Drugs @ FDA: FDA Approved Drug Products. U.S. Food and Drug Administration (FDA), https://www.accessdata.fda.gov/scripts/cder/daf/. 86 Glassmeyer, S.T., Furlong, E.T., Kolpin, D.W., Batt, A.L., Benson, R., Boone, J.S.,... & Wilson, V.S. (2017). Nationwide reconnaissance of contaminants of emerging concern in source and treated drinking waters of the United States. Science of The Total Environment. v581-582, (909-922). 150 NIH. 2018. DailyMed Database. U.S. National Library of Medicine, National Institutes of Health (NIH). https://dailymed.nlm.nih.gov/dailymed/. 153 Occurrence of anthropogenic organic compounds and nutrients in source and finished water in the Sioux Falls area, South Dakota, 2009-10: U.S. Geological Survey Scientific Investigations Report 2012-5098, 21 p. plus appendixes. 161 Scott, T. M., Phillips, P. J., Kolpin, D. W., Colella, K. M., Furlong, E. T., Foreman, W. T., & Gray, J. L. (2018). Pharmaceutical manufacturing facility discharges can substantially increase the pharmaceutical load to US wastewaters. Science of the Total Environment, 636, 69-79. A-46 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 2-(2-Methyl-4-chlorophenoxy)propionic acid (MCPP) CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: 2-(2-Methyl-4-chlorophenoxy)propionic acid (MCPP) CASRN: 93-65-2 DTXSID: DTXSID9024194 Use: Herbicide Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANTSUMMARY& DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 5 non-cancer effects 2 1 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 200 increased kidney weights and chronic nephropathy general population OPP 2019 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 8 EDWC SW 30-Year Mean OPP 2019 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-47 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 2-(2-Methyl-4-chlorophenoxy)propionic acid (MCPP) CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.04 mg/kg/day OPP 2019 Mellert et al. 1996, 1999 increased kidney weights and chronic nephropathy general population 33.8 237 [419] Cancer Classification (CC) S OPP 2019 [4191 Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element I Value Units I Source I Notes Measured Data and Assessment Results Drinking Water Guideline Value I 0.01 mg/L | WHO Drinking Water Quality Guidelines | Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Measured Data and Assessment Results LD50 1210 mg/kg NIH HSDB max LD50 369 mg/kg NIH HSDB min LOAEL 125 mg/kg/day EPA Toxicity Reference Database max LOAEL 50 mg/kg/day EPA Toxicity Reference Database min NOAEL 10 mg/kg/day EPA Toxicity Reference Database min NOAEL 50 mg/kg/day EPA Toxicity Reference Database max Percent of active toxcast in 1.16 percent EPA Chemistry Dashboard vitro assays tested Subchronic LOAEL 9 mg/kg/day EPA Toxicity Reference Database Subchronic NOAEL 3 mg/kg/day EPA Toxicity Reference Database Data Element Value Units Source Notes Modeled Data LD50 0.0039355 mo l/kg TEST QSAR Ames mutagenicity test 0.046 no units TEST QSAR Developmental toxin test 0.691 no units TEST QSAR A-48 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 2-(2-Methyl-4-chlorophenoxy)propionic acid (MCPP) CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev(NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 Pesticide Application Data Number of States Amount Applied (lbs/year) Date Estimated Annual Agricultural Pesticide Use (USGS) 2 2,823 2016 Toxic Release Data Number of States Amount Released (lbs/year) Toxic Release Inventory (TRI) Program (EPA) (2016) 6 254 Chemical Production Data Production Volume (lbs/year) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude USDA Pesticide Data Program (PDP) (Finished) 2001-2013 12 6 Sites 50 0.00052 0.0012 0.00443 0.19 ug/L Ambient Water Prevalence Magnitude USDA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001-2013 229 27 Sites 12 0.00052 0.0014 0.014 0.16 ug/L USDA Pesticide Data Program (PDP) (Groundwater) 2001-2013 218 21 Sites 9.63 0.00052 0.0027 0.0708 0.139 ug/L USDA Pesticide Data Program (PDP) (Untreated) 2001-2013 12 6 Sites 50 0.00052 0.0013 0.012 0.16 ug/L Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990-2018 107 0 Sites 0 Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Estimated Drinking Water Concentration (EDWC) in Surface Water, 30-Year Mean 2019 OPP 8 ug/L Pesticide in Water Calculator (PWC), vl.52 The modeled surface water 30-year mean concentration provided by the most recent available EPA OPP health assessment was selected as the occurrence concentration for MCPP. This value coincides with the critical effect of chronic nephropathy provided Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 7.16E-08 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 3.5293 days Boiling point OPERA QSAR 296.689 degree C Boiling point TEST QSAR 312.482 degree C Vapor pressure OPERA QSAR 0.00000159 mmHg Vapor pressure TEST QSAR 0.0000131 mmHg Solubility in water OPERA QSAR 0.00184223 mol/L Solubility in water TEST QSAR 0.00348337 mol/L Bioconcentration factor OPERA QSAR 3.69239 no units Bioconcentration factor TEST QSAR 5.52077 no units Henry's Law constant OPERA QSAR 1.62E-09 atm-mA3/mol 0 eta no 1/water partitioning coeff. (log Kow) OPERA QSAR 3.05172 no units A-49 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 2-(2-Methyl-4-chlorophenoxy)propionic acid (MCPP) CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 419 USEPA. 2019. Mecoprop-p (MCPP-p): Acute, and Chronic Aggregate Dietary (Drinking Water Only) Exposure and Risk Assessments for the Registration Review Risk Assessment. EPA-HQ-OPP-2014-0361- 0021. DP No. D452571. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticide in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. A-50 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 2,4-DB CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 CONTAMINANT IDENTIFYING INFORMATION Name: 2,4-DB CASRN: 94-82-6 DTXSID: DTXSID7024035 Use: Post-emergent herbicide Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neurotoxicants Neurodev. Disruptors Androgen Receptors in vitro Compounds with neurodev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 4 reproductive and developmental effects 10 7 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value ("g/L) Critical Effect Target Pop. Assessment Source Assessment Pub. Date HRL 800 increased early resorptions; decreased body weight, increased kidney weight, increased incidence of tubular degeneration in females women of child bearing age OPP 2018 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished or Ambient (F W, SW, GW, WW) Source Date 318.68 EDWC SW (acute) OPP 2018 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS RD1 RD 2 RD 3 Not Applicable Not Applicable Not Applicable Basis Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-51 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 2,4-DB CCL5ContaminantlnformationSheet E PA-OG WDW a n d OST Octo be r 2022 HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Qtation Notes Reference Dose (RfD) or Equivalent 0.15 mg/kg/day OPP 2018 Henwood 1990a and b increased early resorptions; decreased body weight, increased kidney weight, increased incidence of tubular degeneration in females women of child bearing age 35.4 847 [393] Cancer Classification (CC) NL OPP 2018 [393] Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Titie-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Acute Human Health Benchmark 20 mg/L EPA HHBP Acute PAD 0.6 mg/kg/day EPA HHBP Chronic Human Health Benchmark 0.2 mg/L EPA HHBP Drinking Water Guideline Value 0.09 mg/L WHO Drinking Water Quality Guidelines Health-Based Screening Level 0.2 mg/L Health-based screening levels from USGS Population-Adjusted Dose (PAD) 0.03 mg/kg/day EPA HHBP Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element | Value | Units | Source | Notes Measured Data and Assessment Results LD50 400 mg/kg NIH HSDB min LD50 700 mg/kg NIH HSDB max LOAEL 125 mg/kg/day EPATox city Reference Database max LOAEL 30 mg/kg/day EPA Tox city Reference Database min NOAEL 3 mg/kg/day EPA Tox city Reference Database min NOAEL 62.5 mg/kg/day EPA Tox city Reference Database max Percent of active toxcast in 2.6 percent EPA Chemistry Dashboard Subchronic LOAEL 25 mg/kg/day EPATox city Reference Database min Subchronic LOAEL 50 mg/kg/day EPA Tox city Reference Database max Subchronic NOAEL 15.8 mg/kg/day EPA Tox city Reference Database max Subchronic NOAEL 4.96 mg/kg/day EPA Tox city Reference Database min Data Element Value Units Source Notes Modeled Data LD50 0.0027227 mo l/kg TEST QSAR Ames mutagenicity test 0.07 no units TEST QSAR Developmental toxin test 0.701 no units TEST QSAR A-52 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 2,4-DB CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 OCCURRENCE DATA Scorin£Data_ Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR)4 2018 - 2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008 - 2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survey (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991 - 2017 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991 - 2017 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991 - 2017 Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) 46 1,445,891 2016 Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting(CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Finished) 2006 - 2020 60 0 Sites 0 US DA Pesticide Data Program (PDP) (Finished) 2001 - 2013 12 1 Sites 8.33 0.023 0.023 0.023 0.023 ug/L Ambient Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Source) 2006 - 2020 620 1 Sites 0.16 6.2 6.2 6.2 6.2 ug/L National Water Information System (USGS NWIS) (Surface Water) 2008 - 2017 206 3 Sites 1.46 0.01 0.03 0.1 0.13 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008 - 2017 554 0 Sites 0 National Water Information System (USGS NWIS) (All Water) 2008 - 2017 760 3 Sites 0.39 0.01 0.03 0.1 0.13 ug/L USDA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001 - 2013 229 0 Sites 0 US DA Pesticide Data Program (PDP) (Groundwater) 2001 - 2013 219 0 Sites 0 USDA Pesticide Data Program (PDP) (Untreated) 2001- 2013 12 0 Sites 0 Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990 - 2018 212 4 Sites 1.89 0.22 0.57 0.948 1.08 ug/L Bradley et al. 2017 (Ambient) [52] 2012 - 2014 38 2 Sites 5.26 0.0281 0.0768 0.116 0.1255 ug/L Arnold et al. 2016 (Filtered) [7] 2012 - 2013 106 0 Sites 0 USGS, McKenzie River, Oregon, 2012 (Ambient) [158] 2002 - 2010 125 14 Samples 11 0.1 ug/L Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Estimated Drinking Water Concentration (EDWC) in Surface Water (acute) 2018 OPP 318.68 ug/L Pesticide Root Zone Model (PRZM) v3.12, Exposure Analysis Modeling System (EXAMS), v2.98.04 The critical effect of increased early resorptions is considered a less-than-chronic response seen during gestation. To be protective of pregnant women and fetuses, the modeled surface water acute concentration found in the most recent available EPA OPP health assess men was selected as the occurrence concentration for 2,4-dichlorophenoxybutyric acid. Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg- Notes Expocast exposure 9.69E-08 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES bio monitoring detect ion n serum (1999-2016) NHANES biomonitoring detection n blood (1999-2016) NHANES bio monitoring detect ion n urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biode gradation ha If-life OPERA QSAR 3.53603 days Boiling point OPERA QSAR 320.542 degree C Boiling point TEST QSAR 321.218 degree C Vapor pressure OPERA QSAR 0.000000498 mmHg Vapor pressure TEST QSAR 0.000011 mmHg Solubility in water OPERA QSAR 0.000375647 mol/L Solubility in water TEST QSAR 0.00034435 mol/L Bioconcentration factor OPERA QSAR 3.46701 no units Bioconcentration factor TEST QSAR 15.5597 no units Flenry's Law constant OPERA QSAR 1.43E-09 atm-mA3/mol Octanol/water partitioning coeff. (log Kow) OPERA QSAR 3.38207 no units A-53 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 2,4-DB CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water- Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 158 Reconnaissance of Land-Use Sources of Pesticides in Drinking Water, McKenzie River, Oregon. U.S. Geological Survey Scientific Investigations Report 2012-5091,46 p. plus appendixes. 393 USEPA. 2018. 2,4-DB: Draft Human Health Risk Assessment in Support of Registration Review. EPA-HQ-OPP-2013-0661-0019. DP No. D448826. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticides in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. A-54 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 2,4-Dichlorophenol CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 CONTAMINANT IDENTIFYING INFORMATION Name: 2,4-Dichlorophenol CASRN: 120-83-2 DTXSID: DTXSID1020439 Use: Biocide; intermediate in production of herbicides Chemical Notes: Is the contaminant on any lists? CERCLA X FIFRA X Human Neurotoxicants Pub Med Neurotoxicants Neurodev. Disruptors Androgen Receptors in vitro Compounds with neurodev effects, Mundy et al 2015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 6 non-cancer effects 1 1 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value ("g/L) Critical Effect Target Pop. Assessment Source Assessment Pub. Date HRL 20 decreased delayed hypersensitivity response general population IRIS 1987 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished or Ambient (F W, SW, GW, WW) Source Date 5 90th Percentile All Ambient Water NWIS 2008-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS RD1 RD 2 RD 3 Not Applicable Not Applicable Not Applicable Basis Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-55 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 2,4-Dichlorophenol CCL5ContaminantlnformationSheet E PA-OG WDW a n d OST Octo be r 2022 HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Qtation Notes Reference Dose (RfD) or Equivalent 0.1 mg/kg/day HC 1987 Kobayashi et al., 1972 changes in liver histopathology general population 33.8 592 [98] Reference Dose (RfD) or Equivalent 0.003 mg/kg/day IRIS 1987 Exon and Kollerl985 decreased delayed hypersensitivity response general population 33.8 17.8 [189] Cancer Classification (CC) NL PPRTV 2007 [280] ATSDR1999 [14] Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Titie-abstract Screen No. PECO Relevant Studies passed full-text review 2006-07-01 2020-03-25 630 1 23 0 Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results 10-day Health Advisory 0.03 mg/L EPA DWSHA 2018 Chronic Health-Based Guidance Value 0.02 mg/L MNDOH Human Health Ambient Water Quality Criteria 0.01 mg/L EPA Human Health Criteria for CWA Intermediate Minimal Risk Level (MRL) 0.003 mg/kg/day CDC ATSDR Lifetime Health Advisory 0.02 mg/L EPA DWSHA 2018 Maximum Allowable Concentration (MAC) 0.9 mg/L Canadian Drinking Water Guidelines Subchronic Provisional RfD 0.02 mg/kg/day EPA PPRTV Cancer Classification (CC) Female.Mice NE no units HHS NTP Cancer Classification (CC) Female.Rats NE no units HHS NTP Cancer Classification (CC) Male.Mice NE no units HHS NTP Cancer Classification (CC) Male.Rats NE no units HHS NTP Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Measured Data and Assessment Results LD50 2050 mg/kg NIH HSDB max LD50 500 mg/kg NIH HSDB min LOAEL 543 mg/kg/day EPA Toxicity Reference Database min LOAEL 768 mg/kg/day EPA Toxicity Reference Database max NOAEL 194 mg/kg/day EPA Toxicity Reference Database Percent of active toxcast in 3.99 percent EPA Chemistry Dashboard vitro assays tested TD50 12400 mg/kg/day NIHCPDB min TD50 458000 mg/kg/day NIHCPDB max Data Element Value Units Source Notes Modeled Data LD50 0.0039355 mo l/kg TEST QSAR Ames mutagenicity test 0.015 no units TEST QSAR Developmental toxin test 0.176 no units TEST QSAR A-56 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 2,4-Dichlorophenol CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contam nant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contam nant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contam nant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contam nant Monitoring Rule (UCMR) 1 2001 - 2003 294 0 Sites 0 Unregulated Contam nant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contam nant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev(NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 22 0 Sites 0 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 13 0 Sites 0 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 9 0 Sites 0 Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) 5 34,293 Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Finished) 2006 - 2020 6 0 Sites 0 Ambient Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Source) 2006 - 2020 36 0 Sites 0 National Water Information System (USGS NWIS) (Surface Water) 2008-2017 148 25 Sites 17 0.01 0.03 5 5 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008-2017 392 8 Sites 2.04 0.01 0.02 1.88 18 ug/L National Water Information System (USGS NWIS) (All Water) 2008-2017 540 33 Sites 6.11 0.01 0.03 5 18 ug/L Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg Notes Expocast exposure 0.000000499 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) 3 ug/l Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicatethere were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 4.02586 days Boiling point OPERA QSAR 211.815 degree C Boiling point TEST QSAR 237.218 degree C Vapor pressure OPERA QSAR 0.0785496 mmHg Vapor pressure TEST QSAR 0.0280543 mmHg Solubility in water OPERA QSAR 0.0237665 mol/L Solubility in water TEST QSAR 0.00864968 mol/L Bioconcentration factor OPERA QSAR 18.2343 no units Bioconcentration factor TEST QSAR 57.4116 no units Henry's Law constant OPERA QSAR 0.00000133 atm-mA3/mol 0 eta no 1/water partitioning coeff. (log Kow) OPERA QSAR 3.04309 no units A-57 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 2,4-Dichlorophenol CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 14 ATSDR. 1999. Toxicological Profile for Chlorophenols. U.S. Department of Health and Human Services, Public Health Service, Agency for Toxic Substances and Disease Registry (ATSDR), Atlanta, GA. 98 Health Canada. 1987. Guideline Technical Document - Chlorophenols. Health Canada (HC), Water and Air Quality Bureau, Healthy Environments and Consumer Safety Branch, Ottawa, Ontario, Canada. 189 USEPA. 1987. Chemical Assessment Summary, 2,4-Dichlorophenol. U.S. Environmental Protection Agency, National Center for Environmental Assessment, Integrated Risk Information System (IRIS), Washington, D.C. 280 USEPA. 2007. Provisional Peer-Reviewed Toxicity Values for 2,4-Dichlorophenol. U.S. Environmental Protection Agency, Office of Research and Development, National Center for Environmental Assessment, Superfund Health Risk Technical Support Center, Cincinnati, OH. A-58 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 2,4-Dinitrophenol CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: 2,4-Dinitrophenol CASRN: 51-28-5 DTXSID: DTXSID0020523 Use: Chemical Notes: Is the contaminant on any lists? CERCLA X FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts X Neu rode v. Disruptors Androgen Receptors in vitro X Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUM MARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT IN FORMATION Potency Severity Prevalence Magnitude 6 non-cancer effects 1 1 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 10 lowest therapeutic dose in humans taking 2,4 dinitrophenol; cataracts were observed in patients receiving as little as 2 mg/kg/day, the lower range of the recommended therapeutic dose general population IRIS 2005 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 26.3 90th Percentile All Ambient Water NWIS 2008-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-59 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 2,4-Dinitrophenol CCL 5 Contaminant Information Sheet EPA-OGWDWand OST October 2022 HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.002 mg/kg/day IRIS 2005 Horner, 1942 lowest theraputic dose in humans taking 2,4 dinitrophenol; cataracts were observed in patients receiving as little as 2 mg/kg/day, the lower range of the recommended therapeutic dose general population 33.8 11.8 [262] NOTE: CCL screening level based on draft ATSDR (2019 assessment, based on 2008 study) is several orders of mag lower than HRL (based on 2006 assessment, 1942 study) Cancer Classification (CC) I PPRTV 2007 [281] Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.00007 mg/kg/day ATSDR 2019 Caldeira da Silva et al. 2008 decreased body weight bottle-fed infants 151 0.0900 [37] Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review 2010-03-01 2020-04-14 326 1 3 0 Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Acute Minimal Risk Level (MRL) 0.01 mg/kg/day CDC ATSDR Chronic Health-Based Guidance Value 0.01 mg/L MN DOH Human Health Ambient Water Quality Criteria 0.01 mg/L EPA Human Health Criteria for CWA Human Health Ambient Water Quality Criteria 0.01 mg/L EPA Human Health Criteria for CWA Subchronic Provisional RfD 0.02 mg/kg/day EPA PPRTV Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Measured Data and Assessment Results LD50 20 mg/kg NIH HSDB min LD50 72 mg/kg NIH HSDB max Percent of active toxcast in 11.86 percent EPA Chemistry Dashboard vitro assays tested Data Element Value Units Source Notes Modeled Data LD50 0.0002529 mo l/kg TEST QSAR Ames mutagenicity test 0.134 no units TEST QSAR Developmental toxin test 0.554 no units TEST QSAR A-60 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 2,4-Dinitrophenol CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contam nant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contam nant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contam nant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contam nant Monitoring Rule (UCMR) 1 2001 - 2003 294 0 Sites 0 Unregulated Contam nant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contam nant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev(NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 22 0 Sites 0 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 13 0 Sites 0 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 9 0 Sites 0 Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) 2 188,429 Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Ambient Water Prevalence Magnitude National Water Information System (USGS NWIS) (Surface Water) 2008-2017 146 3 Sites 2.05 24 25 26.3 27 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008-2017 358 0 Sites 0 National Water Information System (USGS NWIS) (All Water) 2008-2017 504 3 Sites 0.6 24 25 26.3 27 ug/L Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 6.19E-08 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 4.59079 days Boiling point OPERA QSAR 349.689 degree C Boiling point TEST QSAR 325.528 degree C Vapor pressure OPERA QSAR 0.000270249 mmHg Vapor pressure TEST QSAR 0.0000585 mmHg Solubility in water OPERA QSAR 0.00173025 mol/L Solubility in water TEST QSAR 0.0055847 mol/L Bioconcentration factor OPERA QSAR 4.7119 no units Bioconcentration factor TEST QSAR 2.68534 no units Henry's Law constant OPERA QSAR 9.77E-08 atm-mA3/mol 0 eta no l/water partitioning coeff. (log Kow) OPERA QSAR 1.81096 no units A-61 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 2,4-Dinitrophenol CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 37 ATSDR. 2019.Toxicological Profile for Dinitrophenols DRAFT FOR PUBLIC COMMENT. U.S. Department of Health and Human Services, Public Health Service, Agency for Toxic Substances and Disease Registry (ATSDR), Atlanta, GA. 262 USEPA. 2005. Chemical Assessment Summary 2,4-Dinitrophenol. U.S. Environmental Protection Agency, National Center for Environmental Assessment, Integrated Risk Information System (IRIS), Washington, DC. 281 USEPA. 2007. Provisional Peer-Reviewed Toxicity Values for 2,4-Dinitrotoluene. U.S. Environmental Protection Agency, Office of Research and Development, National Center for Environmental Assessment, Superfund Health Risk Technical Support Center, Cincinnati, OH. A-62 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 2,4-Dinitrotoluene CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: 2,4-Dinitrotoluene CASRN: 121-14-2 DTXSID: DTXSID0020529 Use: Chemical intermediate; in propellants Chemical Notes: Is the contaminant on any lists? CERCLA X FIFRA Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUM MARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT IN FORMATION Potency Severity Prevalence Magnitude 5 carcinogen with linear MOA 1 10 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 0.04 mammary gland tumors (adenomas, fibroadenomas, fibromas, adenocarcinomas/carcinomas) in female rats general population OW 2008 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 333 90th Percentile Finished Water UCMR1 2001 - 2003 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS 2,4-DNT appears to occur infrequently at levels of concern in PWSs. 2,4 DNT was detected only once at a minimum reporting level (MRL) of 2 pg/L in any of the PWSs monitored under the UCMR1 [a]. While the MRL is slightly greater than the HRLof 0.05 pg/L, this concentration is within the acceptable 10-4 to the 10-6 cancer risk range targeted by EPA [b]. USE PA, 2008 [297]; [b] USEPA, 2000 [238]; a [296] cited in USEPA, 2008 Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-63 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 2,4-Dinitrotoluene CCL 5 Contaminant Information Sheet EPA-OGWDWand OST October 2022 HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.001 mg/kg/day ATSDR2016 U.S. Army. 1979; Ellis eta 1.1985 "hematological effects (decreased erythrocyte count)" general population 33.8 5.92 [34] Reference Dose (RfD) or Equivalent 0.002 mg/kg/day OW 2008 Ellis et al., 1979; Ellis eta 1.1985 "neurotoxicity and the presence of Heinz bodies and biliary tract hyperplasia" general population 33.8 11.8 [288] Reference Dose (RfD) or Equivalent 0.002 mg/kg/day IRIS 1992 Ellis et al. 1985 "Neurotoxicity, Heinz bodies and biliary tract hyperplasia" general population 33.8 11.8 [214] Cancer Slope Factor (CSF) 0.667 (mg/kg/day)A-l OW 2008 Ellis et al. 1979 mammary gland tumors (adenomas, fibroadenomas, fibromas, adenocarcinomas/carcinomas) in female rats general population 33.8 0.0444 [288] Cancer Classification (CC) L OW 2008 [288] Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL Lowest LOAEL Study Highest NOAEL Health Highest NOAEL Highest NOAEL Study Start Date of End Date of No. Unique References No. Animal Studies No. Human No. PECO Relevant Studies (mg/kg Effects (mg/kg bw/day) Search Search identified in lit search passed Title-abstract Studies passed passed full-text review bw/day) Screen Title-abstract Screen Hepatic, Systemic 50 Maeda, 2015 Gastrointestinal 100 Maeda, 2015 2015-02-01 2019-12-17 65 1 0 1 Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results 10-day Health Advisory 1 mg/L EPA DWSHA2018 Acute Minimal Risk Level (MRL) 0.05 mg/kg/day CDC ATSDR Cancer Slope Factor (CSF) 0.31 (mg/kg/day) A-1 CalEPA OEHHA Chemical Database Human Health Ambient Water Quality Criteria 0.000049 mg/L EPA Human Health Criteria for CWA Inhalation Unit Risk (IUR) 0.000089 ug/mA3 CalEPA OEHHA Chemical Database Intermediate Minimal Risk Level (MRL) 0.007 mg/kg/day CDC ATSDR Lifetime Health Advisory 0.00005 mg/L EPA DWSHA 2018 Cancer Classification (CC) 2B no units WHO IARC Cancer Classification (CC) Female.Mice N no units HHSNTP Cancer Classification (CC) Female.Rats P no units HHSNTP Cancer Classification (CC) Male.Mice N no units HHSNTP Cancer Classification (CC) Male.Rats P no units HHSNTP Data Element Value Units Source Notes Modeled Data LD50 0.0019724 mo l/kg TEST QSAR Ames mutagenicity test 0.808 no units TEST QSAR Developmental toxin test 0.47 no units TEST QSAR Data Element Value Units Source Notes Measured Data and Assessment Results LD50 1954 mg/kg NIH HSDB max LD50 268 mg/kg NIH HSDB min Percent of active toxcast in 2.69 percent EPA Chemistry Dashboard vitro assays tested TD50 68 mg/kg/day NIH CPDB max TD50 9.35 mg/kg/day NIH CPDB min Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. A-64 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 2,4-Dinitrotoluene CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 OCCURRENCE DATA Scoring_Data_ Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contam nant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contam nant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contam nant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contam nant Monitoring Rule (UCMR) 1 2001 - 2003 3.873 1 Sites 0.03 333 333 333 333 Unregulated Contam nant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contam nant Monito ring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survey (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 22 0 Sites 0 National Water Qua lity Assessment (USGS NAWQA) (Surface Water) 1991-2017 13 0 Sites 0 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 9 0 Sites 0 Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) 6 10,733 Chemical Data Reporting (CDR) Results (EPA) (2016) 25K-100K Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Finished) 2006 - 2020 54 0 Sites 0 Ambient Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Source) 2006 - 2020 265 0 Sites 0 National Water Information System (USGS NWIS) (Surface Water) 2008-2017 160 3 Sites 1.88 4.9 5 5 5 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008-2017 410 0 Sites 0 National Water Information System (USGS NWIS) (All Water) 2008-2017 567 3 Sites 0.53 4.9 5 5 5 ug/L Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 3.63E-08 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR4 data used in the CCL5 is a partial datasetand will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 3.55991 days Boiling point OPERA QSAR 297.386 degree C Boiling point TEST QSAR 304.767 degree C Vapor pressure OPERA QSAR 0.000217133 mmHg Vapor pressure TEST QSAR 0.000676083 mmHg Solubility in water OPERA QSAR 0.00127277 mol/L Solubility in water TEST QSAR 0.000635331 mol/L Bioconcentration factor OPERA QSAR 9.38408 no units Bioconcentration factor TEST QSAR 7.7983 no units Henry's Law constant OPERA QSAR 7.58E-08 o E E Octanol/water partitioning coeff. (log Kow) OPERA QSAR 1.93488 no units A-65 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 2,4-Dinitrotoluene CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 34 ATSDR. 2016. Toxicological Profile for Dinitrotoluenes. U.S. Department of Health and Human Services, Public Health Service, Agency for Toxic Substances and Disease Registry (ATSDR), Atlanta, GA. 214 USEPA. 1992. Chemical Assessment Summary 2,4-Dinitrotoluene. U.S. Environmental Protection Agency, National Center for Environmental Assessment, Integrated Risk Information System (IRIS), Washington, DC. 238 USEPA. 2000. Unregulated Contaminant Monitoring Regulation Analytical Methods and Quality Control Manual. EPA 815-R-00-006. 288 USEPA. 2008. Drinking Water Health Advisory for 2,4-Dinitrotoluene and 2,6-Dinitrotoluene. EPA/822/R-08/010. U.S. Environmental Protection Agency, Office of Water, Health and Ecological Criteria Division, Washington, DC. 296 USEPA. 2008. Regulatory Determinations Support Document for Selected Contaminants from the Second Drinking Water Contaminant Candidate List (CCL 2). EPA Report 815-R-08-012. June 2008. 297 USEPA. 2008. The Analysis of Occurrence Data from the First Unregulated Contaminant Monitoring Regulation (UCMR 1) in Support of Regulatory Determinations for the Second Drinking Water Contaminant Candidate List. EPA 815-R-08-013. June. A-66 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 2,6-Dinitrotoluene CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: 2,6-Dinitrotoluene CASRN: 606-20-2 DTXSID: DTXSID5020528 Use: Chemical intermediate in the manufacture of dyes and military and commercial explosives Chemical Notes: Is the contaminant on any lists? CERCLA X FIFRA Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 6 carcinogen with linear MOA 1 1 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 0.02 hepatocellular carcinomas general population PPRTV 2013 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 5 90th Percentile All Ambient Water NWIS 2008-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS 2,6-DNT appears to occur infrequently at levels of concern in PWSs. 2,6- DNT was not detected at a minimum reporting level (MRL) of 2 pg/L in iny of the PWSs monitored under the UCMR 1 [a]. While the MRL is ;lightly greater than the HRL of 0.05 pg/L, this concentration is within he acceptable 10-4 to the 10-6 cancer risk range targeted by EPA [b]. USE PA, 2008 [297]; [b] USEPA, 2000 [238]; a [296] cited in USEPA, 2008 Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-67 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 2,6-Din itr otol uene CCL 5 Contaminant Information Sheet EPA-OGWDWand OST October 2022 HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.0003 mg/kg/day PPRTV 2013 Lee et al. 1976 Increased incidence of splenic extra medullary hematopoiesis general population 33.8 1.78 [330] Reference Dose (RfD) or Equivalent 0.001 mg/kg/day OW 2008 Lee et al. 1976 neurotoxicity, Heinz bodies, bile duct hyperplasia, liver and kidney histopathology, increased incidence of death general population 33.8 5.92 [289] Cancer Slope Factor (CSF) 0.68 (mg/kg/day)A-l IRIS 1990 Ellis et al. 1979 hepatocellular carcinomas and neoplastic nodules; mammary gland adenomas, fibroadenomas, fibromas, and adenocarcinomas/carcinomas general population 33.8 0.0435 [206] Cancer Slope Factor (CSF) 1.5 (mg/kg/day)A-l PPRTV 2013 Leonard et al. 1987 hepatocellular carcinomas general population 33.8 0.0197 [330] Cancer Slope Factor (CSF) 0.667 (mg/kg/day)A-l OW 2008 Ellis et al. 1979; Lee et al. 1985 hepatocellular carcinomas and neoplastic nodules; mammary gland adenomas, fibroadenomas, fibromas, and adenocarcinomas/carcinomas general population 33.8 0.0444 [289] Cancer Classification (CC) B2 IRIS 1990 [206] Cancer Classification (CC) S PPRTV 2013 [330] Cancer Classification (CC) L OW 2008 [289] ATSDR2016 [34] Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Hepatic, Systemic 20 Imamura, 2015 2015-02-01 2020-02-13 31 1 0 1 Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results 10-day Health Advisory 0.04 mg/L EPA DWSHA2018 Acute Minimal Risk Level (MRL) 0.09 mg/kg/day CDC ATSDR Intermediate Minimal Risk Level (MRL) 0.004 mg/kg/day CDC ATSDR Lifetime Health Advisory 0.00005 mg/L EPA DWSHA 2018 Subchronic Provisional RfD 0.003 mg/kg/day EPA PPRTV Cancer Classification (CC) 2B no units WHO IARC Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Measured Data and Assessment Results LD50 177 mg/kg NIH HSDB min LD50 621 mg/kg NIH HSDB max Percent of active toxcast in 1.83 percent EPA Chemistry Dashboard vitro assays tested Data Element Value Units Source Notes Modeled Data LD50 0.0005861 mo l/kg TEST QSAR Ames mutagenicity test 0.613 no units TEST QSAR Developmental toxin test 0.44 no units TEST QSAR A-68 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 2,6-Dinitrotoluene CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 OCCURRENCE DATA Scoring_Data_ Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contam nant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contam nant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contam nant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contam nant Monitoring Rule (UCMR) 1 2001 - 2003 3.873 0 Sites 0 Unregulated Contam nant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contam nant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Qualitv Assessment (USGS NAWQA) (All Water) 1991-2017 22 0 Sites 0 National Water Qua litv Assessment (USGS NAWQA) (Surface Water) 1991-2017 13 0 Sites 0 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 9 0 Sites 0 Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) 3 2,728 Chemical Data Reporting (CDR) Results (EPA) (2016) < 25K Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Finished) 2006 - 2020 37 0 Sites 0 Ambient Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Source) 2006 - 2020 157 0 Sites 0 National Water Information System (USGS NWIS) (Surface Water) 2008-2017 160 5 Sites 3.12 0.1 5 5 5 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008-2017 410 0 Sites 0 National Water Information System (USGS NWIS) (All Water) 2008-2017 567 5 Sites 0.88 0.1 5 5 5 ug/L Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 0.000000129 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 3.72441 days Boiling point OPERA QSAR 297.597 degree C Boiling point TEST QSAR 303.476 degree C Vapor pressure OPERA QSAR 0.000411091 mmHg Vapor pressure TEST QSAR 0.000429536 mmHg Solubility in water OPERA QSAR 0.00117033 mol/L Solubility in water TEST QSAR 0.00157761 mol/L Bioconcentration factor OPERA QSAR 12.4551 no units Bioconcentration factor TEST QSAR 6.20869 no units Henry's Law constant OPERA QSAR 9.26E-08 o E E 0 eta no l/water partitioning coeff. (log Kow) OPERA QSAR 2.00324 no units A-69 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 2,6-Dinitrotoluene CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 34 ATSDR. 2016. Toxicological Profile for Dinitrotoluenes. U.S. Department of Health and Human Services, Public Health Service, Agency for Toxic Substances and Disease Registry (ATSDR), Atlanta, GA. 206 USEPA. 1990. Chemical Assessment Summary, 2,4-/2,6-Dinitrotoluene mixture. U.S. Environmental Protection Agency, National Center for Environmental Assessment, Integrated Risk Information System (IRIS), Washington, D.C. 238 USEPA. 2000. Unregulated Contaminant Monitoring Regulation Analytical Methods and Quality Control Manual. EPA 815-R-00-006. 289 USEPA. 2008. Drinking Water Health Advisory for 2,4-Dinitrotoluene and 2,6-Dinitrotoluene. U.S. Environmental Protection Agency, Office of Water, Office of Science and Technology, Health and Ecological Criteria Division, Washington, D.C. 296 USEPA. 2008. Regulatory Determinations Support Document for Selected Contaminants from the Second Drinking Water Contaminant Candidate List (CCL 2). EPA Report 815-R-08-012. June 2008. 297 USEPA. 2008. The Analysis of Occurrence Data from the First Unregulated Contaminant Monitoring Regulation (UCMR 1) in Support of Regulatory Determinations for the Second Drinking Water Contaminant Candidate List. EPA 815-R-08-013. June. 330 USEPA. 2013. Provisional Peer-Reviewed Toxicity Values for 2,6-Dinitrotoluene. U.S. Environmental Protection Agency, Office of Research and Development, National Center for Environmental Assessment, Superfund Health Risk Technical Support Center, Cincinnati, OH. A-70 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 2-Hydroxyatrazine CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: 2-Hyd roxy at raz i ne CASRN: 2163-68-0 DTXSID: DTXSID6037807 Use: Pesticide Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANTSUMMARY& DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 6 non-cancer effects 10 4 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 400 histopat ho logical changes in the kidney general population OPP 2018 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.2 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-71 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 2-Hydroxyatrazine CCL 5 Contaminant Information Sheet EPA-OGWDWand OST October 2022 HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.0676 mg/kg/day OPP 2018 Chow and Hart 1995 histo pat ho logical changes in the kidney general population 33.8 400 [395] Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element I Value | Units | Source | Notes Measured Data and Assessment Results Chronic Human Health Benchmark 0.06 mg/L EPA HHBP Drinking Water Guideline Value 02 mg/L WHO Drinking Water Quality Guidelines Health-Based Screening Level 0.06 mg/L Health-based screening levels from USGS Population-Adjusted Dose (PAD) 0.01 mg/kg/day EPA HHBP Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Modeled Data LD50 0.0091833 mo l/kg TEST QSAR Ames mutagenicity test 0.145 no units TEST QSAR Developmental toxin test 0.902 no units TEST QSAR Data Element I Value I Units I Source I Notes Measured Data and Assessment Results LOAEL 125 mg/kg/day EPA Tox city Reference Database max LOAEL 7.75 mg/kg/day EPA Tox city Reference Database min NOAEL 1.17 mg/kg/day EPA Tox city Reference Database min NOAEL 25 mg/kg/day EPA Tox city Reference Database max Subchron c LOAEL 18.889999 mg/kg/day EPA Tox city Reference Database min Subchron c LOAEL 59.599998 mg/kg/day EPA Tox city Reference Database max Subchron c NOAEL 6.2 mg/kg/day EPA Tox city Reference Database min Subchron c NOAEL 7.35 mg/kg/day EPA Tox city Reference Database max A-72 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 2 - Hyd r oxyatra z i n e CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contam nant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contam nant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contam nant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contam nant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contam nant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contam nant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 4,188 739 Sites 18 0.00044 0.0402 0.2 7.29 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 486 345 Sites 71 0.00044 0.042 0.2 4.6 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 3.702 394 Sites 11 0.00063 0.018 0.123 7.29 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude USDA Pesticide Data Program (PDP) (Finished) 2001-2013 10 9 Sites 90 0.002 0.015 0.12 0.74 ug/L Ambient Water Prevalence Magnitude National Water Information System (USGS NWIS) (Surface Water) 2008-2017 495 303 Sites 61 0.00052 0.028 0.224 3.27 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008-2017 1,249 175 Sites 14 0.0013 0.019 0.0986 0.822 ug/L National Water Information System (USGS NWIS) (All Water) 2008-2017 1,744 478 Sites 27 0.00052 0.0258 0.204 3.27 ug/L USDA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001-2013 227 162 Sites 71 0.001998 0.023 0.22 1.2 ug/L USDA Pesticide Data Program (PDP) (Groundwater) 2001-2013 218 153 Sites 70 0.001998 0.0238 0.0629 0.255 ug/L USDA Pesticide Data Program (PDP) (Untreated) 2001 - 2013 10 9 Sites 90 0.002 0.023 0.26 1.2 ug/L Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990 - 2018 432 55 Sites 13 0.007 0.015 0.282 0.368 ug/L Bradley etal. 2017 (Ambient) [52] 2012 - 2014 38 19 Sites 50 0.0055 0.0344 0.229 0.5428 ug/L Arnold et al. 2016 (Filtered) [7] 2012 - 2013 690 57 Sites 8.26 8e-04 0.0103 0.0514 0.466 ug/L USGS, McKenzie River, Oregon, 2012 (Ambient) [158] 2002 - 2010 126 11 Samples 8.7 0.042 ug/L Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR4 data used in the CCL5 is a partial datasetand will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 4.30198 days Boiling point OPERA QSAR 332.794 degree C Boiling point TEST QSAR 326.232 degree C Vapor pressure OPERA QSAR 1.11E-10 mmHg Vapor pressure TEST QSAR 8.95E-08 mmHg Solubility in water OPERA QSAR 0.0000634 mol/L Solubility in water TEST QSAR 0.0101859 mol/L Bioconcentration factor OPERA QSAR 5.82054 no units Bioconcentration factor TEST QSAR 3.22107 no units Henry's Law constant OPERA QSAR 9.6E-09 o E E Octanol/water partitioning coeff. (log Kow) OPERA QSAR 1.95934 no units A-73 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 2-Hydroxyatrazine CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 158 Reconnaissance of Land-Use Sources of Pesticides in Drinking Water, McKenzie River, Oregon. U.S. Geological Survey Scientific Investigations Report 2012-5091, 46 p. plus appendixes. 395 USEPA. 2018. Atrazine. Draft Human Health Risk Assessment for Registration Review. EPQ-HQ-OPP-2013-0266-1159. DP No. D418316. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticide in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. A-74 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 2-Methyl-4-chlorophenoxyacetic acid (MCPA) CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: 2-Methyl-4-chlorophenoxyacetic acid (MCPA) CASRN: 94-74-6 DTXSID: DTXSID4024195 Use: Herbicide Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts X Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANTSUMMARY& DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 5 non-cancer effects 8 4 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 300 nephrotoxicity general population OPP 2018 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.3986 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-75 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 2-Methyl-4-chlorophenoxyacetic acid (MCPA) CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.044 mg/kg/day OPP 2018 Kirsch, 1988 nephrotoxicity general population 33.8 260 [402] Cancer Classification (CC) NL OPP 2018 [4021 Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results 10-day Health Advisory 0.1 mg/L EPA DWSHA 2018 Chronic Health-Based Guidance Value 0.003 mg/L MN DOH Lifetime Health Advisory 0.03 mg/L EPA DWSHA 2018 Maximum Allowable Concentration (MAC) 0.1 mg/L Canadian Drinking Water Guidelines Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Measured Data and Assessment Results LD50 439 mg/kg NIH HSDB min LD50 800 mg/kg NIH HSDB max LOAEL 1.02 mg/kg/day EPA Toxicity Reference Database min LOAEL 120 mg/kg/day EPA Toxicity Reference Database max NOAEL 0.21 mg/kg/day EPA Toxicity Reference Database min NOAEL 60 mg/kg/day EPA Toxicity Reference Database max Percent of active toxcast in 1.59 percent EPA Chemistry Dashboard vitro assays tested Subchronic LOAEL 177 mg/kg/day EPA Toxicity Reference Database max Subchronic LOAEL 3 mg/kg/day EPA Toxicity Reference Database min Subchronic NOAEL 1 mg/kg/day EPA Toxicity Reference Database min Subchronic NOAEL 42 mg/kg/day EPA Toxicity Reference Database max Data Element Value Units Source Notes Modeled Data LD50 0.0032359 mo l/kg TEST QSAR Ames mutagenicity test 0.056 no units TEST QSAR Developmental toxin test 0.691 no units TEST QSAR A-76 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 2-Methyl-4-chlorophenoxyacetic acid (MCPA) CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev(NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 7.656 142 Sites 1.85 0.01 0.09 0.399 18.6 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 1.194 136 Sites 11 0.01 0.09 0.394 18.6 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 6.462 6 Sites 0.09 0.03 0.169 8.8 16.6 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) 34 4,113,376 2016 Toxic Release Inventory (TRI) Program (EPA) (2016) 4 474 Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Finished) 2006 - 2020 2 0 Sites 0 USDA Pesticide Data Program (PDP) (Finished) 2001-2013 17 7 Sites 41 0.00065 0.0013 0.0086 0.24 ug/L Ambient Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Source) 2006 - 2020 61 1 Sites 1.64 13 13 13 13 ug/L National Water information System (USGS NWIS) (Surface Water) 2008-2017 461 40 Sites 8.68 0.01 0.079 0.414 1.69 ug/L National Water information System (USGS NWIS) (Groundwater) 2008-2017 950 1 Sites 0.11 0.02 0.02 0.02 0.02 ug/L National Water information System (USGS NWIS) (All Water) 2008-2017 1,411 41 Sites 2.91 0.01 0.0781 0.406 1.69 ug/L USDA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001-2013 229 13 Sites 5.68 0.00065 0.0026 0.012 0.86 ug/L USDA Pesticide Data Program (PDP) (Groundwater) 2001-2013 219 7 Sites 3.2 0.001299 0.00245 0.0109 0.0311 ug/L USDA Pesticide Data Program (PDP) (Untreated) 2001-2013 12 6 Sites 50 0.00065 0.0026 0.012 0.86 ug/L Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990-2018 702 101 Sites 14 0.052 0.141 0.928 13.59 ug/L Bradley et al. 2017 (Ambient) [52] 2012-2014 38 4 Sites 11 0.0217 0.0426 0.0881 0.1057 ug/L Arnold et al. 2016 (Filtered) [7] 2012-2013 690 0 Sites 0 Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 0.00000081 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 3.53805 days Boiling point OPERA QSAR 284.826 degree C Boiling point TEST QSAR 307.8 degree C Vapor pressure OPERA QSAR 0.00000244 mmHg Vapor pressure TEST QSAR 0.0000138 mmHg Solubility in water OPERA QSAR 0.00286854 mol/L Solubility in water TEST QSAR 0.00436516 mol/L Bioconcentration factor OPERA QSAR 3.64059 no units Bioconcentration factor TEST QSAR 2.95801 no units Henry's Law constant OPERA QSAR 6.94E-09 atm-mA3/mol 0 eta no 1/water partitioning coeff. (log Kow) OPERA QSAR 2.87665 no units A-77 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 2-Methyl-4-chlorophenoxyacetic acid (MCPA) CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 402 USEPA. 2018. MCPA. Draft Human Health Risk Assessment in Support of Registration Review. EPA-HQ-OPP-2014-0180-0043. DP No. D446323. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticide in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. A-78 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 2-Methylnaphthalene CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: 2-Methylnaphthalene CASRN: 91-57-6 DTXSID: DTXSID4020878 Use: Insecticide; small quantities for the production of a Iky 1 methyl naphthalene sulfonates as textile auxiliaries, surfactants, and emulsifiers. Chemical Notes: Is the contaminant on any lists? CERCLA X FIFRA Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANTSUMMARY& DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 6 non-cancer effects 8 3 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 20 pulmonary alveolar proteinosis general population IRIS 2003 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.0416 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-79 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 2-Methylnaphthalene CCL 5 Contaminant Information Sheet EPA-OGWDWand OST October 2022 HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.004 mg/kg/day IRIS 2003 Murata et a 1.1997 pulmonary alveolar proteinosis general population 33.8 23.7 [254] Reference Dose (RfD) or Equivalent 0.04 mg/kg/day ATSDR2005 Murata et al. 1997 pulmonary alveolar proteinosis general population 33.8 237 [23] Cancer Classification (CC) I PPRTV 2007 [279] Cancer Classification (CC) I IRIS 2003 [254] Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review 2006-09-01 2020-03-25 71 0 0 Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Chronic Health-Based Guidance Value 0.008 mg/L MN DOH Subchronic Provisional RfD 0.004 mg/kg/day EPA PPRTV Data Element Value Units Source Notes Measured Data and Assessment Results LD50 1630 mg/kg NIH HSDB Percent of active toxcast in 0 percent EPA Chemistry Dashboard vitro assays tested Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Modeled Data LD50 0.0094406 mo l/kg TEST QSAR Ames mutagenicity test TEST QSAR Developmental toxin test 0.514 no units TEST QSAR A-80 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 2-Methylnaphtiialene CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contam nant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contam nant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contam nant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contam nant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contam nant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contam nant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev(NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 567 12 Sites 2.12 0.003 0.013 0.0416 0.16 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 88 8 Sites 9.09 0.003 0.01 0.028 0.05 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 479 4 Sites 0.84 0.011 0.0275 0.108 0.16 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) 1M - 10M Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Glassmeyer et al 2017 (Finished) [86] 2007-2012 25 NA Sites 0 ug/L USGS, Sioux Falls Area, 2012 (Finished) [153] 2009-2010 1 0 Sites 0 Ambient Water Prevalence Magnitude National Water Information System (USGS NWIS) (Surface Water) 2008-2017 750 120 Sites 16 0.003 0.01 0.05 6 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008-2017 782 65 Sites 8.31 0.003 0.014 0.0343 610 ug/L National Water Information System (USGS NWIS) (All Water) 2008-2017 1,532 185 Sites 12 0.003 0.012 0.0499 610 ug/L Glassmeyer et a 1 2017 (Ambient) [86] 2007-2012 25 NA Sites 0 ug/L Bradley et al. 2017 (Ambient) [52] 2012-2014 38 2 Sites 5.26 0.0076 0.00875 0.00967 0.0099 ug/L USGS, Sioux Falls Area, 2012 (Ambient) [153] 2009-2010 2 0 Sites 0 Waste Water Effluent Prevalence Magnitude Scott et al. 2018 (Wastewater) [161] 2011-2017 21 0 Sites 0 Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/ day) Notes Expocast exposure 0.000000578 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 14.9141 days Boiling point OPERA QSAR 246.408 degree C Boiling point TEST QSAR 246.201 degree C Vapor pressure OPERA QSAR 0.026447 mmHg Vapor pressure TEST QSAR 0.0272898 mmHg Solubility in water OPERA QSAR 0.000157227 mol/L Solubility in water TEST QSAR 0.00013213 mol/L Bioconcentration factor OPERA QSAR 72.8094 no units Bioconcentration factor TEST QSAR 358.922 no units Henry's Law constant OPERA QSAR 0.000535625 atm-mA3/mol 0 eta no 1/water partitioning coeff. (log Kow) OPERA QSAR 3.94282 no units A-81 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 2-Methylnaphthalene CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 23 ATSDR. 2005. Toxicological Profile for Naphthalene, 1-Methylnaphthalene, and 2-Methylnaphthalene. U.S. Department of Health and Human Services, Public Health Service, Agency for Toxic Substance! and Disease Registry (ATSDR), Atlanta, GA. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 86 Glassmeyer, S.T., Furlong, E.T., Kolpin, D.W., Batt, A.L., Benson, R., Boone, J.S.,... & Wilson, V.S. (2017). Nationwide reconnaissance of contaminants of emerging concern in source and treated drinking waters of the United States. Science of The Total Environment. v581-582, (909-922). 153 Occurrence of anthropogenic organic compounds and nutrients in source and finished water in the Sioux Falls area, South Dakota, 2009-10: U.S. Geological Survey Scientific Investigations Report 2012-5098, 21 p. plus appendixes. 161 Scott, T. M., Phillips, P. J., Kolpin, D. W., Colella, K. M., Furlong, E. T., Foreman, W. T., & Gray, J. L. (2018). Pharmaceutical manufacturing facility discharges can substantially increase the pharmaceutical load to US wastewaters. Science of the Total Environment, 636, 69-79. 254 USEPA. 2003. Chemical Assessment Summary, 2-Methylnaphthalene. U.S. Environmental Protection Agency, National Center for Environmental Protection, Integrated Risk Information System (IRIS), Washington, D.C. 279 USEPA. 2007. Provisional Peer-Reviewed Toxicity Values for 2-Methylnaphthalene. U.S. Environmental Protection Agency, Office of Research and Development, National Center for Environmental Assessment, Superfund Health Risk Technical Support Center, Cincinnati, OH. A-82 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 e-Chloro-l^S-triazine^/l-diamine CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: 6-C h lo ro-1,3,5 -tria zi n e-2,4-d ia m in e CASRN: 3397-62-4 DTXSID: DTXSID1037806 Use: Herbicide Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 4 reproductive and developmental effects 10 5 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value («"gA) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 400 attenuation of LH surge in females ages 13- 49 (estrous cycle disruption) women of child bearing age OPP 2018 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.382 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-83 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 6-Ch I oro-l,3,5-tria zi ne-2,4-d i a m i ne CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.076 mg/kg/day OPP 2018 Cooperet al. 2010 attenuation of LH surge in females ages 13-49 (estrous cycle disruption) women of child bearing age 35.4 429 [395] Cancer Classification (CC) NL OPP 2018 [3951 Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Acute Human Health Benchmark 0.3 mg/L EPA HHBP Acute PAD 0.01 mg/kg/day EPA HHBP Chronic Human Health Benchmark 0.012 mg/L EPA HHBP Health-Based Screening Level 0.012 mg/L Health-based screening levels from USGS Maximum Allowable Daily Level 100 ug/day CalEPA OEH HA Chemical Database Population-Adjusted Dose (PAD) 0.0018 mg/kg/day EPA HHBP Data Element Value Units Source Notes Measured Data and Assessment Results LOAEL 25 mg/kg/day EPA Toxicity Reference Database min LOAEL 75 mg/kg/day EPA Toxicity Reference Database max NOAEL 2.5 mg/kg/day EPA Toxicity Reference Database min NOAEL 25 mg/kg/day EPA Toxicity Reference Database max Percent of active toxcast in 0 percent EPA Chemistry Dashboard vitro assays tested Subchronic LOAEL 7.5999999 mg/kg/day EPA Toxicity Reference Database Subchronic NOAEL 0.7 mg/kg/day EPA Toxicity Reference Database Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Modeled Data LD50 0.0062374 mo l/kg TEST QSAR Ames mutagenicity test 0.176 no units TEST QSAR Developmental toxin test 0.628 no units TEST QSAR A-84 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 6-Chloro-l,3,5-triazine-2,4-di amine CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 3.405 656 Sites 19 0.0012 0.103 0.382 6.68 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 456 278 Sites 61 0.0013 0.105 0.365 2.4 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 2.949 378 Sites 13 0.0012 0.057 0.778 6.68 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude USDA Pesticide Data Program (PDP) (Finished) 2001-2013 10 3 Sites 30 0.025 0.05 0.05 0.05 ug/L Ambient Water Prevalence Magnitude Drinking Water Monitoring Data - Wl (Source) 2012-2019 2 0 Sites 0 National Water Information System (USGS NWIS) (Surface Water) 2008-2017 354 137 Sites 39 0.0032 0.0842 0.223 1.35 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008-2017 731 188 Sites 26 0.0036 0.16 0.867 2.45 ug/L National Water Information System (USGS NWIS) (All Water) 2008-2017 1,085 325 Sites 30 0.0032 0.0984 0.406 2.45 ug/L USDA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001-2013 227 76 Sites 33 0.015 0.05 0.368 2.9 ug/L USDA Pesticide Data Program (PDP) (Groundwater) 2001-2013 218 73 Sites 33 0.015 0.0865 0.457 2.9 ug/L USDA Pesticide Data Program (PDP) (Untreated) 2001-2013 10 3 Sites 30 0.025 0.05 0.05 0.12 ug/L Bradley et al. 2017 (Ambient) [52] 2012-2014 38 7 Sites 18 0.027 0.074 0.122 0.17 ug/L Arnold et al. 2016 (Filtered) [7] 2012-2013 584 86 Sites 15 0.0012 0.132 1.28 6.3 ug/L Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 4.83E-08 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicatethere were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 8.42524 days Boiling point OPERA QSAR 317.078 degree C Boiling point TEST QSAR 277.429 degree C Vapor pressure OPERA QSAR 7.01E-09 mmHg Vapor pressure TEST QSAR 0.00000585 mmHg Solubility in water OPERA QSAR 0.00462445 mol/L Solubility in water TEST QSAR 0.0302691 mol/L Bioconcentration factor OPERA QSAR 2.87554 no units Bioconcentration factor TEST QSAR 1.65577 no units Henry's Law constant OPERA QSAR 7.17E-08 atm-mA3/mol 0 eta no 1/water partitioning coeff. (log Kow) OPERA QSAR -0.196188 no units A-85 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 6-Chloro-l,3,5-triazine-2,4-diamine CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 395 USEPA. 2018. Atrazine. Draft Human Health Risk Assessment for Registration Review. EPQ-HQ-OPP-2013-0266-1159. DP No. D418316. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. A-86 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Acephate CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Acephate CASRN: 30560-19-1 DTXSID: DTXSID8023846 Use: Insecticide Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 7 reproductive and developmental effects 9 3 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value («"gA) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 0.4 inhibition of brain acetylcholinesterase in male postnatal day 11 pups bottle-fed infants OPP 2018 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.1758 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-87 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Acephate CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.0003 mg/kg/day OPP 2018 Hoberman 2003 inhibition of brain AChE in male pups on PND11. bottle-fed infants 151 0.397 [394] Cancer Classification (CC) C OPP 2018 [3941 Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Acute Human Health Benchmark 0.03 mg/L EPA HHBP Acute PAD 0.005 mg/kg/day EPA HHBP Chronic Human Health Benchmark 0.0077 mg/L EPA HHBP Health-Based Screening Level 0.0077 mg/L Health-based screening levels from USGS Population-Adjusted Dose (PAD) 0.0012 mg/kg/day EPAHHBP Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Measured Data and Assessment Results LD50 233 mg/kg NIH HSDB min LD50 945 mg/kg NIH HSDB max LOAEL 0.25 mg/kg/day EPA Toxicity Reference Database min LOAEL 75 mg/kg/day EPA Toxicity Reference Database max NOAEL 2.5 mg/kg/day EPA Toxicity Reference Database min NOAEL 20 mg/kg/day EPA Toxicity Reference Database max Percent of active toxcast in 1.43 percent EPA Chemistry Dashboard vitro assays tested Subchronic LOAEL 0.12 mg/kg/day EPA Toxicity Reference Database Data Element Value Units Source Notes Modeled Data LD50 0.0019999 mo l/kg TEST QSAR Ames mutagenicity test 0.202 no units TEST QSAR Developmental toxin test 0.743 no units TEST QSAR A-88 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Acephate CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 1.760 135 Sites 7.67 0.00051 0.0212 0.176 10.4 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 322 131 Sites 41 0.00051 0.0212 0.175 10.4 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 1.438 4 Sites 0.28 0.00267 0.00749 0.14 0.229 Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) 36 4,373,575 2016 Toxic Release Inventory (TRI) Program (EPA) (2016) 4 27,210 Chemical Data Reporting (CDR) Results (EPA) (2016) 25K-100K Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Ambient Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Source) 2006 - 2020 3 0 Sites 0 National Water information System (USGS NWIS) (Surface Water) 2008-2017 307 33 Sites 11 0.00082 0.0445 0.277 10.4 ug/L National Water information System (USGS NWIS) (Groundwater) 2008-2017 528 2 Sites 0.38 0.00788 0.113 0.176 0.218 ug/L National Water information System (USGS NWIS) (All Water) 2008-2017 835 35 Sites 4.19 0.00082 0.0445 0.275 10.4 ug/L Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990-2018 118 34 Sites 29 0.132 0.454 2.7 13.5 ug/L Arnold et al. 2016 (Filtered) [7] 2012-2013 584 0 Sites 0 Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 6.17E-08 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) < LOD ug/l Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 3.55348 days Boiling point OPERA QSAR 271.255 degree C Boiling point TEST QSAR Vapor pressure OPERA QSAR 0.00000222 mmHg Vapor pressure TEST QSAR Solubility in water OPERA QSAR 3.1318 mol/L Solubility in water TEST QSAR 0.408319 mol/L Bioconcentration factor OPERA QSAR 1.22201 no units Bioconcentration factor TEST QSAR Henry's Law constant OPERA QSAR 4.76E-09 atm-mA3/mol 0 eta no l/water partitioning coeff. (log Kow) OPERA QSAR -0.710368 no units A-89 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Acephate CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 394 USEPA. 2018. Acephate. Revised Draft Human Health Risk Assessment (DRA) in Support of Registration Review. EPA-HQ-OPP-2008-0915-0025. DP No. D446177. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticide in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. A-90 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Acetamiprid CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Acetamiprid CASRN: 135410-20-7 DTXSID: DTXSID0034300 Use: Insecticide Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Not List ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT IN FORMATION Potency Severity Prevalence Magnitude 4 non-cancer effects 10 2 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 400 reduced body weight and body weight gain in females, hepatocellular vacuolation in males general population OPP 2017 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.02615 90th Percentile All Ambient Water NAWQA 1991-2017 Final Hazard Quotient (HQ) 0.000065 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-91 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Acetamiprid CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.071 mg/kg/day OPP 2017 Hatch 1999 reduced body weight and body weight gain in females, hepatocellular vacuolation in males general population 33.8 420 [375] Cancer Classification (CC) NL OPP 2017 [3751 Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Acute Human Health Benchmark 0.7 mg/L EPA HHBP Acute PAD 0.1 mg/kg/day EPA HHBP Chronic Human Health Benchmark 0.45 mg/L EPA HHBP Health-Based Screening Level 0.45 mg/L Health-based screening levels from USGS Population-Adjusted Dose (PAD) 0.071 mg/kg/day EPA HHBP Notes: Highlighted data indicate value was used in attribute scoring. Blan k fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element I Value I Units I Source I Notes Measured Data and Assessment Results LD50 146 mg/kg NIH HSDB min LD50 217 mg/kg NIH HSDB max LOAEL 17.5 mg/kg/day EPA Toxicity Reference Database min LOAEL 65.599998 mg/kg/day EPA Toxicity Reference Database max NOAEL 25.2 mg/kg/day EPA Toxicity Reference Database max NOAEL 8.8 mg/kg/day EPA Toxicity Reference Database min Percent of active toxcast in vitro assays tested 1.74 percent EPA Chemistry Dashboard Subchronic LOAEL 250.10001 mg/kg/day EPA Toxicity Reference Database max Subchronic LOAEL 32 mg/kg/day EPA Toxicity Reference Database min Subchronic NOAEL 129.4 mg/kg/day EPA Toxicity Reference Database max Subchronic NOAEL 14 mg/kg/day EPA Toxicity Reference Database min Data Element Value Units Source Notes Modeled Data LD50 0.0028314 mo l/kg TEST QSAR Ames mutagenicity test 0.819 no units TEST QSAR Developmental toxin test 0.6 no units TEST QSAR A-92 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Acetamiprid CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 OCCURRENCE DATA Scoring_Data_ Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev(NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 5 2 Sites 40 0.0025 0.004 0.0262 0.0456 National Water Qua lity Assessment (USGS NAWQA) (Surface Water) 1991-2017 5 2 Sites 40 0.0025 0.004 0.0262 0.0456 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) 36 107,391 2016 Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude USDA Pesticide Data Program (PDP) (Finished) 2001-2013 10 0 Sites 0 Ambient Water Prevalence Magnitude National Water Information System (USGS NWIS) (Surface Water) 2008-2017 130 7 Sites 5.38 0.0023 0.0144 0.137 0.227 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008-2017 12 0 Sites 0 National Water Information System (USGS NWIS) (All Water) 2008-2017 142 7 Sites 4.93 0.0023 0.0144 0.137 0.227 ug/L USDA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001-2013 227 0 Sites 0 USDA Pesticide Data Program (PDP) (Groundwater) 2001-2013 218 0 Sites 0 USDA Pesticide Data Program (PDP) (Untreated) 2001-2013 10 0 Sites 0 Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990-2018 178 8 Sites 4.49 0.0262 0.0606 0.165 0.199 ug/L Bradley et al. 2017 (Ambient) [52] 2012-2014 38 1 Sites 2.63 0.0395 0.0395 0.0395 0.0395 ug/L Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 8.48E-08 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 4.87165 days Boiling point OPERA QSAR 315.067 degree C Boiling point TEST QSAR Vapor pressure OPERA QSAR 0.0000916 mmHg Vapor pressure TEST QSAR Solubility in water OPERA QSAR 0.044269 mol/L Solubility in water TEST QSAR 0.0494311 mol/L Bioconcentration factor OPERA QSAR 9.32437 no units Bioconcentration factor TEST QSAR Henry's Law constant OPERA QSAR 3.46E-09 atm-mA3/mol 0 eta no l/water partitioning coeff. (log Kow) OPERA QSAR 1.19577 no units A-93 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Acetamiprid CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 375 USEPA. 2017. Acetamiprid. Acute and Chronic Dietary Exposure and Risk Assessment for Registration Review. EPA-HQ-OPP-2012-0329-0022. DP No. D443740. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticide in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. A-94 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Acetochlor ethanesulfonic acid (ESA) CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Acetochlor ethanesulfonic acid (ESA) CASRN: 187022-11-3 DTXSID: DTXSID6037483 Use: Pesticide degradate Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 4 reproductive and developmental effects 3 7 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value («"gA) Critical Effect Target Pop. Assessment Assessment Pub. Date SL 300 decreased body weight and weight gain, decreased food utilization; increased TSH, T4, andT3; increased relative testes weight general population MDH 2018 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 1.190526 90th Percentile Finished Water UCMR2 2008-2010 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-95 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Acetochlor ethanesulfonic acid (ESA) CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) HRL (ug/L) Assessment Full Citation Notes Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.056 mg/kg/day MDH 2018 Lees 2000 decreased body weight and weight gain, decreased food utilization; increased TSH, T4, and T3; increased relative testes weight general population 33.8 331 [142] Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Acute Health-Based Guidance Value 0.5 mg/L MN DOH Acute Health-Based Guidance Value 0.6 mg/L MN DOH Chronic Health-Based Guidance Value 0.3 mg/L MN DOH Chronic Health-Based Guidance Value 0.3 mg/L MN DOH Short-Term/Subchronic Health-Based Guidance Value 0.5 mg/L MN DOH Short-Term/Subchronic Health-Based Guidance Value 0.6 mg/L MN DOH Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Measured Data and Assessment Results Percent of active toxcast in 0.71 percent EPA Chemistry Dashboard vitro assays tested Data Element Value Units Source Notes Modeled Data LD50 0.011695 mo l/kg TEST QSAR Ames mutagenicity test 0.55 no units TEST QSAR Developmental toxin test 1.155 no units TEST QSAR A-96 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Acetochlor ethanesulfonic acid (ESA) CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contam nant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contam nant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contam nant Monitoring Rule (UCMR) 2 2008-2010 1.198 2 Sites 0.17 1.10526 1.15 1.19 1.2 Unregulated Contam nant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contam nant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contam nant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev(NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 2.719 325 Sites 12 0.012 0.266 1.11 13.2 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 419 212 Sites 51 0.012 0.272 1.12 13.2 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 2.300 113 Sites 4.91 0.02 0.14 0.823 12.3 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Finished) 2006 - 2020 4 0 Sites 0 USDA Pesticide Data Program (PDP) (Finished) 2001-2013 17 7 Sites 41 0.0027 0.039 0.484 1.2 ug/L Bradley et al. 2018 (Finished) [53] 2016 26 3 Sites 12 0.05 0.09 0.106 0.11 ug/L Ambient Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Source) 2006 - 2020 2 0 Sites 0 National Water Information System (USGS NWIS) (Surface Water) 2008-2017 354 73 Sites 21 0.02 0.174 0.62 1.75 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008-2017 826 52 Sites 6.3 0.02 0.15 0.478 0.88 ug/L National Water Information System (USGS NWIS) (All Water) 2008-2017 1,180 125 Sites 11 0.02 0.17 0.581 1.75 ug/L USDA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001-2013 229 155 Sites 68 0.002664 0.063 0.51 1.9 ug/L USDA Pesticide Data Program (PDP) (Groundwater) 2001-2013 219 148 Sites 68 0.002664 0.0654 0.161 1.75 ug/L USDA Pesticide Data Program (PDP) (Untreated) 2001-2013 12 7 Sites 58 0.0027 0.059 0.579 1.9 ug/L Bradley et al. 2017 (Ambient) [52] 2012-2014 38 9 Sites 24 0.02 0.06 0.566 0.67 ug/L Arnold et al. 2016 (Filtered) [7] 2012-2013 584 23 Sites 3.94 0.038 0.178 0.481 0.695 ug/L Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 0.000000125 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 4.28498 days Boiling point OPERA QSAR 314.606 degree C Boiling point TEST QSAR 382.116 degree C Vapor pressure OPERA QSAR 0.000000167 mmHg Vapor pressure TEST QSAR Solubility in water OPERA QSAR 0.0136286 mol/L Solubility in water TEST QSAR 0.00744732 mol/L Bioconcentration factor OPERA QSAR 9.7255 no units Bioconcentration factor TEST QSAR 7.31139 no units Henry's Law constant OPERA QSAR 5.13E-10 atm-mA3/mol 0 eta no l/water partitioning coeff. (log Kow) OPERA QSAR 2.7785 no units A-97 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Acetochlor ethanesulfonic acid (ESA) CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 53 Bradley, P. M., Kolpin, D. W., Romanok, K. M., Smalling, K. L., Focazio, M. J., Brown, J. B.,... & Dietze, J. E. (2018). Reconnaissance of mixed organic and inorganic chemicals in private and public supply tapwaters at selected residential and workplace sites in the United States. Environmental science & technology, 52(23), 13972-13985. 140 MDH. 2016. Toxicological Summary for: Alachlor ESA and Alachlor OXA. Health Based Guidance for Water. Minnesota Department of Health (MDH), Environmental Health Division, Health Risk Assessment Unit, St Paul, MN. 142 MDH. 2018. Toxicological Summary for: Acetochlor ESA. Health Based Guidance for Water. Minnesota Department of Health (MDH), Environmental Health Division, Health Risk Assessment Unit, St Paul MN. A-98 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Acetochlor oxanilic acid (OA) CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Acetochlor oxanilic acid (OA) CASRN: 194992-44-4 DTXSID: DTXSID1037484 Use: Pesticide degradate Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 5 non-cancer effects 1 1 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date SL 100 decreased body weight, body weight gain, and food utilization; decreased thyroid stimulating hormone general population MDH 2018 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 1.039 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-99 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Acetochlor oxanilic acid (OA) CCL 5 Contaminant Information Sheet EPA-OGWDWand OST October 2022 HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.019 mg/kg/day MDH 2018 Albin and Kraus 2000; Williams 2000 decreased body weight, body weight gain, and food utilization; decreased thyroid stimulating hormone general population 33.8 112 [143] Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element I Value I Units I Source 1 Notes Measured Data and Assessment Results Acute Health-Based Guidance Value 0.1 mg/L MN DOH Acute Health-Based Guidance Value 0.2 mg/L MN DOH Chronic Health-Based Guidance Value 0.09 mg/L MN DOH Chronic Health-Based Guidance Value 0.1 mg/L MN DOH Short-Term/Subchronic Health-Based Guidance Value 0.1 mg/L MN DOH Short-Term/Subchronic Health-Based Guidance Value 0.2 mg/L MN DOH Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Modeled Data LD50 0.0098628 mo l/kg TEST QSAR Ames mutagenicity test 0.261 no units TEST QSAR Developmental toxin test 0.88 no units TEST QSAR Data Element | Value | Units | Source I Notes Measured Data and Assessment Results A-100 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Acetochlor oxanilic acid (OA) CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 1.198 0 Sites 0 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 2.724 246 Sites 9.03 0.0053 0.217 1.04 15.4 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 422 203 Sites 48 0.0053 0.218 1.04 15.4 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 2.302 43 Sites 1.87 0.02 0.14 0.5 15 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Finished) 2006 - 2020 4 0 Sites 0 USDA Pesticide Data Program (PDP) (Finished) 2001-2013 17 7 Sites 41 0.00113 0.048 0.615 1.3 ug/L Bradley et al. 2018 (Finished) [53] 2016 26 3 Sites 12 0.02 0.17 0.186 0.19 ug/L Ambient Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Source) 2006 - 2020 2 0 Sites 0 National Water Information System (USGS NWIS) (Surface Water) 2008-2017 355 87 Sites 25 0.0194 0.15 0.567 1.76 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008-2017 830 30 Sites 3.61 0.02 0.05 0.295 0.54 ug/L National Water Information System (USGS NWIS) (All Water) 2008-2017 1,185 117 Sites 9.87 0.0194 0.133 0.532 1.76 ug/L USDA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001-2013 229 129 Sites 56 0.00113 0.062 0.74 1.9 ug/L USDA Pesticide Data Program (PDP) (Groundwater) 2001-2013 219 122 Sites 56 0.002331 0.0544 0.0986 1.03 ug/L USDA Pesticide Data Program (PDP) (Untreated) 2001-2013 12 7 Sites 58 0.00113 0.0705 0.82 1.9 ug/L Bradley et al. 2017 (Ambient) [52] 2012-2014 38 6 Sites 16 0.03 0.075 0.54 0.56 ug/L Arnold et al. 2016 (Filtered) [7] 2012-2013 584 6 Sites 1.03 0.103 0.172 0.438 0.628 ug/L Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/ day) Notes Expocast exposure 8.59E-08 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 3.35388 days Boiling point OPERA QSAR 320.906 degree C Boiling point TEST QSAR 367.714 degree C Vapor pressure OPERA QSAR 0.000000214 mmHg Vapor pressure TEST QSAR 0.000000653 mmHg Solubility in water OPERA QSAR 0.00519245 mol/L Solubility in water TEST QSAR 0.00289068 mol/L Bioconcentration factor OPERA QSAR 2.91563 no units Bioconcentration factor TEST QSAR 1.2331 no units Henry's Law constant OPERA QSAR 7.1E-10 atm-mA3/mol 0 eta no l/water partitioning coeff. (log Kow) OPERA QSAR 2.60609 no units A-101 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Acetochlor oxanilic acid (OA) CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 53 Bradley, P. M., Kolpin, D. W., Romanok, K. M., Smalling, K. L., Focazio, M. J., Brown, J. B.,... & Dietze, J. E. (2018). Reconnaissance of mixed organic and inorganic chemicals in private and public supply tapwaters at selected residential and workplace sites in the United States. Environmental science & technology, 52(23), 13972-13985. 143 MDH. 2018. Toxicological Summary for: Acetochlor OXA. Health Based Guidance for Water. Minnesota Department of Health (MDH), Environmental Health Division, Health Risk Assessment Unit, St Pau MN. A-102 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Acetophenone CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Acetophenone CASRN: 98-86-2 DTXSID: DTXSID6021828 Use: Photosensitizing agents; flavoring Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANTSUMMARY& DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT IN FORMATION Potency Severity Prevalence Magnitude 4 no adverse effects 8 5 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 600 no adverse effects identified at the highest dose tested general population IRIS 1988 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.3 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-103 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Acetophenone CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg- HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.1 mg/kg/day IRIS 1988 Hagen et al. 1967 no adverse effects identified at the highest dose tested general population 33.8 592 [197] NOTE: the 2011 PPRTV assessment declines to derive a chronic RfD for acetophenone because a non- cancer assessment is available Cancer Classification (CC) D IRIS 1988 [197] NOTE: the 2011 PPRTV assessment declines to derive a chronic RfD for acetophenone because a non- cancer assessment is available Cancer Classification (CC) D PPRTV 2011 [322] Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg- CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title- abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review 2010-06-01 2020-04-14 232 2 0 Other Health Data Data Element I Value | Units | Source | Notes Measured Data and Assessment Results Subchronic Provisional RfD | 0.8 | mg/kg/day |EPA PPRTV | Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation forthe critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Modeled Data LD50 0.0125893 mol/kg TEST QSAR Ames mutagenicity test 0.094 no units TEST QSAR Developmental toxin test 0.333 no units TEST QSAR Data Element Value Units Source Notes Measured Data and Assessment Results LD50 3000 mg/kg NIH HSDB max LD50 740 mg/kg NIH HSDB min Percent of active toxcast in vitro assavs tested 0.88 percent EPA Chemistry Dashboard A-104 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Acetophenone CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 OCCURRENCE DATA Scoring_Data_ Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contam nant Monitoring Rule (UCMR)4 2018-2019 Unregulated Contam nant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contam nant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contam nant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contam nant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contam nant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survey (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 563 11 Sites 1.95 0.1 0.2 0.3 0.5 National Water Qua lity Assessment (USGS NAWQA) (Surface Water) 1991-2017 88 11 Sites 12 0.1 0.2 0.3 0.5 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 475 0 Sites 0 Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) 13 981,013 Chemical Data Reporting (CDR) Results (EPA) (2016) 10M - 50M Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Glassmeyer et al 2017 (Finished) [86] 2007-2012 25 NA Sites 4 0.58 0.58 ug/L USGS, Sioux Falls Area, 2012 (Finished) [153] 2009-2010 1 0 Sites 0 Ambient Water Prevalence Magnitude National Water Information System (USGS NWIS) (Surface Water) 2008-2017 743 49 Sites 6.59 0.1 0.3 4.07 5.3 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008-2017 715 6 Sites 0.84 0.2 0.35 2.08 2.5 ug/L National Water Information System (USGS NWIS) (All Water) 2008-2017 1,458 55 Sites 3.77 0.1 0.3 3.25 5.3 ug/L Glassmeyer et al 2017 (Ambient) [86] 2007-2012 25 NA Sites 0 ug/L USGS, Sioux Falls Area, 2012 (Ambient) [153] 2009-2010 2 1 Sites 50 0.3 0.3 0.3 0.3 ug/L Waste Water Effluent Prevalence Magnitude Scott et al. 2018 (Wastewater) [161] 2011-2017 21 9 Sites 43 0.22 0.29 0.36 0.37 ug/L Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 0.0000215 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 5.40713 days Boiling point OPERA QSAR 200.433 degree C Boiling point TEST QSAR 209.024 degree C Vapor pressure OPERA QSAR 0.427749 mmHg Vapor pressure TEST QSAR 0.542001 mmHg Solubility in water OPERA QSAR 0.0393752 mol/L Solubility in water TEST QSAR 0.0215278 mol/L Bioconcentration factor OPERA QSAR 9.03932 no units Bioconcentration factor TEST QSAR 7.63836 no units Henry's Law constant OPERA QSAR 0.000011 atm-mA3/mol 0 eta no l/water partitioning coeff. (log Kow) OPERA QSAR 1.70555 no units A-105 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Acetophenone CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 86 Glassmeyer, S.T., Furlong, E.T., Kolpin, D.W., Batt, A.L., Benson, R., Boone, J.S.,... & Wilson, V.S. (2017). Nationwide reconnaissance of contaminants of emerging concern in source and treated drinking waters of the United States. Science of The Total Environment. v581-582, (909-922). 153 Occurrence of anthropogenic organic compounds and nutrients in source and finished water in the Sioux Falls area, South Dakota, 2009-10: U.S. Geological Survey Scientific Investigations Report 2012-5098, 21 p. plus appendixes. 161 Scott, T. M., Phillips, P. J., Kolpin, D. W., Colella, K. M., Furlong, E. T., Foreman, W. T., & Gray, J. L. (2018). Pharmaceutical manufacturing facility discharges can substantially increase the pharmaceutical load to US wastewaters. Science of the Total Environment, 636, 69-79. 197 USEPA. 1988. Chemical Assessment Summary, Acetophenone. U.S. Environmental Protection Agency, National Center for Environmental Assessment, Integrated Risk Information System (IRIS), Washington, DC. 322 USEPA. 2011. Provisional Peer-Reviewed Toxicity Values for Acetophenone. U.S. Environmental Protection Agency, Office of Research and Development, National Center for Environmental Assessment, Superfund Health Risk Technical Support Center, Cincinnati, OH. A-106 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Acrolein CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Acrolein CASRN: 107-02-8 DTXSID: DTXSID5020023 Use: Aquatic herbicide; rodenticide; industrial chemical Chemical Notes: Is the contaminant on any lists? CERCLA X FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts X Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Ust ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 6 non-cancer effects 3 7 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 20 forestomach squamous epithelial hyperplasia general population ATSDR 2007 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 2.7 90th Percentile All Ambient Water NAWQA 1991-2017 Final Hazard Quotient (HQ) 014 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-107 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Acrolein CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDW and OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg- HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.0005 mg/kg/day IRIS 2003 Parent et al., 1992c increased mortality general population 33.8 2.96 [258] Reference Dose (RfD) or Equivalent 0.004 mg/kg/day ATSDR 2007 NTP2006 forestomach squamous epithelial hyperplasia general population 33.8 23.7 [26] NOTE: no toxicity values were provided in the 2015 OPP assessment because chronic and acute oral exposures to acrolein are not expected based on use patterns, physical-chemical properties, and plant metabolism data. Therefore, the ATSDR Cancer Classification (CC) I OPP 2015 [338] Cancer Classification (CC) I IRIS 2003 [258] PPRTV 2002 [2521 Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg- CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title- abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Acute inhalation Minimal Risk Level (MRL) 0.003 PPm CDC ATSDR Cancer Classification (CC) 3 no units WHO IARC Human Health Ambient Water Quality 0.003 mg/L EPA Human Health Criteria for CWA Criteria Intermediate Inhalation Minimal Risk Level 0.00004 ppm CDC ATSDR (MRL) Intermediate Minimal Risk Level (MRL) 0.004 mg/kg/day CDC ATSDR Reference Concentration (RfC) 0.35 ug/mA3 CalEPA OEHHAChemical Database Reference Concentration (RfC) 0.00002 mg/mA3 EPA IRIS Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Measured Data and Assessment Results LD50 10.3 mg/kg NIH HSDB min LD50 46 mg/kg NIH HSDB max Percent of active toxcast in 0.85 percent EPA Chemistry Dashboard vitro assavs tested Data Element Value Units Source Notes Modeled Data LD50 0,0011588 mol/kg TEST QSAR Ames mutagenicity test 0.51 no units TEST QSAR Developmental toxin test 0.641 no units TEST QSAR A-108 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Acrolein CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 OCCURRENCE DATA Scoring_Data_ Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 1.183 3 Sites 0.25 1 2 2.7 3 National Water Qua lity Assessment (USGS NAWQA) (Surface Water) 1991-2017 102 3 Sites 2.94 1 2 2.7 3 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 1.081 0 Sites 0 Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) 25 1,242,926 Chemical Data Reporting (CDR) Results (EPA) (2016) 250M-500M Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Finished) 2006 - 2020 2 0 Sites 0 Ambient Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Source) 2006 - 2020 19 0 Sites 0 National Water Information System (USGS NWIS) (Surface Water) 2008-2017 69 5 Sites 7.25 0.4 1.3 4.44 7.5 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008-2017 21 0 Sites 0 National Water Information System (USGS NWIS) (All Water) 2008-2017 89 5 Sites 5.62 0.4 1.3 4.44 7.5 ug/L Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990-2018 2 0 Sites 0 Arnold et al. 2016 (Unfiltered) [7] 2012-2013 527 0 Sites 0 Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/ day) Notes Expocast exposure 0.000000128 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 3.67473 days Boiling point OPERA QSAR 59.2581 degree C Boiling point TEST QSAR 52.443 degree C Vapor pressure OPERA QSAR 199.082 mmHg Vapor pressure TEST QSAR 210.378 mmHg Solubility in water OPERA QSAR 4.7652 mol/L Solubility in water TEST QSAR 1.77419 mol/L Bioconcentration factor OPERA QSAR 3.77906 no units Bioconcentration factor TEST QSAR Henry's Law constant OPERA QSAR 0.0000817 atm-mA3/mol 0 eta no l/water partitioning coeff. (log Kow) OPERA QSAR 0.0512154 no units A-109 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Acrolein CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 26 ATSDR. 2007. Toxicological Profile for Acrolein. U.S. Department of Health and Human Services, Public Health Service, Agency for Toxic Substances and Disease Registry (ATSDR), Atlanta, GA. 252 USEPA. 2002. Provisional Peer-Reviewed Toxicity Values for Acrolein. U.S. Environmental Protection Agency, Office of Research and Development, National Center for Environmental Assessment, Superfund Health Risk Technical Support Center, Cincinnati, OH. 258 USEPA. 2003. Toxicological Review of Acrolein (CAS No. 107-02-8). U.S. Environmental Protection Agency, National Center for Environmental Assessment, Integrated Risk Information System (IRIS), Washington, D.C. 338 USEPA. 2015. Acrolein: Human Health Assessment Scoping Document in Support of Registration Review. EPA-HQ-OPP-2015-0571-0005. DP No. D427578. U.S. Environmental Protection Agency, Office o Chemical Safety and Pollution Prevention, Washington, D.C. 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticide in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. A-110 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Acyclovir CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Acyclovir CASRN: 59277-89-3 DTXSID: DTXSID1022556 Use: Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA Human Neurotoxicants PubMed Neu rotoxica nts X Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 6 non-cancer effects 9 3 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date SL 20 lowest therapeutic dose: antiviral/reduce duration and severity of herpes and chicken pox infection bottle-fed infants FDA; NIH 2018; 2018 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.248 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-111 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Acyclovir CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg- HRL (ug/L) Assessment Full Citation Notes Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg- CCL Screening Level (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.0025 mg/kg/day FDA 2018; NIH 2018 Ranbaxy Laboratori es Ltd. lowest therapeutic dose: antiviral/reduce duration and severity of herpes and chicken pox infection bottle-fed infants 151 17.0 [77] [150] NOTE: (LowestTherapeutic Dose/3000x UF) is used in place of an RfD; LTDs were obtained from FDA-approved drug labels Reference Dose (RfD) or Equivalent 0.0025 mg/kg/day FDA 2018; NIH 2018 Ranbaxy Laboratori es Ltd. lowest therapeutic dose: antiviral/reduce duration and severity of herpes and chicken pox infection general population 33.8 59.0 [77] [150] NOTE: (LowestTherapeutic Dose/3000x UF) is used in place of an RfD; LTDs were obtained from FDA-approved drug labels Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title- abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element I Value | Units | Source | Notes Measured Data and Assessment Results Cancer Classification (CC) 3 no units WHO IARC Maximum Recommended Daily Dose 13.3 mg/kg/day FDA Screening level for pharmaceutical - 0.058823529 mg/L EPA Office of Water general population Screening level for pharmaceutical - infants 0.016666667 mg/L I EPA Office of Water Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Measured Data and Assessment Results LD50 10000 mg/kg NIH HSDB Percent of active toxcast in 2.13 percent EPA Chemistry Dashboard vitro assavs tested Data Element Value Units Source Notes Modeled Data LD50 0.0013836 mol/kg TEST QSAR Ames mutagenicity test 0.173 no units TEST QSAR Developmental toxin test 0.62 no units TEST QSAR A-112 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Acyclovir CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contam nant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contam nant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contam nant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contam nant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contam nant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contam nant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 557 16 Sites 2.87 0.00428 0.02 0.248 0.787 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 75 16 Sites 21 0.00428 0.02 0.248 0.787 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 482 0 Sites 0 Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Glassmeyer et al 2017 (Finished) [86] 2007-2012 25 NA Sites 0 ug/L Ambient Water Prevalence Magnitude National Water Information System (USGS NWIS) (Surface Water) 2008-2017 205 53 Sites 26 0.00644 0.0506 0.238 4.35 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008-2017 401 2 Sites 0.5 0.0565 5.23 8.33 10.4 ug/L National Water Information System (USGS NWIS) (All Water) 2008-2017 606 55 Sites 9.08 0.00644 0.0509 0.259 10.4 ug/L Glassmeyer et a 1 2017 (Ambient) [86] 2007-2012 25 NA Sites 0 ug/L Bradley et al. 2017 (Ambient) [52] 2012-2014 38 14 Sites 37 0.0080967 0.314 0.484 0.6951437 ug/L Bexfield et al. 2019 (Groundwater) [49] 2013-2015 1,106 1 Sites 0.09 0.0056912 0.00569 0.00569 0.0056912 ug/L Waste Water Effluent Prevalence Magnitude Scott et al. 2018 (Wastewater) [161] 2011-2017 21 20 Sites 95 0.1394549 0.723 1.43 1.978684 ug/L Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 0.000000148 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 3.54608 days Boiling point OPERA QSAR 307.772 degree C Boiling point TEST QSAR Vapor pressure OPERA QSAR 3.19E-10 mmHg Vapor pressure TEST QSAR 0.000000125 mmHg Solubility in water OPERA QSAR 0.00889126 mol/L Solubility in water TEST QSAR 0.018239 mol/L Bioconcentration factor OPERA QSAR 1.585 no units Bioconcentration factor TEST QSAR 0.179061 no units Henry's Law constant OPERA QSAR 7.37E-11 o E E 0 eta no l/water partitioning coeff. (log Kow) OPERA QSAR -1.51937 no units A-113 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Acyclovir CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 49 Bexfield, L.M., P.L. Toccalino, K. Belitz, W.T. Foreman, and E.T. Furlong. 2019. Hormones and pharmaceuticals in groundwater used as a source of drinking water across the United States. Environmental Science and Technology 53: 2950-2960. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 77 FDA. 2018. Drugs @ FDA: FDA Approved Drug Products. U.S. Food and Drug Administration (FDA), https://www.accessdata.fda.gov/scripts/cder/daf/. 86 Glassmeyer, S.T., Furlong, E.T., Kolpin, D.W., Batt, A.L., Benson, R., Boone, J.S.,... & Wilson, V.S. (2017). Nationwide reconnaissance of contaminants of emerging concern in source and treated drinking waters of the United States. Science of The Total Environment. v581-582, (909-922). 150 NIH. 2018. DailyMed Database. U.S. National Library of Medicine, National Institutes of Health (NIH). https://dailymed.nlm.nih.gov/dailymed/. 161 Scott, T. M., Phillips, P. J., Kolpin, D. W., Colella, K. M., Furlong, E. T., Foreman, W. T., & Gray, J. L. (2018). Pharmaceutical manufacturing facility discharges can substantially increase the pharmaceutical load to US wastewaters. Science of the Total Environment, 636, 69-79. A-114 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Alachlor ethanesulfonic acid (ESA) CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Alachlor ethanesulfonic acid (ESA) CASRN: 142363-53-9 DTXSID: DTXSID6037485 Use: Pesticide degradate Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANTSUMMARY& DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT IN FORMATION Potency Severity Prevalence Magnitude 5 non-cancer effects 3 7 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date SL 70 hematological effects including decreased erythrocyte count, hemolytic anemia, decreased hemoglobin, decreased hematocrit and red cells, increased MCH and MCHC, and decreased body weight and body weight gain general population MDH 2016 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 1.26 90th Percentile Finished Water UCMR2 2008-2010 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-115 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Alachlor ethanesulfonic acid (ESA) CCL 5 Contaminant Information Sheet EPA-OGWDWand OST October 2022 HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.012 mg/kg/day MDH 2016 Heydens et al. 1996; EPA 1998; WDHFS 2005 hematological effects including decreased erythrocyte count, hemolytic anemia, decreased hemoglobin, decreased hematocrit and red cells, increased MCH and MCHC, and decreased body weight and body weight gain general population 33.8 71.0 [140] Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Chronic Health-Based Guidance Value 0.05 mg/L MN DOH Short-Term/Subchronic Health-Based Guidance 0.1 mg/L MN DOH Value Data Element I Value | Units | Source I Notes Measured Data and Assessment Results Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Modeled Data LD50 0.011885 mo l/kg TEST QSAR Ames mutagenicity test 0.566 no units TEST QSAR Developmental toxin test 1.193 no units TEST QSAR A-116 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Alachlor ethanesulfonic acid (ESA) CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST October 2022 Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018 - 2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013 - 2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008 - 2010 1,198 3 Sites 0.25 1 1.2 1.26 1.3 ug/L Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survey (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991 - 2017 2,708 553 Sites 20 0.015 0.15 1.1 34 ug/L National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991 - 2017 418 163 Sites 39 0.015 0.14 0.81 18.9 ug/L National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991 - 2017 2,290 390 Sites 17 0.02 0.215 2.38 34 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Finished) 2006 - 2020 4 0 Sites 0 USDA Pesticide Data Program (PDP) (Finished) 2001 - 2013 17 11 Sites 65 0.0028 0.017 0.0989 1.443 ug/L Community Water System Survey (CWSS) (Finished) [178] 2006 1 NA Sites 0.35 0.35 ug/L Ambient Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Source) 2006 - 2020 2 0 Sites 0 National Water Information System (USGS NWIS) (Surface Water) 2008 - 2017 351 38 Sites 11 0.02 0.06 0.586 1.68 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008 - 2017 822 188 Sites 23 0.02 0.435 1.88 7.07 ug/L National Water Information System (USGS NWIS) (All Water) 2008 - 2017 1,173 226 Sites 19 0.02 0.238 1.55 7.07 ug/L USDA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001 - 2013 229 159 Sites 69 0.0028 0.0208 0.14 4.31 ug/L USDA Pesticide Data Program (PDP) (Groundwater) 2001 - 2013 219 152 Sites 69 0.0028 0.0562 0.609 4.31 ug/L USDA Pesticide Data Program (PDP) (Untreated) 2001 - 2013 12 8 Sites 67 0.0028 0.017 0.1 1.037 ug/L Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990 - 2018 56 1 Sites 1.79 0.064 0.064 0.064 0.064 ug/L Community Water System Survey (CWSS) (Ambient) [178] 2006 1 NA Sites 0.28 4.19 ug/L Bradley et al. 2017 (Ambient) [52] 2012 - 2014 38 8 Sites 21 0.02 0.025 0.119 0.21 ug/L Arnold et al. 2016 (Filtered) [7] 2012 - 2013 584 33 Sites 5.65 0.12 0.331 1.49 3.37 ug/L Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg- bw/day) Notes Expo cast exposure 9.98E-08 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR4data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biode gradation ha If-life OPERA QSAR 4.29515 days Boiling point OPERA QSAR 314.576 degree C Boiling point TEST QSAR 380.403 degree C Vapor pressure OPERA QSAR 0.000000182 mmHg Vapor pressure TEST QSAR Solubility in water OPERA QSAR 0.0112346 mol/L Solubility in water TEST QSAR 0.00360579 mol/L Bioconcentration factor OPERA QSAR 9.61239 no units Bioconcentration factor TEST QSAR 7.53356 no units Flenry's Law constant OPERA QSAR 5.21E-10 atm-mA3/mol Octanol/water partitioning coeff. (logKow) OPERA QSAR 2.78498 no units A-117 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Alachlor ethanesulfonic acid (ESA) CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 140 MDH. 2016. Toxicological Summary for: Alachlor ESA and Alachlor OXA. Health Based Guidance for Water. Minnesota Department of Health (MDH), Environmental Health Division, Health Risk Assessment Unit, St Paul, MN. 178 USEPA (US Environmental Protection Agency). (2009). 2006 Community Water System Survey. Overview, 57. 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticide in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. A-118 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Alachlor oxanilic acid (OA) CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Alachlor oxanilic acid (OA) CASRN: 171262-17-2 DTXSID: DTXSID1037486 Use: Pesticide degradate Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANTSUMMARY& DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 5 non-cancer effects 1 1 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date SL 70 hematological effects including decreased erythrocyte count, hemolytic anemia, decreased hemoglobin, decreased hematocrit and red cells, increased MCH and MCHC, and decreased body weight and body weight gain general population MDH 2016 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.28 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-119 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Alachlor oxanilic acid (OA) CCL 5 Contaminant Information Sheet EPA-OGWDWand OST October 2022 HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.012 mg/kg/day MDH 2016 Heydens et al. 1996; EPA 1998; WDHFS 2005 hematological effects including decreased erythrocyte count, hemolytic anemia, decreased hemoglobin, decreased hematocrit and red cells, increased MCH and MCHC, and decreased body weight and body weight gain general population 33.8 71.0 [140] Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Chronic Health-Based Guidance Value 0.05 mg/L MN DOH Short-Term/Subchronic Health-Based Guidance 0.1 mg/L MN DOH Value Data Element I Value | Units | Source I Notes Measured Data and Assessment Results Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Modeled Data LD50 0.0100693 mo l/kg TEST QSAR Ames mutagenicity test 0.532 no units TEST QSAR Developmental toxin test 0.974 no units TEST QSAR A-120 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Alachlor oxanilic acid (OA) CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST October 2022 Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018 - 2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013 - 2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008 - 2010 1,198 0 Sites 0 ug/L Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survey (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991 - 2017 2,724 271 Sites 9.95 0.0043 0.05 0.28 36 ug/L National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991 - 2017 422 154 Sites 36 0.0043 0.0494 0.2 13.7 ug/L National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991 - 2017 2,302 117 Sites 5.08 0.01 0.114 1.06 36 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting(CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Finished) 2006 - 2020 4 0 Sites 0 USDA Pesticide Data Program (PDP) (Finished) 2001 - 2013 17 7 Sites 41 0.00102 0.008 0.052 0.4995 ug/L Bradley et al. 2018 (Finished) [53] 2016 26 1 Sites 3.85 0.32 0.32 0.32 0.32 ug/L Community Water System Survey (CWSS) (Finished) [178] 2006 1 NA Sites Ambient Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Source) 2006 - 2020 2 0 Sites 0 National Water Information System (USGS NWIS) (Surface Water) 2008 - 2017 355 44 Sites 12 0.0074 0.03 0.105 0.27 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008 - 2017 830 83 Sites 10 0.0157 0.0671 1.49 3.79 ug/L National Water Information System (USGS NWIS) (All Water) 2008 - 2017 1,185 127 Sites 11 0.0074 0.04 0.308 3.79 ug/L USDA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001 - 2013 229 98 Sites 43 0.001016 0.008 0.046 5.38 ug/L USDA Pesticide Data Program (PDP) (Groundwater) 2001 - 2013 219 92 Sites 42 0.001016 0.017 0.338 5.38 ug/L USDA Pesticide Data Program (PDP) (Untreated) 2001 - 2013 12 6 Sites 50 0.00102 0.008 0.041 0.102 ug/L Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990 - 2018 56 0 Sites 0 Community Water System Survey (CWSS) (Ambient) [178] 2006 1 NA Sites 1.85 1.85 ug/L Bradley et al. 2017 (Ambient) [52] 2012 - 2014 38 1 Sites 2.63 0.02 0.02 0.02 0.02 ug/L Arnold et al. 2016 (Filtered) [7] 2012 - 2013 584 11 Sites 1.88 0.0374 0.122 0.92 1.45 ug/L Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg- bw/day) Notes Expocast exposure 0.0000001 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biode gradation ha If-life OPERA QSAR 4.46456 days Boiling point OPERA QSAR 320.913 degree C Boiling point TEST QSAR 368.012 degree C Vapor pressure OPERA QSAR 0.000000225 mmHg Vapor pressure TEST QSAR 0.00000076 mmHg Solubility in water OPERA QSAR 0.00516306 mol/L Solubility in water TEST QSAR 0.0033037 mol/L Bioconcentration factor OPERA QSAR 2.90221 no units Bioconcentration factor TEST QSAR 1.30918 no units Flenry's Law constant OPERA QSAR 7E-10 atm-mA3/mol Octanol/water partitioning coeff. (logKow) OPERA QSAR 2.60613 no units A-121 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Alachlor oxanilic acid (OA) CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 53 Bradley, P. M., Kolpin, D. W., Romanok, K. M., Smalling, K. L., Focazio, M. J., Brown, J. B.,... & Dietze, J. E. (2018). Reconnaissance of mixed organic and inorganic chemicals in private and public supply tapwaters at selected residential and workplace sites in the United States. Environmental science & technology, 52(23), 13972-13985. 140 MDH. 2016. Toxicological Summary for: Alachlor ESA and Alachlor OXA. Health Based Guidance for Water. Minnesota Department of Health (MDH), Environmental Health Division, Health Risk Assessment Unit, St Paul, MN. 178 USEPA (US Environmental Protection Agency). (2009). 2006 Community Water System Survey. Overview, 57. 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticide in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. A-122 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Aldrin CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Aldrin CASRN: 309-00-2 DTXSID: DTXSID8020040 Use: Former insecticide Chemical Notes: Canceled pesticide. Last end of use date: 5/15/1987. Is the contaminant on any lists? CERCLA X FIFRA X Human Neurotoxicants X PubMed Neurotoxicants Neurodev. Disruptors Androgen Receptors in vitro Compounds with neurodev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Not List ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT IN FORMATION Potency Severity Prevalence Magnitude 7 carcinogen with linear MOA 1 6 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 0.002 general population OW 2003 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.667 90th Percentile Finished Water UCM2 1993 -1997 Final Hazard Quotient (HQ) 330 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS RD1 RD 2 RD 3 X Not Applicable Not Applicable Basis Aldrin may cause ad vers e health effects in huma ns, specifica My neurotoxicity to the cen ral nervous system [a,b,c]. However, its occurrence in drinking w ater at frequencies or concentrations significant for public health concer is low; occurrence estimates from a cross- section of States with UCM data are very low with only 0.006% of all samples and 0.02% of PWSs showing detections where the HRL is 0.002 ug/L[d,e]. Furthermore occurrence of aldrin in rinking water supplies is likely to decrease in the coming years, since the chemical is no longer produced or used comrr ercially [f]. [a] Jager, 1970 [113]; [b] ACGIH, 1984 [6]; [c] ATSDR, 2000 [16]; [d] US EPA, 2001 [239]; [e] USE PA, 2001 [247]; [f] ATSDR, 1993 [1]; as cited in USE PA, 2001 [179] Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-123 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Aldrin CCL5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.00003 mg/kg/day IRIS 1987 Fitzhugh et al. 1964 1 ive r toxic ity (les io ns) general population 33.8 0.178 [190] Reference Dose (RfD) or Equivalent 0.00003 mg/kg/day ATS DR 2002 Fitzhugh et al. 1964 histopat ho logical lesions in the liver general population 33.8 0.178 [18] Reference Dose (RfD) or Equivalent 0.00003 mg/kg/day OW 2003 Fitzhugh et al. 1964 histopat ho logical lesions in the liver general population 33.8 0.178 [255] NOTE: canceled registration, OPP does not provide a publicly-available health assessment for aldrin; no new information has been published by EPA regarding health effects of aldrin - refer to the 2003 RegDet supporting documentation Cancer Slope Factor (CSF) 17 (mg/kg/day)A-l IRIS 1987 Davis, 1965; NCI, 1978 general population 33.8 0.00174 [190] Cancer Slope Factor (CSF) 17 (mg/kg/day)A-l OW 2003 Davis, 1965; 1975; NCI, 1978 general population 33.8 0.00174 [255] NOTE: canceled registration, OPP does not provide a publicly-available health assessment for aldrin; no new information has been published by EPA regarding health effects of aldrin - refer to the 2003 RegDet supporting documentation Cancer Classification (CC) B2 IRIS 1987 [190] Cancer Classification (CC) B2 OW 2003 [255] NOTE: canceled registration, OPP does not provide a publicly-available health assessment for aldrin; no new information has been published by EPA regarding health effects of aldrin - refer to the 2003 RegDet supporting documentation OPP Data Element Value Units Assessment Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract No. Human Studies passed Title-abstract No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Notes Measured Data and Assessment Results 10-day Health Advisory 0.0003 mg/L EPA DWSHA 2018 Cancer Slope Factor (CSF) 17 (mg/kg/day) A-1 CalEPA OEHHA Chemical Database Drinking Water Guideline Value 0.00003 mg/L WHO Drinking Water Quality Guidelines Human Health Ambient Water Quality Criteria 7.7E-10 mg/L EPA Human Health Criteria for CWA Inhalation Unit Risk (IUR) 0.0049 (ug/m3)A-l EPA IRIS Inhalation Unit Risk (IUR) 0.0049 ug/mA3 CalEPA OEHHA Chemical Database Lifetime Health Advisory 0.000002 mg/L EPA DWSHA 2018 Subchronic Provisional RfD 0.00004 mg/kg/day EPA PPRTV Cancer Classification (CC) 2A no units WHO IARC Cancer Classification (CC) Female.Mice N no units HHSNTP Cancer Classification (CC) Female.Rats E no units HHSNTP Cancer Classification (CC) Male.Mice P no units HHSNTP Cancer Classification (CC) Male.Rats E no units HHSNTP Data Element Value Units Source Notes Modeled Data LD50 0.00010641 mol/kg TEST QSAR Ames mutagenicity test 0.166 no units TEST QSAR Developmental toxin test 0.493 no units TEST QSAR Data Element Value Units Notes Measured Data and Assessment Results LD50 39 mg/kg NIH HSDB min LD50 45 mg/kg NIH HSDB max Percent of active toxcast in vitro assays tested 30.45 percent EPA Chemistry Dashboard TD50 0.741 mg/kg/day NIH CPDB min TD50 466 mg/kg/day NIH CPDB max Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. A-124 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Aldrin CCL5 Contaminant Informatio OCCURRENCE DATA EPA-OGWDWand OST Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018 - 2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013 - 2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008 - 2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 12,165 2 Sites 0.02 0.46 0.575 0.667 0.69 ug/L Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survey (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991 - 2017 192 2 Sites 1.04 0.0012 0.0256 0.0402 0.05 ug/L National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991 - 2017 84 2 Sites 2.38 0.0012 0.0256 0.0402 0.05 ug/L National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991 - 2017 108 0 Sites 0 PesticideApplication Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) 7 15,373 Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Finished) 2006 - 2020 169 0 Sites 0 Drinking Water Monitoring Data - MA (Finished) 2006 - 2020 822 1 Sites 0.12 0.011 0.011 0.011 0.011 ug/L Drinking Water Monitoring Data - WA (Finished) 2006 - 2011 660 0 Sites 0 USDA Pesticide Data Program (PDP) (Finished) 2001 - 2013 10 0 Sites 0 Ambient Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Source) 2006 - 2020 1,551 1 Sites 0.06 0.084 0.084 0.084 0.084 ug/L Drinking Water Monitoring Data - FL (Source) 2006 - 2011 1 0 Sites 0 Drinking Water Monitoring Data - MA (Source) 2006 - 2020 78 0 Sites 0 Drinking Water Monitoring Data - PA (Source) 2006 - 2011 3 1 Sites 33 0.044 0.044 0.044 0.044 ug/L Drinking Water Monitoring Data - WA (Source) 2006 - 2011 738 0 Sites 0 Drinking Water Monitoring Data - Wl (Source) 2012-2019 92 0 Sites 0 National Water Information System (USGS NWIS) (Surface Water) 2008 - 2017 126 6 Sites 4.76 0.0016 0.011 0.08 0.207 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008 - 2017 297 0 Sites 0 National Water Information System (USGS NWIS) (All Water) 2008-2017 423 6 Sites 1.42 0.0016 0.011 0.08 0.207 ug/L USDA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001-2013 123 0 Sites 0 USDA Pesticide Data Program (PDP) (Groundwater) 2001-2013 113 0 Sites 0 USDA Pesticide Data Program (PDP) (Untreated) 2001-2013 10 0 Sites 0 Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990-2018 94 0 Sites 0 Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mgAg bw/day) Notes Expocast exposure 0.000000127 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) < LOD ng/g NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Value Units Notes Biodegradation half-life OPERA QSAR 363.235 days Boiling point OPERA QSAR 323.744 degree C Boiling point TEST QSAR 355.96 degree C Vapor pressure OPERA QSAR 0.0000876 mmHg Vapor pressure TEST QSAR 0.0000577 mmHg Solubility in water OPERA QSAR 7.58E-08 mol/L Solubility in water TEST QSAR 0.000000117 mol/L Bioconcentration factor OPERA QSAR 6522.68 no units Bioconcentration factor TEST QSAR 4017.91 no units Henry's Law constant OPERA QSAR 0.0000518 atm-mA3/mol Octanol/water partitioning coeff. (log Kow) OPERA QSAR 6.31366 no units A-125 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Aldrin CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 1 Agency for Toxic Substances and Disease Registry (ATSDR). 1993. Toxicological Profile for Aldrin/Dieldrin (update). Atlanta: Agency for Toxic Substances and Disease Registry. 184 pp 6 American Conference of Governmental Industrial Hygienists (ACGIH). 1984. Documentation of the Threshold Limit Values for Substances in Workroom Air. Third Edition. Cincinnati, OH: ACGIH. 139 pp. 16 ATSDR. 2000. Toxicological Profile for Aldrin/Dieldrin (Update). Atlanta, GA: Agency for Toxic Substances and Disease Registry. 280 pp. 18 ATSDR. 2002. Toxicological Profile for Aldrin/Dieldrin. U.S. Department of Health and Human Services, Public Health Service, Agency for Toxic Substances and Disease Registry (ATSDR), Atlanta, GA. 113 Jager, K.W. 1970. Aldrin, Dieldrin, Endrin and Telodrin: An Epidemiological and Toxicological Study of Long-Term Occupational Exposure. New York: Elsevier Publishing Company. 234 pp. 179 USEPA, 2001. Regulatory Determination Support Document for Aldrin and Dieldrin. EPA 815 R-01-011. 190 USEPA. 1987. Chemical Assessment Summary, Aldrin. U.S. Environmental Protection Agency, National Center for Environmental Assessment, Integrated Risk Information System (IRIS), Washington, DC. 239 USEPA. 2001. Analysis of National Occurrence of the 1998 Contaminant Candidate List Regulatory Determination Priority Contaminants in Public Water Systems. Office of Water. EPA report 815-D-01- 002. 77 pp. 247 USEPA. 2001. Occurrence of Unregulated Contaminants in Public Water Systems: An Initial Assessment. Office of Water. EPA report 815-P-00-001. Office of Water. 50 pp. 255 USEPA. 2003. Contaminant Candidate List Regulatory Determination Support Document for Aldrin and Dieldrin. U.S Environmental Protection Agency, Office of Water, Standards and Risk Management Divison, Washington, D.C. 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticide in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. A-126 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 alpha-Hexachlorocyclohexane CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: alpha-Hexachlo rocycloh exa ne CASRN: 319-84-6 DTXSID: DTXSID2020684 Use: Component of benzene h exa chloride (BHC) former insecticide Chemical Notes: Is the contaminant on any lists? CERCLA X FIFRA Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 6 carcinogen with linear MOA 5 3 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 0.005 hepatic nodules and hepatocellular general population IRIS 1987 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.0229 90th Percentile Finished Water UCMR4 2018-2019 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-127 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 alpha-Hexachlorocyclohexane CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg- HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.008 mg/kg/day ATSDR 2005 Fitzhugh et al. 1950 Hepatic effects: hepatic histopat ho logical changes general population 33.8 47.3 [22] Cancer Slope Factor (CSF) 6.3 (mg/kg/day)A-l IRIS 1987 Ito et al.( 1973a hepatic nodules and hepatocellular carcinomas general population 33.8 0.00470 [187] NOTE: this compound is a byproduct of production of gamma HCH (Lindane), which is no longer registered for use as a pesticide in the US Cancer Classification (CC) B2 IRIS 1987 [187] NOTE: this compound is a byproduct of production of gamma HCH (Lindane), which is no longer registered for use as a pesticide in the US Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg- CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title- abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Cancer Slope Factor (CSF) 2.7 (mg/kg/day) A-1 CalEPA 0 EH HA Chemical Database Human Health Ambient Water Quality 0.00000036 mg/L EPA Human Health Criteria for CWA Criteria Inhalation Unit Risk (IUR) 0.0018 (ug/m3)A-l EPA IRIS Inhalation Unit Risk (IUR) 0.00077 ug/mA3 CalEPA OEH HA Chemical Database Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Measured Data and Assessment Results LD50 177 mg/kg NIH HSDB Percent of active toxcast in 14.47 percent EPA Chemistry Dashboard vitro assavs tested Data Element Value Units Source Notes Modeled Data LD50 0.0012794 mol/kg TEST QSAR Ames mutagenicity test 0.233 no units TEST QSAR Developmental toxin test 0.229 no units TEST QSAR A-128 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 alpha-Hexachlorocyclohexane CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contam nant Monitoring Rule (UCMR) 4 2018-2019 3.649 20 Sites 0.55 0.01 0.0135 0.0229 0.067 Unregulated Contam nant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contam nant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contam nant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contam nant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contam nant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev(NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 8.230 23 Sites 0.28 4.00E - 04 0.0118 0.0646 0.21 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 1.820 20 Sites 1.1 4.00E - 04 0.0115 0.067 0.21 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 6.410 3 Sites 0.05 0.0012 0.0327 0.0511 0.059 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Finished) 2006 - 2020 34 1 Sites 2.94 0.012 0.012 0.012 0.012 ug/L USDA Pesticide Data Program (PDP) (Finished) 2001-2013 6 0 Sites 0 Ambient Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Source) 2006 - 2020 253 1 Sites 0.4 0.01 0.01 0.01 0.01 ug/L National Water Information System (USGS NWIS) (Surface Water) 2008-2017 242 4 Sites 1.65 0.01 0.01 0.02 0.06 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008-2017 725 2 Sites 0.28 0.0012 0.0014 0.00185 0.0021 ug/L National Water Information System (USGS NWIS) (All Water) 2008-2017 967 6 Sites 0.62 0.0012 0.01 0.01 0.06 ug/L USDA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001-2013 6 0 Sites 0 USDA Pesticide Data Program (PDP) (Untreated) 2001-2013 6 0 Sites 0 Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 0.000000102 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 18.5267 days Boiling point OPERA QSAR 236.373 degree C Boiling point TEST QSAR 276.233 degree C Vapor pressure OPERA QSAR 0.00355971 mmHg Vapor pressure TEST QSAR 0.0106905 mmHg Solubility in water OPERA QSAR 0.00000849 mol/L Solubility in water TEST QSAR 0.0000484 mol/L Bioconcentration factor OPERA QSAR 1506.74 no units Bioconcentration factor TEST QSAR 157.761 no units Henry's Law constant OPERA QSAR 0.00000734 atm-mA3/mol 0 eta no 1/water partitioning coeff. (log Kow) OPERA QSAR 3.66038 no units A-129 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 alpha-Hexachlorocyclohexane CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 22 ATSDR. 2005. Toxicological Profile for Alpha-, Beta-, Gamma-, and Delta-Hexachlorocyclohexane. U.S. Department of Health and Human Services, Public Health Service, Agency for Toxic Substances and Disease Registry (ATSDR), Atlanta, GA. 187 USEPA. 1987. Chemical Assessment Summary alpha-Hexachlorocyclohexane (alpha-HCH); CASRN 319-84-6. U.S. Environmental Protection Agency, National Center for Environmental Assessment, Integrated Risk Information System (IRIS), Washington, DC. A-130 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Ametryn CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Ametryn CASRN: 834-12-8 DTXSID: DTXSID1023869 Use: Herbicide Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANTSUMMARY& DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 4 non-cancer effects 9 2 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 400 degenerative and inflammatory liver effects general population OPP 2017 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.0101 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-131 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Ametryn CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.072 mg/kg/day OPP 2017 O'Connor 1987 degenerative and inflammatory liver effects general population 33.8 426 [376] Cancer Classification (CC) S OPP 2017 [3761 Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results 10-day Health Advisory 9 mg/L EPA DWSHA 2018 Lifetime Health Advisory 0.06 mg/L EPA DWSHA 2018 Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Measured Data and Assessment Results LD50 3170 mg/kg NIH HSDB max LD50 508 mg/kg NIH HSDB min LOAEL 131 mg/kg/day EPA Toxicity Reference Database max LOAEL 20.9 mg/kg/day EPA Toxicity Reference Database min NOAEL 14 mg/kg/day EPA Toxicity Reference Database max NOAEL 2.5 mg/kg/day EPA Toxicity Reference Database min Percent of active toxcast in 7.08 percent EPA Chemistry Dashboard vitro assays tested Subchronic LOAEL 36.099998 mg/kg/day EPA Toxicity Reference Database Subchronic NOAEL 7.6 mg/kg/day EPA Toxicity Reference Database Data Element Value Units Source Notes Modeled Data LD50 0.0045604 mo l/kg TEST QSAR Ames mutagenicity test 0.207 no units TEST QSAR Developmental toxin test 0.608 no units TEST QSAR A-132 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Ametryn CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 2.091 141 Sites 6.74 1.00E - 04 0.00306 0.0101 1.05 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 434 138 Sites 32 1.00E - 04 0.00304 0.01 1.05 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 1.657 3 Sites 0.18 0.00479 0.0209 0.203 0.281 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) 3 188,062 2016 Toxic Release Inventory (TRI) Program (EPA) (2016) 3 33,682 Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Finished) 2006 - 2020 3 0 Sites 0 Ambient Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Source) 2006 - 2020 17 0 Sites 0 National Water information System (USGS NWIS) (Surface Water) 2008-2017 381 42 Sites 11 0.00092 0.00508 0.03 0.266 ug/L National Water information System (USGS NWIS) (Groundwater) 2008-2017 622 1 Sites 0.16 0.00594 0.00594 0.00594 0.00594 ug/L National Water information System (USGS NWIS) (All Water) 2008-2017 1,003 43 Sites 4.29 0.00092 0.00554 0.03 0.266 ug/L Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990-2018 71 0 Sites 0 Arnold et al. 2016 (Filtered) [7] 2012-2013 584 0 Sites 0 Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 8.11E-08 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 3.35089 days Boiling point OPERA QSAR 343.891 degree C Boiling point TEST QSAR 360.753 degree C Vapor pressure OPERA QSAR 0.00000211 mmHg Vapor pressure TEST QSAR 0.000000871 mmHg Solubility in water OPERA QSAR 0.000630959 mol/L Solubility in water TEST QSAR 0.00110662 mol/L Bioconcentration factor OPERA QSAR 6.50043 no units Bioconcentration factor TEST QSAR 5.28445 no units Henry's Law constant OPERA QSAR 2.36E-08 atm-mA3/mol 0 eta no l/water partitioning coeff. (log Kow) OPERA QSAR 2.94353 no units A-133 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Ametryn CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 376 USEPA. 2017. Ametryn - Preliminary Human Health Risk Assessment for Registration Review. EPA-HQ-OPP-2013-0249-0022. DP No. D440785. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticide in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. A-134 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Ammonia CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Ammonia CASRN: 7664-41-7 DTXSID: DTXSID0023872 Use: Chemical intermediate; defoliant; antifungal agent for Chemical Notes: Is the contaminant on any lists? CERCLA X FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts X Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 1 1 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 1748 90th Percentile Finished Water DW Monitoring 2006 - 2011 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-135 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Ammonia CCL 5 Contaminant Information Sheet EPA-OGWDWand OST October 2022 HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Cancer Classification (CC) D OW1992 [219] PPRTV 2005 [263] WHO 2003 [437] HC 2013 [100] NOTE: All qualifying assessments decline to quantify oral toxicity ATSDR2004 [19] Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Reproductive 10 Zhang, 2018 Renal, Immune, Systemic 50 Zhang, 2018 2015-09-01 2020-03-25 4315 5 20 1 Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Acute inhalation Minimal Risk Level (MRL) 1.7 ppm CDC ATSDR Chronic inhalation Minimal Risk Level (MRL) 0.1 ppm CDC ATSDR Lifetime Health Advisory 30 mg/L EPA DWSHA 2018 Reference Concentration (RfC) 0.5 mg/mA3 EPA IRIS Reference Concentration (RfC) 200 ug/mA3 CalEPA OEHHA Chemical Database Subchronic RfC 0.1 mg/mA3 EPA PPRTV Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Modeled Data LD50 TEST QSAR Ames mutagenicity test TEST QSAR Developmental toxin test TEST QSAR Data Element I Value I Units 1 Source I Notes Measured Data and Assessment Results LD50 | 350 | mg/kg Inih hsdb l A-136 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Ammonia CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 OCCURRENCE DATA Scoring_Data_ Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contam nant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contam nant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contam nant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contam nant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contam nant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contam nant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survey (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 10 0 Sites 0 National Water Qua lity Assessment (USGS NAWQA) (Surface Water) 1991-2017 10 0 Sites 0 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) 50 158,252,384 Chemical Data Reporting (CDR) Results (EPA) (2016) 30B-40B Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Drinking Water Monitoring Data - WA (Finished) 2006-2011 18 7 Sites 39 104 1230 1748 2020 ug/L Glassmeyer et al 2017 (Finished) [86] 2007-2012 25 NA Sites 48 390 790 ug/L Ambient Water Prevalence Magnitude Drinking Water Monitoring Data - WA (Source) 2006-2011 13 6 Sites 46 19 160 1001 1460 ug/L Glassmeyer et al 2017 (Ambient) [86] 2007-2012 25 NA Sites 64 50 240 ug/L Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. A-137 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Ammonia CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 19 ATSDR. 2004. Toxicological Profile for Ammonia. U.S. Department of Health and Human Services, Public Health Service, Agency for Toxic Substances and Disease Registry (ATSDR), Atlanta, GA. 86 Glassmeyer, S.T., Furlong, E.T., Kolpin, D.W., Batt, A.L., Benson, R., Boone, J.S.,... & Wilson, V.S. (2017). Nationwide reconnaissance of contaminants of emerging concern in source and treated drinking waters of the United States. Science of The Total Environment. v581-582, (909-922). 100 Health Canada. 2013 Guideline Technical Document Ammonia. Health Canada (HC), Ottawa, Ontario, Canada. 219 USEPA. 1992. Drinking Water Health Advisories: Ammonia. U.S. Environmental Protection Agency, Office of Water, Health and Ecological Criteria Division, Washington, DC. 263 USEPA. 2005. Provisional Peer-Reviewed Toxicity Values for Ammonia. U.S. Environmental Protection Agency, Office of Research and Development, National Center for Environmental Assessment, Superfund Health Risk Technical Support Center, Cincinnati, OH. 437 WHO. 2003. Ammonia in Drinking-water. Background document for development of WHO Guidelines for Drinking-water Quality. World Health Organization (WHO), Geneva, Switzerland. A-138 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 ANDROSTENEDIONE CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION ANDROSTENEDIONE Chemical Notes: DTXSID8024523 Is the contaminant on any lists? CERCLA FIFRA Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro X Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 5 reproductive and developmental effects 9 1 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value («"gA) Critical Effect Target Pop. Assessment Assessment Pub. Date SL 100 hormone-related effects on male fertility (decreased number of sperm per mg cauda epididymis) general population ECHA 2011 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.00116 90th Percentile Finished Water UCMR3 2013-2015 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-139 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 ANDROSTENEDIONE CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.025 mg/kg/day ECHA 2011 NTP 2010; Blystone et al., 2011 hormone-related effects on male fertility (decreased number of sperm pe mg cauda epididymis) general population 33.8 148 [70] NOTE: An ECHA Derived No Effect Level (DNEL) is used in place of the RfD Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Developmental, Reproductive 1 Sprando, 2004 Systemic, Hepatic, 60 Wiesenfeld, 2006, 2020-04-14 2928 10 18 6 Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Cancer Classification (CC) Female.Mice P no units HHSNTP Cancer Classification (CC) Female.Rats EE no units HHSNTP Cancer Classification (CC) Male.Mice P no units HHS NTP Cancer Classification (CC) Male.Rats EE no units HHSNTP Data Element Value Units Source Notes Measured Data and Assessment Results LD50 1000 mg/kg NIH HSDB max LD50 500 mg/kg NIH HSDB min Percent of active toxcast in 14.15 percent EPA Chemistry Dashboard vitro assays tested Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Modeled Data LD50 0.0168267 mo l/kg TEST QSAR Ames mutagenicity test -0.062 no units TEST QSAR Developmental toxin test 0.958 no units TEST QSAR A-140 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 ANDROSTENEDIONE CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contam nant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contam nant Monitoring Rule (UCMR) 3 2013-2015 1.201 77 Sites 6.41 3.00E - 04 0.00047 0.00116 0.0041 Unregulated Contam nant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contam nant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contam nant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contam nant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev(NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 529 7 Sites 1.32 0.00041 0.00088 0.00217 0.00456 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 29 6 Sites 21 0.00041 0.00072 0.00111 0.00114 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 500 1 Sites 0.2 0.00456 0.00456 0.00456 0.00456 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude USGS, Sioux Falls Area, 2012 (Finished) [153] 2009-2010 1 0 Sites 0 Ambient Water Prevalence Magnitude National Water Information System (USGS NWIS) (Surface Water) 2008-2017 252 30 Sites 12 0.00032 0.00124 0.003 0.00828 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008-2017 354 3 Sites 0.85 0.00225 0.00238 0.00321 0.00356 ug/L National Water Information System (USGS NWIS) (All Water) 2008-2017 606 33 Sites 5.45 0.00032 0.00138 0.0032 0.00828 ug/L Bradley et al. 2017 (Ambient) [52] 2012-2014 38 6 Sites 16 0.001218 0.00283 0.00458 0.006126 ug/L Bexfield et al. 2019 (Groundwater) [49] 2013-2015 1,094 0 Sites 0 USGS, Sioux Falls Area, 2012 (Ambient) [153] 2009-2010 2 2 Sites 100 0.00046 0.00059 0.000694 0.00072 ug/L Waste Water Effluent Prevalence Magnitude Scott et al. 2018 (Wastewater) [161] 2011-2017 21 19 Sites 90 0.000789 0.00209 0.00553 0.007467 ug/L Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 0.00000022 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 58.1212 days Boiling point OPERA QSAR 346.557 degree C Boiling point TEST QSAR 358.124 degree C Vapor pressure OPERA QSAR 0.000000234 mmHg Vapor pressure TEST QSAR 0.000000441 mmHg Solubility in water OPERA QSAR 0.000161292 mol/L Solubility in water TEST QSAR 0.000065 mol/L Bioconcentration factor OPERA QSAR 37.295 no units Bioconcentration factor TEST QSAR 84.3335 no units Henry's Law constant OPERA QSAR 0.000000295 atm-mA3/mol 0 eta no 1/water partitioning coeff. (log Kow) OPERA QSAR 2.87316 no units A-141 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 ANDROSTENEDIONE CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 49 Bexfield, L.M., P.L. Toccalino, K. Belitz, W.T. Foreman, and E.T. Furlong. 2019. Hormones and pharmaceuticals in groundwater used as a source of drinking water across the United States. Environmental Science and Technology 53: 2950-2960. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 70 ECHA. 2011. Registration Dossier for Androst-4-ene-3,17-dione. European Chemicals Agency (ECHA), Helsinki, Finland. https://echa.europa.eu/registration-dossier/-/registered-dossier/13632/l Accessed 5/14/2020. 153 Occurrence of anthropogenic organic compounds and nutrients in source and finished water in the Sioux Falls area, South Dakota, 2009-10: U.S. Geological Survey Scientific Investigations Report 2012-5098, 21 p. plus appendixes. 161 Scott, T. M., Phillips, P. J., Kolpin, D. W., Colella, K. M., Furlong, E. T., Foreman, W. T., & Gray, J. L. (2018). Pharmaceutical manufacturing facility discharges can substantially increase the pharmaceutical load to US wastewaters. Science of the Total Environment, 636, 69-79. A-142 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Anthraquinone CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Anthraquinone CASRN: 84-65-1 DTXSID: DTXSID3020095 Use: Basis for the production of a large number of acid and base dyes, vat dyes, disperse dyes, and reactive dyes. Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUM MARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT IN FORMATION Potency Severity Prevalence Magnitude 4 carcinogen with linear MOA 9 4 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 0.8 increase in hepatocellular adenoma, carcinoma, or hepatoblastoma in male mice general population PPRTV 2011 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.284 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-143 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Anthraquinone CCL 5 Contaminant Information Sheet EPA-OGWDWand OST October 2022 HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.002 mg/kg/day PPRTV 2011 NTP (2005b) pathology in several organs, including the liver, kidney, and spleen, in male and female F344 rats. general population 33.8 11.8 [323] Cancer Slope Factor (CSF) 0.039 (mg/kg/day)A-l PPRTV 2011 NTP (2005b) The increase in hepatocellular adenoma, carcinoma, or hepatoblastoma ir male mice general population 33.8 0.759 [323] Cancer Classification (CC) L PPRTV 2011 [323] Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (ml/kg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Immune, Renal 3.2 Dodd,2013 Whole Body, Hepatic 3.2 Dodd, 2013 2010-02-01 2020-01-15 847 1 1 1 Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Subchronic Provisional RfD 0.01 mg/kg/day EPA PPRTV Cancer Classification (CC) 2B no units WHO IARC Cancer Classification (CC) Female.Mice P no units HHSNTP Cancer Classification (CC) Female.Rats P no units HHSNTP Cancer Classification (CC) Male.Mice P no units HHSNTP Cancer Classification (CC) Male.Rats SE no units HHSNTP Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Measured Data and Assessment Results LD50 5000 mg/kg NIH HSDB Percent of active toxcast in 1.28 percent EPA Chemistry Dashboard vitro assays tested Data Element Value Units Source Notes Modeled Data LD50 0.0150314 mo l/kg TEST QSAR Ames mutagenicity test 0.714 no units TEST QSAR Developmental toxin test 0.517 no units TEST QSAR A-144 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Anthraquinone CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 OCCURRENCE DATA Scoring_Data_ Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev(NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 567 28 Sites 4.94 0.01 0.05 0.284 0.78 National Water Qua lity Assessment (USGS NAWQA) (Surface Water) 1991-2017 88 28 Sites 32 0.01 0.05 0.284 0.78 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 479 0 Sites 0 Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) 10M - 50M Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude USGS, Sioux Falls Area, 2012 (Finished) [153] 2009-2010 1 0 Sites 0 Ambient Water Prevalence Magnitude National Water Information System (USGS NWIS) (Surface Water) 2008-2017 716 197 Sites 28 0.01 0.05 0.34 2.98 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008-2017 690 12 Sites 1.74 0.02 0.05 0.081 0.11 ug/L National Water Information System (USGS NWIS) (All Water) 2008-2017 1,406 209 Sites 15 0.01 0.05 0.34 2.98 ug/L Bradley etal. 2017 (Ambient) [52] 2012-2014 38 16 Sites 42 0.0128 0.0346 0.0522 0.0782 ug/L USGS, Sioux Falls Area, 2012 (Ambient) [153] 2009-2010 2 0 Sites 0 Waste Water Effluent Prevalence Magnitude Scott et al. 2018 (Wastewater) [161] 2011-2017 21 11 Sites 52 0.08 0.081 0.0818 0.082 ug/L Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 0.00000341 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR4 data used in the CCL5 is a partial datasetand will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 18.7227 days Boiling point OPERA QSAR 371.769 degree C Boiling point TEST QSAR 357.578 degree C Vapor pressure OPERA QSAR 0.000000108 mmHg Vapor pressure TEST QSAR 0.000000198 mmHg Solubility in water OPERA QSAR 0.0000094 mol/L Solubility in water TEST QSAR 0.00000416 mol/L Bioconcentration factor OPERA QSAR 28.7099 no units Bioconcentration factor TEST QSAR 101.158 no units Henry's Law constant OPERA QSAR 6.82E-08 atm-mA3/mol Octanol/water partitioning coeff. (log Kow) OPERA QSAR 3.23488 no units A-145 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Anthraquinone CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 153 Occurrence of anthropogenic organic compounds and nutrients in source and finished water in the Sioux Falls area, South Dakota, 2009-10: U.S. Geological Survey Scientific Investigations Report 2012-5098, 21 p. plus appendixes. 161 Scott, T. M., Phillips, P. J., Kolpin, D. W., Colella, K. M., Furlong, E. T., Foreman, W. T., & Gray, J. L. (2018). Pharmaceutical manufacturing facility discharges can substantially increase the pharmaceutical load to US wastewaters. Science of the Total Environment, 636, 69-79. 323 USEPA. 2011. Provisional Peer Reviewed Toxicity Values for 9,10-Anthraquinone(CASRN 84-65-1). EPA/690/R-11/007F. U.S. Environmental Protection Agency, Office of Research and Development, National Center for Environmental Assessment, Superfund Health Risk Technical Support Center, Cincinnati, OH. A-146 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Atenolol CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Atenolol CASRN: 29122-68-7 DTXSID: DTXSID2022628 Use: antihypertensive; antianginal; antiarrhythmic Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA Human Neurotoxicants PubMed Neu rotoxica nts X Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANTSUMMARY& DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 7 non-cancer effects 8 3 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date SL 1 lowest therapeutic dose: beta blocker/blood pressure reduction bottle-fed infants FDA; NIH 2018; 2018 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.08778 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-147 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Atenolol CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.000208333 mg/kg/day FDA 2018; NIH 2018 Caraco Pharmaceut ical Laboratories , LTD. lowest therapeutic dose:beta blocker/blood pressure reduction bottle-fed infants 151 1.40 [77] [150] NOTE: (Lowest Therapeutic Dose/3000x UF) is used in place of an RfD; LTDs were obtained from FDA-approved drug labels Reference Dose (RfD) or Equivalent 0.000208333 mg/kg/day FDA 2018; NIH 2018 Caraco Pharmaceut ical Laboratories . LTD. lowest therapeutic dose:beta blocker/blood pressure reduction general population 33.8 4.90 [77] [150] NOTE: (Lowest Therapeutic Dose/3000x UF) is used in place of an RfD; LTDs were obtained from FDA-approved drug labels Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Maximum Recommended Daily Dose 3.33 mg/kg/day FDA Screening level for pharmaceutical - general 0.004901961 mg/L EPA Office of Water population Screening level for pharmaceutical - infants 0.001388889 mg/L EPA Office of Water Data Element Value Units Source Notes Measured Data and Assessment Results LD50 2000 mg/kg NIH HSDB min LD50 3000 mg/kg NIH HSDB max Percent of active toxcast in vitro assays tested 0.7 percent EPA Chemistry Dashboard Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Modeled Data LD50 0.0089537 mo l/kg TEST QSAR Ames mutagenicity test 0.008 no units TEST QSAR Developmental toxin test 0.512 no units TEST QSAR A-148 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Atenolol CCL5 Contaminant Informatio OCCURRENCE DATA EPA-OGWDWand OST Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018 - 2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013 - 2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008 - 2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survey (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991 - 2017 557 12 Sites 2.15 0.00166 0.0225 0.0878 0.249 ug/L National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991 - 2017 75 12 Sites 16 0.00166 0.0225 0.0878 0.249 ug/L National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991 - 2017 482 0 Sites 0 PesticideApplication Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Glassmeyer et al 2017 (Finished) [86] 2007 - 2012 25 NA Sites 0 ug/L Padhye et al. 2013 (Finished) [155] 2009 - 2010 8 1 Samples 12 0 0 3.41e-05 +/- 0 ug/L Ambient Water Prevalence Magnitude National Water Information System (USGS NWIS) (Surface Water) 2008 - 2017 205 41 Sites 20 0.00096 0.0194 0.149 0.515 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008 - 2017 401 3 Sites 0.75 0.0081 0.00869 0.00872 0.00874 ug/L National Water Information System (USGS NWIS) (All Water) 2008 - 2017 606 44 Sites 7.26 0.00096 0.0179 0.148 0.515 ug/L Glassmeyer et a 12017 (Ambient) [86] 2007 - 2012 25 NA Sites 4 0.0298 0.0298 ug/L Batt et al. 2016 (Ambient) [46] 2008 - 2009 182 88 Sites 48 0.0019 0.0115 0.0653 0.1864 ug/L Bradley et a 1. 2017 (Ambient) [52] 2012 - 2014 38 15 Sites 39 0.0079363 0.171 0.422 0.5510741 ug/L Bexfield et al. 2019 (Groundwater) [49] 2013 - 2015 1,106 1 Sites 0.09 0.0087356 0.00874 0.00874 0.0087356 ug/L Padhye et al. 2013 (Ambient) [155] 2009 - 2010 8 0 Samples 0 0 0 0 ug/L Batt et al. (2008) via Kostich et al. 2010 (Ambient) [127] 2010 NA NA 0.035 ug/L Benotti et al. (2009) via Kostich et al. 2010 (Ambient) [127] 2010 NA NA 0.036 ug/L Conkle et al. (2008) via Kostich et al. 2010 (Ambient) [127] 2010 NA NA 0.02 ug/L Vanderford et al. (2006) via Kostich et al. 2010 (Ambient) [127] 2010 NA NA 0.859 ug/L Waste Water Effluent Prevalence Magnitude Scott et al. 2018 (Wastewater) [161] 2011 - 2017 21 21 Sites 100 0.0417468 0.579 1.47 3.233452 ug/L Kostich et al. 2014 (Wastewater) [126] not reported 50 48 Sites 96 0.0085 0.596 1.73 3.0733 ug/L Batt et al. (2008) via Kostich et al. 2010 (Wastewater) [127] 2010 NA NA 0.96 ug/L Conkle et al. (2008) via Kostich et al. 2010 (Wastewater) [127] 2010 NA NA 1.442 ug/L Palmer et al. (2008) via Kostich et al. 2010 (Wastewater) [127] 2010 NA NA 14.2 ug/L Vanderford et al. (2006) via Kostich et al. 2010 (Wastewater) [127] 2010 NA NA 3.06 ug/L Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 0.000000188 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for aII years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR4 data used in the CCL5 is a partial data set and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Value Units Notes Biodegradation half-life OPERA QSAR 3.34423 days Boiling point OPERA QSAR 296.692 degree C Boiling point TEST QSAR 384.93 degree C Vapor pressure OPERA QSAR 1.11E-09 mmHg Vapor pressure TEST QSAR 2.78E-08 mmHg Solubility in water OPERA QSAR 0.0489742 mol/L Solubility in water TEST QSAR 0.0201372 mol/L Biocon cent ration factor OPERA QSAR 1.41866 no units Biocon cent ration factor TEST QSAR 2.208 no units Henry's Law constant OPERA QSAR 4.35E-10 atm-mA3/mol Octanol/water partitioning coeff. (log Kow) OPERA QSAR 0.0522496 no units A-149 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Atenolol CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 46 Batt, A. L., Kincaid, T. M., Kostich, M. S., Lazorchak, J. M., & Olsen, A. R. (2016). Evaluating the extent of pharmaceuticals in surface waters of the United States using a Nationaicale Rivers and Streams Assessment survey. Environmental toxicology and chemistry, 35(4), 874-881. 49 Bexfield, L.M., P.L. Toccalino, K. Belitz, W.T. Foreman, and E.T. Furlong. 2019. Hormones and pharmaceuticals in groundwater used as a source of drinking water across the United States. Environmental Science and Technology 53: 2950-2960. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 77 FDA. 2018. Drugs @ FDA: FDA Approved Drug Products. U.S. Food and Drug Administration (FDA), https://www.accessdata.fda.gov/scripts/cder/daf/. 86 Glassmeyer, S.T., Furlong, E.T., Kolpin, D.W., Batt, A.L., Benson, R., Boone, J.S.,... & Wilson, V.S. (2017). Nationwide reconnaissance of contaminants of emerging concern in source and treated drinking waters of the United States. Science of The Total Environment. v581-582, (909-922). 126 Kostich MS, et al. 2014 Concentrations of prioritized pharmaceuticals in effluents from 50 large wastewater treatment plants in the US and implications for risk estimation. Environ Pollut. 2014 Jan;184:354-9. doi: 10.1016/j.envpol.2013.09.013. Epub 2013 Oct 3. PMID: 24095705. 127 Kostich, MS, etal., 2010. Predicting variability of aquatic concentrations of human pharmaceuticals. Sci. Total Environ. 408 (20), 4504e4510. 150 NIH. 2018. DailyMed Database. U.S. National Library of Medicine, National Institutes of Health (NIH). https://dailymed.nlm.nih.gov/dailymed/. 155 Padhye, L.P., Yao, H., Kung'u, F.T., and Huang, C.H. Year-long evaluation on the occurrence and fate of pharmaceuticals, personal care products, and endocrine disrupting chemicals in an urban drinking water treatment plant. 2014. Water Research 51 (2014) 266-276. 161 Scott, T. M., Phillips, P. J., Kolpin, D. W., Colella, K. M., Furlong, E. T., Foreman, W. T., & Gray, J. L. (2018). Pharmaceutical manufacturing facility discharges can substantially increase the pharmaceutical load to US wastewaters. Science of the Total Environment, 636, 69-79. A-150 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Azoxystrobin CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Azoxystrobin CASRN: 131860-33-8 DTXSID: DTXSID0032520 Use: Agricu Itu ra 1 fu ng ic id e Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Not List ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT IN FORMATION Potency Severity Prevalence Magnitude 4 non-cancer effects 10 2 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 1000 reduced body weights in both sexes and bile duct lesions in males general population OPP 2018 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.0265 90th Percentile All Ambient Water NAWQA 1991-2017 Final Hazard Quotient (HQ) 0.000027 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-151 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Azoxystrobin CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.18 mg/kg/day OPP 2018 Milburn 1995 reduced body weights in both sexes and bile duct lesions in males general population 33.8 1070 [396] Cancer Classification (CC) NL OPP 2018 [3961 Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Acute Human Health Benchmark 4.5 mg/L EPA HHBP Acute PAD 0.67 mg/kg/day EPA HHBP Chronic Human Health Benchmark 1.2 mg/L EPA HHBP Health-Based Screening Level 1.2 mg/L Health-based screening levels from USGS Population-Adjusted Dose (PAD) 0.18 mg/kg/day EPA HHBP Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element I Value I Units I Source I Notes Measured Data and Assessment Results LD50 5000 mg/kg NIH HSDB LOAEL 25 mg/kg/day EPA Toxicity Reference Database min LOAEL 500 mg/kg/day EPA Toxicity Reference Database max NOAEL 150 mg/kg/day EPA Toxicity Reference Database max NOAEL 22.3 mg/kg/day EPA Toxicity Reference Database min Percent of active toxcast in vitro assays tested 21.17 percent EPA Chemistry Dashboard Subchronic LOAEL 211 mg/kg/day EPA Toxicity Reference Database min Subchronic LOAEL 250 mg/kg/day EPA Toxicity Reference Database max Subchronic NOAEL 22.4 mg/kg/day EPA Toxicity Reference Database min Subchronic NOAEL 50 mg/kg/day EPA Toxicity Reference Database max Data Element Value Units Source Notes Modeled Data LD50 0.001052 mo l/kg TEST QSAR Ames mutagenicity test 0.199 no units TEST QSAR Developmental toxin test 0.961 no units TEST QSAR A-152 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Azoxystrobin CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev(NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 1.763 263 Sites 15 0.00012 0.00323 0.0265 2.91 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 324 253 Sites 78 0.00012 0.00323 0.0265 2.91 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 1.439 10 Sites 0.69 0.00036 0.00121 0.0144 0.26 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) 48 2,436,869 2016 Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude USDA Pesticide Data Program (PDP) (Finished) 2001-2013 10 8 Sites 80 0.0013 0.0032 0.0375 0.39 ug/L Bradley et al. 2018 (Finished) [53] 2016 26 1 Sites 3.85 0.0218 0.0218 0.0218 0.0218 ug/L Ambient Water Prevalence Magnitude National Water Information System (USGS NWIS) (Surface Water) 2008-2017 434 186 Sites 43 0.00013 0.0066 0.141 128 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008-2017 531 6 Sites 1.13 0.00061 0.00169 0.00654 0.0101 ug/L National Water Information System (USGS NWIS) (All Water) 2008-2017 965 192 Sites 20 0.00013 0.00651 0.141 128 ug/L USDA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001-2013 227 12 Sites 5.29 0.0013 0.0013 0.0196 0.662 ug/L USDA Pesticide Data Program (PDP) (Groundwater) 2001-2013 218 3 Sites 1.38 0.0044 0.0084 0.467 0.662 ug/L USDA Pesticide Data Program (PDP) (Untreated) 2001-2013 10 9 Sites 90 0.0013 0.0013 0.0184 0.24 ug/L Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990-2018 676 311 Sites 46 0.0033 0.0332 0.412 2.67 ug/L Bradley etal. 2017 (Ambient) [52] 2012-2014 38 9 Sites 24 0.005 0.0281 0.252 0.2795 ug/L Arnold et al. 2016 (Filtered) [7] 2012-2013 584 4 Sites 0.68 4e-04 0.0013 0.00194 0.002 ug/L Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 2.46E-08 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR4 data used in the CCL5 is a partial datasetand will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 4.28513 days Boiling point OPERA QSAR 359.001 degree C Boiling point TEST QSAR 474.033 degree C Vapor pressure OPERA QSAR 1.89E-12 mmHg Vapor pressure TEST QSAR 9.42E-11 mmHg Solubility in water OPERA QSAR 0.0000121 mol/L Solubility in water TEST QSAR 0.00000154 mol/L Bioconcentration factor OPERA QSAR 12.6717 no units Bioconcentration factor TEST QSAR Henry's Law constant OPERA QSAR 3.48E-09 atm-mA3/mol Octanol/water partitioning coeff. (log Kow) OPERA QSAR 2.71667 no units A-153 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Azoxystrobin CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 53 Bradley, P. M., Kolpin, D. W., Romanok, K. M., Smalling, K. L., Focazio, M. J., Brown, J. B.,... & Dietze, J. E. (2018). Reconnaissance of mixed organic and inorganic chemicals in private and public supply tapwaters at selected residential and workplace sites in the United States. Environmental science & technology, 52(23), 13972-13985. 396 USEPA. 2018. Azoxystrobin: Revised Human Health Draft Risk Assessment for Registration Review. EPA-HQ-OPP-2009-0835-0043. DP No. D444164. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticide in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. A-154 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Benfluralin CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Benfluralin CASRN: 1861-40-1 DTXSID: DTXSID3023899 Use: Pre-emergent d in rtroan iline herbicide used to control grasses and other weed species Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANTSUMMARY& DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 6 non-cancer effects 8 2 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 30 increased histopathologic lesions of the kidneys general population OPP 2017 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.011 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-155 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Benfluralin CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.005 mg/kg/day OPP 2017 Moore 1996,1998 increased histopathologic lesions of the kidneys general population 33.8 29.6 [377] Cancer Classification (CC) S OPP 2017 [3771 Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Chronic Human Health Benchmark 0.03 mg/L EPA HHBP Health-Based Screening Level 0.03 mg/L Health-based screening levels from USGS Population-Adjusted Dose (PAD) 0.005 mg/kg/day EPAHHBP Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Measured Data and Assessment Results LD50 10000 mg/kg NIH HSDB max LD50 5000 mg/kg NIH HSDB min LOAEL 1000 mg/kg/day EPA Toxicity Reference Database max LOAEL 25 mg/kg/day EPA Toxicity Reference Database min NOAEL 475 mg/kg/day EPA Toxicity Reference Database max NOAEL 5 mg/kg/day EPA Toxicity Reference Database min Percent of active toxcast in 9.87 percent EPA Chemistry Dashboard vitro assays tested Subchronic LOAEL 25 mg/kg/day EPA Toxicity Reference Database Subchronic NOAEL 5 mg/kg/day EPA Toxicity Reference Database Data Element Value Units Source Notes Modeled Data LD50 0.0156315 mo l/kg TEST QSAR Ames mutagenicity test 0.608 no units TEST QSAR Developmental toxin test 1.142 no units TEST QSAR A-156 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Benfluralin CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST October 2022 Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR)4 2018 - 2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013 - 2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008 - 2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitor ing-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survey (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991 - 2017 10,167 152 Sites 1.5 0.001 0.004 0.011 0.205 ug/L National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991 - 2017 2,044 133 Sites 6.51 0.001 0.0045 0.012 0.205 ug/L National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991 - 2017 8,123 19 Sites 0.23 0.001 0.004 0.008 0.011 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) 7 53,174 2016 Toxic Release Inventory (TRI) Program (EPA) (2016) 2 1,250 Chemical Data Reporting (CDR) Results (EPA) (2016) N on-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Finished) 2006 - 2020 1 0 Sites 0 USDA Pesticide Data Program (PDP) (Finished) 2001 - 2013 17 0 Sites 0 USGS, Sioux Falls Area, 2012 (Finished) [153] 2009 - 2010 1 0 Sites 0 Ambient Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Source) 2006 - 2020 33 0 Sites 0 National Water Information System (USGS NWIS) (Surface Water) 2008 - 2017 706 22 Sites 3.12 0.001 0.007 0.019 0.088 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008 - 2017 2,606 18 Sites 0.69 0.001 0.003 0.0068 0.014 ug/L National Water Information System (USGS NWIS) (All Water) 2008 - 2017 3,311 40 Sites 1.21 0.001 0.005 0.018 0.088 ug/L USDA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001 - 2013 149 0 Sites 0 USDA Pesticide Data Program (PDP) (Groundwater) 2001 - 2013 139 0 Sites 0 USDA Pesticide Data Program (PDP) (Untreated) 2001 - 2013 12 0 Sites 0 Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990 - 2018 1,268 16 Sites 1.26 0.007 0.0125 0.203 2.71 ug/L Bradley et al. 2017 (Ambient) [52] 2012 - 2014 38 2 Sites 5.26 2.04e-05 5.69e-05 8.61e-05 9.34e-05 ug/L Arnold et al. 2016 (Filtered) [7] 2012 - 2013 106 0 Sites 0 USGS, Sioux Falls Area, 2012 (Ambient) [153] 2009 - 2010 2 0 Sites 0 lA/osfe Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg- bw/day) Notes Expocast exposure 0.000000121 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection n serum (1999-2016) NHANES biomonitoring detection n blood (1999-2016) NHANES biomonitoring detection n urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blank fie Ids indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation ha If-life OPERA QSAR 3.54014 days Boiling point OPERA QSAR 366.246 degree C Boiling point TEST QSAR 361.409 degree C Vapor pressure OPERA QSAR 0.0000568 mmHg Vapor pressure TEST QSAR 0.00000446 mmHg Solubility in water OPERA QSAR 0.000000357 mol/L Solubility in water TEST QSAR 0.00000164 mol/L B ioco nee nt rat io n facto r OPERA QSAR 941.493 no units B ioco nee nt rat io n facto r TEST QSAR 234.963 no units Flenry's Law constant OPERA QSAR 0.0000487 atm-mA3/mol Octanol/water partitioning coeff. (log Kow) OPERA QSAR 5.26734 no units A-157 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Benfluralin CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 153 Occurrence of anthropogenic organic compounds and nutrients in source and finished water in the Sioux Falls area, South Dakota, 2009-10: U.S. Geological Survey Scientific Investigations Report 2012-5098, 21 p. plus appendixes. 377 USEPA. 2017. Benfluralin: Human Health Draft Risk Assessment for Registration Review. EPA-HQ-OPP-2011-0931-0039. DP No. D431028. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticide in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. A-158 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Bensulide CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Chemical Notes: DTXSID9032329 Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants X PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 5 reproductive and developmental effects 7 6 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value («"gA) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 8 inhibition of red blood cell chol in esterase in pups bottle-fed infants OPP 2016 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 979 EDWCSW peak OPP 2016 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-159 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Bensulide CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.006 mg/kg/day OPP 2016 Barnett 2014 inhibition of red blood cell cholinesterase in pups bottle-fed infants 151 7.95 [361] Cancer Classification (CC) E OPP 2016 [3611 Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Acute Human Health Benchmark 1 mg/L EPA HHBP Acute PAD 0.15 mg/kg/day EPA HHBP Chronic Human Health Benchmark 0.03 mg/L EPA HHBP Population-Adjusted Dose (PAD) 0.005 mg/kg/day EPA HHBP Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element I Value I Units I Source I Notes Measured Data and Assessment Results LD50 1540 mg/kg NIH HSDB max LD50 270 mg/kg NIH HSDB min LOAEL 4 mg/kg/day EPA Toxicity Reference Database min LOAEL 95 mg/kg/day EPA Toxicity Reference Database max NOAEL 0.5 mg/kg/day EPA Toxicity Reference Database min NOAEL 23 mg/kg/day EPA Toxicity Reference Database max Percent of active toxcast in vitro assays tested 24.56 percent EPA Chemistry Dashboard Subchronic LOAEL 1 mg/kg/day EPA Toxicity Reference Database min Subchronic LOAEL 15 mg/kg/day EPA Toxicity Reference Database max Subchronic NOAEL 5 mg/kg/day EPA Toxicity Reference Database Data Element Value Units Source Notes Modeled Data LD50 0.0004446 mo l/kg TEST QSAR Ames mutagenicity test 0.636 no units TEST QSAR Developmental toxin test 0.742 no units TEST QSAR A-160 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Bensulide CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev(NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 Pesticide Application Data Number of States Amount Applied (lbs/year) Date Estimated Annual Agricultural Pesticide Use (USGS) 9 710,457 2016 Toxic Release Data Number of States Amount Released (lbs/year) Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Production Data Production Volume (lbs/year) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Ambient Water Prevalence Magnitude Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990-2018 544 320 Sites 59 0.02 0.69 6.38 142 ug/L Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Estimated Drinking Water Concentration (EDWC) in Surface Water, Peak 2016 OPP 979 ug/L Tier II Surface Water Concentration Calculator Kwrn v1 1Q6 The critical effect of chol in esterase inhibition in postnatal day 11 pups is considered a less-than-chronic response in a sensitive population. To be protective of this population, the modeled surface water peak concentration was selected as the occurrence Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 0.000000142 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 104.45 days Boiling point OPERA QSAR 394.639 degree C Boiling point TEST QSAR Vapor pressure OPERA QSAR 0.000000972 mmHg Vapor pressure TEST QSAR 0.00000121 mmHg Solubility in water OPERA QSAR 0.0000651 mol/L Solubility in water TEST QSAR 0.0000385 mol/L Bioconcentration factor OPERA QSAR 4.85073 no units Bioconcentration factor TEST QSAR 13.4276 no units Henry's Law constant OPERA QSAR 0.00000159 atm-mA3/mol 0 eta no 1/water partitioning coeff. (log Kow) OPERA QSAR 4.0814 no units A-161 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Bensulide CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 361 USEPA. 2016. Bensulide: Human Health Risk Assessment to Support Registration Review. EPA-HQ-OPP-2008-0022-0019. DP No. D428598. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticide in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. A-162 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Bentazon CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Chemical Notes: DTXSID0023901 Former herbicide Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 4 reproductive and developmental effects 9 3 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value («"gA) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 200 decreased pup body weight during lactation bottle-fed infants OPP 2014 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.14 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-163 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Bentazon CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.15 mg/kg/day OPP 2014 Suteret al. 1989 decreased pup body weight during lactation bottle-fed infants 151 199 [335] Cancer Classification (CC) E OPP 2014 [3351 Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results 10-day Health Advisory 0.3 mg/L EPA DWSHA2018 Acute Health-Based Guidance Value 0.06 mg/L MN DOH Acute Health-Based Guidance Value 0.4 mg/L MN DOH Chronic Health-Based Guidance Value 0.03 mg/L MN DOH Lifetime Health Advisory 0.2 mg/L EPA DWSHA 2018 Public Health Goal 0.2 mg/L CalEPA OEHHA Public Health Goals Short-Term/Subchronic Health-Based Guidance 0.05 mg/L MN DOH Value Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Modeled Data LD50 TEST QSAR Ames mutagenicity test TEST QSAR Developmental toxin test 1.022 no units TEST QSAR Data Element Value Units Source Notes Measured Data and Assessment Results LD50 1139 mg/kg NIH HSDB max LD50 383.2 mg/kg NIH HSDB min LOAEL 13.1 mg/kg/day EPA Toxicity Reference Database min LOAEL 249 mg/kg/day EPA Toxicity Reference Database max NOAEL 3.2 mg/kg/day EPA Toxicity Reference Database min NOAEL 62 mg/kg/day EPA Toxicity Reference Database max Percent of active toxcast in 3.41 percent EPA Chemistry Dashboard vitro assays tested Subchronic LOAEL 243.3 mg/kg/day EPA Toxicity Reference Database Subchronic NOAEL 86.1 mg/kg/day EPA Toxicity Reference Database A-164 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Bentazon CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev(NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 7.741 470 Sites 6.07 0.00051 0.0129 0.14 19 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 1.195 273 Sites 23 0.00051 0.0121 0.12 19 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 6.546 197 Sites 3.01 0.00193 0.06 0.926 11.5 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) 41 2,631,678 2016 Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Finished) 2006 - 2020 211 0 Sites 0 USDA Pesticide Data Program (PDP) (Finished) 2001-2013 17 8 Sites 47 3e-04 0.0013 0.00757 0.1 ug/L Ambient Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Source) 2006 - 2020 2,231 3 Sites 0.13 4.6 5.3 8.42 9.2 ug/L National Water information System (USGS NWIS) (Surface Water) 2008-2017 476 96 Sites 20 0.00117 0.0104 0.0772 13.2 ug/L National Water information System (USGS NWIS) (Groundwater) 2008-2017 1,059 39 Sites 3.68 0.00601 0.0354 0.115 4.49 ug/L National Water information System (USGS NWIS) (All Water) 2008-2017 1,535 135 Sites 8.79 0.00117 0.0121 0.0874 13.2 ug/L USDA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001-2013 229 79 Sites 34 3e-04 0.0013 0.0098 1.31 ug/L USDA Pesticide Data Program (PDP) (Groundwater) 2001-2013 219 72 Sites 33 3e-04 0.00111 0.0186 1.31 ug/L USDA Pesticide Data Program (PDP) (Untreated) 2001-2013 12 7 Sites 58 3e-04 0.0014 0.0097 0.194 ug/L Bradley et al. 2017 (Ambient) [52] 2012-2014 38 5 Sites 13 0.0116 0.0187 0.0624 0.088 ug/L Arnold et al. 2016 (Filtered) [7] 2012-2013 690 13 Sites 1.88 0.0019 0.0216 0.124 0.398 ug/L USGS, McKenzie River, Oregon, 2012 (Ambient) [158] 2002-2010 126 4 Samples 3.2 0.03 ug/L Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 0.000000017 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 4.9037 days Boiling point OPERA QSAR 303.93 degree C Boiling point TEST QSAR Vapor pressure OPERA QSAR 0.000000943 mmHg Vapor pressure TEST QSAR Solubility in water OPERA QSAR 0.00219058 mol/L Solubility in water TEST QSAR 0.0000541 mol/L Bioconcentration factor OPERA QSAR 1.4173 no units Bioconcentration factor TEST QSAR Henry's Law constant OPERA QSAR 2.59E-10 atm-mA3/mol 0 eta no 1/water partitioning coeff. (log Kow) OPERA QSAR 2.10469 no units A-165 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Bentazon CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 158 Reconnaissance of Land-Use Sources of Pesticides in Drinking Water, McKenzie River, Oregon. U.S. Geological Survey Scientific Investigations Report 2012-5091, 46 p. plus appendixes. 335 USEPA. 2014. Sodium Bentazon - Preliminary Human Health Risk Assessment for Registration Review. EPA-HQ-OPP-2010-0117. DP No. D417312. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. A-166 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Benzophenone CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Benzophenone CASRN: 119-61-9 DTXSID: DTXSID0021961 Use: Chemical intemediate used pesticide, fragrance, varnish, antihistamines Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANTSUMMARY& DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 4 non-cancer effects 10 4 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date SL 300 increased renal tubule hyperplasia general population MDH 2019 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.112 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-167 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Benzophenone CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDW and OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg- HRL (ug/L) Assessment Full Citation Notes Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg- CCL Screening Level (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.03 mg/kg/day ECHA 2018 NTP2006 "non-neoplastic kidney effects" general population 33.8 178 [67] Reference Dose (RfD) or Equivalent 0.053 mg/kg/day MDH 2019 National Toxicology Program, 2006 " Increased renal tubule hyperplasia" general population 33.8 314 [146] Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title- abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Hepatic 6.445 Hoshino, 2005 Female Reproductive, Nervous System, Gastrointestinal, Musculoskeletal, Endocrine 4199 Chhabra, 2000 2020-01-28 1221 7 15 5 Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Cancer Classification (CC) 2B no units WHO IARC Cancer Classification (CC) Female.Mice SE no units HHS NTP Cancer Classification (CC) Female.Rats no units HHS NTP Cancer Classification (CC) Male.Mice SE no units HHS NTP Cancer Classification (CC) Male.Rats SE no units HHS NTP Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Measured Data and Assessment Results LD50 10000 mg/kg NIH HSDB max LD50 1900 mg/kg NIH HSDB min LOAEL 130 mg/kg/day EPA Toxicity Reference Database max LOAEL 8.776 mg/kg/day EPA Toxicity Reference Database min NOAEL 40.52 mg/kg/day EPA Toxicity Reference Database max NOAEL 5 mg/kg/day EPA Toxicity Reference Database min Percent of active toxcast in 3.43 percent EPA Chemistry Dashboard vitro assays tested Data Element Value Units Source Notes Modeled Data LD50 0.0262422 mol/kg TEST QSAR Ames mutagenicity test 0.378 no units TEST QSAR Developmental toxin test 0.553 no units TEST QSAR A-168 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Benzophenone CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contam nant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contam nant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contam nant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contam nant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contam nant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contam nant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 556 74 Sites 13 0.01 0.04 0.112 0.4 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 86 29 Sites 34 0.01 0.04 0.117 0.33 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 470 45 Sites 9.57 0.01 0.06 0.105 0.4 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) 1M - 10M Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Glassmeyer et al 2017 (Finished) [86] 2007-2012 25 NA Sites 0 ug/L USGS, Sioux Falls Area, 2012 (Finished) [153] 2009-2010 1 0 Sites 0 Ambient Water Prevalence Magnitude National Water Information System (USGS NWIS) (Surface Water) 2008-2017 713 243 Sites 34 0.01 0.05 0.13 6.83 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008-2017 688 89 Sites 13 0.01 0.025 0.076 0.34 ug/L National Water Information System (USGS NWIS) (All Water) 2008-2017 1,401 332 Sites 24 0.01 0.04 0.12 6.83 ug/L Glassmeyer et a 1 2017 (Ambient) [86] 2007-2012 25 NA Sites 0 ug/L Bradley et al. 2017 (Ambient) [52] 2012-2014 38 12 Sites 32 0.0714 0.184 0.214 0.221 ug/L USGS, Sioux Falls Area, 2012 (Ambient) [153] 2009-2010 2 2 Sites 100 Waste Water Effluent Prevalence Magnitude Scott et al. 2018 (Wastewater) [161] 2011-2017 21 20 Sites 95 0.051 0.17 0.34 0.36 ug/L Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 0.0000335 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 3.31313 days Boiling point OPERA QSAR 306.491 degree C Boiling point TEST QSAR 303.142 degree C Vapor pressure OPERA QSAR 0.00114394 mmHg Vapor pressure TEST QSAR 0.000349945 mmHg Solubility in water OPERA QSAR 0.00063623 mol/L Solubility in water TEST QSAR 0.00027227 mol/L Bioconcentration factor OPERA QSAR 25.7151 no units Bioconcentration factor TEST QSAR 87.9023 no units Henry's Law constant OPERA QSAR 0.0000011 atm-mA3/mol 0 eta no l/water partitioning coeff. (log Kow) OPERA QSAR 3.27814 no units A-169 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Benzophenone CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 67 Danish Environmental Protection Agency. 2018. Substance Evaluation Conclusion as required by REACH Article 48 and Evaluation Report for Benzophenone EC No 204-337-6 CAS No 119-61-9. Copenhagen, Denmark. EC No 204-337-6 86 Glassmeyer, S.T., Furlong, E.T., Kolpin, D.W., Batt, A.L., Benson, R., Boone, J.S.,... & Wilson, V.S. (2017). Nationwide reconnaissance of contaminants of emerging concern in source and treated drinking waters of the United States. Science of The Total Environment. v581-582, (909-922). 146 MDH. 2019 Toxicological Summary for Benzophenone. Minnesota Department of Health (MDH), Environmental Health Division, Health Risk Assessment Unit, St Paul, MN. 153 Occurrence of anthropogenic organic compounds and nutrients in source and finished water in the Sioux Falls area, South Dakota, 2009-10: U.S. Geological Survey Scientific Investigations Report 2012-5098, 21 p. plus appendixes. 161 Scott, T. M., Phillips, P. J., Kolpin, D. W., Colella, K. M., Furlong, E. T., Foreman, W. T., & Gray, J. L. (2018). Pharmaceutical manufacturing facility discharges can substantially increase the pharmaceutical load to US wastewaters. Science of the Total Environment, 636, 69-79. A-170 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Bifenthrin CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Chemical Notes: DTXSID9020160 Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts X Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 5 reproductive and developmental effects 7 1 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value («"gA) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 10 reduced locomotor activity bottle-fed infants OPP 2012 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.0122 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-171 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Bifenthrin CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.01 mg/kg/day OPP 2012 Wolansky et al. 2006 reduced locomotor activity bottle-fed infants 151 13.2 [324] Cancer Classification (CC) C OPP 2012 [3241 Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Acute Human Health Benchmark 0.07 mg/L EPA HHBP Acute PAD 0.01 mg/kg/day EPA HHBP Health-Based Screening Level 0.07 mg/L Health-based screening levels from USGS Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Measured Data and Assessment Results LD50 4450 mg/kg NIH HSDB max LD50 54.5 mg/kg NIH HSDB min LOAEL 16.299999 mg/kg/day EPA Toxicity Reference Database max LOAEL 2 mg/kg/day EPA Toxicity Reference Database min NOAEL 1 mg/kg/day EPA Toxicity Reference Database min NOAEL 7.4 mg/kg/day EPA Toxicity Reference Database max Percent of active toxcast in 10.19 percent EPA Chemistry Dashboard vitro assays tested Subchronic LOAEL 5 mg/kg/day EPA Toxicity Reference Database min Subchronic LOAEL 7.5 mg/kg/day EPA Toxicity Reference Database max Subchronic NOAEL 2.5 mg/kg/day EPA Toxicity Reference Database min Subchronic NOAEL 4.3 mg/kg/day EPA Toxicity Reference Database max Data Element Value Units Source Notes Modeled Data LD50 0.0001361 mo l/kg TEST QSAR Ames mutagenicity test 0.392 no units TEST QSAR Developmental toxin test 0.781 no units TEST QSAR A-172 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Bifentiirin CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contam nant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contam nant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contam nant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contam nant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contam nant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contam nant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 1.994 21 Sites 1.05 5.00E - 05 0.00232 0.0122 0.129 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 339 18 Sites 5.31 5.00E - 05 0.00239 0.0109 0.0446 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 1.655 3 Sites 0.18 8.00E-05 0.00061 0.0905 0.129 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) 48 1,403,807 2016 Toxic Release Inventory (TRI) Program (EPA) (2016) 10 16,519 Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude USDA Pesticide Data Program (PDP) (Finished) 2001-2013 17 2 Sites 12 0.0053 0.0207 0.0329 0.036 ug/L Ambient Water Prevalence Magnitude National Water Information System (USGS NWIS) (Surface Water) 2008-2017 436 21 Sites 4.82 0.00148 0.0116 0.0581 0.35 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008-2017 530 0 Sites 0 National Water Information System (USGS NWIS) (All Water) 2008-2017 966 21 Sites 2.17 0.00148 0.0116 0.0581 0.35 ug/L USDA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001-2013 201 1 Sites 0.5 0.008 0.008 0.008 0.008 ug/L USDA Pesticide Data Program (PDP) (Groundwater) 2001-2013 190 0 Sites 0 USDA Pesticide Data Program (PDP) (Untreated) 2001-2013 12 1 Sites 8.33 0.008 0.008 0.008 0.008 ug/L Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990-2018 4,917 970 Sites 20 0.00062 0.0123 0.0799 5.633527 ug/L Bradley et al. 2017 (Ambient) [52] 2012-2014 38 1 Sites 2.63 0.0218 0.0218 0.0218 0.0218 ug/L Arnold et al. 2016 (Filtered) [7] 2012-2013 584 1 Sites 0.17 le-04 le-04 le-04 le-04 ug/L Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 2.33E-08 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 3.54094 days Boiling point OPERA QSAR 370.963 degree C Boiling point TEST QSAR 411.331 degree C Vapor pressure OPERA QSAR 0.000000153 mmHg Vapor pressure TEST QSAR 0.000000121 mmHg Solubility in water OPERA QSAR 0.000000189 mol/L Solubility in water TEST QSAR 4.98E-08 mol/L Bioconcentration factor OPERA QSAR 4985.6 no units Bioconcentration factor TEST QSAR 381.944 no units Henry's Law constant OPERA QSAR 4.88E-08 atm-mA3/mol 0 eta no l/water partitioning coeff. (log Kow) OPERA QSAR 6.79073 no units A-173 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Bifenthrin CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 324 USEPA. 2012. Bifenthrin: Human Health Risk Assessment to Support Section 3 New Uses for a Bed Bug Treatment, Grass Grown for Seed, Tolerances for Imported Tea, and a Section 18 Emergency Exemption Use on Apple, Nectarine, and Peach. EPA-HQ-OPP-2016-0236-0007. DP No. D372550. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticide in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. A-174 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Bisphenol A (4^4'-lsopropylidenediphenol) CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: BisphenolA(4,4'-lsopropylidenediphenol) CASRN: 80-05-7 DTXSID: DTXSID7020182 Use: Production of polycarbonate and epoxy resins. Formerly used as fungicide. Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA Human Neurotoxicants PubMed Neu rotoxica nts X Neu rode v. Disruptors Androgen Receptors in vitro X Compounds with neu rod ev effects, Mundy et a 12015 X CONTAMINANT SUMMARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 6 non-cancer effects 8 5 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date SL 20 hepatocyte hypertrophy and increased liver weight (absolute and relative) general population ECHA 2015 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 1.6016 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-175 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Bisphenol A (4,4'-lsopropylidenediphenol) CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg- HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.05 IRIS 1988 NTP 1982 "reduced mean bodyweight" general population 33.8 296 [196] Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg- CCL Screening Level (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.004 mg/kg/day ECHA 2015 Tyl et al. 2008 hepatocyte hypertrophy and increased liver weight (absolute and relative) general population 33,8 0.0237 [72] NOTE: Due to the large amount of literature published after the 1988 IRIS assessment (an estimated 800 studies were expected to be relevant and require full text review), no additional searches are going to be taken at this time. If BPA is listed on the CCL, efforts to Reference Dose (RfD) or Equivalent 0.016 mg/kg/day NSF2008 Tyl et al. (2007) reduced body weight gain in rats and minimal to mild hepatocyte hypertrophy in adult F0 and F1 males and F1 female mice general population 33.8 94.7 [444] Reference Dose (RfD) or Equivalent 0.0065 mg/kg/day MDH 2015 Tyl et al. 2008 "Centrilobular hepatocyte hypertrophy, increased kidney weight" general population 33.8 38.5 [138] Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title- abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review 1987-09-01 2019-12-17 9149 230 20 Screening stopped in the middle of title/abstract screening due to extremely high number of includes, which was deemed outside the scope of this rapid systematic review. No further Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Acute Health-Based Guidance Value 0.1 mg/L MN DOH Chronic Health-Based Guidance Value 0.02 mg/L MN DOH Sho rt-T erm/SubchronicHealth-Based 0.02 mg/L MN DOH Guidance Value Cancer Classification (CC) Female.Mice no units HHSNTP Cancer Classification (CC) Female.Rats E no units HHSNTP Cancer Classification (CC) Male,Mice E no units HHSNTP Cancer Classification (CC) Male.Rats E no units HHS NTP Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Modeled Data LD50 0.0179887 mol/kg TEST QSAR Ames mutagenicity test 0.086 no units TEST QSAR Developmental toxin test 0.711 no units TEST QSAR Data Element Value Units Source Notes Measured Data and Assessment Results LD50 2230 mg/kg NIH HSDB min LD50 5280 mg/kg NIH HSDB max Percent of active toxcast in 21.33 percent EPA Chemistry Dashboard vitro assays tested TD50 1320000 mg/kg/day NIHCPDB max TD50 445 mg/kg/dav NIHCPDB min A-176 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Bisphenol A (4,4'-lsopropylidenedipher CCL5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDWand OST Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018 - 2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013 - 2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008 - 2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survey (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991 - 2017 732 12 Sites 1.64 0.03 0.251 1.6 2.64 ug/L National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991 - 2017 86 4 Sites 4.65 0.03 0.105 0.273 0.278 ug/L National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991 - 2017 646 8 Sites 1.24 0.107 0.298 2.13 2.64 u«/L PesticideApplication Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) 29 3,104,838 Chemical Data Reporting (CDR) Results (EPA) (2016) 1B-5B Noil-Nation ally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Drinking Water Monitoring Data -CA (Finished) 2006 - 2020 1 0 Sites 0 Bradley et al. 2018 (Finished) [53] 2016 26 1 Sites 3.85 9.157284 9.16 9.16 9.157284 ug/L Glassmeyer et al 2017 (Finished) [86] 2007 - 2012 25 NA Sites 0 ug/L Padhye et al. 2013 (Finished) [155] 2009 - 2010 8 4 Samples 50 0 2.7e-06 4.43e-05 +/- 1.01e-05 ug/L USGS, Sioux Falls Area, 2012 (Finished) [153] 2009 - 2010 1 0 Sites 0 Ambient Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Source) 2006 - 2020 2 0 Sites 0 National Water Information System (USGS NWIS) (All Water) 2008 - 2017 1,200 205 Sites 17 0.01 0.08 0.49 4.97 ug/L National Water Information System (USGS NWIS) (Surface Water) 2008 - 2017 532 157 Sites 30 0.01 0.08 0.464 2.97 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008 - 2017 619 47 Sites 7.59 0.02 0.09 1.05 4.97 ug/L National Water Information System (USGS NWIS) (All Water) 2008 - 2017 1,151 204 Sites 18 0.01 0.08 0.49 4.97 ug/L Glassmeyer et a 12017 (Ambient) [86] 2007 - 2012 25 NA Sites 4 0.029 0.029 ug/L Bradley et a 1. 2017 (Ambient) [52] 2012 - 2014 38 15 Sites 39 0.0253 0.0649 0.134 0.163 ug/L Bexfield et al. 2019 (Groundwater) [49] 2013 - 2015 1,077 7 Sites 0.65 0.171062 0.193 0.34 0.430036 ug/L Padhye et al. 2013 (Ambient) [155] 2009 - 2010 8 6 Samples 75 0 1.27e-05 2.19e-05 +/- 1.6e-06 ug/L USGS, Sioux Falls Area, 2012 (Ambient) [153] 2009 - 2010 2 2 Sites 100 Waste Water Effluent Prevalence Magnitude Scott et al. 2018 (Wastewater) [161] 2011-2017 20 2 Sites 10 0.152752 0.242 0.401 0.441148 ug/L Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mgAg bw/day) Notes Expocast exposure 0.0000211 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) 4.9 ug/l Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR4 data used in the CCL5 is a partial data set and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Value Units Notes Biodegradation half-life OPERA QSAR 15.1318 days Boiling point OPERA QSAR 343.216 degree C Boiling point TEST QSAR 359.933 degree C Vapor pressure OPERA QSAR 6.83E-08 mmHg Vapor pressure TEST QSAR 0.00000259 mmHg Solubility in water OPERA QSAR 0.000535206 mol/L Solubility in water TEST QSAR 0.00124451 mol/L Bioconeentration factor OPERA QSAR 43.6947 no units Bioconeentration factor TEST QSAR 117.22 no units Henry's Law constant OPERA QSAR 0.000000126 atm-mA3/mol Octanol/water partitioning coeff. (log Kow) OPERA QSAR 3.35076 no units A-177 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Bisphenol A (4,4'-lsopropylidenediphenol) CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 49 Bexfield, L.M., P.L. Toccalino, K. Belitz, W.T. Foreman, and E.T. Furlong. 2019. Hormones and pharmaceuticals in groundwater used as a source of drinking water across the United States. Environmental Science and Technology 53: 2950-2960. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 53 Bradley, P. M., Kolpin, D. W., Romanok, K. M., Smalling, K. L., Focazio, M. J., Brown, J. B.,... & Dietze, J. E. (2018). Reconnaissance of mixed organic and inorganic chemicals in private and public supply tapwaters at selected residential and workplace sites in the United States. Environmental science & technology, 52(23), 13972-13985. 72 ECHA. 2015. Committee for Risk Assessment (RAC) Opinion on an Annex XV dossier proposing restrictions on bisphenol A. European Chemicals Agency (ECHA), Helsinki, Finland. ECHA/RAC/RES-O- 0000001412-86-56/F. 86 Glassmeyer, S.T., Furlong, E.T., Kolpin, D.W., Batt, A.L., Benson, R., Boone, J.S.,... & Wilson, V.S. (2017). Nationwide reconnaissance of contaminants of emerging concern in source and treated drinking waters of the United States. Science of The Total Environment. v581-582, (909-922). 138 MDH. 2015. Toxicological Summary for: Bisphenol A. Minnesota Department of Health (MDH), Environmental Health Division, Health Risk Assessment Unit, St Paul, MN. 153 Occurrence of anthropogenic organic compounds and nutrients in source and finished water in the Sioux Falls area, South Dakota, 2009-10: U.S. Geological Survey Scientific Investigations Report 2012-5098, 21 p. plus appendixes. 155 Padhye, L.P., Yao, H., Kung'u, F.T., and Huang, C.H. Year-long evaluation on the occurrence and fate of pharmaceuticals, personal care products, and endocrine disrupting chemicals in an urban drinking water treatment plant. 2014. Water Research 51 (2014) 266-276. 161 Scott, T. M., Phillips, P. J., Kolpin, D. W., Colella, K. M., Furlong, E. T., Foreman, W. T., & Gray, J. L. (2018). Pharmaceutical manufacturing facility discharges can substantially increase the pharmaceutical load to US wastewaters. Science of the Total Environment, 636, 69-79. 196 USEPA. 1988. Chemical Assessment Summary Bisphenol A. U.S. Environmental Protection Agency, National Center for Environmental Assessment, Integrated Risk Information System (IRIS), Washingtor DC. 444 Willhite, C., Ball. G.,and McLellan, C. 2008. Journal of Toxicology and Environmental Health, Part B. 11:69-146. A-178 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Boron CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Boron CASRN: 7440-42-8 DTXSID: DTXSID3023922 Use: Former pesticide; oxygen scavenger; catalyst; in composite structural materials Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANTSUMMARY& DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT IN FORMATION Potency Severity Prevalence Magnitude 4 reproductive and developmental effects 10 10 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value («"gA) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 1000 decreased fetal body weights women of child bearing age OW 2008 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 475 90th Percentile Finished Water NIRS 1984-1986 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Boron was found at levels greater than the HRL(and VSthe HRL) in ral of the ground water systems surveyed by NIRS, it was not found at levels greater than the HRL (or Vi the HRL) in the surface irs sources evaluated in the AwwaRF study [a, b, d]. EPA believes that the overall national occurrence and exposure from both surface nd ground water systems together is likely to be lower than the a lues observed for the NIRS ground water data [c,d]. Frey, et a I, 2004 [82 [d] USE PA, 2008 [298]; ; [b] Seidel, 2006 [162]; [c] USE PA, 2004 [261]; is cited in USEPA, 2008 [296] Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-179 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Boron CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg- HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.035 mg/kg/day HC 1990 Weirand Fisher 1972 testicular atrophy and spermatogenesis arrest general population 33.8 207 [90] Reference Dose (RfD) or Equivalent 0.17 mg/kg/day OW 2008 Allen et al. 1996; Heindel et al. 1992; Price et al. 1994 and decreased fetal body weights women of childbearing age 35.4 960 [292] Reference Dose (RfD) or Equivalent 0.2 mg/kg/day ATSDR2010 Weirand Fisher 1972 testicular atrophy and systemic effects general population 33.8 1180 [28] Reference Dose (RfD) or Equivalent 0.17 mg/kg/day WHO 2009 Allen et al. 1996; Heindel et al. 1992; Price et al. 1994 and decreased fetal body weights women of childbearing age 35.4 960 [441] Reference Dose (RfD) or Equivalent 0.2 mg/kg/day IRIS 2004 Price et al.( 1996a; Heindel et al.. decreased fetal weight women of childbearing age 35.4 1130 [259] Cancer Classification (CC) | IRIS 2004 [259] Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg- CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title- abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Reproductive 1 Marat, 2018 Developmental, Svstemic 125 El-Dakdoky, 2013 2009-11-01 2020-02-13 2877 9 30 4 Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results 10-day Health Advisory 3 mg/L EPA DWSHA 2018 Acute Health-Based Guidance Value 0.5 mg/L MN DOH Acute inhalation Minimal Risk Level (MRL) 0.3 mg/mA3 CDC ATSDR Chronic Health-Based Guidance Value 0.5 mg/L MN DOH Drinking Water Guideline Value 2.4 mg/L WHO Drinking Water Quality Guidelines Lifetime Health Advisory 6 mg/L EPA DWSHA 2018 Maximum Allowable Concentration (MAC) 5 mg/L Canadian Drinking Water Guidelines Sh ort-T erm/SubchronicHealth-Based 0.5 mg/L MN DOH Guidance Value Data Element Value Units Source Notes Modeled Data LD50 TEST QSAR Ames mutagenicity test TEST QSAR Developmental toxin test TEST QSAR Data Element | Value | Units | Source | Notes Measured Data and Assessment Results Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. A-180 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Boron CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 OCCURRENCE DATA Scoring_Data_ Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contam nant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contam nant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contam nant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contam nant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contam nant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contam nant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev (NIRS) 1984 -1986 989 810 Sites 82 5 47 475 3950 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 6.327 6.014 Sites 95 0 38 210 8470 National Water Qua lity Assessment (USGS NAWQA) (Surface Water) 1991-2017 414 388 Sites 94 0 40 193 4200 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 5.913 5.626 Sites 95 1 33 247 8470 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) 25K-100K Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Finished) 2006 - 2020 273 192 Sites 70 0.076 180 500 9000 ug/L Community Water System Survey (CWSS) (Finished) [178] 2006 5 NA Sites 140 200 ug/L Ambient Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Source) 2006 - 2020 1,929 1,184 Sites 61 0.0151 240 1000 235000 ug/L Drinking Water Monitoring Data - Wl (Source) 2012-2019 1 0 Sites 0 National Water Information System (USGS NWIS) (Surface Water) 2008 - 2017 2,101 1,959 Sites 93 1.79 55 301 56700 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008 - 2017 8,067 7,586 Sites 94 1 65 728 564000 ug/L National Water Information System (USGS NWIS) (All Water) 2008 - 2017 10,148 9,526 Sites 94 1 60 467 564000 ug/L Arnold et al. 2016 (Filtered) [7] 2012 - 2013 757 738 Sites 97 3 34 446 4080 ug/L Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. A-181 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Boron CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 28 ATSDR. 2010. Toxicological Profile for Boron. U.S. Department of Health and Human Services, Public Health Service, Agency for Toxic Substances and Disease Registry (ATSDR), Atlanta, GA. 82 Frey, M.M., C. Seidel, M. Edwards, J. Parks, and L. McNeill. 2004. Occurrence Survey for Boron and Hexavalent Chromium. AwwaRF Report 91044F. 90 HC. 1990. Guideline Technical Document - Boron. Health Canada (HC), Water and Air Quality Bureau, Healthy Environments and Consumer Safety Branch, Ottawa, Ontario, Canada. 162 Seidel, C. 2006. Email Communication to Brent Ranalli at The Cadmus Group, Inc. [concerning boron data from an AwwaRF-sponsored study, with data in an attached spreadsheet]. Denver, CO: McGuirc Malcolm Pirnie. May 19. 178 USE PA (US Environmental Protection Agency). (2009). 2006 Community Water System Survey. Overview, 57. 259 USEPA. 2004. Chemical Assessment Summary, Boron. U.S. Environmental Protection Agency, National Center for Environmental Assessment, Integrated Risk Information System (IRIS), Washington, D.C. 261 USEPA. 2004. Integrated Risk Information System (IRIS), Boron and Compounds. August. Available on the Internet at: http://www.epa.gov/iris/subst/0410.htm. Accessed February 2, 2005. 292 USEPA. 2008. Health Effects Support Document for Boron. U.S. Environmental Protection Agency, Office of Water, Health and Ecological Criteria Division, Washington, D.C. 296 USEPA. 2008. Regulatory Determinations Support Document for Selected Contaminants from the Second Drinking Water Contaminant Candidate List (CCL 2). EPA Report 815-R-08-012. June 2008. 298 USEPA. 2008. The Analysis of Occurrence Data from the Unregulated Contaminant Monitoring (UCM) Program and National Inorganics and Radionuclides Survey (NIRS) in Support of Regulatory Determinations for the Second Drinking Water Contaminant Candidate List. EPA 815-D-08-014. June. 441 WHO. 2009. Boron in Drinking-water. Background document for development of WHO Guidelines for Drinking-water Quality. World Health Organization (WHO), Geneva, Switzerland. A-182 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Boscalid CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Boscalid CASRN: 188425-85-6 DTXSID: DTXSID6034392 Use: Fungicide Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Not List ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 4 non-cancer effects 10 3 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 1000 thyroid lesions general population OPP 2019 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.0258 90th Percentile All Ambient Water NAWQA 1991-2017 Final Hazard Quotient (HQ) 0.000026 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-183 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Boscalid CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.22 mg/kg/day OPP 2019 Mellert et al. 2001a and b; MRID 45723501 thyroid lesions general population 33.8 1300 [414] Cancer Classification (CC) S OPP 2019 [4141 Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Chronic Human Health Benchmark 1.4 mg/L EPA HHBP Health-Based Screening Level 1.4 mg/L Health-based screening levels from USGS Population-Adjusted Dose (PAD) 0.218 mg/kg/day EPAHHBP Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element I Value I Units I Source I Notes Measured Data and Assessment Results LD50 5000 mg/kg NIH HSDB LOAEL 1034.5 mg/kg/day EPA Toxicity Reference Database max LOAEL 57.400002 mg/kg/day EPA Toxicity Reference Database min NOAEL 12.5 mg/kg/day EPA Toxicity Reference Database min NOAEL 300 mg/kg/day EPA Toxicity Reference Database max Percent of active toxcast in vitro assays tested 6.37 percent EPA Chemistry Dashboard Subchronic LOAEL 78.099998 mg/kg/day EPA Toxicity Reference Database min Subchronic LOAEL 788 mg/kg/day EPA Toxicity Reference Database max Subchronic NOAEL 277 mg/kg/day EPA Toxicity Reference Database max Subchronic NOAEL 8.1 mg/kg/day EPA Toxicity Reference Database min Data Element Value Units Source Notes Modeled Data LD50 0.0093325 mo l/kg TEST QSAR Ames mutagenicity test 0.516 no units TEST QSAR Developmental toxin test 0.762 no units TEST QSAR A-184 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Boscalid CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 OCCURRENCE DATA Scoring_Data_ Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contam nant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contam nant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contam nant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contam nant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contam nant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contam nant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survey (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 14 3 Sites 21 0.0057 0.0102 0.0258 0.0288 National Water Qua lity Assessment (USGS NAWQA) (Surface Water) 1991-2017 14 3 Sites 21 0.0057 0.0102 0.0258 0.0288 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) 42 782,294 2016 Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude USDA Pesticide Data Program (PDP) (Finished) 2001-2013 5 0 Sites 0 Bradley et al. 2018 (Finished) [53] 2016 26 3 Sites 12 0.0029 0.0034 0.00556 0.0061 ug/L Ambient Water Prevalence Magnitude National Water Information System (USGS NWIS) (Surface Water) 2008-2017 136 70 Sites 51 0.0014 0.0208 0.215 11.2 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008-2017 3 0 Sites 0 National Water Information System (USGS NWIS) (All Water) 2008-2017 139 70 Sites 50 0.0014 0.0208 0.215 11.2 ug/L USDA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001-2013 221 0 Sites 0 USDA Pesticide Data Program (PDP) (Groundwater) 2001-2013 216 0 Sites 0 USDA Pesticide Data Program (PDP) (Untreated) 2001-2013 5 0 Sites 0 Bradley et al. 2017 (Ambient) [52] 2012-2014 38 11 Sites 29 0.0052 0.009 0.215 0.6781 ug/L Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 1.82E-08 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicatethere were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 4.73188 days Boiling point OPERA QSAR 396.769 degree C Boiling point TEST QSAR 446.25 degree C Vapor pressure OPERA QSAR 5.4E-09 mmHg Vapor pressure TEST QSAR 1.04E-08 mmHg Solubility in water OPERA QSAR 0.000026 mol/L Solubility in water TEST QSAR 0.00000553 mol/L Bioconcentration factor OPERA QSAR 776.451 no units Bioconcentration factor TEST QSAR 107.152 no units Henry's Law constant OPERA QSAR 2.84E-09 atm-mA3/mol 0 eta no 1/water partitioning coeff. (log Kow) OPERA QSAR 3.15332 no units A-185 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Boscalid CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 53 Bradley, P. M., Kolpin, D. W., Romanok, K. M., Smalling, K. L., Focazio, M. J., Brown, J. B.,... & Dietze, J. E. (2018). Reconnaissance of mixed organic and inorganic chemicals in private and public supply tapwaters at selected residential and workplace sites in the United States. Environmental science & technology, 52(23), 13972-13985. 414 USEPA. 2019. Boscalid. Human Health Risk Assessment for Registration Review. EPA-HQ-OPP-2014-0199-0020. DP No. D451675. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. A-186 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Bromacil CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Chemical Notes: DTXSID4022020 Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANTSUMMARY& DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 5 non-cancer effects 9 3 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 100 decreases in mean absolute body weight and decreased food efficiency general population OPP 2016 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.12 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-187 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Bromacil CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.0196 mg/kg/day OPP 2016 Bogdanffy 1989 decreases in mean absolute body weight and decreased food efficiency general population 33.8 116 [362] Cancer Classification (CC) C OPP 2016 [3621 Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results 10-day Health Advisory 5 mg/L EPA DWSHA 2018 Lifetime Health Advisory 0.07 mg/L EPA DWSHA 2018 Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Measured Data and Assessment Results LD50 5200 mg/kg NIH HSDB max LD50 641 mg/kg NIH HSDB min LOAEL 300 mg/kg/day EPA Toxicity Reference Database max LOAEL 9.8199997 mg/kg/day EPA Toxicity Reference Database min NOAEL 100 mg/kg/day EPA Toxicity Reference Database max NOAEL 2.64 mg/kg/day EPA Toxicity Reference Database min Percent of active toxcast in 2.9 percent EPA Chemistry Dashboard vitro assays tested Data Element Value Units Source Notes Modeled Data LD50 0.0047643 mo l/kg TEST QSAR Ames mutagenicity test 0.514 no units TEST QSAR Developmental toxin test 0.87 no units TEST QSAR A-188 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Bromacil CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 7.914 482 Sites 6.09 0.00043 0.0124 0.12 21.7 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 1.235 268 Sites 22 0.00055 0.0117 0.095 5.42 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 6.680 214 Sites 3.2 0.00043 0.05 0.956 21.7 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) 3 253,973 2016 Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Finished) 2006 - 2020 174 0 Sites 0 USDA Pesticide Data Program (PDP) (Finished) 2001-2013 15 4 Sites 27 0.0086 0.045 0.0654 0.069 ug/L Glassmeyer et al 2017 (Finished) [86] 2007-2012 25 NA Sites 0 ug/L USGS, Sioux Falls Area, 2012 (Finished) [153] 2009-2010 1 0 Sites 0 Ambient Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Source) 2006 - 2020 2,117 1 Sites 0.05 1.5 1.5 1.5 1.5 ug/L USDA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001-2013 227 53 Sites 23 0.002 0.016 0.179 21.8 ug/L USDA Pesticide Data Program (PDP) (Groundwater) 2001-2013 219 46 Sites 21 0.002 0.0445 1.8 21.8 ug/L USDA Pesticide Data Program (PDP) (Untreated) 2001-2013 10 7 Sites 70 0.002 0.014 0.0573 0.41 ug/L Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990-2018 2,953 100 Sites 3.39 0.027 0.122 2.22 68 ug/L Glassmeyer et al 2017 (Ambient) [86] 2007 - 2012 25 NA Sites 0 ug/L Bradley et al. 2017 (Ambient) [52] 2012 - 2014 38 5 Sites 13 0.02 0.028 0.0948 0.1 ug/L Arnold et al. 2016 (Filtered) [7] 2012 - 2013 690 32 Sites 4.64 4e-04 0.0164 1.07 7.76 ug/L USGS, Sioux Falls Area, 2012 (Ambient) [153] 2009-2010 2 0 Sites 0 Waste Water Effluent Prevalence Magnitude Scott et al. 2018 (Wastewater) [161] 2011-2017 21 0 Sites 0 Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 8.46E-08 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 3.35662 days Boiling point OPERA QSAR 290.845 degree C Boiling point TEST QSAR 315.49 degree C Vapor pressure OPERA QSAR 0.00178266 mmHg Vapor pressure TEST QSAR 0.000000402 mmHg Solubility in water OPERA QSAR 0.324213 mol/L Solubility in water TEST QSAR 0.00179473 mol/L Bioconcentration factor OPERA QSAR 2.42732 no units Bioconcentration factor TEST QSAR 3.5156 no units Henry's Law constant OPERA QSAR 0.00000138 o E E 0 eta no l/water partitioning coeff. (log Kow) OPERA QSAR 2.07377 no units A-189 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Bromacil CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 86 Glassmeyer, S.T., Furlong, E.T., Kolpin, D.W., Batt, A.L., Benson, R., Boone, J.S.,... & Wilson, V.S. (2017). Nationwide reconnaissance of contaminants of emerging concern in source and treated drinking waters of the United States. Science of The Total Environment. v581-582, (909-922). 153 Occurrence of anthropogenic organic compounds and nutrients in source and finished water in the Sioux Falls area, South Dakota, 2009-10: U.S. Geological Survey Scientific Investigations Report 2012-5098, 21 p. plus appendixes. 161 Scott, T. M., Phillips, P. J., Kolpin, D. W., Colella, K. M., Furlong, E. T., Foreman, W. T., & Gray, J. L. (2018). Pharmaceutical manufacturing facility discharges can substantially increase the pharmaceutical load to US wastewaters. Science of the Total Environment, 636, 69-79. 362 USEPA. 2016. Bromacil and its Lithium Salt - Draft Human Health Risk Assessment for Registration Review. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticide in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. A-190 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Bromoxynil CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Bromoxynil CASRN: 1689-84-5 DTXSID: DTXSID3022162 Use: Herbicide Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Ust ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT IN FORMATION Potency Severity Prevalence Magnitude 5 carcinogen with linear MOA 6 3 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 0.3 hepatocellular tumors general population OPP 2018 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.22 90th Percentile All Ambient Water NAWQA 1991-2017 Final Hazard Quotient (HQ) 073 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-191 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Bromoxynil CCL 5 Contaminant Information Sheet EPA-OGWDWand OST October 2022 HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.015 mg/kg/day OPP 2018 Harlinget al. 1988 and 1989 increased incidence of panting and decreased absolute body weight general population 33.8 88.8 [397] Cancer Slope Factor (CSF) 0.103 (mg/kg/day)A-l OPP 2018 Budd and Rinde 1997 hepatocellular tumors general population 33.8 0.287 [397] Cancer Classification (CC) C OPP 2018 [397] Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Acute Human Health Benchmark 0.5 mg/L EPA HHBP Acute PAD 0.08 mg/kg/day EPA HHBP Cancer Slope Factor (CSF) 0.103 (mg/kg/day)A-l EPA HHBP Chronic Human Health Benchmark 0.000311 mg/L EPA HHBP Chronic Human Health Benchmark 0.096 mg/L EPA HHBP Health-Based Screening Level 0.000311 mg/L Health-based screening levels from USGS Health-Based Screening Level 0.096 mg/L Health-based screening levels from USGS Maximum Allowable Concentration (MAC) 0.005 mg/L Canadian Drinking Water Guidelines Population-Adjusted Dose (PAD) 0.015 mg/kg/day EPA HHBP Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Measured Data and Assessment Results LD50 365 mg/kg NIH HSDB max LD50 63 mg/kg NIH HSDB min LOAEL 1.5 mg/kg/day EPA Toxicity Reference Database min LOAEL 12 mg/kg/day EPA Toxicity Reference Database max NOAEL 0.3 mg/kg/day EPA Toxicity Reference Database min NOAEL 3.7 mg/kg/day EPA Toxicity Reference Database max Percent of active toxcast in 14.48 percent EPA Chemistry Dashboard vitro assays tested Data Element Value Units Source Notes Modeled Data LD50 0.0011535 mo l/kg TEST QSAR Ames mutagenicity test 0.367 no units TEST QSAR Developmental toxin test TEST QSAR A-192 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Bromoxynil CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contam nant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contam nant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contam nant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contam nant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contam nant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contam nant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev(NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 7.736 60 Sites 0.78 6.00E - 04 0.0228 0.22 6.1 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 1.196 53 Sites 4.43 6.00E - 04 0.0235 0.219 6.1 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 6.540 7 Sites 0.11 0.01 0.02 0.121 0.311 Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) 36 2,957,908 2016 Toxic Release Inventory (TRI) Program (EPA) (2016) 2 31 Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude USDA Pesticide Data Program (PDP) (Finished) 2001-2013 13 0 Sites 0 Ambient Water Prevalence Magnitude National Water Information System (USGS NWIS) (Surface Water) 2008-2017 476 9 Sites 1.89 0.0056 0.01 0.19 0.269 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008-2017 1,059 1 Sites 0.09 0.01 0.01 0.01 0.01 ug/L National Water Information System (USGS NWIS) (All Water) 2008-2017 1,535 10 Sites 0.65 0.0056 0.01 0.182 0.269 ug/L USDA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001-2013 8 1 Sites 12 0.065 0.065 0.065 0.065 ug/L USDA Pesticide Data Program (PDP) (Groundwater) 2001-2013 2 0 Sites 0 USDA Pesticide Data Program (PDP) (Untreated) 2001-2013 6 1 Sites 17 0.065 0.065 0.065 0.065 ug/L Bradley etal. 2017 (Ambient) [52] 2012-2014 38 4 Sites 11 0.0128 0.0194 0.0902 0.1185 ug/L Arnold et al. 2016 (Filtered) [7] 2012-2013 690 0 Sites 0 Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 0.000000092 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR4 data used in the CCL5 is a partial datasetand will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 4.8868 days Boiling point OPERA QSAR 306.681 degree C Boiling point TEST QSAR 295.87 degree C Vapor pressure OPERA QSAR 0.000000232 mmHg Vapor pressure TEST QSAR 0.000264241 mmHg Solubility in water OPERA QSAR 0.000863573 mol/L Solubility in water TEST QSAR 0.000237684 mol/L Bioconcentration factor OPERA QSAR 5.7625 no units Bioconcentration factor TEST QSAR 12.331 no units Henry's Law constant OPERA QSAR 0.000000153 atm-mA3/mol Octanol/water partitioning coeff. (log Kow) OPERA QSAR 2.62395 no units A-193 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Bromoxynil CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 397 USEPA. 2018. Bromoxynil and Bromoxynil Esters: Human Health Draft Risk Assessment for Registration Review. EPA-HQ-OPP-2012-0896-0021. DP No. D444387. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. A-194 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Bupropion CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Bupropion CASRN: 34911-55-2 DTXSID: DTXSID7022706 Use: antidepressant Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA Human Neurotoxicants PubMed Neu rotoxica nts X Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 6 non-cancer effects 8 3 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date SL 8 lowest therapeutic dose: aminoketone antidepressant/ maintaining antidepressant response, treat depressive episode bottle-fed infants FDA; NIH 2018; 2018 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.10344 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-195 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Bupropion CCL 5 Contaminant Information Sheet EPA-OGWDWand OST October 2022 HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.00125 mg/kg/day FDA 2018; NIH 2018 Solco Healthcare US LLC lowest therapeutic dose: aminoketone antidepressant/ maintaining antidepressant response, treat depressive episode bottle-fed infants 151 8.30 [77] [150] NOTE: (Lowest Therapeutic Dose/3000x UF) is used in place of an RfD; LTDs were obtained from FDA-approved drug labels Reference Dose (RfD) or Equivalent 0.00125 mg/kg/day FDA 2018; NIH 2018 Solco Healthcare US LLC lowest therapeutic dose: aminoketone antidepressant/ maintaining antidepressant response, treat depressive episode general population 33.8 29.0 [77] [150] NOTE: (Lowest Therapeutic Dose/3000x UF) is used in place of an RfD; LTDs were obtained from FDA-approved drug la bels Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Maximum Recommended Daily Dose 7.5 mg/kg/day FDA Screening level for pharmaceutical - general 0.029411765 mg/L EPA Office of Water population Screening level for pharmaceutical - infants 0.008333333 mg/L EPA Office of Water Data Element Value Units Source Notes Measured Data and Assessment Results LD50 575 mg/kg NIH HSDB min LD50 600 mg/kg NIH HSDB max Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Modeled Data LD50 0.0045709 mo l/kg TEST QSAR Ames mutagenicity test 0.071 no units TEST QSAR Developmental toxin test 0.358 no units TEST QSAR A-196 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Bupropion CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev(NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 557 11 Sites 1.97 0.00107 0.0139 0.103 0.148 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 75 11 Sites 15 0.00107 0.0139 0.103 0.148 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 482 0 Sites 0 Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Glassmeyer et al 2017 (Finished) [86] 2007-2012 25 NA Sites 12 0.0103 0.01091 ug/L Ambient Water Prevalence Magnitude National Water Information System (USGS NWIS) (Surface Water) 2008-2017 205 47 Sites 23 6.00E - 04 0.00403 0.2 0.339 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008-2017 401 4 Sites 1 0.00282 0.0162 0.0284 0.034 ug/L National Water Information System (USGS NWIS) (All Water) 2008 - 2017 606 51 Sites 8.42 6.00E - 04 0.00467 0.198 0.339 ug/L Glassmeyer et al 2017 (Ambient) [86] 2007 - 2012 25 NA Sites 20 0.00636 0.00941 ug/L Bradley et al. 2017 (Ambient) [52] 2012 - 2014 38 12 Sites 32 0.0007854 0.048 0.0796 0.1595924 ug/L Bexfieid et al. 2019 (Groundwater) [49] 2013 - 2015 1,106 3 Sites 0.27 0.0044212 0.0093 0.02 0.0226803 ug/L Waste Water Effluent Prevalence Magnitude Scott et al. 2018 (Wastewater) [161] 2011 - 2017 21 18 Sites 86 0.0179911 0.0935 0.988 89.4629985 ug/L Shultz et al. (2008) via Kostich et al. 2010 (Wastewater) [127] 2010 NA NA 0.6 ug/L Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 3.38965 days Boiling point OPERA QSAR 307.696 degree C Boiling point TEST QSAR 295.443 degree C Vapor pressure OPERA QSAR 0.00000469 mmHg Vapor pressure TEST QSAR 0.0000116 mmHg Solubility in water OPERA QSAR 0.000646695 mol/L Solubility in water TEST QSAR 0.000368978 mol/L Bioconcentration factor OPERA QSAR 69.189 no units Bioconcentration factor TEST QSAR 50.3501 no units Henry's Law constant OPERA QSAR 3.04E-09 o E E 0 eta no l/water partitioning coeff. (log Kow) OPERA QSAR 1.91432 no units A-197 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Bupropion CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 49 Bexfield, L.M., P.L. Toccalino, K. Belitz, W.T. Foreman, and E.T. Furlong. 2019. Hormones and pharmaceuticals in groundwater used as a source of drinking water across the United States. Environmental Science and Technology 53: 2950-2960. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 77 FDA. 2018. Drugs @ FDA: FDA Approved Drug Products. U.S. Food and Drug Administration (FDA), https://www.accessdata.fda.gov/scripts/cder/daf/. 86 Glassmeyer, S.T., Furlong, E.T., Kolpin, D.W., Batt, A.L., Benson, R., Boone, J.S.,... & Wilson, V.S. (2017). Nationwide reconnaissance of contaminants of emerging concern in source and treated drinking waters of the United States. Science of The Total Environment. v581-582, (909-922). 127 Kostich, MS, etal., 2010. Predicting variability of aquatic concentrations of human pharmaceuticals. Sci. Total Environ. 408 (20), 4504e4510. 150 NIH. 2018. DailyMed Database. U.S. National Library of Medicine, National Institutes of Health (NIH). https://dailymed.nlm.nih.gov/dailymed/. 161 Scott, T. M., Phillips, P. J., Kolpin, D. W., Colella, K. M., Furlong, E. T., Foreman, W. T., & Gray, J. L. (2018). Pharmaceutical manufacturing facility discharges can substantially increase the pharmaceutical load to US wastewaters. Science of the Total Environment, 636, 69-79. A-198 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Butyl benzyl phthalate CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Butyl benzyl phthalate CASRN: 85-68-7 DTXSID: DTXSID3020205 Use: Chemical intermediate; plasticizer Chemical Notes: Is the contaminant on any lists? CERCLA X FIFRA Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro X Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 3 carcinogen with linear MOA 9 7 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 20 increased incidence of pancreatic cancer in male F334 rats general population PPRTV 2002 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 1.3 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-199 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Butyl benzyl phthalate CCL 5 Contaminant Information Sheet EPA-OGWDWand OST October 2022 HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.2 mg/kg/day IRIS 1989 NTP1985 "Significantly increased liver- to-body weight and liver-to-brain weight ratios" general population 33.8 1180 [203] Reference Dose (RfD) or Equivalent 0.2 mg/kg/day OW1991 NTP 1985 increased liver weight in rats general population 33.8 1180 [211] Cancer Slope Factor (CSF) 0.0019 (mg/kg/day)A-l PPRTV 2002 NTP1997a increased incidence of pancreatic cancer in male F334 rats general population 33.8 15.6 [253] Cancer Classification (CC) C OW 1991 [211] Cancer Classification (CC) C PPRTV 2002 [253] Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Neurological, Systemic 2 Betz, 2013 Hematologic 1500 Uriu-Adams, 2001 2001-10-01 2019-12-17 656 12 34 11 Other Health Data Data Element I Value I Units I Source 1 Notes Measured Data and Assessment Results Acute Health-Based Guidance Value 0.1 mg/L MN DOH Acute Health-Based Guidance Value 0.1 mg/L MN DOH Cancer Classification (CC) 3 no units WHO IARC Chronic Health-Based Guidance Value 0.1 mg/L MN DOH Human Health Ambient Water Quality Criteria 0.0001 mg/L EPA Human Health Criteria forCWA Maximum Allowable Daily Level 1200 ug/day CalEPA OEH HA Chemical Database Short-Term/Subchronic Health-Based Guidance Value 0.1 mg/L MN DOH Cancer Classification (CC) Female.Mice N no units HHSNTP Cancer Classification (CC) Female.Mice NT no units HHSNTP Cancer Classificat on (CC) Female.Rats EE no units HHSNTP Cancer Classificat on (CC) Female.Rats P no units HHSNTP Cancer Classificat on (CC) Male.Mice N no units HHSNTP Cancer Classificat on (CC) Male.Mice NT no units HHSNTP Cancer Classificat on (CC) Male.Rats IS no units HHSNTP Cancer Classificat on (CC) Ma le.Rats SE no units HHS NTP Data Element Value Units Source Notes Modeled Data LD50 0.0591562 mo l/kg TEST QSAR Ames mutagenicity test 0.035 no units TEST QSAR Developmental toxin test 0.749 no units TEST QSAR Data Element Value Units Source Notes Measured Data and Assessment Results LD50 13750 mg/kg NIH HSDB max LD50 2000 mg/kg NIH HSDB min LOAEL 100 mg/kg/day EPA Toxicity Reference Database Percent of active toxcast in 9.87 percent EPA Chemistry Dashboard vitro assays tested TD50 347 mg/kg/day NIH CPDB min TD50 47000 mg/kg/day NIH CPDB max Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. A-200 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Butyl benzyl phthalate CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 OCCURRENCE DATA Scoring_Data_ Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contam nant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contam nant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contam nant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contam nant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contam nant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contam nant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 22 2 Sites 9.09 1.3 1.3 1.3 1.3 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 13 2 Sites 15 1.3 1.3 1.3 1.3 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 9 0 Sites 0 Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) 10M - 50M Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Finished) 2006 - 2020 21 1 Sites 4.76 0.005 0.029 0.0674 0.077 ug/L Drinking Water Monitoring Data - WA (Finished) 2006-2011 484 0 Sites 0 Ambient Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Source) 2006 - 2020 221 2 Sites 0.9 0.003 0.042 5.41 8.5 ug/L Drinking Water Monitoring Data - WA (Source) 2006-2011 638 1 Sites 0.16 4.7 5.2 5.6 5.7 ug/L National Water Information System (USGS NWIS) (Surface Water) 2008-2017 143 15 Sites 10 0.2 0.8 5 5 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008 - 2017 344 17 Sites 4.94 0.5 0.8 1.11 2.1 ug/L National Water Information System (USGS NWIS) (All Water) 2008-2017 487 32 Sites 6.57 0.2 0.8 5 5 ug/L Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 0.000115 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 3.35267 days Boiling point OPERA QSAR 365.191 degree C Boiling point TEST QSAR 392.394 degree C Vapor pressure OPERA QSAR 0.00000447 mmHg Vapor pressure TEST QSAR 0.00000433 mmHg Solubility in water OPERA QSAR 0.00000908 mol/L Solubility in water TEST QSAR 0.0000185 mol/L Bioconcentration factor OPERA QSAR 19.3088 no units Bioconcentration factor TEST QSAR 16.6725 no units Henry's Law constant OPERA QSAR 2.82E-08 o E E 0 eta no l/water partitioning coeff. (log Kow) OPERA QSAR 4.46009 no units A-201 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Butyl benzyl phthalate CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 203 USEPA. 1989. Chemical Assessment Summary Butyl benzyl phthalate. U.S. Environmental Protection Agency, National Center for Environmental Assessment, Integrated Risk Information System (IRIS), Washington, DC. 211 USEPA. 1991. Drinking Water Criteria Document for Phthalic Acid Esthers (PAES). U.S. Environmental Protection Agency, Office of Water, Health and Ecological Criteria Division, Washington, DC. 253 USEPA. 2002. Provisional Peer Reviewed Toxicity Values for Butyl benzyl phthalate (CASRN 85-68-7) Derivation of a Carcinogenicity Assessment. U.S. Environmental Protection Agency, Office of Researcl and Development, National Center for Environmental Assessment, Superfund Health Risk Technical Support Center, Cincinnati, OH. A-202 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Caffeine CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Chemical Notes: DTXSID0020232 CNS stimulant Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts X Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 X CONTAMINANT SUMMARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 10 4 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.2782 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-203 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Caffeine CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes NOTE: Though there are over the-counter labels for caffeine, there are no FDA approved formulations for adults. For this reason, a health concentration was not developed. Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Cancer Classification (CC) 3 no units WHO IARC Maximum Recommended Daily Dose 10 mg/kg/day FDA Screening level for pharmaceutical - general 0.058823529 mg/L EPA Office of Water population Screening level for pharmaceutical - infants 0.016666667 mg/L EPA Office of Water Data Element Value Units Source Notes Measured Data and Assessment Results LD50 127 mg/kg NIH HSDB min LD50 230 mg/kg NIH HSDB max Percent of active toxcast in 7.84 percent EPA Chemistry Dashboard vitro assays tested Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Modeled Data LD50 0.0011429 mo l/kg TEST QSAR Ames mutagenicity test 0.192 no units TEST QSAR Developmental toxin test 0.799 no units TEST QSAR A-204 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Caffeine CCL5 Contaminant Informatio OCCURRENCE DATA EPA-OGWDWand OST Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018 - 2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013 - 2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008 - 2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survey (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991 - 2017 3,465 417 Sites 12 0.0025 0.046 0.278 15 ug/L National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991 - 2017 341 222 Sites 65 0.004 0.0554 0.325 15 ug/L National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991 - 2017 3,124 195 Sites 6.24 0.0025 0.01 0.0384 2.82 us/L PesticideApplication Data Number of States Amount Applied (lbs/year) Date Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Data Number of States Amount Released (lbs/year) Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Production Data Production Volume (lbs/year) Chemical Data Reporting (CDR) Results (EPA) (2016) 100K-500K Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Drinking Water Monitoring Data -CA (Finished) 2006 - 2020 58 9 Sites 16 0.051 0.064 0.17 0.37 ug/L Bradley et al. 2018 (Finished) [53] 2016 26 1 Sites 3.85 0.0589107 0.0589 0.0589 0.0589107 ug/L Glassmeyer et a 1 2017 (Finished) [86] 2007 - 2012 25 NA Sites 0 ug/L Community Water System Survey (CWSS) (Finished) [178] 2006 1 NA Sites 0.017 0.017 ug/L Padhye et al. 2013 (Finished) [155] 2009 - 2010 8 3 Samples 38 0 0 1.16e-05+/-7e- 07 ug/L USGS, Sioux Falls Area, 2012 (Finished) [153] 2009 - 2010 1 0 Sites 0 Ambient Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Source) 2006 - 2020 266 34 Sites 13 0.05 0.19 0.427 1.5 ug/L National Water Information System (USGS NWIS) (Surface Water) 2008 - 2017 1,019 526 Sites 52 0.00583 0.06 0.322 18 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008 - 2017 1,697 69 Sites 4.07 0.005 0.0323 0.108 0.267 ug/L National Water Information System (USGS NWIS) (All Water) 2008 - 2017 2,715 595 Sites 22 0.005 0.06 0.314 18 ug/L Glass meyer et a 1 2017 (Ambient) [86] 2007 - 2012 25 NA Sites 12 0.0703 0.09089 ug/L Bradley et al. 2017 (Ambient) [52] 2012 - 2014 38 28 Sites 74 0.0068603 0.0874 0.227 1.275935 ug/L Arnold et al. 2016 (Filtered) [7] 2012 - 2013 106 0 Sites 0 Bexfield et al. 2019 (Groundwater) [49] 2013-2015 1,106 11 Sites 0.99 0.1254262 0.246 0.974 1.359395 ug/L Padhye et al. 2013 (Ambient) [155] 2009-2010 8 4 Samples 50 0 2.7e-06 1.59e-05+/-6e- 07 ug/L USGS, Sioux Falls Area, 2012 (Ambient) [153] 2009-2010 2 2 Sites 100 0.002 0.0145 0.0247 0.025 ug/L USGS, McKenzie River, Oregon, 2012 (Ambient) [158] 2002-2010 126 40 Samples 32 11.4 ug/L Waste Water Effluent Prevalence Magnitude Scott et al. 2018 (Wastewater) [161] 2011-2017 21 21 Sites | 100 0.0189615 1 0.14 1 1.8 1 3.1 1 ug/L Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mgAg bw/day) Notes Expocast exposure 0.0000242 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Value Units Notes Biodegradation half-life OPERA QSAR 3.52242 days Boiling point OPERA QSAR 286.771 degree C Boiling point TEST QSAR 337.485 degree C Vapor pressure OPERA QSAR 0.00000208 mmHg Vapor pressure TEST QSAR 0.00000241 mmHg Solubility in water OPERA QSAR 0.101085 mol/L Solubility in water TEST QSAR 0.054325 mol/L Bioconcentration factor OPERA QSAR 1.86426 no units Bioconcentration factor TEST QSAR 1.31522 no units Henry's Law constant OPERA QSAR 0.00000159 atm-mA3/mol Octanol/water partitioning coeff. (log Kow) OPERA QSAR -0.119469 no units A-205 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Caffeine CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 49 Bexfield, L. M., P.L. Toccalino, K. Belitz, W.T. Foreman, and E.T. Furlong. 2019. Hormones and pharmaceuticals in groundwater used as a source of drinking water across the United States. Environmental Science and Technology 53: 2950-2960. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 53 Bradley, P. M., Kolpin, D. W., Romanok, K. M., Smalling, K. L., Focazio, M. J., Brown, J. B.,... & Dietze, J. E. (2018). Reconnaissance of mixed organic and inorganic chemicals in private and public supply tapwaters at selected residential and workplace sites in the United States. Environmental science & technology, 52(23), 13972-13985. 86 Glassmeyer, S.T., Furlong, E.T., Kolpin, D.W., Batt, A.L., Benson, R., Boone, J.S.,... & Wilson, V.S. (2017). Nationwide reconnaissance of contaminants of emerging concern in source and treated drinking waters of the United States. Science of The Total Environment. v581-582, (909-922). 153 Occurrence of anthropogenic organic compounds and nutrients in source and finished water in the Sioux Falls area, South Dakota, 2009-10: U.S. Geological Survey Scientific Investigations Report 2012-5098, 21 p. plus appendixes. 155 Padhye, L.P., Yao, H., Kung'u, F.T., and Huang, C.H. Year-long evaluation on the occurrence and fate of pharmaceuticals, personal care products, and endocrine disrupting chemicals in an urban drinking water treatment plant. 2014. Water Research 51 (2014) 266-276. 158 Reconnaissance of Land-Use Sources of Pesticides in Drinking Water, McKenzie River, Oregon. U.S. Geological Survey Scientific Investigations Report 2012-5091, 46 p. plus appendixes. 161 Scott, T. M., Phillips, P. J., Kolpin, D. W., Colella, K. M., Furlong, E. T., Foreman, W. T., & Gray, J. L. (2018). Pharmaceutical manufacturing facility discharges can substantially increase the pharmaceutical load to US wastewaters. Science of the Total Environment, 636, 69-79. 178 USE PA (US Environmental Protection Agency). (2009). 2006 Community Water System Survey. Overview, 57. A-206 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Calcium CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Calcium CASRN: 7440-70-2 DTXSID: DTXSID9050484 Use: Element, used in alloys and deoxidizerfor copper, beryllium, steel Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 10 10 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 96865 90th Percentile Finished Water NIRS 1984-1986 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-207 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Calcium CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes HC 2019 [97] NOTE: There is no evidence of adverse health effects from calcium in drinking water Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 2500 mg/day IOM 2010 no adverse effects general population 2413 207000 nm Literature Search Summary Lowest LOAEL Health Effects Lowest LOAE L (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Measured Data and Assessment Results I Value I Measured Data and Assessment Results I I Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Modeled Data LD50 TEST QSAR Ames mutagenicity test TEST QSAR Developmental toxin test TEST QSAR A-208 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Calcium CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev (NIRS) 1984 -1986 989 986 Sites 100 25 37453 96865 1116000 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 12.127 12.124 Sites 100 20 37000 94540 5200000 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 2.626 2.626 Sites 100 22 33700 82000 5200000 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 9.502 9.499 Sites 100 20 51800 120000 1940000 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) 1M - 10M Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Finished) 2006 - 2020 660 653 Sites 99 100 49000 96000 1.2e+08 ug/L Drinking Water Monitoring Data - MA (Finished) 2006 - 2020 549 532 Sites 97 30 17600 49200 481000 ug/L Drinking Water Monitoring Data - WA (Finished) 2006-2011 221 215 Sites 97 780 22000 56950 121000 ug/L Glassmeyer et al 2017 (Finished) [86] 2007-2012 25 NA Sites 100 39300 78400 ug/L Community Water System Survey (CWSS) (Finished) [178] 2006 11 NA Sites 30000 95000 ug/L Ambient Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Source) 2006 - 2020 5,442 5,427 Sites 100 100 43000 121000 1.3e+08 ug/L Drinking Water Monitoring Data - MA (Source) 2006 - 2020 88 88 Sites 100 202 27700 52790 539000 ug/L Drinking Water Monitoring Data - ME (Source) 2009 1 1 Sites 100 25000 25000 25000 25000 ug/L Drinking Water Monitoring Data - PA (Source) 2006-2011 13 13 Sites 100 2100 45700 103360 197000 ug/L Drinking Water Monitoring Data - WA (Source) 2006-2011 344 341 Sites 99 810 24900 66730 140000 ug/L Drinking Water Monitoring Data - Wl (Source) 2012-2019 147 146 Sites 99 550 53000 94480 3e+05 ug/L Glassmeyer et a 1 2017 (Ambient) [86] 2007 - 2012 25 NA Sites 100 38900 129000 ug/L Arnold et al. 2016 (Filtered) [7] 2012 - 2013 758 757 Sites 100 42 32600 100400 476000 ug/L Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. A-209 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Calcium CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 86 Glassmeyer, S.T., Furlong, E.T., Kolpin, D.W., Batt, A.L., Benson, R., Boone, J.S.,... & Wilson, V.S. (2017). Nationwide reconnaissance of contaminants of emerging concern in source and treated drinking waters of the United States. Science of The Total Environment. v581-582, (909-922). 97 HC. 2019. Guidelines for Canadian Drinking Water Quality Summary Table. Health Canada (HC), Water and Air Quality Bureau, Health Environments and Consumer Safety Branch, Ottawa, Ontario, Canada. 111 IOM. 2010. Dietary Reference Intakes for Calcium and Vitamin D. Institute of Medicine (IOM), National Academies of Science, Washington, D.C. 178 USEPA (US Environmental Protection Agency). (2009). 2006 Community Water System Survey. Overview, 57. A-210 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Camphor CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Camphor CASRN: 76-22-2 DTXSID: DTXSID5030955 Use: Starting reagent for organic synthesis. Used as an odorant and flavorant. Plasticizer in cosmetics and as a preservative. Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts X Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 9 3 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.0592 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-211 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Camphor CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes NOTE: No health assessments found Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review 2020-04-07 1181 2 8 0 Other Health Data Measured Data and Assessment Results Data Element Value Units Source Notes Measured Data and Assessment Results LD50 1310 mg/kg NIH HSDB Percent of active toxcast in 0.43 percent EPA Chemistry Dashboard vitro assays tested Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. Data Element Value Units Source Notes PECO = Population, Exposure, Comparator, Outcome. Modeled Data LD50 0.0098855 mo l/kg TEST QSAR Ames mutagenicity test -0.018 no units TEST QSAR Developmental toxin test 0.94 no units TEST QSAR A-212 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Camphor CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 OCCURRENCE DATA Scoring_Data_ Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 571 28 Sites 4.9 0.004 0.0125 0.0592 7.6 National Water Qua lity Assessment (USGS NAWQA) (Surface Water) 1991-2017 88 25 Sites 28 0.004 0.013 0.0598 7.6 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 483 3 Sites 0.62 0.004 0.006 0.0368 0.05 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) 100K - 500K Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Glassmeyer et al 2017 (Finished) [86] 2007-2012 25 NA Sites 0 ug/L USGS, Sioux Falls Area, 2012 (Finished) [153] 2009-2010 1 0 Sites 0 Ambient Water Prevalence Magnitude National Water Information System (USGS NWIS) (Surface Water) 2008-2017 721 340 Sites 47 0.005 0.03 0.11 3.9 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008 - 2017 692 27 Sites 3.9 0.004 0.028 0.34 1.08 ug/L National Water Information System (USGS NWIS) (All Water) 2008 - 2017 1,413 367 Sites 26 0.004 0.03 0.11 3.9 ug/L Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990 - 2018 15 1 Sites 6.67 0.105 0.105 0.105 0.105 ug/L Glassmeyer et al 2017 (Ambient) [86] 2007 - 2012 25 NA Sites 0 ug/L Bradley etal. 2017 (Ambient) [52] 2012 - 2014 38 14 Sites 37 0.0108 0.0214 0.0415 0.0486 ug/L USGS, Sioux Falls Area, 2012 (Ambient) [153] 2009 - 2010 2 0 Sites 0 Waste Water Effluent Prevalence Magnitude Scott et al. 2018 (Wastewater) [161] 2011 - 2017 21 8 Sites 38 0.025 0.045 0.075 0.13 ug/L Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 0.0000102 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR4 data used in the CCL5 is a partial datasetand will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 5.16263 days Boiling point OPERA QSAR 204.644 degree C Boiling point TEST QSAR 203.784 degree C Vapor pressure OPERA QSAR 0.340707 mmHg Vapor pressure TEST QSAR 0.214289 mmHg Solubility in water OPERA QSAR 0.00489575 mol/L Solubility in water TEST QSAR 0.0111944 mol/L Bioconcentration factor OPERA QSAR 14.6711 no units Bioconcentration factor TEST QSAR 55.7186 no units Henry's Law constant OPERA QSAR 0.0000794 o E E Octanol/water partitioning coeff. (log Kow) OPERA QSAR 2.64083 no units A-213 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Camphor CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 86 Glassmeyer, S.T., Furlong, E.T., Kolpin, D.W., Batt, A.L., Benson, R., Boone, J.S.,... & Wilson, V.S. (2017). Nationwide reconnaissance of contaminants of emerging concern in source and treated drinking waters of the United States. Science of The Total Environment. v581-582, (909-922). 153 Occurrence of anthropogenic organic compounds and nutrients in source and finished water in the Sioux Falls area, South Dakota, 2009-10: U.S. Geological Survey Scientific Investigations Report 2012-5098, 21 p. plus appendixes. 161 Scott, T. M., Phillips, P. J., Kolpin, D. W., Colella, K. M., Furlong, E. T., Foreman, W. T., & Gray, J. L. (2018). Pharmaceutical manufacturing facility discharges can substantially increase the pharmaceutical load to US wastewaters. Science of the Total Environment, 636, 69-79. 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticide in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. A-214 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Carbamazepine CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Chemical Notes: DTXSID4022731 Is the contaminant on any lists? CERCLA FIFRA Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 X CONTAMINANTSUMMARY& DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 6 non-cancer effects 9 2 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date SL 6 lowest therapeutic dose: anticonvulsant/ bottle-fed infants FDA; NIH 2018; 2018 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.07999 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-215 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Carbamazepine CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDW and OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg- HRL (ug/L) Assessment Full Citation Notes Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg- CCL Screening Level (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.000833333 mg/kg/day FDA 2018; NIH 2018 Caraco Pharmaceutic al La boratories. lowest therapeutic dose:anticonvulsant/ seizure therapy bottle-fed infants 151 5.60 [77] [150] NOTE: (LowestTherapeutic Dose/3000x UF) is used in place of an RfD; LTDs were obtained from FDA-approved Reference Dose (RfD) or Equivalent 0.000833333 mg/kg/day FDA 2018; NIH 2018 Caraco Pharmaceutic al Laboratories. lowest therapeutic dose:anticonvulsant/ seizure therapy general population 33.8 20.0 [77] [150] NOTE: (LowestTherapeutic Dose/3000x UF) is used in place of an RfD; LTDs were obtained from FDA-aooroved Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title- abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review 2020-01-28 10463 Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Acute Health-Based Guidance Value 0.04 mg/L MN DOH Acute Health-Based Guidance Value 0.04 mg/L MN DOH Chronic Health-Based Guidance Value 0.04 mg/L MN DOH Maximum Recommended Daily Dose 26.7 mg/kg/day FDA Screening level for pharmaceutical - general population 0.019607843 mg/L EPA Office of Water Screening level for pharmaceutical - infants 0.005555556 mg/L EPA Office of Water Sh ort-T erm/SubchronicHealth-Based Guidance Value 0.04 mg/L MN DOH Data Element Value Units Source Notes Measured Data and Assessment Results Percent of active toxcast in 2.19 percent EPA Chemistry Dashboard vitro assays tested Data Element Value Units Source Notes Modeled Data LD50 0.0068707 mol/kg TEST QSAR Ames mutagenicity test 0.428 no units TEST QSAR Developmental toxin test 0.792 no units TEST QSAR Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. A-216 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Carbamazepine CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST October 2022 Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR)4 2018 - 2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013 - 2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008 - 2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survey (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991 - 2017 626 62 Sites 9.9 0.00021 0.00478 0.08 0.468 ug/L National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991 - 2017 75 41 Sites 55 0.00021 0.00475 0.0821 0.334 ug/L National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991 - 2017 551 21 Sites 3.81 0.00033 0.00495 0.0571 0.468 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Finished) 2006 - 2020 1 0 Sites 0 Bradley et al. 2018 (Finished) [53] 2016 26 2 Sites 7.69 0.0005503 0.000656 0.00074 0.0007611 ug/L Glassmeyer et al 2017 (Finished) [86] 2007 - 2012 25 NA Sites 8 0.0177 0.0265 ug/L Padhye et al. 2013 (Finished) [155] 2009 - 2010 8 1 Samples 12 0 0 2.5e-05 +/- 8.8e- 06 ug/L USGS, Sioux Falls Area, 2012 (Finished) [153] 2009 - 2010 1 0 Sites 0 Kleywegt et al. (2011) via Uslu et al. (2013) (Finished) [433] 2011 NA NA 0.601 ug/L Tabe et al. (2009) via Uslu et al. (2013) (Finished) [433] 2009 NA NA 4e-04 ug/L Kormos et al. (2007) via Uslu et al. (2013) (Finished) [433] 2007 NA NA 0.721 ug/L IL EPA (2008) via Uslu et al. (2013) (Finished) [433] 2008 NA NA 0.007 ug/L Snyder et al. (2007) via Kumar et al. (2010) (Finished) [128] 2007 20 NA Samples 0.0011 0.0028 0.0057 ug/L Ambient Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Source) 2006 - 2020 1 0 Sites 0 National Water Information System (USGS NWIS) (Surface Water) 2008 - 2017 502 246 Sites 49 0.00018 0.012 0.114 0.521 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008 - 2017 940 58 Sites 6.17 0.00046 0.0157 0.301 1 ug/L National Water Information System (USGS NWIS) (All Water) 2008 - 2017 1,441 304 Sites 21 0.00018 0.012 0.13 1 ug/L Glassmeyer et al 2017 (Ambient) [86] 2007 - 2012 25 NA Sites 28 0.0159 0.0357 ug/L Batt et al. 2016 (Ambient) [46] 2008 - 2009 182 74 Sites 41 0.0015 0.0116 0.0514 0.2493 ug/L Bradley et al. 2017 (Ambient) [52] 2012 - 2014 38 22 Sites 58 0.0008717 0.0707 0.204 0.3827473 ug/L Bexfield et al. 2019 (Groundwater) [49] 2013 - 2015 1,106 18 Sites 1.63 0.0029133 0.00852 0.102 0.1620862 ug/L Padhye et al. 2013 (Ambient) [155] 2009 - 2010 8 8 Samples 100 5e-07 +/- le-07 9e-07 4.1e-06 +/- 1.2 e- 06 ug/L USGS, Sioux Falls Area, 2012 (Ambient) [153] 2009 - 2010 2 2 Sites 100 0.001 0.0055 0.0122 0.014 ug/L Kleywegt et al. (2011) via Uslu et al. (2013) (Ambient) [433] 2011 NA NA 0.749 ug/L Tabe et al. (2009) via Uslu et al. (2013) (Ambient) [433] 2009 NA NA 0.002 ug/L Kormos et al. (2007) via Uslu et a 1. (2013) (Ambient) [433] 2007 NA NA 1.015 ug/L Rahman et al. (2010) via Uslu et al. (2013) (Ambient) [433] 2010 NA NA 0.0779 ug/L IL EPA (2008) via Uslu et al. (2013) (Ambient) [433] 2008 NA NA 0.009 ug/L Snyder et al. (2007) via Kumar et al. (2010) (Ambient) [128] 2007 20 NA Samples 0.0012 0.0031 0.039 ug/L Batt et al. (2008) via Kostich et al. 2010 (Ambient) [127] 2010 NA NA 0.02 ug/L A-217 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Benotti et al. (2007) via Kostich et al. 2010 (Ambient) [127] 2010 NA NA 0.078 ug/L Benotti et al. (2009) via Kostich et al. 2010 (Ambient) [127] 2010 NA NA 0.051 ug/L Conkle et al. (2008) via Kostich et al. 2010 (Ambient) [127] 2010 NA NA 0.034 ug/L Conley et al. (2008) via Kostich et al. 2010 (Ambient) [127] 2010 NA NA 0.023 ug/L Conley et al. (2008b) via Kostich et al. 2010 (Ambient) [127] 2010 NA NA 0.0056 ug/L Drewes et al. (2002) via Kostich et al. 2010 (Ambient) [127] 2010 NA NA 0.61 ug/L Focazio et al. (2008) via Kostich et al. 2010 (Ambient) [127] 2010 NA NA 0.19 ug/L Glassmeyer et al. (2005) via Kostich et al. 2010 (Ambient) [127] 2010 NA NA 0.186 ug/L Kolpin et al. (2004) via Kostich et al. 2010 (Ambient) [127] 2010 NA NA 0.263 ug/L Spongberget al. (2008) via Kostich et al. 2010 (Ambient) [127] 2010 NA NA 0.014 ug/L Stackelberg et al. (2004) via Kostich et al. 2010 (Ambient) [127] 2010 NA NA 1.5 ug/L Stackelberg et al. (2007) via Kostich et al. 2010 (Ambient) [127] 2010 NA NA 0.6 ug/L Stand ley et al. (2008) via Kostich et al. 2010 (Ambient) [127] 2010 NA NA 0.0024 ug/L Trenholm et al. (2006) via Kostich et al. 2010 (Ambient) [127] 2010 NA NA 0.0025 ug/L Vanderford et al. (2003) via Kostich et al. 2010 (Ambient) [127] 2010 NA NA 0.092 ug/L Vanderford et al. (2006) via Kostich et al. 2010 (Ambient) [127] 2010 NA NA 0.203 ug/L Zhang et al. (2007) via Kostich et al. 2010 (Ambient) [127] 2010 NA NA 0.114 ug/L Waste Water Effluent Prevalence Magnitude Scott et al. 2018 (Wastewater) [161] 2011 - 2017 21 20 Sites 95 0.0394095 0.169 0.409 0.7300448 ug/L Kostich et al. 2014 (Wastewater) [126] not reported 50 48 Sites 96 0.0242 0.101 0.271 0.4612 ug/L Batt et al. (2008) via Kostich et al. 2010 (Wastewater) [127] 2010 NA NA 0.8 ug/L Benotti et al. (2007) via Kostich et al. 2010 (Wastewater) [127] 2010 NA NA 0.196 ug/L Conkle et al. (2008) via Kostich et al. 2010 (Wastewater) [127] 2010 NA NA 0.11 ug/L Drewes et al. (2002) via Kostich etal. 2010 (Wastewater) [127] 2010 NA NA 0.445 ug/L Glassmeyer et al. (2005) via Kostich et al. 2010 (Wastewater) [127] 2010 NA NA 0.27 ug/L Gross et al. (2004) via Kostich et al. 2010 (Wastewater) [127] 2010 NA NA 0.059 ug/L Levine etal. (2006) via Kostich et al. 2010(Wastewater) [127] 2010 NA NA 0.21 ug/L Palmer et al. (2008) via Kostich et al. 2010 (Wastewater) [127] 2010 NA NA 0.551 ug/L Soli man et al. (2007) via Kostich et al. 2010 (Wastewater) [127] 2010 NA NA 0.7 ug/L Spongberg et al. (2008) via Kostich et al. 2010 (Wastewater) [127] 2010 NA NA 0.111 ug/L Trenholm etal. (2006) via Kostich etal. 2010 (Wastewater) [127] 2010 NA NA 0.274 ug/L Vanderford et al. (2006) via Kostich et al. 2010 (Wastewater) [127] 2010 NA NA 0.232 ug/L Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg- bw/day) Notes Expocast exposure 0.00000236 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR4data used in the CCL5 is a partial data set and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Value Units Notes Biodegradation half-life OPERA QSAR 5.03451 days Boiling point OPERA QSAR 320.593 degree C Boiling point TEST QSAR 384.336 degree C Vapor pressure OPERA QSAR 6.85 E-10 mmHg Vapor pressure TEST QSAR 3.22 E-08 mmHg Solubility in water OPERA QSAR 0.000382424 mol/L Solubility in water TEST QSAR 0.0000255 mol/L Bioconcentration factor OPERA QSAR 16.3863 no units Bioconcentration factor TEST QSAR 26.6073 no units Henry's Law constant OPERA QSAR 1.02 E-09 atm-mA3/mol Octanol/water partitioning coeff. (log Kow) OPERA QSAR 2.46475 no units A-218 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Carbamazepine CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 46 Batt, A. L., Kincaid, T. M., Kostich, M. S., Lazorchak, J. M., & Olsen, A. R. (2016). Evaluating the extent of pharmaceuticals in surface waters of the United States using a Nationaicale Rivers and Streams Assessment survey. Environmental toxicology and chemistry, 35(4), 874-881. 49 Bexfield, L.M., P.L. Toccalino, K. Belitz, W.T. Foreman, and E.T. Furlong. 2019. Hormones and pharmaceuticals in groundwater used as a source of drinking water across the United States. Environmental Science and Technology 53: 2950-2960. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 53 Bradley, P. M., Kolpin, D. W., Romanok, K. M., Smalling, K. L., Focazio, M. J., Brown, J. B.,... & Dietze, J. E. (2018). Reconnaissance of mixed organic and inorganic chemicals in private and public supply tapwaters at selected residential and workplace sites in the United States. Environmental science & technology, 52(23), 13972-13985. 77 FDA. 2018. Drugs @ FDA: FDA Approved Drug Products. U.S. Food and Drug Administration (FDA), https://www.accessdata.fda.gov/scripts/cder/daf/. 86 Glassmeyer, S.T., Furlong, E.T., Kolpin, D.W., Batt, A.L., Benson, R., Boone, J.S.,... & Wilson, V.S. (2017). Nationwide reconnaissance of contaminants of emerging concern in source and treated drinking waters of the United States. Science of The Total Environment. v581-582, (909-922). 126 Kostich MS, et al. 2014 Concentrations of prioritized pharmaceuticals in effluents from 50 large wastewater treatment plants in the US and implications for risk estimation. Environ Pollut. 2014 Jan;184:354-9. doi: 10.1016/j.envpol.2013.09.013. Epub 2013 Oct 3. PMID: 24095705. 127 Kostich, MS, et al., 2010. Predicting variability of aquatic concentrations of human pharmaceuticals. Sci. Total Environ. 408 (20), 4504e4510. 128 Kumar, A. and Xagoraraki, 1., 2010. Human health risk assessment of pharmaceuticals in water: An uncertainty analysis for meprobamate, carbamazepine, and phenytoin. Regulatory Toxicology and Pharmacology, 57(2-3), pp.146-156. 150 NIH. 2018. DailyMed Database. U.S. National Library of Medicine, National Institutes of Health (NIH). https://dailymed.nlm.nih.gov/dailymed/. 153 Occurrence of anthropogenic organic compounds and nutrients in source and finished water in the Sioux Falls area, South Dakota, 2009-10: U.S. Geological Survey Scientific Investigations Report 2012-5098, 21 p. plus appendixes. 155 Padhye, L.P., Yao, H., Kung'u, F.T., and Huang, C.H. Year-long evaluation on the occurrence and fate of pharmaceuticals, personal care products, and endocrine disrupting chemicals in an urban drinking water treatment plant. 2014. Water Research 51 (2014) 266-276. 161 Scott, T. M., Phillips, P. J., Kolpin, D. W., Colella, K. M., Furlong, E. T., Foreman, W. T., & Gray, J. L. (2018). Pharmaceutical manufacturing facility discharges can substantially increase the pharmaceutical load to US wastewaters. Science of the Total Environment, 636, 69-79. 433 Uslu, M., Jasim, S., Arvai, A., Bewtra, J. and Biswas, N., 2013. A Survey of Occurrence and Risk Assessment of Pharmaceutical Substances in the Great Lakes Basin. Ozone: Science & Engineering, 35(4), pp.249-262. A-219 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Carbaryl CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Carbaryl CASRN: 63-25-2 DTXSID: DTXSID9020247 Use: Insecticide; veterinary medication Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants X PubMed Neu rotoxica nts X Neu rode v. Disruptors Androgen Receptors in vitro X Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 5 reproductive and developmental effects 1 6 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value («"gA) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 10 brain acetylcholinesterase inhibition in pups bottle-fed infants OPP 2017 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 2.4 90th Percentile Finished Water UCM2 1993 -1997 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-220 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Carbaryl CCL 5 Contaminant Information Sheet EPA-OGWDWand OST October 2022 HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.01 mg/kg/day OPP 2017 Moser 2006 brain acetylcholinesterase inhibition in pups bottle-fed infants 151 13.2 [378] Cancer Slope Factor (CSF) 0.000875 (mg/kg/day)A-l OPP 2017 Hamada 1993 hemangiosarcoma general population 33.8 33.8 [378] Cancer Classification (CC) L OPP 2017 [378] Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results 10-day Health Advisory 1 mg/L EPA DWSHA 2018 Cancer Classification (CC) 3 no units WHO IARC Lifetime Health Advisory 0.04 mg/L EPA DWSHA 2018 Maximum Allowable Concentration (MAC) 0.09 mg/L Canadian Drinking Water Guidelines Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Measured Data and Assessment Results LD50 128 mg/kg NIH HSDB min LD50 500 mg/kg NIH HSDB max LOAEL 1248.9301 mg/kg/day EPA Toxicity Reference Database max LOAEL 3.0999999 mg/kg/day EPA Toxicity Reference Database min NOAEL 180.86 mg/kg/day EPA Toxicity Reference Database max NOAEL 4 mg/kg/day EPA Toxicity Reference Database min Percent of active toxcast in 11.51 percent EPA Chemistry Dashboard vitro assays tested Data Element Value Units Source Notes Modeled Data LD50 0.0014689 mo l/kg TEST QSAR Ames mutagenicity test 0.655 no units TEST QSAR Developmental toxin test 0.784 no units TEST QSAR A-221 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Carbaryl CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST October 2022 Nationally Representative Water Data Date Number of Number of PWS/Sites/ Percent with Minimum Cone. Median Cone. 90th Percentile Maximum Cone. Cone Units Notes PWS/ Sites/ Detects Samples Detects (Detects) (Detects) (Detects) (Detects) Samples Finished Water Preva ence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018 - 2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013 - 2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008 - 2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 12,623 4 Sites 0.03 0.68 1 2.4 3 ug/L Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survey (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991 - 2017 11,274 820 Sites 7.27 0.00038 0.011 0.074 23.5 ug/L National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991 - 2017 2,227 750 Sites 34 0.00038 0.011 0.074 23.5 ug/L National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991 - 2017 9,048 70 Sites 0.77 0.00048 0.0075 0.0364 0.781 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) 43 1,981,350 2016 Toxic Release Inventory (TRI) Program (EPA) (2016) 9 872 Chemical Data Reporting (CDR) Re suits (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/ Sites/ Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone Units Notes Finished Water Prevalence Magnitude Drinking Water Monitoring Data -CA (Finished) 2006 - 2020 171 0 Sites 0 Drinking Water Monitoring Data - MA (Finished) 2006 - 2020 820 0 Sites 0 Drinking Water Monitoring Data - WA(Finished) 2006 - 2011 255 0 Sites 0 US DA Pesticide Data Program (PDP) (Finished) 2001 - 2013 17 5 Sites 29 0.002 0.005 0.069 0.3 ug/L USGS, Sioux Falls Area, 2012 (Finished) [153] 2009 - 2010 1 0 Sites 0 Ambient Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Source) 2006 - 2020 1,747 0 Sites 0 Drinking Water Monitoring Data - MA (Source) 2006 - 2020 77 1 Sites 1.3 0.75 0.75 0.75 0.75 ug/L Drinking Water Monitoring Data - PA (Source) 2006 - 2011 1 0 Sites 0 Drinking Water Monitoring Data - WA (Source) 2006 - 2011 422 0 Sites 0 Drinking Water Monitoring Data - Wl (Source) 2012-2019 92 0 Sites 0 National Water Information System (USGS NWIS) (Surface Water) 2008 - 2017 1,564 363 Sites 23 0.00089 0.016 0.135 3.13 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008 - 2017 3,658 24 Sites 0.66 0.00037 0.007 0.039 0.0886 ug/L National Water Information System (USGS NWIS) (All Water) 2008 - 2017 5,221 387 Sites 7.41 0.00037 0.015 0.13 3.13 ug/L US DA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001 - 2013 229 7 Sites 3.06 0.002 0.018 0.0643 0.33 ug/L US DA Pesticide Data Program (PDP) (Groundwater) 2001 - 2013 219 2 Sites 0.91 0.0125 0.02 0.0511 0.0612 ug/L US DA Pesticide Data Program (PDP) (Untreated) 2001 - 2013 12 5 Sites 42 0.002 0.018 0.065 0.33 ug/L Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990 - 2018 9,207 332 Sites 3.61 0.003 0.11 0.533 13 ug/L Bradley et al. 2017 (Ambient) [52] 2012 - 2014 38 11 Sites 29 0.0032 0.0135 0.0899 0.257 ug/L Arnold et al. 2016 (Filtered) [7] 2012 - 2013 796 6 Sites 0.75 5e-04 6e-04 0.0027 0.0033 ug/L USGS, Sioux Falls Area, 2012 (Ambient) [153] 2009 - 2010 2 0 Sites 0 USGS, McKenzie River, Oregon, 2012 (Ambient) [158] 2002 - 2010 133 35 Samples 26 1.3 ug/L Waste Water Effluent Prevalence Magnitude Scott et al. 2018 (Wastewater) [161] 2011 - 2017 21 3 Sites | 14 0.093 | 0.093 | 0.093 | 0.093 | ug/L Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg- bw/day) Notes Expocast exposure 5.61E-08 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial datasetand will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompT ox Dashboard) Value Units Notes Biodegradation half-life OPERA QSAR 3.55485 days Boiling point OPERA QSAR 312.24 degree C Boiling point TEST QSAR 311.019 degree C Vapor pressure OPERA QSAR 0.00000118 mmHg Vapor pressure TEST QSAR 0.00000562 mmHg Solubility in water OPERA QSAR 0.000534089 mol/L Solubility in water TEST QSAR 0.000414954 mol/L Bioconcentration factor OPERA QSAR 10.3318 no units Bioconcentration factor TEST QSAR 4.69894 no units Henry's Law constant OPERA QSAR 1.55E-09 atm-mA3/mol Octanol/water partitioning coeff. (log Kow) OPERA QSAR 2.38412 no units A-222 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Carbaryl CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulorigoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 153 Occurrence of anthropogenic organic compounds and nutrients in source and finished water in the Sioux Falls area, South Dakota, 2009-10: U.S. Geological Survey Scientific Investigations Report 2012-5098, 21 p. plus appendixes. 158 Reconnaissance of Land-Use Sources of Pesticides in Drinking Water, McKenzie River, Oregon. U.S. Geological Survey Scientific Investigations Report 2012-5091, 46 p. plus appendixes. 161 Scott, T. M., Phillips, P. J., Kolpin, D. W., Colella, K. M., Furlong, E. T., Foreman, W. T., & Gray, J. L. (2018). Pharmaceutical manufacturing facility discharges can substantially increase the pharmaceutical load to US wastewaters. Science of the Total Environment, 636, 69-79. 378 USEPA. 2017. Carbaryl: Draft Human Health Risk Assessment in Support of Registration Review. EPA-HQ-OPP-2010-0230-0034. DP No. D433668. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticide in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. A-223 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Carbendazim CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Carbendazim CASRN: 10605-21-7 DTXSID: DTXSID4024729 Use: Fungicide Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Ust ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 3 carcinogen with linear MOA 10 3 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 10 hepatocellularadenomaand/orcarcinoma general population OPP 2014 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.07612 90th Percentile All Ambient Water NAWQA 1991-2017 Final Hazard Quotient (HQ) 0.0076 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-224 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Carbendazim CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg- HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.025 mg/kg/day OPP 2014 Sherman et al. 1972 decreased body weight and food consumption general population 33.8 148 [337] Cancer Slope Factor (CSF) 0.00239 (mg/kg/day)A-l OPP 2014 Wood 1982; Schneider et al. 1982 hepatocellular adenoma and/or carcinoma general population 33.8 12.4 [337] Cancer Classification (CC) C OPP 2014 [337] Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg- CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title- abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Acute Human Health Benchmark 0.11 mg/L EPA HHBP Acute PAD 0.017 mg/kg/day EPA HHBP Cancer Slope Factor (CSF) 0.00239 (mg/kg/day) A-1 EPA HHBP Chronic Human Health Benchmark 0.16 mg/L EPA HHBP Chronic Human Health Benchmark 0.0134 mg/L EPA HHBP Health-Based Screening Level 0.16 mg/L Health-based screening levels from USGS Health-Based Screening Level 0.0134 mg/L Health-based screening levels from USGS Population-Ad justed Dose (PAD) 0.025 mg/kg/day EPA HHBP Data Element Value Units Source Notes Measured Data and Assessment Results LD50 15000 mg/kg NIH HSDB max LD50 5000 mg/kg NIH HSDB min LOAEL 16.540001 mg/kg/day EPA Toxicity Reference Database min LOAEL 90 mg/kg/day EPA Toxicity Reference Database max NOAEL 20 mg/kg/day EPA Toxicity Reference Database max NOAEL 7.19 mg/kg/day EPA Toxicity Reference Database min Percent of active toxcast in 10.79 percent EPA Chemistry Dashboard vitro assays tested Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Modeled Data LD50 0.0082794 mol/kg TEST QSAR Ames mutagenicity test 0.605 no units TEST QSAR Developmental toxin test 0.884 no units TEST QSAR A-225 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Carbendazim CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 1.757 212 Sites 12 0.00014 0.014 0.0761 1.79 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 322 198 Sites 61 0.00014 0.014 0.0759 1.79 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 1.435 14 Sites 0.98 0.00105 0.0127 0.13 0.251 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude USDA Pesticide Data Program (PDP) (Finished) 2001-2013 7 1 Sites 14 0.003 0.003 0.003 0.003 ug/L Ambient Water Prevalence Magnitude USDA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001-2013 115 4 Sites 3.48 0.003 0.003 0.033 0.121 ug/L USDA Pesticide Data Program (PDP) (Groundwater) 2001-2013 109 1 Sites 0.92 0.005 0.005 0.0153 0.0179 ug/L USDA Pesticide Data Program (PDP) (Untreated) 2001 - 2013 7 3 Sites 43 0.003 0.003 0.033 0.121 ug/L Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990 - 2018 122 33 Sites 27 0.0043 0.0197 0.0605 0.1559 ug/L Arnold et al. 2016 (Filtered) [7] 2012 - 2013 584 5 Sites 0.86 0.0013 0.0054 0.101 0.157 ug/L Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 0.00000001 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR4 data used in the CCL5 is a partial datasetand will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 3.54241 days Boiling point OPERA QSAR 275.322 degree C Boiling point TEST QSAR 374.376 degree C Vapor pressure OPERA QSAR 2.04E-09 mmHg Vapor pressure TEST QSAR 1.17E-08 mmHg Solubility in water OPERA QSAR 0.0024081 mol/L Solubility in water TEST QSAR 0.000907821 mol/L Bioconcentration factor OPERA QSAR 2.44925 no units Bioconcentration factor TEST QSAR 1.6293 no units Henry's Law constant OPERA QSAR 1.38E-09 o E E Octanol/water partitioning coeff. (log Kow) OPERA QSAR 1.43961 no units A-226 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Carbendazim CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 337 USEPA. 2014. Thiophanate-Methyl and Carbendazim (MBC). Human Health Assessment Scoping Document in Support of Registration Review. EPA-HQ-OPP-2014-0004-0010. DP No. D413079. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticide in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. A-227 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Carbon disulfide CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Carbon disulfide CASRN: 75-15-0 DTXSID: DTXSID6023947 Use: Former insecticide/fumigant; rubber additive; industrial solvent; chemical intermediate Chemical Notes: Is the contaminant on any lists? CERCLA X FIFRA X Human Neurotoxicants X PubMed Neu rotoxica nts X Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 4 reproductive and developmental effects 10 4 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value («"gA) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 600 fetal toxicity and fetal malformations women of child bearing age IRIS 1987 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.4 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-228 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Carbon disulfide CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.1 mg/kg/day IRIS 1987 Hardin et al. 1981 fetal toxicity and fetal malformations women of childbearingage 35.4 565 [191] NOTE: high volatility and very low odor threshold: from 0.0243 mg/m3 to 23.1 mg/m3 (0.0078 to 7.4 ppm) ATSDR1996 mi Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Systemic, Neurological 200 Gao, 2014 1995-08-01 2020-02-13 528 10 71 2 Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Acute Minimal Risk Level (MRL) 0.01 mg/kg/day CDC ATSDR Benchmark 0.16 mg/L CalEPA OEHHA Chemical Database Chronic Health-Based Guidance Value 0.7 mg/L MN DOH Chronic inhalation Minimal Risk Level (MRL) 0.3 ppm CDC ATSDR Reference Concentration (RfC) 0.7 mg/mA3 EPA IRIS Reference Concentration (RfC) 800 ug/mA3 CalEPA OEHHA Chemical Database Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Measured Data and Assessment Results LD50 2125 mg/kg NIH HSDB min LD50 3188 mg/kg NIH HSDB max Percent of active toxcast in 0.43 percent EPA Chemistry Dashboard vitro assays tested Data Element Value Units Source Notes Modeled Data LD50 TEST QSAR Ames mutagenicity test 0.705 no units TEST QSAR Developmental toxin test TEST QSAR A-229 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Carbon disulfide CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contam nant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contam nant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contam nant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contam nant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contam nant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contam nant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev(NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 6.049 723 Sites 12 0.01 0.1 0.4 34 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 243 54 Sites 22 0.01 0.02 0.1 34 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 5.806 669 Sites 12 0.01 0.1 0.6 7.3 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) 29 8,774,313 Chemical Data Reporting (CDR) Results (EPA) (2016) 250M-500M Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Finished) 2006 - 2020 127 8 Sites 6.3 0.5 0.73 1.6 8.72 ug/L Bradley et al. 2018 (Finished) [53] 2016 26 9 Sites 35 0.01649 0.0211 0.151 0.2946 ug/L Ambient Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Source) 2006 - 2020 799 20 Sites 2.5 0.51 0.74 3.4 240 ug/L National Water Information System (USGS NWIS) (Surface Water) 2008-2017 187 15 Sites 8.02 0.1 0.1 0.2 0.3 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008-2017 3,202 168 Sites 5.25 0.1 0.3 3 12.4 ug/L National Water Information System (USGS NWIS) (All Water) 2008-2017 3,385 183 Sites 5.41 0.1 0.2 2.87 12.4 ug/L Bradley et al. 2017 (Ambient) [52] 2012-2014 38 14 Sites 37 0.01248 0.0357 0.137 0.2378 ug/L Arnold et al. 2016 (Unfiltered) [7] 2012-2013 685 120 Sites 18 0.0102 0.0749 0.61 4.2 ug/L Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 0.00000243 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 18.0411 days Boiling point OPERA QSAR 47.2959 degree C Boiling point TEST QSAR Vapor pressure OPERA QSAR 365.359 mmHg Vapor pressure TEST QSAR Solubility in water OPERA QSAR 0.0213938 mol/L Solubility in water TEST QSAR Bioconcentration factor OPERA QSAR 18.2423 no units Bioconcentration factor TEST QSAR Henry's Law constant OPERA QSAR 0.00944903 atm-mA3/mol 0 eta no 1/water partitioning coeff. (log Kow) OPERA QSAR 1.95653 no units A-230 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Carbon disulfide CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 11 ATSDR. 1996. Toxicological Profile for Carbon Disulfide. U.S. Department of Health and Human Services, Public Health Service, Agency for Toxic Substances and Disease Registry (ATSDR), Atlanta, GA. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 53 Bradley, P. M., Kolpin, D. W., Romanok, K. M., Smalling, K. L., Focazio, M. J., Brown, J. B.,... & Dietze, J. E. (2018). Reconnaissance of mixed organic and inorganic chemicals in private and public supply tapwaters at selected residential and workplace sites in the United States. Environmental science & technology, 52(23), 13972-13985. 191 USEPA. 1987. Chemical Assessment Summary, Carbon Disulfide. U.S. Environmental Protection Agency, National Center for Environmental Assessment, Integrated Risk Information System (IRIS), Washington, D.C. A-231 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Chlordecone CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Chlordecone CASRN: 143-50-0 DTXSID: DTXSID1020770 Use: Formerly as insecticide, fungicide, miticide Chemical Notes: Canceled pesticide. Last end of use date: 4/4/1977. Is the contaminant on any lists? CERCLA X FIFRA X Human Neurotoxicants X PubMed Neu rotoxica nts X Neu rode v. Disruptors Androgen Receptors in vitro X Compounds with neu rod ev effects, Mundy et a 12015 X CONTAMINANT SUMMARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 7 carcinogen with linear MOA Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 0.003 liver hepatocellular carcinoma general population IRIS 2009 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.2 90th Percentile All Ambient Water NWIS 2008-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-232 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Chlordecone CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDW and OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg- HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.0003 mg/kg/day IRIS 2009 Larson et al. 1979 renal lesions (glomerulosclerosis) in female rats general population 33.8 1.78 [300] NOTE: canceled registration, OPP does not provide a publicly- available health assessment for chlordecone; the chlordecone entry in the IRIS database was preserved at the request of EPA program offices Cancer Slope Factor (CSF) 10 (mg/kg/day)A-l IRIS 2009 NCI 1976 liver hepatocellular carcinoma general population 33.8 0.00296 [300] NOTE: canceled registration, OPP does not provide a publicly- available health assessment for chlordecone; the chlordecone entry in the IRIS database was preserved at the request of EPA program offices Cancer Classification (CC) L IRIS 2009 [300] NOTE: canceled registration, OPP does not provide a publicly- available health assessment for chlordecone; the chlordecone entry in the IRIS database was preserved at the request of EPA program offices OPP Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg- CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title- abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Acute Minimal Risk Level (MRL) 0.01 mg/kg/day CDC ATSDR Cancer Slope Factor (CSF) 16 (mg/kg/day) A-1 CalEPA OEHHAChemical Database Inhalation Unit Risk (IUR) 0.0046 ug/mA3 CalEPA OEHHA Chemical Database Intermediate Minimal Risk Level (MRL) 0.0005 mg/kg/day CDC ATSDR Cancer Classification (CC) 2B no units WHO IARC Cancer Classification (CC) Female.Mice P no units HHS NTP Cancer Classification (CC) Female.Rats P no units HHS NTP Cancer Classification (CC) Male.Mice P no units HHS NTP Cancer Classification (CC) Male.Rats P no units HHS NTP Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Modeled Data LD50 0.0003882 mol/kg TEST QSAR Ames mutagenicity test 0.529 no units TEST QSAR Developmental toxin test TEST QSAR Data Element Value Units Source Notes Measured Data and Assessment Results LD50 2550 mg/kg NIH HSDB max LD50 65 mg/kg NIH HSDB min Percent of active toxcast in 44.29 percent EPA Chemistry Dashboard vitro assays tested TD50 0.705 mg/kg/day NIHCPDB min TD50 29.3 mg/kg/dav NIHCPDB max A-233 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Chlordecone CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contam nant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contam nant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contam nant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contam nant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contam nant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contam nant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev(NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Ambient Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Source) 2006 - 2020 1 0 Sites 0 National Water Information System (USGS NWIS) (Surface Water) 2008-2017 2 2 Sites 100 0.2 0.2 0.2 0.2 ug/L National Water Information System (USGS NWIS) (All Water) 2008-2017 2 2 Sites 100 0.2 0.2 0.2 0.2 ug/L Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 0.000000194 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicatethere were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 913.927 days Boiling point OPERA QSAR 373.013 degree C Boiling point TEST QSAR 354.456 degree C Vapor pressure OPERA QSAR 0.000000162 mmHg Vapor pressure TEST QSAR 0.000000465 mmHg Solubility in water OPERA QSAR 0.00000296 mol/L Solubility in water TEST QSAR 0.00000232 mol/L Bioconcentration factor OPERA QSAR 1458.84 no units Bioconcentration factor TEST QSAR Henry's Law constant OPERA QSAR 0.0000926 atm-mA3/mol 0 eta no 1/water partitioning coeff. (log Kow) OPERA QSAR 5.49303 no units A-234 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Chlordecone CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 300 USEPA. 2009. Chemical Assessment Summary, Chlordecone (Kepone). U.S. Environmental Protection Agency, National Center for Environmental Assessment, Integrated Risk Information System (IRIS), Washington, D.C. A-235 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Chloromethane (Methyl chloride) CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Chloromethane (Methyl chloride) CASRN: 74-87-3 DTXSID: DTXSID0021541 Use: Foaming agent; in organic synthesis; naturally- occurring gas Chemical Notes: Is the contaminant on any lists? CERCLA X FIFRA X Human Neurotoxicants X PubMed Neu rotoxica nts X Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 9 6 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 1.7 90th Percentile Finished Water UCMR3 2013-2015 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-236 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Chloromethane (Methyl chloride) CCL 5 Contaminant Information Sheet EPA-OGWDWand OST October 2022 HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.0036 mg/kg/day OW1989 Repko et a I,, 1976 mild neurological effects general population 33.8 21.3 [205] Cancer Classification (CC) I PPRTV 2012 [326] NOTE: no oral toxicity values have been derived for chloromethane because it primarily exists as a gas Cancer Classification (CC) D IRIS 2001 [243] Cancer Classification (CC) C OW 1989 [205] ATSDR1998 [13] Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results 10-day Health Advisory 0.4 mg/L EPA DWSHA 2018 Acute inhalation Minimal Risk Level (MRL) 0.5 ppm CDC ATSDR Cancer Classification (CC) 3 no units WHO IARC Chronic inhalation Minimal Risk Level (MRL) 0.05 ppm CDC ATSDR Intermediate Inhalation Minimal Risk Level 0.2 ppm CDC ATSDR (MRL) Reference Concentration (RfC) 0.09 mg/mA3 EPA IRIS Subchronic RfC 3 mg/mA3 EPA PPRTV Data Element Value Units Source Notes Modeled Data LD50 0.0057016 mo l/kg TEST QSAR Ames mutagenicity test 0.487 no units TEST QSAR Developmental toxin test TEST QSAR Data Element I Value I Units 1 Source I Notes Measured Data and Assessment Results LD50 | 1800 | mg/kg Inih hsdb l Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. A-237 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Chloromethane (Methyl chloride) CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 OCCURRENCE DATA Scorin£Data_ Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018 - 2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013 - 2015 4,916 138 Sites 2.81 0.2 0.4 1.7 11.3 ug/L Unregulated Contaminant Monitoring Rule (UCMR) 2 2008 - 2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 23,478 528 Sites 2.25 0.00073 1.4 5 312 ug/L Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 20,246 248 Sites 1.22 0.01 1.9 12.2 550 ug/L National Inorganics and Radionuclides Survey (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991 - 2017 7,366 189 Sites 2.57 0.02 0.1 0.2 320 ug/L National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991 - 2017 269 53 Sites 20 0.02 0.1 0.1 320 ug/L National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991 - 2017 7,097 136 Sites 1.92 0.1 0.1 0.2 21 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) 24 1,088,720 Chemical Data Reporting (CDR) Results (EPA) (2016) 1B-5B Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Finished) 2006 - 2020 398 40 Sites 10 0.19 0.745 1.6 35 ug/L Drinking Water Monitoring Data - MA (Finished) 2006 - 2020 899 83 Sites 9.23 0.5 1.1 3.85 44.6 ug/L Drinking Water Monitoring Data - WA (Finished) 2006 - 2011 1,188 28 Sites 2.36 0.07 1.42 4.73 320 ug/L Bradley et al. 2018 (Finished) [53] 2016 26 6 Sites 23 0.1607 0.186 0.233 0.2694 ug/L Ambient Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Source) 2006 - 2020 4,242 218 Sites 5.14 0.076 0.75 2 21.2 ug/L Drinking Water Monitoring Data - FL (Source) 2006 - 2011 3 2 Sites 67 0.49 36.2 64.8 72 ug/L Drinking Water Monitoring Data - MA (Source) 2006 - 2020 133 17 Sites 13 0.5 0.7 3.66 4.9 ug/L Drinking Water Monitoring Data - PA (Source) 2006 - 2011 14 0 Sites 0 Drinking Water Monitoring Data - WA (Source) 2006 - 2011 1,666 8 Sites 0.48 0.65 0.83 5.04 6.3 ug/L Drinking Water Monitoring Data - Wl (Source) 2012-2019 135 0 Sites 0 National Water Information System (USGS NWIS) (Surface Water) 2008 - 2017 240 3 Sites 1.25 0.2 0.4 0.82 1 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008 - 2017 3,492 38 Sites 1.09 0.1 0.4 1.1 4 ug/L National Water Information System (USGS NWIS) (All Water) 2008 - 2017 3,728 41 Sites 1.1 0.1 0.4 1.08 4 ug/L Arnold et al. 2016 (Unfiltered) [7] 2012 - 2013 685 2 Sites 0.29 0.3 1.45 2.37 2.6 ug/L Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg- bw/day) Notes Expocast exposure Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection n serum (1999-2016) NHANES biomonitoring detection n blood (1999-2016) NHANES biomonitoring detection n urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 16.4952 days Boiling point OPERA QSAR -26.1513 degree C Boiling point TEST QSAR -0.434 degree C Vapor pressure OPERA QSAR 2473.43 mmHg Vapor pressure TEST QSAR 1866.38 mmHg Solubility in water OPERA QSAR 0.0623759 mol/L Solubility in water TEST QSAR 0.418794 mol/L Bioconeentration factor OPERA QSAR 9.6851 no units Bioconeentration factor TEST QSAR 3.8815 no units Henry's Law constant OPERA QSAR 0.00943159 atm-mA3/mol Octanol/water partitioning coeff. (log Kow) OPERA QSAR 0.947026 no units A-238 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Chloromethane (Methyl chloride) CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 13 ATSDR. 1998. Toxicological Profile for Chloromethane. U.S. Department of Health and Human Services, Public Health Service, Agency for Toxic Substances and Disease Registry (ATSDR), Atlanta, GA. 53 Bradley, P. M., Kolpin, D. W., Romanok, K. M., Smalling, K. L., Focazio, M. J., Brown, J. B.,... & Dietze, J. E. (2018). Reconnaissance of mixed organic and inorganic chemicals in private and public supply tapwaters at selected residential and workplace sites in the United States. Environmental science & technology, 52(23), 13972-13985. 205 USEPA. 1989. Chloromethane Health Advisory. U.S. Environmental Protection Agency, Office of Water, Washington, D.C. 243 USEPA. 2001. Chemical Assessment Summary, Chloromethane. U.S. Environmental Protection Agency, National Center for Environmental Assessment, Integrated Risk Information System (IRIS), Washington, D.C. 326 USEPA. 2012. Provisional Peer-Reviewed Toxicity Values for Chloromethane. U.S. Environmental Protection Agency, Office of Research and Development, National Center for Environmental Assessment Superfund Health Risk Technical Support Center, Cincinnati, OH. A-239 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Chlorothalonil CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Chlorothalonil CASRN: 1897-45-6 DTXSID: DTXSID0020319 Use: Fungicide; bactericide Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANTSUMMARY& DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 5 non-cancer effects 4 4 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 100 renal epithelial hyperplasia in the proximal convoluted tubules of females general population OPP 2010 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.51 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-240 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Chlorothalonil CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.02 mg/kg/day OPP 2010 Spencer- Briggs 1996 renal epithelial hyperplasia in the proximal convoluted tubules of females general population 33.8 118 [309] Cancer Classification (CC) L OPP 2010 [3091 Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results 10-day Health Advisory 0.2 mg/L EPA DWSHA2018 Cancer Slope Factor (CSF) 0.017 (mg/kg/day)A-l CalEPA OEH HA Chemical Database Chronic Health-Based Guidance Value 0.003 mg/L MN DOH Lifetime Health Advisory 0.0015 mg/L EPA DWSHA 2018 Cancer Classification (CC) 2B no units WHO IARC Cancer Classification (CC) Female.Mice N no units HHSNTP Cancer Classification (CC) Female.Rats P no units HHSNTP Cancer Classification (CC) Male.Mice N no units HHSNTP Cancer Classification (CC) Male.Rats P no units HHS NTP Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Measured Data and Assessment Results LD50 10000 mg/kg NIH HSDB max LD50 242 mg/kg NIH HSDB min LOAEL 0.9 mg/kg/day EPA Toxicity Reference Database min LOAEL 500 mg/kg/day EPA Toxicity Reference Database max NOAEL 1.8 mg/kg/day EPA Toxicity Reference Database min NOAEL 250 mg/kg/day EPA Toxicity Reference Database max Percent of active toxcast in 37.28 percent EPA Chemistry Dashboard vitro assays tested Subchronic LOAEL 2.3 mg/kg/day EPA Toxicity Reference Database min Subchronic LOAEL 750 mg/kg/day EPA Toxicity Reference Database max Subchronic NOAEL 1.5 mg/kg/day EPA Toxicity Reference Database min Subchronic NOAEL 250 mg/kg/day EPA Toxicity Reference Database max TD50 1180 mg/kg/day NIH CPDB min TD50 20100 mg/kg/day NIH CPDB max Data Element Value Units Source Notes Modeled Data LD50 0.0048978 mo l/kg TEST QSAR Ames mutagenicity test 0.05 no units TEST QSAR Developmental toxin test 0.29 no units TEST QSAR A-241 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Chlorothalonil CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 5.787 21 Sites 0.36 0.01 0.09 0.51 3.33 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 951 16 Sites 1.68 0.01 0.07 0.626 3.33 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 4.836 5 Sites 0.1 0.09 0.25 0.385 0.41 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) 48 11,506,189 2016 Toxic Release Inventory (TRI) Program (EPA) (2016) 7 1,036,501 Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Finished) 2006 - 2020 69 0 Sites 0 USDA Pesticide Data Program (PDP) (Finished) 2001-2013 12 0 Sites 0 Ambient Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Source) 2006 - 2020 739 3 Sites 0.41 0.018 0.033 0.0354 0.036 ug/L National Water Information System (USGS NWIS) (Surface Water) 2008-2017 137 22 Sites 16 1.00E - 04 0.0046 0.0282 0.158 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008-2017 70 0 Sites 0 National Water Information System (USGS NWIS) (All Water) 2008-2017 207 22 Sites 11 1.00E - 04 0.0046 0.0282 0.158 ug/L USDA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001-2013 229 1 Sites 0.44 3.2 3.2 3.2 3.2 ug/L USDA Pesticide Data Program (PDP) (Groundwater) 2001-2013 218 1 Sites 0.46 3.2 3.2 3.2 3.2 ug/L USDA Pesticide Data Program (PDP) (Untreated) 2001-2013 12 0 Sites 0 Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990-2018 565 5 Sites 0.88 0.0067 0.105 0.159 0.187 ug/L Bradley et al. 2017 (Ambient) [52] 2012-2014 38 5 Sites 13 0.0033 0.0061 0.00638 0.0065 ug/L Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 0.000000218 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 5.52071 days Boiling point OPERA QSAR 344.049 degree C Boiling point TEST QSAR 341.73 degree C Vapor pressure OPERA QSAR 0.000000897 mmHg Vapor pressure TEST QSAR 0.000218776 mmHg Solubility in water OPERA QSAR 0.00000281 mol/L Solubility in water TEST QSAR 0.0000229 mol/L Bioconcentration factor OPERA QSAR 75.4862 no units Bioconcentration factor TEST QSAR 44.2 no units Henry's Law constant OPERA QSAR 0.00000281 o E E 0 eta no l/water partitioning coeff. (log Kow) OPERA QSAR 3.09917 no units A-242 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Chlorothalonil CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 309 USEPA. 2010. Chlorothalonil. Registration Request for Use on Low-Growing Berry Subgroup 13-07G; Bushberry Subgroup 13-07B; Onion, Bulb Subgroup 3-07A; and Onion, Green Subgroup 3-07B. Human Health Risk Assessment. EPA-HQ-OPP-2018-0517-0003. DP No. D370486. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticide in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. A-243 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Chlorpyrifos CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Chlorpyrifos CASRN: 2921-88-2 DTXSID: DTXSID4020458 Use: Insecticide Chemical Notes: Is the contaminant on any lists? CERCLA X FIFRA X Human Neurotoxicants X PubMed Neu rotoxica nts X Neu rode v. Disruptors X Androgen Receptors in vitro X Compounds with neu rod ev effects, Mundy et a 12015 X CONTAMINANT SUMMARY & DECISION CCL5 List Decision Ust ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 7 reproductive and developmental effects 1 4 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value («"gA) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 2 decreased brain cholinesterase activity women of child bearing age OPP 2011 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.0305 90th Percentile Finished Water UCMR4 2018-2019 Final Hazard Quotient (HQ) 0.015 PUBLIC NOMINATION STATUS Public Nomination X PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-244 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Chlorpyrifos CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.0003 mg/kg/day OPP 2011 Hoberman 1998; Mandralla & Brzakl998 decreased brain cholinesterase activity in pregnant dams women of childbearingage 35.4 1.69 [318] Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results 10-day Health Advisory 0.03 mg/L EPA DWSHA 2018 Acute Health-Based Guidance Value 0.002 mg/L MN DOH Acute Health-Based Guidance Value 0.0006 mg/L MN DOH Acute Minimal Risk Level (MRL) 0.003 mg/kg/day CDC ATSDR Chronic Health-Based Guidance Value 0.0006 mg/L MN DOH Drinking Water Guideline Value 0.03 mg/L WHO Drinking Water Quality Guidelines Intermediate Minimal Risk Level (MRL) 0.003 mg/kg/day CDC ATSDR Lifetime Health Advisory 0.002 mg/L EPA DWSHA 2018 Maximum Allowable Concentration (MAC) 0.09 mg/L Canadian Drinking Water Guidelines Short-Term/Subchronic Health-Based Guidance Value 0.0006 mg/L MN DOH Data Element I Value I Units I Source I Notes Measured Data and Assessment Results LD50 1000 mg/kg NIH HSDB max LD50 26.9 mg/kg NIH HSDB min LOAEL 15 mg/kg/day EPA Toxicity Reference Database max LOAEL 0.03 mg/kg/day EPA Toxicity Reference Database min NOAEL 0.01 mg/kg/day EPA Toxicity Reference Database min NOAEL 3 mg/kg/day EPA Toxicity Reference Database max Percent of active toxcast in vitro assays tested 18.73 percent EPA Chemistry Dashboard Subchronic LOAEL 0.75 mg/kg/day EPA Toxicity Reference Database Subchronic NOAEL 0.15 mg/kg/day EPA Toxicity Reference Database Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Modeled Data LD50 0.0003048 mo l/kg TEST QSAR Ames mutagenicity test -0.097 no units TEST QSAR Developmental toxin test 0.595 no units TEST QSAR A-245 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Chlorpyrifos CCL5 Contaminant Informatio OCCURRENCE DATA EPA-OGWDWand OST Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018 - 2019 3,649 1 Sites 0.03 0.0305 0.0305 0.0305 0.0305 ug/L Unregulated Contaminant Monitoring Rule (UCMR) 3 2013 - 2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008 - 2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survey (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991 - 2017 11,249 620 Sites 5.51 0.00022 0.007 0.029 0.57 ug/L National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991 - 2017 2,233 573 Sites 26 0.00022 0.007 0.029 0.57 ug/L National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991 - 2017 9,017 47 Sites 0.52 0.00057 0.005 0.0149 0.215 ug/L PesticideApplication Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) 48 7,971,347 2016 Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Drinking Water Monitoring Data -CA (Finished) 2006 - 2020 6 0 Sites 0 USDA Pesticide Data Program (PDP) (Finished) 2001 - 2013 17 0 Sites 0 USGS, Sioux Falls Area, 2012 (Finished) [153] 2009 - 2010 1 0 Sites 0 USGS, Sioux Falls Area, 2012 (Finished) [153] 2009 - 2010 1 0 Sites 0 Ambient Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Source) 2006 - 2020 92 0 Sites 0 National Water Information System (USGS NWIS) (Surface Water) 2008 - 2017 1,553 94 Sites 6.05 0.00051 0.0067 0.0618 11.3 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008 - 2017 3,630 6 Sites 0.17 0.0028 0.00485 0.0205 0.0398 ug/L National Water Information System (USGS NWIS) (All Water) 2008 - 2017 5,182 100 Sites 1.93 0.00051 0.0067 0.0606 11.3 ug/L USDA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001 - 2013 229 0 Sites 0 USDA Pesticide Data Program (PDP) (Groundwater) 2001 - 2013 219 0 Sites 0 USDA Pesticide Data Program (PDP) (Untreated) 2001 - 2013 12 0 Sites 0 Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990 - 2018 20,007 3,554 Sites 18 7e-07 0.0188 0.162 9.4 ug/L Bradley et al. 2017 (Ambient) [52] 2012 - 2014 38 30 Sites 79 2.42e-05 0.000322 0.00396 0.0904 ug/L Arnold et al. 2016 (Filtered) [7] 2012 - 2013 690 1 Sites 0.14 6e-04 6e-04 6e-04 6e-04 ug/L USGS, Sioux Falls Area, 2012 (Ambient) [153] 2009 - 2010 2 1 Sites 50 0.009 0.0095 0.0099 0.01 ug/L USGS, Sioux Falls Area, 2012 (Ambient) [153] 2009-2010 2 0 Sites 0 USGS, McKenzie River, Oregon, 2012 (Ambient) [158] 2002-2010 133 1 Samples 0.8 0.01 ug/L Waste Water Effluent Prevalence Magnitude Scott et al. 2018 (Wastewater) [161] 2011-2017 21 0 Sites 0 Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mgAg bw/day) Notes Expocast exposure 0.000000023 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial data set and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Value Units Notes Biodegradation half-life OPERA QSAR 4.75106 days Boiling point OPERA QSAR 371.599 degree C Boiling point TEST QSAR Vapor pressure OPERA QSAR 0.0000259 mmHg Vapor pressure TEST QSAR 0.0000308 mmHg Solubility in water OPERA QSAR 0.00000316 mol/L Solubility in water TEST QSAR 0.00000236 mol/L Bioconeentration factor OPERA QSAR 1687.74 no units Bioconeentration factor TEST QSAR 380.189 no units Henry's Law constant OPERA QSAR 0.00000209 atm-mA3/mol Octanol/water partitioning coeff. (log Kow) OPERA QSAR 4.85185 no units A-246 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Chlorpyrifos CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulorigoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 153 Occurrence of anthropogenic organic compounds and nutrients in source and finished water in the Sioux Falls area, South Dakota, 2009-10: U.S. Geological Survey Scientific Investigations Report 2012-5098, 21 p. plus appendixes. 158 Reconnaissance of Land-Use Sources of Pesticides in Drinking Water, McKenzie River, Oregon. U.S. Geological Survey Scientific Investigations Report 2012-5091, 46 p. plus appendixes. 161 Scott, T. M., Phillips, P. J., Kolpin, D. W., Colella, K. M., Furlong, E. T., Foreman, W. T., & Gray, J. L. (2018). Pharmaceutical manufacturing facility discharges can substantially increase the pharmaceutical load to US wastewaters. Science of the Total Environment, 636, 69-79. 318 USEPA. 2011. Chlorpyrifos: Preliminary Human Health Risk Assessment for Registration Review. EPA-HQ-OPP-2008-0850-0025. DP No. D388070. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticide in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. A-247 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Clomazone CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Chemical Notes: DTXSID1032355 Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 3 no adverse effects 9 4 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 5000 no adverse effects identified general population OPP 2018 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.39567 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-248 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Clomazone CCL 5 Contaminant Information Sheet EPA-OGWDWand OST October 2022 HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.84 mg/kg/day OPP 2018 Morrow 1983 no effects identified at loael selected as pod general population 33.8 4970 [398] Cancer Classification (CC) NL OPP 2018 [398] Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element I Value | Units | Source | Notes Measured Data and Assessment Results Acute Human Health Benchmark 30 mg/L EPA HHBP Acute PAD 1 mg/kg/day EPA HHBP Chronic Human Health Benchmark 54 mg/L EPA HHBP Population-Adjusted Dose (PAD) 0.84 mg/kg/day EPA HHBP Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Modeled Data LD50 0.0025942 mo l/kg TEST QSAR Ames mutagenicity test 1.078 no units TEST QSAR Developmental toxin test 0.592 no units TEST QSAR Data Element Value Units Source Notes Measured Data and Assessment Results LD50 1369 mg/kg NIH HSDB min LD50 2077 mg/kg NIH HSDB max LOAEL 100 mg/kg/day EPA Toxicity Reference Database min LOAEL 300 mg/kg/day EPA Toxicity Reference Database max NOAEL 100 mg/kg/day EPA Toxicity Reference Database max NOAEL 50 mg/kg/day EPA Toxicity Reference Database min Percent of active toxcast in 5.13 percent EPA Chemistry Dashboard vitro assays tested Sub chronic LOAEL 273 mg/kg/day EPA Toxicity Reference Database Subchronic NOAEL 160.9 mg/kg/day EPA Toxicity Reference Database A-249 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Clomazone CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 OCCURRENCE DATA Scoring_Data_ Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 14 1 Sites 7.14 0.01 0.0659 0.396 0.537 National Water Qua lity Assessment (USGS NAWQA) (Surface Water) 1991-2017 14 1 Sites 7.14 0.01 0.0659 0.396 0.537 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) 33 1,039,399 2016 Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude USDA Pesticide Data Program (PDP) (Finished) 2001-2013 5 0 Sites 0 Ambient Water Prevalence Magnitude National Water Information System (USGS NWIS) (Surface Water) 2008-2017 132 33 Sites 25 0.0022 0.0476 1.45 19.4 ug/L National Water information System (USGS NWIS) (Groundwater) 2008-2017 3 0 Sites 0 National Water information System (USGS NWIS) (All Water) 2008-2017 135 33 Sites 24 0.0022 0.0476 1.45 19.4 ug/L USDA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001-2013 221 0 Sites 0 USDA Pesticide Data Program (PDP) (Groundwater) 2001-2013 216 0 Sites 0 USDA Pesticide Data Program (PDP) (Untreated) 2001-2013 5 0 Sites 0 Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990-2018 414 129 Sites 31 0.0045 0.288 2.82 12 ug/L Bradley et al. 2017 (Ambient) [52] 2012-2014 38 2 Sites 5.26 0.0064 0.467 0.835 0.9271 ug/L Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 7.58E-08 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 3.33433 days Boiling point OPERA QSAR 279.519 degree C Boiling point TEST QSAR 310.651 degree C Vapor pressure OPERA QSAR 0.000103082 mmHg Vapor pressure TEST QSAR 0.0000329 mmHg Solubility in water OPERA QSAR 0.00482471 mol/L Solubility in water TEST QSAR 0.00106414 mol/L Bioconcentration factor OPERA QSAR 37.6372 no units Bioconcentration factor TEST QSAR Henry's Law constant OPERA QSAR 3.33E-08 atm-mA3/mol 0 eta no l/water partitioning coeff. (log Kow) OPERA QSAR 2.35315 no units A-250 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Clomazone CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 398 USEPA. 2018. Clomazone: Human Health Risk Assessment for Proposed (1) New Uses on Cilantro, Dill, and Rapeseed Subgroup 20A; (2) Tolerance Revisions of Cucurbit Vegetable Group 9; (3) Tolerance Expansions of Representative Commodities to (i) Cottonseed Subgroup20C, (ii) Stalk and Stem Vegetable Subgroup 22A, except Kohlrabi, (iii) Dry Bean, and (iv)Succulent Bean; and (4) Tolerance Conversions from Crop Subgroup 5A (Head and Stem Brassica) to Crop Group 5-16 (Brassica Head and Stem Vegetable), Chinese Broccoli and Kohlrabi. EPA-HQ-OPP-2017-0372-0008. DP No. D445140. 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticide in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. A-251 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Clopyralid CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Clopyralid CASRN: 1702-17-6 DTXSID: DTXSID9029221 Use: Herbicide, food additive Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Not List ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 4 non-cancer effects 5 4 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 900 increased epithelial hyperplasia and thickening of the limiting ridge ofthe stomach general population OPP 2019 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.132 90th Percentile All Ambient Water NAWQA 1991-2017 Final Hazard Quotient (HQ) 0.00015 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-252 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Clopyralid CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.15 mg/kg/day OPP 2019 Barn a-Lloyd eta 1.1985 and 1986 increased epithelial hyperplasia and thickening of the limiting ridge of the stomach general population 33.8 888 [415] Cancer Classification (CC) NL OPP 2019 [4151 Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Chronic Human Health Benchmark 0.96 mg/L EPA HHBP Health-Based Screening Level 0.96 mg/L Health-based screening levels from USGS Population-Adjusted Dose (PAD) 0.15 mg/kg/day EPAHHBP Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Measured Data and Assessment Results LD50 4300 mg/kg NIH HSDB min LD50 5000 mg/kg NIH HSDB max LOAEL 150 mg/kg/day EPA Toxicity Reference Database min LOAEL 2000 mg/kg/day EPA Toxicity Reference Database max NOAEL 15 mg/kg/day EPA Toxicity Reference Database min NOAEL 500 mg/kg/day EPA Toxicity Reference Database max Percent of active toxcast in 2.38 percent EPA Chemistry Dashboard vitro assays tested Subchronic LOAEL 5000 mg/kg/day EPA Toxicity Reference Database Subchronic NOAEL 2000 mg/kg/day EPA Toxicity Reference Database Data Element Value Units Source Notes Modeled Data LD50 0.0099541 mo l/kg TEST QSAR Ames mutagenicity test 0.114 no units TEST QSAR Developmental toxin test 0.26 no units TEST QSAR A-253 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Clopyralid CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev(NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 6,464 34 Sites 0.53 0.01 0.04 0.132 0.53 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 969 30 Sites 3.1 0.01 0.04 0.136 0.53 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 5.495 4 Sites 0.07 0.01 0.015 0.02 0.02 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) 46 2,037,895 2016 Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude USDA Pesticide Data Program (PDP) (Finished) 2001-2013 17 6 Sites 35 0.0057 0.012 0.0474 0.684 ug/L Ambient Water Prevalence Magnitude National Water information System (USGS NWIS) (Surface Water) 2008-2017 198 0 Sites 0 National Water Information System (USGS NWIS) (Groundwater) 2008-2017 542 0 Sites 0 National Water Information System (USGS NWIS) (All Water) 2008-2017 740 0 Sites 0 USDA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001-2013 229 9 Sites 3.93 0.005661 0.012 0.036 0.36 ug/L USDA Pesticide Data Program (PDP) (Groundwater) 2001-2013 218 5 Sites 2.29 0.005661 0.00566 0.0227 0.024 ug/L USDA Pesticide Data Program (PDP) (Untreated) 2001-2013 12 4 Sites 33 0.0057 0.012 0.036 0.36 ug/L Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990-2018 182 0 Sites 0 Arnold et al. 2016 (Filtered) [7] 2012-2013 106 0 Sites 0 Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 1.17E-08 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 3.53754 days Boiling point OPERA QSAR 286.1 degree C Boiling point TEST QSAR 293.982 degree C Vapor pressure OPERA QSAR 0.0000209 mmHg Vapor pressure TEST QSAR 0.0000647 mmHg Solubility in water OPERA QSAR 0.00334275 mol/L Solubility in water TEST QSAR 0.0301995 mol/L Bioconcentration factor OPERA QSAR 3.76695 no units Bioconcentration factor TEST QSAR 2.5527 no units Henry's Law constant OPERA QSAR 4.79E-09 atm-mA3/mol 0 eta no 1/water partitioning coeff. (log Kow) OPERA QSAR 1.19217 no units A-254 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Clopyralid CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 415 USEPA. 2019. Clopyralid. Draft Human Health Risk Assessment for Registration Review of the Herbicide. E PA-HQ-OPP-2014-0167-0031. DP No. D442247. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticide in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. A-255 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Clothianidin CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Chemical Notes: DTXSID2034465 Insecticide used on food crops Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 4 reproductive and developmental effects 10 1 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value («"gA) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 100 decreased body weight gain, delayed sexual maturation, decreased thymus weights in F1 pups, increased stillbirths in Fland F2 bottle-fed infants OPP 2019 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.0017 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-256 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Clothianidin CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.098 mg/kg/day OPP 2019 Freshwater and Astroff 2000 decreased body weight gain, delayed sexual maturation, decreased thymus weights in F1 pups, increased stillbirths in F1 and F2 bottle-fed infants 151 130 [416] Cancer Classification (CC) NL OPP 2019 [4161 Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Acute Health-Based Guidance Value 0.2 mg/L MN DOH Acute Human Health Benchmark 1.7 mg/L EPA HHBP Acute PAD 0.25 mg/kg/day EPA HHBP Chronic Health-Based Guidance Value 0.2 mg/L MN DOH Chronic Human Health Benchmark 0.63 mg/L EPA HHBP Health-Based Screening Level 0.63 mg/L Health-based screening levels from USGS Population-Adjusted Dose (PAD) 0.098 mg/kg/day EPA H HBP Short-Term/Subchronic Health-Based Guidance 0.2 mg/L MN DOH Value Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Measured Data and Assessment Results LD50 389 mg/kg NIH HSDB min LD50 5000 mg/kg NIH HSDB max LOAEL 215.89999 mg/kg/day EPA Toxicity Reference Database max LOAEL 31.200001 mg/kg/day EPA Toxicity Reference Database min NOAEL 10 mg/kg/day EPA Toxicity Reference Database min NOAEL 65.1 mg/kg/day EPA Toxicity Reference Database max Percent of active toxcast in 1.94 percent EPA Chemistry Dashboard vitro assays tested Subchronic LOAEL 202 mg/kg/day EPA Toxicity Reference Database max Subchronic LOAEL 40.900002 mg/kg/day EPA Toxicity Reference Database min Subchronic NOAEL 21.2 mg/kg/day EPA Toxicity Reference Database min Subchronic NOAEL 34 mg/kg/day EPA Toxicity Reference Database max Data Element Value Units Source Notes Modeled Data LD50 0.0023933 mo l/kg TEST QSAR Ames mutagenicity test 0.998 no units TEST QSAR Developmental toxin test 0.597 no units TEST QSAR A-257 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Clothianidin CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 OCCURRENCE DATA Scoring_Data_ Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 5 1 Sites 20 9.00E - 04 0.0014 0.0017 0.0019 National Water Qua lity Assessment (USGS NAWQA) (Surface Water) 1991-2017 5 1 Sites 20 9.00E - 04 0.0014 0.0017 0.0019 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) 31 163,492 2016 Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude USDA Pesticide Data Program (PDP) (Finished) 2001-2013 10 3 Sites 30 0.008 0.008 0.0102 0.018 ug/L Klarich et al. 2017 (Finished) [117] 2016 20 16 Sites 80 0.00389 0.0119 0.0291 0.03346 ug/L Ambient Water Prevalence Magnitude National Water Information System (USGS NWIS) (Surface Water) 2008-2017 131 55 Sites 42 9.00E - 04 0.0092 0.0783 1.34 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008 - 2017 12 4 Sites 33 0.0123 0.0274 0.0491 0.0555 ug/L National Water Information System (USGS NWIS) (All Water) 2008 - 2017 143 59 Sites 41 9.00E - 04 0.0094 0.0777 1.34 ug/L USDA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001 - 2013 227 3 Sites 1.32 0.008 0.008 0.0265 0.045 ug/L USDA Pesticide Data Program (PDP) (Groundwater) 2001 - 2013 218 0 Sites 0 USDA Pesticide Data Program (PDP) (Untreated) 2001 - 2013 10 3 Sites 30 0.008 0.008 0.0265 0.045 ug/L Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990 - 2018 279 5 Sites 1.79 0.0311 0.0462 0.0645 0.0675 ug/L Bradley etal. 2017 (Ambient) [52] 2012 - 2014 38 9 Sites 24 0.0026 0.0113 0.0438 0.0663 ug/L Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 9.22E-08 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR4 data used in the CCL5 is a partial datasetand will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 3.55019 days Boiling point OPERA QSAR 326.625 degree C Boiling point TEST QSAR Vapor pressure OPERA QSAR 0.000000197 mmHg Vapor pressure TEST QSAR Solubility in water OPERA QSAR 0.00076435 mol/L Solubility in water TEST QSAR 0.00200447 mol/L Bioconcentration factor OPERA QSAR 9.38346 no units Bioconcentration factor TEST QSAR Henry's Law constant OPERA QSAR 1.82E-09 o E E 0 eta no l/water partitioning coeff. (log Kow) OPERA QSAR 0.762847 no units A-258 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Cloth ianidin CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 117 Klarich, K.L., Pflug, N.C., DeWald, E.M., Hladik, M.L., Kolpin, D.W., Cwiertny, D.M. and LeFevre, G.H., 2017. Occurrence of neonicotinoid insecticides in finished drinking water and fate during drinking water treatment. Environmental Science & Technology Letters, 4(5), pp. 168-173. 416 USEPA. 2019. Clothianidin. Human Health Risk Assessment to Address Residues from New/Amended Uses of Thiamethoxam. EPA-HQ-OPP-2018-0779-0004. DP No. D446686. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticide in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. A-259 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Cobalt CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Cobalt CASRN: 7440-48-4 DTXSID: DTXSID1031040 Use: Use data a re for cobaItous ch loride: Formerlyin medicines; as germicide; naturally-occurring Chemical Notes: Is the contaminant on any lists? CERCLA X FIFRA Human Neurotoxicants PubMed Neu rotoxica nts X Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 7 reproductive and developmental effects 9 7 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value («"gA) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 2 "decreased iodine uptake in humans" women of child bearing age PPRTV 2008 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 5.198 90th Percentile Finished Water UCMR3 2013-2015 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-260 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Cobalt CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.0003 mg/kg/day PPRTV 2008 Roche and Layrisse 1956 "decreased iodine uptake in humans" women of child bearing age 35.4 1.69 [294] ATSDR2004 [201 Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Hematologic, Systemic 10 Nejad, 2014 Immune 10 Nejad, 2014 2007-08-01 2019-10-22 6161 13 287 2 Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Chronic inhalation Minimal Risk Level (MRL) 0.0001 mg/mA3 CDC ATSDR Inhalation Unit Risk (IUR) 9 ug/mA3 EPA PPRTV Intermediate Minimal Risk Level (MRL) 0.01 mg/kg/day CDC ATSDR Reference Concentration (RfC) 0.000006 mg/mA3 EPA PPRTV Subchronic Provisional RfD 0.003 mg/kg/day EPA PPRTV Subchronic RfC 0.00002 mg/mA3 EPA PPRTV Cancer Classification (CC) 2B no un ts WHO IARC Cancer Classification (CC) 2B no un ts WHO IARC Cancer Classification (CC) Female.Mice P no un ts HHSNTP Cancer Classification (CC) Female.Rats P no un ts HHSNTP Cancer Classification (CC) Male.Mice P no un ts HHSNTP Cancer Classification (CC) Male.Rats P no un ts HHSNTP Data Element Value Units Source Notes Modeled Data LD50 TEST QSAR Ames mutagenicity test TEST QSAR Developmental toxin test TEST QSAR Data Element I Value I Units 1 Source I Notes Measured Data and Assessment Results LD50 | 6171 | mg/kg Inih HSDB l Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. A-261 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Cobalt CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 OCCURRENCE DATA Scoring_Data_ Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 4,922 247 Sites 5.02 1 1.8 5.2 1097.099 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State(UCM-State) Round 2 1993 -1997 Unregulated Contaminant Mon itoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and RadionuclidesSurvev(NIRS) 1984 -1986 989 3 Sites 0.3 6 10 10 11 Ambient Water Prevalence Magnitude National Water Qualitv Assessment (USGS NAWQA) (All Water) 1991-2017 7.630 5.028 Sites 66 0.007 0.151 1.55 684 National Water Qua litv Assessment (USGS NAWQA) (Surface Water) 1991-2017 466 137 Sites 29 0.02 0.167 1.03 53.2 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 7.164 4.891 Sites 68 0.007 0.147 1.64 684 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) 38 240,271 Chemical Data Reporting (CDR) Results (EPA) (2016) 10M - 50M Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Finished) 2006 - 2020 70 33 Sites 47 0.002 0.108 0.3 1.07 ug/L Bradley et al. 2018 (Finished) [53] 2016 26 12 Sites 46 0.04 0.11 0.147 0.18 ug/L Community Water System Survey (CWSS) (Finished) [178] 2006 1 NA Sites Ambient Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Source) 2006 - 2020 139 47 Sites 34 0.009 0.166 2.1 29 ug/L National Water Information System (USGS NWIS) (Surface Water) 2008 - 2017 1,272 1,167 Sites 92 0.005 0.21 1.5 508 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008 - 2017 4,565 2,769 Sites 61 0.007 0.129 2.88 1230 ug/L National Water Information System (USGS NWIS) (All Water) 2008 - 2017 5,825 3,934 Sites 68 0.005 0.19 1.95 1230 ug/L Arnold et al. 2016 (Filtered) [7] 2012 - 2013 757 602 Sites 80 0.022 0.0775 0.881 52.4 ug/L Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) 0.28 ug/l NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR4 data used in the CCL5 is a partial datasetand will be complete in Dec. 2020. A-262 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Cobalt CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 20 ATSDR. 2004. Toxicological Profile for Cobalt. U.S. Department of Health and Human Services, Public Health Service, Agency for Toxic Substances and Disease Registry (ATSDR), Atlanta, GA. 53 Bradley, P. M., Kolpin, D. W., Romanok, K. M., Smalling, K. L., Focazio, M. J., Brown, J. B.,... & Dietze, J. E. (2018). Reconnaissance of mixed organic and inorganic chemicals in private and public supply tapwaters at selected residential and workplace sites in the United States. Environmental science & technology, 52(23), 13972-13985. 178 USEPA (US Environmental Protection Agency). (2009). 2006 Community Water System Survey. Overview, 57. 294 USEPA. 2008. Provisional Peer Reviewed Toxicity Values for Cobalt (CASRN 7440-48-4). EPA/690/R-08/008F. U.S. Environmental Protection Agency, Office of Research and Development, National Center for Environmental Assessment, Superfund Health Risk Technical Support Center, Cincinnati, OH. A-263 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Cotinine CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Chemical Notes: DTXSID1047576 Urinary metabolite of Is the contaminant on any lists? CERCLA FIFRA Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 9 3 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.1058 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-264 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Cotinine CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes NOTE: No health assessments found Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review 2020-04-06 4070 9 129 0 Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Data Element Value Units Source Notes Measured Data and Assessment Results Percent of active toxcast in 0.6 percent EPA Chemistry Dashboard vitro assays tested Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Modeled Data LD50 0.0026363 mo l/kg TEST QSAR Ames mutagenicity test 0.336 no units TEST QSAR Developmental toxin test 0.642 no units TEST QSAR A-265 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Cotinine CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 1.142 64 Sites 5.6 0.00027 0.0117 0.106 0.38 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 144 63 Sites 44 0.00027 0.012 0.106 0.38 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 998 1 Sites 0.1 0.00506 0.00506 0.00506 0.00506 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Bradley et al. 2018 (Finished) [53] 2016 26 4 Sites 15 0.0010904 0.00166 0.00235 0.0025508 ug/L Glassmeyer et al 2017 (Finished) [86] 2007-2012 25 NA Sites 8 0.011 0.01581 ug/L Padhye et al. 2013 (Finished) [155] 2009-2010 8 1 Samples 12 0 0 4e-07 +/- 4e-07 ug/L USGS, Sioux Falls Area, 2012 (Finished) [153] 2009-2010 1 0 Sites 0 IL EPA (2008) via Uslu et al. (2013) (Finished) [433] 2008 NA NA 0.006 ug/L Ambient Water Prevalence Magnitude Glassmeyer et al 2017 (Ambient) [86] 2007-2012 25 NA Sites 8 0.0153 0.01886 ug/L Bradley et al. 2017 (Ambient) [52] 2012-2014 38 23 Sites 61 0.0011136 0.0173 0.0489 0.0680997 ug/L Padhye et al. 2013 (Ambient) [155] 2009-2010 8 2 Samples 25 0 0 2.7e-06 +/- 4e- 07 ug/L USGS, Sioux Falls Area, 2012 (Ambient) [153] 2009-2010 2 0 Sites 0 IL EPA (2008) via Uslu et al. (2013) (Ambient) [433] 2008 NA NA 0.012 ug/L Waste Water Effluent Prevalence Magnitude Scott et al. 2018 (Wastewater) [161] 2011-2017 21 21 Sites 100 0.0111602 0.042 0.192 0.2647215 ug/L Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 0.000000117 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) 0.388 ng/ml NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR4 data used in the CCL5 is a partial datasetand will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 3.34908 days Boiling point OPERA QSAR 280.912 degree C Boiling point TEST QSAR 279.705 degree C Vapor pressure OPERA QSAR 0.000289385 mmHg Vapor pressure TEST QSAR 0.000944061 mmHg Solubility in water OPERA QSAR 0.252783 mol/L Solubility in water TEST QSAR 0.0369828 mol/L Bioconcentration factor OPERA QSAR 3.16285 no units Bioconcentration factor TEST QSAR 2.46604 no units Henry's Law constant OPERA QSAR 0.000000115 o E E 0 eta no l/water partitioning coeff. (log Kow) OPERA QSAR 0.190328 no units A-266 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Cotinine CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 53 Bradley, P. M., Kolpin, D. W., Romanok, K. M., Smalling, K. L., Focazio, M. J., Brown, J. B.,... & Dietze, J. E. (2018). Reconnaissance of mixed organic and inorganic chemicals in private and public supply tapwaters at selected residential and workplace sites in the United States. Environmental science & technology, 52(23), 13972-13985. 86 Glassmeyer, S.T., Furlong, E.T., Kolpin, D.W., Batt, A.L., Benson, R., Boone, J.S.,... & Wilson, V.S. (2017). Nationwide reconnaissance of contaminants of emerging concern in source and treated drinking waters of the United States. Science of The Total Environment. v581-582, (909-922). 153 Occurrence of anthropogenic organic compounds and nutrients in source and finished water in the Sioux Falls area, South Dakota, 2009-10: U.S. Geological Survey Scientific Investigations Report 2012-5098, 21 p. plus appendixes. 155 Padhye, L.P., Yao, H., Kung'u, F.T., and Huang, C.H. Year-long evaluation on the occurrence and fate of pharmaceuticals, personal care products, and endocrine disrupting chemicals in an urban drinking water treatment plant. 2014. Water Research 51 (2014) 266-276. 161 Scott, T. M., Phillips, P. J., Kolpin, D. W., Colella, K. M., Furlong, E. T., Foreman, W. T., & Gray, J. L. (2018). Pharmaceutical manufacturing facility discharges can substantially increase the pharmaceutical load to US wastewaters. Science of the Total Environment, 636, 69-79. 433 Uslu, M., Jasim, S., Arvai, A., Bewtra, J. and Biswas, N., 2013. A Survey of Occurrence and Risk Assessment of Pharmaceutical Substances in the Great Lakes Basin. Ozone: Science & Engineering, 35(4), pp.249-262. A-267 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Cumene CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Chemical Notes: DTXSID1021827 Is the contaminant on any lists? CERCLA FIFRA Human Neurotoxicants X PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANTSUMMARY& DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 4 non-cancer effects 4 6 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 600 increased average kidney weights general population IRIS 1997 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 3.24 90th Percentile Finished Water UCM1 1988-1992 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-268 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Cumene CCL 5 Contaminant Information Sheet EPA-OGWDWand OST October 2022 HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.1 mg/kg/day IRIS 1997 Wolf etal. 1956 increased average kidney weight general population 33.8 592 [225] Reference Dose (RfD) or Equivalent 0.1 mg/kg/day WHO 1999 Wolf et al. 1956 increased average kidney weight general population 33.8 592 [436] Cancer Classification (CC) D IRIS 1997 [225] Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review 2001-09-01 2020-04-14 480 0 4 Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results 10-day Health Advisory 11 mg/L EPA DWSHA2018 Chronic Health-Based Guidance Value 0.3 mg/L MN DOH Reference Concentration (RfC) 0.4 mg/mA3 EPA IRIS Cancer Classification (CC) 2B no units WHO IARC Cancer Classification (CC) Female.Mice P no units HHSNTP Cancer Classification (CC) Female. Rats SE no units HHSNTP Cancer Classification (CC) Ma le.Mice CE no units HHSNTP Cancer Classification (CC) Male.Rats CE no units HHSNTP Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Measured Data and Assessment Results LD50 1400 mg/kg NIH HSDB min LD50 2910 mg/kg NIH HSDB max Percent of active toxcast in 5.96 percent EPA Chemistry Dashboard vitro assays tested Data Element Value Units Source Notes Modeled Data LD50 0.020893 mo l/kg TEST QSAR Ames mutagenicity test 0.04 no units TEST QSAR Developmental toxin test 0.5 no units TEST QSAR A-269 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Cumene CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contam nant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contam nant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contam nant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contam nant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contam nant Monitoring-State (UCM-State) Round 2 1993 -1997 22.995 56 Sites 0.24 0.1 0.6 2.58 15 Unregulated Contam nant Monitoring-State (UCM-State) Round 1 1988 -1992 12.771 35 Sites 0.27 0.01 0.9 3.24 6 National Inorganics and Radionuclides Survev (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 6.831 75 Sites 1.1 0.005 0.03 3.5 27 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 277 14 Sites 5.05 0.005 0.2 3.5 3.8 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 6.554 61 Sites 0.93 0.005 0.0285 3.76 27 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) 41 924,489 Chemical Data Reporting (CDR) Results (EPA) (2016) 5B - 10B Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Glassmeyer et al 2017 (Finished) [86] 2007-2012 9 NA Sites 0 ug/L USGS, Sioux Falls Area, 2012 (Finished) [153] 2009-2010 1 0 Sites 0 Ambient Water Prevalence Magnitude National Water Information System (USGS NWIS) (Surface Water) 2008-2017 846 17 Sites 2.01 0.01 0.01 0.09 1.77 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008-2017 3,434 34 Sites 0.99 0.01 0.0355 0.83 39.6 ug/L National Water Information System (USGS NWIS) (All Water) 2008-2017 4,277 51 Sites 1.19 0.01 0.0245 0.8 39.6 ug/L Glassmeyer et a 1 2017 (Ambient) [86] 2007-2012 9 NA Sites 0 ug/L Arnold et al. 2016 (Unfiltered) [7] 2012-2013 158 1 Sites 0.63 0.064 0.064 0.064 0.064 ug/L Southeast Stream Quality Assessment (SESQA) (Ambient) [102] 2014 1 0 Sites 0 Southeast Stream Quality Assessment (SESQA) (Ambient) [102] 2014 2 0 Sites 0 USGS, Sioux Falls Area, 2012 (Ambient) [153] 2009-2010 2 1 Sites 50 Waste Water Effluent Prevalence Magnitude Scott et al. 2018 (Wastewater) [161] 2011-2017 21 0 Sites 0 Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 0.000106 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) < LOD ng/ml NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 12.7811 days Boiling point OPERA QSAR 157.394 degree C Boiling point TEST QSAR 160.61 degree C Vapor pressure OPERA QSAR 3.23017 mmHg Vapor pressure TEST QSAR 2.95121 mmHg Solubility in water OPERA QSAR 0.000517581 mol/L Solubility in water TEST QSAR 0.000954993 mol/L Bioconcentration factor OPERA QSAR 48.173 no units Bioconcentration factor TEST QSAR 239.43 no units Henry's Law constant OPERA QSAR 0.00860044 o E E 0 eta no l/water partitioning coeff. (log Kow) OPERA QSAR 3.82156 no units A-270 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Cumene CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 86 Glassmeyer, S.T., Furlong, E.T., Kolpin, D.W., Batt, A.L., Benson, R., Boone, J.S.,... & Wilson, V.S. (2017). Nationwide reconnaissance of contaminants of emerging concern in source and treated drinking waters of the United States. Science of The Total Environment. v581-582, (909-922). 102 https://webapps.usgs.gOv/rsqa/#l/region/SESQA 153 Occurrence of anthropogenic organic compounds and nutrients in source and finished water in the Sioux Falls area, South Dakota, 2009-10: U.S. Geological Survey Scientific Investigations Report 2012-5098, 21 p. plus appendixes. 161 Scott, T. M., Phillips, P. J., Kolpin, D. W., Colella, K. M., Furlong, E. T., Foreman, W. T., & Gray, J. L. (2018). Pharmaceutical manufacturing facility discharges can substantially increase the pharmaceutical load to US wastewaters. Science of the Total Environment, 636, 69-79. 225 USEPA. 1997. Chemical Assessment Summary, Cumene. U.S. Environmental Protection Agency, National Center for Environmental Assessment, Integrated Risk Information System (IRIS), Washington, D.C. 436 WHO. 1999. Concise International Chemical Assessment Document 18, Cumene. World Health Organization (WHO), Geneva, Switzerland. A-271 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Cycloate CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Cycloate CASRN: 1134-23-2 DTXSID: DTXSID6032356 Use: Herbicide for annual grasses, nutgrass, many broadleafweeds in sugar beets, table beets, spinach Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANTSUMMARY& DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 7 non-cancer effects 2 3 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 3 spinal nerve axonal atrophy and femoral nerve alterations in females general population OPP 2015 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.1139 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-272 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Cycloate CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.0005 mg/kg/day OPP 2015 S prague et al. 1984 spinal nerve axonal atrophy and femoral nerve alterations in females general population 33.8 2.96 [339] Cancer Classification (CC) NL OPP 2015 [3391 Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Acute Human Health Benchmark 0.45 mg/L EPA HHBP Acute PAD 0.067 mg/kg/day EPA HHBP Chronic Human Health Benchmark 0.03 mg/L EPA HHBP Health-Based Screening Level 0.03 mg/L Health-based screening levels from USGS Population-Adjusted Dose (PAD) 0.005 mg/kg/day EPAHHBP Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Measured Data and Assessment Results LD50 1275 mg/kg NIH HSDB min LD50 4175 mg/kg NIH HSDB max LOAEL 175 mg/kg/day EPA Toxicity Reference Database max LOAEL 3.0999999 mg/kg/day EPA Toxicity Reference Database min NOAEL 0.5 mg/kg/day EPA Toxicity Reference Database min NOAEL 75 mg/kg/day EPA Toxicity Reference Database max Percent of active toxcast in 2.32 percent EPA Chemistry Dashboard vitro assays tested Data Element Value Units Source Notes Modeled Data LD50 0.0067608 mo l/kg TEST QSAR Ames mutagenicity test 0.352 no units TEST QSAR Developmental toxin test 0.445 no units TEST QSAR A-273 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Cycloate CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 OCCURRENCE DATA Scoring_Data_ Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev(NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 2.751 4 Sites 0.15 0.009 0.02 0.114 0.48 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 221 4 Sites 1.81 0.009 0.02 0.114 0.48 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 2.530 0 Sites 0 Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) 2 48,166 2016 Toxic Release Inventory (TRI) Program (EPA) (2016) 1 10 Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Finished) 2006 - 2020 3 0 Sites 0 USDA Pesticide Data Program (PDP) (Finished) 2001-2013 13 0 Sites 0 Ambient Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Source) 2006 - 2020 16 0 Sites 0 National Water information System (USGS NWIS) (Surface Water) 2008-2017 363 2 Sites 0.55 0.0016 0.03 0.0986 0.128 ug/L National Water information System (USGS NWIS) (Groundwater) 2008-2017 621 0 Sites 0 National Water information System (USGS NWIS) (All Water) 2008-2017 984 2 Sites 0.2 0.0016 0.03 0.0986 0.128 ug/L USDA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001-2013 121 0 Sites 0 USDA Pesticide Data Program (PDP) (Groundwater) 2001-2013 114 0 Sites 0 USDA Pesticide Data Program (PDP) (Untreated) 2001-2013 8 0 Sites 0 Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990-2018 180 31 Sites 17 0.0136 0.105 0.306 0.601 ug/L Bradley et al. 2017 (Ambient) [52] 2012-2014 38 1 Sites 2.63 0.0287 0.0287 0.0287 0.0287 ug/L Arnold et al. 2016 (Filtered) [7] 2012-2013 106 0 Sites 0 Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 8.41E-08 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 2.66986 days Boiling point OPERA QSAR 253.174 degree C Boiling point TEST QSAR Vapor pressure OPERA QSAR 0.0017037 mmHg Vapor pressure TEST QSAR 0.00480839 mmHg Solubility in water OPERA QSAR 0.000321829 mol/L Solubility in water TEST QSAR 0.00052723 mol/L Bioconcentration factor OPERA QSAR 44.9671 no units Bioconcentration factor TEST QSAR 27.1019 no units Henry's Law constant OPERA QSAR 0.000000169 atm-mA3/mol 0 eta no 1/water partitioning coeff. (log Kow) OPERA QSAR 3.79283 no units A-274 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Cycloate CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 339 USEPA. 2015. Cycloate. Human Health Scoping Document in Support of Registration Review. EPA-HQ-OPP-2015-0288-0008. DP No. D424437. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticide in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. A-275 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Cyfluthrin CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Cyfluthrin CASRN: 68359-37-5 DTXSID: DTXSID5035957 Use: Insecticide; medication Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUM MARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT IN FORMATION Potency Severity Prevalence Magnitude 6 reproductive and developmental effects 1 1 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value («"gA) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 5 reduced motor activity bottle-fed infants OPP 2017 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 3.677 EDWC SW (acute) OPP 2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-276 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Cyfluthrin CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.0039 mg/kg/day OPP 2017 Wolansky et al. 2006 reduced motor activity bottle-fed infants 151 5.17 [379] Cancer Classification (CC) NL OPP 2017 [3791 Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Acute Human Health Benchmark 0.1 mg/L EPA HHBP Acute Human Health Benchmark 0.1 mg/L EPA HHBP Acute PAD 0.02 mg/kg/day EPA HHBP Acute PAD 0.02 mg/kg/day EPA HHBP Chronic Human Health Benchmark 0.15 mg/L EPA HHBP Chronic Human Health Benchmark 0.15 mg/L EPA HHBP Health-Based Screening Level 0.15 mg/L Health-based screening levels from USGS Population-Adjusted Dose (PAD) 0.024 mg/kg/day EPA HHBP Population-Adjusted Dose (PAD) 0.024 mg/kg/day EPA HHBP Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element I Value I Units I Source I Notes Measured Data and Assessment Results Inhalation LOAEL 0.14 mg/L EPA Toxicity Reference Database max Inhalation LOAEL 0.0011013 mg/L EPA Toxicity Reference Database min Inhalation NOAEL 0.0011013 mg/L EPA Toxicity Reference Database min Inhalation NOAEL 0.0259 mg/L EPA Toxicity Reference Database max LD50 140 mg/kg NIH HSDB min LD50 500 mg/kg NIH HSDB max LOAEL 114.8 mg/kg/day EPA Toxicity Reference Database max LOAEL 9 mg/kg/day EPA Toxicity Reference Database min NOAEL 3 mg/kg/day EPA Toxicity Reference Database min NOAEL 38.4 mg/kg/day EPA Toxicity Reference Database max Percent of active toxcast in vitro assays tested 8.29 percent EPA Chemistry Dashboard Subchronic LOAEL 13.9 mg/kg/day EPA Toxicity Reference Database min Subchronic LOAEL 38.900002 mg/kg/day EPA Toxicity Reference Database max Subchronic NOAEL 10.9 mg/kg/day EPA Toxicity Reference Database max Subchronic NOAEL 2.5 mg/kg/day EPA Toxicity Reference Database min Data Element Value Units Source Notes Modeled Data LD50 0.0015311 mo l/kg TEST QSAR Ames mutagenicity test 0.002 no units TEST QSAR Developmental toxin test 0.873 no units TEST QSAR A-277 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Cyfluthrin CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 OCCURRENCE DATA Scoring_Data_ Nationally Representative Water Data Date Number of Number of PWS/Sites/ Percent with Minimum Cone. Median Cone. 90th Percentile Maximum Cone. Cone. Units Notes PWS/ Sites/ Detects Samples Detects (Detects) (Detects) (Detects) (Detects) Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev(NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 3.675 0 Sites 0 National Water Qua lity Assessment (USGS NAWQA) (Surface Water) 1991-2017 383 0 Sites 0 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 3.292 0 Sites 0 Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) 48 279,251 2016 Toxic Release Inventory (TRI) Program (EPA) (2016) 2 21 Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude USDA Pesticide Data Program (PDP) (Finished) 2001-2013 17 0 Sites 0 USGS, Sioux Falls Area, 2012 (Finished) [153] 2009-2010 1 0 Sites 0 Ambient Water Prevalence Magnitude National Water Information System (USGS NWIS) (Surface Water) 2008-2017 576 1 Sites 0.17 0.098 0.098 0.098 0.098 ug/L National Water information System (USGS NWIS) (Groundwater) 2008-2017 2,014 1 Sites 0.05 0.015 0.015 0.015 0.015 ug/L National Water information System (USGS NWIS) (All Water) 2008-2017 2,589 2 Sites 0.08 0.015 0.0565 0.0814 0.098 ug/L USDA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001-2013 201 0 Sites 0 USDA Pesticide Data Program (PDP) (Groundwater) 2001-2013 190 0 Sites 0 USDA Pesticide Data Program (PDP) (Untreated) 2001-2013 12 0 Sites 0 Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990-2018 4,669 343 Sites 7.35 0.000838 0.0082 0.0322 3.4 ug/L Bradley et al. 2017 (Ambient) [52] 2012-2014 38 7 Sites 18 0.000263 0.000548 0.000831 0.000964 ug/L Arnold et al. 2016 (Filtered) [7] 2012-2013 106 0 Sites 0 USGS, Sioux Falls Area, 2012 (Ambient) [153] 2009-2010 2 0 Sites 0 Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Estimated Drinking Water Concentration (EDWC) in Surface Water (acute) 2017 OPP 3.677 ug/L Tier 1, FQPA Index Reservoir Screening Tool (FIRST) Model (alfalfa) The critical effect of reduced motor activity was based on an acute population adjusted dose and is considered a less-than-chronic response. To account for this, the modeled surface water acute concentration found in the most recent available EPA OPP health assessment was selected as the occurrence concentration for cyfluthrin. Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 0.0000019 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 3.35028 days Boiling point OPERA QSAR 424.382 degree C Boiling point TEST QSAR 442.743 degree C Vapor pressure OPERA QSAR 3.81E-10 mmHg Vapor pressure TEST QSAR 6.1E-10 mmHg Solubility in water OPERA QSAR 0.000000029 mol/L Solubility in water TEST QSAR 5.37E-08 mol/L Bioconcentration factor OPERA QSAR 414.928 no units Bioconcentration factor TEST QSAR 928.966 no units Henry's Law constant OPERA QSAR 4.42E-09 atm-mA3/mol 0 eta no l/water partitioning coeff. (log Kow) OPERA QSAR 6.08154 no units A-278 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Cyfluthrin CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 153 Occurrence of anthropogenic organic compounds and nutrients in source and finished water in the Sioux Falls area, South Dakota, 2009-10: U.S. Geological Survey Scientific Investigations Report 2012-5098, 21 p. plus appendixes. 379 USEPA. 2017. Cyfluthrin and Beta-Cyfluthrin: Acute and Chronic Aggregate Dietary (Food and Drinking Water) Exposure and Risk Assessment for Registration Review. EPA-HQ-OPP-2010-0684-0101. DP No. D435057. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticide in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. A-279 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Cyhalothrin CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Cyhalothrin CASRN: 68085-85-8 DTXSID: DTXSID6023997 Use: Insecticide Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants X PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANTSUMMARY& DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT IN FORMATION Potency Severity Prevalence Magnitude 6 reproductive and developmental effects Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value («"gA) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL l reduced motor activity bottle-fed infants OPP 2017 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-280 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Cyhalothrin CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.00093 mg/kg/day OPP 2017 Moseret al. 2016 reduced motor activity bottle-fed infants 151 1.23 [385] Cancer Classification (CC) NL OPP 2017 [3851 Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Acute Human Health Benchmark 0.03 mg/L EPA HHBP Acute PAD 0.005 mg/kg/day EPA HHBP Chronic Human Health Benchmark 0.006 mg/L EPA HHBP Health-Based Screening Level 0.006 mg/L Health-based screening levels from USGS Intermediate Minimal Risk Level (MRL) 0.01 mg/kg/day CDC ATSDR Population-Adjusted Dose (PAD) 0.001 mg/kg/day EPA HHBP Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Measured Data and Assessment Results LD50 20 mg/kg NIH HSDB min LD50 5000 mg/kg NIH HSDB max LOAEL 5 mg/kg/day EPA Toxicity Reference Database min LOAEL 75 mg/kg/day EPA Toxicity Reference Database max NOAEL 1.5 mg/kg/day EPA Toxicity Reference Database min NOAEL 15 mg/kg/day EPA Toxicity Reference Database max Percent of active toxcast in 13.19 percent EPA Chemistry Dashboard vitro assays tested Subchronic LOAEL 12.5 mg/kg/day EPA Toxicity Reference Database max Subchronic LOAEL 2.5 mg/kg/day EPA Toxicity Reference Database min Subchronic NOAEL 1 mg/kg/day EPA Toxicity Reference Database min Subchronic NOAEL 2.5 mg/kg/day EPA Toxicity Reference Database max Data Element Value Units Source Notes Modeled Data LD50 TEST QSAR Ames mutagenicity test TEST QSAR Developmental toxin test TEST QSAR A-281 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Cyhalothrin CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev(NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 Pesticide Application Data Number of States Amount Applied (lbs/year) Date Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Data Number of States Amount Released (lbs/year) Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Production Data Production Volume (lbs/year) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude USDA Pesticide Data Program (PDP) (Finished) 2001-2013 10 0 Sites 0 Ambient Water Prevalence Magnitude USDA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001-2013 123 0 Sites 0 USDA Pesticide Data Program (PDP) (Groundwater) 2001-2013 113 0 Sites 0 USDA Pesticide Data Program (PDP) (Untreated) 2001-2013 10 0 Sites 0 Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Limit of solubility as a surrogate for occurrence concentration, Surface Water, Peak 2017 OPP 5 ug/L Cyhalothrin is very insoluble in water and residues in drinking water are expected to be very low. Therefore, the limit of solubility of cyhalothrin (5 ppb) reported in the most recent EPA OPP health assessment was used as the occurrence concentration for Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 0.000000177 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 3.54201 days Boiling point OPERA QSAR 422.672 degree C Boiling point TEST QSAR Vapor pressure OPERA QSAR 4.02E-09 mmHg Vapor pressure TEST QSAR Solubility in water OPERA QSAR 1.97E-08 mol/L Solubility in water TEST QSAR Bioconcentration factor OPERA QSAR 133.673 no units Bioconcentration factor TEST QSAR Henry's Law constant OPERA QSAR 0.000000012 atm-mA3/mol 0 eta no l/water partitioning coeff. (log Kow) OPERA QSAR 6.63514 no units A-282 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Cyhalothrin CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 385 USEPA. 2017. Lambda-& Gamma-Cyhalothrin: Human Health Draft Risk Assessment for Registration Review. EPA-HQ-OPP-2010-0480-0299. DP No. 426321. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. A-283 ------- EPA-Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Cypermethrin CCL 5 Contaminant Information Sheet EPA-OGWDW and OST CONTAMINANT IDENTIFYING INFORMATION CONTAMINANT SUMMARY & DECISION Name: Cypermethrin CASRN: 52315-07-8 DTXSID: DTXSID1023998 Use: Insecticide; veterinary medication Chemical Notes: This CIS also contains some data for the following: -Alpha cypermethrin -Beta cypermethrin -D-tran s-be ta-Cy perm ethri n -S-cypermethrin -Zeta cypermethrin -Cypermethrin, wf Draft CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Is the contaminant on any lists? CERCLA FIFRA X; applies to Alpha-cy perm ethri n, cypermethrin, d-trans-beta- cypermethrin, and zeta cypermethrin Human Neurotoxicants X Pub Med Neurotoxicants Neurodev. Disruptors Androgen Receptors in vitro Compounds with neurodev effects, Mundy et al 2015 x Potency Severity Prevalence Magnitude 5 reproductive and developmental effects 2 2 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 30 reduced motor activity bottle-fed infants OPP 2017 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished or Ambient (FW, SW, GW, WW) Source Date 0.0155 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. Green highlighting indicates a change made between the draft and final CCL 5. A-284 ------- EPA-Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Cypermethrin CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.024 mg/kg/day OPP 2017 Wolansky et a 1.2006 reduced motor activity bottle-fed infants 151 31.8 [380] Cancer Classification (CC) C OPP 2017 [3801 Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Acute Human Health Benchmark 0.15 mg/L EPA HHBP alpha-cypermethrin Acute Human Health Benchmark 0.15 mg/L EPA HHBP cypermethrin Acute Human Health Benchmark 0.15 mg/L EPA HHBP zeta-cypermethrin Acute PAD 0.023 mg/kg/day EPA HHBP alpha-cypermethrin Acute PAD 0.023 mg/kg/day EPA HHBP cypermethrin Acute PAD 0.023 mg/kg/day EPA HHBP zeta-cypermethrin Health-Based Screening Level 0.15 mg/L Health-based screening levels from USGS Notes: Yellow highlighted data indicate value was used in attribute scoring. Green highlighted data indicates a change made between the draft and final CCL 5. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Measured Data and Assessment Results LD50 14.9 mg/kg NIH HSDB min LD50 7180 mg/kg NIH HSDB max LOAEL 450 mg/kg/day EPA Toxicity Reference Database max LOAEL 5 mg/kg/day EPA Toxicity Reference Database min NOAEL 1 mg/kg/day EPA Toxicity Reference Database min NOAEL 100 mg/kg/day EPA Toxicity Reference Database max Percent of active toxcast in 10.78 percent EPA Chemistry Dashboard max vitro assays tested Percent of active toxcast in 5.96 percent EPA Chemistry Dashboard min; alpha-cypermethrin vitro assays tested Subchronic LOAEL 28.2000008 mg/kg/day EPA Toxicity Reference Database min Subchronic LOAEL 37 mg/kg/day EPA Toxicity Reference Database max Subchronic NOAEL 16.3 mg/kg/day EPA Toxicity Reference Database min Subchronic NOAEL 34.3 mg/kg/day EPA Toxicity Reference Database max Data Element Value Units Source Notes Modeled Data LD50 0.00172982 mo l/kg TEST QSAR Ames mutagenicity test 0.163 no units TEST QSAR Developmental toxin test 0.877 no units TEST QSAR A-285 ------- EPA-Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Cypermetiirin CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST October 2022 Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008 - 2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev(NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 3.675 5 Sites 0.14 0.006 0.009 0.0155 0.018 National Water Qualitv Assessment (USGS NAWQA) (Surface Water) 1991-2017 383 4 Sites 1.04 0.006 0.011 0.016 0.018 National Water Qualitv Assessment (USGS NAWQA) (Groundwater) 1991-2017 3.292 1 Sites 0.03 0.009 0.009 0.009 0.009 Ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Notes Toxic Release Data Number of States Amount Released Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) 20 23,804 2016 a 1 p ha -cy pe rmeth ri n Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) 14 64,415 2016 cypermethrin 44 275,902 2016 zeta-cypermeth rin Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Sam oles Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude USDA Pesticide Data Program (PDP) (Finished) 2001-2013 15 0 Sites 0 USGS, Sioux Falls Area, 2012 (Finished) [153] 2009 - 2010 1 0 Sites 0 Ambient Water Prevalence Magnitude USDA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001-2013 123 0 Sites 0 USDA Pesticide Data Program (PDP) (Groundwater) 2001 - 2013 113 0 Sites 0 USDA Pesticide Data Program (PDP) (Untreated) 2001 - 2013 10 0 Sites 0 Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990 - 2018 1,129 84 Sites 7.44 0.0017 0.0107 0.0392 0.357 ug/L Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990 - 2018 3,711 112 Sites 3.02 0.000516 0.00825 0.0479 1.25293 ug/L s-cypermethrin Arnold et al. 2016 (Filtered) [7] 2012 - 2013 106 0 Sites 0 Southeast Stream Quality Assessment (SESQA) (Ambient) [102] 2014 1 0 Sites 0 Cypermethrin, wf USGS, Sioux Falls Area, 2012 (Ambient) [153] 2009 - 2010 2 0 Sites 0 USGS, McKenzie River, Oregon, 2012 (Ambient) [158] 2002 - 2010 71 1 Samples 1.4 0.014 ug/L Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 0.00000162 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Green highlighted data indicates a change made between the draft and final CCL 5. Blank fields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the draft CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 3.34971 days Boiling point OPERA QSAR 424.351 degree C Boiling point TEST QSAR 445.159 degree C Vapor pressure OPERA QSAR 4.74E-09 mmHg Vapor pressure TEST QSAR 1.12E-09 mmHg Solubility in water OPERA QSAR 0.000000368 mol/L Solubility in water TEST QSAR 6.27E-08 mol/L Bioconcentration factor OPERA QSAR 349.137 no units Bioconcentration factor TEST QSAR 741.31 no units Henry's Law constant OPERA QSAR 1.99E-09 o E E Octanol/water partitioning coeff. (log Kow) OPERA QSAR 6.47753 no units A-286 ------- EPA-Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Cypermethrin CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 102 https://webapps.usgs.gOv/rsqa/#l/region/SESQA 153 Occurrence of anthropogenic organic compounds and nutrients in source and finished water in the Sioux Falls area, South Dakota, 2009-10: U.S. Geological Survey Scientific Investigations Report 2012-5098, 21 p. plus appendixes. 158 Reconnaissance of Land-Use Sources of Pesticides in Drinking Water, McKenzie River, Oregon. U.S. Geological Survey Scientific Investigations Report 2012-5091,46 p. plus appendixes. 380 USEPA. 2017. Cypermethrin, Zeta-cypermethrin, and Alpha-cypermethrin. Draft Human Health Risk Assessment for Registration Review. EPA-HQ-OPP-2012-0167-0116. DP No. D425964. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticides in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. A-287 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Cyprodinil CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Cyprodinil CASRN: 121552-61-2 DTXSID: DTXSID1032359 Use: Fungcide used on fruits and vegetables Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Not List ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 5 non-cancer effects 10 2 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 200 histopat ho logical alterations in the liver (spongiosis he pat is) in males general population OPP 2015 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.00868 90th Percentile All Ambient Water NAWQA 1991-2017 Final Hazard Quotient (HQ) 0.000043 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-288 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Cyprodinil CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.027 mg/kg/day OPP 2015 Frankhauser 1994 histopathological alterations in the liver (spongiosis hepatis) in males general population 33.8 160 [340] Cancer Classification (CC) NL OPP 2015 [3401 Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Acute Human Health Benchmark 10 mg/L EPA HHBP Acute PAD 2 mg/kg/day EPA HHBP Chronic Human Health Benchmark 0.17 mg/L EPA HHBP Health-Based Screening Level 0.17 mg/L Health-based screening levels from USGS Population-Adjusted Dose (PAD) 0.027 mg/kg/day EPA HHBP Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element I Value I Units I Source I Notes Measured Data and Assessment Results LD50 2000 mg/kg NIH HSDB LOAEL 1000 mg/kg/day EPA Toxicity Reference Database max LOAEL 35.599998 mg/kg/day EPA Toxicity Reference Database min NOAEL 200 mg/kg/day EPA Toxicity Reference Database max NOAEL 3.22 mg/kg/day EPA Toxicity Reference Database min Percent of active toxcast in vitro assays tested 23.88 percent EPA Chemistry Dashboard Subchronic LOAEL 18.950001 mg/kg/day EPA Toxicity Reference Database min Subchronic LOAEL 559.65997 mg/kg/day EPA Toxicity Reference Database max Subchronic NOAEL 231.93 mg/kg/day EPA Toxicity Reference Database max Subchronic NOAEL 3.24 mg/kg/day EPA Toxicity Reference Database min Data Element Value Units Source Notes Modeled Data LD50 0.0048865 mo l/kg TEST QSAR Ames mutagenicity test 0.679 no units TEST QSAR Developmental toxin test 0.516 no units TEST QSAR A-289 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Cyprodinil CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 OCCURRENCE DATA Scoring_Data_ Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 14 2 Sites 14 0.0066 0.0079 0.00868 0.0092 National Water Qua lity Assessment (USGS NAWQA) (Surface Water) 1991-2017 14 2 Sites 14 0.0066 0.0079 0.00868 0.0092 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) 31 271,518 2016 Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Ambient Water Prevalence Magnitude National Water Information System (USGS NWIS) (Surface Water) 2008-2017 132 16 Sites 12 2.00E - 04 0.0092 0.0764 0.111 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008-2017 3 0 Sites 0 National Water Information System (USGS NWIS) (All Water) 2008-2017 135 16 Sites 12 2.00E - 04 0.0092 0.0764 0.111 ug/L Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990-2018 259 15 Sites 5.79 0.0091 0.034 0.125 0.144 ug/L Bradley et al. 2017 (Ambient) [52] 2012-2014 38 1 Sites 2.63 0.0334 0.0334 0.0334 0.0334 ug/L Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 1.36E-08 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 2.93362 days Boiling point OPERA QSAR 320.755 degree C Boiling point TEST QSAR 345.205 degree C Vapor pressure OPERA QSAR 0.0000023 mmHg Vapor pressure TEST QSAR 0.00000114 mmHg Solubility in water OPERA QSAR 0.0000588 mol/L Solubility in water TEST QSAR 0.000378443 mol/L Bioconcentration factor OPERA QSAR 29.7556 no units Bioconcentration factor TEST QSAR 40.5509 no units Henry's Law constant OPERA QSAR 0.000000025 atm-mA3/mol 0 eta no l/water partitioning coeff. (log Kow) OPERA QSAR 3.88086 no units A-290 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Cyprodinil CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 340 USEPA. 2015. Cyprodinil. Human Health Risk Assessment for the Expansion of Existing Crop Group/Representative Commodity Uses to Stone Fruit Group 12-12, and Adding New Uses on the Artichoke, Guava, Pomegranate, Passionfruit, Feijoa, Jaboticaba, WaxJambu, Starfruit, and Acerola and Amended Uses on Greenhouse Cucumbers and Small Tomatoes. EPA-HQ-OPP-2014-0506-0013. DP No. D425998. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticide in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. A-291 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Desethylatrazine CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Desethylatrazine CASRN: 6190-65-4 DTXSID: DTXSID5037494 Use: Degradation product of atrazine Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 4 reproductive and developmental effects 10 3 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value («"gA) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 400 attenuation of LH surge in females ages 13- 49 (estrous cycle disruption) women of child bearing age OPP 2018 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.16 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-292 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Desethylatrazine CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.076 mg/kg/day OPP 2018 Cooperet al. 2010 attenuation of LH surge in females ages 13-49 (estrous cycle disruption) women of childbearingage 35.4 429 [395] Cancer Classification (CC) NL OPP 2018 [3951 Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element I Value Units I Source | Notes Measured Data and Assessment Results Maximum Allowable Daily Level I 100 ug/day ICalEPA OEHHA Chemical Database | Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Measured Data and Assessment Results LOAEL 100 mg/kg/day EPA Toxicity Reference Database max LOAEL 25 mg/kg/day EPA Toxicity Reference Database min NOAEL 25 mg/kg/day EPA Toxicity Reference Database max NOAEL 5 mg/kg/day EPA Toxicity Reference Database min Percent of active toxcast in 1.53 percent EPA Chemistry Dashboard vitro assays tested Subchronic LOAEL 35.099998 mg/kg/day EPA Toxicity Reference Database Subchronic NOAEL 3.3 mg/kg/day EPA Toxicity Reference Database Data Element Value Units Source Notes Modeled Data LD50 0.0072444 mo l/kg TEST QSAR Ames mutagenicity test 0.194 no units TEST QSAR Developmental toxin test 0.582 no units TEST QSAR A-293 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Desetiiylatrazine CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev(NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 11,386 4.408 Sites 39 0.00068 0.023 0.16 6.08 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 2.318 1.703 Sites 73 0.00068 0.025 0.16 6.08 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 9.069 2.705 Sites 30 0.001 0.013 0.165 2.6 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude USDA Pesticide Data Program (PDP) (Finished) 2001-2013 17 9 Sites 53 0.00072 0.0413 0.157 0.928 ug/L USGS, Sioux Falls Area, 2012 (Finished) [153] 2009-2010 1 1 Sites 100 0.006 0.008 0.0216 0.032 ug/L Ambient Water Prevalence Magnitude National Water Information System (USGS NWIS) (Surface Water) 2008-2017 990 688 Sites 69 0.00104 0.04 0.254 3.63 ug/L National Water information System (USGS NWIS) (Groundwater) 2008-2017 3,239 940 Sites 29 0.00075 0.023 0.18 2.34 ug/L National Water information System (USGS NWIS) (All Water) 2008-2017 4,228 1,628 Sites 39 0.00075 0.0351 0.215 3.63 ug/L USDA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001-2013 229 155 Sites 68 0.000716 0.031 0.21 1.55 ug/L USDA Pesticide Data Program (PDP) (Groundwater) 2001-2013 219 149 Sites 68 0.000716 0.0208 0.156 1.55 ug/L USDA Pesticide Data Program (PDP) (Untreated) 2001-2013 12 7 Sites 58 0.00072 0.041 0.219 1.3 ug/L Bradley et al. 2017 (Ambient) [52] 2012-2014 38 26 Sites 68 0.0047 0.0179 0.14 0.851 ug/L Arnold et al. 2016 (Filtered) [7] 2012-2013 690 115 Sites 17 0.002 0.0276 0.157 0.802 ug/L USGS, Sioux Falls Area, 2012 (Ambient) [153] 2009-2010 2 2 Sites 100 0.008 0.024 0.0664 0.114 ug/L USGS, McKenzie River, Oregon, 2012 (Ambient) [158] 2002-2010 134 21 Samples 16 0.013 ug/L Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 6.61E-08 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) < LOD ug/l Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 3.36178 days Boiling point OPERA QSAR 330.895 degree C Boiling point TEST QSAR 323.062 degree C Vapor pressure OPERA QSAR 6.42E-09 mmHg Vapor pressure TEST QSAR 0.000000337 mmHg Solubility in water OPERA QSAR 0.00132007 mol/L Solubility in water TEST QSAR 0.0100925 mol/L Bioconcentration factor OPERA QSAR 10.3224 no units Bioconcentration factor TEST QSAR 3.41979 no units Henry's Law constant OPERA QSAR 2.43E-08 atm-mA3/mol 0 eta no 1/water partitioning coeff. (log Kow) OPERA QSAR 1.56449 no units A-294 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Desethylatrazine CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 153 Occurrence of anthropogenic organic compounds and nutrients in source and finished water in the Sioux Falls area, South Dakota, 2009-10: U.S. Geological Survey Scientific Investigations Report 2012-5098, 21 p. plus appendixes. 158 Reconnaissance of Land-Use Sources of Pesticides in Drinking Water, McKenzie River, Oregon. U.S. Geological Survey Scientific Investigations Report 2012-5091, 46 p. plus appendixes. 395 USEPA. 2018. Atrazine. Draft Human Health Risk Assessment for Registration Review. EPQ-HQ-OPP-2013-0266-1159. DP No. D418316. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. A-295 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Desisopropylatrazine CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Des iso p ropy latra z i ne CASRN: 1007-28-9 DTXSID: DTXSID0037495 Use: Degradation product of atrazine Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 4 reproductive and developmental effects 10 4 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value («"gA) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 400 attenuation of LH surge in females ages 13- 49 (estrous cycle disruption) women of child bearing age OPP 2018 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.2311 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-296 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Desisopropylatrazine CCL 5 Contaminant Information Sheet EPA-OGWDWand OST October 2022 HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.076 mg/kg/day OPP 2018 Cooperet al. 2010 attenuation of LH surge in females ages 13-49 (estrous cycle disruption) women of childbearingage 35.4 429 [395] Cancer Classification (CC) NL OPP 2018 [395] Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element I Value | Units | Source | Notes Measured Data and Assessment Results Maximum Allowable Daily Level | 100 | ug/day |CalEPA OEHHA Chemical Database | Notes: Highlighted data indicate value was used in attribute scoring. Blan k fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Modeled Data LD50 0.0071121 mo l/kg TEST QSAR Ames mutagenicity test 0.08 no units TEST QSAR Developmental toxin test 0.372 no units TEST QSAR Data Element Value Units Source Notes Measured Data and Assessment Results LOAEL 25 mg/kg/day EPA Toxicity Reference Database NOAEL 5 mg/kg/day EPA Toxicity Reference Database Percent of active toxcast in 2.65 percent EPA Chemistry Dashboard vitro assays tested Subchronic LOAEL 18 mg/kg/day EPA Toxicity Reference Database Subchronic NOAEL 3.8 mg/kg/day EPA Toxicity Reference Database A-297 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Desisopropylatrazine CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contam nant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contam nant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contam nant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contam nant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contam nant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contam nant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev(NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 4,489 802 Sites 18 0.001 0.0474 0.231 4.44 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude USDA Pesticide Data Program (PDP) (Finished) 2001-2013 17 9 Sites 53 0.0027 0.0163 0.063 0.469 ug/L Ambient Water Prevalence Magnitude National Water Information System (USGS NWIS) (All Water) 2008-2017 2,038 374 Sites 18 0 0.0441 0.17 2.66 ug/L USDA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001-2013 229 68 Sites 30 0.0027 0.017 0.19 1.03 ug/L USDA Pesticide Data Program (PDP) (Groundwater) 2001-2013 219 61 Sites 28 0.005162 0.083 0.105 1.03 ug/L USDA Pesticide Data Program (PDP) (Untreated) 2001-2013 12 7 Sites 58 0.0027 0.0163 0.199 0.776 ug/L Arnold et al. 2016 (Filtered) [7] 2012-2013 690 61 Sites 8.84 0.0032 0.0224 0.212 0.489 ug/L Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 6.57E-08 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) < LOD ug/l Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 3.34468 days Boiling point OPERA QSAR 328.615 degree C Boiling point TEST QSAR 291.377 degree C Vapor pressure OPERA QSAR 5.11E-09 mmHg Vapor pressure TEST QSAR 0.000000149 mmHg Solubility in water OPERA QSAR 0.00268187 mol/L Solubility in water TEST QSAR 0.0161065 mol/L Bioconcentration factor OPERA QSAR 10.1928 no units Bioconcentration factor TEST QSAR 2.23357 no units Henry's Law constant OPERA QSAR 1.02E-08 atm-mA3/mol 0 eta no 1/water partitioning coeff. (log Kow) OPERA QSAR 1.26299 no units A-298 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Desisopropylatrazine CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 395 USEPA. 2018. Atrazine. Draft Human Health Risk Assessment for Registration Review. EPQ-HQ-OPP-2013-0266-1159. DP No. D418316. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. A-299 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Desvenlafaxine CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Desvenlafaxine CASRN: 93413-62-8 DTXSID: DTXSID40869118 Use: Medication used to treat depression Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUM MARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT IN FORMATION Potency Severity Prevalence Magnitude 7 non-cancer effects 9 4 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date SL 1 lowest therapeutic dose: inhibition of reuptake/treatment of depressive disorder bottle-fed infants FDA; NIH 2018; 2018 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.361 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-300 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Desvenlafaxine CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.0071 mg/kg/day FDA 2018; NIH 2018 Wyeth Pharmaceut icals Inc. 2014b lowest theraputic dose -- Developmental (persistent pulmonary hypertensionand nervoussystemeffects), gastrointestinal system (nausea, constipation, decreased appetite, weight loss); male reproductive effects (erectile dysfunction, Desvenlafaxine ejaculation failure/disorder, decreased libido), nervous system (effects on serotonin hormone receptor interaction, abnormal dreams, sweating, dizziness, insomnia, mydriasis, blurred/abnormal vision, and neuroendocrine- bottle-fed infants 151 9.40 [77] [150] NOTE: (Lowest Therapeutic Dose/3000x UF) is used in place of an RfD; LTDs were obtained from FDA-approved drug labels Reference Dose (RfD) or Equivalent 0.000208333 mg/kg/day FDA 2018; NIH 2018 Alembic Pharmaceut icals Limited lowest therapeutic dose: inhibition of serotonin and norepinephrine re uptake/treatment of depressive disorder bottle-fed infants 151 1.40 [77] [150] NOTE: (Lowest Therapeutic Dose/3000x UF) is used in place of an RfD; LTDs were obtained from FDA-approved drug labels Reference Dose (RfD) or Equivalent 0.000208333 mg/kg/day FDA 2018; NIH 2018 Alembic Pharmaceut icals Limited lowest therapeutic dose: inhibition of serotonin and norepinephrine re uptake/treatment of depressive disorder general population 33.8 4.90 [77] [150] NOTE: (Lowest Therapeutic Dose/3000x UF) is used in place of an RfD; LTDs were obtained from FDA-approved drug labels Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Acute Health-Based Guidance Value 0.02 mg/L MN DOH Acute Health-Based Guidance Value 0.02 mg/L MN DOH Chronic Health-Based Guidance Value 0.02 mg/L MN DOH Chronic Health-Based Guidance Value 0.02 mg/L MN DOH Screening level for pharmaceutical - general 0.004901961 mg/L EPA Office of Water population Screening level for pharmaceutical - infants 0.001388889 mg/L EPA Office of Water Short-Term/Subchronic Health-Based Guidance 0.02 mg/L MN DOH Value Short-Term/Subchronic Health-Based Guidance 0.02 mg/L MN DOH Value Data Element Value Units Source Notes Modeled Data LD50 0.0027542 mo l/kg TEST QSAR Ames mutagenicity test 0.31 no units TEST QSAR Developmental toxin test 0.652 no units TEST QSAR Data Element I Value | Units | Source I Notes Measured Data and Assessment Results Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. A-301 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Desvenlafaxine CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contam nant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contam nant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contam nant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contam nant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contam nant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contam nant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev(NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 557 22 Sites 3.95 0.00072 0.0307 0.361 1.02 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 75 18 Sites 24 0.00072 0.035 0.378 1.02 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 482 4 Sites 0.83 0.00135 0.00633 0.0224 0.0307 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Glassmeyer et al 2017 (Finished) [86] 2007-2012 25 NA Sites 0 ug/L Ambient Water Prevalence Magnitude National Water Information System (USGS NWIS) (Surface Water) 2008-2017 205 87 Sites 42 0.00068 0.0141 0.228 2.09 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008-2017 401 6 Sites 1.5 0.00071 0.00918 0.78 0.91 ug/L National Water Information System (USGS NWIS) (All Water) 2008-2017 606 93 Sites 15 0.00068 0.0138 0.332 2.09 ug/L Glassmeyer et al 2017 (Ambient) [86] 2007-2012 25 NA Sites 16 0.0283 0.06043 ug/L Bradley etal. 2017 (Ambient) [52] 2012-2014 38 22 Sites 58 0.0017892 0.0865 0.822 1.953482 ug/L Bexfieid et al. 2019 (Groundwater) [49] 2013-2015 1,106 0 Sites 0 Waste Water Effluent Prevalence Magnitude Scott et al. 2018 (Wastewater) [161] 2011-2017 21 19 Sites 90 0.0930062 0.693 1.14 4.4928736 ug/L Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR4 data used in the CCL5 is a partial datasetand will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 4.65547 days Boiling point OPERA QSAR 313.112 degree C Boiling point TEST QSAR 327.611 degree C Vapor pressure OPERA QSAR 5.09E-08 mmHg Vapor pressure TEST QSAR 0.00000177 mmHg Solubility in water OPERA QSAR 0.0207862 mol/L Solubility in water TEST QSAR 0.000695024 mol/L Bioconcentration factor OPERA QSAR 16.0501 no units Bioconcentration factor TEST QSAR 73.6207 no units Henry's Law constant OPERA QSAR 0.000000483 o E E Octanol/water partitioning coeff. (log Kow) OPERA QSAR 2.58575 no units A-302 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Desvenlafaxine CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 49 Bexfield, L.M., P.L. Toccalino, K. Belitz, W.T. Foreman, and E.T. Furlong. 2019. Hormones and pharmaceuticals in groundwater used as a source of drinking water across the United States. Environmental Science and Technology 53: 2950-2960. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 77 FDA. 2018. Drugs @ FDA: FDA Approved Drug Products. U.S. Food and Drug Administration (FDA), https://www.accessdata.fda.gov/scripts/cder/daf/. 86 Glassmeyer, S.T., Furlong, E.T., Kolpin, D.W., Batt, A.L., Benson, R., Boone, J.S.,... & Wilson, V.S. (2017). Nationwide reconnaissance of contaminants of emerging concern in source and treated drinking waters of the United States. Science of The Total Environment. v581-582, (909-922). 150 NIH. 2018. DailyMed Database. U.S. National Library of Medicine, National Institutes of Health (NIH). https://dailymed.nlm.nih.gov/dailymed/. 161 Scott, T. M., Phillips, P. J., Kolpin, D. W., Colella, K. M., Furlong, E. T., Foreman, W. T., & Gray, J. L. (2018). Pharmaceutical manufacturing facility discharges can substantially increase the pharmaceutical load to US wastewaters. Science of the Total Environment, 636, 69-79. A-303 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Diazepam CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Diazepam CASRN: 439-14-5 DTXSID: DTXSID4020406 Use: anxiolytic; skeletal muscle relaxant Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts X Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 X CONTAMINANTSUMMARY& DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT IN FORMATION Potency Severity Prevalence Magnitude 8 non-cancer effects 4 1 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date SL 0.1 lowest therapeutic dose: anxiolytic, sedative, muscle-relaxant, anticonvulsant and bottle-fed infants FDA; NIH 2018; 2018 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.001014 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-304 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Diazepam CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 1.66667 E-05 mg/kg/day FDA 2018; NIH 2018 Mayne Pharma lowest therapeutic dose: anxiolytic, sedative, muscle-relaxant, anticonvulsant and amnestic effects bottle-fed infants 151 0.110 [77] [150] NOTE: (Lowest Therapeutic Dose/3000x UF) is used in place of an RfD; LTDs were obtained from FDA-approved drug labels Reference Dose (RfD) or Equivalent 1.66667 E-05 mg/kg/day FDA 2018; NIH 2018 Mayne Pharma lowest therapeutic dose: anxiolytic, sedative, muscle-relaxant, anticonvulsant and amnestic effects general population 33.8 0.390 [77] [150] NOTE: (Lowest Therapeutic Dose/3000x UF) is used in place of an RfD; LTDs were obtained from FDA-approved drug labels Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Cancer Classification (CC) 3 no units WHO IARC Maximum Recommended Daily Dose 0.667 mg/kg/day FDA Screening level for pharmaceutical - general 0.000392157 mg/L EPA Office of Water population Screening level for pharmaceutical - infants 0.000111111 mg/L EPA Office of Water Data Element Value Units Source Notes Measured Data and Assessment Results LD50 48 mg/kg NIH HSDB min LD50 710 mg/kg NIH HSDB max Percent of active toxcast in 12.77 percent EPA Chemistry Dashboard vitro assays tested Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Modeled Data LD50 0.0059979 mo l/kg TEST QSAR Ames mutagenicity test 0.064 no units TEST QSAR Developmental toxin test 0.731 no units TEST QSAR A-305 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Diazepam CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev(NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 556 2 Sites 0.36 0.00047 0.00081 0.00101 0.00115 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 75 1 Sites 1.33 0.00047 0.00047 0.00047 0.00047 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 481 1 Sites 0.21 0.00115 0.00115 0.00115 0.00115 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Glassmeyer et al 2017 (Finished) [86] 2007-2012 25 NA Sites 4 0.00085 0.00085 ug/L Ambient Water Prevalence Magnitude National Water Information System (USGS NWIS) (Surface Water) 2008-2017 210 2 Sites 0.95 0.00035 0.0902 0.144 0.18 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008-2017 401 2 Sites 0.5 0.00463 0.00577 0.00645 0.00691 ug/L National Water Information System (USGS NWIS) (All Water) 2008-2017 611 4 Sites 0.65 0.00035 0.00577 0.111 0.18 ug/L Glassmeyer et al 2017 (Ambient) [86] 2007-2012 25 NA Sites 0 ug/L Bradley et al. 2017 (Ambient) [52] 2012-2014 38 6 Sites 16 0.001681 0.00219 0.004 0.0047434 ug/L Bexfieid et al. 2019 (Groundwater) [49] 2013-2015 1,106 0 Sites 0 Benotti et al. (2009) via Kostich et al. 2010 (Ambient) [127] 2010 NA NA 0.00047 ug/L Vanderford et al. (2003) via Kostich et al. 2010 (Ambient) [127] 2010 NA NA 0.0013 ug/L Vanderford et al. (2006) via Kostich et al. 2010 (Ambient) [127] 2010 NA NA 0.0026 ug/L Waste Water Effluent Prevalence Magnitude Scott et al. 2018 (Wastewater) [161] 2011-2017 21 17 Sites 81 0.0005702 0.0032 0.124 4.77 ug/L Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 3.22E-08 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR4 data used in the CCL5 is a partial datasetand will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 3.35313 days Boiling point OPERA QSAR 357.022 degree C Boiling point TEST QSAR 349.282 degree C Vapor pressure OPERA QSAR 2.09E-08 mmHg Vapor pressure TEST QSAR 2.42E-08 mmHg Solubility in water OPERA QSAR 0.000162557 mol/L Solubility in water TEST QSAR 0.000107152 mol/L Bioconcentration factor OPERA QSAR 68.2943 no units Bioconcentration factor TEST QSAR 60.1174 no units Henry's Law constant OPERA QSAR 2.19E-08 atm-mA3/mol Octanol/water partitioning coeff. (log Kow) OPERA QSAR 2.87833 no units A-306 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Diazepam CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 49 Bexfield, L.M., P.L. Toccalino, K. Belitz, W.T. Foreman, and E.T. Furlong. 2019. Hormones and pharmaceuticals in groundwater used as a source of drinking water across the United States. Environmental Science and Technology 53: 2950-2960. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 77 FDA. 2018. Drugs @ FDA: FDA Approved Drug Products. U.S. Food and Drug Administration (FDA), https://www.accessdata.fda.gov/scripts/cder/daf/. 86 Glassmeyer, S.T., Furlong, E.T., Kolpin, D.W., Batt, A.L., Benson, R., Boone, J.S.,... & Wilson, V.S. (2017). Nationwide reconnaissance of contaminants of emerging concern in source and treated drinking waters of the United States. Science of The Total Environment. v581-582, (909-922). 127 Kostich, MS, etal., 2010. Predicting variability of aquatic concentrations of human pharmaceuticals. Sci. Total Environ. 408 (20), 4504e4510. 150 NIH. 2018. DailyMed Database. U.S. National Library of Medicine, National Institutes of Health (NIH). https://dailymed.nlm.nih.gov/dailymed/. 161 Scott, T. M., Phillips, P. J., Kolpin, D. W., Colella, K. M., Furlong, E. T., Foreman, W. T., & Gray, J. L. (2018). Pharmaceutical manufacturing facility discharges can substantially increase the pharmaceutical load to US wastewaters. Science of the Total Environment, 636, 69-79. A-307 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Diazinon CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Diazinon CASRN: 333-41-5 DTXSID: DTXSID9020407 Use: Pesticide; veterinary medication Chemical Notes: Is the contaminant on any lists? CERCLA X FIFRA X Human Neurotoxicants X PubMed Neu rotoxica nts X Neu rode v. Disruptors Androgen Receptors in vitro X Compounds with neu rod ev effects, Mundy et a 12015 X CONTAMINANT SUMMARY & DECISION CCL5 List Decision Ust ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 7 reproductive and developmental effects 1 1 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value («"gA) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 0.5 inhibition of red blood cell acetylcholinesterase in female pups bottle-fed infants OPP 2016 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.091 90th Percentile All Ambient Water NAWQA 1991-2017 Final Hazard Quotient (HQ) 018 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-308 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Diazinon CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg- HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.00035 mg/kg/day OPP 2016 Parker 2003 inhibition of red blood cell acetylcholinesterase in female pups bottle-fed infants 151 0.464 [363] NOTE: this compound is a organophosphate pesticide. EPA has created a cumulative risk assessment regarding the common mechanisms of oraanoDhosDhate Cancer Classification (CC) NL OPP 2016 [363] NOTE: this compound is a organophosphate pesticide. EPA has created a cumulative risk assessment regarding the common mechanisms of Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg- CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title- abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results 10-day Health Advisory 0.02 mg/L EPA DWSHA 2018 Acute Minimal Risk Level (MRL) 0.006 mg/kg/day CDC ATSDR Intermediate Inhalation Minimal Risk Level (MRL) 0.01 mg/mA3 CDC ATSDR Intermediate Minimal Risk Level (MRL) 0.002 mg/kg/day CDC ATSDR Lifetime Health Advisory 0.001 mg/L EPA DWSHA 2018 Maximum Allowable Concentration (MAC) 0.02 mg/L Canadian Drinking Water Guidelines Cancer Classification (CC) 2A no units WHO IARC Cancer Classification (CC) Female.Mice no units HHS NTP Cancer Classification (CC) Female.Rats N no units HHSNTP Cancer Classification (CC) Male.Mice N no units HHS NTP Cancer Classification (CC) Male.Rats N no units HHSNTP Data Element | Value | Units | Source | Notes Measured Data and Assessment Results LD50 1340 mg/kg NIH HSDB max LD50 2.8 mg/kg NIH HSDB min LOAEL 0.02 mg/kg/day EPA Toxicity Reference Database min LOAEL 100 mg/kg/day EPA Toxicity Reference Database max NOAEL 25 mg/kg/day EPA Toxicity Reference Database max NOAEL 0.0037 mg/kg/day EPA Toxicity Reference Database min Percent of active toxcast in vitro assays tested 6.9 percent EPA Chemistry Dashboard Subchronic LOAEL 0.3 mg/kg/day EPA Toxicity Reference Database Subchronic NOAEL 0.04 mg/kg/day EPA Toxicity Reference Database TD50 20.4 mg/kg/day NIH CPDB min TD50 6230 mg/kg/dav NIH CPDB max Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Modeled Data LD50 0.0005861 mol/kg TEST QSAR Ames mutagenicity test 0.26 no units TEST QSAR Developmental toxin test 0.609 no units TEST QSAR A-309 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Diazinon CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST October 2022 Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR)4 2018 - 2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013 - 2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008 - 2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 295 0 Sites 0 ug/L Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survey (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991 - 2017 11,244 995 Sites 8.85 7.00E - 05 0.0117 0.091 19 ug/L National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991 - 2017 2,229 885 Sites 40 1.00E - 04 0.0118 0.0914 3.8 ug/L National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991 - 2017 9,016 110 Sites 1.22 7.00E - 05 0.0082 0.0518 19 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) 12 73,164 2016 Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting(CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Finished) 2006 - 2020 173 0 Sites 0 USDA Pesticide Data Program (PDP) (Finished) 2001 - 2013 17 3 Sites 18 0.00999 0.0345 0.111 0.133 ug/L USGS, Sioux Falls Area, 2012 (Finished) [153] 2009 - 2010 1 0 Sites 0 Ambient Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Source) 2006 - 2020 1,871 1 Sites 0.05 0.007 0.007 0.007 0.007 ug/L National Water Information System (USGS NWIS) (Surface Water) 2008 - 2017 1,553 74 Sites 4.76 0.00014 0.008 0.218 1.97 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008 - 2017 3,630 4 Sites 0.11 0.007 0.094 0.177 0.189 ug/L National Water Information System (USGS NWIS) (All Water) 2008 - 2017 5,182 78 Sites 1.51 0.00014 0.00886 0.214 1.97 ug/L USDA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001 - 2013 229 3 Sites 1.31 0.0164 0.0655 0.0943 0.1 ug/L USDA Pesticide Data Program (PDP) (Groundwater) 2001 - 2013 219 2 Sites 0.91 0.05 0.0655 0.0779 0.081 ug/L USDA Pesticide Data Program (PDP) (Untreated) 2001 - 2013 12 1 Sites 8.33 0.0164 0.0582 0.0916 0.1 ug/L Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990 - 2018 19,790 5,003 Sites 25 le-05 0.042 0.43 331 ug/L Bradley et al. 2017 (Ambient) [52] 2012 - 2014 38 3 Sites 7.89 0.0212 0.0342 0.228 0.276 ug/L Arnold et al. 2016 (Filtered) [7] 2012 - 2013 690 1 Sites 0.14 le-04 le-04 le-04 le-04 ug/L USGS, Sioux Falls Area, 2012 (Ambient) [153] 2009 - 2010 2 0 Sites 0 USGS, McKenzie River, Oregon, 2012 (Ambient) [158] 2002 - 2010 133 18 Samples 14 0.115 ug/L Waste Water Effluent Prevalence Magnitude Scott et al. 2018 (Wastewater) [161] 2011-2017 21 1 Sites 4.76 Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg- bw/day) Notes Expocast exposure 0.000000102 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR4data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biode gradation ha If-life OPERA QSAR 4.76627 days Boiling point OPERA QSAR 340.43 degree C Boiling point TEST QSAR Vapor pressure OPERA QSAR 0.0000812 mmHg Vapor pressure TEST QSAR 0.0000769 mmHg Solubility in water OPERA QSAR 0.00011245 mol/L Solubility in water TEST QSAR 0.000074 mol/L Bioconcentration factor OPERA QSAR 69.9796 no units Bioconcentration factor TEST QSAR 94.189 no units Flenry's Law constant OPERA QSAR 0.000000144 atm-mA3/mol Octanol/water partitioning coeff. (log Kow) OPERA QSAR 3.71388 no units A-310 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Diazinon CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 153 Occurrence of anthropogenic organic compounds and nutrients in source and finished water in the Sioux Falls area, South Dakota, 2009-10: U.S. Geological Survey Scientific Investigations Report 2012-5098, 21 p. plus appendixes. 158 Reconnaissance of Land-Use Sources of Pesticides in Drinking Water, McKenzie River, Oregon. U.S. Geological Survey Scientific Investigations Report 2012-5091, 46 p. plus appendixes. 161 Scott, T. M., Phillips, P. J., Kolpin, D. W., Colella, K. M., Furlong, E. T., Foreman, W. T., & Gray, J. L. (2018). Pharmaceutical manufacturing facility discharges can substantially increase the pharmaceutical load to US wastewaters. Science of the Total Environment, 636, 69-79. 363 USEPA. 2016. Diazinon Draft Human Health Risk Assessment for Registration Review. EPA-HQ.-OPP-2008-0351-0093. DP No. D419216. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticide in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. A-311 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Dicamba CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Chemical Notes: DTXSID4024018 Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUM MARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT IN FORMATION Potency Severity Prevalence Magnitude 5 reproductive and developmental effects 4 5 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value («"gA) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 50 decreased pup weight bottle-fed infants OPP 2016 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 1.576 90th Percentile Finished Water UCM2 1993-1997 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-312 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Dicamba CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.04 mg/kg/day OPP 2016 Masters 1993 decreased pup weight bottle-fed infants 151 53.0 [364] Cancer Classification (CC) NL OPP 2016 [3641 Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Chronic Health-Based Guidance Value 0.2 mg/L MN DOH Lifetime Health Advisory 4 mg/L EPA DWSHA 2018 Maximum Allowable Concentration (MAC) 0.12 mg/L Canadian Drinking Water Guidelines Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Measured Data and Assessment Results LD50 3000 mg/kg NIH HSDB max LD50 757 mg/kg NIH HSDB min LOAEL 122 mg/kg/day EPA Toxicity Reference Database min LOAEL 419 mg/kg/day EPA Toxicity Reference Database max NOAEL 160 mg/kg/day EPA Toxicity Reference Database max NOAEL 30 mg/kg/day EPA Toxicity Reference Database min Percent of active toxcast in 1.02 percent EPA Chemistry Dashboard Data Element Value Units Source Notes Modeled Data LD50 0.0046452 mo l/kg TEST QSAR Ames mutagenicity test 0.143 no units TEST QSAR Developmental toxin test 0.447 no units TEST QSAR A-313 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Dicamba CCL5ContaminantlnformationSheet EPA-OGWDWand OST October2022 OCCURRENCE DATA Scoring Data Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018 - 2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013 - 2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008 - 2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 14,034 48 Sites 0.34 0.02 0.2 1.58 4.06 ug/L Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survey (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991 - 2017 7,759 133 Sites 1.71 0.01 0.15 0.998 9.97 ug/L National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991 - 2017 1,208 116 Sites 9.6 0.01 0.15 0.979 9.97 ug/L National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991 - 2017 6,551 17 Sites 0.26 0.01 0.14 1.15 4.03 Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) 48 9,773,162 2016 Toxic Release Inventory (TRI) Program (EPA) (2016) 12 103,082 Chemical Data Reporting (CDR) Re suits (EPA) (2016) Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/ Sites/ Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevs ence Magnitude Drinking Water Monitoring Data -CA (Finished) 2006 - 2020 185 0 Sites 0 Drinking Water Monitoring Data - MA (Finished) 2006 - 2020 819 3 Sites 0.37 0.1 0.7 0.7 0.7 ug/L Drinking Water Monitoring Data - WA(Finished) 2006 - 2011 782 0 Sites 0 Disinfection Byproducts ICR 1997-1998. (Finished) 1997 -1998 291 273 Sites 94 1 11 26 114.4 ug/L US DA Pesticide Data Program (PDP) (Finished) 2001 - 2013 12 2 Sites 17 0.025 0.068 0.0888 0.094 ug/L Community Water System Survey (CWSS) (Finished) [178] 2006 3 NA Sites 50 50 ug/L Ambient Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Source) 2006 - 2020 1,936 5 Sites 0.26 0.21 2.7 2.92 3 ug/L Drinking Water Monitoring Data - MA (Source) 2006 - 2020 77 0 Sites 0 Drinking Water Monitoring Data - PA (Source) 2006 - 2011 2 1 Sites 50 0.44 0.44 0.44 0.44 ug/L Drinking Water Monitoring Data - WA (Source) 2006 - 2011 968 0 Sites 0 Drinking Water Monitoring Data - Wl (Source) 2012-2019 117 0 Sites 0 National Water Information System (USGS NWIS) (Surface Water) 2008 - 2017 480 26 Sites 5.42 0.01 0.165 1.24 16.6 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008 - 2017 1,059 0 Sites 0 National Water Information System (USGS NWIS) (All Water) 2008 - 2017 1,539 26 Sites 1.69 0.01 0.165 1.24 16.6 ug/L US DA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001 - 2013 229 6 Sites 2.62 0.0165 0.0705 0.112 0.112 ug/L US DA Pesticide Data Program (PDP) (Groundwater) 2001 - 2013 218 3 Sites 1.38 0.0165 0.0165 0.0925 0.111555 ug/L US DA Pesticide Data Program (PDP) (Untreated) 2001 - 2013 12 3 Sites 25 0.025 0.091 0.111 0.112 ug/L Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990 - 2018 1,058 286 Sites 27 0.05 0.117 0.517 14 ug/L Bradley et al. 2017 (Ambient) [52] 2012 - 2014 38 1 Sites 2.63 0.1453 0.145 0.145 0.1453 ug/L Arnold et al. 2016 (Filtered) [7] 2012 - 2013 690 1 Sites 0.14 0.474 0.474 0.474 0.474 ug/L USGS, McKenzie River, Oregon, 2012 (Ambient) [158] 2002 - 2010 126 1 Samples 0.8 0.58 ug/L Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg- bw/day) Notes Expocast exposure 1.26E-08 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial datasetand will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompT ox Dashboard) Value Units Notes Biodegradation half-life OPERA QSAR 3.51412 days Boiling point OPERA QSAR 301.323 degree C Boiling point TEST QSAR 314.148 degree C Vapor pressure OPERA QSAR 0.0000115 mmHg Vapor pressure TEST QSAR 0.0000306 mmHg Solubility in water OPERA QSAR 0.0145152 mol/L Solubility in water TEST QSAR 0.00726106 mol/L Bioconcentration factor OPERA QSAR 3.37811 no units Bioconcentration factor TEST QSAR 4.12098 no units Henry's Law constant OPERA QSAR 9.42E-10 atm-mA3/mol Octanol/water partitioning coeff. (log Kow) OPERA QSAR 2.25754 no units A-314 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Dicamba CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulorigoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 158 Reconnaissance of Land-Use Sources of Pesticides in Drinking Water, McKenzie River, Oregon. U.S. Geological Survey Scientific Investigations Report 2012-5091, 46 p. plus appendixes. 178 USEPA (US Environmental Protection Agency). (2009). 2006 Community Water System Survey. Overview, 57. 364 USEPA. 2016. Dicamba and Dicamba BAPMASalt: Human-Health Risk Assessment for Proposed Section 3 New Uses on Dicamba-tolerant Cotton and Soybean. E PA-HQ-OPP-2012-0841-0052. DP Nos. D378366 D404917 D402514 D421306. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticide in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. A-315 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Dichlorvos (DDVP) CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Dichlorvos (DDVP) CASRN: 62-73-7 DTXSID: DTXSID5020449 Use: Insecticide; veterinary medicine Chemical Notes: Is the contaminant on any lists? CERCLA X FIFRA X Human Neurotoxicants X PubMed Neu rotoxica nts X Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANTSUMMARY& DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 7 non-cancer effects 7 2 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 3 red blood cell and plasma cholinesterase inhibition general population OPP 2006 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.09118 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-316 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Dichlorvos(DDVP) CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.0005 mg/kg/day OPP 2006 Markiewicz, 1990 plasma and red blood cell cholinesterase inhibition general population 33.8 2.96 [265] Cancer Classification (CC) S OPP 2006 [2651 Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Acute Human Health Benchmark 0.05 mg/L EPA HHBP Acute inhalation Minimal Risk Level (MRL) 0.002 ppm CDC ATSDR Acute Minimal Risk Level (MRL) 0.004 mg/kg/day CDC ATSDR Acute PAD 0.008 mg/kg/day EPA HHBP Cancer Slope Factor (CSF) 0.29 (mg/kg/day) A-1 CalEPA OEH HA Chemical Database Chronic Human Health Benchmark 0.003 mg/L EPA HHBP Chronic inhalation Minimal Risk Level (MRL) 0.00006 ppm CDC ATSDR Health-Based Screening Level 0.003 mg/L Health-based screening levels from USGS Inhalation Unit Risk (IUR) 0.000083 ug/mA3 CalEPA OEH HA Chemical Database Intermediate Inhalation Minimal Risk Level (MRL) 0.0003 ppm CDC ATSDR Intermediate Minimal Risk Level (MRL) 0.003 mg/kg/day CDC ATSDR Population-Adjusted Dose (PAD) 0.0005 mg/kg/day EPA HHBP Reference Concentration (RfC) 0.0005 mg/mA3 EPA IRIS Cancer Classification (CC) 2B no units WHO IARC Cancer Classification (CC) Female.Mice N no units HHSNTP Cancer Classification (CC) Female.Mice P no units HHSNTP Cancer Classification (CC) Female.Rats EE no units HHSNTP Cancer Classification (CC) Female.Rats N no units HHSNTP Cancer Classification (CC) Male.Mice N no units HHSNTP Cancer Classification (CC) Male.Mice SE no units HHSNTP Cancer Classification (CC) Male.Rats N no units HHSNTP Cancer Classification (CC) Male.Rats SE no units HHSNTP Data Element Value Units Source Notes Modeled Data LD50 0.0000565 mo l/kg TEST QSAR Ames mutagenicity test 0.617 no units TEST QSAR Developmental toxin test 0.71 no units TEST QSAR Data Element I Value I Units I Source I Notes Measured Data and Assessment Results Inhalation LOAEL 0.05532 mg/L EPA Toxicity Reference Database Inhalation NOAEL 0.00553 mg/L EPA Toxicity Reference Database LD50 140 mg/kg NIH HSDB max LD50 6.51 mg/kg NIH HSDB min LOAEL 1 mg/kg/day EPA Toxicity Reference Database NOAEL 0.05 mg/kg/day EPA Toxicity Reference Database Percent of active toxcast in vitro assays tested 7.13 percent EPA Chemistry Dashboard Subchronic LOAEL 1.5 mg/kg/day EPA Toxicity Reference Database Subchronic NOAEL 0.1 mg/kg/day EPA Toxicity Reference Database TD50 3.21 mg/kg/day NIH CPDB min TD50 7850 mg/kg/day NIH CPDB max Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. A-317 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Dichlorvos (DDVP) CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 4,978 60 Sites 1.21 0.0012 0.01 0.0912 0.402 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 615 58 Sites 9.43 0.0012 0.01 0.0896 0.402 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 4.363 2 Sites 0.05 0.0103 0.111 0.172 0.212 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) 3 19 Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Finished) 2006 - 2020 1 0 Sites 0 USDA Pesticide Data Program (PDP) (Finished) 2001-2013 15 1 Sites 6.67 0.027 0.027 0.027 0.027 ug/L USGS, Sioux Falls Area, 2012 (Finished) [153] 2009-2010 1 0 Sites 0 Ambient Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Source) 2006 - 2020 30 0 Sites 0 National Water Information System (USGS NWIS) (Surface Water) 2008-2017 1,094 52 Sites 4.75 0.0062 0.0559 0.258 2.24 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008-2017 2,766 1 Sites 0.04 0.0778 0.0778 0.0778 0.0778 ug/L National Water Information System (USGS NWIS) (All Water) 2008-2017 3,859 53 Sites 1.37 0.0062 0.058 0.257 2.24 ug/L USDA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001-2013 120 1 Sites 0.83 0.027 0.0432 0.0562 0.0595 ug/L USDA Pesticide Data Program (PDP) (Groundwater) 2001-2013 113 0 Sites 0 USDA Pesticide Data Program (PDP) (Untreated) 2001-2013 8 1 Sites 12 0.027 0.0432 0.0562 0.0595 ug/L Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990-2018 9,029 20 Sites 0.22 0.007 0.109 0.531 0.634 ug/L Arnold et al. 2016 (Filtered) [7] 2012-2013 690 0 Sites 0 USGS, Sioux Falls Area, 2012 (Ambient) [153] 2009-2010 2 0 Sites 0 Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 1.37E-08 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 4.13846 days Boiling point OPERA QSAR 226.392 degree C Boiling point TEST QSAR 215.618 degree C Vapor pressure OPERA QSAR 0.0189601 mmHg Vapor pressure TEST QSAR 0.047863 mmHg Solubility in water OPERA QSAR 0.0349528 mol/L Solubility in water TEST QSAR 0.159221 mol/L Bioconcentration factor OPERA QSAR 0.579336 no units Bioconcentration factor TEST QSAR 3.75837 no units Henry's Law constant OPERA QSAR 3.85E-09 atm-mA3/mol 0 eta no l/water partitioning coeff. (log Kow) OPERA QSAR 1.38464 no units A-318 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Dichlorvos (DDVP) CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 153 Occurrence of anthropogenic organic compounds and nutrients in source and finished water in the Sioux Falls area, South Dakota, 2009-10: U.S. Geological Survey Scientific Investigations Report 2012-5098, 21 p. plus appendixes. 265 USEPA. 2006. Dichlorvos (DDVP) HED Chapter of the Reregistration Eligibility Decision Document (RED). EPA-HQ-OPP-2002-0302-0016. DP No. D330262. U.S. Environmental Protection Agency, Office of Prevention, Pesticides and Toxic Substances, Washington, D.C. 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticide in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. A-319 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Dicrotophos CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Dicrotophos CASRN: 141-66-2 DTXSID: DTXSID9023914 Use: Insecticide Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Ust ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT IN FORMATION Potency Severity Prevalence Magnitude 8 reproductive and developmental effects 6 3 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value («"gA) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 0.04 inhibition of brain cholinesterase bottle-fed infants OPP 2015 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.158 90th Percentile All Ambient Water NAWQA 1991-2017 Final Hazard Quotient (HQ) 40 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-320 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Dicrotophos CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.00003 mg/kg/day OPP 2015 Allen 1998; Horner 1995 inhibition of brain cholinesterase in adult rat bottle-fed infants 151 0.0397 [341] Cancer Classification (CC) S OPP 2015 [3411 Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Acute Human Health Benchmark 0.0005 mg/L EPA HHBP Acute PAD 0.00007 mg/kg/day EPA HHBP Chronic Human Health Benchmark 0.0002 mg/L EPA HHBP Health-Based Screening Level 0.0002 mg/L Health-based screening levels from USGS Population-Adjusted Dose (PAD) 0.00003 mg/kg/day EPA HHBP Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Measured Data and Assessment Results LD50 21 mg/kg NIH HSDB max LD50 9 mg/kg NIH HSDB min LOAEL 0.02 mg/kg/day EPA Toxicity Reference Database min LOAEL 1.58 mg/kg/day EPA Toxicity Reference Database max NOAEL 0.5 mg/kg/day EPA Toxicity Reference Database max NOAEL 0.025 mg/kg/day EPA Toxicity Reference Database min Percent of active toxcast in 1.14 percent EPA Chemistry Dashboard vitro assays tested Data Element Value Units Source Notes Modeled Data LD50 0.00003 mo l/kg TEST QSAR Ames mutagenicity test 0.421 no units TEST QSAR Developmental toxin test 0.694 no units TEST QSAR A-321 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Dicrotophos CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev(NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 4,916 33 Sites 0.67 5.00E - 04 0.0102 0.158 6.83 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 581 29 Sites 4.99 5.00E - 04 0.01 0.152 6.83 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 4.335 4 Sites 0.09 0.00289 0.03 0.156 0.233 u Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) 15 1,067,130 2016 Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Finished) 2006 - 2020 1 0 Sites 0 USDA Pesticide Data Program (PDP) (Finished) 2001-2013 17 2 Sites 12 0.0015 0.0015 0.00283 0.0034 ug/L USGS, Sioux Falls Area, 2012 (Finished) [153] 2009-2010 1 0 Sites 0 Ambient Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Source) 2006 - 2020 1 0 Sites 0 USDA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001-2013 145 2 Sites 1.38 0.0015 0.0015 0.0015 0.0015 ug/L USDA Pesticide Data Program (PDP) (Groundwater) 2001-2013 135 0 Sites 0 USDA Pesticide Data Program (PDP) (Untreated) 2001-2013 12 2 Sites 17 0.0015 0.0015 0.0015 0.0015 ug/L Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990-2018 3 0 Sites 0 Arnold et al. 2016 (Filtered) [7] 2012-2013 690 0 Sites 0 USGS, Sioux Falls Area, 2012 (Ambient) [153] 2009-2010 2 0 Sites 0 Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 0.000000999 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 4.1385 days Boiling point OPERA QSAR 309.886 degree C Boiling point TEST QSAR 299.282 degree C Vapor pressure OPERA QSAR 0.000160652 mmHg Vapor pressure TEST QSAR 0.000208449 mmHg Solubility in water OPERA QSAR 3.40278 mol/L Solubility in water TEST QSAR 0.0542001 mol/L Bioconcentration factor OPERA QSAR 0.922274 no units Bioconcentration factor TEST QSAR 1.64437 no units Henry's Law constant OPERA QSAR 6.11E-11 atm-mA3/mol 0 eta no l/water partitioning coeff. (log Kow) OPERA QSAR -0.0116744 no units A-322 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Dicrotophos CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 153 Occurrence of anthropogenic organic compounds and nutrients in source and finished water in the Sioux Falls area, South Dakota, 2009-10: U.S. Geological Survey Scientific Investigations Report 2012-5098, 21 p. plus appendixes. 341 USEPA. 2015. Dicrotophos: Revised Human Health Risk Assessment for Registration Review of Dicrotophos. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticide in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. A-323 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Dieldrin CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Dieldrin CASRN: 60-57-1 DTXSID: DTXSID9020453 Use: Restricted insecticide Chemical Notes: Canceled pesticide. Last end of use date: 5/15/1987. Is the contaminant on any lists? CERCLA X FIFRA X Human Neu rotoxica nts X PubMed Neu rotoxica nts X Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 X CONTAMINANT SUMMARY & DECISION CCL5 List Decision Ust ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT IN FORMATION Potency Severity Prevalence Magnitude 7 carcinogen with linear MOA 1 5 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 0.002 general population OW 2003 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.764 90th Percentile Finished Water UCM2 1993 -1997 Final Hazard Quotient (HQ) 380 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS RD1 RD 2 RD 3 X Not Applicable Not Applicable Basis Dieldrin may cause adve rse health effects in hurr ans, specifically neurotoxicity to the cen ral nervous system [a,b,c]. However, its occurrence in drinking w ater at frequencies or concentrations significant for public hej Ith concern is low; occu re nee estimates from a cross-section of States with UCM data are very low with only 0.06% of all samples and 0.1% of PWSs showing detect ~ns where the HRL is 0.002 ug/L [d,e]. Furthe more, occurrence of die drin in drinking water supplies in the is likely t decrease in the coming years, since the chemical is no longer produced or used com me r ially [f|. [a] Jager, 1970 [113]; [b] ACGIH, 1984 [6]; [c] ATSDR, 2000 [16]; [d] USE PA, 2001 [239]; [e] US EPA, 2001 [247]; [f] ATSDR, 1993 [2]; as cited in USEPA, 2001 [179] Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-324 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Qualifying Assessments, Exposure Factors, and HRL Determination Critical Effect Target Population Reference Dose(RfD)orEquivalent general population Reference Dose(RfD)orEquivalent increased liver weight, liver parenchymal cell changes, focal hyperplasia general population Reference Dose (Rf D) or Equivalent increased liver weight, liver parenchymal cell changes, focal hyperplasia general population : canceled registration, OPF does not provide a publicly- available health assessment for been published by EPA regarding health effects of dieldrin - refer to the 2003 RegDet supporting CancerSlopeFactor (CSF) (Davis and Fitzhugh, 1 Thorpe and Walker, 197 Meierhenry et al., IS general population CancerSlopeFactor (CSF) Davis and Fitzhugh, IE Thorpe and Walker, 197: Meierhenry et al., 19 general population : canceled registration, OPF does not provide a publicly- available health assessment for been published by EPA regarding health effects of dieldrin - refer to the 2003 RegDet supporting Cancer Classification (CC) Cancer Classification (CC) : canceled registration, OPF does not provide a publicly- available health assessment for been published by EPA regarding health effects of dieldrin - refer to the 2003 RegDet supporting Non-Qualifying Assessments, Exposi m£ra_^creenmgj_eueJJ3etermmatrans_ Critical Effect Target Population literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL Study Other Health Data Data Element 1 Value I Units I Source I Notes Measured Data and Assessment Results 10-day Health Advisory 0.0005 mg/L EPA DWSHA 2018 Acute Health-Based Guidance Value 0.0002 mg/L MN DOH Acute Health-Based Guidance Value 0.0002 mg/L MNDOH Acute Health-Based Guidance Value 0.0002 mg/L MN DOH CancerSlopeFactor (CSF) 16 (mg/kg/day)A-l CalEPA OEHHA Chemical Database Chronic Health-Based Guidance Value 0.0002 mg/L MN DOH Chronic Health-Based Guidance Value 0.0002 mg/L MN DOH Chronic Health-Based Guidance Value 0.0000006 mg/L MN DOH Chronic Health-Based Guidance Value 0.0000006 mg/L MN DOH Drinking Water Guideline Value 0.00003 mg/L WHO Drinking Water Quality Guidelines Human Health Ambient Water Quality Criteria 1.2E-09 mg/L EPA Human Health Criteria for CWA Inhalation Unit Risk (IUR) 0.0046 (Lg/m3)"-l EPA IRIS Inhalation Unit Risk (IUR) 0.0046 ug/mA3 CalEPA OEHHA Chemical Database Intermediate Minimal Risk Level (MRL) 0.0001 mg/kg/day CDC ATSDR Lifetime Health Advisory 0.000002 mg/L EPA DWSHA 2018 Short-Term/Subchronic Health-Based Guidance Value 0.0002 mg/L MNDOH Short-Term/Subchronic Health-Based Guidance Value 0.0002 mg/L MNDOH Cancer Classification (CC) Female.Mice N no units HHSNTP Cancer Classification (CC) Fen^e-Mice NT no units HHSNTP Cancer Classification (CC) Female.RatsN no units HHSNTP Cancer Classification (CC) Female.RatsN no units HHSNTP Cancer Classification (CC) Male.Mice E no units HHSNTP Cancer Classification (CC) Male.Mice NT no units HHSNTP Cancer Classification (CC) Male.Rats N no units HHSNTP Cancer Classification (CC) Male.Rats N no units HHSNTP Measured Data and Assessment Results EPA Chemistry Dashboard Data Element | Value | Units | Source | Notes Modeled Data LD50 0.0000284 mo l/kg TEST QSAR Ames mutag enicity test 0.019 no units TEST QSAR Developmental toxin test 0.55 no units TEST QSAR i attribute sco ring. A-325 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST October 2022 Nationally Representa! Number of PWS/ Sites/ Samples Number of Detects PWS/Sites/ Samples Percent with Detects linimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) laximum Cone. (Detects) Finished Water 2018-2019 2013 -2015 2008-2010 2001-2003 -ing-State (UCM-State) Round 2 1993 -1997 -ing-State (UCM-State) Round 1 National Inorganics and Radionuclides Survey (NIRS) Ambient Water 1991 -2017 it (USGS NAWQA) (Surface Water) 1991 -2017 1991 -2017 Pesticide Application Data Estimated Annual Agricultural Pesticide Number of States mount Applied (lbs/year) Toxic Release Data Number of States nount Released (lbs/year) Chemical Production Data Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) Production Volume (lbs/year) Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Finished) 2006 -2020 162 0 S tes 0 Drinking Water Monitoring Data - MA (Finished) 2006 -2020 822 2 S tes 0.24 0.037 0.0385 0.0397 0.04 ug/L Drinking Water Monitoring Data - WA (Finished) 2006 -2011 825 0 s tes 0 USDA Pesticide Data Program (PDP) (Finished) 2001 -2013 13 0 s tes 0 USGS, Sioux Falls Area, 2012 (Finished) [153] 2009 -2010 1 0 s tes 0 Hawaii Department of Health (Finished) [172] 2014 1 NA s tes 0.01 0.01 0.01 0.01 ug/L Ambient Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Source) 2006 - 2020 1,514 4 s tes 0.26 0.01 0.025 31.2 52 ug/L Drinking Water Monitoring Data - FL(Source) 2006 -2011 1 0 s tes 0 Drinking Water Monitoring Data - MA (Source) 2006 - 2020 77 0 s tes 0 Drinking Water Monitoring Data - PA (Source) 2006 - 2011 3 1 s tes 33 0.044 0.044 0.044 0.044 ug/L Drinking Water Monitoring Data - WA (Source) 2006 - 2011 999 0 s tes 0 Drinking Water Monitoring Data - Wl (Source) 2012-2019 92 0 s tes 0 National Water Information System (USGS NWIS) (Surface Water) 2008-2017 747 42 s tes 5.62 5.00E - 04 0.003 0.0166 0.13 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008-2017 2,630 69 s tes 2.62 0.001 0.0158 0.074 1.78 ug/L National Water Information System (USGS NWIS) (All Water) 2008-2017 3,376 111 s tes 3.29 5.00E - 04 0.008 0.0686 1.78 ug/L USDA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001 - 2013 8 0 s tes 0 USDA Pesticide Data Program (PDP) (Groundwater) 2001 - 2013 2 0 s tes 0 USDA Pesticide Data Program (PDP) (Untreated) 2001 - 2013 6 0 s tes 0 Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990 - 2018 604 45 s tes 7.45 0.003 0.011 0.197 0.38 ug/L Bradley etal. 2017 (Ambient) [52] 2012 - 2014 38 28 s tes 74 6.78e-05 0.000774 0.00245 0.0128 ug/L Arnold etal. 2016 (Filtered) [7] 2012 - 2013 106 2 s tes 1.89 0.002 0.003 0.0038 0.004 ug/L USGS, Sioux Falls Area, 2012 (Ambient) [153] 2009 - 2010 2 0 s tes 0 Minnesota Department of Health (Ambient) [149] 1970 - 2016 NA 32 Samples 0.01 0.9 ug/L Village Creek, AL (Ambient) [75] 2015 4 NA Sites 0.00096 0.0013 0.00142 0.0015 ug/L W/oste Water Effl uent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure [mg/kg-bw/day) Notes Expocast exposure 0.000000129 Biomonitoring Data 'nitoring detectior n blood (1999-2016) n urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 343.763 days Boiling point OPERA QSAR 329.92 degree C Boiling point TEST QSAR 384.804 degree C Vapor pressure OPERA QSAR 0.00000411 mmHg Vapor pressure TEST QSAR 0.00000224 mmHg Solubility in water OPERA QSAR 0.000000419 mol/L Solubility in water TEST QSAR 0.0000026 mol/L Bioconcentration factor OPERA QSAR 6042.55 no units Bioconcentration factor TEST QSAR 918.333 no units Henry's Law constant OPERA QSAR 0.000013 atm-mA3/mol Octanol/water partitioning coeff. (leg Kow) OPERA QSAR 5.43154 no units A-326 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Dieldrin CCL 5 Contaminant Information Sheet EPA-OGWDWand OST October 2022 Reference Number Full Reference Agency for Toxic Substances and Disease Registry (ATSDR). 1993. Toxicological Profile for Aldrin/Dieldrin (update). Atlanta: Agency for Toxic Substances and Disease Registry. 184 pp. American Conference of Governmental Industrial Hygienists (ACGIH). 1984. Documentation of the Threshold Limit Values for Substances in Workroom Air. Third Edition. Cincinnati, OH: ACGIH. 139 pp. Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water- Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. ATSDR. 2000. Toxicological Profile for Aldrin/Dieldrin (Update). Atlanta, GA: Agency for Toxic Substances and Disease Registry. 280 pp. 18 ATSDR. 2002. Toxicological Profile for Aldrin/Dieldrin. U.S. Department of Health and Human Services, Public Health Service, Agency for Toxic Substances and Disease Registry (ATSDR), Atlanta, GA. Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 75 EPA Region 4. Village Creek Dieldrin Screening. June 2015. https://www.birminghamal.gov/wp-content/uploads/2017/08/15-0308-Village-Creek-Dieldrin-Screening-Final-Report-v081015.pdf Jager, K.W. 1970. Aldrin, Dieldrin, Endrinand Telodrin: An Epidemiological and Toxicological Study of Long-Term Occupational Exposure. New York: Elsevier Publishing Company. 234 pp. 149 Minnesota Department of Health. Dieldrin and Drinking Water. October 2016. https://www.health.state.mn.us/communities/environment/risk/docs/guidance/gw/dieldrininfo.pdf Occurrence of anthropogenic organic compounds and nutrients in source and finished water in the Sioux Falls area, South Dakota, 2009-10: U.S. Geological Survey Scientific Investigations Report 2012-5098, 21 p. plus appendixes. 172 State of Hawaii Department of Health. Trace levels of dieldrin and bromacil in two Oahu Water Systems. January 2015. https://health.hawaii.gov/news/files/2013/05/TRACE-LEVELS-OF-DIELDRIN-AND- BROMACIL-DETECTED-IN-TWO-OAHU-WATER-SYSTEMS.pdf USEPA, 2001. Regulatory Determination Support Document for Aldrin and Dieldrin. EPA 815 R-01-011. 198 USEPA. 1988. Chemical Assessment Summary, Dieldrin. U.S. Environmental Protection Agency, National Center for Environmental Assessment, Integrated Risk Information System (IRIS), Washington, DC. USEPA. 2001. Analysis of National Occurrence of the 1998 Contaminant Candidate List Regulatory Determination Priority Contaminants in Public Water Systems. Office of Water. EPA report 815-D-01-002. 77 pp. 247 USEPA. 2001. Occurrence of Unregulated Contaminants in Public Water Systems: An Initial Assessment. Office of Water. EPA report 815-P-00-001. Office of Water. 50 pp. USEPA. 2003. Cuntarninant Candidate LitL Regulatury BetennfnatfunSuppur I Ducument fur Aldrin and Dieldrin. U.S Envirunmental Prutectiun Agency, Office uf Water, SLynddrdbdnd RibkManagement Divibun, W^t^t^i^fiiger, M., Deng, X., Budd, R., Xie, T- Wang, D.,... & Guh, K. 5. (2019). The Surface Water Database (SURF). ACalifurnia Database fur Surface Water Pesticide Muni Luring Bala. In Pebticideb in Surface Water: Monitoring Modeling Risk Assessment and Management (pp 215 232) American Chemical Society 255 451 A-327 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Diethyl phthalate CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Diethyl phthalate CASRN: 84-66-2 DTXSID: DTXSID7021780 Use: Solvent for nitrocellulose and cellulose acetate, plasticizer, wetting agent; in plastics, perfumery as fixative and solvent, alcohol denaturant, plasticizer in solid rocket propellants. Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUM MARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT IN FORMATION Potency Severity Prevalence Magnitude 3 non-cancer effects 9 5 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 4000 decreased weight gain and kidney weight general population OW 1992 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.62 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-328 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Diethyl phthalate CCL 5 Contaminant Information Sheet EPA-OGWDWand OST October 2022 HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.8 mg/kg/day IRIS 1987 Brown et al. 1978 decreased growth rate and food consumption and altered organ weights general population 33.8 4730 [192] Reference Dose (RfD) or Equivalent 0.75 mg/kg/day OW1992 Brown et al. 1978 decreased weight gain and kidney weight general population 33.8 4440 [218] Cancer Classification (CC) D IRIS 1987 [192] Cancer Classification (CC) D OW 1992 [218] ATSDR1995 [9] Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Systemic, Reproductive, Hepatic 0.57 Pereira, 2008, Pereira, 2006 Reproductive 1470 Yamasaki, 2005 1994-06-01 2020-04-14 728 10 39 7 Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Chronic Health-Based Guidance Value 6 mg/L MN DOH Human Health Ambient Water Quality Criteria 0.6 mg/L EPA Human Health Criteria forCWA Intermediate Minimal Risk Level (MRL) 6 mg/kg/day CDC ATSDR Cancer Classification (CC) Female.Mice EE no units HHSNTP Cancer Classification (CC) Female.Rats NE no units HHSNTP Cancer Classification (CC) Male.Mice EE no units HHSNTP Cancer Classification (CC) Male.Rats NE no units HHS NTP Data Element Value Units Source Notes Measured Data and Assessment Results LD50 1000 mg/kg NIH HSDB min LD50 9200 mg/kg NIH HSDB max LOAEL 1150 mg/kg/day EPA Toxicity Reference Database max LOAEL 197 mg/kg/day EPA Toxicity Reference Database min NOAEL 267 mg/kg/day EPA Toxicity Reference Database max NOAEL 56 mg/kg/day EPA Toxicity Reference Database min Percent of active toxcast in 1.44 percent EPA Chemistry Dashboard vitro assays tested Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Modeled Data LD50 0.0157036 mo l/kg TEST QSAR Ames mutagenicity test 0.16 no units TEST QSAR Developmental toxin test 0.748 no units TEST QSAR A-329 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Diethyl phthalate CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 OCCURRENCE DATA Scoring_Data_ Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contam nant Monitoring Rule (UCMR)4 2018-2019 Unregulated Contam nant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contam nant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contam nant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contam nant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contam nant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev(NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 46 3 Sites 6.52 0.1 0.2 0.62 0.8 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 37 3 Sites 8.11 0.1 0.2 0.62 0.8 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 9 0 Sites 0 Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) 1M - 10M Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Finished) 2006 - 2020 17 1 Sites 5.88 0.007 0.0435 5.5 6.2 ug/L Drinking Water Monitoring Data - WA (Finished) 2006-2011 483 1 Sites 0.21 4.9 4.9 4.9 4.9 ug/L USGS, Sioux Falls Area, 2012 (Finished) [153] 2009-2010 1 1 Sites 100 0.1 0.1 0.1 0.1 ug/L Ambient Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Source) 2006 - 2020 113 2 Sites 1.77 0.005 0.046 6.34 13.6 ug/L Drinking Water Monitoring Data - WA (Source) 2006-2011 638 2 Sites 0.31 0.421 0.76 1.03 1.1 ug/L National Water Information System (USGS NWIS) (Surface Water) 2008-2017 631 137 Sites 22 0.09 0.2 0.588 5 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008-2017 605 52 Sites 8.6 0.06 0.2 1.3 60.4 ug/L National Water Information System (USGS NWIS) (All Water) 2008-2017 1,236 189 Sites 15 0.06 0.2 0.6 60.4 ug/L Bradley et al. 2017 (Ambient) [52] 2012-2014 38 2 Sites 5.26 0.128 0.135 0.141 0.142 ug/L USGS, Sioux Falls Area, 2012 (Ambient) [153] 2009-2010 2 1 Sites 50 0.1 0.1 0.1 0.1 ug/L Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 0.0000694 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 4.31107 days Boiling point OPERA QSAR 297.011 degree C Boiling point TEST QSAR 312.231 degree C Vapor pressure OPERA QSAR 0.00203233 mmHg Vapor pressure TEST QSAR 0.00091622 mmHg Solubility in water OPERA QSAR 0.00366221 mol/L Solubility in water TEST QSAR 0.00165196 mol/L Bioconcentration factor OPERA QSAR 7.15782 no units Bioconcentration factor TEST QSAR 6.45654 no units Henry's Law constant OPERA QSAR 2.38E-08 atm-mA3/mol 0 eta no l/water partitioning coeff. (log Kow) OPERA QSAR 2.36526 no units A-330 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Diethyl phthalate CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 9 ATSDR. 1995. Toxicological Profile for Diethyl Phthalate. U.S. Department of Health and Human Services, Public Health Service, Agency for Toxic Substances and Disease Registry (ATSDR), Atlanta, GA. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 153 Occurrence of anthropogenic organic compounds and nutrients in source and finished water in the Sioux Falls area, South Dakota, 2009-10: U.S. Geological Survey Scientific Investigations Report 2012-5098, 21 p. plus appendixes. 192 USEPA. 1987. Chemical Assessment Summary, Diethyl Phthalate. U.S. Environmental Protection Agency, National Center for Environmental Assessment, Integrated Risk Information System (IRIS), Washington, DC. 218 USEPA. 1992. Drinking Water Criteria Document for Phthalic Acid Esters (PAEs). U.S. Environmental Protection Agency, Office of Health and Environmental Assessment, Environmental Criteria and Assessment Office, Cincinnati, OH. A-331 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Difenoconazole CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Difenoconazole CASRN: 119446-68-3 DTXSID: DTXSID4032372 Use: Fungicide, insecticide, seed treatment/protectant. Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Not List ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT IN FORMATION Potency Severity Prevalence Magnitude 7 non-cancer effects 9 3 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 60 cumulative decreases in body weight gains general population OPP 2017 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.0182 90th Percentile All Ambient Water NAWQA 1991-2017 Final Hazard Quotient (HQ) 0.00030 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-332 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Difenoconazole CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.01 mg/kg/day OPP 2017 Cox 1989 cumulative decreases in body weight gains general population 33.8 59.2 [381] Cancer Classification (CC) S OPP 2017 [3811 Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Acute Human Health Benchmark 1.7 mg/L EPA HHBP Acute PAD 0.25 mg/kg/day EPA HHBP Chronic Human Health Benchmark 0.06 mg/L EPA HHBP Population-Adjusted Dose (PAD) 0.01 mg/kg/day EPA HHBP Notes: Highlighted data indicate value was used in attribute scoring. Blan k fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Measured Data and Assessment Results LD50 1453 mg/kg NIH HSDB min LD50 2150 mg/kg NIH HSDB max LOAEL 12.5 mg/kg/day EPA Toxicity Reference Database min LOAEL 171.25 mg/kg/day EPA Toxicity Reference Database max NOAEL 1.25 mg/kg/day EPA Toxicity Reference Database min NOAEL 84.525 mg/kg/day EPA Toxicity Reference Database max Percent of active toxcast in 32.36 percent EPA Chemistry Dashboard vitro assays tested Sub chronic LOAEL 10 mg/kg/day EPA Toxicity Reference Database min Sub chronic LOAEL 75 mg/kg/day EPA Toxicity Reference Database max Subchronic NOAEL 1 mg/kg/day EPA Toxicity Reference Database min Subchronic NOAEL 25 mg/kg/day EPA Toxicity Reference Database max Data Element Value Units Source Notes Modeled Data LD50 0.0025468 mo l/kg TEST QSAR Ames mutagenicity test 0.467 no units TEST QSAR Developmental toxin test 0.413 no units TEST QSAR A-333 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Difenoconazole CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 OCCURRENCE DATA Scoring_Data_ Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev(NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 14 1 Sites 7.14 0.0182 0.0182 0.0182 0.0182 National Water Qua lity Assessment (USGS NAWQA) (Surface Water) 1991-2017 14 1 Sites 7.14 0.0182 0.0182 0.0182 0.0182 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) 47 400,757 2016 Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude USDA Pesticide Data Program (PDP) (Finished) 2001-2013 15 1 Sites 6.67 0.0053 0.0053 0.0053 0.0053 ug/L Ambient Water Prevalence Magnitude National Water Information System (USGS NWIS) (Surface Water) 2008-2017 132 4 Sites 3.03 0.0084 0.0296 0.168 0.249 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008-2017 3 0 Sites 0 National Water Information System (USGS NWIS) (All Water) 2008-2017 135 4 Sites 2.96 0.0084 0.0296 0.168 0.249 ug/L USDA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001-2013 227 1 Sites 0.44 0.0053 0.0053 0.0053 0.0053 ug/L USDA Pesticide Data Program (PDP) (Groundwater) 2001-2013 218 0 Sites 0 USDA Pesticide Data Program (PDP) (Untreated) 2001-2013 10 1 Sites 10 0.0053 0.0053 0.0053 0.0053 ug/L Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990-2018 123 1 Sites 0.81 0.0182 0.0182 0.0182 0.0182 ug/L Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 0.000000137 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 3.36121 days Boiling point OPERA QSAR 335.605 degree C Boiling point TEST QSAR 413.931 degree C Vapor pressure OPERA QSAR 6.17E-10 mmHg Vapor pressure TEST QSAR 1.75E-09 mmHg Solubility in water OPERA QSAR 0.0000202 mol/L Solubility in water TEST QSAR 0.000014 mol/L Bioconcentration factor OPERA QSAR 230.63 no units Bioconcentration factor TEST QSAR 148.936 no units Henry's Law constant OPERA QSAR 0.00000505 atm-mA3/mol 0 eta no l/water partitioning coeff. (log Kow) OPERA QSAR 4.07726 no units A-334 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Difenoconazole CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 381 USEPA. 2017. Difenoconazole: human health risk assessment for proposed new foliar uses on cotton, rice and wild rice. EPA-HQ-OPP-2016-0254-0010. DP No. D432211. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticide in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. A-335 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Dimethenamid CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Chemical Notes: Dimethenamid DTXSID4032376 Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 5 non-cancer effects 9 2 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 300 decreased body weight gain and decreased body weight, increased microscopic hepatic general population OPP 2014 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.103 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-336 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Dimethenamid CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.05 mg/kg/day OPP 2014 Ruckman et al. 1990; Sandoz Crop Protection Corp. 1990 decreased body weight gain and decreased body weight, increased microscopic hepatic lesions, increased food conversion ratios in females general population 33.8 296 [332] Cancer Classification (CC) C OPP 2014 [332] Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element I Value I Units I Source I Notes Data Element I Value I Units I Source I Notes Measured Data and Assessment Results Measured Data and Assessment Results Acute Health-Based Guidance Value 0.6 mg/L MN DOH LD50 371 mg/kg NIH HSDB min Acute Human Health Benchmark 10 mg/L EPA HHBP LD50 427 mg/kg NIH HSDB max Acute PAD 2 mg/kg/day EPA HHBP LOAEL 200 mg/kg/day EPA Toxicity Reference Database max Chronic Health-Based Guidance Value 0.3 mg/L MN DOH LOAEL 36 mg/kg/day EPA Toxicity Reference Database min Chronic Human Health Benchmark 0.3 mg/L EPA HHBP NOAEL 6.8 mg/kg/day EPA Toxicity Reference Database min Health-Based Screening Level 0.3 mg/L Health-based screening levels from USGS NOAEL 75 mg/kg/day EPA Toxicity Reference Database max Population-Adjusted Dose (PAD) 0.05 mg/kg/day EPA H HBP Percent of active toxcast in vitro assays tested 12.84 percent EPA Chemistry Dashboard Short-Term/Subchronic Health-Based Guidance Value 0.6 mg/L MN DOH Subchronic LOAEL 33.599998 mg/kg/day EPA Toxicity Reference Database min Subchronic LOAEL 98 mg/kg/day EPA Toxicity Reference Database max Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. Subchronic NOAEL 4.98 mg/kg/day EPA Toxicity Reference Database min Subchronic NOAEL 40.1 mg/kg/day EPA Toxicity Reference Database max The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Modeled Data LD50 TEST QSAR Ames mutagenicity test 0.443 no units TEST QSAR Developmental toxin test 0.711 no units TEST QSAR A-337 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Dim eth en am id CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contam nant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contam nant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contam nant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contam nant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contam nant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contam nant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev(NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 2.362 205 Sites 8.68 0.00012 0.00812 0.103 7 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 347 194 Sites 56 0.00012 0.00814 0.103 7 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 2.015 11 Sites 0.55 0.00031 0.00161 0.021 0.25 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) 16 1,115,877 2016 Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude USDA Pesticide Data Program (PDP) (Finished) 2001-2013 12 5 Sites 42 0.000999 0.0024 0.011 0.075 ug/L Ambient Water Prevalence Magnitude National Water Information System (USGS NWIS) (Surface Water) 2008-2017 358 97 Sites 27 0.00018 0.0175 0.214 3.19 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008-2017 848 10 Sites 1.18 0.0017 0.07 0.754 0.842 ug/L National Water Information System (USGS NWIS) (All Water) 2008-2017 1,206 107 Sites 8.87 0.00018 0.0187 0.237 3.19 ug/L USDA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001-2013 229 6 Sites 2.62 0.000999 0.0042 0.0299 0.51 ug/L USDA Pesticide Data Program (PDP) (Groundwater) 2001-2013 219 1 Sites 0.46 0.004162 0.00416 0.00416 0.004162 ug/L USDA Pesticide Data Program (PDP) (Untreated) 2001-2013 12 5 Sites 42 0.000999 0.0042 0.03 0.51 ug/L Bradley et al. 2017 (Ambient) [52] 2012-2014 38 4 Sites 11 0.03 0.03 0.079 0.1 ug/L Arnold et al. 2016 (Filtered) [7] 2012-2013 584 6 Sites 1.03 3e-04 0.0024 0.0152 0.0224 ug/L Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 9.96E-08 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 3.34757 days Boiling point OPERA QSAR 294.303 degree C Boiling point TEST QSAR 337.241 degree C Vapor pressure OPERA QSAR 0.000122276 mmHg Vapor pressure TEST QSAR 0.0000108 mmHg Solubility in water OPERA QSAR 0.00253016 mol/L Solubility in water TEST QSAR 0.000765597 mol/L Bioconcentration factor OPERA QSAR 45.9219 no units Bioconcentration factor TEST QSAR 17.8238 no units Henry's Law constant OPERA QSAR 3.83E-08 atm-mA3/mol 0 eta no 1/water partitioning coeff. (log Kow) OPERA QSAR 2.13166 no units A-338 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Dimethenamid CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 332 USEPA. 2014. Dimethenamid/Dimethenamid-P. Human Health Risk Assessment for Proposed New Use on Cotton Subgroup 20C. EPA-HQ-OPP-2013-0670-0005. DP No. D418118. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. A-339 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Dimethenamid OA CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Chemical Notes: Dimethenamid OA DTXSID4037530 Pesticide metabolite Is the contaminant on any lists? CERCLA FIFRA Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUM MARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT IN FORMATION Potency Severity Prevalence Magnitude 4 non-cancer effects 9 4 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date SL 400 Decrease in body weight gain; liver effects (increased relative liver weight, bile duct hyperplasia) general population MDH 2013 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.209 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-340 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Dimethenamid OA CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.06 mg/kg/day MDH 2013 Ruckman 1990 Decrease in body weight gain; liver effects (increased relative liver weight bile duct hyperplasia) general population 33.8 355 [135] NOTE: MN DOH determined that the RfD determined for dimethenamid would be protective for Dimethenamid OXA. MN DOH states that there are insuficient data to calculate a unique RfD for this compound. Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Acute Health-Based Guidance Value 0.6 mg/L MN DOH Chronic Health-Based Guidance Value 0.3 mg/L MN DOH Short-Term/Subchronic Health-Based Guidance 0.6 mg/L MN DOH Value Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Modeled Data LD50 0.0005164 mo l/kg TEST QSAR Ames mutagenicity test -0.084 no units TEST QSAR Developmental toxin test 0.898 no units TEST QSAR Data Element I Value | Units | Source I Notes Measured Data and Assessment Results A-341 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Dim eth en am id OA CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contam nant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contam nant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contam nant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contam nant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contam nant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contam nant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev(NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 2.539 73 Sites 2.88 0.0126 0.0748 0.209 0.596 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 363 68 Sites 19 0.0126 0.0747 0.209 0.596 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 2.176 5 Sites 0.23 0.03 0.0843 0.183 0.216 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude USDA Pesticide Data Program (PDP) (Finished) 2001-2013 12 5 Sites 42 0.00105 0.0022 0.0144 0.03 ug/L Ambient Water Prevalence Magnitude USDA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001-2013 229 25 Sites 11 0.001049 0.0045 0.039 0.061 ug/L USDA Pesticide Data Program (PDP) (Groundwater) 2001-2013 218 20 Sites 9.17 0.001049 0.0078 0.0311 0.0441 ug/L USDA Pesticide Data Program (PDP) (Untreated) 2001-2013 12 5 Sites 42 0.00105 0.00425 0.039 0.061 ug/L Bradley etal. 2017 (Ambient) [52] 2012-2014 38 2 Sites 5.26 0.02 0.02 0.02 0.02 ug/L Arnold et al. 2016 (Filtered) [7] 2012-2013 584 0 Sites 0 Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR4 data used in the CCL5 is a partial datasetand will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 3.34519 days Boiling point OPERA QSAR 306.88 degree C Boiling point TEST QSAR 366.15 degree C Vapor pressure OPERA QSAR 0.00000997 mmHg Vapor pressure TEST QSAR 0.00000151 mmHg Solubility in water OPERA QSAR 0.0182443 mol/L Solubility in water TEST QSAR 0.0122462 mol/L Bioconcentration factor OPERA QSAR 3.10149 no units Bioconcentration factor TEST QSAR 0.92045 no units Henry's Law constant OPERA QSAR 7.22E-10 atm-mA3/mol Octanol/water partitioning coeff. (log Kow) OPERA QSAR 1.82828 no units A-342 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Dimethenamid OA CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 135 MDH. 2013. Dimethenamid Degradates: ESAand OXA. Health Based Guidance for Water. Minnesota Department of Health (MDH), Environmental Health Division, Health Risk Assessment Unit, St Paul, MN. A-343 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Dimethoate CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION DTXSID7020479 Chemical Notes: Is the contaminant on any lists? CERCLA X FIFRA X Human Neurotoxicants X PubMed Neu rotoxica nts X Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Ust ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT IN FORMATION Potency Severity Prevalence Magnitude 7 reproductive and developmental effects 1 1 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value («"gA) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 0.3 inhibition of brain acetylcholinesterase bottle-fed infants OPP 2015 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.04707 90th Percentile All Ambient Water NAWQA 1991-2017 Final Hazard Quotient (HQ) 016 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Dimethoate has the potential to cause adverse health effects, lieluding cholinesterase inhibition. However, dimethoate does not ppear to occur in PWSs with a frequency and at levels of public lealth concern [a,b]. Dimethoate was not detected inaa number UCMR2 samples collected by PWSs at levels greater than the VS HRL (7.7 |ig/L), the HRL (15.4 ng/L),orthe MRL(0.7 pg/L)[c,d], EPA eludes that regulation of dimethoate does not represent a aningful opportunity for health risk reduction for persons served by PWSs due to the relatively small number of people likely exposed to dimethoate through drinking water [c,d]. USE PA, 2007 [284]; [b] USEPA, 2007 [283]; [c] USEPA, 2010 [310]; [d] USE PA, 2015 [350]; as cited in USEPA, 2014 [334] Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-344 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Dimethoate CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.00022 mg/kg/day OPP 2015 US EPA OP CRA 2002 & 2006; American Cyanamid Company 1986 inhibition of brain acetylcholinesterase bottle-fed infants 151 0.291 [360] Cancer Classification (CC) C OPP 2015 [3601 Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Acute Human Health Benchmark 0.087 mg/L EPA HHBP Acute PAD 0.013 mg/kg/day EPA HHBP Chronic Human Health Benchmark 0.014 mg/L EPAHHBP Drinking Water Guideline Value 0.006 mg/L WHO Drinking Water Quality Guidelines Health-Based Screening Level 0.014 mg/L Health-based screening levels from USGS Maximum Allowable Concentration (MAC) 0.02 mg/L Canadian Drinking Water Guidelines Population-Adjusted Dose (PAD) 0.0022 mg/kg/day EPAHHBP Cancer Classification (CC) Female.Mice N no units HHSNTP Cancer Classification (CC) Female.Rats N no units HHSNTP Cancer Classification (CC) Male.Mice N no units HHSNTP Cancer Classification (CC) Male.Rats N no units HHSNTP Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Modeled Data LD50 0.0004656 mo l/kg TEST QSAR Ames mutagenicity test 0.366 no units TEST QSAR Developmental toxin test 0.724 no units TEST QSAR Data Element Value Units Source Notes Measured Data and Assessment Results LD50 50 mg/kg NIH HSDB min LD50 600 mg/kg NIH HSDB max LOAEL 0.25 mg/kg/day EPA Toxicity Reference Database min LOAEL 18 mg/kg/day EPA Toxicity Reference Database max NOAEL 0.05 mg/kg/day EPA Toxicity Reference Database min NOAEL 6 mg/kg/day EPA Toxicity Reference Database max Percent of active toxcast in 3.15 percent EPA Chemistry Dashboard vitro assays tested TD50 222 mg/kg/day NIHCPDB max TD50 92.4 mg/kg/day NiHCPDB min A-345 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Dimethoate CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST October 2022 Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018 - 2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013 - 2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008 - 2010 4,140 0 Sites 0 ug/L Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monito ring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survey (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991 - 2017 4,941 64 Sites 1.3 0.00034 0.009 0.0471 1.95 ug/L National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991 - 2017 581 62 Sites 11 0.00034 0.009 0.0448 1.95 ug/L National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991 - 2017 4,360 2 Sites 0.05 0.061 0.152 0.207 0.243 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) 41 1,419,642 2016 Toxic Release Inventory (TRI) Program (EPA) (2016) 2 42 Chemical Data Reporting (CDR) Results (EPA) (2016) N on-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Finished) 2006 - 2020 184 0 Sites 0 USDA Pesticide Data Program (PDP) (Finished) 2001 - 2013 17 2 Sites 12 0.0075 0.0378 0.062 0.068 ug/L USGS, Sioux Falls Area, 2012 (Finished) [153] 2009 - 2010 1 0 Sites 0 Ambient Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Source) 2006 - 2020 2,100 2 Sites 0.1 0.082 0.541 0.908 1 ug/L National Water Information System (USGS NWIS) (Surface Water) 2008 - 2017 724 24 Sites 3.31 0.00045 0.0227 0.126 0.271 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008 - 2017 2,523 3 Sites 0.12 0.0036 0.133 0.824 1.12 ug/L National Water Information System (USGS NWIS) (All Water) 2008 - 2017 3,246 27 Sites 0.83 0.00045 0.0228 0.133 1.12 ug/L USDA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001 - 2013 229 1 Sites 0.44 0.0088 0.0088 0.0088 0.0088 ug/L USDA Pesticide Data Program (PDP) (Groundwater) 2001 - 2013 219 0 Sites 0 USDA Pesticide Data Program (PDP) (Untreated) 2001 - 2013 12 1 Sites 8.33 0.0088 0.0088 0.0088 0.0088 ug/L Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990 - 2018 12,194 762 Sites 6.25 0.007 0.219 1.34 16.4 ug/L Bradley et al. 2017 (Ambient) [52] 2012 - 2014 38 2 Sites 5.26 0.133 0.184 0.226 0.236 ug/L Arnold et al. 2016 (Filtered) [7] 2012 - 2013 690 1 Sites 0.14 0.061 0.061 0.061 0.061 ug/L USGS, Sioux Falls Area, 2012 (Ambient) [153] 2009 - 2010 2 0 Sites 0 lA/osfe Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg- bw/day) Notes Expocast exposure 0.000000994 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection n serum (1999-2016) NHANES biomonitoring detection n blood (1999-2016) NHANES biomonitoring detection n urine (1999-2016) < LOD ug/l Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Bio degradation ha If-life OPERA QSAR 73.9608 days Boiling point OPERA QSAR 308.683 degree C Boiling point TEST QSAR Vapor pressure OPERA QSAR 0.0000177 mmHg Vapor pressure TEST QSAR 0.0000248 mmHg Solubility in water OPERA QSAR 0.104479 mol/L Solubility in water TEST QSAR 0.0171002 mol/L Bio concent rat ion factor OPERA QSAR 1.77267 no units Bio concent rat ion factor TEST QSAR 3.70681 no units Flenry's Law constant OPERA QSAR 2.06E-08 atm-mA3/mol Octanol/water partitioning coeff. (log Kow) OPERA QSAR 0.833231 no units A-346 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Dimethoate CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulorigoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 153 Occurrence of anthropogenic organic compounds and nutrients in source and finished water in the Sioux Falls area, South Dakota, 2009-10: U.S. Geological Survey Scientific Investigations Report 2012-5098, 21 p. plus appendixes. 283 USEPA. 2007. Revised Interim Reregistration Decision for Dimethoate. Available on the Internet at: http://www.epa.gov/pesticides/reregistration/REDs/dimethoate_ired_revised.pdf. 284 USEPA. 2007. Unregulated Contaminant Monitoring Regulation (UCMR)for Public Water Systems Revisions. Federal Register. Vol. 72, No. 2, p. 367, January 4, 2007. 310 USEPA. 2010. Data Management and Analytical Plan for the Second Unregulated Contaminant Monitoring Regulation (UCMR 2) Data. June 2010 Draft Report Submitted to EPA. 334 USEPA. 2014. Regulatory Determinations 3 Support Document. April 2014. EPA Publication # 815-R14-003. 350 USEPA. 2015. Occurrence Data from the Second Unregulated Contaminant Monitoring Regulation (UCMR 2). Including Appendices A-C. EPA 815-R-15-013. December 2015. 360 USEPA. 2015. Dimethoate: Human Health Risk Assessment for Registration Review. EPA-HQ-OPP-2009-0059-0027. DP No. D416010. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticide in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. A-347 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Di-n-butyl phthalate CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Di-n-butyl phthalate CASRN: 84-74-2 DTXSID: DTXSID2021781 Use: Plasticizer in nitrocellulose lacquers, elastomers, explosives, nail polish and solid rocket propellants; in perfumes; in textiles; in safety glass; insecticides; in printing inks; resin solvent; paper coatings; and adhesives. Chemical Notes: Is the contaminant on any lists? CERCLA X FIFRA X Human Neu rotoxica nts X PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro X Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANTSUMMARY& DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT IN FORMATION Potency Severity Prevalence Magnitude 4 reproductive and developmental effects 10 7 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value («"gA) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 3000 "Increased incidence of retained areolas and nipple in the male offspring of rats" women of child bearing age ATSDR 2001 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 1.9 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-348 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Di-n-butyl phthalate CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.1 mg/kg/day IRIS 1987 Smith 1953 increased mortality general population 33.8 592 [188] Reference Dose (RfD) or Equivalent 0.1 mg/kg/day OW1991 Smith 1953 "absense of increased mortality and hemotalogical effects" general population 33.8 592 [211] Reference Dose (RfD) or Equivalent 0.5 mg/kg/day ATSDR2001 Mylchreest eta 1.2000 "Increased incidence of retained areolas and nipple in the male offspring of rats" women of child bearing age 35.4 2820 [17] Cancer Classification (CC) D IRIS 1987 [188] Cancer Classification (CC) D OW 1991 [2111 Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Neurological 0.01 Hoshi, 2009 Developmental; 2000 Dobrzynska, 2011; 2000-09-01 2019-12-17 1867 80 64 50 Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Acute Health-Based Guidance Value 0.02 mg/L MN DOH Acute Health-Based Guidance Value 0.02 mg/L MN DOH Chronic Health-Based Guidance Value 0.02 mg/L MN DOH Human Health Ambient Water Quality Criteria 0.02 mg/L EPA Human Health Criteria for CWA Short-Term/Subchronic Health-Based Guidance 0.02 mg/L MN DOH Value Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Measured Data and Assessment Results LD50 10000 mg/kg NIH HSDB max LD50 4840 mg/kg NIH HSDB min Percent of active toxcast in 9.76 percent EPA Chemistry Dashboard vitro assays tested Data Element Value Units Source Notes Modeled Data LD50 0.0436516 mo l/kg TEST QSAR Ames mutagenicity test 0.09 no units TEST QSAR Developmental toxin test 0.71 no units TEST QSAR A-349 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Di-n-butyl phthalate CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 OCCURRENCE DATA Scorin£_Data_ Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev(NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 22 4 Sites 18 0.3 1.5 1.9 2 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 13 4 Sites 31 0.3 1.5 1.9 2 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 9 0 Sites 0 Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) 1M - 10M Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Finished) 2006 - 2020 26 1 Sites 3.85 0.002 0.034 0.129 0.137 ug/L Drinking Water Monitoring Data - WA (Finished) 2006-2011 483 2 Sites 0.41 0.637 1.3 14.2 26.4 ug/L Ambient Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Source) 2006 - 2020 247 7 Sites 2.83 0.006 0.178 6.76 8.1 ug/L Drinking Water Monitoring Data - FL (Source) 2006-2011 1 1 Sites 100 1.1 1.1 1.1 1.1 ug/L Drinking Water Monitoring Data - WA (Source) 2006-2011 638 8 Sites 1.25 0.477 1.5 3.42 6 ug/L National Water Information System (USGS NWIS) (Surface Water) 2008-2017 154 25 Sites 16 0.11 0.44 5 5 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008-2017 360 46 Sites 13 0.04 0.09 0.377 1.65 ug/L National Water Information System (USGS NWIS) (All Water) 2008-2017 514 71 Sites 14 0.04 0.13 0.865 5 ug/L Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 0.00008 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 4.33363 days Boiling point OPERA QSAR 332.592 degree C Boiling point TEST QSAR 348.35 degree C Vapor pressure OPERA QSAR 0.0000243 mmHg Vapor pressure TEST QSAR 0.0000263 mmHg Solubility in water OPERA QSAR 0.0000362 mol/L Solubility in water TEST QSAR 0.0000407 mol/L Bioconcentration factor OPERA QSAR 134.136 no units Bioconcentration factor TEST QSAR 11.17 no units Henry's Law constant OPERA QSAR 0.0000012 o E E Octanol/water partitioning coeff. (log Kow) OPERA QSAR 4.5098 no units A-350 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Di-n-butyl phthalate CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 17 ATSDR. 2001. Toxicological Profile for Di-n-Butyl Phthalate. U.S. Department of Health and Human Services, Public Health Service, Agency for Toxic Substances and Disease Registry (ATSDR), Atlanta, GA 188 USEPA. 1987. Chemical Assessment Summary di-n-butyl phthalate. U.S. Environmental Protection Agency, National Center for Environmental Assessment, Integrated Risk Information System (IRIS), Washington, DC. 211 USEPA. 1991. Drinking Water Criteria Document for Phthalic Acid Esthers (PAES). U.S. Environmental Protection Agency, Office of Water, Health and Ecological Criteria Division, Washington, DC. A-351 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Diuron CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Diuron CASRN: 330-54-1 DTXSID: DTXSID0020446 Use: Herbicide (HSDB Chemical Notes: Is the contaminant on any lists? CERCLA X FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUM MARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT IN FORMATION Potency Severity Prevalence Magnitude 4 carcinogen with linear MOA 4 7 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 2 urinary bladder carcinomas general population OPP 2015 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 2.1 90th Percentile Finished Water UCMR1 2001-2003 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-352 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Diuron CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg- HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.001 mg/kg/day OPP 2015 Schmidt, 1985; Ross berg & Wirnitzer, 1985; Ross berg, 1995; Malek, 1997 hemolytic anemia and compensatory hematopoeisis general population 33.8 5.92 [342] Cancer Slope Factor (CSF) 0.0191 (mg/kg/day)A-l OPP 2015 Schmidt 1985; Ross berg and Wirnitzer, 1985; Ross berg, 1995; Malek 1997; Eiben. 1983 urinary bladder carcinomas general population 33.8 1.55 [342] Cancer Classification (CC) L OPP 2015 [342] Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg- CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title- abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results 10-day Health Advisory 1 mg/L EPA DWSHA 2018 Lifetime Health Advisory 0.002 mg/L EPA DWSHA 2018 Maximum Allowable Concentration (MAC) 0.15 mg/L Canadian Drinking Water Guidelines Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Measured Data and Assessment Results LD50 1017 mg/kg NIH HSDB min LD50 3400 mg/kg NIH HSDB max LOAEL 1 mg/kg/day EPA Toxicity Reference Database min LOAEL 640.13 mg/kg/day EPA Toxicity Reference Database max NOAEL 10 mg/kg/day EPA Toxicity Reference Database min NOAEL 77.5 mg/kg/day EPA Toxicity Reference Database max Percent of active toxcast in 7.46 percent EPA Chemistry Dashboard vitro assays tested Data Element Value Units Source Notes Modeled Data LD50 0.0047098 mol/kg TEST QSAR Ames mutagenicity test 0.027 no units TEST QSAR Developmental toxin test 0.759 no units TEST QSAR A-353 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Diuron CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contam nant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contam nant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contam nant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contam nant Monitoring Rule (UCMR) 1 2001 - 2003 293 1 Sites 0.34 2.1 2.1 2.1 2.1 Unregulated Contam nant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contam nant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev(NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 7.756 698 Sites 9 0.00021 0.0256 0.24 27.7 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 1.199 452 Sites 38 0.00021 0.0253 0.24 27.7 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 6.557 246 Sites 3.75 0.00054 0.03 0.25 5.53 Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) 47 3,410,787 2016 Toxic Release Inventory (TRI) Program (EPA) (2016) 9 37,175 Chemical Data Reporting (CDR) Results (EPA) (2016) 100K-500K Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Finished) 2006 - 2020 26 0 Sites 0 USDA Pesticide Data Program (PDP) (Finished) 2001-2013 15 10 Sites 67 0.0027 0.0072 0.057 1.3 ug/L Bradley et al. 2018 (Finished) [53] 2016 26 1 Sites 3.85 0.0041 0.0041 0.0041 0.0041 ug/L Ambient Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Source) 2006 - 2020 213 9 Sites 4.23 1.2 3.5 3.5 3.5 ug/L National Water Information System (USGS NWIS) (Surface Water) 2008-2017 560 255 Sites 46 0.00102 0.0208 0.138 25 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008-2017 1,240 47 Sites 3.79 0.00266 0.02 0.105 0.487 ug/L National Water Information System (USGS NWIS) (All Water) 2008-2017 1,800 302 Sites 17 0.00102 0.0206 0.135 25 ug/L USDA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001-2013 227 37 Sites 16 0.0027 0.013 0.06 1.2 ug/L USDA Pesticide Data Program (PDP) (Groundwater) 2001-2013 219 29 Sites 13 0.0027 0.0141 0.0589 0.134 ug/L USDA Pesticide Data Program (PDP) (Untreated) 2001-2013 10 8 Sites 80 0.0027 0.012 0.06 1.2 ug/L Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990-2018 8,018 1,811 Sites 23 0.0032 0.41 4.2 860 ug/L Bradley etal. 2017 (Ambient) [52] 2012-2014 38 20 Sites 53 0.0024 0.0256 0.193 1.362 ug/L Arnold et al. 2016 (Filtered) [7] 2012-2013 690 19 Sites 2.75 5e-04 0.0225 0.0758 0.121 ug/L USGS, McKenzie River, Oregon, 2012 (Ambient) [158] 2002-2010 126 21 Samples 17 6.07 ug/L Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 1.31E-08 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 3.55395 days Boiling point OPERA QSAR 323.013 degree C Boiling point TEST QSAR 298.055 degree C Vapor pressure OPERA QSAR 8.24E-08 mmHg Vapor pressure TEST QSAR 0.000000828 mmHg Solubility in water OPERA QSAR 0.000238919 mol/L Solubility in water TEST QSAR 0.00027227 mol/L Bioconcentration factor OPERA QSAR 15.9255 no units Bioconcentration factor TEST QSAR 22.9087 no units Henry's Law constant OPERA QSAR 1.06E-09 atm-mA3/mol 0 eta no l/water partitioning coeff. (log Kow) OPERA QSAR 2.55186 no units A-354 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Diuron CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 53 Bradley, P. M., Kolpin, D. W., Romanok, K. M., Smalling, K. L., Focazio, M. J., Brown, J. B.,... & Dietze, J. E. (2018). Reconnaissance of mixed organic and inorganic chemicals in private and public supply tapwaters at selected residential and workplace sites in the United States. Environmental science & technology, 52(23), 13972-13985. 158 Reconnaissance of Land-Use Sources of Pesticides in Drinking Water, McKenzie River, Oregon. U.S. Geological Survey Scientific Investigations Report 2012-5091, 46 p. plus appendixes. 342 USEPA. 2015. Diuron. Human Health Assessment Scoping Document in Support of Registration Review. EPA-HQ-OPP-2015-0077-0004. DP No. D423231. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticide in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. A-355 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 EPTC CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Chemical Notes: DTXSID1024091 Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANTSUMMARY& DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT IN FORMATION Potency Severity Prevalence Magnitude 5 non-cancer effects 1 1 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 300 decreased body weight and increased incidences of myocardial and neuromuscular general population OPP 2017 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.0724 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS EPTC does not appear to occur at health levels of concern in PWSs and EPA has made a determiniation thatterbacil does not present a ningfuI opportunity for health risk reduction. While EPTC has been found in ambient waters at levels less than the HRLof 175 pg (as as the HRL) [a,b], it was not found in the UCM R1 su rvey of public water supplies [c]. Kolpin & Martin, 2003 [123]; [b] Martin, Crawford, & Lars [134]; [c] USE PA, 2008 [297]; as cited in USE PA, 2008 [296] i, 2003 Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-356 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 EPTC CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.05 mg/kg/day OPP 2017 Warner 1983 decreased body weight and increased incidences of myocardial and neuromuscular lesions general population 33.8 296 [382] Cancer Classification (CC) NL OPP 2017 [3821 Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Acute Health-Based Guidance Value 0.3 mg/L MN DOH Acute Health-Based Guidance Value 0.3 mg/L MN DOH Acute Human Health Benchmark 1 mg/L EPA HHBP Acute PAD 0.2 mg/kg/day EPA HHBP Chronic Health-Based Guidance Value 0.04 mg/L MN DOH Chronic Health-Based Guidance Value 0.2 mg/L MN DOH Chronic Human Health Benchmark 0.3 mg/L EPA HHBP Health-Based Screening Level 0.3 mg/L Health-based screening levels from USGS Maximum Allowable Daily Level 700 ug/day CalEPA OEH HA Chemical Database Population-Adjusted Dose (PAD) 0.05 mg/kg/day EPA HHBP Short-Term/Subchronic Health-Based Guidance Value 0.09 mg/L MN DOH Data Element I Value I Units I Source I Notes Measured Data and Assessment Results LD50 112 mg/kg NIH HSDB min LD50 2550 mg/kg NIH HSDB max LOAEL 300 mg/kg/day EPA Toxicity Reference Database max LOAEL 8 mg/kg/day EPA Toxicity Reference Database min NOAEL 1 mg/kg/day EPA Toxicity Reference Database min NOAEL 100 mg/kg/day EPA Toxicity Reference Database max Percent of active toxcast in vitro assays tested 3.64 percent EPA Chemistry Dashboard Subchronic LOAEL 15 mg/kg/day EPA Toxicity Reference Database min Subchronic LOAEL 45 mg/kg/day EPA Toxicity Reference Database max Subchronic NOAEL 15 mg/kg/day EPA Toxicity Reference Database max Subchronic NOAEL 3 mg/kg/day EPA Toxicity Reference Database min Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Modeled Data LD50 0.0048753 mo l/kg TEST QSAR Ames mutagenicity test 0.356 no units TEST QSAR Developmental toxin test 0.59 no units TEST QSAR A-357 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 EPTC CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 3.873 0 Sites 0 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev(NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 10.705 423 Sites 3.95 4.00E - 04 0.008 0.0724 40 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 2.055 369 Sites 18 4.00E - 04 0.008 0.0722 40 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 8.650 54 Sites 0.62 0.001 0.0047 0.0607 0.952 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) 29 3,047,799 2016 Toxic Release Inventory (TRI) Program (EPA) (2016) 1 170 Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Finished) 2006 - 2020 58 0 Sites 0 Drinking Water Monitoring Data - WA (Finished) 2006-2011 482 0 Sites 0 USDA Pesticide Data Program (PDP) (Finished) 2001-2013 17 1 Sites 5.88 0.017 0.028 0.06 0.068 ug/L Ambient Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Source) 2006 - 2020 315 0 Sites 0 Drinking Water Monitoring Data - WA (Source) 2006-2011 634 0 Sites 0 National Water Information System (USGS NWIS) (Surface Water) 2008-2017 936 32 Sites 3.42 4.00E - 04 0.0061 0.0474 0.838 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008-2017 2,019 16 Sites 0.79 0.0017 0.0115 0.103 0.168 ug/L National Water Information System (USGS NWIS) (All Water) 2008-2017 2,954 48 Sites 1.62 4.00E - 04 0.00705 0.0637 0.838 ug/L USDA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001-2013 229 2 Sites 0.87 0.008 0.028 0.137 0.2 ug/L USDA Pesticide Data Program (PDP) (Groundwater) 2001-2013 219 0 Sites 0 USDA Pesticide Data Program (PDP) (Untreated) 2001-2013 12 2 Sites 17 0.008 0.028 0.137 0.2 ug/L Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990-2018 3,722 391 Sites 11 0.002 0.0228 0.5 23 ug/L Bradley etal. 2017 (Ambient) [52] 2012 - 2014 38 4 Sites 11 0.0116 0.0708 0.196 0.224 ug/L Arnold et al. 2016 (Filtered) [7] 2012 - 2013 690 1 Sites 0.14 0.016 0.016 0.016 0.016 ug/L Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 5.95E-08 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR4 data used in the CCL5 is a partial datasetand will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 3.73295 days Boiling point OPERA QSAR 215.91 degree C Boiling point TEST QSAR Vapor pressure OPERA QSAR 0.0226925 mmHg Vapor pressure TEST QSAR 0.011508 mmHg Solubility in water OPERA QSAR 0.00143197 mol/L Solubility in water TEST QSAR 0.00174582 mol/L Bioconcentration factor OPERA QSAR 23.7326 no units Bioconcentration factor TEST QSAR 14.6893 no units Henry's Law constant OPERA QSAR 0.00000125 o E E Octanol/water partitioning coeff. (log Kow) OPERA QSAR 3.21713 no units A-358 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 EPTC CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulorigoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 123 Kolpin, D.W. and J.D. Martin. 2003. Pesticides in Ground Water: Summary Statistics; Preliminary Results from Cycle 1 of the National Water Quality Assessment Program (NAWQA), 1992-2001. Available on the Internet at: http://ca.water.usgs.gov/pnsp/pestgw/Pest-GW_2001_Text.html. 134 Martin, J.D., C.G. Crawford, and S.J. Larson. 2003. Pesticides in Streams: Summary Statistics; Preliminary Results from Cycle 1 of the National Water Quality Assessment Program (NAWQA), 1992-2001. Available on the Internet at: http://ca.water.usgs.gov/pnsp/pestsw/Pest-SW_2001_Text.html. 296 USEPA. 2008. Regulatory Determinations Support Document for Selected Contaminants from the Second Drinking Water Contaminant Candidate List (CCL 2). EPA Report 815-R-08-012. June 2008. 297 USEPA. 2008. The Analysis of Occurrence Data from the First Unregulated Contaminant Monitoring Regulation (UCMR 1) in Support of Regulatory Determinations for the Second Drinking Water Contaminant Candidate List. EPA 815-R-08-013. June. 382 USEPA. 2017. EPTC: (S-Ethyl dipropylthiocarbamate) Acute and Chronic Aggregate Dietary (Food and Drinking Water), Exposure and Risk Assessments for Registration Review. EPA-HQ-OPP-2012-0720- 0019. DP No. D439764. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticide in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. A-359 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Esfenvalerate CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Esfenvalerate CASRN: 66230-04-4 DTXSID: DTXSID4032667 Use: Insecticide; medication Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUM MARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT IN FORMATION Potency Severity Prevalence Magnitude 6 reproductive and developmental effects 1 1 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value («"gA) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 5 reduced locomotor activity bottle-fed infants OPP 2017 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 7.54 EDWC SW (acute) OPP 2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-360 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Esf en valerate CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.0037 mg/kg/day OPP 2017 Wolansky et al. 2006 reduced locomotor activity bottle-fed infants 151 4.90 [383] Cancer Classification (CC) E OPP 2017 [3831 Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Acute Human Health Benchmark 0.012 mg/L EPA HHBP Acute PAD 0.0018 mg/kg/day EPA HHBP Chronic Human Health Benchmark 0.012 mg/L EPA HHBP Health-Based Screening Level 0.012 mg/L Health-based screening levels from USGS Population-Adjusted Dose (PAD) 0.0018 mg/kg/day EPA HHBP Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element I Value I Units I Source I Notes Measured Data and Assessment Results Acute LOAEL 7.5 mg/kg/day EPA Toxicity Reference Database Acute NOAEL 2.5 mg/kg/day EPA Toxicity Reference Database LD50 325 mg/kg NIH HSDB max LD50 88 mg/kg NIH HSDB min LOAEL 2.5 mg/kg/day EPA Toxicity Reference Database min LOAEL 3 mg/kg/day EPA Toxicity Reference Database max Percent of active toxcast in vitro assays tested 11.45 percent EPA Chemistry Dashboard Subchronic LOAEL 7.5 mg/kg/day EPA Toxicity Reference Database min Subchronic LOAEL 75 mg/kg/day EPA Toxicity Reference Database max Subchronic NOAEL 2.5 mg/kg/day EPA Toxicity Reference Database min Subchronic NOAEL 22.5 mg/kg/day EPA Toxicity Reference Database max Data Element Value Units Source Notes Modeled Data LD50 0.0006934 mo l/kg TEST QSAR Ames mutagenicity test 0.3 no units TEST QSAR Developmental toxin test 0.75 no units TEST QSAR A-361 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Esfenvalerate CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 OCCURRENCE DATA Scoring_Data_ Nationally Representative Water Data Date Number of Number of PWS/Sites/ Percent with Minimum Cone. Median Cone. 90th Percentile Maximum Cone. Cone. Units Notes PWS/ Sites/ Detects Samples Detects (Detects) (Detects) (Detects) (Detects) Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev(NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 2.965 0 Sites 0 National Water Qua lity Assessment (USGS NAWQA) (Surface Water) 1991-2017 645 0 Sites 0 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 2.320 0 Sites 0 Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) 47 157,875 2016 Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude USDA Pesticide Data Program (PDP) (Finished) 2001-2013 15 0 Sites 0 Ambient Water Prevalence Magnitude National Water Information System (USGS NWIS) (Surface Water) 2008-2017 140 0 Sites 0 National Water Information System (USGS NWIS) (Groundwater) 2008-2017 3 0 Sites 0 National Water Information System (USGS NWIS) (All Water) 2008-2017 143 0 Sites 0 USDA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001-2013 119 0 Sites 0 USDA Pesticide Data Program (PDP) (Groundwater) 2001-2013 111 0 Sites 0 USDA Pesticide Data Program (PDP) (Untreated) 2001-2013 8 0 Sites 0 Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990-2018 4,983 152 Sites 3.05 0.000335 0.015 0.134 3.48 ug/L Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Estimated Drinking Water Concentration (EDWC) in Surface Water (acute) 2017 OPP 7.54 ug/L Tier 1, FQPA Index Reservoir Screening Tool (FIRST) Model The critical effect of reduced locomotor activity was based on an acute population adjusted dose and is considered a less-than- chronic response. To account for this, the modeled surface water acute concentration was selected as the occurrence concentration for esfenvalerate. Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 0.0000017 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 3.35348 days Boiling point OPERA QSAR 434.894 degree C Boiling point TEST QSAR 456.288 degree C Vapor pressure OPERA QSAR 1.64E-09 mmHg Vapor pressure TEST QSAR 1.31E-09 mmHg Solubility in water OPERA QSAR 0.000000197 mol/L Solubility in water TEST QSAR 0.000000282 mol/L Bioconcentration factor OPERA QSAR 646.164 no units Bioconcentration factor TEST QSAR 240.991 no units Henry's Law constant OPERA QSAR 7.95E-08 atm-mA3/mol 0 eta no l/water partitioning coeff. (log Kow) OPERA QSAR 6.17889 no units A-362 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Esfenvalerate CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 383 USEPA. 2017. Esfenvalerate. Draft Human Health Risk Assessment for Registration Review. EPA-HQ-OPP-2009-0301-0074. DP No. D414149. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticide in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. A-363 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Et half luralin CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Eth a If luralin CASRN: 55283-68-6 DTXSID: DTXSID8032386 Use: Herbicide used on used on beans, watermelons, sunflowers, cantaloupes, and cucumbers Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 4 carcinogen with linear MOA 6 3 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 0.3 mammary gland fibro-adenomas and combined ad e no mas/fib ro-ade no mas general population OPP 2016 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.0751 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-364 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Ethalfluralin CCL 5 Contaminant Information Sheet EPA-OGWDWand OST October 2022 HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.04 mg/kg/day OPP 2016 Adams 1985 increased urinary bilirubin, variations in erythrocyte morphology, increased thrombocyte count, increased erythroid series of the bone marrow general population 33.8 237 [365] Cancer Slope Factor (CSF) 0.089 (mg/kg/day)A-l OPP 2016 Adams et al. 1981; Adams 1981 mammary gland fibro-adenomas and combined adenomas/fibro- adenomas general population 33.8 0.332 [365] Cancer Classification (CC) C OPP 2016 [365] Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Acute Human Health Benchmark 21 mg/L EPA HHBP Acute PAD 0.75 mg/kg/day EPA HHBP Cancer Slope Factor (CSF) 0.089 (mg/kg/day)A-l EPA HHBP Chronic Human Health Benchmark 0.3 mg/L EPA HHBP Chronic Human Health Benchmark 0.00036 mg/L EPA HHBP Health-Based Screening Level 0.3 mg/L Health-based screening levels from USGS Health-Based Screening Level 0.00036 mg/L Health-based screening levels from USGS Population-Adjusted Dose (PAD) 0.04 mg/kg/day EPA HHBP Data Element I Value I Units I Source I Notes Measured Data and Assessment Results LD50 5000 mg/kg NIH HSDB LOAEL 20 mg/kg/day EPA Toxicity Reference Database min LOAEL 250 mg/kg/day EPA Toxicity Reference Database max NOAEL 4 mg/kg/day EPA Toxicity Reference Database min NOAEL 50 mg/kg/day EPA Toxicity Reference Database max Percent of active toxcast in vitro assays tested 7.89 percent EPA Chemistry Dashboard Subchronic LOAEL 125 mg/kg/day EPA Toxicity Reference Database Subchronic NOAEL 27.5 mg/kg/day EPA Toxicity Reference Database Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Modeled Data LD50 0.0147571 mo l/kg TEST QSAR Ames mutagenicity test 0.628 no units TEST QSAR Developmental toxin test 1.214 no units TEST QSAR A-365 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Etiialfluralin CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 8.238 59 Sites 0.72 0.001 0.014 0.0751 0.768 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 1.828 54 Sites 2.95 0.001 0.014 0.0742 0.768 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 6.410 5 Sites 0.08 0.004 0.005 0.048 0.09 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) 45 1,391,050 2016 Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude USDA Pesticide Data Program (PDP) (Finished) 2001-2013 15 0 Sites 0 Ambient Water Prevalence Magnitude National Water Information System (USGS NWIS) (Surface Water) 2008-2017 333 2 Sites 0.6 0.0016 0.0044 0.00762 0.009 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008-2017 615 0 Sites 0 National Water Information System (USGS NWIS) (All Water) 2008-2017 948 2 Sites 0.21 0.0016 0.0044 0.00762 0.009 ug/L USDA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001-2013 225 0 Sites 0 USDA Pesticide Data Program (PDP) (Groundwater) 2001-2013 218 0 Sites 0 USDA Pesticide Data Program (PDP) (Untreated) 2001-2013 8 0 Sites 0 Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990-2018 1,348 24 Sites 1.78 0.005 0.031 0.0751 0.13 ug/L Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 0.000000105 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 3.53726 days Boiling point OPERA QSAR 350.978 degree C Boiling point TEST QSAR 350.199 degree C Vapor pressure OPERA QSAR 0.0000691 mmHg Vapor pressure TEST QSAR 0.00000379 mmHg Solubility in water OPERA QSAR 0.000000666 mol/L Solubility in water TEST QSAR 0.00000234 mol/L Bioconcentration factor OPERA QSAR 199.31 no units Bioconcentration factor TEST QSAR 184.502 no units Henry's Law constant OPERA QSAR 0.000000345 o E E 0 eta no l/water partitioning coeff. (log Kow) OPERA QSAR 5.13595 no units A-366 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Ethalfluralin CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 365 USEPA. 2016. Ethalfluralin: Human Health Draft Risk Assessment for Registration Review. EPA-HQ-OPP-2011-0094-0016. DP No. D429844. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticide in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. A-367 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Ethion CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Ethion CASRN: 563-12-2 DTXSID: DTXSID2024086 Use: Insecticide Chemical Notes: Canceled pesticide. Last end of use date: 12/31/2004. Is the contaminant on any lists? CERCLA X FIFRA X Human Neurotoxicants X PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANTSUMMARY& DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 7 non-cancer effects 2 2 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 3 plasma, red blood cell, and brain cholinesterase inhibition general population OPP 2001 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.0088 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-368 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Ethion CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.0005 mg/kg/day OPP 2001 Bailey 1989 plasma, red blood cell, and brain cholinesterase inhibition general population 33.8 2.96 [245] NOTE: canceled registration Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Acute Minimal Risk Level (MRL) 0.002 mg/kg/day CDC ATSDR Intermediate Minimal Risk Level (MRL) 0.002 mg/kg/day CDC ATSDR Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Measured Data and Assessment Results LD50 208 mg/kg NIH HSDB max LD50 24.4 mg/kg NIH HSDB min LOAEL 0.049 mg/kg/day EPA Toxicity Reference Database min LOAEL 9.6000004 mg/kg/day EPA Toxicity Reference Database max NOAEL 2.4 mg/kg/day EPA Toxicity Reference Database max NOAEL 0.028 mg/kg/day EPA Toxicity Reference Database min Percent of active toxcast in 10.88 percent EPA Chemistry Dashboard vitro assays tested Data Element Value Units Source Notes Modeled Data LD50 0.0000755 mo l/kg TEST QSAR Ames mutagenicity test 0.338 no units TEST QSAR Developmental toxin test TEST QSAR A-369 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Etiiion CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 3.699 6 Sites 0.16 0.003 0.0065 0.0088 0.01 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 402 3 Sites 0.75 0.004 0.008 0.0094 0.01 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 3.297 3 Sites 0.09 0.003 0.005 0.0071 0.008 Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) 1 0.661 2015 Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude USDA Pesticide Data Program (PDP) (Finished) 2001-2013 15 0 Sites 0 USGS, Sioux Falls Area, 2012 (Finished) [153] 2009-2010 1 0 Sites 0 Ambient Water Prevalence Magnitude National Water Information System (USGS NWIS) (Surface Water) 2008-2017 470 1 Sites 0.21 0.108 0.108 0.108 0.108 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008-2017 2,012 0 Sites 0 National Water Information System (USGS NWIS) (All Water) 2008 - 2017 2,481 1 Sites 0.04 0.108 0.108 0.108 0.108 ug/L USDA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001 - 2013 123 0 Sites 0 USDA Pesticide Data Program (PDP) (Groundwater) 2001 - 2013 114 0 Sites 0 USDA Pesticide Data Program (PDP) (Untreated) 2001 - 2013 10 0 Sites 0 Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990 - 2018 614 2 Sites 0.33 0.01 0.03 0.046 0.05 ug/L Arnold et al. 2016 (Filtered) [7] 2012 - 2013 106 0 Sites 0 USGS, Sioux Falls Area, 2012 (Ambient) [153] 2009 - 2010 2 0 Sites 0 Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 0.000000118 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR4 data used in the CCL5 is a partial datasetand will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 526.103 days Boiling point OPERA QSAR 395.284 degree C Boiling point TEST QSAR Vapor pressure OPERA QSAR 0.00000179 mmHg Vapor pressure TEST QSAR 0.00000561 mmHg Solubility in water OPERA QSAR 0.00000621 mol/L Solubility in water TEST QSAR 0.0000151 mol/L Bioconcentration factor OPERA QSAR 242.157 no units Bioconcentration factor TEST QSAR 58.3445 no units Henry's Law constant OPERA QSAR 0.000000452 o E E 0 eta no l/water partitioning coeff. (log Kow) OPERA QSAR 4.72384 no units A-370 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Ethion CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 153 Occurrence of anthropogenic organic compounds and nutrients in source and finished water in the Sioux Falls area, South Dakota, 2009-10: U.S. Geological Survey Scientific Investigations Report 2012-5098, 21 p. plus appendixes. 245 USE PA. 2001. Ethion RED. U.S. Environmental Protection Agency, Office of Prevention, Pesticides and Toxic Substances, Washington, D.C. 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticide in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. A-371 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Ethoprop CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Chemical Notes: DTXSID4032611 Is the contaminant on any lists? CERCLA X FIFRA X Human Neurotoxicants X PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 6 reproductive and developmental effects 2 4 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value («"gA) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 0.9 inhibition of red blood cell chol in esterase in pups bottle-fed infants OPP 2015 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.0563 90th Percentile Finished Water UCMR4 2018-2019 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-372 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Ethoprop CCL 5 Contaminant Information Sheet EPA-OGWDWand OST October 2022 HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.00065 mg/kg/day OPP 2015 Chartieret al. 2005 inhibition of red blood cell cholinesterase in pups bottle-fed infants 151 0.861 [343] Cancer Slope Factor (CSF) 0.0281 (mg/kg/day)A-l OPP 2015 Williams 1992 malignant adrenal pheochromocytomas in males general population 33.8 1.05 [343] Cancer Classification (CC) L OPP2015 [343] Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL Lowest LOAEL Study Highest NOAEL Health Highest NOAEL Highest NOAEL Study Start Date of End Date of No. Unique References No. Animal Studies No. Human No. PECO Relevant Studies (mg/kg Effects (mg/kg bw/day) Search Search identified in lit search passed Title-abstract Studies passed passed full-text review bw/day) Screen Title-abstract Screen Other Health Data Data Element Value Units Source Notes Data Element Value Units Source Notes Measured Data and Assessment Results Measured Data and Assessment Results Acute Human Health Benchmark 0.051 mg/L EPA HHBP LD50 216 mg/kg NIH HSDB max Acute PAD 0.0076 mg/kg/day EPA HHBP LD50 5.62 mg/kg NIH HSDB min Cancer Slope Factor (CSF) 0.0281 (mg/kg/day)A-l EPA HHBP LOAEL 0.254 mg/kg/day EPA Toxicity Reference Database min Chronic Human Health Benchmark 0.00114 mg/L EPA HHBP LOAEL 24 mg/kg/day EPA Toxicity Reference Database max Chronic Human Health Benchmark 0.009 mg/L EPA HHBP NOAEL 13 mg/kg/day EPA Toxicity Reference Database max Health-Based Screening Level 0.00114 mg/L Health-based screening levels from USGS NOAEL 0.032 mg/kg/day EPA Toxicity Reference Database min Health-Based Screening Level 0.009 mg/L Health-based screening levels from USGS Percent of active toxcast in 3.88 percent EPA Chemistry Dashboard vitro assays tested Population-Adjusted Dose (PAD) 0.0014 mg/kg/day EPA HHBP Subchronic LOAEL 0.025 mg/kg/day EPA Toxicity Reference Database Subchronic NOAEL 0.01 mg/kg/day EPA Toxicity Reference Database Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Modeled Data LD50 0.0001291 mo l/kg TEST QSAR Ames mutagenicity test -0.038 no units TEST QSAR Developmental toxin test 0.477 no units TEST QSAR A-373 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Etiioprop CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 3.648 4 Sites 0.11 0.0326 0.0485 0.0563 0.059 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 10.705 104 Sites 0.97 2.00E - 04 0.011 0.0796 5.75 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 2.055 100 Sites 4.87 2.00E - 04 0.011 0.0795 5.75 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 8.650 4 Sites 0.05 0.006 0.009 0.149 0.243 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Estimated Annual Agricultural Pesticide Use (USGS) 14 883,037 2016 Toxic Release Data Number of States Amount Released (lbs/year) Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Production Data Production Volume (lbs/year) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Finished) 2006 - 2020 2 0 Sites 0 USDA Pesticide Data Program (PDP) (Finished) 2001-2013 15 1 Sites 6.67 0.027 0.027 0.027 0.027 ug/L Ambient Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Source) 2006 - 2020 11 0 Sites 0 National Water Information System (USGS NWIS) (Surface Water) 2008 - 2017 841 17 Sites 2.02 0.00094 0.00334 0.148 0.268 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008 - 2017 2,018 1 Sites 0.05 0.00114 0.00114 0.00114 0.00114 ug/L National Water Information System (USGS NWIS) (All Water) 2008 - 2017 2,858 18 Sites 0.63 0.00094 0.0032 0.147 0.268 ug/L USDA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001 - 2013 123 0 Sites 0 USDA Pesticide Data Program (PDP) (Groundwater) 2001 - 2013 114 0 Sites 0 USDA Pesticide Data Program (PDP) (Untreated) 2001 - 2013 10 0 Sites 0 Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990 - 2018 6,608 29 Sites 0.44 0.003 0.112 0.729 5.4094 ug/L Bradley et al. 2017 (Ambient) [52] 2012 - 2014 38 1 Sites 2.63 0.122 0.122 0.122 0.122 ug/L Arnold et al. 2016 (Filtered) [7] 2012 - 2013 690 0 Sites 0 Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 8.62E-08 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 74.8059 days Boiling point OPERA QSAR 286.424 degree C Boiling point TEST QSAR Vapor pressure OPERA QSAR 0.000409034 mmHg Vapor pressure TEST QSAR 0.000234963 mmHg Solubility in water OPERA QSAR 0.00240073 mol/L Solubility in water TEST QSAR 0.00295121 mol/L Bioconcentration factor OPERA QSAR 20.4104 no units Bioconcentration factor TEST QSAR 33.4965 no units Henry's Law constant OPERA QSAR 0.000000701 o E E 0 eta no l/water partitioning coeff. (log Kow) OPERA QSAR 3.42685 no units A-374 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Ethoprop CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 343 USEPA. 2015. Ethoprop. Preliminary Occupational and Residential Exposure/Risk Assessment for Registration Review. EPA-HQ-OPP-2008-0560-0056. DP No. D421954. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticide in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. A-375 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Ethyl citrate CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Ethyl citrate CASRN: 77-93-0 DTXSID: DTXSID0040701 Use: Solvent and plasticizerfor nitrocellulose and natural resins, softener, paint removers, agglutinant, perfume base, food additive Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 3 no adverse effects 9 4 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date SL 20000 no adverse effect level general population Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.19 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-376 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Ethyl citrate CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDW and OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg- HRL (ug/L) Assessment Full Citation Notes Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg- CCL Screening Level (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 4 mg/kg/day Finkelstein and Gold, 1959 no adverse effect level general population 33.8 23700 [78] NOTE: No health assessments found; NOAEL/UF used in place of the RfD, NOAEL obtained from a study identified by the rapid systematic literature review Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title- abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Endocrine, Systemic, Renal, Immunological, Hepatic, Gastrointestinal, Respiratory, Cardiovascular, Hematological 4000 Finkelstein, 1959 2020-04-14 83 2 0 1 Other Health Data Data Element Measured Data and Assessment Results Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Measured Data and Assessment Results LD50 3200 mg/kg NIH HSDB min LD50 35000 mg/kg NIH HSDB max Percent of active toxcast in 1.2 percent EPA Chemistry Dashboard vitro assavs tested Data Element Value Units Source Notes Modeled Data LD50 0.0146893 mol/kg TEST QSAR Ames mutagenicity test 0.349 no units TEST QSAR Developmental toxin test 0.701 no units TEST QSAR A-377 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Ethyl citrate CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contam nant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contam nant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contam nant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contam nant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contam nant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contam nant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 567 17 Sites 3 0.01 0.04 0.19 0.48 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 88 16 Sites 18 0.01 0.04 0.186 0.43 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 479 1 Sites 0.21 0.48 0.48 0.48 0.48 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) 1M - 10M Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Glassmeyer et al 2017 (Finished) [86] 2007-2012 25 NA Sites 4 0.013 0.013 ug/L USGS, Sioux Falls Area, 2012 (Finished) [153] 2009-2010 1 0 Sites 0 Ambient Water Prevalence Magnitude National Water Information System (USGS NWIS) (Surface Water) 2008-2017 715 197 Sites 28 0.01 0.06 14.2 334 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008-2017 689 10 Sites 1.45 0.01 0.02 0.04 0.09 ug/L National Water Information System (USGS NWIS) (All Water) 2008-2017 1,404 207 Sites 15 0.01 0.06 14 334 ug/L Glassmeyer et a 1 2017 (Ambient) [86] 2007-2012 25 NA Sites 0 ug/L Bradley et al. 2017 (Ambient) [52] 2012-2014 38 15 Sites 39 0.0266 0.11 0.462 0.694 ug/L USGS, Sioux Falls Area, 2012 (Ambient) [153] 2009-2010 2 1 Sites 50 Waste Water Effluent Prevalence Magnitude Scott et al. 2018 (Wastewater) [161] 2011-2017 21 19 Sites 90 0.14 0.47 1.28 2 ug/L Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 0.0000592 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 3.81755 days Boiling point OPERA QSAR 292.74 degree C Boiling point TEST QSAR 316.611 degree C Vapor pressure OPERA QSAR 0.000485688 mmHg Vapor pressure TEST QSAR 0.0000562 mmHg Solubility in water OPERA QSAR 0.229189 mol/L Solubility in water TEST QSAR 0.0166725 mol/L Bioconcentration factor OPERA QSAR 3.52492 no units Bioconcentration factor TEST QSAR 1.36144 no units Henry's Law constant OPERA QSAR 2.49E-09 atm-mA3/mol 0 eta no l/water partitioning coeff. (log Kow) OPERA QSAR 0.512786 no units A-378 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Ethyl citrate CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 78 Finkelstein M. and Gold, H. 1959. Toxicology of the citric acid esters: tributyl citrate, acetyl tributyl citrate, triethyl citrate, and acetyl triethyl citrate. Toxicology and applied pharmacology. 1(283-98). 86 Glassmeyer, S.T., Furlong, E.T., Kolpin, D.W., Batt, A.L., Benson, R., Boone, J.S.,... & Wilson, V.S. (2017). Nationwide reconnaissance of contaminants of emerging concern in source and treated drinking waters of the United States. Science of The Total Environment. v581-582, (909-922). 153 Occurrence of anthropogenic organic compounds and nutrients in source and finished water in the Sioux Falls area, South Dakota, 2009-10: U.S. Geological Survey Scientific Investigations Report 2012-5098, 21 p. plus appendixes. 161 Scott, T. M., Phillips, P. J., Kolpin, D. W., Colella, K. M., Furlong, E. T., Foreman, W. T., & Gray, J. L. (2018). Pharmaceutical manufacturing facility discharges can substantially increase the pharmaceutical load to US wastewaters. Science of the Total Environment, 636, 69-79. A-379 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Famoxadone CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Famoxadone CASRN: 131807-57-3 DTXSID: DTXSID8034588 Use: Fungicide Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUM MARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT IN FORMATION Potency Severity Prevalence Magnitude 6 non-cancer effects 1 2 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 8 microscopic lens lesions (cataracts) general population OPP 2015 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.0059 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-380 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Famoxadone CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.0014 mg/kg/day OPP 2015 Tompkins 1995; Salik 1995 microscopic lens lesions (cataracts) general population 33.8 8.28 [344] Cancer Classification (CC) NL OPP 2015 [3441 Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Chronic Human Health Benchmark 0.009 mg/L EPA HHBP Health-Based Screening Level 0.009 mg/L Health-based screening levels from USGS Population-Adjusted Dose (PAD) 0.0014 mg/kg/day EPA HHBP Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element I Value I Units I Source I Notes Measured Data and Assessment Results LD50 5000 mg/kg NIH HSDB LOAEL 1000 mg/kg/day EPA Toxicity Reference Database max LOAEL 8.8000002 mg/kg/day EPA Toxicity Reference Database min NOAEL 1.2 mg/kg/day EPA Toxicity Reference Database min NOAEL 350 mg/kg/day EPA Toxicity Reference Database max Percent of active toxcast in vitro assays tested 26.49 percent EPA Chemistry Dashboard Sub chronic LOAEL 10 mg/kg/day EPA Toxicity Reference Database min Subchronic LOAEL 534 mg/kg/day EPA Toxicity Reference Database max Subchronic NOAEL 1.3 mg/kg/day EPA Toxicity Reference Database min Subchronic NOAEL 79.9 mg/kg/day EPA Toxicity Reference Database max Data Element Value Units Source Notes Modeled Data LD50 0.0038548 mo l/kg TEST QSAR Ames mutagenicity test 0.201 no units TEST QSAR Developmental toxin test 0.803 no units TEST QSAR A-381 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Famoxadone CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 OCCURRENCE DATA Scoring_Data_ Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev(NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 1.348 1 Sites 0.07 0.0059 0.0059 0.0059 0.0059 National Water Qua lity Assessment (USGS NAWQA) (Surface Water) 1991-2017 290 1 Sites 0.34 0.0059 0.0059 0.0059 0.0059 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 1.058 0 Sites 0 Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) 36 56,460 2016 Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Ambient Water Prevalence Magnitude National Water Information System (USGS NWIS) (Surface Water) 2008-2017 273 1 Sites 0.37 0.0091 0.016 0.0196 0.0216 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008-2017 153 0 Sites 0 National Water Information System (USGS NWIS) (All Water) 2008-2017 426 1 Sites 0.23 0.0091 0.016 0.0196 0.0216 ug/L Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990-2018 134 4 Sites 2.99 0.0091 0.016 0.0201 0.0216 ug/L Arnold et al. 2016 (Filtered) [7] 2012-2013 584 0 Sites 0 Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 0.000000023 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR4 data used in the CCL5 is a partial datasetand will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 3.54781 days Boiling point OPERA QSAR 408.651 degree C Boiling point TEST QSAR Vapor pressure OPERA QSAR 6.94E-09 mmHg Vapor pressure TEST QSAR 1.3E-10 mmHg Solubility in water OPERA QSAR 0.000000238 mol/L Solubility in water TEST QSAR 0.00000161 mol/L Bioconcentration factor OPERA QSAR 83.2068 no units Bioconcentration factor TEST QSAR 38.5478 no units Henry's Law constant OPERA QSAR 5.34E-09 atm-mA3/mol Octanol/water partitioning coeff. (log Kow) OPERA QSAR 4.59956 no units A-382 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Famoxadone CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 344 USEPA. 2015. Famoxadone. Fluman Flealth Assessment Scoping Document in Support of Registration Review. EPA-FIQ-OPP-2015-0094-0002. DP No. D423286. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticide in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. A-383 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Fenbuconazole CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Fenbuconazole CASRN: 114369-43-6 DTXSID: DTXSID8032548 Use: Fungicide Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANTSUMMARY& DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT IN FORMATION Potency Severity Prevalence Magnitude 3 carcinogen with linear MOA 1 1 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 8 hepatocellular adenomas and carcinomas in mice; thyroid follicular adenomas and combined adenomas/carcinomas in rats general population OPP 2019 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 11.7 EDWCSW (chronic, OPP 2019 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-384 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Fenbuconazole CCL 5 Contaminant Information Sheet EPA-OGWDWand OST October 2022 HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.03 mg/kg/day OPP 2019 Wolfe 1990 decreased body weight gain, increased thyroid weight, histo pat ho logical lesions in liver and thyroid gland general population 33.8 178 [417] Cancer Slope Factor (CSF) 0.00359 (mg/kg/day)A-l OPP 2019 Wolfe 1990 and 1991a and b hepatocellular adenomas and carcinomas in mice; thyroid follicular adenomas and combined adenomas/carcinomas in rats general population 33.8 8.24 [417] Cancer Classification (CC) C OPP 2019 [417] Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Acute Human Health Benchmark 8 mg/L EPA HHBP Acute PAD 0.3 mg/kg/day EPA HHBP Cancer Slope Factor (CSF) 0.00359 (mg/kg/day)A-l EPA HHBP Chronic Human Health Benchmark 0.2 mg/L EPA HHBP Chronic Human Health Benchmark 0.00891 mg/L EPA HHBP Population-Adjusted Dose (PAD) 0.03 mg/kg/day EPA HHBP Notes: Highlighted data indicate value was used in attribute scoring. Blan k fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Measured Data and Assessment Results LOAEL 3.75 mg/kg/day EPA Toxicity Reference Database min LOAEL 75 mg/kg/day EPA Toxicity Reference Database max NOAEL 0.38 mg/kg/day EPA Toxicity Reference Database min NOAEL 30 mg/kg/day EPA Toxicity Reference Database max Percent of active toxcast in 17.11 percent EPA Chemistry Dashboard vitro assays tested Subchronic LOAEL 13.27 mg/kg/day EPA Toxicity Reference Database max Subchronic LOAEL 5.0999999 mg/kg/day EPA Toxicity Reference Database min Subchronic NOAEL 1.5 mg/kg/day EPA Toxicity Reference Database min Subchronic NOAEL 5.7 mg/kg/day EPA Toxicity Reference Database max Data Element Value Units Source Notes Modeled Data LD50 0.0034834 mo l/kg TEST QSAR Ames mutagenicity test 0.752 no units TEST QSAR Developmental toxin test 0.488 no units TEST QSAR A-385 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Fenbuconazole CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 OCCURRENCE DATA Scoring_Data_ Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev(NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 14 0 Sites 0 National Water Qua lity Assessment (USGS NAWQA) (Surface Water) 1991-2017 14 0 Sites 0 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) 30 46,778 2016 Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude USDA Pesticide Data Program (PDP) (Finished) 2001-2013 13 1 Sites 7.69 0.057 0.057 0.057 0.057 ug/L Ambient Water Prevalence Magnitude National Water Information System (USGS NWIS) (Surface Water) 2008-2017 132 0 Sites 0 National Water Information System (USGS NWIS) (Groundwater) 2008-2017 3 0 Sites 0 National Water Information System (USGS NWIS) (All Water) 2008-2017 135 0 Sites 0 USDA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001-2013 121 0 Sites 0 USDA Pesticide Data Program (PDP) (Groundwater) 2001-2013 114 0 Sites 0 USDA Pesticide Data Program (PDP) (Untreated) 2001-2013 8 0 Sites 0 Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990-2018 99 0 Sites 0 Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Estimated Drinking Water Concentration (EDWC) in Surface Water (chronic, cancer) 2019 OPP 11.7 ug/L Tier II Pesticide Root Zone Model (PRZM) - Exposure Analysis Modeling System (EXAMS) The modeled surface water chronic, cancer concentration provided by the most recent available EPA OPP health assessment was selected as the occurrence concentration for fenbuconazole. This value coincides with the critical effects of thyroid and liver adenomas and carcinomas provided within the health effects report. Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 0.000000133 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 3.3514 days Boiling point OPERA QSAR 335.634 degree C Boiling point TEST QSAR 445.687 degree C Vapor pressure OPERA QSAR 4.42E-08 mmHg Vapor pressure TEST QSAR 5.66E-09 mmHg Solubility in water OPERA QSAR 0.0000013 mol/L Solubility in water TEST QSAR 0.0000166 mol/L Bioconcentration factor OPERA QSAR 281.827 no units Bioconcentration factor TEST QSAR 132.739 no units Henry's Law constant OPERA QSAR 0.00000424 atm-mA3/mol 0 eta no l/water partitioning coeff. (log Kow) OPERA QSAR 3.14361 no units A-386 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Fenbuconazole CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 417 USEPA. 2019. Fenbuconazole: Human Health Risk Assessment for Proposed Use on Imported Tea. EPA-HQ-OPP-2018-0300-0004. DP No. D446940. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticide in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. A-387 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Fenitrothion CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Chemical Notes: DTXSID4032613 Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants X PubMed Neu rotoxica nts X Neu rode v. Disruptors Androgen Receptors in vitro X Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUM MARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT IN FORMATION Potency Severity Prevalence Magnitude 7 reproductive and developmental effects Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value («"gA) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 0.2 plasma chol in esterase inhibition and histopathology of lymph nodes bottle-fed infants OPP 2010 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.078 90th Percentile Ambient (SW) Water SURF 1990-2018 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-388 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Fenitrothion CCL 5 Contaminant Information Sheet EPA-OGWDWand OST October 2022 HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.000125 mg/kg/day OPP 2010 Spicerl986 plasma cholinesterase inhibition and histopathology of lymph nodes bottle-fed infants 151 0.166 [313] Cancer Classification (CC) E OPP 2010 [313] Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element I Value | Units | Source | Notes Measured Data and Assessment Results Acute Human Health Benchmark 0.0017 mg/L EPA HHBP Acute PAD 0.00025 mg/kg^day EPA HHBP Chronic Human Health Benchmark 0.0008 mg/L EPA HHBP Population-Adjusted Dose (PAD) 0.000125 mg/kg/day EPA HHBP Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Modeled Data LD50 0.0001122 mo l/kg TEST QSAR Ames mutagenicity test 0.548 no units TEST QSAR Developmental toxin test 0.713 no units TEST QSAR Data Element Value Units Source Notes Measured Data and Assessment Results LD50 1720 mg/kg NIH HSDB max LD50 500 mg/kg NIH HSDB min LOAEL 0.25 mg/kg/day EPA Toxicity Reference Database min LOAEL 30 mg/kg/day EPA Toxicity Reference Database max NOAEL 0.125 mg/kg/day EPA Toxicity Reference Database min NOAEL 10 mg/kg/day EPA Toxicity Reference Database max Percent of active toxcast in 15.77 percent EPA Chemistry Dashboard vitro assays tested Subchronic LOAEL 1.5 mg/kg/day EPA Toxicity Reference Database Subchronic NOAEL 0.5 mg/kg/day EPA Toxicity Reference Database A-389 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Fenitrotiiion CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contam nant Monitoring Rule (UCMR)4 2018-2019 Unregulated Contam nant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contam nant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contam nant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contam nant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contam nant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev(NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude USDA Pesticide Data Program (PDP) (Finished) 2001-2013 17 0 Sites 0 Ambient Water Prevalence Magnitude USDA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001-2013 201 0 Sites 0 USDA Pesticide Data Program (PDP) (Groundwater) 2001-2013 191 0 Sites 0 USDA Pesticide Data Program (PDP) (Untreated) 2001-2013 12 0 Sites 0 Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990-2018 2,406 1 Sites 0.04 0.078 0.078 0.078 0.078 ug/L Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes 2010 OPP ug/L No modeled concentrations were provided by OPP because "it is highly unlikely that fenitrothion will reach drinking water resources..." due to its selective uses in bait traps. "The only route of [oral] exposure ... is in the diet from imported wheat." Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/ day) Notes Expocast exposure 0.000000078 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 4.49784 days Boiling point OPERA QSAR 353.148 degree C Boiling point TEST QSAR Vapor pressure OPERA QSAR 0.0000185 mmHg Vapor pressure TEST QSAR 0.000016 mmHg Solubility in water OPERA QSAR 0.000156501 mol/L Solubility in water TEST QSAR 0.0000621 mol/L Bioconcentration factor OPERA QSAR 83.6872 no units Bioconcentration factor TEST QSAR 57.1479 no units Henry's Law constant OPERA QSAR 0.000000596 atm-mA3/mol 0 eta no l/water partitioning coeff. (log Kow) OPERA QSAR 3.37577 no units A-390 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Fenitrothion CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 313 USEPA. 2010. Fenitrothion. Risk Assessment to Support Final Registration Review Decision. EPA-HQ-OPP-2009-0172-0016. DP No. D383647. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticide in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. A-391 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Fenpropathrin CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Fenpropathrin CASRN: 39515-41-8 DTXSID: DTXSID0024002 Use: Insecticide Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Not List ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT IN FORMATION Potency Severity Prevalence Magnitude 5 reproductive and developmental effects 1 1 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value («"gA) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 20 reduced motor activity bottle-fed infants OPP 2016 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.0324 90th Percentile Ambient (SW) Water CA SURF 1990-2018 Final Hazard Quotient (HQ) 0.0016 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-392 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Fenpropathrin CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.017 mg/kg/day OPP 2016 Wolansky et al. 2006 reduced motor activity bottle-fed infants 151 22.5 [366] Cancer Classification (CC) NL OPP 2016 [3661 Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Acute Human Health Benchmark 0.11 mg/L EPA HHBP Acute PAD 0.017 mg/kg/day EPA HHBP Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element I Value I Units I Source I Notes Measured Data and Assessment Results LD50 66.7 mg/kg NIH HSDB min LD50 70.6 mg/kg NIH HSDB max LOAEL 19.450001 mg/kg/day EPA Toxicity Reference Database max LOAEL 2 mg/kg/day EPA Toxicity Reference Database min NOAEL 0.4 mg/kg/day EPA Toxicity Reference Database min NOAEL 7.23 mg/kg/day EPA Toxicity Reference Database max Percent of active toxcast in vitro assays tested 12.5 percent EPA Chemistry Dashboard Sub chronic LOAEL 30 mg/kg/day EPA Toxicity Reference Database max Sub chronic LOAEL 6.25 mg/kg/day EPA Toxicity Reference Database min Subchronic NOAEL 15 mg/kg/day EPA Toxicity Reference Database Data Element Value Units Source Notes Modeled Data LD50 0.0004742 mo l/kg TEST QSAR Ames mutagenicity test 0.248 no units TEST QSAR Developmental toxin test 0.825 no units TEST QSAR A-393 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Fenpropathrin CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 OCCURRENCE DATA Scoring_Data_ Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev(NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 14 0 Sites 0 National Water Qua lity Assessment (USGS NAWQA) (Surface Water) 1991-2017 14 0 Sites 0 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) 24 185,210 2016 Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude USDA Pesticide Data Program (PDP) (Finished) 2001-2013 13 0 Sites 0 Ambient Water Prevalence Magnitude National Water Information System (USGS NWIS) (Surface Water) 2008-2017 140 0 Sites 0 National Water Information System (USGS NWIS) (Groundwater) 2008-2017 3 0 Sites 0 National Water Information System (USGS NWIS) (All Water) 2008-2017 143 0 Sites 0 USDA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001-2013 121 0 Sites 0 USDA Pesticide Data Program (PDP) (Groundwater) 2001-2013 114 0 Sites 0 USDA Pesticide Data Program (PDP) (Untreated) 2001-2013 8 0 Sites 0 Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990-2018 2,562 29 Sites 1.13 0.001092 0.005 0.0324 2.979733 ug/L Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Limit of solubility surrogate for occurrence concentration, Surface Water Peak 2016 OPP 10.3 ug/L Fenpropathrin is very insoluble in water and residues in drinking water are expected to be very low. Therefore, no modeling of estimated occurrence was conducted and the limit of solubility of fenpropathrin (10.3 ppb) reported in the most recent EPA OPP health assessment was used as a surrogate for the peak expected occurrence concentration. Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 0.0000001 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 3.53866 days Boiling point OPERA QSAR 370.491 degree C Boiling point TEST QSAR 414.903 degree C Vapor pressure OPERA QSAR 0.00000331 mmHg Vapor pressure TEST QSAR 0.000000011 mmHg Solubility in water OPERA QSAR 0.0000003 mol/L Solubility in water TEST QSAR 0.000000228 mol/L Bioconcentration factor OPERA QSAR 217.595 no units Bioconcentration factor TEST QSAR 744.732 no units Henry's Law constant OPERA QSAR 9.96E-08 atm-mA3/mol 0 eta no l/water partitioning coeff. (log Kow) OPERA QSAR 5.47445 no units A-394 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Fenpropathrin CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 366 USEPA. 2016. Fenpropathrin. Draft Human Health Risk Assessment for Registration Review. EPA-HQ-OPP-2010-0422-0017. DP No. D425768. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticide in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. A-395 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Fenthion CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Chemical Notes: DTXSID8020620 Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants X PubMed Neu rotoxica nts X Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANTSUMMARY& DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT IN FORMATION Potency Severity Prevalence Magnitude 7 non-cancer effects 1 1 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 0.4 plasma chol in esterase inhibition general population OPP 2001 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.19 EEC SW 56-day average (chronic) OPP 2001 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Not Applicable Not Applicable Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-396 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Fenthion CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.00007 mg/kg/day OPP 2001 Rosenblum 1980 plasma cholinesterase inhibition general population 33.8 0.414 [246] Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Acute Human Health Benchmark 0.005 mg/L EPA HHBP Acute PAD 0.0007 mg/kg/day EPA HHBP Chronic Human Health Benchmark 0.0004 mg/L EPA HHBP Health-Based Screening Level 0.0004 mg/L Health-based screening levels from USGS Population-Adjusted Dose (PAD) 0.00007 mg/kg/day EPA HHBP Cancer Classification (CC) Female.Mice N no units HHSNTP Cancer Classification (CC) Female.Rats N no units HHSNTP Cancer Classification (CC) Male.Mice E no units HHSNTP Cancer Classification (CC) Male.Rats N no units HHS NTP Data Element I Value I Units I Source I Notes Measured Data and Assessment Results LD50 150 mg/kg NIH HSDB min LD50 245 mg/kg NIH HSDB max LOAEL 18 mg/kg/day EPA Toxicity Reference Database max LOAEL 0.03 mg/kg/day EPA Toxicity Reference Database min NOAEL 0.056 mg/kg/day EPA Toxicity Reference Database min NOAEL 6 mg/kg/day EPA Toxicity Reference Database max Percent of active toxcast in vitro assays tested 11.56 percent EPA Chemistry Dashboard TD50 1.03 mg/kg/day NIHCPDB min TD50 29.4 mg/kg/day NIHCPDB max Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Modeled Data LD50 0.0002965 mo l/kg TEST QSAR Ames mutagenicity test 0.214 no units TEST QSAR Developmental toxin test 0.588 no units TEST QSAR A-397 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Fenthion CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of Number of PWS/Sites/ Percent with Minimum Cone. Median Cone. 90th Percentile Maximum Cone. Cone. Units Notes PWS/ Sites/ Detects Samples Detects (Detects) (Detects) (Detects) (Detects) Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev(NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 336 0 Sites 0 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 36 0 Sites 0 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 300 0 Sites 0 Pesticide Application Data Number of States Amount Applied (lbs/year) Date Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Data Number of States Amount Released (lbs/year) Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Production Data Production Volume (lbs/year) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Finished) 2006 - 2020 1 0 Sites 0 USDA Pesticide Data Program (PDP) (Finished) 2001-2013 15 0 Sites 0 Ambient Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Source) 2006 - 2020 3 0 Sites 0 National Water Information System (USGS NWIS) (Surface Water) 2008-2017 59 0 Sites 0 National Water Information System (USGS NWIS) (Groundwater) 2008-2017 1 0 Sites 0 National Water Information System (USGS NWIS) (All Water) 2008-2017 60 0 Sites 0 USDA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001-2013 123 0 Sites 0 USDA Pesticide Data Program (PDP) (Groundwater) 2001-2013 114 0 Sites 0 USDA Pesticide Data Program (PDP) (Untreated) 2001-2013 10 0 Sites 0 Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990-2018 4,579 0 Sites 0 Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Estimated Environmental Concentration (EEC) in Surface Water, 56-day Average (chronic) 2001 OPP 0.19 ug/L GENeric Estimated Environmental Concentration ffiFNFFD Mnripl The estimated environmental concentration provided by the most recent available EPA OPP health assessment was selected as the occurrence value for fenthion. The 56-day concentration in surface water was the only value available as an estimate of chronic Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 8.99E-08 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters Source Value Units Notes (EPA CompTox Dashboard) Biodegradation half-life OPERA QSAR 4.47178 days Boiling point OPERA QSAR 361.38 degree C Boiling point TEST QSAR Vapor pressure OPERA QSAR 0.0000182 mmHg Vapor pressure TEST QSAR 0.0000659 mmHg Solubility in water OPERA QSAR 0.0000218 mol/L Solubility in water TEST QSAR 0.0000212 mol/L Bioconcentration factor OPERA QSAR 285.803 no units Bioconcentration factor TEST QSAR 130.317 no units Henry's Law constant OPERA QSAR 0.00000106 atm-mA3/mol 0 eta no l/water partitioning coeff. (log Kow) OPERA QSAR 4.07281 no units A-398 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Fenthion CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 246 USEPA. 2001. Interim Reregistration Eligibility Decision for Fenthion. EPA 738-R-00-013. U.S. Environmental Protection Agency, Office of Prevention, Pesticides and Toxic Substances, Washington, D.C. 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticide in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. A-399 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Fexofenadine CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Chemical Notes: DTXSID00861411 Is the contaminant on any lists? CERCLA FIFRA Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANTSUMMARY& DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT IN FORMATION Potency Severity Prevalence Magnitude 7 non-cancer effects 9 4 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date SL 3 lowest therapeutic dose: anxiolytic, sedative, muscle-relaxant, anticonvulsant and bottle-fed infants FDA; NIH 2018; 2018 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 1.4 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-400 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Fexofenadine CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWandOST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.0005 mg/kg/day FDA 2018; NIH 2018 Major Pharmaceuticals lowest therapeutic dose: anxiolytic, sedative, muscle-relaxant, anticonvulsant and amnestic effects bottle-fed infants 151 3.30 [77] [150] NOTE: (Lowest Therapeutic Dose/3000x UF) is used in place of an RfD; LTDs were obtained from FDA-approved drug labels Reference Dose (RfD) or Equivalent 0.0005 mg/kg/day FDA 2018; NIH 2018 Major Pharmaceuticals lowest therapeutic dose: anxiolytic, sedative, muscle-relaxant, anticonvulsant and amnestic effects general population 33.8 12.0 [77] [150] NOTE: (Lowest Therapeutic Dose/3000x UF) is used in place of an RfD; LTDs were obtained from FDA-approved drug labels Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Screening level for pharmaceutical - general 0.011764706 mg/L EPA Office of Water population Screening level for pharmaceutical - infants 0.003333333 mg/L EPA Office of Water Data Element Value Units Source Notes Measured Data and Assessment Results Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Modeled Data LD50 0.0019634 mo l/kg TEST QSAR Ames mutagenicity test 0.02 no units TEST QSAR Developmental toxin test 0.836 no units TEST QSAR A-401 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Fexofenadine CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contam nant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contam nant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contam nant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contam nant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contam nant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contam nant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev(NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 557 24 Sites 4.31 0.00197 0.0348 1.4 3.89 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 75 24 Sites 32 0.00197 0.0348 1.4 3.89 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 482 0 Sites 0 Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Glassmeyer et al 2017 (Finished) [86] 2007-2012 25 NA Sites 0 ug/L Ambient Water Prevalence Magnitude Glassmeyer et al 2017 (Ambient) [86] 2007-2012 25 NA Sites 8 0.112 0.16309 ug/L Bradley et al. 2017 (Ambient) [52] 2012-2014 38 16 Sites 42 0.010424 0.576 1.74 2.047397 ug/L Bexfieid etal. 2019 (Groundwater) [49] 2013-2015 1,106 0 Sites 0 Waste Water Effluent Prevalence Magnitude Scott et al. 2018 (Wastewater) [161] 2011-2017 21 20 Sites 95 0.015476 1.13 2.79 17.37626 ug/L Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg Notes Expocast exposure Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR4 data used in the CCL5 is a partial datasetand will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 26.1502 days Boiling point OPERA QSAR 422.926 degree C Boiling point TEST QSAR 514.695 degree C Vapor pressure OPERA QSAR 2.56E-09 mmHg Vapor pressure TEST QSAR 1.45E-11 mmHg Solubility in water OPERA QSAR 0.0000028 mol/L Solubility in water TEST QSAR 0.0000137 mol/L Bioconcentration factor OPERA QSAR 13.808 no units Bioconcentration factor TEST QSAR 15.9956 no units Henry's Law constant OPERA QSAR 2.51E-08 o E E Octanol/water partitioning coeff. (log Kow) OPERA QSAR 4.63629 no units A-402 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Fexofenadine CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 49 Bexfield, L.M., P.L. Toccalino, K. Belitz, W.T. Foreman, and E.T. Furlong. 2019. Hormones and pharmaceuticals in groundwater used as a source of drinking water across the United States. Environmental Science and Technology 53: 2950-2960. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 77 FDA. 2018. Drugs @ FDA: FDA Approved Drug Products. U.S. Food and Drug Administration (FDA), https://www.accessdata.fda.gov/scripts/cder/daf/. 86 Glassmeyer, S.T., Furlong, E.T., Kolpin, D.W., Batt, A.L., Benson, R., Boone, J.S.,... & Wilson, V.S. (2017). Nationwide reconnaissance of contaminants of emerging concern in source and treated drinking waters of the United States. Science of The Total Environment. v581-582, (909-922). 150 NIH. 2018. DailyMed Database. U.S. National Library of Medicine, National Institutes of Health (NIH). https://dailymed.nlm.nih.gov/dailymed/. 161 Scott, T. M., Phillips, P. J., Kolpin, D. W., Colella, K. M., Furlong, E. T., Foreman, W. T., & Gray, J. L. (2018). Pharmaceutical manufacturing facility discharges can substantially increase the pharmaceutical load to US wastewaters. Science of the Total Environment, 636, 69-79. A-403 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Fipronil CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Fipronil CASRN: 120068-37-3 DTXSID: DTXSID4034609 Use: insecticide, seed treatment/protectant Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 9 reduced longevity 9 2 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 1 increased incidence of seizures and death, changes in clinical chemistry (protein), increased TSH, decreased T4 women of child bearing age OPP 2011 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.02 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-404 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Fipronil CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.0002 mg/kg/day OPP 2011 Aughton 1993 increased incidence of seizures and death, alterations in clinical chemistry (protein), increased TSH, decreased T4 women of childbearingage 35.4 1.13 [319] Cancer Classification (CC) C OPP 2011 [3191 Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Acute Human Health Benchmark 0.17 mg/L EPA HHBP Acute PAD 0.025 mg/kg/day EPA HHBP Chronic Human Health Benchmark 0.001 mg/L EPA HHBP Health-Based Screening Level 0.001 mg/L Health-based screening levels from USGS Population-Adjusted Dose (PAD) 0.0002 mg/kg/day EPAHHBP Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element I Value I Units I Source I Notes Measured Data and Assessment Results LD50 103 mg/kg NIH HSDB max LD50 91 mg/kg NIH HSDB min LOAEL 26.299999 mg/kg/day EPA Toxicity Reference Database max LOAEL 0.059 mg/kg/day EPA Toxicity Reference Database min NOAEL 0.025 mg/kg/day EPA Toxicity Reference Database min NOAEL 4 mg/kg/day EPA Toxicity Reference Database max Percent of active toxcast in vitro assays tested 26.37 percent EPA Chemistry Dashboard Subchronic LOAEL 0.32 mg/kg/day EPA Toxicity Reference Database min Subchronic LOAEL 3.2 mg/kg/day EPA Toxicity Reference Database max Subchronic NOAEL 0.11 mg/kg/day EPA Toxicity Reference Database min Subchronic NOAEL 1.72 mg/kg/day EPA Toxicity Reference Database max Data Element Value Units Source Notes Modeled Data LD50 TEST QSAR Ames mutagenicity test TEST QSAR Developmental toxin test TEST QSAR A-405 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Fipronil CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 5.307 402 Sites 7.57 0.00014 0.0063 0.02 6.41 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 634 326 Sites 51 0.00014 0.00619 0.019 6.41 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 4.673 76 Sites 1.63 0.00096 0.008 0.0503 0.43 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) 12 7,124 2016 Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude USDA Pesticide Data Program (PDP) (Finished) 2001-2013 8 0 Sites 0 USGS, Sioux Falls Area, 2012 (Finished) [153] 2009-2010 1 0 Sites 0 Ambient Water Prevalence Magnitude National Water Information System (USGS NWIS) (Surface Water) 2008-2017 1,001 321 Sites 32 0.00022 0.0067 0.035 0.181 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008-2017 3,062 46 Sites 1.5 0.001 0.005 0.0168 0.035 ug/L National Water Information System (USGS NWIS) (All Water) 2008-2017 4,062 367 Sites 9.03 0.00022 0.0065 0.033 0.181 ug/L USDA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001-2013 121 15 Sites 12 0.00058 0.00058 0.00226 0.013 ug/L USDA Pesticide Data Program (PDP) (Groundwater) 2001-2013 114 11 Sites 9.65 0.00058 0.0014 0.00531 0.013 ug/L USDA Pesticide Data Program (PDP) (Untreated) 2001-2013 8 4 Sites 50 0.00058 0.00058 0.00132 0.0028 ug/L Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990-2018 1,135 513 Sites 45 0.00031 0.051 0.203 2.11 ug/L Bradley etal. 2017 (Ambient) [52] 2012-2014 38 17 Sites 45 0.0066 0.0238 0.0948 0.153 ug/L Arnold et al. 2016 (Filtered) [7] 2012-2013 690 4 Sites 0.58 0.001 0.0014 0.00255 0.003 ug/L USGS, Sioux Falls Area, 2012 (Ambient) [153] 2009-2010 2 1 Sites 50 0.001 0.001 0.001 0.001 ug/L USGS, McKenzie River, Oregon, 2012 (Ambient) [158] 2002 - 2010 119 5 Samples 4.2 0.041 ug/L Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 2.65E-08 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 3.54048 days Boiling point OPERA QSAR 323.014 degree C Boiling point TEST QSAR Vapor pressure OPERA QSAR 2.17E-09 mmHg Vapor pressure TEST QSAR Solubility in water OPERA QSAR 0.00000538 mol/L Solubility in water TEST QSAR 0.000065 mol/L Bioconcentration factor OPERA QSAR 5.12606 no units Bioconcentration factor TEST QSAR Henry's Law constant OPERA QSAR 9.05E-09 atm-mA3/mol 0 eta no l/water partitioning coeff. (log Kow) OPERA QSAR 3.93502 no units A-406 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Fipronil CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 153 Occurrence of anthropogenic organic compounds and nutrients in source and finished water in the Sioux Falls area, South Dakota, 2009-10: U.S. Geological Survey Scientific Investigations Report 2012-5098, 21 p. plus appendixes. 158 Reconnaissance of Land-Use Sources of Pesticides in Drinking Water, McKenzie River, Oregon. U.S. Geological Survey Scientific Investigations Report 2012-5091, 46 p. plus appendixes. 319 USEPA. 2011. Fipronil. Human Health Assessment Scoping Document in Support of Registration Review. EPA-HQ-OPP-2011-0448-0004. DP No. D387318. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticide in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. A-407 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Fluconazole CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Fluconazole CASRN: 86386-73-4 DTXSID: DTXSID3020627 Use: Antifungal Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA Human Neurotoxicants PubMed Neu rotoxica nts X Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANTSUMMARY& DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 7 non-cancer effects 9 3 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date SL 1 lowest therapeutic dose: treatment of va gi na 1 ca nd id ias is (va gi na 1 yeast i nfect io ns due to Candida), oropharyngeal and esophageal candidiasis, cryptococcal meningitis bottle-fed infants FDA; NIH 2018; 2018 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.357 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-40 8 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Fluconazole CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.000208333 mg/kg/day FDA 2018; NIH 2018 Teva Pharmaceuticals USA, Inc. lowest therapeutic dose treatment of vaginal candidiasis (vaginal yeast infections due to Candida), oropharyngeal and esophageal candidiasis, cryptococcal meningitis bottle-fed infants 151 1.40 [77] [150] NOTE: (Lowest Therapeutic Dose/3000x UF) is used in place of an RfD; LTDs were obtained from FDA-approved drug labels Reference Dose (RfD) or Equivalent 0.000208333 mg/kg/day FDA 2018; NIH 2018 Teva Pharmaceuticals USA, Inc. lowest therapeutic dose treatment of vaginal candidiasis (vaginal yeast infections due to Candida), oropharyngeal and esophageal candidiasis, cryptococcal meningitis general population 33.8 4.90 [77] [150] NOTE: (Lowest Therapeutic Dose/3000x UF) is used in place of an RfD; LTDs were obtained from FDA-approved drug labels Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review 2020-01-28 5574 Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Screening level for pharmaceutical - general 0.004901961 mg/L EPA Office of Water population Screening level for pharmaceutical - infants 0.001388889 mg/L EPA Office of Water Data Element Value Units Source Notes Measured Data and Assessment Results Percent of active toxcast in 0.45 percent EPA Chemistry Dashboard vitro assays tested Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Modeled Data LD50 0.0021727 mo l/kg TEST QSAR Ames mutagenicity test 0.828 no units TEST QSAR Developmental toxin test TEST QSAR A-409 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Fluconazole CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contam nant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contam nant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contam nant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contam nant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contam nant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contam nant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 557 14 Sites 2.51 0.00139 0.025 0.357 0.482 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 75 12 Sites 16 0.00139 0.025 0.395 0.482 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 482 2 Sites 0.41 0.00501 0.0895 0.14 0.174 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Glassmeyer et al 2017 (Finished) [86] 2007-2012 25 NA Sites 0 ug/L Ambient Water Prevalence Magnitude Glassmeyer et al 2017 (Ambient) [86] 2007-2012 25 NA Sites 4 0.0337 0.03367 ug/L Bradley et al. 2017 (Ambient) [52] 2012-2014 38 14 Sites 37 0.0053864 0.108 0.196 0.2324315 ug/L Bexfieid et al. 2019 (Groundwater) [49] 2013 - 2015 1,106 1 Sites 0.09 0.0507747 0.0508 0.0508 0.0507747 ug/L Waste Water Effluent Prevalence Magnitude Scott et al. 2018 (Wastewater) [161] 2011 - 2017 21 21 Sites 100 0.0700863 0.146 0.497 555 ug/L Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/ day) Notes Expocast exposure 0.000000221 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 4.46378 days Boiling point OPERA QSAR 293.089 degree C Boiling point TEST QSAR 408.078 degree C Vapor pressure OPERA QSAR 2.39E-09 mmHg Vapor pressure TEST QSAR 2.99E-08 mmHg Solubility in water OPERA QSAR 0.0101826 mol/L Solubility in water TEST QSAR 0.00134586 mol/L Bioconcentration factor OPERA QSAR 6.95881 no units Bioconcentration factor TEST QSAR 20.797 no units Henry's Law constant OPERA QSAR 7.12E-09 o E E 0 eta no l/water partitioning coeff. (log Kow) OPERA QSAR 0.62128 no units A-410 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Fluconazole CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 49 Bexfield, L.M., P.L. Toccalino, K. Belitz, W.T. Foreman, and E.T. Furlong. 2019. Hormones and pharmaceuticals in groundwater used as a source of drinking water across the United States. Environmental Science and Technology 53: 2950-2960. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 77 FDA. 2018. Drugs @ FDA: FDA Approved Drug Products. U.S. Food and Drug Administration (FDA), https://www.accessdata.fda.gov/scripts/cder/daf/. 86 Glassmeyer, S.T., Furlong, E.T., Kolpin, D.W., Batt, A.L., Benson, R., Boone, J.S.,... & Wilson, V.S. (2017). Nationwide reconnaissance of contaminants of emerging concern in source and treated drinking waters of the United States. Science of The Total Environment. v581-582, (909-922). 150 NIH. 2018. DailyMed Database. U.S. National Library of Medicine, National Institutes of Health (NIH). https://dailymed.nlm.nih.gov/dailymed/. 161 Scott, T. M., Phillips, P. J., Kolpin, D. W., Colella, K. M., Furlong, E. T., Foreman, W. T., & Gray, J. L. (2018). Pharmaceutical manufacturing facility discharges can substantially increase the pharmaceutical load to US wastewaters. Science of the Total Environment, 636, 69-79. A-411 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Flufenacet CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Flufenacet CASRN: 142459-58-3 DTXSID: DTXSID2032552 Use: Preemergent herbicide Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 6 reproductive and developmental effects 8 3 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value («"gA) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 2 decreased pup body weight, delayed eye opening, delayed preputial separation, decreased caudate putamen size bottle-fed infants OPP 2015 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.228 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-412 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Flufenacet CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.0017 mg/kg/day OPP 2015 Hoberman 2000 decreased pup body weight, delayed eye opening, delayed preputial separation, decreased caudate putamen size bottle-fed infants 151 2.25 [345] Cancer Classification (CC) NL OPP 2015 [3451 Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Acute Human Health Benchmark 0.011 mg/L EPA HHBP Acute PAD 0.0017 mg/kg/day EPA HHBP Chronic Human Health Benchmark 0.011 mg/L EPA HHBP Health-Based Screening Level 0.011 mg/L Health-based screening levels from USGS Population-Adjusted Dose (PAD) 0.0017 mg/kg/day EPAHHBP Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element I Value I Units I Source I Notes Measured Data and Assessment Results LD50 2347 mg/kg NIH HSDB max LD50 371 mg/kg NIH HSDB min LOAEL 1.2 mg/kg/day EPA Toxicity Reference Database min LOAEL 1000 mg/kg/day EPA Toxicity Reference Database max NOAEL 1.29 mg/kg/day EPA Toxicity Reference Database min NOAEL 25 mg/kg/day EPA Toxicity Reference Database max Percent of active toxcast in vitro assays tested 12.4 percent EPA Chemistry Dashboard Subchronic LOAEL 6 mg/kg/day EPA Toxicity Reference Database min Subchronic LOAEL 64.199997 mg/kg/day EPA Toxicity Reference Database max Subchronic NOAEL 1.7 mg/kg/day EPA Toxicity Reference Database min Subchronic NOAEL 24.5 mg/kg/day EPA Toxicity Reference Database max Data Element Value Units Source Notes Modeled Data LD50 0.0039995 mo l/kg TEST QSAR Ames mutagenicity test 0.556 no units TEST QSAR Developmental toxin test 0.742 no units TEST QSAR A-413 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Flufenacet CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contam nant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contam nant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contam nant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contam nant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contam nant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contam nant Monito ring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev(NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 973 15 Sites 1.54 0.02 0.03 0.228 0.44 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 69 12 Sites 17 0.02 0.03 0.252 0.44 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 904 3 Sites 0.33 0.02 0.04 0.047 0.05 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) 14 115,383 2016 Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude USDA Pesticide Data Program (PDP) (Finished) 2001-2013 4 1 Sites 25 0.075 0.075 0.075 0.075 ug/L Ambient Water Prevalence Magnitude National Water Information System (USGS NWIS) (Surface Water) 2008-2017 113 3 Sites 2.65 0.02 0.03 0.065 0.08 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008-2017 342 0 Sites 0 National Water Information System (USGS NWIS) (All Water) 2008-2017 455 3 Sites 0.66 0.02 0.03 0.065 0.08 ug/L USDA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001-2013 4 0 Sites 0 USDA Pesticide Data Program (PDP) (Untreated) 2001-2013 4 0 Sites 0 Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 0.00000012 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 3.53831 days Boiling point OPERA QSAR 350.468 degree C Boiling point TEST QSAR 362.085 degree C Vapor pressure OPERA QSAR 0.000000773 mmHg Vapor pressure TEST QSAR 0.000000151 mmHg Solubility in water OPERA QSAR 0.000125919 mol/L Solubility in water TEST QSAR 0.0000364 mol/L Bioconcentration factor OPERA QSAR 10.967 no units Bioconcentration factor TEST QSAR 51.9996 no units Henry's Law constant OPERA QSAR 7.92E-09 atm-mA3/mol 0 eta no 1/water partitioning coeff. (log Kow) OPERA QSAR 3.14459 no units A-414 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Flufenacet CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 345 USEPA. 2015. Flufenacet: Fluman Flealth Draft Risk Assessment for Registration Review. EPA HQ-OPP-2010-0863-0017. DP No. D416546. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. A-415 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Fluometuron CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Chemical Notes: DTXSID8020628 Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANTSUMMARY& DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 4 carcinogen with linear MOA 9 4 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 2 combined adenomas/carcinomas in the lung of males and malignant lymphocytic lymphomas in females general population OPP 2016 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 1.116 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-416 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Fluometuron CCL 5 Contaminant Information Sheet EPA-OGWDWand OST October 2022 HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.005 mg/kg/day OPP 2016 Burdock et al. 1982 decreased body weight gain, increased splenic hemosiderin pigment deposition general population 33.8 29.6 [367] Cancer Slope Factor (CSF) 0.018 (mg/kg/day)A-l OPP 2016 Burdocket al. 1982 combined adenomas/carcinomas in the lung of males and malignant lymphocytic lymphomas in females general population 33.8 1.64 [367] Cancer Classification (CC) C OPP 2016 [367] Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results 10-day Health Advisory 2 mg/L EPA DWSHA 2018 Cancer Classification (CC) 3 no units WHO IARC Lifetime Health Advisory 0.09 mg/L EPA DWSHA 2018 Cancer Classification (CC) Female.Mice N no units HHSNTP Cancer Classification (CC) Female.Rats N no units HHSNTP Cancer Classification (CC) Male.Mice E no units HHSNTP Cancer Classification (CC) Male.Rats N no units HHSNTP Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Modeled Data LD50 0.0031915 mo l/kg TEST QSAR Ames mutagenicity test 0.047 no units TEST QSAR Developmental toxin test 0.851 no units TEST QSAR Data Element I Value I Units I Source I Notes Measured Data and Assessment Results LD50 6416 mg/kg NIH HSDB max LD50 810 mg/kg NIH HSDB min LOAEL 100 mg/kg/day EPA Toxicity Reference Database min LOAEL 260.20001 mg/kg/day EPA Toxicity Reference Database max NOAEL 10 mg/kg/day EPA Toxicity Reference Database min NOAEL 83.9 mg/kg/day EPA Toxicity Reference Database max Percent of active toxcast in vitro assays tested 3.04 percent EPA Chemistry Dashboard TD50 1420 mg/kg/day NIH CPDB max TD50 55.4 mg/kg/day NIH CPDB min A-417 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Fluometuron CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev(NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 7.813 242 Sites 3.1 0.00011 0.07 1.12 31.5 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 1.222 136 Sites 11 0.00011 0.06 1.09 31.5 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 6.591 106 Sites 1.61 0.00035 0.17 1.27 2.26 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) 15 1,023,468 2016 Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Finished) 2006 - 2020 3 0 Sites 0 USDA Pesticide Data Program (PDP) (Finished) 2001-2013 15 6 Sites 40 0.001998 0.007 0.007 0.042 ug/L Ambient Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Source) 2006 - 2020 24 0 Sites 0 National Water information System (USGS NWIS) (Surface Water) 2008-2017 495 26 Sites 5.25 0.00424 0.03 0.108 0.79 ug/L National Water information System (USGS NWIS) (Groundwater) 2008-2017 1,249 14 Sites 1.12 0.00938 0.106 0.316 2.71 ug/L National Water Information System (USGS NWIS) (All Water) 2008-2017 1,744 40 Sites 2.29 0.00424 0.04 0.27 2.71 ug/L USDA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001-2013 227 14 Sites 6.17 0.001998 0.007 0.083 0.229 ug/L USDA Pesticide Data Program (PDP) (Groundwater) 2001-2013 219 8 Sites 3.65 0.006993 0.083 0.22 0.229 ug/L USDA Pesticide Data Program (PDP) (Untreated) 2001-2013 10 6 Sites 60 0.001998 0.007 0.007 0.1 ug/L Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990-2018 393 1 Sites 0.25 3 3 3 3 ug/L Bradley et al. 2017 (Ambient) [52] 2012-2014 38 3 Sites 7.89 0.0086 0.014 0.0168 0.0175 ug/L Arnold et al. 2016 (Filtered) [7] 2012-2013 690 7 Sites 1.01 3e-04 0.0011 0.0315 0.0514 ug/L USGS, McKenzie River, Oregon, 2012 (Ambient) [158] 2002-2010 126 2 Samples 1.6 0.02 ug/L Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 7.92E-08 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 4.65653 days Boiling point OPERA QSAR 302.918 degree C Boiling point TEST QSAR 280.864 degree C Vapor pressure OPERA QSAR 0.00000113 mmHg Vapor pressure TEST QSAR 0.000000807 mmHg Solubility in water OPERA QSAR 0.000355964 mol/L Solubility in water TEST QSAR 0.000616595 mol/L Bioconcentration factor OPERA QSAR 10.1821 no units Bioconcentration factor TEST QSAR 28.774 no units Henry's Law constant OPERA QSAR 8.44E-09 atm-mA3/mol 0 eta no 1/water partitioning coeff. (log Kow) OPERA QSAR 2.43892 no units A-418 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Fluometuron CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 158 Reconnaissance of Land-Use Sources of Pesticides in Drinking Water, McKenzie River, Oregon. U.S. Geological Survey Scientific Investigations Report 2012-5091, 46 p. plus appendixes. 367 USEPA. 2016. Fluometuron. Human Health Assessment Scoping Document in Support of Registration Review. EPA-HQ-OPP-2015-0746-0009. DP No. D430248; D391415. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticide in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. A-419 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Fluoranthene CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Fluoranthene CASRN: 206-44-0 DTXSID: DTXSID3024104 Use: Poly eye lie aromatic hydrocarbon; occurs as a result of incomplete burning Chemical Notes: Is the contaminant on any lists? CERCLA X FIFRA Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANTSUMMARY& DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 5 non-cancer effects 9 2 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 200 nephropathy, increased liver weights, hematological alterations, and clinical effects general population IRIS 1990 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.056 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-420 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Fluoranthene CCL 5 Contaminant Information Sheet EPA-OGWDWand OST October 2022 HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.04 mg/kg/day IRIS 1990 USE PA 1988 nephropathy, increased liverweights, hematological alterations, and clinical effects general population 33.8 237 [207] Reference Dose (RfD) or Equivalent 0.0125 mg/kg/day WHO 2003 USE PA 1988 nephropathy, increased liverweights, hematological alterations, and clinical effects general population 33.8 74.0 [438] Cancer Classification (CC) 1 PPRTV 2012 [327] Cancer Classification (CC) D IRIS 1990 [207] ATSDR1995 [10] Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review 2011-12-01 2020-03-13 818 0 7 Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Cancer Classification (CC) 3 no units WHO IARC Chronic Health-Based Guidance Value 0.3 mg/L MN DOH Chronic Health-Based Guidance Value 0.07 mg/L MN DOH Human Health Ambient Water Quality Criteria 0.02 mg/L EPA Human Health Criteria for CWA intermediate Minimal Risk Level (MRL) 0.4 mg/kg/day CDC ATSDR Short-Term/Subchronic Health-Based Guidance Value 0.1 mg/L MN DOH Subchronic Provisional RfD 0.1 mg/kg/day EPA PPRTV Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Measured Data and Assessment Results LD50 2000 mg/kg NIH HSDB Percent of active toxcast in 10.62 percent EPA Chemistry Dashboard vitro assays tested Data Element Value Units Source Notes Modeled Data LD50 0.0049091 mo l/kg TEST QSAR Ames mutagenicity test 0.836 no units TEST QSAR Developmental toxin test 0.74 no units TEST QSAR A-421 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Fluorantiiene CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 589 42 Sites 7.13 0.003 0.01 0.056 0.15 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 101 34 Sites 34 0.003 0.0105 0.064 0.15 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 488 8 Sites 1.64 0.005 0.01 0.0323 0.044 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Data Number of States Amount Released (lbs/year) Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Production Data Production Volume (lbs/year) Chemical Data Reporting (CDR) Results (EPA) (2016) 500K-1M Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Finished) 2006 - 2020 20 1 Sites 5 0.002 0.002 0.002 0.002 ug/L Drinking Water Monitoring Data - WA (Finished) 2006-2011 481 0 Sites 0 Glassmeyer et al 2017 (Finished) [86] 2007-2012 25 NA Sites 0 ug/L USGS, Sioux Falls Area, 2012 (Finished) [153] 2009-2010 1 0 Sites 0 Ambient Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Source) 2006 - 2020 90 1 Sites 1.11 0.034 0.034 0.034 0.034 ug/L Drinking Water Monitoring Data - WA (Source) 2006-2011 634 0 Sites 0 National Water Information System (USGS NWIS) (Surface Water) 2008-2017 865 283 Sites 33 0.002 0.03 0.425 25.6 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008-2017 1,096 62 Sites 5.66 0.003 0.02 0.195 6 ug/L National Water Information System (USGS NWIS) (All Water) 2008-2017 1,961 345 Sites 18 0.002 0.03 0.41 25.6 ug/L Glassmeyer et a 1 2017 (Ambient) [86] 2007 - 2012 25 NA Sites 0 ug/L Bradley et al. 2017 (Ambient) [52] 2012 - 2014 38 15 Sites 39 0.0045 0.0122 0.0339 0.0564 ug/L USGS, Sioux Falls Area, 2012 (Ambient) [153] 2009 - 2010 2 0 Sites 0 Waste Water Effluent Prevalence Magnitude Scott et al. 2018 (Wastewater) [161] 2011 - 2017 21 5 Sites 24 Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 0.000000955 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR4 data used in the CCL5 is a partial datasetand will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 162.696 days Boiling point OPERA QSAR 392.038 degree C Boiling point TEST QSAR 378.496 degree C Vapor pressure OPERA QSAR 0.00000386 mmHg Vapor pressure TEST QSAR 0.000000371 mmHg Solubility in water OPERA QSAR 0.000000668 mol/L Solubility in water TEST QSAR 0.000000318 mol/L Bioconcentration factor OPERA QSAR 2457.49 no units Bioconcentration factor TEST QSAR 480.839 no units Henry's Law constant OPERA QSAR 0.0000109 o E E 0 eta no l/water partitioning coeff. (log Kow) OPERA QSAR 5.17848 no units A-422 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Fluoranthene CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 10 ATSDR. 1995. Toxicological Profile for Polycyclic Aromatic Hydrocarbons. U.S. Department of Health and Human Services, Public Health Service, Agency for Toxic Substances and Disease Registry (ATSDR), Atlanta, GA. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 86 Glassmeyer, S.T., Furlong, E.T., Kolpin, D.W., Batt, A.L., Benson, R., Boone, J.S.,... & Wilson, V.S. (2017). Nationwide reconnaissance of contaminants of emerging concern in source and treated drinking waters of the United States. Science of The Total Environment. v581-582, (909-922). 153 Occurrence of anthropogenic organic compounds and nutrients in source and finished water in the Sioux Falls area, South Dakota, 2009-10: U.S. Geological Survey Scientific Investigations Report 2012-5098, 21 p. plus appendixes. 161 Scott, T. M., Phillips, P. J., Kolpin, D. W., Colella, K. M., Furlong, E. T., Foreman, W. T., & Gray, J. L. (2018). Pharmaceutical manufacturing facility discharges can substantially increase the pharmaceutical load to US wastewaters. Science of the Total Environment, 636, 69-79. 207 USEPA. 1990. Chemical Assessment Summary, Fluoranthene. U.S. Environmental Protection Agency, National Center for Environmental Assessment, Integrated Risk Information System (IRIS), Washington, D.C. 327 USEPA. 2012. Provisional Peer-Reviewed Toxicity Values for Fluoranthene. U.S. Environmental Protection Agency, Office of Research and Development, National Center for Environmental Assessment, Superfund Health Risk Technical Support Center, Cincinnati, OH. 438 WHO. 2003. Guidelines for Drinking Water Quality: Polynyclear Aromatic Hydrocarbons (PAHs). World Health Organization (WHO), Geneva, Switzerland. A-423 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Fluoxetine CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Chemical Notes: DTXSID7023067 Is the contaminant on any lists? CERCLA FIFRA Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 X CONTAMINANT SUMMARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 7 non-cancer effects 5 2 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date SL 0.6 lowest therapeutic dose: treatment of major depressive disorder/bulimia nervosa/OCD/Panic disorder bottle-fed infants FDA; NIH 2018; 2018 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.014322 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-424 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Fluoxetine CCL 5 Contaminant Information Sheet EPA-OGWDWand OST October 2022 HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 8.33333E-05 mg/kg/day FDA 2018; NIH 2018 McKesson Packaging Services Business Unit of McKesson Corporation lowest therapeutic dose: treatment of major depressive disorder/bulimia nervosa/OCD/Panic disorder bottle-fed infants 151 0.560 [77] [150] NOTE: (Lowest Therapeutic Dose/3000x UF) is used in place of an RfD; LTDs were obtained from FDA-approved drug labels Reference Dose (RfD) or Equivalent 8.33333E-05 mg/kg/day FDA 2018; NIH 2018 McKesson Packaging Services Business Unit of McKesson Corporation lowest therapeutic dose: treatment of major depressive disorder/bulimia nervosa/OCD/Panic disorder general population 33.8 2.00 [77] [150] NOTE: (Lowest Therapeutic Dose/3000x UF) is used in place of an RfD; LTDs were obtained from FDA-approved drug labels Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Maximum Recommended Daily Dose 1.33 mg/kg/day FDA Screening level for pharmaceutical - general population 0.001960784 mg/L EPA Office of Water Screening level for pharmaceutical - infants 0.000555556 mg/L EPA Office of Water Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Measured Data and Assessment Results Percent of active toxcast in 34.04 percent EPA Chemistry Dashboard vitro assavs tested Data Element Value Units Source Notes Modeled Data LD50 0.0034514 mo l/kg TEST QSAR Ames mutagenicity test 0.158 no units TEST QSAR Developmental toxin test 0.795 no units TEST QSAR A-425 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Fluoxetine CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST October 2022 Nationally Representative Water Data Date Number of Number of PWS/ Sites/ Percent with Minimum Cone. Median Cone. 90th Percentile Maximum Cone. Cone. Units Notes PWS/ Sites/ Detects Samples Detects (Detects) (Detects) (Detects) (Detects) Finished Water Prevalen ce Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013 -2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001-2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988-1992 National Inorganics and Radionuclides Survey (NIRS) 1984-1986 Ambient Water Prevalen ce Magnitude National Water Quality Assessment (USGS NAWQA) (All Water 1991 -2017 557 3 Sites 0.54 0.00585 0.00784 0.0143 0.0171 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991 -2017 75 2 Sites 2.67 0.00585 0.00684 0.00744 0.00784 National Water Quality Assessment (USGS NAWQA) (Ground Water 1991 -2017 482 1 Sites 0.21 0.0171 0.0171 0.0171 0.0171 Pesticide Application Data Number of States Amount Applied Date Toxic Re ease Data Number of Amount Released Chemical Production Data Production Volume (lbs/year) (lbs/year) States (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-National ly Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Furlong etal 2017 (Finished) [83] 2007 -2012 NA NA Sites 0 ug/L Glassmeyer et al 2017 (Finished) [86] 2007 -2012 9 NA Sites 0 ug/L Padhye etal. 2013 (Finished) [155] 2009 -2010 8 1 Samples 12 0 0 1.92e-05 +/- 7e- 07 ug/L IL EPA (2008) via Uslu et al. (2013) (Finished) [433] 2008 NA NA 0.001 ug/L Ambient Water Prevalen ce Magnitude National Water Information System (USGS NWIS) (Surface Water) 2008-2017 206 4 S tes 1.94 0.002 0.0522 0.0896 0.169 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008-2017 401 0 S tes 0 National Water Information System (USGS NWIS) (All Water) 2008-2017 607 4 S tes 0.66 0.002 0.0522 0.0896 0.169 ug/L Furlong etal 2017 (Ambient) [83] 2007 -2012 NA NA S tes 0 ug/L Glassmeyer et al 2017 (Ambient) [86] 2007 -2012 9 NA S tes 11 0.00053 0.00053 ug/L Batt etal. 2016 (Ambient) [46] 2008 - 2009 182 10 S tes 5.49 9e-04 0.00465 0.0133 0.0248 ug/L Bradley et al. 2017 (Ambient) [52] 2012 - 2014 38 3 S tes 7.89 0.0065174 0.0136 0.0224 0.0246002 ug/L Bexfield et al. 2019 (Groundwater) [49] 2013 - 2015 1,106 1 S tes 0.09 0.0170815 0.0171 0.0171 0.0170815 ug/L Padhye et al. 2013 (Ambient) [155] 2009 - 2010 8 3 Samples 38 0 0 9e-07 +/- le-07 ug/L Rahman et al. (2010) via Uslu et al. (2013) (Ambient) [433] 2010 NA NA 0.0475 ug/L IL EPA (2008) via Uslu et al. (2013) (Ambient) [433] 2008 NA NA 0.002 ug/L Barnes et al. (2008) via Kostich et al. 2010 (Ambient) [127] 2010 NA NA 0.056 ug/L Benotti et al. (2009) via Kostich et al. 2010 (Ambient) [127] 2010 NA NA 0.0033 ug/L Con ley et al. (2008) via Kostich et al. 2010 (Ambient) [127] 2010 NA NA 0.01 ug/L Kolpin et al. (2002) via Kostich et al. 2010 (Ambient) [127] 2010 NA NA 0.012 ug/L Vanderford et al. (2003) via Kostich et al. 2010 (Ambient) [127] 2010 NA NA 0.0055 ug/L Vanderford et al. (2006) via Kostich et al. 2010 (Ambient) [127] 2010 NA NA 0.0026 ug/L W/oste Water Effluent Prevalence Magnitude Scott et al. 2018 (Wastewater) [161] 2011 - 2017 21 13 Sites 62 0.0025456 0.01 0.0333 0.0432505 ug/L Kostich etal. 2014(Wastewater) [126] not reported 48 18 Sites 38 0.0032 0.0199 0.0272 0.0312 ug/L Batt etal. (2008) via Kostich etal. 2010 (Wastewater) [127] 2010 NA NA 0.073 ug/L Glassmeyer et al. (2005) via Kostich et al. 2010 (Wastewater) [127] 2010 NA NA 0.021 ug/L Shultz et al. (2008) via Kostich et al. 2010 (Wastewater) [127] 2010 NA NA 0.07 ug/L Vanderford et al. (2006) via Kostich et al. 2010 (Wastewater) [127 2010 NA NA 0.025 ug/L Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg-bw/day) Notes Expocast exposure 3.67 E-08 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 3.54542 days Boiling point OPERA QSAR 316.438 degree C Boiling point TEST QSAR 343.305 degree C Vapor pressure OPERA QSAR 0.000000398 mmHg Vapor pressure TEST QSAR 0.00000143 mmHg Solubility in water OPERA QSAR 0.0000392 mol/L Solubility in water TEST QSAR 0.0000237 mol/L Bioconcentration factor OPERA QSAR 125.272 no units Bioconcentration factor TEST QSAR 171.791 no units Henry's Law constant OPERA QSAR 0.000000144 atm-mA3/mol Octanol/water partitioning coeff. (log Kow) OPERA QSAR 4.13029 no units A-426 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Fluoxetine CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 46 Batt, A. L., Kincaid, T. M., Kostich, M. S., Lazorchak, J. M., & Olsen, A. R. (2016). Evaluating the extent of pharmaceuticals in surface waters of the United States using a Nationaicale Rivers and Streams Assessment survey. Environmental toxicology and chemistry, 35(4), 874-881. 49 Bexfield, L.M., P.L. Toccalino, K. Belitz, W.T. Foreman, and E.T. Furlong. 2019. Hormones and pharmaceuticals in groundwater used as a source of drinking water across the United States. Environmental Science and Technology 53: 2950-2960. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 77 FDA. 2018. Drugs @ FDA: FDA Approved Drug Products. U.S. Food and Drug Administration (FDA), https://www.accessdata.fda.gov/scripts/cder/daf/. 83 Furlong, E.T., Batt, A.L., Glassmeyer, S.T., Noriega, M.C., Kolpin, D.W., Mash, H., Schenck, K.M. (2017). Nationwide reconnaissance of contaminants of emerging concern in source and treated drinking waters of the United States: Pharmaceuticals. Science of The Total Environment. 579 (1629-1642). 86 Glassmeyer, S.T., Furlong, E.T., Kolpin, D.W., Batt, A.L., Benson, R., Boone, J.S.,... & Wilson, V.S. (2017). Nationwide reconnaissance of contaminants of emerging concern in source and treated drinking waters of the United States. Science of The Total Environment. v581-582, (909-922). 126 Kostich MS, et al. 2014 Concentrations of prioritized pharmaceuticals in effluents from 50 large wastewater treatment plants in the US and implications for risk estimation. Environ Pollut. 2014 Jan;184:354-9. doi: 10.1016/j.envpol.2013.09.013. Epub 2013 Oct 3. PMID: 24095705. 127 Kostich, MS, etal., 2010. Predicting variability of aquatic concentrations of human pharmaceuticals. Sci. Total Environ. 408 (20), 4504e4510. 150 NIH. 2018. DailyMed Database. U.S. National Library of Medicine, National Institutes of Health (NIH). https://dailymed.nlm.nih.gov/dailymed/. 155 Padhye, L.P., Yao, H., Kung'u, F.T., and Huang, C.H. Year-long evaluation on the occurrence and fate of pharmaceuticals, personal care products, and endocrine disrupting chemicals in an urban drinking water treatment plant. 2014. Water Research 51 (2014) 266-276. 161 Scott, T. M., Phillips, P. J., Kolpin, D. W., Colella, K. M., Furlong, E. T., Foreman, W. T., & Gray, J. L. (2018). Pharmaceutical manufacturing facility discharges can substantially increase the pharmaceutical load to US wastewaters. Science of the Total Environment, 636, 69-79. 433 Uslu, M., Jasim, S., Arvai, A., Bewtra, J. and Biswas, N., 2013. A Survey of Occurrence and Risk Assessment of Pharmaceutical Substances in the Great Lakes Basin. Ozone: Science & Engineering, 35(4), pp.249-262. A-427 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Galaxolide CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Galaxolide CASRN: 1222-05-5 DTXSID: DTXSID8027373 Use: Fragrance ingredient in perfumes, soaps, cosmetics, and detergents. Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Not List ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 3 no adverse effects 9 4 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date SL 20000 no adverse effects seen at highest dose general population ECHA 2011 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.18 90th Percentile All Ambient Water NAWQA 1991-2017 Final Hazard Quotient (HQ) 0.000009 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-42 8 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Galaxolide CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 3.8 mg/kg/day ECHA 2011 Api and Ford 1999 no adverse effects at the highest dose tested general population 33.8 22500 [71] NOTE: An ECHA Derived No Effect Level (DNEL) is used in place of the RfD Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Hepatic 5 Api, 1999 Respiratory, Reproductive, 150 Api, 1999 2020-04-06 385 2 0 2 Other Health Data Measured Data and Assessment Results Data Element Value Units Source Notes Measured Data and Assessment Results LD50 4640 mg/kg NIH HSDB Percent of active toxcast in 25 percent EPA Chemistry Dashboard vitro assays tested Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Modeled Data LD50 0.0032063 mo l/kg TEST QSAR Ames mutagenicity test -0.048 no units TEST QSAR Developmental toxin test 0.709 no units TEST QSAR A-429 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Galaxolide CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 OCCURRENCE DATA Scoring_Data_ Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 570 52 Sites 9.12 0.007 0.057 0.18 2.4 National Water Qua lity Assessment (USGS NAWQA) (Surface Water) 1991-2017 87 40 Sites 46 0.007 0.065 0.2 2.4 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 483 12 Sites 2.48 0.008 0.017 0.0484 0.081 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) 1M - 10M Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Glassmeyer et al 2017 (Finished) [86] 2007-2012 25 NA Sites 24 0.0365 0.061 ug/L USGS, Sioux Falls Area, 2012 (Finished) [153] 2009-2010 1 0 Sites 0 Ambient Water Prevalence Magnitude National Water Information System (USGS NWIS) (Surface Water) 2008-2017 717 279 Sites 39 0.005 0.04 0.23 4.6 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008 - 2017 692 38 Sites 5.49 0.004 0.0375 0.942 1.72 ug/L National Water Information System (USGS NWIS) (All Water) 2008-2017 1,409 317 Sites 22 0.004 0.04 0.256 4.6 ug/L Glassmeyer et al 2017 (Ambient) [86] 2007 - 2012 25 NA Sites 36 0.028 0.11 ug/L Bradley etal. 2017 (Ambient) [52] 2012 - 2014 38 20 Sites 53 0.0076 0.285 1.03 1.4 ug/L USGS, Sioux Falls Area, 2012 (Ambient) [153] 2009 - 2010 2 1 Sites 50 Waste Water Effluent Prevalence Magnitude Scott et al. 2018 (Wastewater) [161] 2011 - 2017 21 21 Sites 100 0.49 1.2 2 4.6 ug/L Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/ day) Notes Expocast exposure Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR4 data used in the CCL5 is a partial datasetand will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 28.8833 days Boiling point OPERA QSAR 323.86 degree C Boiling point TEST QSAR 312.099 degree C Vapor pressure OPERA QSAR 0.000374131 mmHg Vapor pressure TEST QSAR 0.000385478 mmHg Solubility in water OPERA QSAR 0.00000606 mol/L Solubility in water TEST QSAR 0.000015 mol/L Bioconcentration factor OPERA QSAR 788.097 no units Bioconcentration factor TEST QSAR 1667.25 no units Henry's Law constant OPERA QSAR 0.0000223 o E E Octanol/water partitioning coeff. (log Kow) OPERA QSAR 5.75078 no units A-430 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Galaxolide CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 71 ECHA. 2011. Registration Dossier: l,3,4,6,7,8-hexahydro-4,6,6,7,8,8-hexamethylindeno[5,6-c]pyran. European Chemicals Agency (ECHA), Helsinki, Finland, https://echa.europa.eu/registration-dossier/- /registered-dossier/14504/1. Accessed 03/03/2020 86 Glassmeyer, S.T., Furlong, E.T., Kolpin, D.W., Batt, A.L., Benson, R., Boone, J.S.,... & Wilson, V.S. (2017). Nationwide reconnaissance of contaminants of emerging concern in source and treated drinking waters of the United States. Science of The Total Environment. v581-582, (909-922). 153 Occurrence of anthropogenic organic compounds and nutrients in source and finished water in the Sioux Falls area, South Dakota, 2009-10: U.S. Geological Survey Scientific Investigations Report 2012-5098, 21 p. plus appendixes. 161 Scott, T. M., Phillips, P. J., Kolpin, D. W., Colella, K. M., Furlong, E. T., Foreman, W. T., & Gray, J. L. (2018). Pharmaceutical manufacturing facility discharges can substantially increase the pharmaceutical load to US wastewaters. Science of the Total Environment, 636, 69-79. A-431 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Gemfibrozil CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Gemfibrozil CASRN: 25812-30-0 DTXSID: DTXSID0020652 Use: a nt ihy pe rl i po prote i ne m ic Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA Human Neurotoxicants PubMed Neu rotoxica nts X Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Not List ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT IN FORMATION Potency Severity Prevalence Magnitude 6 non-cancer effects Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date SL 30 lowest therapeutic dose: lipid regulation (decreases VLDL, increases HDL cholesterol) bottle-fed infants FDA; NIH 2018; 2018 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.06654 90th Percentile Ambient Water Batt et al. 2016 Final Hazard Quotient (HQ) 0.0022 PUBLIC NOMINATION STATUS Public Nomination X PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-43 2 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Gemfibrozil CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.005 mg/kg/day FDA 2018; NIH 2018 Watson Laboratories, Inc. lowest therapeutic dose; lipid regulation (decreases VLDL, increases HDL cholesterol) bottle-fed infants 151 33.0 [77] [150] NOTE: (Lowest Therapeutic Dose/3000x UF) is used in place of an RfD; LTDs were obtained from FDA-approved drug labels Reference Dose (RfD) or Equivalent 0.005 mg/kg/day FDA 2018; NIH 2018 Watson Laboratories, Inc. lowest therapeutic dose; lipid regulation (decreases VLDL, increases HDL cholesterol) general population 33.8 120 [77] [150] NOTE: (Lowest Therapeutic Dose/3000x UF) is used in place of an RfD; LTDs were obtained from FDA-approved drug labels Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Cancer Classification (CC) 3 no units WHO IARC Maximum Recommended Daily Dose 20 mg/kg/day FDA Screening level for pharmaceutical - general 0.117647059 mg/L EPA Office of Water population Screening level for pharmaceutical - infants 0.033333333 mg/L EPA Office of Water Data Element Value Units Source Notes Measured Data and Assessment Results LD50 316 mg/kg NIH HSDB min LD50 479 mg/kg NIH HSDB max Percent of active toxcast in 2.56 percent EPA Chemistry Dashboard vitro assays tested Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Modeled Data LD50 0.001875 mo l/kg TEST QSAR Ames mutagenicity test 0.229 no units TEST QSAR Developmental toxin test 0.849 no units TEST QSAR A-433 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Gemfibrozil CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST October 2022 Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contam nant Monitoring Rule (UCMR) 4 2018 - 2019 Unregulated Contam nant Monitoring Rule (UCMR) 3 2013 - 2015 Unregulated Contam nant Monitoring Rule (UCMR) 2 2008 - 2010 Unregulated Contam nant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contam nant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contam nant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survey (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991 - 2017 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991 - 2017 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991 - 2017 Pesticide Application Data Number of States Amount Applied Date Toxic Release Data Number of States Amount Released Chemical Production Data Production Volume (lbs/year) (lbs/year) (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of Number of PWS/ Sites/ Percent with Minimum Cone. Median Cone. 90th Percentile Maximum Cone. Cone. Units Notes PWS/ Sites/ Detects Samples Detects (Detects) (Detects) (Detects) (Detects) Samples Finished Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Finished) 2006 - 2020 1 0 Sites 0 Glassmeyer et a 1 2017 (Finished) [86] 2007 - 2012 25 NA Sites 0 ug/L Kleywegt et al. (2011) via Uslu et al. (2013) (Finished) [433] 2011 NA NA 0.004 ug/L Tabe et al. (2009) via Uslu et al. (2013) (Finished) [433] 2009 NA NA 0.002 ug/L Kormos et al. (2007) via Uslu et al. (2013) (Finished) [433] 2007 NA NA 0.003 ug/L IL EPA (2008) via Uslu et al. (2013) (Finished) [433] 2008 NA NA 0.0106 ug/L Ambient Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Source) 2006 - 2020 2 0 Sites 0 Glassmeyer et a 1 2017 (Ambient) [86] 2007 - 2012 25 NA Sites 0 ug/L Batt et al. 2016 (Ambient) [46] 2008 - 2009 182 27 Sites 15 0.0051 0.0225 0.0665 0.1125 ug/L Kleywegt et al. (2011) via Uslu et al. (2013) (Ambient) [433] 2011 NA NA 0.009 ug/L Tabe et al. (2009) via Uslu et al. (2013) (Ambient) [433] 2009 NA NA 0.004 ug/L Kormos et al. (2007) via Uslu et a 1. (2013) (Ambient) [433] 2007 NA NA 0.006 ug/L IL EPA (2008) via Uslu et al. (2013) (Ambient) [433] 2008 NA NA 0.0174 ug/L Benotti et al. (2009) via Kostich et al. 2010 (Ambient) [127] 2010 NA NA 0.024 ug/L Conkle et al. (2008) via Kostich et al. 2010 (Ambient) [127] 2010 NA NA 0.081 ug/L Fono et al. (2006) via Kostich et al. 2010 (Ambient) [127] 2010 NA NA 0.079 ug/L Gross et al. (2004) via Kostich et al. 2010 (Ambient) [127] 2010 NA NA 0.18 ug/L Kolpin et al. (2002) via Kostich et al. 2010 (Ambient) [127] 2010 NA NA 0.79 ug/L Lin et al. (2006) via Kostich et al. 2010 (Ambient) [127] 2010 NA NA 0.065 ug/L Spongberget al. (2008) via Kostich et al. 2010 (Ambient) [127] 2010 NA NA 0.006 ug/L Trenholm et al. (2006) via Kostich et al. 2010 (Ambient) [127] 2010 NA NA 0.0048 ug/L Vanderford et al. (2003) via Kostich et al. 2010 (Ambient) [127] 2010 NA NA 0.056 ug/L Vanderford et al. (2006) via Kostich et al. 2010 (Ambient) [127] 2010 NA NA 0.17 ug/L A-434 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Waste Water Effluent Prevalence Magnitude Kostich et al. 2014 (Wastewater) [126] not reported 50 38 Sites 76 0.0908 0.506 1.4 2.3396 ug/L Batt et al. (2008) via Kostich et al. 2010 (Wastewater) [127] 2010 NA NA 1.22 ug/L Conkle et al. (2008) via Kostich et al. 2010 (Wastewater) [127] 2010 NA NA 1.819 ug/L Drewes et al. (2002) via Kostich et al. 2010 (Wastewater) [127] 2010 NA NA 1.235 ug/L Fono et al. (2006) via Kostich et al. 2010 (Wastewater) [127] 2010 NA NA 0.234 ug/L Gross et al. (2004) via Kostich et al. 2010 (Wastewater) [127] 2010 NA NA 0.158 ug/L Soliman et al. (2007) via Kostich et al. 2010 (Wastewater) [127] 2010 NA NA 0.5 ug/L Spongberget al. (2008) via Kostich et al. 2010 (Wastewater) [127] 2010 NA NA 0.451 ug/L Trenholm et al. (2006) via Kostich et al. 2010 (Wastewater) [127] 2010 NA NA 1.22 ug/L Vanderford et al. (2006) via Kostich et al. 2010 (Wastewater) [127] 2010 NA NA 4.77 ug/L Yu et al. (2006) via Kostich et al. 2010 (Wastewater) [127] 2010 NA NA 0.41 ug/L Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg- bw/day) Notes Expocast exposure 0.000000193 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR4data used in the CCL5 is a partial data set and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biode gradation ha If-life OPERA QSAR 3.52148 days Boiling point OPERA QSAR 326.707 degree C Boiling point TEST QSAR 349.352 degree C Vapor pressure OPERA QSAR 0.00000936 mmHg Vapor pressure TEST QSAR 0.00000172 mmHg Solubility in water OPERA QSAR 0.000247743 mol/L Solubility in water TEST QSAR 0.0000685 mol/L Bioconcentration factor OPERA QSAR 3.16534 no units Bioconcentration factor TEST QSAR 16.1065 no units Henry's Law constant OPERA QSAR 8.62 E-09 atm-mA3/mol Octanol/water partitioning coeff. (log Kow) OPERA QSAR 4.42964 no units A-435 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Gemfibrozil CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 46 Batt, A. L., Kincaid, T. M., Kostich, M. S., Lazorchak, J. M., & Olsen, A. R. (2016). Evaluating the extent of pharmaceuticals in surface waters of the United States using a Nationaicale Rivers and Streams Assessment survey. Environmental toxicology and chemistry, 35(4), 874-881. 77 FDA. 2018. Drugs @ FDA: FDA Approved Drug Products. U.S. Food and Drug Administration (FDA), https://www.accessdata.fda.gov/scripts/cder/daf/. 86 Glassmeyer, S.T., Furlong, E.T., Kolpin, D.W., Batt, A.L., Benson, R., Boone, J.S.,... & Wilson, V.S. (2017). Nationwide reconnaissance of contaminants of emerging concern in source and treated drinking waters of the United States. Science of The Total Environment. v581-582, (909-922). 126 Kostich MS, et al. 2014 Concentrations of prioritized pharmaceuticals in effluents from 50 large wastewater treatment plants in the US and implications for risk estimation. Environ Pollut. 2014 Jan;184:354-9. doi: 10.1016/j.envpol.2013.09.013. Epub 2013 Oct 3. PMID: 24095705. 127 Kostich, MS, etal., 2010. Predicting variability of aquatic concentrations of human pharmaceuticals. Sci. Total Environ. 408 (20), 4504e4510. 150 NIH. 2018. DailyMed Database. U.S. National Library of Medicine, National Institutes of Health (NIH). https://dailymed.nlm.nih.gov/dailymed/. 433 Uslu, M., Jasim, S., Arvai, A., Bewtra, J. and Biswas, N., 2013. A Survey of Occurrence and Risk Assessment of Pharmaceutical Substances in the Great Lakes Basin. Ozone: Science & Engineering, 35(4), pp.249-262. A-436 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Halon 1011 (bromochloromethane) CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Halon 1011 (bromochloromethane) CASRN: 74-97-5 DTXSID: DTXSID4021503 Use: Fire extinguishing flu id; chemical intermediate Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 9 5 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.3954 90th Percentile Finished Water UCMR3 2013-2015 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-437 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Halon 1011 (bromochloromethane) CCL 5 Contaminant Information Sheet EPA-OGWDWand OST October 2022 HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.013 mg/kg/day OW1989 Torkelson et al., 1960 increased liver to bodyweight ratio general population 33.8 76.9 [202] Cancer Classification (CC) D OW1989 [202] Cancer Classification (CC) D IRIS 1991 [210] Cancer Classification (CC) 1 PPRTV 2009 [302] Note: No toxicity values have been derived for bromochloromethane Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (ml/kg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review 2008-09-01 2020-04-14 6 0 0 Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results 10-day Health Advisory 1 mg/L EPA DWSHA 2018 Lifetime Health Advisory 0.09 mg/L EPA DWSHA 2018 Subchronic RfC 0.1 mg/mA3 EPA PPRTV Data Element Value Units Source Notes Measured Data and Assessment Results LD50 4300 mg/kg NIH HSDB min LD50 5000 mg/kg NIH HSDB max Percent of active toxcast in 0.85 percent EPA Chemistry Dashboard vitro assays tested Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Modeled Data LD50 0.0023878 mo l/kg TEST QSAR Ames mutagenicity test 0.69 no units TEST QSAR Developmental toxin test TEST QSAR A-438 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Halon 1011 (bromochloromethane) CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 4,916 309 Sites 6.29 0.06 0.11 0.395 5.17 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 22.974 106 Sites 0.46 0.0023 1 6 33.4 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 12.881 65 Sites 0.5 0.05 1 10 210 National Inorganics and Radionuclides Survev(NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 7.734 19 Sites 0.25 0.01 0.14 0.445 1.15 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 264 4 Sites 1.52 0.01 0.38 0.441 0.45 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 7.470 15 Sites 0.2 0.02 0.075 0.384 1.15 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Finished) 2006 - 2020 401 11 Sites 2.74 0.5 0.805 3.65 6 ug/L Drinking Water Monitoring Data - MA (Finished) 2006 - 2020 888 29 Sites 3.27 0.5 2.4 6.26 18 ug/L Drinking Water Monitoring Data - WA (Finished) 2006-2011 1,188 1 Sites 0.08 0.66 0.66 0.66 0.66 ug/L Bradley et al. 2018 (Finished) [53] 2016 26 1 Sites 3.85 0.07637 0.0764 0.0764 0.07637 ug/L Ambient Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Source) 2006 - 2020 4,242 23 Sites 0.54 0.4 1.15 3 8.9 ug/L Drinking Water Monitoring Data - MA (Source) 2006 - 2020 130 0 Sites 0 Drinking Water Monitoring Data - PA (Source) 2006-2011 13 0 Sites 0 Drinking Water Monitoring Data - WA (Source) 2006-2011 1,665 0 Sites 0 Drinking Water Monitoring Data - Wl (Source) 2012-2019 33 1 Sites 3.03 0.61 0.61 0.61 0.61 ug/L National Water information System (USGS NWIS) (Surface Water) 2008-2017 169 9 Sites 5.33 0.01 0.04 0.06 0.06 ug/L National Water information System (USGS NWIS) (Groundwater) 2008-2017 3,487 8 Sites 0.23 0.02 0.035 0.09 0.17 ug/L National Water information System (USGS NWIS) (All Water) 2008-2017 3,653 17 Sites 0.47 0.01 0.04 0.07 0.17 ug/L Bradley et al. 2017 (Ambient) [52] 2012-2014 38 5 Sites 13 0.02169 0.0357 0.0554 0.05931 ug/L Arnold et al. 2016 (Unfiltered) [7] 2012-2013 685 1 Sites 0.15 0.03 0.03 0.03 0.03 ug/L Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 4.55E-08 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 14.1519 days Boiling point OPERA QSAR 64.2952 degree C Boiling point TEST QSAR 66.832 degree C Vapor pressure OPERA QSAR 181.807 mmHg Vapor pressure TEST QSAR 231.206 mmHg Solubility in water OPERA QSAR 0.0723047 mol/L Solubility in water TEST QSAR 0.0625173 mol/L Bioconcentration factor OPERA QSAR 5.65089 no units Bioconcentration factor TEST QSAR 4.40555 no units Henry's Law constant OPERA QSAR 0.0038283 atm-mA3/mol 0 eta no 1/water partitioning coeff. (log Kow) OPERA QSAR 1.45955 no units A-439 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Halon 1011 (bromochloromethane) CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 53 Bradley, P. M., Kolpin, D. W., Romanok, K. M., Smalling, K. L., Focazio, M. J., Brown, J. B.,... & Dietze, J. E. (2018). Reconnaissance of mixed organic and inorganic chemicals in private and public supply tapwaters at selected residential and workplace sites in the United States. Environmental science & technology, 52(23), 13972-13985. 202 USEPA. 1989. Bromochloromethane Health Advisory. U.S. Environmental Protection Agency, Office of Water, Washington, D.C. 210 USEPA. 1991. Chemical Assessment Summary, Bromochloromethane. U.S. Environmental Protection Agency, National Center for Environmental Protection, Integrated Risk Information System (IRIS), Washington, D.C. 302 USEPA. 2009. Provisional Peer-Reviewed Toxicity Values for Bromochloromethane. U.S. Environmental Protection Agency, Office of Research and Development, National Center for Environmental Assessment, Superfund Health Risk Technical Support Center, Cincinnati, OH. A-440 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 HCFC-22 CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: HCFC-22 CASRN: 75-45-6 DTXSID: DTXSID6020301 Use: Refrigerant; low-temperature solvent; fluorocarbon resins, especially tetrafluoroethylene polymers; gas Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 9 5 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 1.2 90th Percentile Finished Water UCMR3 2013-2015 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-441 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 HCFC-22 CCL 5 Contaminant Information Sheet EPA-OGWDWand OST October 2022 HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes IRIS 1993 [221] NOTE: HCFC-22 is highly volitile. No oral toxicity values were derived. No PECO-re levant studies were found in the rapid systematic literature review. Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review 2002-08-01 2020-03-25 130 0 2 Other Health Data Data Element Value Units Source Notes Data Element Value Units Source Notes Measured Data and Assessment Results Measured Data and Assessment Results Cancer Classification (CC) 3 no units WHO IARC III 1 Reference Concentration (RfC) 50 mg/mA3 EPA IRIS Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Modeled Data LD50 TEST QSAR Ames mutagenicity test 0.574 no units TEST QSAR Developmental toxin test 0.57 no units TEST QSAR A-442 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 HCFC-22 CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 4,916 286 Sites 5.82 0.08 0.22 1.2 250 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev(NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 1.411 55 Sites 3.9 0.02 0.08 0.895 15.6 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 51 3 Sites 5.88 0.07 0.095 0.224 0.35 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 1.360 52 Sites 3.82 0.02 0.07 0.907 15.6 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) 23 1,908,568 Chemical Data Reporting (CDR) Results (EPA) (2016) 100 M - 250 M Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Bradley et al. 2018 (Finished) [53] 2016 26 1 Sites 3.85 0.04688 0.0469 0.0469 0.04688 ug/L Ambient Water Prevalence Magnitude National Water Information System (USGS NWIS) (Surface Water) 2008-2017 47 2 Sites 4.26 0.03 0.3 0.57 0.57 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008-2017 824 39 Sites 4.73 0.03 0.175 1.71 4.02 ug/L National Water Information System (USGS NWIS) (All Water) 2008-2017 871 41 Sites 4.71 0.03 0.175 1.71 4.02 ug/L Bradley et al. 2017 (Ambient) [52] 2012-2014 38 2 Sites 5.26 0.03401 0.301 0.515 0.5687 ug/L Arnold et al. 2016 (Unfiltered) [7] 2012-2013 527 11 Sites 2.09 0.02 0.08 0.18 0.56 ug/L Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 0.000000574 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 7.58302 days Boiling point OPERA QSAR -36.5186 degree C Boiling point TEST QSAR -10.361 degree C Vapor pressure OPERA QSAR 5705.02 mmHg Vapor pressure TEST QSAR 3273.41 mmHg Solubility in water OPERA QSAR 0.0211658 mol/L Solubility in water TEST QSAR 0.159221 mol/L Bioconcentration factor OPERA QSAR 10.1839 no units Bioconcentration factor TEST QSAR 4.19759 no units Henry's Law constant OPERA QSAR 0.0424827 atm-mA3/mol 0 eta no 1/water partitioning coeff. (log Kow) OPERA QSAR 1.00459 no units A-443 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 HCFC-22 CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 53 Bradley, P. M., Kolpin, D. W., Romanok, K. M., Smalling, K. L., Focazio, M. J., Brown, J. B.,... & Dietze, J. E. (2018). Reconnaissance of mixed organic and inorganic chemicals in private and public supply tapwaters at selected residential and workplace sites in the United States. Environmental science & technology, 52(23), 13972-13985. 221 USEPA. 1993. Chemical Assessment Summary, Chlorodifluoromethane. U.S. Environmental Protection Agency, National Center for Environmental Protection, Integrated Risk Information System (IRIS), Washington, D.C. A-444 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Heroin CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Heroin CASRN: 561-27-3 DTXSID: DTXSID6046761 Use: Addictive substance of abuse; used for the relief of severe pain, especially in terminal illness Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-445 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Heroin CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes NOTE: derivative of morphine; no health assessments found Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Measured Data and Assessment Results Data Element | Value | Units | Source I Notes Measured Data and Assessment Results Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Modeled Data LD50 TEST QSAR Ames mutagenicity test TEST QSAR Developmental toxin test TEST QSAR A-446 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Heroin CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contam nant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contam nant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contam nant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contam nant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contam nant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contam nant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev(NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Ambient Water Prevalence Magnitude Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. A-447 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Heroin CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference A-448 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Hexazinone CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Chemical Notes: DTXSID4024145 Post emergence contact herbicide Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 5 non-cancer effects 9 2 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 300 decreased body weight, hepatotoxicity (clinical chemical changes and microscopic general population OPP 2015 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.021 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-449 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Hexazinone CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.05 mg/kg/day OPP 2015 Dalgard 1991 decreased body weight, he pat otoxicity (clinical chemical changes and microscopic lesions) general population 33.8 296 [349] NOTE: Though this compound is listed as having a D cancer classification in the OPP assessment, the document also states: "Hexazinone is classified as "Likely at high doses, but unlikely to be carcinogenic to humans at low doses." Therefore, a cancer dietary exposure analysis is not required." Cancer Classification (CC) D OPP 2015 [349] NOTE: Though this compound is listed as having a D cancer classification in the OPP assessment, the document also states: "Hexazinone is classified as "Likely at high doses, but unlikely to be carcinogenic to humans at low doses." Therefore, a cancer dietary exposure analysis is not required." Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results 10-day Health Advisory 2 mg/L EPA DWSHA 2018 Lifetime Health Advisory 0.4 mg/L EPA DWSHA 2018 Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element | Value | Units | Source | Notes Measured Data and Assessment Results LD50 3400 mg/kg NIH HSDB max LD50 860 mg/kg NIH HSDB min LOAEL 37.57 mg/kg/day EPA Toxicity Reference Database min LOAEL 900 mg/kg/day EPA Toxicity Reference Database max NOAEL 400 mg/kg/day EPA Toxicity Reference Database max NOAEL 5 mg/kg/day EPA Toxicity Reference Database min Percent of active toxcast in vitro assays tested 1.26 percent EPA Chemistry Dashboard Sub chronic LOAEL 122.5 mg/kg/day EPA Toxicity Reference Database min Sub chronic LOAEL 440.39999 mg/kg/day EPA Toxicity Reference Database max Subchronic NOAEL 31.6 mg/kg/day EPA Toxicity Reference Database min Subchronic NOAEL 87.3 mg/kg/day EPA Toxicity Reference Database max Data Element Value Units Source Notes Modeled Data LD50 0.0074473 mol/kg TEST QSAR Ames mutagenicity test 0.624 no units TEST QSAR Developmentaltoxintest 1.093 no units TEST QSAR A-450 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Hexazinone CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev(NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 4,886 375 Sites 7.67 1.00E - 04 0.00382 0.021 1.23 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 582 211 Sites 36 1.00E - 04 0.00361 0.019 1.23 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 4.304 164 Sites 3.81 0.00015 0.01 0.0871 1.13 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) 27 483,326 2016 Toxic Release Inventory (TRI) Program (EPA) (2016) 3 1,574 Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Finished) 2006 - 2020 1 0 Sites 0 USDA Pesticide Data Program (PDP) (Finished) 2001-2013 10 3 Sites 30 8e-04 8e-04 0.0025 0.087 ug/L Bradley et al. 2018 (Finished) [53] 2016 26 2 Sites 7.69 0.0065 0.0076 0.00848 0.0087 ug/L USGS, Sioux Falls Area, 2012 (Finished) [153] 2009-2010 1 0 Sites 0 Ambient Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Source) 2006 - 2020 1 0 Sites 0 USDA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001-2013 227 17 Sites 7.49 8e-04 8e-04 0.0115 0.11 ug/L USDA Pesticide Data Program (PDP) (Groundwater) 2001-2013 218 14 Sites 6.42 8e-04 0.0046 0.0122 0.021 ug/L USDA Pesticide Data Program (PDP) (Untreated) 2001-2013 10 3 Sites 30 8e-04 8e-04 0.00425 0.11 ug/L Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990-2018 1,615 347 Sites 21 0.0036 0.025 0.128 35 ug/L Bradley et al. 2017 (Ambient) [52] 2012-2014 38 7 Sites 18 0.0029 0.0168 0.036 0.0466 ug/L Arnold et al. 2016 (Filtered) [7] 2012-2013 690 39 Sites 5.65 3e-04 0.0016 0.00666 0.0929 ug/L USGS, Sioux Falls Area, 2012 (Ambient) [153] 2009-2010 2 0 Sites 0 USGS, McKenzie River, Oregon, 2012 (Ambient) [158] 2002-2010 71 19 Samples 27 0.097 ug/L Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 7.69E-08 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 4.72279 days Boiling point OPERA QSAR 324.385 degree C Boiling point TEST QSAR Vapor pressure OPERA QSAR 0.00000035 mmHg Vapor pressure TEST QSAR 0.000000111 mmHg Solubility in water OPERA QSAR 0.0801096 mol/L Solubility in water TEST QSAR 0.00772681 mol/L Bioconcentration factor OPERA QSAR 2.40816 no units Bioconcentration factor TEST QSAR 5.98412 no units Henry's Law constant OPERA QSAR 0.000000166 atm-mA3/mol 0 eta no 1/water partitioning coeff. (log Kow) OPERA QSAR 1.76651 no units A-451 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Hexazinone CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 53 Bradley, P. M., Kolpin, D. W., Romanok, K. M., Smalling, K. L., Focazio, M. J., Brown, J. B.,... & Dietze, J. E. (2018). Reconnaissance of mixed organic and inorganic chemicals in private and public supply tapwaters at selected residential and workplace sites in the United States. Environmental science & technology, 52(23), 13972-13985. 153 Occurrence of anthropogenic organic compounds and nutrients in source and finished water in the Sioux Falls area, South Dakota, 2009-10: U.S. Geological Survey Scientific Investigations Report 2012-5098, 21 p. plus appendixes. 158 Reconnaissance of Land-Use Sources of Pesticides in Drinking Water, McKenzie River, Oregon. U.S. Geological Survey Scientific Investigations Report 2012-5091, 46 p. plus appendixes. 349 USEPA. 2015. Hexazinone: Draft Human Health Risk Assessment for Registration Review. EPA-HQ-OPP-2009-0755-0019. DP No. D424526. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticide in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. A-452 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Imazalil CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Imazalil CASRN: 35554-44-0 DTXSID: DTXSID8024151 Use: Fungicide Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Not List ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 4 carcinogen with linear MOA 10 4 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 0.5 hepatocytic neoplasm general population OPP 2018 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.0654 90th Percentile All Ambient Water NAWQA 1991-2017 Final Hazard Quotient (HQ) 013 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-45 3 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Imazalil CCL 5 Contaminant Information Sheet EPA-OGWDWand OST October 2022 HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.108 mg/kg/day OPP 2018 Van Deun 1999 reductions in body weight and weight gain and macro and microscopic effects in the liver (male and female) and thyroid (male) general population 33.8 639 [399] Cancer Slope Factor (CSF) 0.0611 (mg/kg/day)A-l OPP 2018 Verstraeten 1993 hepatocytic neoplasm general population 33.8 0.484 [399] Cancer Classification (CC) L OPP 2018 [399] Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Acute Human Health Benchmark 0.47 mg/L EPA HHBP Acute PAD 0.017 mg/kg/day EPA HHBP Cancer Slope Factor (CSF) 0.0611 (mg/kg/day)A-l EPA HHBP Chronic Human Health Benchmark 0.016 mg/L EPA HHBP Chronic Human Health Benchmark 0.000524 mg/L EPA HHBP Population-Adjusted Dose (PAD) 0.0025 mg/kg/day EPAHHBP Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Measured Data and Assessment Results LD50 227 mg/kg NIH HSDB min LD50 640 mg/kg NIH HSDB max LOAEL 120 mg/kg/day EPA Toxicity Reference Database max LOAEL 20 mg/kg/day EPA Toxicity Reference Database min NOAEL 2.5 mg/kg/day EPA Toxicity Reference Database min NOAEL 40 mg/kg/day EPA Toxicity Reference Database max Percent of active toxcast in 32.93 percent EPA Chemistry Dashboard vitro assays tested Subchronic LOAEL 20 mg/kg/day EPA Toxicity Reference Database min Subchronic LOAEL 37.900002 mg/kg/day EPA Toxicity Reference Database max Subchronic NOAEL 15 mg/kg/day EPA Toxicity Reference Database min Subchronic NOAEL 22.3 mg/kg/day EPA Toxicity Reference Database max Data Element Value Units Source Notes Modeled Data LD50 0.0028973 mo l/kg TEST QSAR Ames mutagenicity test 0.541 no units TEST QSAR Developmental toxin test 0.281 no units TEST QSAR A-454 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Imazalil CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 OCCURRENCE DATA Scoring_Data_ Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev(NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 14 2 Sites 14 0.0534 0.0609 0.0654 0.0684 National Water Qua lity Assessment (USGS NAWQA) (Surface Water) 1991-2017 14 2 Sites 14 0.0534 0.0609 0.0654 0.0684 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) 1 36,692 2016 Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude USDA Pesticide Data Program (PDP) (Finished) 2001-2013 2 0 Sites 0 Ambient Water Prevalence Magnitude National Water Information System (USGS NWIS) (Surface Water) 2008-2017 132 7 Sites 5.3 0.0116 0.0307 0.1 0.119 ug/L National Water information System (USGS NWIS) (Groundwater) 2008-2017 3 0 Sites 0 National Water information System (USGS NWIS) (All Water) 2008-2017 135 7 Sites 5.19 0.0116 0.0307 0.1 0.119 ug/L Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990-2018 191 12 Sites 6.28 0.0116 0.03 0.0965 0.1189 ug/L Bradley et al. 2017 (Ambient) [52] 2012-2014 38 3 Sites 7.89 0.0517 0.0521 0.221 0.2634 ug/L Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 1.65E-08 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 3.35613 days Boiling point OPERA QSAR 346.361 degree C Boiling point TEST QSAR 344.153 degree C Vapor pressure OPERA QSAR 0.00000235 mmHg Vapor pressure TEST QSAR 0.00000314 mmHg Solubility in water OPERA QSAR 0.000551691 mol/L Solubility in water TEST QSAR 0.000328095 mol/L Bioconcentration factor OPERA QSAR 35.0705 no units Bioconcentration factor TEST QSAR 168.655 no units Henry's Law constant OPERA QSAR 0.000000522 atm-mA3/mol 0 eta no 1/water partitioning coeff. (log Kow) OPERA QSAR 3.66695 no units A-455 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Imazalil CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 399 USEPA. 2018. Imazalil. Acute, Chronic, and Cancer Dietary (Food Only) Exposure and Risk Assessment in Support of the HED Draft Risk Assessment for Registration Review. E P A-HQ-OPP-2013-0305-0026 DP No. D446973. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticide in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. A-456 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Imazapyr CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Chemical Notes: DTXSID8034665 Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANTSUMMARY& DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT IN FORMATION Potency Severity Prevalence Magnitude 3 no adverse effects 4 6 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 10000 no adverse effects identified general population OPP 2006 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 79 EDWC SW 30-Year mean (chronic, non- cancer) OPP 2006 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-457 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Imazapyr CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 2.5 mg/kg/day OPP 2006 Shellenberger 1987 no effects identified at loael selected as pod general population 33.8 14800 [271] Cancer Classification (CC) E OPP 2006 [2711 Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Chronic Human Health Benchmark 16 mg/L EPA HHBP Health-Based Screening Level 16 mg/L Health-based screening levels from USGS Population-Adjusted Dose (PAD) 2.5 mg/kg/day EPAHHBP Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Measured Data and Assessment Results LD50 2000 mg/kg NIH HSDB min LD50 5000 mg/kg NIH HSDB max LOAEL 1000 mg/kg/day EPA Toxicity Reference Database NOAEL 300 mg/kg/day EPA Toxicity Reference Database Percent of active toxcast in vitro assays tested 1.48 percent EPA Chemistry Dashboard Data Element Value Units Source Notes Modeled Data LD50 0.0046026 mo l/kg TEST QSAR Ames mutagenicity test 0.624 no units TEST QSAR Developmental toxin test 0.879 no units TEST QSAR A-458 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Imazapyr CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 OCCURRENCE DATA Scoring_Data_ Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev(NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 National Water Qua lity Assessment (USGS NAWQA) (Surface Water) 1991-2017 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) 4 358,171 2016 Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude USDA Pesticide Data Program (PDP) (Finished) 2001-2013 15 9 Sites 60 0.001498 0.002 0.0097 0.2 ug/L Ambient Water Prevalence Magnitude National Water Information System (USGS NWIS) (Surface Water) 2008-2017 3 1 Sites 33 0.026 0.026 0.026 0.026 ug/L National Water Information System (USGS NWIS) (All Water) 2008-2017 3 1 Sites 33 0.026 0.026 0.026 0.026 ug/L USDA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001-2013 227 114 Sites 50 0.001498 0.0035 0.02 3.054 ug/L USDA Pesticide Data Program (PDP) (Groundwater) 2001-2013 219 107 Sites 49 0.0015 0.0149 0.131 3.054 ug/L USDA Pesticide Data Program (PDP) (Untreated) 2001 - 2013 10 8 Sites 80 0.001498 0.002 0.01 0.21 ug/L USGS, McKenzie River, Oregon, 2012 (Ambient) [158] 2002 - 2010 52 7 Samples 14 0.209 ug/L Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Estimated Drinking Water Concentration (EDWC) in Surface Water, 30-Year Mean (chronic, non-cancer) 2006 OPP 79 ug/L Tier 1 FQPA Index Reservoir Screening Tool (FIRST) The modeled surface water chronic, non-cancer concentration provided by the most recent available EPA OPP health assessment was selected as the occurrence concentration for imazapyr. This value coincides with the chronic health effects data which report Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg Notes Expocast exposure 9.23E-08 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR4 data used in the CCL5 is a partial datasetand will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 3.33907 days Boiling point OPERA QSAR 276.309 degree C Boiling point TEST QSAR Vapor pressure OPERA QSAR 1.73E-10 mmHg Vapor pressure TEST QSAR 1.43E-08 mmHg Solubility in water OPERA QSAR 0.0301436 mol/L Solubility in water TEST QSAR 0.0043451 mol/L Bioconcentration factor OPERA QSAR 5.19409 no units Bioconcentration factor TEST QSAR 1.93197 no units Henry's Law constant OPERA QSAR 3.08E-10 atm-mA3/mol Octanol/water partitioning coeff. (log Kow) OPERA QSAR 0.4738 no units A-459 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Imazapyr CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 158 Reconnaissance of Land-Use Sources of Pesticides in Drinking Water, McKenzie River, Oregon. U.S. Geological Survey Scientific Investigations Report 2012-5091, 46 p. plus appendixes. 271 USEPA. 2006. Reregistration Eligibility Decision for Imazapyr. EPA-HQ-OPP-2005-0495-0031. OPP-2005-0495. U.S. Environmental Protection Agency, Office of Prevention, Pesticides and Toxic Substances, Washington, D.C. A-460 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Imazaquin CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Imazaquin CASRN: 81335-37-7 DTXSID: DTXSID3024152 Use: Herbicide used on broad leaved weeds in soya beans Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 4 non-cancer effects 9 3 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 1000 decreased body weights (within 4 weeks of exposure), slight anemia, clinical chemistry/hematology changes, and evidence of skeletal muscle myopathy general population OPP 2018 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.18 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-461 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Imazaquin CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.25 mg/kg/day OPP 2018 American Cyanamid Company, 1984 decreased body weights (within first 4 weeks of exposure), slight anemia, clinical chemistry/hematology changes, and evidence of skeletal muscle myopathy general population 33.8 1480 [400] Cancer Classification (CC) E OPP 2018 [4001 Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Chronic Human Health Benchmark 1.6 mg/L EPA HHBP Health-Based Screening Level 1.6 mg/L Health-based screening levels from USGS Population-Adjusted Dose (PAD) 0.25 mg/kg/day EPAHHBP Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Measured Data and Assessment Results LD50 2363 mg/kg NIH HSDB min LD50 5000 mg/kg NIH HSDB max LOAEL 125 mg/kg/day EPA Toxicity Reference Database min LOAEL 600 mg/kg/day EPA Toxicity Reference Database max NOAEL 25 mg/kg/day EPA Toxicity Reference Database min NOAEL 250 mg/kg/day EPA Toxicity Reference Database max Percent of active toxcast in 1.65 percent EPA Chemistry Dashboard vitro assays tested Data Element Value Units Source Notes Modeled Data LD50 0.011298 mo l/kg TEST QSAR Ames mutagenicity test 0.56 no units TEST QSAR Developmental toxin test 0.945 no units TEST QSAR A-462 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Imazaquin CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contam nant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contam nant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contam nant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contam nant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contam nant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contam nant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev(NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 4,148 170 Sites 4.1 0.00102 0.0154 0.18 5.9 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 472 114 Sites 24 0.00102 0.0151 0.18 5.9 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 3.676 56 Sites 1.52 0.00152 0.02 0.132 0.7 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) 15 52,207 2016 Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude USDA Pesticide Data Program (PDP) (Finished) 2001-2013 17 5 Sites 29 0.0018 0.004 0.0184 0.047 ug/L Ambient Water Prevalence Magnitude National Water Information System (USGS NWIS) (Surface Water) 2008-2017 475 31 Sites 6.53 0.00159 0.0131 0.0792 0.255 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008-2017 1,051 27 Sites 2.57 0.00093 0.01 0.02 0.07 ug/L National Water Information System (USGS NWIS) (All Water) 2008-2017 1,526 58 Sites 3.8 0.00093 0.01 0.056 0.255 ug/L USDA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001-2013 229 17 Sites 7.42 0.0018 0.00735 0.0245 0.058 ug/L USDA Pesticide Data Program (PDP) (Groundwater) 2001-2013 219 12 Sites 5.48 0.0018 0.008 0.0357 0.0458 ug/L USDA Pesticide Data Program (PDP) (Untreated) 2001-2013 12 5 Sites 42 0.0018 0.005 0.0228 0.058 ug/L Bradley et al. 2017 (Ambient) [52] 2012-2014 38 3 Sites 7.89 0.0128 0.0133 0.0322 0.0369 ug/L Arnold et al. 2016 (Filtered) [7] 2012-2013 690 6 Sites 0.87 0.0015 0.00305 0.0289 0.05 ug/L Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 8.51E-08 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicatethere were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 3.34801 days Boiling point OPERA QSAR 288.545 degree C Boiling point TEST QSAR Vapor pressure OPERA QSAR 1.27E-10 mmHg Vapor pressure TEST QSAR 5.35E-10 mmHg Solubility in water OPERA QSAR 0.000453923 mol/L Solubility in water TEST QSAR 0.000450817 mol/L Bioconcentration factor OPERA QSAR 2.886 no units Bioconcentration factor TEST QSAR 3.4435 no units Henry's Law constant OPERA QSAR 2.11E-10 atm-mA3/mol 0 eta no 1/water partitioning coeff. (log Kow) OPERA QSAR 1.87775 no units A-463 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Imazaquin CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 400 USEPA. 2018. Imazaquin: Draft Human Health Risk Assessment for Registration Review. EPA-HQ-OPP-2014-0224-0020. DP No. D445078. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. A-464 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Imazethapyr CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Chemical Notes: DTXSID3024287 Herbicide used o Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 3 no adverse effects 9 3 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 10000 no effects identified at loael selected as pod general population OPP 2002 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.09264 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-465 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Imazethapyr CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 2.5 mg/kg/day OPP 2002 American Cyanamid Co. 1987 no effects identified at loael selected as pod general population 33.8 14800 [250] Cancer Classification (CC) NL OPP 2002 [2501 Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Chronic Human Health Benchmark 16 mg/L EPA HHBP Health-Based Screening Level 16 mg/L Health-based screening levels from USGS Population-Adjusted Dose (PAD) 2.5 mg/kg/day EPAHHBP Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Measured Data and Assessment Results LD50 5000 mg/kg NIH HSDB LOAEL 125 mg/kg/day EPA Toxicity Reference Database min LOAEL 1500 mg/kg/day EPA Toxicity Reference Database max NOAEL 25 mg/kg/day EPA Toxicity Reference Database min NOAEL 750 mg/kg/day EPA Toxicity Reference Database max Percent of active toxcast in 1.27 percent EPA Chemistry Dashboard vitro assays tested Data Element Value Units Source Notes Modeled Data LD50 0.001349 mo l/kg TEST QSAR Ames mutagenicity test 0.639 no units TEST QSAR Developmental toxin test 0.927 no units TEST QSAR A-466 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Imazethapyr CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 4,118 232 Sites 5.63 4.00E - 05 0.0167 0.0926 2.71 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 472 174 Sites 37 4.00E - 05 0.0167 0.0938 2.71 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 3.646 58 Sites 1.59 0.00021 0.0131 0.07 0.242 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) 43 641,374 2016 Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude USDA Pesticide Data Program (PDP) (Finished) 2001-2013 17 5 Sites 29 0.002 0.004 0.018 0.063 ug/L Ambient Water Prevalence Magnitude National Water Information System (USGS NWIS) (Surface Water) 2008-2017 475 71 Sites 15 0.00112 0.0172 0.0726 0.65 ug/L National Water information System (USGS NWIS) (Groundwater) 2008-2017 1,057 10 Sites 0.95 0.00674 0.01 0.0189 0.02 ug/L National Water information System (USGS NWIS) (All Water) 2008-2017 1,532 81 Sites 5.29 0.00112 0.0162 0.0686 0.65 ug/L USDA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001-2013 229 52 Sites 23 0.001665 0.004 0.0157 0.137 ug/L USDA Pesticide Data Program (PDP) (Groundwater) 2001-2013 219 47 Sites 21 0.001665 0.00255 0.00304 0.0082 ug/L USDA Pesticide Data Program (PDP) (Untreated) 2001-2013 12 5 Sites 42 0.002 0.004 0.0174 0.137 ug/L Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990-2018 35 0 Sites 0 Arnold et al. 2016 (Filtered) [7] 2012-2013 690 14 Sites 2.03 0.000211 0.0037 0.0249 0.07 ug/L Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 9.56E-08 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 3.34063 days Boiling point OPERA QSAR 277.233 degree C Boiling point TEST QSAR Vapor pressure OPERA QSAR 1.57E-10 mmHg Vapor pressure TEST QSAR 5.12E-09 mmHg Solubility in water OPERA QSAR 0.00538382 mol/L Solubility in water TEST QSAR 0.00181552 mol/L Bioconcentration factor OPERA QSAR 4.52231 no units Bioconcentration factor TEST QSAR 2.50611 no units Henry's Law constant OPERA QSAR 9.25E-10 atm-mA3/mol 0 eta no l/water partitioning coeff. (log Kow) OPERA QSAR 1.45322 no units A-467 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Imazethapyr CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 250 USEPA. 2002. Health Effects Division (HED) Risk Assessment for Imazethapyr. EPA-HQ-OPP-2002-0189-0003. DP Nos. D232428 D269226 D277925. U.S. Environmental Protection Agency, Office of Prevention, Pesticides and Toxic Substances, Washington, D.C. 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticide in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. A-468 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Imidacloprid CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Imidacloprid CASRN: 138261-41-3 DTXSID: DTXSID5032442 Use: Insecticide used on pests on agricultural and nursery crops Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts X Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Not List ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 4 non-cancer effects 9 3 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 500 increased incidence of tremors general population OPP 2017 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.09098 90th Percentile All Ambient Water NAWQA 1991-2017 Final Hazard Quotient (HQ) 0.00018 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-469 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Imidacloprid CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDW and OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg- HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.08 mg/kg/day OPP 2017 Ruf1990 increased incidence of tremors general population 33.8 473 [384] Cancer Classification (CC) NL OPP 2017 [3841 Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg- CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title- abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Acute Human Health Benchmark 0.93 mg/L EPA HHBP Acute PAD 0.14 mg/kg/day EPA HHBP Chronic Human Health Benchmark 0.36 mg/L EPA HHBP Health-Based Screening Level 0.36 mg/L Health-based screening levels from USGS Population-Ad justed Dose (PAD) 0.057 mg/kg/dav EPA HHBP Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Measured Data and Assessment Results LD50 4870 mg/kg NIH HSDB max LD50 98 mg/kg NIH HSDB min LOAEL 16.9 mg/kg/day EPA Toxicity Reference Database min LOAEL 414 mg/kg/day EPA Toxicity Reference Database max NOAEL 274 mg/kg/day EPA Toxicity Reference Database max NOAEL 7.6 mg/kg/day EPA Toxicity Reference Database min Percent of active toxcast in 0.84 percent EPA Chemistry Dashboard vitro assays tested Data Element Value Units Source Notes Modeled Data LD50 0.0012162 mol/kg TEST QSAR Ames mutagenicity test 0.912 no units TEST QSAR Developmental toxin test 0.805 no units TEST QSAR A-470 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Imidacloprid CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev(NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 4,177 399 Sites 9.55 0.00066 0.0242 0.091 2.15 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 471 272 Sites 58 0.00066 0.0242 0.089 2.15 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 3.706 127 Sites 3.43 0.00151 0.0269 0.226 1.99 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) 48 987,466 2016 Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude USDA Pesticide Data Program (PDP) (Finished) 2001-2013 17 8 Sites 47 0.002498 0.0025 0.0106 0.099 ug/L Bradley et al. 2018 (Finished) [53] 2016 26 3 Sites 12 0.004 0.0072 0.00952 0.0101 ug/L Klarich et al. 2017 (Finished) [117] 2016 20 16 Sites 80 0.00122 0.00396 0.0162 0.02636 ug/L Ambient Water Prevalence Magnitude National Water Information System (USGS NWIS) (Surface Water) 2008-2017 624 203 Sites 33 0.00071 0.0245 0.155 4.18 ug/L National Water information System (USGS NWIS) (Groundwater) 2008-2017 1,057 32 Sites 3.03 0.00351 0.03 0.282 4.48 ug/L National Water Information System (USGS NWIS) (All Water) 2008-2017 1,681 235 Sites 14 0.00071 0.0245 0.158 4.48 ug/L USDA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001-2013 229 23 Sites 10 0.002498 0.006 0.0264 0.202 ug/L USDA Pesticide Data Program (PDP) (Groundwater) 2001-2013 219 18 Sites 8.22 0.0025 0.0103 0.031 0.124 ug/L USDA Pesticide Data Program (PDP) (Untreated) 2001-2013 12 5 Sites 42 0.002498 0.0025 0.0247 0.202 ug/L Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990-2018 1,031 668 Sites 65 0.0201 0.222 1.23 12.7 ug/L Bradley et al. 2017 (Ambient) [52] 2012-2014 38 14 Sites 37 0.0036 0.0275 0.0696 0.1428 ug/L Arnold et al. 2016 (Filtered) [7] 2012-2013 690 14 Sites 2.03 0.0015 0.0126 0.0782 0.741 ug/L USGS, McKenzie River, Oregon, 2012 (Ambient) [158] 2002-2010 126 2 Samples 1.6 0.159 ug/L Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 1.54E-08 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 3.541 days Boiling point OPERA QSAR 322.953 degree C Boiling point TEST QSAR Vapor pressure OPERA QSAR 1.19E-09 mmHg Vapor pressure TEST QSAR Solubility in water OPERA QSAR 0.00210815 mol/L Solubility in water TEST QSAR 0.00205589 mol/L Bioconcentration factor OPERA QSAR 9.64405 no units Bioconcentration factor TEST QSAR Henry's Law constant OPERA QSAR 2.56E-10 atm-mA3/mol 0 eta no 1/water partitioning coeff. (log Kow) OPERA QSAR 0.599499 no units A-471 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Imidacloprid CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 53 Bradley, P. M., Kolpin, D. W., Romanok, K. M., Smalling, K. L., Focazio, M. J., Brown, J. B.,... & Dietze, J. E. (2018). Reconnaissance of mixed organic and inorganic chemicals in private and public supply tapwaters at selected residential and workplace sites in the United States. Environmental science & technology, 52(23), 13972-13985. 117 Klarich, K.L., Pflug, N.C., DeWald, E.M., Hladik, M.L., Kolpin, D.W., Cwiertny, D.M. and LeFevre, G.H., 2017. Occurrence of neonicotinoid insecticides in finished drinking water and fate during drinking water treatment. Environmental Science & Technology Letters, 4(5), pp. 168-173. 158 Reconnaissance of Land-Use Sources of Pesticides in Drinking Water, McKenzie River, Oregon. U.S. Geological Survey Scientific Investigations Report 2012-5091, 46 p. plus appendixes. 384 USEPA. 2017. Imidacloprid. Acute and Chronic Aggregate Dietary (Food and Drinking Water) Exposure and Risk Assessments for the Registration Review Risk Assessment. EPA-HQ-OPP-2008-0844-1236. DP Nos. D438392 D438433. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticide in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. A-472 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Indoxacarb CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Chemical Notes: DTXSID1032690 Broad spectrum insecticide Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 5 non-cancer effects 6 1 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 100 decreased body weight, body weight gain, food consumption, and food efficiency; decreased hematocrit, hemoglobin and red blood cells general population OPP 2018 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.069398 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-473 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Indoxacarb CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDW and OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg- HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.02 mg/kg/day OPP 2018 Long et al. 1998; Frame 1997; Breslin 1997 decreased body weight, body weight gain, food consumption, and food efficiency general population BB.8 118 [401] Cancer Classification (CC) NL OPP 2018 [401] Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg- CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title- abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Acute Human Health Benchmark 0.8 mg/L EPA HHBP Acute PAD 0.12 mg/kg/day EPA HHBP Chronic Human Health Benchmark 0.1 mg/L EPA HHBP Health-Based Screening Level 0.1 mg/L Health-based screening levels from USGS Population-Ad justed Dose (PAD) 0.02 mg/kg/day EPA HHBP Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Measured Data and Assessment Results LD50 1732 mg/kg NIH HSDB max LD50 268 mg/kg NIH HSDB min LOAEL 1000 mg/kg/day EPA Toxicity Reference Database max LOAEL 2.1300001 mg/kg/day EPA Toxicity Reference Database min NOAEL 1.114 mg/kg/day EPA Toxicity Reference Database min NOAEL 500 mg/kg/day EPA Toxicity Reference Database max Percent of active toxcast in vitro 18.17 percent EPA Chemistry Dashboard assays tested Subchronic LOAEL 3.78 mg/kg/day EPA Toxicity Reference Database min Subchronic LOAEL 30 mg/kg/day EPA Toxicity Reference Database max Subchronic NOAEL 16 mg/kg/day EPA Toxicity Reference Database max Subchronic NOAEL 3.09 mg/kg/day EPA Toxicity Reference Database min Data Element Value Units Source Notes Modeled Data LD50 0,0007798 mol/kg TEST QSAR Ames mutagenicity test 0.589 no units TEST QSAR Developmental toxin test 1.1 no units TEST QSAR A-474 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Indoxacarb CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev(NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 1.761 12 Sites 0.68 0.00104 0.0017 0.0694 0.273 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 322 11 Sites 3.42 0.00104 0.00153 0.00338 0.0859 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 1.439 1 Sites 0.07 0.273 0.273 0.273 0.273 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) 32 100,007 2016 Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Ambient Water Prevalence Magnitude National Water Information System (USGS NWIS) (Surface Water) 2008-2017 359 4 Sites 1.11 0.00195 0.107 0.169 0.187 ug/L National Water information System (USGS NWIS) (Groundwater) 2008-2017 528 0 Sites 0 National Water information System (USGS NWIS) (All Water) 2008-2017 887 4 Sites 0.45 0.00195 0.107 0.169 0.187 ug/L Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990-2018 202 7 Sites 3.47 0.066 0.071 0.851 2.01 ug/L Arnold et al. 2016 (Filtered) [7] 2012-2013 584 0 Sites 0 Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg Notes Expocast exposure 0.000000197 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 5.1378 days Boiling point OPERA QSAR 349.98 degree C Boiling point TEST QSAR Vapor pressure OPERA QSAR 2.38E-10 mmHg Vapor pressure TEST QSAR 8.99E-11 mmHg Solubility in water OPERA QSAR 0.0000344 mol/L Solubility in water TEST QSAR 0.00000211 mol/L Bioconcentration factor OPERA QSAR 4.57962 no units Bioconcentration factor TEST QSAR 36.7282 no units Henry's Law constant OPERA QSAR 0.000000022 atm-mA3/mol 0 eta no 1/water partitioning coeff. (log Kow) OPERA QSAR 4.33162 no units A-475 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Indoxacarb CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 401 USEPA. 2018. Indoxacarb: Update to the Human Health Draft Risk Assessment for Indoxacarb to Support Registration Review and the Proposed New Use for Controlling Ants at Ornamental Nurseries, Sod Farms, and Livestock Corrals of non-Food Bearing Animals. EPA-HQ-OPP-2013-0367-0050. DP No. D445517. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticide in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. A-476 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Iprodione CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Iprodione CASRN: 36734-19-7 DTXSID: DTXSID3024154 Use: Fungicide Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro X Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUM MARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT IN FORMATION Potency Severity Prevalence Magnitude 5 carcinogen with linear MOA 7 4 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 0.7 leydig cell tumor general population OPP 2012 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 2.208 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-477 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Iprodione CCL 5 Contaminant Information Sheet EPA-OGWDWand OST October 2022 HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.05 mg/kg/day OPP 2012 Blystone et al. 2007; Chambers et al. 1992; Larochelle 1993 reduced serum testosterone general population 33.8 296 [325] Cancer Slope Factor (CSF) 0.0439 (mg/kg/day)A-l OPP 2012 Chambers et al. 1992 leydig cell tumor general population 33.8 0.674 [325] Cancer Classification (CC) L OPP 2012 [325] Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Acute Human Health Benchmark 1 mg/L EPA HHBP Acute PAD 0.05 mg/kg/day EPA HHBP Cancer Slope Factor (CSF) 0.0439 (mg/kg/day)A-l EPA HHBP Chronic Human Health Benchmark 0.3 mg/L EPA HHBP Chronic Human Health Benchmark 0.000729 mg/L EPA HHBP Health-Based Screening Level 0.3 mg/L Health-based screening levels from USGS Health-Based Screening Level 0.000729 mg/L Health-based screening levels from USGS Population-Adjusted Dose (PAD) 0.05 mg/kg/day EPAHHBP Notes: Highlighted data indicate value was used in attribute scoring. Blan k fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Measured Data and Assessment Results LD50 3500 mg/kg NIH HSDB min LD50 4000 mg/kg NIH HSDB max LOAEL 12.4 mg/kg/day EPA Toxicity Reference Database min LOAEL 200 mg/kg/day EPA Toxicity Reference Database max NOAEL 2.5 mg/kg/day EPA Toxicity Reference Database min NOAEL 90 mg/kg/day EPA Toxicity Reference Database max Percent of active toxcast in 8.93 percent EPA Chemistry Dashboard vitro assays tested Subchronic LOAEL 151 mg/kg/day EPA Toxicity Reference Database min Subchronic LOAEL 180 mg/kg/day EPA Toxicity Reference Database max Subchronic NOAEL 60 mg/kg/day EPA Toxicity Reference Database min Subchronic NOAEL 89 mg/kg/day EPA Toxicity Reference Database max Data Element Value Units Source Notes Modeled Data LD50 0.0095719 mo l/kg TEST QSAR Ames mutagenicity test 0.085 no units TEST QSAR Developmental toxin test 1.168 no units TEST QSAR A-478 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Iprodione CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev(NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 3.669 46 Sites 1.25 0.01 0.048 2.21 141 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 383 45 Sites 12 0.01 0.049 2.22 141 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 3.286 1 Sites 0.03 0.016 0.016 0.016 0.016 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) 23 376,298 2016 Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude USDA Pesticide Data Program (PDP) (Finished) 2001-2013 11 0 Sites 0 Bradley et al. 2018 (Finished) [53] 2016 26 2 Sites 7.69 0.0174 0.0174 0.0174 0.0174 ug/L USGS, Sioux Falls Area, 2012 (Finished) [153] 2009-2010 1 0 Sites 0 Ambient Water Prevalence Magnitude National Water Information System (USGS NWIS) (Surface Water) 2008-2017 569 33 Sites 5.8 0.006 0.0346 0.196 1.24 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008-2017 2,014 0 Sites 0 National Water Information System (USGS NWIS) (All Water) 2008-2017 2,582 33 Sites 1.28 0.006 0.0346 0.196 1.24 ug/L USDA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001-2013 4 0 Sites 0 USDA Pesticide Data Program (PDP) (Untreated) 2001-2013 4 0 Sites 0 Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990-2018 15 0 Sites 0 Bradley etal. 2017 (Ambient) [52] 2012-2014 38 3 Sites 7.89 0.0246 0.0304 0.0745 0.0855 ug/L Arnold et al. 2016 (Filtered) [7] 2012-2013 106 0 Sites 0 USGS, Sioux Falls Area, 2012 (Ambient) [153] 2009-2010 2 0 Sites 0 Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 1.64E-08 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 3.35536 days Boiling point OPERA QSAR 352.665 degree C Boiling point TEST QSAR 428.894 degree C Vapor pressure OPERA QSAR 5.56E-09 mmHg Vapor pressure TEST QSAR 7.85E-10 mmHg Solubility in water OPERA QSAR 0.0000573 mol/L Solubility in water TEST QSAR 0.0000681 mol/L Bioconcentration factor OPERA QSAR 210.915 no units Bioconcentration factor TEST QSAR 15.3815 no units Henry's Law constant OPERA QSAR 3.27E-09 atm-mA3/mol 0 eta no l/water partitioning coeff. (log Kow) OPERA QSAR 2.99477 no units A-479 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Iprodione CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulorigoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 53 Bradley, P. M., Kolpin, D. W., Romanok, K. M., Smalling, K. L., Focazio, M. J., Brown, J. B.,... & Dietze, J. E. (2018). Reconnaissance of mixed organic and inorganic chemicals in private and public supply tapwaters at selected residential and workplace sites in the United States. Environmental science & technology, 52(23), 13972-13985. 153 Occurrence of anthropogenic organic compounds and nutrients in source and finished water in the Sioux Falls area, South Dakota, 2009-10: U.S. Geological Survey Scientific Investigations Report 2012-5098, 21 p. plus appendixes. 325 USEPA. 2012. Iprodione. Acute Probabilistic, Chronic and Cancer Aggregate (Food and Drinking Water) Dietary Exposure and Risk Assessments for Parent and 3,5-DCAto Support New Section 3 Registration Actions on Cucurbits (Crop Group 9) and Fruiting Vegetables (Crop Group 8-10) and to Support a Tolerance for Imported Canola. EPA-HQ-OPP-2012-0392-0008. DP No. D392706. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticide in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. A-480 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Isophorone CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Isophorone CASRN: 78-59-1 DTXSID: DTXSID8020759 Use: Solvent mixtures for finishes, for polyvinyl and nitrocellulose resins, stoving lacquers Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants X PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUM MARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT IN FORMATION Potency Severity Prevalence Magnitude 2 carcinogen with linear MOA 9 2 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 50 preputial gland carcinomas general population OPP 1999 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.129 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-481 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Isophorone CCL 5 Contaminant Information Sheet EPA-OGWDWand OST October 2022 HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.2 mg/kg/day IRIS 1989 Nor-Am Agricultural Products 1972 no adverse effects at highest dose tested general population 33.8 1180 [204] Reference Dose (RfD) or Equivalent 0.15 mg/kg/day OW1992 Nor-Am Agricultural Products 1972 no adverse effects at highest dose tested general population 33.8 888 [220] Reference Dose (RfD) or Equivalent 0.15 mg/kg/day OPP1999 Nor-Am Agricultural Products 1972 no adverse effects at highest dose tested general population 33.8 888 [234] Reference Dose (RfD) or Equivalent 0.2 mg/kg/day ATSDR2018 N TP 1986 hepatic, renal, and gastrointestinal lesions general population 33.8 1180 [36] Cancer Slope Factor (CSF) 0.00095 (mg/kg/day) A-1 IRIS 1989 N TP 1986 preputial gland carcinoma general population 33.8 31.1 [204] Cancer Slope Factor (CSF) 0.004 (mg/kg/day) A-1 OW 1992 N TP 1986 renal tubular cell tumors and preputial gland carcinomas general population 33.8 7.40 [220] Cancer Slope Factor (CSF) 0.000608 (mg/kg/day) A-1 OPP1999 N TP 1986 preputial gland carcinoma general population 33.8 48.7 [234] Cancer Classification (CC) C IRIS 1989 [204] Cancer Classification (CC) C OW 1992 [220] Cancer Classification (CC) C OPP1999 [234] Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (ml/kg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review 2017-07-01 2020-02-13 25 0 2 Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results 10-day Health Advisory 15 mg/L EPA DWSHA 2018 Chronic Health-Based Guidance Value 0.1 mg/L MN DOH Human Health Ambient Water Quality Criteria 0.034 mg/L EPA Human Health Criteria for CWA Intermediate Minimal Risk Level (MRL) 3 mg/kg/day CDC ATSDR Lifetime Health Advisory 0.04 mg/L EPA DWSHA 2018 Lifetime Health Advisory 0.1 mg/L EPA DWSHA 2018 Reference Concentration (RfC) 2000 ug/mA3 CalEPA OEHHA Chemical Database Cancer Classification (CC) Female.Mice NE no units HHSNTP Cancer Classification (CC) Female.Rats NE no units HHSNTP Cancer Classification (CC) Male.Mice EE no units HHSNTP Cancer Classification (CC) Male.Rats SE no units HHS NTP Data Element Value Units Source Notes Modeled Data LD50 0.0104954 mo l/kg TEST QSAR Ames mutagenicity test 0.25 no units TEST QSAR Developmental toxin test 0.944 no units TEST QSAR Data Element Value Units Source Notes Measured Data and Assessment Results LD50 1000 mg/kg NIH HSDB min LD50 3200 mg/kg NIH HSDB max Percent of active toxcast in 2.72 percent EPA Chemistry Dashboard vitro assays tested TD50 16600 mg/kg/day NIH CPDB max TD50 203 mg/kg/day NIH CPDB min Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. A-482 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Isophorone CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contam nant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contam nant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contam nant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contam nant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contam nant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contam nant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 1.920 52 Sites 2.71 0.003 0.01 0.129 3.9 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 150 36 Sites 24 0.003 0.01 0.0991 3.9 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 1.770 16 Sites 0.9 0.005 0.0105 0.316 0.54 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) 10M - 50M Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Finished) 2006 - 2020 12 1 Sites 8.33 0.149 0.149 0.149 0.149 ug/L Glassmeyer et al 2017 (Finished) [86] 2007-2012 25 NA Sites 4 0.032 0.032 ug/L USGS, Sioux Falls Area, 2012 (Finished) [153] 2009-2010 1 0 Sites 0 Ambient Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Source) 2006 - 2020 47 0 Sites 0 National Water Information System (USGS NWIS) (Surface Water) 2008-2017 830 414 Sites 50 0.002 0.011 0.0437 18.2 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008 - 2017 1,871 99 Sites 5.29 0.002 0.013 0.0605 0.18 ug/L National Water Information System (USGS NWIS) (All Water) 2008 - 2017 2,701 513 Sites 19 0.002 0.011 0.0452 18.2 ug/L Glassmeyer et al 2017 (Ambient) [86] 2007 - 2012 25 NA Sites 0 ug/L Bradley et al. 2017 (Ambient) [52] 2012 - 2014 38 24 Sites 63 0.0038 0.012 0.0267 0.0991 ug/L Arnold et al. 2016 (Unfiltered) [7] 2012 - 2013 527 0 Sites 0 USGS, Sioux Falls Area, 2012 (Ambient) [153] 2009 - 2010 2 1 Sites 50 Waste Water Effluent Prevalence Magnitude Scott et al. 2018 (Wastewater) [161] 2011 - 2017 21 14 Sites 67 0.017 0.03 0.0694 0.081 ug/L Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg Notes Expocast exposure 0.0000459 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 3.55543 days Boiling point OPERA QSAR 210.791 degree C Boiling point TEST QSAR 211.454 degree C Vapor pressure OPERA QSAR 0.616548 mmHg Vapor pressure TEST QSAR 0.429536 mmHg Solubility in water OPERA QSAR 0.0353497 mol/L Solubility in water TEST QSAR 0.0304088 mol/L Bioconcentration factor OPERA QSAR 2.63961 no units Bioconcentration factor TEST QSAR 8.27942 no units Henry's Law constant OPERA QSAR 0.0000366 o E E Octanol/water partitioning coeff. (log Kow) OPERA QSAR 2.02537 no units A-483 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Isophorone CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 36 ATSDR. 2018. Toxicological Profile for Isophorone. U.S. Department of Health and Human Services, Public Health Service, Agency for Toxic Substances and Disease Registry (ATSDR), Atlanta, GA. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 86 Glassmeyer, S.T., Furlong, E.T., Kolpin, D.W., Batt, A.L., Benson, R., Boone, J.S.,... & Wilson, V.S. (2017). Nationwide reconnaissance of contaminants of emerging concern in source and treated drinking waters of the United States. Science of The Total Environment. v581-582, (909-922). 153 Occurrence of anthropogenic organic compounds and nutrients in source and finished water in the Sioux Falls area, South Dakota, 2009-10: U.S. Geological Survey Scientific Investigations Report 2012-5098, 21 p. plus appendixes. 161 Scott, T. M., Phillips, P. J., Kolpin, D. W., Colella, K. M., Furlong, E. T., Foreman, W. T., & Gray, J. L. (2018). Pharmaceutical manufacturing facility discharges can substantially increase the pharmaceutical load to US wastewaters. Science of the Total Environment, 636, 69-79. 204 USEPA. 1989. Chemical Assessment Summary, Isophorone. U.S. Environmental Protection Agency, National Center for Environmental Assessment, Integrated Risk Information System (IRIS), Washington D.C. 220 USEPA. 1992. Isophorone Drinking Water Health Advisory. U.S. Environmental Protection Agency, Office of Water, Washington, D.C. 234 USEPA. 1999. Isophorone - Report of the Hazard Identification Assessment Review Committee. U.S. Environmental Protection Agency, Office of Prevention, Pesticides, and Toxic Substances, Office of Pesticides Programs, Health Effects Division, Washington, D.C. A-484 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Isoxaflutole CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Isoxaflutole CASRN: 141112-29-0 DTXSID: DTXSID5034723 Use: Herbicide; for use on corn fields Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 4 carcinogen with linear MOA 7 3 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 3 general population OPP 2011 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.1998 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-48 5 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Isoxaflutole CCL 5 Contaminant Information Sheet EPA-OGWDWand OST October 2022 HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.02 mg/kg/day OPP 2011 Chase 1995 liver, thyroid, ocular, nervous system toxicity general population 33.8 118 [320] Cancer Slope Factor (CSF) 0.0114 (mg/kg/day)A-l OPP 2011 Chase 1995 liver adenomas and carcinomas general population 33.8 2.60 [320] Cancer Classification (CC) L OPP 2011 [320] Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Acute Human Health Benchmark 0.6 mg/L EPA HHBP Acute PAD 0.02 mg/kg/day EPA HHBP Cancer Slope Factor (CSF) 0.0114 (mg/kg/day)A-l EPA HHBP Chronic Human Health Benchmark 0.1 mg/L EPA HHBP Chronic Human Health Benchmark 0.00281 mg/L EPA HHBP Health-Based Screening Level 0.1 mg/L Health-based screening levels from USGS Health-Based Screening Level 0.00281 mg/L Health-based screening levels from USGS Population-Adjusted Dose (PAD) 0.02 mg/kg/day EPA HHBP Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Measured Data and Assessment Results LD50 5000 mg/kg NIH HSDB LOAEL 5 mg/kg/day EPA Toxicity Reference Database min LOAEL 500 mg/kg/day EPA Toxicity Reference Database max NOAEL 1.79 mg/kg/day EPA Toxicity Reference Database min NOAEL 100 mg/kg/day EPA Toxicity Reference Database max Percent of active toxcast in 3.38 percent EPA Chemistry Dashboard vitro assays tested Data Element Value Units Source Notes Modeled Data LD50 0.0023388 mo l/kg TEST QSAR Ames mutagenicity test 0.62 no units TEST QSAR Developmental toxin test 0.897 no units TEST QSAR A-486 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Isoxaflutole CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contam nant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contam nant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contam nant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contam nant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contam nant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contam nant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 1.699 22 Sites 1.29 0.0028 0.0257 0.2 0.66 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 322 21 Sites 6.52 0.0028 0.0219 0.141 0.66 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 1.377 1 Sites 0.07 0.261 0.261 0.261 0.261 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) 35 717,004 2016 Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude USDA Pesticide Data Program (PDP) (Finished) 2001-2013 13 0 Sites 0 Ambient Water Prevalence Magnitude National Water Information System (USGS NWIS) (Surface Water) 2008-2017 302 2 Sites 0.66 0.178 0.178 0.178 0.178 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008-2017 528 0 Sites 0 National Water Information System (USGS NWIS) (All Water) 2008 - 2017 830 2 Sites 0.24 0.178 0.178 0.178 0.178 ug/L USDA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001 - 2013 221 0 Sites 0 USDA Pesticide Data Program (PDP) (Groundwater) 2001 - 2013 216 0 Sites 0 USDA Pesticide Data Program (PDP) (Untreated) 2001 - 2013 5 0 Sites 0 Arnold et al. 2016 (Filtered) [7] 2012 - 2013 584 0 Sites 0 Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 1.97E-08 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR4 data used in the CCL5 is a partial datasetand will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 3.53704 days Boiling point OPERA QSAR 371.042 degree C Boiling point TEST QSAR 316.595 degree C Vapor pressure OPERA QSAR 0.000000009 mmHg Vapor pressure TEST QSAR 5.09E-08 mmHg Solubility in water OPERA QSAR 0.0000252 mol/L Solubility in water TEST QSAR 0.0000219 mol/L Bioconcentration factor OPERA QSAR 4.99662 no units Bioconcentration factor TEST QSAR 207.491 no units Henry's Law constant OPERA QSAR 2.3E-10 o E E 0 eta no l/water partitioning coeff. (log Kow) OPERA QSAR 2.47956 no units A-487 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Isoxaflutole CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 320 USEPA. 2011. Isoxaflutole. Section 3 Registration for Use on Soybeans. Human Health Risk Assessment. EPA-HQ-OPP-2010-0845-0005. DP No. D382796. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. A-488 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Lactofen CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Chemical Notes: DTXSID7024160 Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANTSUMMARY& DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 5 non-cancer effects 2 5 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 50 increased incidence of proteinaceous casts in kidneys and decreases in thyroid and adrenal gland weights general population OPP 2007 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.2322 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-48 9 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Lactofen CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.008 mg/kg/day OPP 2007 Tisdel et al. 1982 increased incidence of proteinaceous casts in kidneys and decreases in thyroid and adrenal gland weights general population 33.8 47.3 [277] Cancer Classification (CC) NL OPP 2007 [2771 Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Acute Human Health Benchmark 0.47 mg/L EPA HHBP Acute PAD 0.017 mg/kg/day EPA HHBP Chronic Human Health Benchmark 0.05 mg/L EPA HHBP Health-Based Screening Level 0.05 mg/L Health-based screening levels from USGS Population-Adjusted Dose (PAD) 0.008 mg/kg/day EPA HHBP Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Measured Data and Assessment Results LD50 5000 mg/kg NIH HSDB LOAEL 1.4 mg/kg/day EPA Toxicity Reference Database min LOAEL 150 mg/kg/day EPA Toxicity Reference Database max NOAEL 0.79 mg/kg/day EPA Toxicity Reference Database min NOAEL 50 mg/kg/day EPA Toxicity Reference Database max Percent of active toxcast in 13.87 percent EPA Chemistry Dashboard vitro assays tested Subchronic LOAEL 73.699997 mg/kg/day EPA Toxicity Reference Database Subchronic NOAEL 17 mg/kg/day EPA Toxicity Reference Database Data Element Value Units Source Notes Modeled Data LD50 0.0062661 mo l/kg TEST QSAR Ames mutagenicity test 0.466 no units TEST QSAR Developmental toxin test 1.012 no units TEST QSAR A-490 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Lactofen CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contam nant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contam nant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contam nant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contam nant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contam nant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contam nant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 1.737 2 Sites 0.12 0.101 0.183 0.232 0.265 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 322 1 Sites 0.31 0.101 0.101 0.101 0.101 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 1.415 1 Sites 0.07 0.265 0.265 0.265 0.265 Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) 32 785,344 2016 Toxic Release Inventory (TRI) Program (EPA) (2016) 1 1,845 Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude USDA Pesticide Data Program (PDP) (Finished) 2001-2013 2 0 Sites 0 Ambient Water Prevalence Magnitude National Water Information System (USGS NWIS) (Surface Water) 2008-2017 304 2 Sites 0.66 0.154 0.163 0.168 0.172 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008-2017 528 0 Sites 0 National Water Information System (USGS NWIS) (All Water) 2008-2017 832 2 Sites 0.24 0.154 0.163 0.168 0.172 ug/L Arnold et al. 2016 (Filtered) [7] 2012 - 2013 584 0 Sites 0 Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 0.000000159 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 3.54533 days Boiling point OPERA QSAR 378.705 degree C Boiling point TEST QSAR 425.323 degree C Vapor pressure OPERA QSAR 6.62E-08 mmHg Vapor pressure TEST QSAR 2.29E-08 mmHg Solubility in water OPERA QSAR 0.000000301 mol/L Solubility in water TEST QSAR 0.000000822 mol/L Bioconcentration factor OPERA QSAR 93.5153 no units Bioconcentration factor TEST QSAR 30.4088 no units Henry's Law constant OPERA QSAR 1.05E-08 o E E 0 eta no l/water partitioning coeff. (log Kow) OPERA QSAR 4.66713 no units A-491 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Lactofen CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 277 USEPA. 2007. Lactofen: Revised Human Health Risk Assessment for Proposed Uses on Fruiting Vegetables and Okra. EPA-HQ-OPP-2006-0178-0008. DP No. D339011. U.S. Environmental Protection Agency, Office of Prevention, Pesticides and Toxic Substances, Washington, D.C. A-492 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 lambda-Cyhalothrin CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: lambda-Cyha loth rin CASRN: 91465-08-6 DTXSID: DTXSID7032559 Use: Insecticide (HSDB -data forcyhalothrin, CASRN 68085- 85-8) Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants X PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 6 reproductive and developmental effects 2 2 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value («"gA) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL l reduced motor activity bottle-fed infants OPP 2017 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.0236 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-493 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 lambda-Cyhalothrin CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.00093 mg/kg/day OPP 2017 Moseret al. 2016 reduced motor activity bottle-fed infants 151 1.23 [385] Cancer Classification (CC) NL OPP 2017 [3851 Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Acute Human Health Benchmark 0.03 mg/L EPA HHBP Acute Minimal Risk Level (MRL) 0.01 mg/kg/day CDC ATSDR Acute Minimal Risk Level (MRL) 0.02 mg/kg/day CDC ATSDR Acute PAD 0.005 mg/kg/day EPA HHBP Chronic Human Health Benchmark 0.006 mg/L EPA HHBP Health-Based Screening Level 0.006 mg/L Health-based screening levels from USGS Population-Adjusted Dose (PAD) 0.001 mg/kg/day EPA HHBP Data Element Value Units Source Notes Measured Data and Assessment Results LOAEL 0.5 mg/kg/day EPA Toxicity Reference Database min LOAEL 5 mg/kg/day EPA Toxicity Reference Database max NOAEL 0.1 mg/kg/day EPA Toxicity Reference Database min NOAEL 1.5 mg/kg/day EPA Toxicity Reference Database max Percent of active toxcast in 9.32 percent EPA Chemistry Dashboard vitro assays tested Subchronic LOAEL 12.5 mg/kg/day EPA Toxicity Reference Database Subchronic NOAEL 2.5 mg/kg/day EPA Toxicity Reference Database Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Modeled Data LD50 0.0011776 mo l/kg TEST QSAR Ames mutagenicity test -0.114 no units TEST QSAR Developmental toxin test 0.956 no units TEST QSAR A-494 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 lambda-Cyhalothrin CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contam nant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contam nant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contam nant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contam nant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contam nant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contam nant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 3.055 4 Sites 0.13 0.003 0.0075 0.0236 0.034 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 190 2 Sites 1.05 0.007 0.0075 0.0078 0.008 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 2.865 2 Sites 0.07 0.003 0.0185 0.0278 0.034 u Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) 48 773,940 2016 Toxic Release Inventory (TRI) Program (EPA) (2016) 0 0 Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude USDA Pesticide Data Program (PDP) (Finished) 2001-2013 7 0 Sites 0 Ambient Water Prevalence Magnitude National Water Information System (USGS NWIS) (Surface Water) 2008-2017 437 1 Sites 0.23 0.048 0.048 0.048 0.048 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008-2017 981 1 Sites 0.1 0.006 0.006 0.006 0.006 ug/L National Water Information System (USGS NWIS) (All Water) 2008-2017 1,417 2 Sites 0.14 0.006 0.027 0.0396 0.048 ug/L USDA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001-2013 118 0 Sites 0 USDA Pesticide Data Program (PDP) (Groundwater) 2001-2013 111 0 Sites 0 USDA Pesticide Data Program (PDP) (Untreated) 2001-2013 7 0 Sites 0 Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990-2018 4,815 237 Sites 4.92 7e-04 0.00511 0.0222 0.447 ug/L Bradley et al. 2017 (Ambient) [52] 2012-2014 38 8 Sites 21 9.23e-05 0.000314 0.0018 0.0022 ug/L Arnold et al. 2016 (Filtered) [7] 2012-2013 106 0 Sites 0 Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 0.00000189 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 3.54201 days Boiling point OPERA QSAR 422.672 degree C Boiling point TEST QSAR 431.019 degree C Vapor pressure OPERA QSAR 4.02E-09 mmHg Vapor pressure TEST QSAR 2.05E-09 mmHg Solubility in water OPERA QSAR 1.97E-08 mol/L Solubility in water TEST QSAR 0.000000071 mol/L Bioconcentration factor OPERA QSAR 133.673 no units Bioconcentration factor TEST QSAR 342.768 no units Henry's Law constant OPERA QSAR 0.000000012 atm-mA3/mol 0 eta no l/water partitioning coeff. (log Kow) OPERA QSAR 6.63514 no units A-495 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 lambda-Cyhalothrin CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 385 USEPA. 2017. Lambda-& Gamma-Cyhalothrin: Human Health Draft Risk Assessment for Registration Review. EPA-HQ-OPP-2010-0480-0299. DP No. 426321. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticide in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. A-496 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Lidocaine CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Chemical Notes: DTXSID1045166 Is the contaminant on any lists? CERCLA FIFRA Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 X CONTAMINANTSUMMARY& DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 6 non-cancer effects 10 1 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date SL 8 lowest therapeutic dose:local anesthesia bottle-fed infants FDA; NIH 2018; 2018 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.0318 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-497 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Lidocaine CCL 5 Contaminant Information Sheet EPA-OGWDWand OST October 2022 HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.00125 mg/kg/day FDA 2018; NIH 2018 Fresenius Kabi USA, LLC lowest therapeutic dose:local anesthesia bottle-fed infants 151 8.30 [77] [150] NOTE: (Lowest Therapeutic Dose/3000x UF) is used in place of an RfD; LTDs were obtained from FDA-approved drug labels Reference Dose (RfD) or Equivalent 0.00125 mg/kg/day FDA 2018; NIH 2018 Fresenius Kabi USA, LLC lowest therapeutic dose:local anesthesia general population 33.8 29.0 [77] [150] NOTE: (Lowest Therapeutic Dose/3000x UF) is used in place of an RfD; LTDs were obtained from FDA-approved drug labels Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Screening level for pharmaceutical - general 0.029411765 mg/L EPA Office of Water population Screening level for pharmaceutical - infants 0.008333333 mg/L EPA Office of Water Data Element Value Units Source Notes Measured Data and Assessment Results LD50 220 mg/kg NIH HSDB min LD50 317 mg/kg NIH HSDB max Percent of active toxcast in vitro assays tested 4.68 percent EPA Chemistry Dashboard Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Modeled Data LD50 0.0073961 mo l/kg TEST QSAR Ames mutagenicity test 0.073 no units TEST QSAR Developmental toxin test 0.277 no units TEST QSAR A-498 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Lidocaine CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 557 136 Sites 24 0.00038 0.00289 0.0318 0.438 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 75 39 Sites 52 0.00038 0.00356 0.0688 0.438 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 482 97 Sites 20 0.00038 0.00262 0.0132 0.0508 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Bradley et al. 2018 (Finished) [53] 2016 26 1 Sites 3.85 0.0237378 0.0237 0.0237 0.0237378 ug/L Glassmeyer et al 2017 (Finished) [86] 2007-2012 25 NA Sites 0 ug/L Ambient Water Prevalence Magnitude National Water Information System (USGS NWIS) (Surface Water) 2008-2017 209 97 Sites 46 0.00042 0.00813 0.175 0.438 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008-2017 401 35 Sites 8.73 0.00058 0.00496 0.0769 0.505 ug/L National Water Information System (USGS NWIS) (All Water) 2008-2017 610 132 Sites 22 0.00042 0.0069 0.154 0.505 ug/L Glassmeyer et al 2017 (Ambient) [86] 2007-2012 25 NA Sites 8 0.0296 0.0297 ug/L Bradley etal. 2017 (Ambient) [52] 2012-2014 38 21 Sites 55 0.0009345 0.0841 0.248 0.4088204 ug/L Bexfieid et al. 2019 (Groundwater) [49] 2013 - 2015 1,106 2 Sites 0.18 0.0276506 0.0336 0.0384 0.0396035 ug/L Waste Water Effluent Prevalence Magnitude Scott et al. 2018 (Wastewater) [161] 2011 - 2017 21 19 Sites 90 0.0863121 0.321 0.586 2.6986356 ug/L Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 3.11E-08 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR4 data used in the CCL5 is a partial datasetand will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 3.35565 days Boiling point OPERA QSAR 308.77 degree C Boiling point TEST QSAR 323.774 degree C Vapor pressure OPERA QSAR 7.96E-08 mmHg Vapor pressure TEST QSAR 0.00000094 mmHg Solubility in water OPERA QSAR 0.0095648 mol/L Solubility in water TEST QSAR 0.00334965 mol/L Bioconcentration factor OPERA QSAR 15.25 no units Bioconcentration factor TEST QSAR 11.885 no units Henry's Law constant OPERA QSAR 3.51E-10 o E E 0 eta no l/water partitioning coeff. (log Kow) OPERA QSAR 2.4589 no units A-499 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Lidocaine CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 49 Bexfield, L.M., P.L. Toccalino, K. Belitz, W.T. Foreman, and E.T. Furlong. 2019. Hormones and pharmaceuticals in groundwater used as a source of drinking water across the United States. Environmental Science and Technology 53: 2950-2960. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 53 Bradley, P. M., Kolpin, D. W., Romanok, K. M., Smalling, K. L., Focazio, M. J., Brown, J. B.,... & Dietze, J. E. (2018). Reconnaissance of mixed organic and inorganic chemicals in private and public supply tapwaters at selected residential and workplace sites in the United States. Environmental science & technology, 52(23), 13972-13985. 77 FDA. 2018. Drugs @ FDA: FDA Approved Drug Products. U.S. Food and Drug Administration (FDA), https://www.accessdata.fda.gov/scripts/cder/daf/. 86 Glassmeyer, S.T., Furlong, E.T., Kolpin, D.W., Batt, A.L., Benson, R., Boone, J.S.,... & Wilson, V.S. (2017). Nationwide reconnaissance of contaminants of emerging concern in source and treated drinking waters of the United States. Science of The Total Environment. v581-582, (909-922). 150 NIH. 2018. DailyMed Database. U.S. National Library of Medicine, National Institutes of Health (NIH). https://dailymed.nlm.nih.gov/dailymed/. 161 Scott, T. M., Phillips, P. J., Kolpin, D. W., Colella, K. M., Furlong, E. T., Foreman, W. T., & Gray, J. L. (2018). Pharmaceutical manufacturing facility discharges can substantially increase the pharmaceutical load to US wastewaters. Science of the Total Environment, 636, 69-79. A-500 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Linuron CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Chemical Notes: DTXSID2024163 Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro X Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANTSUMMARY& DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 5 non-cancer effects 1 1 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 50 hematological changes general population OPP 2019 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.1589 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-501 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Linuron CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.0077 mg/kg/day OPP 2019 Malley 1988 hematological changes general population 33.8 45.6 [418] Cancer Classification (CC) C OPP 2019 [4181 Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Acute Human Health Benchmark 3.3 mg/L EPA HHBP Acute PAD 0.12 mg/kg/day EPA HHBP Chronic Health-Based Guidance Value 0.001 mg/L MN DOH Chronic Human Health Benchmark 0.049 mg/L EPA HHBP Health-Based Screening Level 0.049 mg/L Health-based screening levels from USGS Population-Adjusted Dose (PAD) 0.0077 mg/kg/day EPAHHBP Data Element Value Units Source Notes Measured Data and Assessment Results LD50 4000 mg/kg NIH HSDB max LD50 500 mg/kg NIH HSDB min LOAEL 261 mg/kg/day EPA Toxicity Reference Database max LOAEL 3.49 mg/kg/day EPA Toxicity Reference Database min NOAEL 0.79 mg/kg/day EPA Toxicity Reference Database min NOAEL 63 mg/kg/day EPA Toxicity Reference Database max Percent of active toxcast in 10.35 percent EPA Chemistry Dashboard vitro assays tested Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Modeled Data LD50 0.0056494 mo l/kg TEST QSAR Ames mutagenicity test 0.605 no units TEST QSAR Developmental toxin test 0.569 no units TEST QSAR A-502 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Linuron CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 293 0 Sites 0 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev(NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 10,134 151 Sites 1.49 3.00E - 04 0.018 0.159 5.28 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 2.045 132 Sites 6.45 5.00E - 04 0.018 0.161 5.28 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 8.089 19 Sites 0.23 3.00E - 04 0.00632 0.06 0.272 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) 39 506,914 2016 Toxic Release Inventory (TRI) Program (EPA) (2016) 4 10 Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Finished) 2006 - 2020 3 0 Sites 0 USDA Pesticide Data Program (PDP) (Finished) 2001-2013 17 3 Sites 18 0.0027 0.0075 0.164 0.315 ug/L Ambient Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Source) 2006 - 2020 41 0 Sites 0 National Water Information System (USGS NWIS) (Surface Water) 2008-2017 624 13 Sites 2.08 0.00218 0.00683 0.174 0.246 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008-2017 1,623 3 Sites 0.18 0.003 0.071 0.0956 0.111 ug/L National Water Information System (USGS NWIS) (All Water) 2008-2017 2,247 16 Sites 0.71 0.00218 0.0113 0.111 0.246 ug/L USDA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001-2013 229 2 Sites 0.87 0.0042 0.00835 0.0166 0.019 ug/L USDA Pesticide Data Program (PDP) (Groundwater) 2001-2013 219 0 Sites 0 USDA Pesticide Data Program (PDP) (Untreated) 2001-2013 12 2 Sites 17 0.0042 0.00835 0.0166 0.019 ug/L Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990-2018 6,817 178 Sites 2.61 0.0031 0.0148 0.573 5.6 ug/L Bradley et al. 2017 (Ambient) [52] 2012-2014 38 2 Sites 5.26 0.02 0.03 0.038 0.04 ug/L Arnold et al. 2016 (Filtered) [7] 2012-2013 690 8 Sites 1.16 3e-04 0.00095 0.00163 0.0017 ug/L Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 1.47E-08 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicatethere were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 3.52572 days Boiling point OPERA QSAR 323.038 degree C Boiling point TEST QSAR 304.222 degree C Vapor pressure OPERA QSAR 0.00000285 mmHg Vapor pressure TEST QSAR 0.000000679 mmHg Solubility in water OPERA QSAR 0.000410555 mol/L Solubility in water TEST QSAR 0.000829851 mol/L Bioconcentration factor OPERA QSAR 19.518 no units Bioconcentration factor TEST QSAR Henry's Law constant OPERA QSAR 7.35E-10 atm-mA3/mol 0 eta no 1/water partitioning coeff. (log Kow) OPERA QSAR 3.05312 no units A-503 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Linuron CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 418 USEPA. 2019. Linuron: Revised Human Health Draft Risk Assessment to Support Registration Review. EPA-HQ-OPP-2010-0228-0065. DP No. D444117. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticide in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. A-504 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Lithium CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Lithium CASRN: 7439-93-2 DTXSID: DTXSID5036761 Use: Metal, pharmaceutical. Used as As anode in electrochemical cells and batteries; as chemical intermediate in organic Chemical Notes: This CIS also contains some data for the following: -Lithium chloride -Lithium, total Is the contaminant on any lists? CERCLA FIFRA X [lithium chloride] Human Neurotoxicants Pub Med Neurotoxicants X Neurodev. Disruptors Androgen Receptors in vitro Compounds with neurodev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 3 non-cancer effects 10 9 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 10 renal, neurologic, and endocrine gland effects general population PPRTV 2008 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished or Ambient (FW, SW, GW, WW) Source Date 63 90th Percentile Finished Water NIRS 1984-1986 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS RD1 RD 2 RD 3 Not Applicable Not Applicable Not Applicable Basis Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. Green highlighting indicates a change made between the draft and final CCL 5. A-505 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Lithium CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 2 ug/kg/day PPRTV 2008 Baldessarini and Tarazi 2001 renal, neurologic, and endocrine gland effects general population 33.8 11.8 [295] Cancer Classification (CC) I PPRTV 2008 [2951 Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Reproductive, Cardiovascular, Hepatic, Neurological, Developmental, Renal, Systemic, Immune, Metabolic 15 Ahmad, 2011; Abu-Taweel 2012 Neurological 29.94 Riadh, 2011 2007-06-01 2019-10-21 5278 46 189 5 Other Health Data Data Element I Value Units 1 Source I Notes Measured Data and Assessment Results Subchronic Provisional RfD I 0.002 mg/kg/day I EPA PPRTV l Data Element Value Units Source Notes Measured Data and Assessment Results LD50 1165 mg/kg NIH HSDB max; lithium chloride LD50 526 ms/ks NIH HSDB min; lithium chloride Notes: Yellow highlighted data indicate value was used in attribute scoring. Green highlighted data indicates a change made between the draft and final CCL 5. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Modeled Data LD50 TEST QSAR Ames mutagenicity test TEST QSAR Developmental toxin test TEST QSAR A-506 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Lithium CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDWand OST October 2022 Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prev alence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018 - 2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013 - 2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008 - 2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev(NIRS) 1984 -1986 988 551 Sites 56 5 15 63 7929 Ambient Water Prev alence Magnitude National Water Qualitv Assessment (USGS NAWQA) (All Water) 1991 - 2017 5.983 5.683 Sites 95 0.15 4.51 43.9 2420 National Water Qualitv Assessment (USGS NAWQA) (Surface Water) 1991 - 2017 271 213 Sites 79 0.15 4.39 43.5 460 National Water Qualitv Assessment (USGS NAWQA) (Ground Water) 1991 - 2017 5.712 5.470 Sites 96 0.15 4.66 44.7 2420 u Pesticide Application Data Number of States Amount Applied (lbs/year) Date Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Data Number of States Amount Released (lbs/year) Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Production Data Production Volume (lbs/year) Chemical Data Reporting (CDR) Results (EPA) (2016) 1M - 10M Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90tii Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Finished) 2006 - 2020 7 7 Sites 100 0.003 3.3 5.2 16 ug/L Lithium, total Bradley et al. 2018 (Finished) [53] 2016 26 23 Sites 88 0.35 1.95 13.6 71.05 ug/L Glassmeyer et al 2017 (Finished) [86] 2007 - 2012 25 NA Sites 56 10.8 42.7 ug/L Community Water System Survey (CWSS) (Finished) [178] 2006 1 NA Sites 2.7 2.7 ug/L Ambient Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Source) 2006 - 2020 21 10 Sites 48 0.002 2.8 9.7 40 ug/L Lithium, total National Water Information System (USGS NWIS) (Surface Water) 2008 - 2017 1,324 1,159 Sites 88 0 4.5 43.5 70400 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008 - 2017 5,801 5,648 Sites 97 0.07 15.3 100 80600 ug/L National Water Information System (USGS NWIS) (All Water) 2008 - 2017 7,115 6,797 Sites 96 0 9.46 73.4 80600 ug/L Glassmeyer et a 1 2017 (Ambient) [86] 2007 - 2012 25 NA Sites 56 10.7 46 ug/L Arnold et al. 2016 (Filtered) [7] 2012 - 2013 757 729 Sites 96 0.22 5.39 39.6 285 ug/L Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure Biomonitoring Data Detection at 90tii Percentile Units Notes NHANES biomonitoring detection n serum (1999-2016) NHANES biomonitoring detection n blood (1999-2016) NHANES biomonitoring detection n urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Green highlighted data indicates a change made between the draft and final CCL 5. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. A-507 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Lithium CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 53 Bradley, P. M., Kolpin, D. W., Romanok, K. M., Smalling, K. L., Focazio, M. J., Brown, J. B.,... & Dietze, J. E. (2018). Reconnaissance of mixed organic and inorganic chemicals in private and public supply tapwaters at selected residential and workplace sites in the United States. Environmental science & technology, 52(23), 13972-13985. 86 Glassmeyer, S.T., Furlong, E.T., Kolpin, D.W., Batt, A.L., Benson, R., Boone, J.S.,... & Wilson, V.S. (2017). Nationwide reconnaissance of contaminants of emerging concern in source and treated drinking waters of the United States. Science of The Total Environment. v581-582, (909-922). 178 USEPA (US Environmental Protection Agency). (2009). 2006 Community Water System Survey. Overview, 57. 295 USEPA. 2008. Provisional Peer Reviewed Toxicity Values for Lithium (CASRN 7439-93-2). EPA/690/R-08/016F. U.S. Environmental Protection Agency, Office of Research and Development, National Center for Environmental Assessment, Superfund Health Risk Technical Support Center, Cincinnati, OH. A-508 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Loratadine CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Chemical Notes: DTXSID2023224 Is the contaminant on any lists? CERCLA FIFRA Human Neurotoxicants PubMed Neu rotoxica nts X Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANTSUMMARY& DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 8 non-cancer effects 6 1 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date SL 0.3 lowest therapeutic dose: Antihista mine/relieves of symptoms due to hay fever or other upper respiratory allergies such as runny nose, itchy, watery eyes bottle-fed infants FDA; NIH 2018; 2018 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.0017 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-509 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Loratadine CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 4.16667 E-05 mg/kg/day FDA 2018; NIH 2018 Bayer Healthcare LLC lowest therapeutic dose:Antihistamine/relieves of symptoms due to hay fever or other upper respiratory allergies such as runny nose, itchy, watery eyes bottle-fed infants 151 0.280 [77] [150] NOTE: (Lowest Therapeutic Dose/3000x UF) is used in place of an RfD; LTDs were obtained from FDA-approved drug labels Reference Dose (RfD) or Equivalent 4.16667 E-05 mg/kg/day FDA 2018; NIH 2018 Bayer Healthcare LLC lowest therapeutic dose:Antihistamine/relieves of symptoms due to hay fever or other upper respiratory allergies such as runny nose, itchy, watery eyes general population 33.8 0.980 [77] [150] NOTE: (Lowest Therapeutic Dose/3000x UF) is used in place of an RfD; LTDs were obtained from FDA-approved drug labels Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Maximum Recommended Daily Dose 0.167 mg/kg/day FDA Screening level for pharmaceutical - general 0.000980392 mg/L EPA Office of Water population Screening level for pharmaceutical - infants 0.000277778 mg/L EPA Office of Water Data Element Value Units Source Notes Measured Data and Assessment Results LD50 5000 mg/kg NIH HSDB Percent of active toxcast in 37 percent EPA Chemistry Dashboard vitro assays tested Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Modeled Data LD50 0.0011588 mo l/kg TEST QSAR Ames mutagenicity test -0.082 no units TEST QSAR Developmental toxin test 0.8 no units TEST QSAR A-510 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Loratadine CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contam nant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contam nant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contam nant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contam nant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contam nant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contam nant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 557 4 Sites 0.72 0.00022 0.00059 0.0017 0.00279 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 75 3 Sites 4 0.00034 6e-04 0.00192 0.00279 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 482 1 Sites 0.21 0.00022 0.00022 0.00022 0.00022 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Glassmeyer et al 2017 (Finished) [86] 2007-2012 25 NA Sites 0 ug/L Ambient Water Prevalence Magnitude National Water Information System (USGS NWIS) (Surface Water) 2008-2017 205 10 Sites 4.88 0.00016 0.00154 0.0134 0.151 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008-2017 401 1 Sites 0.25 0.00097 0.00097 0.00097 0.00097 ug/L National Water Information System (USGS NWIS) (All Water) 2008-2017 606 11 Sites 1.82 0.00016 0.00142 0.0134 0.151 ug/L Glassmeyer et a 1 2017 (Ambient) [86] 2007-2012 25 NA Sites 0 ug/L Bradley et al. 2017 (Ambient) [52] 2012-2014 38 6 Sites 16 0.0007989 0.00138 0.00211 0.0022605 ug/L Bexfield et al. 2019 (Groundwater) [49] 2013-2015 1,106 0 Sites 0 Waste Water Effluent Prevalence Magnitude Scott et al. 2018 (Wastewater) [161] 2011-2017 21 12 Sites 57 0.0016315 0.0026 0.0153 0.0638996 ug/L Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/ day) Notes Expocast exposure 0.000000259 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 3.35836 days Boiling point OPERA QSAR 365.058 degree C Boiling point TEST QSAR 474.912 degree C Vapor pressure OPERA QSAR 3.83E-10 mmHg Vapor pressure TEST QSAR 2.27E-10 mmHg Solubility in water OPERA QSAR 0.00000725 mol/L Solubility in water TEST QSAR 0.0000128 mol/L Bioconcentration factor OPERA QSAR 124.017 no units Bioconcentration factor TEST QSAR 28.6418 no units Henry's Law constant OPERA QSAR 0.000000016 atm-mA3/mol 0 eta no l/water partitioning coeff. (log Kow) OPERA QSAR 4.96583 no units A-511 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Loratadine CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 49 Bexfield, L.M., P.L. Toccalino, K. Belitz, W.T. Foreman, and E.T. Furlong. 2019. Hormones and pharmaceuticals in groundwater used as a source of drinking water across the United States. Environmental Science and Technology 53: 2950-2960. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 77 FDA. 2018. Drugs @ FDA: FDA Approved Drug Products. U.S. Food and Drug Administration (FDA), https://www.accessdata.fda.gov/scripts/cder/daf/. 86 Glassmeyer, S.T., Furlong, E.T., Kolpin, D.W., Batt, A.L., Benson, R., Boone, J.S.,... & Wilson, V.S. (2017). Nationwide reconnaissance of contaminants of emerging concern in source and treated drinking waters of the United States. Science of The Total Environment. v581-582, (909-922). 150 NIH. 2018. DailyMed Database. U.S. National Library of Medicine, National Institutes of Health (NIH). https://dailymed.nlm.nih.gov/dailymed/. 161 Scott, T. M., Phillips, P. J., Kolpin, D. W., Colella, K. M., Furlong, E. T., Foreman, W. T., & Gray, J. L. (2018). Pharmaceutical manufacturing facility discharges can substantially increase the pharmaceutical load to US wastewaters. Science of the Total Environment, 636, 69-79. A-512 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Magnesium CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Magnesium CASRN: 7439-95-4 DTXSID: DTXSID0049658 Use: Metal, used in alloys commonly with aluminum Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA Human Neurotoxicants PubMed Neu rotoxica nts X Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 3 non-cancer effects 10 10 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date SL 7000 "mild diarrhea and other mild gastrointestinal complaints" reversible bottle-fed infants IOM 1997 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 35511 90th Percentile Finished Water NIRS 1984-1986 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-513 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Magnesium CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 5 mg/kg/day IOM 1997 Bashiretal., 1993 mild diarrhea and other mild gastrointestinal complaints bottle-fed infants 151 6620 [107] NOTE: this compound is a nutrient Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Measured Data and Assessment Results I Value I Measured Data and Assessment Results I I Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Modeled Data LD50 TEST QSAR Ames mutagenicity test TEST QSAR Developmental toxin test TEST QSAR A-514 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Magnesium CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev (NIRS) 1984 -1986 988 976 Sites 99 50 9948 35511 115887 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 12.121 12.118 Sites 100 5 9630 32300 2.00E+06 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 2.620 2.620 Sites 100 41 8760 29100 2.00E+06 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 9.502 9.499 Sites 100 5 12700 40100 1800000 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) 250M-500M Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Finished) 2006 - 2020 621 598 Sites 96 57 14600 32000 1400000 ug/L Drinking Water Monitoring Data - MA (Finished) 2006 - 2020 542 521 Sites 96 10 3500 8500 70000 ug/L Drinking Water Monitoring Data - WA (Finished) 2006-2011 206 201 Sites 98 100 8000 19720 49500 ug/L Glassmeyer et al 2017 (Finished) [86] 2007-2012 25 NA Sites 100 8810 31700 ug/L Community Water System Survey (CWSS) (Finished) [178] 2006 12 NA Sites 9950 24000 ug/L Ambient Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Source) 2006 - 2020 5,422 5,288 Sites 98 3 14000 47000 7.1e+07 ug/L Drinking Water Monitoring Data - MA (Source) 2006 - 2020 81 81 Sites 100 400 4400 8000 55400 ug/L Drinking Water Monitoring Data - PA (Source) 2006-2011 3 3 Sites 100 2600 14800 19530 19600 ug/L Drinking Water Monitoring Data - WA (Source) 2006-2011 308 304 Sites 99 120 10850 25710 59500 ug/L Drinking Water Monitoring Data - Wl (Source) 2012-2019 141 140 Sites 99 160 23000 43700 77300 ug/L Glassmeyer et al 2017 (Ambient) [86] 2007 - 2012 25 NA Sites 100 10600 44600 ug/L Arnold et al. 2016 (Filtered) [7] 2012 - 2013 758 757 Sites 100 13 5840 35440 133000 ug/L Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/ day) Notes Expocast exposure Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. A-515 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Magnesium CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 86 Glassmeyer, S.T., Furlong, E.T., Kolpin, D.W., Batt, A.L., Benson, R., Boone, J.S.,... & Wilson, V.S. (2017). Nationwide reconnaissance of contaminants of emerging concern in source and treated drinking waters of the United States. Science of The Total Environment. v581-582, (909-922). 107 IOM. 1997. Standing Committee on the Scientific Evaluation of Dietary Reference Intakes, Food and Nutrition Board. Dietary Reference Intakes for calcium, phosphorus, magnesium, vitamin D, and fluoride. Institute of Medicine (IOM), National Academy Press, Washington, DC. 178 USEPA (US Environmental Protection Agency). (2009). 2006 Community Water System Survey. Overview, 57. A-516 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Malathion CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Chemical Notes: DTXSID4020791 Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts X Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 5 reproductive and developmental effects 9 3 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value («"gA) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 10 inhibition of red blood cell acetylcholinesterase in pups bottle-fed infants OPP 2016 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.078 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-517 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Malathion CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.01 mg/kg/day OPP 2016 Fulcher 2001; Barnett 2006, 2008 inhibition of red blood cell acetylcholinesterase in pups bottle-fed infants 151 13.2 [368] Cancer Classification (CC) S OPP 2016 [3681 Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element I Value I Units I Source I Notes Measured Data and Assessment Results 10-day Health Advisory 0.2 mg/L EPA DWSHA 2018 Acute inhalation Minimal Risk Level (MRL) 0.2 mg/mA3 CDC ATSDR Intermediate Inhalation Minimal Risk Level (MRL) 0.02 mg/mA3 CDC ATSDR Intermediate Minimal Risk Level (MRL) 0.02 mg/kg/day CDC ATSDR Lifetime Health Advisory 0.5 mg/L EPA DWSHA 2018 Maximum Allowable Concentration (MAC) 0.19 mg/L Canadian Drinking Water Guidelines Cancer Classification (CC) 2A no units WHO IARC Cancer Classification (CC) Female.Mice N no units HHSNTP Cancer Classification (CC) Female.Mice NT no units HHSNTP Cancer Classificat on (CC) Female.Rats N no units HHSNTP Cancer Classificat on (CC) Female.Rats N no units HHSNTP Cancer Classificat on (CC) Male.Mice N no units HHSNTP Cancer Classificat on (CC) Male.Mice NT no units HHSNTP Cancer Classificat on (CC) Male.Rats N no units HHSNTP Cancer Classificat on (CC) Male.Rats N no units HHSNTP Data Element I Value I Units I Source I Notes Measured Data and Assessment Results LD50 190 mg/kg NIH HSDB min LD50 5843 mg/kg NIH HSDB max LOAEL 1476 mg/kg/day EPA Toxicity Reference Database max LOAEL 29 mg/kg/day EPA Toxicity Reference Database min NOAEL 451 mg/kg/day EPA Toxicity Reference Database max NOAEL 5 mg/kg/day EPA Toxicity Reference Database min Percent of active toxcast in vitro assays tested 12.14 percent EPA Chemistry Dashboard TD50 44700 mg/kg/day NIH CPDB max TD50 66.6 mg/kg/day NIH CPDB min Data Element Value Units Source Notes Modeled Data LD50 0.0010471 mo l/kg TEST QSAR Ames mutagenicity test 0.383 no units TEST QSAR Developmental toxin test 0.378 no units TEST QSAR Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. A-518 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Ma lath ion CCL5 Contaminant Informatio OCCURRENCE DATA EPA-OGWDWand OST Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018 - 2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013 - 2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008 - 2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survey (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991 - 2017 11,237 416 Sites 3.7 0.00041 0.014 0.078 9.58 ug/L National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991 - 2017 2,230 383 Sites 17 0.00041 0.014 0.078 9.58 ug/L National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991 - 2017 9,008 33 Sites 0.37 0.00107 0.006 0.0248 0.239 ug/L PesticideApplication Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) 33 1,346,697 2016 Toxic Release Inventory (TRI) Program (EPA) (2016) 10 108,619 Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Drinking Water Monitoring Data -CA (Finished) 2006 - 2020 3 0 Sites 0 Drinking Water Monitoring Data - WA (Finished) 2006 - 2011 481 0 Sites 0 USDA Pesticide Data Program (PDP) (Finished) 2001 - 2013 17 2 Sites 12 0.01 0.063 0.254 0.331 ug/L USGS, Sioux Falls Area, 2012 (Finished) [153] 2009 - 2010 1 0 Sites 0 Ambient Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Source) 2006 - 2020 37 0 Sites 0 Drinking Water Monitoring Data - WA (Source) 2006 - 2011 634 0 Sites 0 National Water Information System (USGS NWIS) (Surface Water) 2008 - 2017 1,003 50 Sites 4.99 6.00E-04 0.022 0.418 5.46 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008 - 2017 3,060 3 Sites 0.1 0.01 0.108 0.159 0.181 ug/L National Water Information System (USGS NWIS) (All Water) 2008 - 2017 4,062 53 Sites 1.3 6.00E-04 0.0223 0.401 5.46 ug/L USDA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001 - 2013 229 4 Sites 1.75 0.00999 0.0763 0.269 0.312 ug/L USDA Pesticide Data Program (PDP) (Groundwater) 2001-2013 219 3 Sites 1.37 0.05 0.103 0.278 0.312 ug/L USDA Pesticide Data Program (PDP) (Untreated) 2001-2013 12 1 Sites 8.33 0.00999 0.00999 0.00999 0.00999 ug/L Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990-2018 15,764 712 Sites 4.52 0.006 0.089 0.848 46 ug/L Bradley et al. 2017 (Ambient) [52] 2012-2014 38 3 Sites 7.89 0.0166 0.0374 0.0518 0.0554 ug/L Arnold et al. 2016 (Filtered) [7] 2012-2013 690 3 Sites 0.43 0.0011 0.0017 0.0891 0.111 ug/L USGS, Sioux Falls Area, 2012 (Ambient) [153] 2009-2010 2 0 Sites 0 USGS, McKenzie River, Oregon, 2012 (Ambient) [158] 2002-2010 133 3 Samples 2.3 0.04 ug/L Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mgAg bw/day) Notes Expocast exposure 0.00000153 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. "All Water7' data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 25.141 days Boiling point OPERA QSAR 359.971 degree C Boiling point TEST QSAR 284.068 degree C Vapor pressure OPERA QSAR 0.00000395 mmHg Vapor pressure TEST QSAR 0.00000723 mmHg Solubility in water OPERA QSAR 0.000634727 mol/L Solubility in water TEST QSAR 0.000760326 mol/L Bioconeentration factor OPERA QSAR 26.329 no units Bioconeentration factor TEST QSAR 9.86279 no units Henry's Law constant OPERA QSAR 3.85E-09 atm-mA3/mol Octanol/water partitioning coeff. (log Kow) OPERA QSAR 2.24648 no units A-519 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Malathion CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 153 Occurrence of anthropogenic organic compounds and nutrients in source and finished water in the Sioux Falls area, South Dakota, 2009-10: U.S. Geological Survey Scientific Investigations Report 2012-5098, 21 p. plus appendixes. 158 Reconnaissance of Land-Use Sources of Pesticides in Drinking Water, McKenzie River, Oregon. U.S. Geological Survey Scientific Investigations Report 2012-5091, 46 p. plus appendixes. 368 USEPA. 2016. Malathion: Human Health Draft Risk Assessment for Registration Review. E PA-HQ-OPP-2009-0317-0080. DP No. D414107. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticide in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. A-520 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Manganese CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Manganese CASRN: 7439-96-5 DTXSID: DTXSID2024169 Use: Manufacturing of steel alloys, in dry-cell batteries, electrical coils, ceramics, matches, glass, dyes, fertilizers, welding rods, as oxidizing agents, and as animal food additives. Chemical Notes: This CIS also contains some data for the following: -Manganese & Manganese Compounds -Manganese Compounds Isthe contaminant on any lists? CERCLA X FIFRA Human Neurotoxicants Pub Med Neurotoxicants X Neurodev. Disruptors X Androgen Receptors in vitro Compounds with neurodev effects, Mundy et a 12015 X CONTAMINANT SUMMARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 5 reproductive and developmental effects 10 7 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value ("g/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 30 various neurological end points in rats including behavioral and sensorimotor effects, corresponding neurostructural and neurochemical changes, persistent later-life consequences of developmental exposures after levels of manganese in the brain have returned bottle-fed infants HC 2019 Cone, in water for HQ ("g/L) 90th Percentile or Maximum (if measured cone) Finished or Ambient (FW, SW, GW, WW) Source Date 29.2 90th Percentile Finished Water UCMR4 2018-2019 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS RD1 RD 2 RD 3 X Not Applicable Not Applicable Managanese is a naturally occurring element and an essential nutrient of which ingestion is not known to present adverse health effects at low levels [a]. Drinking water contributes only a small portion of norma I oral intake, contributing to approximately 2.8 x 10-4 mg/kg-day of daily manganese exposure (calculated using the median concentration of detections of NIRS data (0.012 mg/L), and assuming a daily intake of 2 Lof drinking water by a 70 kg adult for a calcualted exposure ) [b,c]. It is unlikely that regulation of manganese in drinking water would represent a meaningful opportunity for health risk reduction in persons served by public water systems. [a] USE PA, 2003 [257]; [b] 10 M, 2001 [106]; [c] NIRS, 2016 [151]; £ USE PA, 2001 [180] Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. Green highlighting indicates a change made between the draft and final CCL 5. A-521 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Manganese CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.025 mg/kg/day HC 2019 Kern etal., 2010,2011; Beaudin et al., 2013 various neurological endpoints in rats. "In addition to demonstratingthat exposure to manganese in early life can result in behavioural and sensorimotor effects, these studies provided mechanistic support by demonstrating corresponding neurostructural and neurochemical changes. Further, Kern et al. (2011) and Beaudin et al. (2013) demonstrated the ability of manganese exposure in early life to result in effects that persist into adulthood, after levels of manganese in the brain have returned to normal." bottle-fed infants 151 33.1 [101] Reference Dose (RfD) or Equivalent 0.14 mg/kg/day IRIS 1988 NRC 1989; Freeland- Graveset al. 1987; WHO 1973 "CNS effects" general population 33.8 828 [199] Reference Dose (RfD) or Equivalent 0.14 mg/kg/day OW 2004 NRC 1989; WHO 1973; Schroeder etal. 1966 "NOAELfor chronic ingestion of manganese by humans" general population 33.8 828 [260] Cancer Classification (CC) D IRIS 1988 [1991 Cancer Classification (CC) D OW 2004 [2601 Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Reproductive 0.01 Souza, 2019 Developmental 11 Foster, 2018 2018-05-01 2019-10-25 1413 13 91 3 Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results 10-day Health Advisory 1 mg/L EPA DWSHA 2018 Chronic Health-Based Guidance Value 0.1 mg/L MN DOH Human Health Ambient Water Quality Criteria 0.05 mg/L EPA Human Health Criteria for CWA Lifetime Health Advisory 0.3 mg/L EPA DWSHA 2018 Reference Concentration (RfC) 0.09 ug/mA3 CalEPA OEHHA Chemical Database manganese & manganese compounds Reference Concentration (RfC) 0.00005 mg/mA3 EPA IRIS Notes: Yellow highlighted data indicate value was used in attribute scoring. Green highlighted data indicates a change made between the draft and final CCL 5. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Modeled Data LD50 TEST QSAR Ames mutagenicity test TEST QSAR Developmental toxin test TEST QSAR Data Element | Value | Units | Source | Notes Measured Data and Assessment Results A-522 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Manganese CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDWand OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes finished Water Preva ence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018 - 2019 3,743 3,293 Sites 88 0.4 2.76 29.2 3960 ug/L Unregulated Contaminant Monitoring Rule (UCMR) 3 2013 - 2015 799 668 Sites 84 1 5.5 57 3550 ug/L Unregulated Contaminant Monitoring Rule (UCMR) 2 2008 - 2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survey (NIRS) 1984 -1986 989 672 Sites 68 1 12 126 1341 ug/L Ambient Water Preva ence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991 - 2017 11,988 10,113 Sites 84 0.05 18 195 59000 ug/L National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991 - 2017 2,538 2,439 Sites 96 0.1 18.4 122 12000 ug/L National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991 - 2017 9.451 7.674 Sites 81 0.05 17 440 59000 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Data Number of States Amount Released Notes Toxic Release Inventory (TRI) Program (EPA) (2016) 47 31,505,117 manganese 50 190,761,638 manganese compounds Chemical Production Data Production Volume (lbs/year) Chemical Data Reporting (CDR) Results (EPA) (2016) 250M - 500M NorvScoring_Data_ Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes finished Water Preva ence Magnitude Drinking Water Monitoring Data - CA (Finished) 2006 - 2020 926 562 Sites 61 0.002 28 190 93300 ug/L Drinking Water Monitoring Data - MA (Finished) 2006 - 2020 1,665 1,305 Sites 78 0.38 59 475 159000 ug/L Drinking Water Monitoring Data - WA (Finished) 2006 - 2011 998 519 Sites 52 0.6 30 210 6700 ug/L Bradley et al. 2018 (Finished) [53] 2016 26 22 Sites 85 0.55 1.84 13.8 44.47 ug/L Glassmeyer et al 2017 (Finished) [86] 2007 - 2012 25 NA Sites 64 2.6 55.6 ug/L Community Water System Survey (CWSS) (Finished) [178] 2006 1 NA Sites 0.003 0.003 ug/L Ambient Water Preva ence Magnitude Drinking Water Monitoring Data - CA (Source) 2006 - 2020 5,546 2,858 Sites 52 0.003 87 510 36000 ug/L Drinking Water Monitoring Data - FL (Source) 2006 - 2011 35 29 Sites 83 0.3 6.4 42 90 ug/L Drinking Water Monitoring Data - MA (Source) 2006 - 2020 407 362 Sites 89 0.93 182 1180 11000 ug/L Drinking Water Monitoring Data - PA (Source) 2006 - 2011 52 45 Sites 87 0.04 70 374 1500 ug/L Drinking Water Monitoring Data - WA (Source) 2006 - 2011 1,560 804 Sites 52 0.6 50 240 9150 ug/L Drinking Water Monitoring Data - Wl (Source) 2012-2019 145 124 Sites 86 0.516 25 140 10600 ug/L National Water Information System (USGS NWIS) (Surface Water) 2008 - 2017 3,519 3,463 Sites 98 0.04 30 231 357000 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008 - 2017 11,832 9,545 Sites 81 0.019 19.9 641 680000 ug/L National Water Information System (USGS NWIS) (All Water) 2008 - 2017 15,319 12,981 Sites 85 0.019 28.8 316 680000 ug/L Glassmeyer et al 2017 (Ambient) [86] 2007 - 2012 25 NA Sites 92 43 1497 ug/L Arnold et al. 2016 (Filtered) [7] 2012 - 2013 757 653 Sites 86 0.15 8.06 175 3110 ug/L Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure Biomonitoring Data Detection at 90th Percentile Units Notes NHANES bio monitoring detect ion in serum (1999-2016) NHANES bio monitoring detect ion in blood (1999-2016) 14.8 ug/l NHANES bio monitoring detect ion in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Green highlighted data indicates a change made between the draft and final CCL 5. Blank fields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. A-523 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Manganese CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 53 Bradley, P. M., Kolpin, D. W., Romanok, K. M., Smalling, K. L., Focazio, M. J., Brown, J. B.,... & Dietze, J. E. (2018). Reconnaissance of mixed organic and inorganic chemicals in private and public supply tapwaters at selected residential and workplace sites in the United States. Environmental science & technology, 52(23), 13972-13985. 86 Glassmeyer, S.T., Furlong, E.T., Kolpin, D.W., Batt, A.L., Benson, R., Boone, J.S.,... & Wilson, V.S. (2017). Nationwide reconnaissance of contaminants of emerging concern in source and treated drinking waters of the United States. Science of The Total Environment. v581-582, (909-922). 101 Health Canada. 2019. Guideline Technical Document Manganese. Health Canada (HC), Ottawa, Ontario, Canada. 106 Institute of Medicine (IOM). 2001. Dietary Reference Intakes for Vitamin A, Vitamin K, Arsenic, Boron, Chromium, Copper, Iodine, Iron, Manganese, Molybdenum, Nickel, Silicon, Vanadium and Zinc: A Report of the Panel on Micronutrients, Subcommittees on Upper Reference Levels of Nutrients and of Interpretation and Use of Dietary Reference Intakes, and the Standing Committee on the Scientific Evaluation of Dietary Reference Intakes, Food and Nutrition Board, Institute of Medicine. Washington, DC: National Academy Press (prepublication version). Available on the Internet at: 151 NIRS. 2016. Summary of data provided in tabular form in docket; www.regulations.gov Docket ID EPA-HQ-OW-2007-1189. 178 USEPA (US Environmental Protection Agency). (2009). 2006 Community Water System Survey. Overview, 57. 180 USEPA, 2001. Regulatory Determination Support Document for Manganese. EPA 815 R-01-013. 199 USEPA. 1988. Manganese; CASRN 7439-96-5. U.S. Environmental Protection Agency, National Center for Environmental Assessment, Integrated Risk Information System (IRIS), Washington, DC. 257 USEPA. 2003. Health Effects Support Document for Manganese. Office of Water. EPA Report 822-R-03-003. February 2003.164pp. 260 USEPA. 2004. Drinking Water Health Advisory for Manganese. EPA-822-R-04-003. U.S. Environmental Protection Agency, Office of Water, Health and Ecological Criteria Division, Washington, DC. A-524 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Meprobamate CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Meprobamate CASRN: 57-53-4 DTXSID: DTXSID3023261 Use: anxiolytic Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA Human Neurotoxicants PubMed Neu rotoxica nts X Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANTSUMMARY& DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 6 non-cancer effects 9 3 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date SL 30 lowest therapeutic dose: short-term relief of the symptoms of anxiety bottle-fed infants FDA; NIH 2018; 2018 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.06641 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-525 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Meprobamate CCL 5 Contaminant Information Sheet EPA-OGWDWand OST October 2022 HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.005 mg/kg/day FDA 2018; NIH 2018 Alembic Pharmaceuticals Inc. lowest therapeutic dose: short-term relief of the symptoms of anxiety bottle-fed infants 151 33.0 [77] [150] NOTE: (Lowest Therapeutic Dose/3000x UF) is used in place of an RfD; LTDs were obtained from FDA-approved drug labels Reference Dose (RfD) or Equivalent 0.005 mg/kg/day FDA 2018; NIH 2018 Alembic Pharmaceuticals Inc. lowest therapeutic dose: short-term relief of the symptoms of anxiety general population 33.8 120 [77] [150] NOTE: (Lowest Therapeutic Dose/3000x UF) is used in place of an RfD; LTDs were obtained from FDA-approved drug labels Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Maximum Recommended Daily Dose 40 mg/kg/day FDA Screening level for pharmaceutical - general 0.117647059 mg/L EPA Office of Water population Screening level for pharmaceutical - infants 0.033333333 mg/L EPA Office of Water Data Element Value Units Source Notes Measured Data and Assessment Results LD50 1410 mg/kg NIH HSDB max LD50 750 mg/kg NIH HSDB min Percent of active toxcast in vitro assays tested 0.43 percent EPA Chemistry Dashboard Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Modeled Data LD50 0.0038637 mo l/kg TEST QSAR Ames mutagenicity test 0.522 no units TEST QSAR Developmental toxin test 0.896 no units TEST QSAR A-526 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Meprobamate CCL5 Contaminant Informatio OCCURRENCE DATA EPA-OGWDWand OST Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018 - 2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013 - 2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008 - 2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survey (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991 - 2017 557 18 Sites 3.23 0.00243 0.0203 0.0664 0.164 ug/L National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991 - 2017 75 11 Sites 15 0.00243 0.0202 0.0527 0.137 ug/L National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991 - 2017 482 7 Sites 1.45 0.00965 0.0385 0.142 0.164 ug/L PesticideApplication Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Bradley et a 1. 2018 (Finished) [53] 2016 26 1 Sites 3.85 0.0183328 0.0183 0.0183 0.0183328 ug/L Glassmeyer et al 2017 (Finished) [86] 2007 - 2012 25 NA Sites 0 ug/L Snyder et al. (2007) via Kumar et al. (2010) (Finished) [128] 2007 20 NA Samples 0.0016 0.0038 0.013 ug/L Ambient Water Prevalence Magnitude National Water Information System (USGS NWIS) (Surface Water) 2008 - 2017 210 63 Sites 30 0.00176 0.0102 0.0422 0.199 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008 - 2017 401 18 Sites 4.49 0.00335 0.0189 0.056 0.0658 ug/L National Water Information System (USGS NWIS) (All Water) 2008 - 2017 611 81 Sites 13 0.00176 0.0115 0.0436 0.199 ug/L Glassmeyer et al 2017 (Ambient) [86] 2007 - 2012 25 NA Sites 4 0.0142 0.01418 ug/L Bradley et a 1. 2017 (Ambient) [52] 2012 - 2014 38 16 Sites 42 0.0085162 0.0422 0.327 0.405929 ug/L Bexfield et al. 2019 (Groundwater) [49] 2013 - 2015 1,106 8 Sites 0.72 0.0171232 0.0211 0.0761 0.1639527 ug/L Snyder et al. (2007) via Kumar et a 1. (2010) (Ambient) [128] 2007 20 NA Samples 0.0014 0.0059 0.016 ug/L Benotti et al. (2009) via Kostich et al. 2010 (Ambient) [127] 2010 NA NA 0.073 ug/L Stand ley et al. (2008) via Kostich et al. 2010 (Ambient) [127] 2010 NA NA 0.007 ug/L Trenholm et al. (2006) via Kostich et al. 2010 (Ambient) [127] 2010 NA NA 0.01 ug/L Vanderford et al. (2003) via Kostich et al. 2010 (Ambient) [127] 2010 NA NA 0.22 ug/L Vanderford et al. (2006) via Kostich et al. 2010 (Ambient) [127] 2010 NA NA 0.594 ug/L Waste Water Effluent Prevalence Magnitude Scott et al. 2018 (Wastewater) [161] 2011 - 2017 21 20 Sites 95 0.0341876 0.117 0.709 1.3396304 ug/L Trenholm et al. (2006) via Kostich et al. 2010 (Wastewater) [127] 2010 NA NA 0.56 ug/L Vanderford et al. (2006) via Kostich et al. 2010 (Wastewater) [127] 2010 NA NA 1.44 ug/L Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 2.46E-08 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES bion onitoring detection in serum (1999-2016) NHANES bion onitoring detection in blood (1999-2016) NHANES bion onitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. "All Water" data from NWISand NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPACompTox Dashboard) Value Units Notes Biodegradation ha If-life OPERA QSAR 4.65279 days Boiling point OPERA QSAR 255.297 degree C Boiling point TEST QSAR 303.784 degree C Vapor pressure OPERA QSAR 3.42E-09 mmHg Vapor pressure TEST QSAR 0.000325087 mmHg Solubility in water OPERA QSAR 0.0171375 mol/L Solubility in water TEST QSAR 0.0240991 mol/L Bioconcentration factor OPERA QSAR 1.78529 no units Bioconcentration factor TEST QSAR 1.19124 no units Henry's Law constant OPERA QSAR 1.04E-09 atm-mA3/mol Octanol/water partitioning coeff. (log Kow) OPERA QSAR 0.860718 no units A-527 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Meprobamate CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 49 Bexfield, L.M., P.L. Toccalino, K. Belitz, W.T. Foreman, and E.T. Furlong. 2019. Hormones and pharmaceuticals in groundwater used as a source of drinking water across the United States. Environmental Science and Technology 53: 2950-2960. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 53 Bradley, P. M., Kolpin, D. W., Romanok, K. M., Smalling, K. L., Focazio, M. J., Brown, J. B.,... & Dietze, J. E. (2018). Reconnaissance of mixed organic and inorganic chemicals in private and public supply tapwaters at selected residential and workplace sites in the United States. Environmental science & technology, 52(23), 13972-13985. 77 FDA. 2018. Drugs @ FDA: FDA Approved Drug Products. U.S. Food and Drug Administration (FDA), https://www.accessdata.fda.gov/scripts/cder/daf/. 86 Glassmeyer, S.T., Furlong, E.T., Kolpin, D.W., Batt, A.L., Benson, R., Boone, J.S.,... & Wilson, V.S. (2017). Nationwide reconnaissance of contaminants of emerging concern in source and treated drinking waters of the United States. Science of The Total Environment. v581-582, (909-922). 127 Kostich, MS, et al., 2010. Predicting variability of aquatic concentrations of human pharmaceuticals. Sci. Total Environ. 408 (20), 4504e4510. 128 Kumar, A. and Xagoraraki, 1., 2010. Human health risk assessment of pharmaceuticals in water: An uncertainty analysis for meprobamate, carbamazepine, and phenytoin. Regulatory Toxicology and Pharmacology, 57(2-3), pp.146-156. 150 NIH. 2018. DailyMed Database. U.S. National Library of Medicine, National Institutes of Health (NIH). https://dailymed.nlm.nih.gov/dailymed/. 161 Scott, T. M., Phillips, P. J., Kolpin, D. W., Colella, K. M., Furlong, E. T., Foreman, W. T., & Gray, J. L. (2018). Pharmaceutical manufacturing facility discharges can substantially increase the pharmaceutical load to US wastewaters. Science of the Total Environment, 636, 69-79. A-528 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Metalaxyl CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Metalaxyl CASRN: 57837-19-1 DTXSID: DTXSID6024175 Use: Fungicide Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 4 reproductive and developmental effects 9 2 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value («"gA) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 700 dose-related increases in clinical signs of toxicity (e.g., post-dosing convulsions) bottle-fed infants OPP 2016 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.0453 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-529 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Metalaxyl CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.5 mg/kg/day OPP 2016 Ciba-Geigy Corp. 1985 dose-related increases in clinical signs of toxicity (e.g., post-dosing convulsions) bottle-fed infants 151 662 [369] Cancer Classification (CC) NL OPP 2016 [3691 Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Health-Based Screening Level 0.474 mg/L Health-based screening levels from USGS Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Measured Data and Assessment Results LD50 669 mg/kg NIH HSDB min LD50 7120 mg/kg NIH HSDB max LOAEL 30.629999 mg/kg/day EPA Toxicity Reference Database min LOAEL 400 mg/kg/day EPA Toxicity Reference Database max NOAEL 250 mg/kg/day EPA Toxicity Reference Database max NOAEL 7.8 mg/kg/day EPA Toxicity Reference Database min Percent of active toxcast in 3.26 percent EPA Chemistry Dashboard vitro assays tested Sub chronic LOAEL 30.629999 mg/kg/day EPA Toxicity Reference Database Subchronic NOAEL 7.8 mg/kg/day EPA Toxicity Reference Database Data Element Value Units Source Notes Modeled Data LD50 0.0090573 mo l/kg TEST QSAR Ames mutagenicity test 0.191 no units TEST QSAR Developmental toxin test 0.606 no units TEST QSAR A-530 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Metalaxyl CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST October 2022 Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018 - 2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013 - 2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008 - 2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survey (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991 - 2017 5,889 367 Sites 6.23 0.00012 0.009 0.0453 3.02 ug/L National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991 - 2017 715 277 Sites 39 0.00012 0.009 0.0426 1.48 ug/L National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991 - 2017 5,174 90 Sites 1.74 0.00032 0.01 0.28 3.02 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) 2 2,967 2016 Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) N on-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude USDA Pesticide Data Program (PDP) (Finished) 2001 - 2013 13 4 Sites 31 0.005 0.005 0.0115 0.0375 ug/L Bradley et al. 2018 (Finished) [53] 2016 26 2 Sites 7.69 0.0203 0.0209 0.0214 0.0215 ug/L Community Water System Survey (CWSS) (Finished) [178] 2006 1 NA Sites USGS, Sioux Falls Area, 2012 (Finished) [153] 2009 - 2010 1 0 Sites 0 Ambient Water Prevalence Magnitude National Water Information System (USGS NWIS) (Surface Water) 2008 - 2017 1,407 202 Sites 14 0.00032 0.013 0.11 9.05 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008 - 2017 3,270 61 Sites 1.87 0.00081 0.01 0.371 7.33 ug/L National Water Information System (USGS NWIS) (All Water) 2008 - 2017 4,676 263 Sites 5.62 0.00032 0.0124 0.117 9.05 ug/L USDA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001 - 2013 179 32 Sites 18 0.0042 0.005 0.0393 0.955 ug/L USDA Pesticide Data Program (PDP) (Groundwater) 2001 - 2013 172 27 Sites 16 0.0042 0.0107 0.0589 0.955 ug/L USDA Pesticide Data Program (PDP) (Untreated) 2001 - 2013 7 5 Sites 71 0.005 0.005 0.0375 0.0375 ug/L Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990 - 2018 26 0 Sites 0 Community Water System Survey (CWSS) (Ambient) [178] 2006 1 NA Sites 0.845 1.31 ug/L Bradley et al. 2017 (Ambient) [52] 2012 - 2014 38 8 Sites 21 0.0085 0.0437 0.116 0.1508 ug/L Arnold et al. 2016 (Filtered) [7] 2012 - 2013 796 18 Sites 2.26 3e-04 9e-04 0.243 1.06 ug/L USGS, Sioux Falls Area, 2012 (Ambient) [153] 2009 - 2010 2 0 Sites 0 lA/osfe Water Effluent Prevalence Magnitude Scott et al. 2018 (Wastewater) [161] 2011-2017 20 0 Sites 0 Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg- bw/day) Notes Expocast exposure 0.000000101 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blank fie Ids indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Bio degradation ha If-life OPERA QSAR 4.29311 days Boiling point OPERA QSAR 299.877 degree C Boiling point TEST QSAR 344.018 degree C Vapor pressure OPERA QSAR 0.00000522 mmHg Vapor pressure TEST QSAR 0.00000547 mmHg Solubility in water OPERA QSAR 0.0163893 mol/L Solubility in water TEST QSAR 0.00233884 mol/L B io co n ce nt rat io n facto r OPERA QSAR 8.24464 no units B io co n ce nt rat io n facto r TEST QSAR 17.1396 no units Henry's Law constant OPERA QSAR 3.9E-09 atm-mA3/mol Octanol/water partitioning coeff. (log Kow) OPERA QSAR 1.76605 no units A-531 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Metalaxyl CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulorigoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 53 Bradley, P. M., Kolpin, D. W., Romanok, K. M., Smalling, K. L., Focazio, M. J., Brown, J. B.,... & Dietze, J. E. (2018). Reconnaissance of mixed organic and inorganic chemicals in private and public supply tapwaters at selected residential and workplace sites in the United States. Environmental science & technology, 52(23), 13972-13985. 153 Occurrence of anthropogenic organic compounds and nutrients in source and finished water in the Sioux Falls area, South Dakota, 2009-10: U.S. Geological Survey Scientific Investigations Report 2012-5098, 21 p. plus appendixes. 161 Scott, T. M., Phillips, P. J., Kolpin, D. W., Colella, K. M., Furlong, E. T., Foreman, W. T., & Gray, J. L. (2018). Pharmaceutical manufacturing facility discharges can substantially increase the pharmaceutical load to US wastewaters. Science of the Total Environment, 636, 69-79. 178 USE PA (US Environmental Protection Agency). (2009). 2006 Community Water System Survey. Overview, 57. 369 USEPA. 2016. Mefenoxam. Human Health Risk Assessment for Proposed Use on the Rapeseed Subgroup 20A. EPA-HQ-OPP-2015-0014-0008. DP No. D424727. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticide in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. A-532 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Metformin CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Chemical Notes: DTXSID2023270 Is the contaminant on any lists? FIFRA Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 5 non-cancer effects 10 3 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date SL 40 lowest therapeutic dose: decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization bottle-fed infants FDA; NIH 2018; 2018 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.333 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-533 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Metformin CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.00625 mg/kg/day FDA 2018; NIH 2018 Ascend Laboratories , LLC lowest therapeutic dose: decreases hepatic glucose production, decrease; intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization bottle-fed infants 151 42.0 [77] [150] NOTE: (Lowest Therapeutic Dose/3000x UF) is used in place of an RfD; LTDs were obtained from FDA-approved drug labels Reference Dose (RfD) or Equivalent 0.00625 mg/kg/day FDA 2018; NIH 2018 Ascend Laboratories , LLC lowest therapeutic dose: decreases hepatic glucose production, decrease; intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization general population 33.8 150 [77] [150] NOTE: (Lowest Therapeutic Dose/3000x UF) is used in place of an RfD; LTDs were obtained from FDA-approved drug labels Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Maximum Recommended Daily Dose 50 mg/kg/day FDA Screening level for pharmaceutical - general population 0.147058824 mg/L EPA Office of Water Screening level for pharmaceutical - infants 0.041666667 mg/L EPA Office of Water Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Measured Data and Assessment Results Percent of active toxcast in 0.75 percent EPA Chemistry Dash board vitro assays tested Data Element Value Units Source Notes Modeled Data LD50 0.0012106 mo l/kg TEST QSAR Ames mutagenicity test 0.207 no units TEST QSAR Developmental toxin test TEST QSAR A-534 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Metformin CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 553 70 Sites 13 0.00138 0.0275 0.333 2.64 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 75 69 Sites 92 0.00138 0.0276 0.333 2.64 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 478 1 Sites 0.21 0.00163 0.00163 0.00163 0.00163 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Glassmeyer et al 2017 (Finished) [86] 2007-2012 25 NA Sites 0 ug/L Ambient Water Prevalence Magnitude National Water Information System (USGS NWIS) (Surface Water) 2008-2017 205 169 Sites 82 0.0013 0.0732 0.656 13.5 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008-2017 399 11 Sites 2.76 0.00087 0.00401 0.401 0.627 ug/L National Water Information System (USGS NWIS) (All Water) 2008-2017 604 180 Sites 30 0.00087 0.0721 0.633 13.5 ug/L Glassmeyer et al 2017 (Ambient) [86] 2007-2012 25 NA Sites 0 ug/L Bradley et al. 2017 (Ambient) [52] 2012-2014 38 25 Sites 66 0.0103849 0.41 2.05 4.3079718 ug/L Bexfieid et al. 2019 (Groundwater) [49] 2013-2015 1,106 2 Sites 0.18 0.0325339 0.0356 0.0381 0.0386649 ug/L Benotti et al. (2007) via Kostich et al. 2010 (Ambient) [127] 2010 NA NA 0.092 ug/L Kolpin et al. (2002) via Kostich et al. 2010 (Ambient) [127] 2010 NA NA 0.15 ug/L Waste Water Effluent Prevalence Magnitude Scott et al. 2018 (Wastewater) [161] 2011-2017 19 19 Sites 100 0.0259915 1.81 28.4 35.91536 ug/L Benotti et al. (2007) via Kostich et al. 2010 (Wastewater) [127] 2010 NA NA 47.253 ug/L Glassmeyer et al. (2005) via Kostich et al. 2010 (Wastewater) [127] 2010 NA NA 0.698 ug/L Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/ day) Notes Expocast exposure 1.47E-08 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR4 data used in the CCL5 is a partial datasetand will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 3.98474 days Boiling point OPERA QSAR 256.674 degree C Boiling point TEST QSAR Vapor pressure OPERA QSAR 6.56E-10 mmHg Vapor pressure TEST QSAR Solubility in water OPERA QSAR 0.0483462 mol/L Solubility in water TEST QSAR 0.530884 mol/L Bioconcentration factor OPERA QSAR 1.94277 no units Bioconcentration factor TEST QSAR Henry's Law constant OPERA QSAR 3.46E-09 o E E 0 eta no l/water partitioning coeff. (log Kow) OPERA QSAR 0.735672 no units A-535 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Metformin CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 49 Bexfield, L.M., P.L. Toccalino, K. Belitz, W.T. Foreman, and E.T. Furlong. 2019. Hormones and pharmaceuticals in groundwater used as a source of drinking water across the United States. Environmental Science and Technology 53: 2950-2960. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 77 FDA. 2018. Drugs @ FDA: FDA Approved Drug Products. U.S. Food and Drug Administration (FDA), https://www.accessdata.fda.gov/scripts/cder/daf/. 86 Glassmeyer, S.T., Furlong, E.T., Kolpin, D.W., Batt, A.L., Benson, R., Boone, J.S.,... & Wilson, V.S. (2017). Nationwide reconnaissance of contaminants of emerging concern in source and treated drinking waters of the United States. Science of The Total Environment. v581-582, (909-922). 127 Kostich, MS, etal., 2010. Predicting variability of aquatic concentrations of human pharmaceuticals. Sci. Total Environ. 408 (20), 4504e4510. 150 NIH. 2018. DailyMed Database. U.S. National Library of Medicine, National Institutes of Health (NIH). https://dailymed.nlm.nih.gov/dailymed/. 161 Scott, T. M., Phillips, P. J., Kolpin, D. W., Colella, K. M., Furlong, E. T., Foreman, W. T., & Gray, J. L. (2018). Pharmaceutical manufacturing facility discharges can substantially increase the pharmaceutical load to US wastewaters. Science of the Total Environment, 636, 69-79. A-536 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Methocarbamol CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Chemical Notes: Methocarbamol DTXSID6023286 ikeletal muscle relaxanl Is the contaminant on any lists? CERCLA FIFRA Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANTSUMMARY& DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 5 non-cancer effects 9 3 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date SL 100 lowest t h e ra peut ic d ose: rel ief of d iscomfo rt associated with acute, painful musculoskeletal conditions bottle-fed infants FDA; NIH 2018; 2018 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.2468 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-537 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Methocarbamol CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.016666667 mg/kg/day FDA 2018; NIH 2018 Granules India Ltd lowest therapeutic dose: relief of discomfort associated with acute, painful musculoskeletal conditions bottle-fed infants 151 110 [77] [150] NOTE: (Lowest Therapeutic Dose/3000x UF) is used in place of an RfD; LTDs were obtained from FDA-approved drug labels Reference Dose (RfD) or Equivalent 0.016666667 mg/kg/day FDA 2018; NIH 2018 Granules India Ltd lowest therapeutic dose: relief of discomfort associated with acute, painful musculoskeletal conditions general population 33.8 390 [77] [150] NOTE: (Lowest Therapeutic Dose/3000x UF) is used in place of an RfD; LTDs were obtained from FDA-approved drug labels Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Maximum Recommended Daily Dose 100 mg/kg/day FDA Screening level for pharmaceutical - general population 0.392156863 mg/L EPA Office of Water Screening level for pharmaceutical - infants 0.111111111 mg/L EPA Office of Water Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Measured Data and Assessment Results Percent of active toxcast in 1.7 percent EPA Chemistry Dashboard vitro assays tested Data Element Value Units Source Notes Modeled Data LD50 0.0036141 mo l/kg TEST QSAR Ames mutagenicity test 0.734 no units TEST QSAR Developmental toxin test 0.731 no units TEST QSAR A-538 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Methocarbamol CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 557 22 Sites 3.95 0.00074 0.0242 0.247 2.49 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 75 21 Sites 28 0.00074 0.026 0.259 2.49 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 482 1 Sites 0.21 0.00145 0.00145 0.00145 0.00145 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Bradley et al. 2018 (Finished) [53] 2016 26 1 Sites 3.85 0.5983694 0.598 0.598 0.5983694 ug/L Glassmeyer et al 2017 (Finished) [86] 2007-2012 25 NA Sites 0 ug/L Ambient Water Prevalence Magnitude National Water Information System (USGS NWIS) (Surface Water) 2008-2017 207 84 Sites 41 0.00076 0.0196 0.139 0.383 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008-2017 401 6 Sites 1.5 0.00198 0.0334 0.269 0.55 ug/L National Water Information System (USGS NWIS) (All Water) 2008-2017 608 90 Sites 15 0.00076 0.0196 0.139 0.55 ug/L Glassmeyer et al 2017 (Ambient) [86] 2007-2012 25 NA Sites 8 0.0291 0.0323 ug/L Bradley et al. 2017 (Ambient) [52] 2012-2014 38 16 Sites 42 0.0139004 0.188 0.736 2.6272938 ug/L Bexfieid et al. 2019 (Groundwater) [49] 2013-2015 1,106 0 Sites 0 Waste Water Effluent Prevalence Magnitude Scott et al. 2018 (Wastewater) [161] 2011-2017 21 19 Sites 90 0.0153466 0.306 0.719 7.79 ug/L Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/ day) Notes Expocast exposure 0.000000165 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR4 data used in the CCL5 is a partial datasetand will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 4.48255 days Boiling point OPERA QSAR 312.903 degree C Boiling point TEST QSAR 362.745 degree C Vapor pressure OPERA QSAR 7.2E-09 mmHg Vapor pressure TEST QSAR 0.000000925 mmHg Solubility in water OPERA QSAR 0.100228 mol/L Solubility in water TEST QSAR 0.0132739 mol/L Bioconcentration factor OPERA QSAR 1.10629 no units Bioconcentration factor TEST QSAR 2.10863 no units Henry's Law constant OPERA QSAR 5.9E-10 o E E 0 eta no l/water partitioning coeff. (log Kow) OPERA QSAR 0.65558 no units A-539 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Methocarbamol CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 49 Bexfield, L.M., P.L. Toccalino, K. Belitz, W.T. Foreman, and E.T. Furlong. 2019. Hormones and pharmaceuticals in groundwater used as a source of drinking water across the United States. Environmental Science and Technology 53: 2950-2960. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 53 Bradley, P. M., Kolpin, D. W., Romanok, K. M., Smalling, K. L., Focazio, M. J., Brown, J. B.,... & Dietze, J. E. (2018). Reconnaissance of mixed organic and inorganic chemicals in private and public supply tapwaters at selected residential and workplace sites in the United States. Environmental science & technology, 52(23), 13972-13985. 77 FDA. 2018. Drugs @ FDA: FDA Approved Drug Products. U.S. Food and Drug Administration (FDA), https://www.accessdata.fda.gov/scripts/cder/daf/. 86 Glassmeyer, S.T., Furlong, E.T., Kolpin, D.W., Batt, A.L., Benson, R., Boone, J.S.,... & Wilson, V.S. (2017). Nationwide reconnaissance of contaminants of emerging concern in source and treated drinking waters of the United States. Science of The Total Environment. v581-582, (909-922). 150 NIH. 2018. DailyMed Database. U.S. National Library of Medicine, National Institutes of Health (NIH). https://dailymed.nlm.nih.gov/dailymed/. 161 Scott, T. M., Phillips, P. J., Kolpin, D. W., Colella, K. M., Furlong, E. T., Foreman, W. T., & Gray, J. L. (2018). Pharmaceutical manufacturing facility discharges can substantially increase the pharmaceutical load to US wastewaters. Science of the Total Environment, 636, 69-79. A-540 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Methomyl CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Methomyl CASRN: 16752-77-5 DTXSID: DTXSID1022267 Use: Insecticide Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants X PubMed Neu rotoxica nts X Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 6 reproductive and developmental effects 1 6 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value («"gA) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 2 increases in peak red blood cell acetylcholinesterase inhibition in human bottle-fed infants OPP 2018 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 2.92 90th Percentile Finished Water UCM2 1993-1997 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-541 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Methomyl CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.0015 mg/kg/day OPP 2018 McFarlane 1998 increases in peak red blood cell acetylcholinesterase inhibition in human bottle-fed infants 151 1.99 [403] Cancer Classification (CC) NL OPP 2018 [4031 Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results 10-day Health Advisory 0.3 mg/L EPA DWSHA 2018 Lifetime Health Advisory 0.2 mg/L EPA DWSHA 2018 Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Measured Data and Assessment Results LD50 10 mg/kg NIH HSDB min LD50 45 mg/kg NIH HSDB max LOAEL 10 mg/kg/day EPA Toxicity Reference Database min LOAEL 56.5 mg/kg/day EPA Toxicity Reference Database max NOAEL 2.5 mg/kg/day EPA Toxicity Reference Database min NOAEL 38.8 mg/kg/day EPA Toxicity Reference Database max Percent of active toxcast in 2.28 percent EPA Chemistry Dashboard vitro assays tested Subchronic LOAEL 12.5 mg/kg/day EPA Toxicity Reference Database Subchronic NOAEL 2.5 mg/kg/day EPA Toxicity Reference Database Data Element Value Units Source Notes Modeled Data LD50 0.0002421 mo l/kg TEST QSAR Ames mutagenicity test 0.871 no units TEST QSAR Developmental toxin test 0.501 no units TEST QSAR A-542 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Methomyl CCL5 Contaminant Informatio OCCURRENCE DATA EPA-OGWDWand OST Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018 - 2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013 - 2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008 - 2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 12,604 9 Sites 0.07 0.1 1 2.92 3 ug/L Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survey (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991 - 2017 7,697 83 Sites 1.08 0.00018 0.00502 0.166 3 ug/L National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991 - 2017 1,197 74 Sites 6.18 0.00018 0.005 0.141 3 ug/L National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991 - 2017 6,501 9 Sites 0.14 0.00032 0.025 0.248 0.38 ug/L PesticideApplication Data Number of States Amount Applied (lbs/year) Date Estimated Annual Agricultural Pesticide Use (USGS) 43 902,435 2016 Toxic Release Data Number of States Amount Released (lbs/year) Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Production Data Production Volume (lbs/year) Chemical Data Reporting (CDR) Results (EPA) (2016) Noil-Nation ally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Drinking Water Monitoring Data -CA (Finished) 2006 - 2020 169 0 Sites 0 Drinking Water Monitoring Data - MA (Finished) 2006 - 2020 820 0 Sites 0 Drinking Water Monitoring Data -WA (Finished) 2006 - 2011 255 0 Sites 0 USDA Pesticide Data Program (PDP) (Finished) 2001 - 2013 17 0 Sites 0 Ambient Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Source) 2006 - 2020 1,740 0 Sites 0 Drinking Water Monitoring Data - MA (Source) 2006 - 2020 77 0 Sites 0 Drinking Water Monitoring Data - PA (Source) 2006 - 2011 1 0 Sites 0 Drinking Water Monitoring Data - WA (Source) 2006 - 2011 422 0 Sites 0 Drinking Water Monitoring Data -Wl (Source) 2012-2019 92 0 Sites 0 National Water Information System (USGS NWIS) (Surface Water) 2008 - 2017 475 18 Sites 3.79 0.00024 0.00504 0.056 0.295 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008 - 2017 1,051 3 Sites 0.29 0.009 0.011 0.0537 0.072 ug/L National Water Information System (USGS NWIS) (All Water) 2008 - 2017 1,526 21 Sites 1.38 0.00024 0.00797 0.0672 0.295 ug/L USDA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001 - 2013 229 1 Sites 0.44 0.0122 0.0122 0.0122 0.0122 ug/L USDA Pesticide Data Program (PDP) (Groundwater) 2001 - 2013 219 0 Sites 0 USDA Pesticide Data Program (PDP) (Untreated) 2001-2013 12 1 Sites 8.33 0.0122 0.0122 0.0122 0.0122 ug/L Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990-2018 6,790 539 Sites 7.94 0.021 0.211 1.64 55.3 ug/L Bradley et al. 2017 (Ambient) [52] 2012-2014 38 1 Sites 2.63 0.0282 0.0282 0.0282 0.0282 ug/L Arnold et al. 2016 (Filtered) [7] 2012-2013 690 4 Sites 0.58 3e-04 0.0024 0.00778 0.01 ug/L Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mgAg bw/day) Notes Expocast exposure 5.76E-08 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for aII years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial data set and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Value Units Notes Biodegradation half-life OPERA QSAR 3.54233 days Boiling point OPERA QSAR 230.04 degree C Boiling point TEST QSAR 204.528 degree C Vapor pressure OPERA QSAR 0.0000114 mmHg Vapor pressure TEST QSAR 0.000257632 mmHg Solubility in water OPERA QSAR 0.237365 mol/L Solubility in water TEST QSAR 0.201837 mol/L Bioconeentration factor OPERA QSAR 3.54556 no units Bioconeentration factor TEST QSAR 2.29615 no units Henry's Law constant OPERA QSAR 2.02E-08 atm-mA3/mol Octanol/water partitioning coeff. (log Kow) OPERA QSAR 0.58656 no units A-543 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Methomyl CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 403 USEPA. 2018. Methomyl and Thiodicarb: Draft Human Health Risk Assessment in Support of Registration Review. EPA-HQ-OPP-2009-0432-0017. DP Nos. D420613 D439094. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticide in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. A-544 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Methyl mercury CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Methyl mercury CASRN: 22967-92-6 DTXSID: DTXSID9024198 Use: Fungicide and seed borne diseases, as timber preservatives, and disinfectants Chemical Notes: Is the contaminant on any lists? CERCLA X FIFRA Human Neurotoxicants X PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 X CONTAMINANT SUMMARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 7 reproductive and developmental effects 10 1 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value («"gA) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 0.4 Developmental neuropsychological impairment IRIS 2001 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.00038 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-545 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Methyl mercury CCL 5 Contaminant Information Sheet EPA-OGWDWand OST October 2022 HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.0003 mg/kg/day ATSDR 1999; 2013 Davidson et al. 1998 Effects of prenatal and postnatal methylmercury exposure from fish consumption on neurodevelopment: lactating women 46.9 1.28 [15] [33] Reference Dose (RfD) or Equivalent 0.0001 mg/kg/day IRIS 2001 Grandjean et al., 1997; Budtz J0rgensen et al., 1999a Developmental neuropsychological impairment lactating women 46.9 0.426 [242] Cancer Classification (CC) C IRIS 2001 [242] Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAE L (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Systemic, Neurological 0.000913 Li, 2018 Neurological, Hepatic, Renal, Systemic 4 Abdalla, 2012 2012-03-01 2020-01-15 2245 31 125 17 Other Health Data Data Element I Value Units 1 Source I Notes Measured Data and Assessment Results Cancer Classification (CC) 1 2B no units IWHO IARC l Data Element I Value I Units 1 Source I Notes Measured Data and Assessment Results LD50 | 58 | mg/kg Inih hsdb l Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Modeled Data LD50 TEST QSAR Ames mutagenicity test TEST QSAR Developmental toxin test TEST QSAR A-546 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Methyl mercury CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 510 416 Sites 82 4.00E - 05 0.00011 0.00038 2 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 447 384 Sites 86 4.00E - 05 0.00011 0.000345 0.00406 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 63 32 Sites 51 4.00E - 05 0.00027 0.0013 2 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Ambient Water Prevalence Magnitude National Water Information System (USGS NWIS) (Surface Water) 2008-2017 552 469 Sites 85 1.00E - 05 0.00019 0.0018 0.22 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008-2017 26 18 Sites 69 5.00E - 05 0.00017 0.000536 0.0013 ug/L National Water Information System (USGS NWIS) (All Water) 2008 - 2017 573 484 Sites 84 1.00E - 05 0.00019 0.0018 0.22 ug/L Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. A-547 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Methyl mercury CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 15 ATSDR. 1999. TOXICOLOGICAL PROFILE FOR MERCURY. U.S. Department of Health and Human Services, Public Health Service, Agency for Toxic Substances and Disease Registry (ATSDR), Atlanta, GA. 33 ATSDR. 2013. Addendum to the Toxicological Profile for Mercury (Alkeyl and Dialkyl compounds). U.S. Department of Health and Human Services, Public Health Service, Agency for Toxic Substances and Disease Registry (ATSDR), Atlanta, GA 242 USEPA. 2001. Chemical Assessment Summary Methylmercury. U.S. Environmental Protection Agency, National Center for Environmental Assessment, Integrated Risk Information System (IRIS), Washington, DC. A-548 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Methyl tert-butyl ether (MTBE) CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Met hy 1 te rt-buty 1 eth e r (MTB E) CASRN: 1634-04-4 DTXSID: DTXSID3020833 Use: Octane booster in gasoline; manufacture of isobutene; extraction solvent Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Final Hazard Quotient (HQ) Potency Severity Prevalence Magnitude no adverse effects 5 8 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 20 organoleptic end point OW 1997 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 34.6 90th Percentile Finished Water UCMR1 2001-2003 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-549 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Methyl tert-butyl ether (MTBE) CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes WHO 2005 [440] OW1997 [226] NOTE: The MTBE Health Advisory notes that keeping levels of contamination MTBE in the range of 20 to 40 ug/L or below would protect consumer acceptance of the water resource and would also provide a large margin of exposure (safety) from toxic effects. HC 2006 [99] ATSDR 1996 [12] CALEPA 1999 [56] Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Hematological, Cardiovascular 0.0055 Saeedi, 2017b Nervous, Respiratory, 1600 Dong-mei, 2009 2005-01-01 2020-01-15 909 9 10 8 Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Acute Health-Based Guidance Value 0.7 mg/L MN DOH Acute inhalation Minimal Risk Level (MRL) 2 ppm CDC ATSDR Acute Minimal Risk Level (MRL) 0.4 mg/kg/day CDC ATSDR Cancer Classification (CC) 3 no units WHO IARC Cancer Slope Factor (CSF) 0.0018 (mg/kg/day) A-1 CalEPA OEHHA Chemical Database Chronic Health-Based Guidance Value 0.7 mg/L MN DOH Chronic Health-Based Guidance Value 0.006 mg/L MN DOH Chronic inhalation Minimal Risk Level (MRL) 0.7 ppm CDC ATSDR Inhalation Unit Risk (IUR) 0.00000026 ug/mA3 CalEPA OEHHA Chemical Database Intermediate Inhalation Minimal Risk Level (MRL) 0.7 ppm CDC ATSDR Intermediate Minimal Risk Level (MRL) 0.3 mg/kg/day CDC ATSDR Public Health Goal 0.013 mg/L CalEPA OEHHA Public Health Goals Reference Concentration (RfC) 3 mg/mA3 EPA IRIS Reference Concentration (RfC) 8000 ug/mA3 CalEPA OEHHA Chemical Database Short-Term/Subchronic Health-Based Guidance Value 0.7 mg/L MN DOH Maximum Allowable Concentration (MAC) None no units Canadian Drinking Water Guidelines Data Element Value Units Source Notes Measured Data and Assessment Results LD50 4000 mg/kg NIH HSDB Percent of active toxcast in 2.13 percent EPA Chemistry Dashboard vitro assays tested Data Element Value Units Source Notes Modeled Data LD50 0.0128233 mo l/kg TEST QSAR Ames mutagenicity test 0.033 no units TEST QSAR Developmental toxin test 0.384 no units TEST QSAR Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. A-550 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Methyl tert-butyl ether (MTBE) CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contam nant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contam nant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contam nant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contam nant Monitoring Rule (UCMR) 1 2001 - 2003 3.871 19 Sites 0.49 5 9.2 34.6 49 Unregulated Contam nant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contam nant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 7.709 870 Sites 11 0.01 0.21 3.47 23000 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 263 122 Sites 46 0.01 0.24 1.81 81.3 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 7.446 748 Sites 10 0.01 0.2 6.3 23000 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) 34 1,740,624 Chemical Data Reporting (CDR) Results (EPA) (2016) 1B-5B Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Finished) 2006 - 2020 495 13 Sites 2.63 0.024 1.8 4.4 55 ug/L Drinking Water Monitoring Data - MA (Finished) 2006 - 2020 926 231 Sites 25 0.5 1.3 8.1 265 ug/L Community Water System Survey (CWSS) (Finished) [178] 2006 1 NA Sites 0.5 5 ug/L Ambient Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Source) 2006 - 2020 4,763 70 Sites 1.47 0.06 6.22 36 1900 ug/L Drinking Water Monitoring Data - FL (Source) 2006-2011 5 4 Sites 80 0.14 0.52 1.6 3.7 ug/L Drinking Water Monitoring Data - MA (Source) 2006 - 2020 138 46 Sites 33 0.5 4.2 101 880 ug/L Drinking Water Monitoring Data - PA (Source) 2006-2011 24 14 Sites 58 0.2 6 1300 61000 ug/L Drinking Water Monitoring Data - Wl (Source) 2012-2019 101 1 Sites 0.99 39 73.5 101 108 ug/L National Water Information System (USGS NWIS) (Surface Water) 2008-2017 283 21 Sites 7.42 0.01 0.05 0.189 0.97 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008-2017 4,403 312 Sites 7.09 0.01 0.16 1.56 1080 ug/L National Water Information System (USGS NWIS) (All Water) 2008-2017 4,683 333 Sites 7.11 0.01 0.15 1.38 1080 ug/L Community Water System Survey (CWSS) (Ambient) [178] 2006 1 NA Sites 1.05 5.2 ug/L Bradley et al. 2017 (Ambient) [52] 2012 - 2014 38 4 Sites 11 0.01845 0.0237 0.0388 0.04319 ug/L Arnold et al. 2016 (Unfiltered) [7] 2012 - 2013 685 55 Sites 8.03 0.01 0.06 0.765 4.47 ug/L Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 0.000000122 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) < LOD pg/ml NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 7.21225 days Boiling point OPERA QSAR 58.0708 degree C Boiling point TEST QSAR 68.237 degree C Vapor pressure OPERA QSAR 316.295 mmHg Vapor pressure TEST QSAR 215.278 mmHg Solubility in water OPERA QSAR 0.330721 mol/L Solubility in water TEST QSAR 0.290402 mol/L Bioconcentration factor OPERA QSAR 2.51817 no units Bioconcentration factor TEST QSAR 4.0738 no units Henry's Law constant OPERA QSAR 0.000937822 o E E 0 eta no l/water partitioning coeff. (log Kow) OPERA QSAR 1.0899 no units A-551 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Methyl tert-butyl ether (MTBE) CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 12 ATSDR. 1996. Toxicological Profile for Methyl tert-Butyl Ether. U.S. Department of Health and Human Services, Public Health Service, Agency for Toxic Substances and Disease Registry (ATSDR), Atlanta, GA. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 56 CalEPA. 1999. Public Health Goal for Methyl Tertiary Butyl Ether (MTBE) in Drinking Water. California Environmental Protection Agency (CalEPA), Office of Environmental Health Hazard Assessment, Pesticide and Environmental Toxicology Section, Sacramento, CA. 99 Health Canada. 2006. Guidelines for Canadian Drinking Water Quality: Guidline Technical Document Methyl Tertiary-Butyl Ether. Health Canada (HC), Ottawa, Ontario, Canada. 178 USE PA (US Environmental Protection Agency). (2009). 2006 Community Water System Survey. Overview, 57. 226 USEPA. 1997. Drinking Water Advisory: Consumer Acceptability Advice and Health Effects Analysis on Methyl Tertiary-Butyl Ether (MtBE). U.S. Environmental Protection Agency, Office of Water, Health and Ecological Criteria Division, Washington, DC. 440 WHO. 2005. Methyl tertiary-Butyl Ether (MTBE) in Drinking-water Background document for development of WHO Guidelines for Drinking-water Quality. World Health Organization (WHO), Geneva, Switzerland. A-552 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Metolachlor ethanesulfonic acid (ESA) CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Metolachlorethanesulfonicacid( ESA) CASRN: 171118-09-5 DTXSID: DTXSID1037567 Use: Pesticide degradate Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 4 non-cancer effects 8 7 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date SL 2000 increased liver weight and increased serum liver enzymes general population MDH 2018 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 2.619857 90th Percentile Finished Water UCMR2 2008-2010 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-553 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Metolachlor ethanesulfonic acid (ESA) CCL 5 Contaminant Information Sheet EPA-OGWDWand OST October 2022 HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.07 mg/kg/day CALEPA 2017 Altmann 1999 changes in clinical chemistry data and absolute liver weight general population 33.8 414 [61] Reference Dose (RfD) or Equivalent 0.27 mg/kg/day MDH 2018 Altmann 1999 increased liver weight and increased serum liver enzymes general population 33.8 1600 [144] Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Chronic Health-Based Guidance Value 0.8 mg/L MN DOH Short-Term/Subchronic Health-Based Guidance Value 4 mg/L MN DOH Data Element Value Units Source Notes Measured Data and Assessment Results Percent of active toxcast in 1.77 percent EPA Chemistry Dashboard vitro assays tested Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Modeled Data LD50 0.0101625 mo l/kg TEST QSAR Ames mutagenicity test 0.62 no units TEST QSAR Developmental toxin test 1.269 no units TEST QSAR A-554 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Metolachlor ethanesulfonic acid (ESA) CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST October 2022 Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR)4 2018 - 2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013 - 2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008 - 2010 1,198 19 Sites 1.59 1 1.44 2.62 3.95455 ug/L Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survey (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991 - 2017 2,722 915 Sites 34 0.0036 0.284 1.66 35 ug/L National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991 - 2017 422 312 Sites 74 0.0036 0.28 1.51 8.4 ug/L National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991 - 2017 2,300 603 Sites 26 0.0048 0.315 4.92 35 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting(CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Finished) 2006 - 2020 4 0 Sites 0 USDA Pesticide Data Program (PDP) (Finished) 2001 - 2013 17 14 Sites 82 6e-04 0.054 0.69 2.5 ug/L Bradley et al. 2018 (Finished) [53] 2016 26 7 Sites 27 0.02 0.027 0.212 0.23 ug/L Community Water System Survey (CWSS) (Finished) [178] 2006 1 NA Sites 2.35 2.35 ug/L Ambient Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Source) 2006 - 2020 2 0 Sites 0 National Water Information System (USGS NWIS) (Surface Water) 2008 - 2017 355 169 Sites 48 0.0075 0.182 0.827 2.89 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008 - 2017 830 290 Sites 35 0.0123 0.291 2.2 14.8 ug/L National Water Information System (USGS NWIS) (All Water) 2008 - 2017 1,185 459 Sites 39 0.0075 0.208 1.25 14.8 ug/L USDA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001 - 2013 229 193 Sites 84 0.000599 0.066 0.735 18 ug/L USDA Pesticide Data Program (PDP) (Groundwater) 2001 - 2013 219 186 Sites 85 0.000599 0.0528 0.87 18 ug/L USDA Pesticide Data Program (PDP) (Untreated) 2001 - 2013 12 9 Sites 75 6e-04 0.0735 0.716 3.603 ug/L Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990 - 2018 56 33 Sites 59 0.05 0.128 0.272 0.502 ug/L Community Water System Survey (CWSS) (Ambient) [178] 2006 1 NA Sites 1.55 6.01 ug/L Bradley et al. 2017 (Ambient) [52] 2012 - 2014 38 22 Sites 58 0.02 0.125 0.416 1 ug/L Arnold et al. 2016 (Filtered) [7] 2012 - 2013 584 106 Sites 18 0.0048 0.338 3.48 31.1 ug/L lA/osfe Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg- bw/day) Notes Expo cast exposure 0.000000125 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR4data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biode gradation ha If-life OPERA QSAR 4.64024 days Boiling point OPERA QSAR 314.443 degree C Boiling point TEST QSAR 404.135 degree C Vapor pressure OPERA QSAR 5.03 E-08 mmHg Vapor pressure TEST QSAR Solubility in water OPERA QSAR 0.0102496 mol/L Solubility in water TEST QSAR 0.00190108 mol/L Bioconcentration factor OPERA QSAR 9.61626 no units Bioconcentration factor TEST QSAR 9.95405 no units Flenry's Law constant OPERA QSAR 4.27E-10 atm-mA3/mol Octanol/water partitioning coeff. (log Kow) OPERA QSAR 3.49063 no units A-555 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Metolachlor ethanesulfonic acid (ESA) CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 53 Bradley, P. M., Kolpin, D. W., Romanok, K. M., Smalling, K. L., Focazio, M. J., Brown, J. B.,... & Dietze, J. E. (2018). Reconnaissance of mixed organic and inorganic chemicals in private and public supply tapwaters at selected residential and workplace sites in the United States. Environmental science & technology, 52(23), 13972-13985. 61 CalEPA. 2017. Public Health Concentration: Metolachlor and Metolachlor Degradates Ethanesulfonic Acid and Oxanilic Acid in Groundwater. California Environmental Protection Agency (CalEPA), Office of Environmental Health Hazard Assessment, Pesticide and Environmental Toxicology Branch, Sacramento, CA. 144 MDH. 2018. Toxicological Summary for: Metolachlor ESA. Health Based Guidance for Water. Minnesota Department of Health (MDH), Environmental Health Division, Health Risk Assessment Unit, St Paul, MN. 178 USE PA (US Environmental Protection Agency). (2009). 2006 Community Water System Survey. Overview, 57. 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticide in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. A-556 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Metolachlor oxanilic acid (OA) CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Metolachlor oxanilic acid (OA) CASRN: 152019-73-3 DTXSID: DTXSID6037568 Use: Pesticide degradate Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 4 non-cancer effects 1 8 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date SL 2000 changes in blood chemistry parameters without identified specific target organs general population MDH 2018 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 3.4468 90th Percentile Finished Water UCMR2 2008-2010 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-557 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Metolachlor oxanilic acid (OA) CCL 5 Contaminant Information Sheet EPA-OGWDWand OST October 2022 HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.17 mg/kg/day CALEPA 2017 Lees 2004 changes in clinic chemistry data general population 33.8 1010 [61] Reference Dose (RfD) or Equivalent 0.27 mg/kg/day MDH 2018 Syngenta 2004 changes in blood chemistry parameters without identified specific target organs general population 33.8 1600 [145] Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Acute Health-Based Guidance Value 3 mg/L MN DOH Chronic Health-Based Guidance Value 0.8 mg/L MN DOH Short-Term/Subchronic Health-Based Guidance Value 3 mg/L MN DOH Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Measured Data and Assessment Results Percent of active toxcast in 0.72 percent EPA Chemistry Dashboard vitro assays tested Data Element Value Units Source Notes Modeled Data LD50 0.0094624 mo l/kg TEST QSAR Ames mutagenicity test 0.353 no units TEST QSAR Developmental toxin test 0.732 no units TEST QSAR A-558 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Metolachlor oxanilic acid (OA) CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST October 2022 Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018 - 2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013 - 2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008 - 2010 1,198 1 Sites 0.08 2.502 3.08 3.45 3.539 ug/L Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-St ate (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-St ate (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survey (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991 - 2017 2,723 500 Sites 18 0.01 0.245 1.02 19 ug/L National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991 - 2017 423 234 Sites 55 0.01 0.244 0.942 12 ug/L National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991 - 2017 2,300 266 Sites 12 0.02 0.28 1.97 19 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Finished) 2006 - 2020 4 0 Sites 0 USDA Pesticide Data Program (PDP) (Finished) 2001 - 2013 17 13 Sites 76 0.003 0.036 0.315 4.42 ug/L Bradley et al. 2018 (Finished) [53] 2016 26 4 Sites 15 0.03 0.155 0.332 0.38 ug/L Community Water System Survey (CWSS) (Finished) [178] 2006 1 NA Sites 1.77 1.77 ug/L Ambient Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Source) 2006 - 2020 2 0 Sites 0 National Water Information System (USGS NWIS) (Surface Water) 2008 - 2017 355 110 Sites 31 0.012 0.17 0.508 2.5 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008 - 2017 830 160 Sites 19 0.02 0.19 1.5 19.6 ug/L National Water Information System (USGS NWIS) (All Water) 2008 - 2017 1,185 270 Sites 23 0.012 0.178 0.738 19.6 ug/L USDA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001 - 2013 229 181 Sites 79 0.003 0.04 0.29 4.36 ug/L USDA Pesticide Data Program (PDP) (Groundwater) 2001 - 2013 219 174 Sites 79 0.003 0.0213 0.214 4.36 ug/L USDA Pesticide Data Program (PDP) (Untreated) 2001 - 2013 12 9 Sites 75 0.003 0.0565 0.311 1.5 ug/L Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990 - 2018 56 22 Sites 39 0.05 0.062 0.0924 0.113 ug/L Community Water System Survey (CWSS) (Ambient) [178] 2006 1 NA Sites 1.08 5.14 ug/L Bradley et al. 2017 (Ambient) [52] 2012 - 2014 38 16 Sites 42 0.02 0.04 0.205 0.66 ug/L Arnold et al. 2016 (Filtered) [7] 2012 - 2013 584 30 Sites 5.14 0.051 0.314 1.84 17.6 ug/L lA/osfe Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg- bw/day) Notes Exp oca st exposure 0.000000119 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection n serum (1999-2016) NHANES biomonitoring detection n blood (1999-2016) NHANES biomonitoring detection n urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR4data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biode gradation ha If-life OPERA QSAR 3.35407 days Boiling point OPERA QSAR 319.319 degree C Boiling point TEST QSAR 356.287 degree C Vapor pressure OPERA QSAR 0.000000191 mmHg Vapor pressure TEST QSAR 0.000000653 mmHg Solubility in water OPERA QSAR 0.00424338 mol/L Solubility in water TEST QSAR 0.00225944 mol/L Bioconcentration factor OPERA QSAR 2.91419 no units Bioconcentration factor TEST QSAR 1.57398 no units Flenry's Law constant OPERA QSAR 8.32E-09 atm-mA3/mol Octanol/water partitioning coeff. (log Kow) OPERA QSAR 2.6119 no units A-559 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Metolachlor oxanilic acid (OA) CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 53 Bradley, P. M., Kolpin, D. W., Romanok, K. M., Smalling, K. L., Focazio, M. J., Brown, J. B.,... & Dietze, J. E. (2018). Reconnaissance of mixed organic and inorganic chemicals in private and public supply tapwaters at selected residential and workplace sites in the United States. Environmental science & technology, 52(23), 13972-13985. 61 CalEPA. 2017. Public Health Concentration: Metolachlor and Metolachlor Degradates Ethanesulfonic Acid and Oxanilic Acid in Groundwater. California Environmental Protection Agency (CalEPA), Office of Environmental Health Hazard Assessment, Pesticide and Environmental Toxicology Branch, Sacramento, CA. 145 MDH. 2018. Toxicological Summary for: Metolachlor OXA. Health Based Guidance for Water. Minnesota Department of Health (MDH), Environmental Health Division, Health Risk Assessment Unit, St Paul, MN. 178 USE PA (US Environmental Protection Agency). (2009). 2006 Community Water System Survey. Overview, 57. 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticide in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. A-560 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Metoprolol CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Metoprolol CASRN: 51384-51-1 DTXSID: DTXSID2023309 Use: beta-1 blocking agent that is commonly used to treat ANGINA PECTORIS; HYPERTENSION; and CARDIAC ARRHYTHMIAS Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANTSUMMARY& DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 7 non-cancer effects 8 3 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date SL 0.7 lowest therapeutic dose: treatment of hypertension bottle-fed infants FDA; NIH 2018; 2018 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.126 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-561 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Metoprolol CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDW and OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg- HRL (ug/L) Assessment Full Citation Notes Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg- CCL Screening Level (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.000104167 mg/kg/day FDA 2018; NIH 2018 Ethex Corporatio lowest therapeutic dose: treatment of hypertension bottle-fed infants 151 0.690 [77] [150] NOTE: (LowestTherapeutic Dose/30OOx UF) is used in place of an RfD; LTDs were obtained from FDA-approved drug labels Reference Dose (RfD) or Equivalent 0.000104167 mg/kg/day FDA 2018; NIH 2018 Ethex Corporatio lowest therapeutic dose: treatment of hypertension general population 33.8 2.50 [77] [150] NOTE: (LowestTherapeutic Dose/30 OOx UF) is used in place of an RfD; LTDs were obtained from FDA-approved drug labels Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title- abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review 2020-01-28 3342 Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Maximum Recommended Daily Dose 6.67 mg/kg/day FDA Screening level for pharmaceutical - 0.00245098 mg/L EPA Office of Water general population Screening level for pharmaceutical - infants 0.000694444 mg/L EPA Office of Water Data Element Value Units Source Notes Measured Data and Assessment Results LD50 1158 mg/kg NIH HSDB min LD50 3090 mg/kg NIH HSDB max Percent of active toxcast in vitro assays tested 2.99 percent EPA Chemistry Dashboard Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Modeled Data LD50 0.0121339 mol/kg TEST QSAR Ames mutagenicity test 0.04 no units TEST QSAR Developmental toxin test 0.497 no units TEST QSAR A-562 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Metoprolol CCL5 Contaminant Informatio OCCURRENCE DATA EPA-OGWDWand OST Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018 - 2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013 - 2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008 - 2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survey (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991 - 2017 557 13 Sites 2.33 0.00147 0.0156 0.126 0.416 ug/L National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991 - 2017 75 12 Sites 16 0.00147 0.0169 0.128 0.416 ug/L National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991 - 2017 482 1 Sites 0.21 0.00196 0.00196 0.00196 0.00196 ug/L PesticideApplication Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Glassmeyer et al 2017 (Finished) [86] 2007 - 2012 25 NA Sites 12 0.0085 0.0184 ug/L Padhye et al. 2013 (Finished) [155] 2009 - 2010 8 1 Samples 12 0 0 le-07+/-0 ug/L Ambient Water Prevalence Magnitude National Water Information System (USGS NWIS) (Surface Water) 2008 - 2017 205 55 Sites 27 0.00146 0.00776 0.171 0.521 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008 - 2017 401 3 Sites 0.75 0.0668 0.123 0.164 0.182 ug/L National Water Information System (USGS NWIS) (All Water) 2008 - 2017 606 58 Sites 9.57 0.00146 0.0083 0.176 0.521 ug/L Glassmeyer et al 2017 (Ambient) [86] 2007 - 2012 25 NA Sites 32 0.0114 0.0378 ug/L Batt et al. 2016 (Ambient) [46] 2008 - 2009 182 73 Sites 40 0.0043 0.0175 0.0751 0.2177 ug/L Bradley et a 1. 2017 (Ambient) [52] 2012 - 2014 38 16 Sites 42 0.0020983 0.0637 0.116 0.3671431 ug/L Bexfield et al. 2019 (Groundwater) [49] 2013 - 2015 1,106 0 Sites 0 Padhye et al. 2013 (Ambient) [155] 2009 - 2010 8 8 Samples 100 le-07 +/- 0 le-07 3e-07 +/- le-07 ug/L Batt et al. (2008) via Kostich et al. 2010 (Ambient) [127] 2010 NA NA 0.012 ug/L Fono et al. (2006) via Kostich et al. 2010 (Ambient) [127] 2010 NA NA 0.571 ug/L Waste Water Effluent Prevalence Magnitude Scott et al. 2018 (Wastewater) [161] 2011 - 2017 21 21 Sites 100 0.0201093 0.173 0.654 6.989373 ug/L Kostich et al. 2014 (Wastewater) [126] not reported 50 49 Sites 98 0.1077 0.398 0.723 1.1692 ug/L Batt et al. (2008) via Kostich et al. 2010 (Wastewater) [127] 2010 NA NA 0.65 ug/L Conkle et al. (2008) via Kostich et al. 2010 (Wastewater) [127] 2010 NA NA 0.211 ug/L Fono et a1. (2006) via Kostich et al. 2010 (Wastewater) [127] 2010 NA NA 2.269 ug/L Hugget et al. (2003) via Kostich et al. 2010 (Wastewater) [127] 2010 NA NA 1.2 ug/L Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposu re Biomonitoring Data Detection at 90th Percentile Units Notes NHANES bion onitoring detection in serum (1999-2016) NHANES bion onitoring detection in blood (1999-2016) NHANES bion onitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. "All Water" data from NWISand NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation ha If-life OPERA QSAR 3.35452 days Boiling point OPERA QSAR 311.409 degree C Boiling point TEST QSAR 361.85 degree C Vapor pressure OPERA QSAR 0.000000498 mmHg Vapor pressure TEST QSAR 0.0000013 mmHg Solubility in water OPERA QSAR 0.0459364 mol/L Solubility in water TEST QSAR 0.0223357 mol/L Bioconcentration factor OPERA QSAR 17.2182 no units Bioconcentration factor TEST QSAR 32.8852 no units Henry's Law constant OPERA QSAR 0.000000126 atm-mA3/mol Octanol/water partitioning coeff. (log Kow) OPERA QSAR 1.93639 no units A-563 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Metoprolol CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 46 Batt, A. L., Kincaid, T. M., Kostich, M. S., Lazorchak, J. M., & Olsen, A. R. (2016). Evaluating the extent of pharmaceuticals in surface waters of the United States using a Nationaicale Rivers and Streams Assessment survey. Environmental toxicology and chemistry, 35(4), 874-881. 49 Bexfield, L.M., P.L. Toccalino, K. Belitz, W.T. Foreman, and E.T. Furlong. 2019. Hormones and pharmaceuticals in groundwater used as a source of drinking water across the United States. Environmental Science and Technology 53: 2950-2960. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 77 FDA. 2018. Drugs @ FDA: FDA Approved Drug Products. U.S. Food and Drug Administration (FDA), https://www.accessdata.fda.gov/scripts/cder/daf/. 86 Glassmeyer, S.T., Furlong, E.T., Kolpin, D.W., Batt, A.L., Benson, R., Boone, J.S.,... & Wilson, V.S. (2017). Nationwide reconnaissance of contaminants of emerging concern in source and treated drinking waters of the United States. Science of The Total Environment. v581-582, (909-922). 126 Kostich MS, et al. 2014 Concentrations of prioritized pharmaceuticals in effluents from 50 large wastewater treatment plants in the US and implications for risk estimation. Environ Pollut. 2014 Jan;184:354-9. doi: 10.1016/j.envpol.2013.09.013. Epub 2013 Oct 3. PMID: 24095705. 127 Kostich, MS, etal., 2010. Predicting variability of aquatic concentrations of human pharmaceuticals. Sci. Total Environ. 408 (20), 4504e4510. 150 NIH. 2018. DailyMed Database. U.S. National Library of Medicine, National Institutes of Health (NIH). https://dailymed.nlm.nih.gov/dailymed/. 155 Padhye, L.P., Yao, H., Kung'u, F.T., and Huang, C.H. Year-long evaluation on the occurrence and fate of pharmaceuticals, personal care products, and endocrine disrupting chemicals in an urban drinking water treatment plant. 2014. Water Research 51 (2014) 266-276. 161 Scott, T. M., Phillips, P. J., Kolpin, D. W., Colella, K. M., Furlong, E. T., Foreman, W. T., & Gray, J. L. (2018). Pharmaceutical manufacturing facility discharges can substantially increase the pharmaceutical load to US wastewaters. Science of the Total Environment, 636, 69-79. A-564 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Metribuzin CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION DTXSID6024204 Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Not List ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT IN FORMATION Potency Severity Prevalence Magnitude 6 non-cancer effects 1 4 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 8 increased thyroid and liver weights, thyroid follicular cell hyperplasia general population OPP 2017 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.1 90th Percentile Finished Water UCM2 1993-1997 Final Hazard Quotient (HQ) 0.013 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Metribuzin may cause advi evidences has shown from systems and the nur through drinking water are that regulation health risk reduction in pei i,b,c,d,e]. Basis irse health effects at high doses, as animal studies, but its occurrence in public ibers of people potentially exposed low [a,b,c,d,e]. Therefore, metribuzin may at frequencies that are of public health represents a meaningful opportunity for sons served by public water systems USE PA, 1998 [184]; [b] Kolpin, Barbash, & Gilliom, 1998 [124]; [c USE PA, 2001 [239]; [d] USE PA, 2001 [247]; [e] US EPA, 2003 [186]; a: cited in USE PA, 2001 [181] Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-565 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Metribuzin CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWandOST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.0013 mg/kg/day OPP 2017 Christenson & Wahle, 1993 increased thyroid and liver weights, thyroid follicular cell hyperplasia, decreased body weight and body weight gains general population 33.8 7.69 [386] Cancer Classification (CC) D OPP 2017 [3861 Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results 10-day Health Advisory 5 mg/L EPA DWSHA 2018 Acute Health-Based Guidance Value 0.01 mg/L MN DOH Acute Health-Based Guidance Value 0.03 mg/L MN DOH Chronic Health-Based Guidance Value 0.01 mg/L MN DOH Lifetime Health Advisory 0.07 mg/L EPA DWSHA 2018 Maximum Allowable Concentration (MAC) 0.08 mg/L Canadian Drinking Water Guidelines Short-Term/Subchronic Health-Based Guidance 0.01 mg/L MN DOH Value Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Modeled Data LD50 0.0042658 mo l/kg TEST QSAR Ames mutagenicity test 0.63 no units TEST QSAR Developmental toxin test 0.056 no units TEST QSAR Data Element I Value I Units I Source I Notes Measured Data and Assessment Results LD50 2200 mg/kg NIH HSDB max LD50 250 mg/kg NIH HSDB min LOAEL 200 mg/kg/day EPA Toxicity Reference Database max LOAEL 7.5 mg/kg/day EPA Toxicity Reference Database min NOAEL 1.5 mg/kg/day EPA Toxicity Reference Database min NOAEL 70 mg/kg/day EPA Toxicity Reference Database max Percent of active toxcast in vitro assays tested 3.22 percent EPA Chemistry Dashboard Sub chronic LOAEL 3 mg/kg/day EPA Toxicity Reference Database Subchronic NOAEL 1.25 mg/kg/day EPA Toxicity Reference Database A-566 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Metribuzin CCL5 Contaminant Informatio OCCURRENCE DATA EPA-OGWDWand OST Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018 - 2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013 - 2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008 - 2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 13,512 1 Sites 0.01 0.1 0.1 0.1 0.1 ug/L Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survey (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991 - 2017 11,379 606 Sites 5.33 0.001 0.02 0.17 15.6 ug/L National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991 - 2017 2,318 466 Sites 20 0.001 0.0205 0.17 15.6 ug/L National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991 - 2017 9,062 140 Sites 1.54 0.002 0.013 0.204 3.69 us/L PesticideApplication Data Number of States Amount Applied (lbs/year) Date Estimated Annual Agricultural Pesticide Use (USGS) 48 5,804,692 2016 Toxic Release Data Number of States Amount Released (lbs/year) Toxic Release Inventory (TRI) Program (EPA) (2016) 8 15,725 Chemical Production Data Production Volume (lbs/year) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Finished) 2006 - 2020 182 0 Sites 0 Drinking Water Monitoring Data - MA (Finished) 2006 - 2020 822 1 Sites 0.12 0.1 0.1 0.1 0.1 ug/L Drinking Water Monitoring Data - WA (Finished) 2006 - 2011 822 1 Sites 0.12 0.05 0.085 0.223 0.28 ug/L USDA Pesticide Data Program (PDP) (Finished) 2001 - 2013 15 3 Sites 20 0.0107 0.257 1.63 3.76 ug/L USGS, Sioux Falls Area, 2012 (Finished) [153] 2009 - 2010 1 0 Sites 0 Ambient Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Source) 2006 - 2020 2,171 0 Sites 0 Drinking Water Monitoring Data - MA (Source) 2006 - 2020 78 0 Sites 0 Drinking Water Monitoring Data - WA (Source) 2006 - 2011 997 0 Sites 0 Drinking Water Monitoring Data - Wl (Source) 2012-2019 92 0 Sites 0 National Water Information System (USGS NWIS) (Surface Water) 2008 - 2017 965 151 Sites 16 0.0018 0.0319 0.146 6.7 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008 - 2017 3,126 43 Sites 1.38 0.002 0.0105 0.0286 0.319 ug/L National Water Information System (USGS NWIS) (All Water) 2008 - 2017 4,090 194 Sites 4.74 0.0018 0.028 0.139 6.7 ug/L USDA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001 - 2013 226 3 Sites 1.33 0.0107 0.106 2.4 29.742 ug/L USDA Pesticide Data Program (PDP) (Groundwater) 2001 - 2013 218 0 Sites 0 USDA Pesticide Data Program (PDP) (Untreated) 2001-2013 9 3 Sites 33 0.0107 0.106 2.4 29.742 ug/L Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990-2018 1,320 27 Sites 2.05 0.006 0.012 0.0394 0.182 ug/L Bradley et al. 2017 (Ambient) [52] 2012-2014 38 3 Sites 7.89 0.0159 0.0184 0.436 0.541 ug/L Arnold et al. 2016 (Filtered) [7] 2012-2013 690 4 Sites 0.58 0.0038 0.292 0.628 0.651 ug/L USGS, Sioux Falls Area, 2012 (Ambient) [153] 2009-2010 2 0 Sites 0 Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mgAg bw/day) Notes Expocast exposure 0.000000012 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Value Units Notes Biodegradation half-life OPERA QSAR 3.7541 days Boiling point OPERA QSAR 299.501 degree C Boiling point TEST QSAR Vapor pressure OPERA QSAR 0.000000949 mmHg Vapor pressure TEST QSAR Solubility in water OPERA QSAR 0.00612378 mol/L Solubility in water TEST QSAR 0.00851138 mol/L Bioconcentration factor OPERA QSAR 2.56621 no units Bioconcentration factor TEST QSAR Henry's Law constant OPERA QSAR 2.17E-09 atm-mA3/mol Octanol/water partitioning coeff. (log Kow) OPERA QSAR 1.70267 no units A-567 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Metribuzin CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulorigoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 124 Kolpin, D.W., J.E. Barbash, and R.J. Gilliom. 1998. Occurrence of Pesticides in Shallow Groundwater of the United States: Initial Results from the National Water Quality Assessment Program. Env. Sci. Tech. 32:558-566. 153 Occurrence of anthropogenic organic compounds and nutrients in source and finished water in the Sioux Falls area, South Dakota, 2009-10: U.S. Geological Survey Scientific Investigations Report 2012-5098, 21 p. plus appendixes. 181 USEPA, 2001. Regulatory Determination Support Document for Metribuzin. EPA 815 R-01-010. 184 USEPA. 1998. R.E.D. Facts: Metribuzin. EPA Report 738-F-96-006. 7 pp. Available on the Internet at: http://www.epa.gov/oppsrrdl/REDs/ Last modified: 8/29/2000. 186 USEPA. 2003. Health Effects Support Document for Metribuzin. Office of Water. EPA Report822-R-03-004. February 2003. 84 pp. 239 USEPA. 2001. Analysis of National Occurrence of the 1998 Contaminant Candidate List Regulatory Determination Priority Contaminants in Public Water Systems. Office of Water. EPA report 815-D-01- 002. 77 pp. 247 USEPA. 2001. Occurrence of Unregulated Contaminants in Public Water Systems: An Initial Assessment. Office of Water. EPA report 815-P-00-001. Office of Water. 50 pp. 386 USEPA. 2017. Metribuzin: Draft Risk Assessment for Registration Review. EPA-HQ-OPP-2012-0487-0022. DP No. D432005. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticide in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. A-568 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Molybdenum CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Molybdenum CASRN: 7439-98-7 DTXSID: DTXSID1024207 Use: Use data for molybdenum trioxide: As steel alloy; chemical reagent; naturally-occurring Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANTSUMMARY& DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 6 non-cancer effects 10 7 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 30 increased uric acid levels general population IRIS 1992 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 7.5 90th Percentile Finished Water UCMR3 2013-2015 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-569 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Molybdenum CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.07 mg/L WHO 2011 Chappell et al. 1979 altered urinary levels of molybdenum and copper, altered serum levels of uric acid and ceruloplasmin general population 33.8 414 [442] Reference Dose (RfD) or Equivalent 0.005 mg/kg/day IRIS 1992 Koval'skiy et al., 1961 increased uric acid levels general population 33.8 29.6 [215] Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Endocrine, Immune, Neurological 5 Murray 2019 Reproductive, Renal, 40 Murray 2019 2016-04-01 2020-02-13 1086 2 34 1 Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results 10-day Health Advisory 0.08 mg/L EPA DWSHA2018 Chronic inhalation Minimal Risk Level (MRL) 0.0004 mg/mA3 CDC ATSDR Lifetime Health Advisory 0.04 mg/L EPA DWSHA 2018 Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Modeled Data LD50 TEST QSAR Ames mutagenicity test TEST QSAR Developmental toxin test TEST QSAR Data Element I Value | Units | Source I Notes Measured Data and Assessment Results A-570 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Molybdenum CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 4,922 2,546 Sites 52 1 2.4 7.5 196 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev (NIRS) 1984 -1986 989 77 Sites 7.79 6 10 32 181 Ambient Water Prevalence Magnitude National Water Qualitv Assessment (USGS NAWQA) (All Water) 1991-2017 7.709 5.849 Sites 76 0.01 1.57 8.95 4730 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 471 287 Sites 61 0.1 2.23 10 157 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 7.238 5.562 Sites 77 0.01 1.33 8.28 4730 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) 10M - 50M Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Finished) 2006 - 2020 81 57 Sites 70 0.011 2.58 7.1 55 ug/L Bradley et al. 2018 (Finished) [53] 2016 26 21 Sites 81 0.09 0.65 2.1 10.58 ug/L Community Water System Survey (CWSS) (Finished) [178] 2006 2 NA Sites 16 31 ug/L Ambient Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Source) 2006 - 2020 173 127 Sites 73 0.11 3.27 10 230 ug/L National Water Information System (USGS NWIS) (Surface Water) 2008 - 2017 1,379 1,188 Sites 86 0.01 0.602 4.09 1137 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008 - 2017 6,146 5,571 Sites 91 0.01 1.76 11 28000 ug/L National Water Information System (USGS NWIS) (All Water) 2008 - 2017 7,514 6,751 Sites 90 0.01 1.02 7.1 28000 ug/L Arnold et al. 2016 (Filtered) [7] 2012 - 2013 757 658 Sites 87 0.014 0.544 7 110 ug/L Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) 107 ug/l Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. A-571 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Molybdenum CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 53 Bradley, P. M., Kolpin, D. W., Romanok, K. M., Smalling, K. L., Focazio, M. J., Brown, J. B.,... & Dietze, J. E. (2018). Reconnaissance of mixed organic and inorganic chemicals in private and public supply tapwaters at selected residential and workplace sites in the United States. Environmental science & technology, 52(23), 13972-13985. 178 USE PA (US Environmental Protection Agency). (2009). 2006 Community Water System Survey. Overview, 57. 215 USEPA. 1992. Chemical Assessment Summary, Molybdenum. U.S. Environmental Protection Agency, National Center for Environmental Assessment, Integrated Risk Information System (IRIS), Washington, D.C. 442 WHO. 2011. Molybdenum in Drinking-water. Background document for development of WHO Guidelines for Drinking-water Quality. World Health Organization (WHO), Geneva, Switzerland. A-572 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Morphine CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Morphine CASRN: 57-27-2 DTXSID: DTXSID9023336 Use: narcotic analgesic Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANTSUMMARY& DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 7 non-cancer effects 1 1 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date SL 0.8 lowest therapeutic dose:severe pain management bottle-fed infants FDA; NIH 2018; 2018 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.07293 90th Percentile All Ambient Water NWIS 2008-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-573 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Morphine CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDW and OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg- HRL (ug/L) Assessment Full Citation Notes Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg- CCL Screening Level (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.000125 mg/kg/day FDA 2018; NIH 2018 Actavis Pharma, Inc. lowest therapeutic dose:severe pain management bottle-fed infants 151 0.830 [77] [150] NOTE: (Lowest Therapeutic Dose/3000x UF) is used in place of an RfD; LTDs were obtained from FDA-approved drug Reference Dose (RfD) or Equivalent 0.000125 mg/kg/day FDA 2018; NIH 2018 Actavis Pharma, Inc. lowest therapeutic dose:severe pain management general population 33.8 2.90 [77] [150] NOTE: (Lowest Therapeutic Dose/3000x UF) is used in place of an RfD; LTDs were obtained from FDA-approved drug Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title- abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full- text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Maximum Recommended Daily Dose 1.67 mg/kg/day FDA Screening level for pharmaceutical - 0.002941176 mg/L EPA Office of Water general population Screening level for pharmaceutical - infants 0.000833333 mg/L EPA Office of Water Data Element Value Units Source Notes Measured Data and Assessment Results LD50 335 mg/kg NIH HSDB min LD50 745 mg/kg NIH HSDB max Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Modeled Data LD50 0.0007345 mol/kg TEST QSAR Ames mutagenicity test 0.366 no units TEST QSAR Developmental toxin test 0.915 no units TEST QSAR A-574 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Morphine CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST October 2022 Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR)4 2018 - 2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013 - 2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008 - 2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survey (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991 - 2017 557 0 Sites 0 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991 - 2017 75 0 Sites 0 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991 - 2017 482 0 Sites 0 Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting(CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Furlong et al 2017 (Finished) [83] 2007 - 2012 NA NA Sites 0 ug/L Ambient Water Prevalence Magnitude National Water Information System (USGS NWIS) (Surface Water) 2008 - 2017 205 6 Sites 2.93 0.00224 0.0189 0.0729 0.185 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008 - 2017 401 0 Sites 0 National Water Information System (USGS NWIS) (All Water) 2008 - 2017 606 6 Sites 0.99 0.00224 0.0189 0.0729 0.185 ug/L Furlong et al 2017 (Ambient) [83] 2007 - 2012 NA NA Sites 0 ug/L Bradley et al. 2017 (Ambient) [52] 2012 - 2014 38 7 Sites 18 0.0057436 0.0152 0.0868 0.1145373 ug/L Bexfield et al. 2019 (Groundwater) [49] 2013 - 2015 1,106 0 Sites 0 Waste Water Effluent Prevalence Magnitude Scott et al. 2018 (Wastewater) [161] 2011 - 2017 21 13 Sites 62 0.0086904 0.0583 0.547 0.5896521 ug/L Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg- bw/day) Notes Expocast exposure Biomonitoring Data Detection at 90th Percentile Units Notes NHANES bio monitoring detect ion in serum (1999-2016) NHANES bio monitoring detect ion in blood (1999-2016) NHANES bio monitoring detect ion in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR4data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biode gradation ha If-life OPERA QSAR 25.9487 days Boiling point OPERA QSAR 385.353 degree C Boiling point TEST QSAR 430.461 degree C Vapor pressure OPERA QSAR 2.04E-09 mmHg Vapor pressure TEST QSAR 2.4E-09 mmHg Solubility in water OPERA QSAR 0.000940938 mol/L Solubility in water TEST QSAR 0.00465586 mol/L Bioconcentration factor OPERA QSAR 52.5833 no units Bioconcentration factor TEST QSAR 71.2853 no units Flenry's Law constant OPERA QSAR 6.9E-11 atm-mA3/mol Octanol/water partitioningcoeff. (log Kow) OPERA QSAR 1.06081 no units A-575 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Morphine CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 49 Bexfield, L.M., P.L. Toccalino, K. Belitz, W.T. Foreman, and E.T. Furlong. 2019. Hormones and pharmaceuticals in groundwater used as a source of drinking water across the United States. Environmental Science and Technology 53: 2950-2960. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 77 FDA. 2018. Drugs @ FDA: FDA Approved Drug Products. U.S. Food and Drug Administration (FDA), https://www.accessdata.fda.gov/scripts/cder/daf/. 83 Furlong, E.T., Batt, A.L., Glassmeyer, S.T., Noriega, M.C., Kolpin, D.W., Mash, H., Schenck, K.M. (2017). Nationwide reconnaissance of contaminants of emerging concern in source and treated drinking waters of the United States: Pharmaceuticals. Science of The Total Environment. 579 (1629-1642). 150 NIH. 2018. DailyMed Database. U.S. National Library of Medicine, National Institutes of Health (NIH). https://dailymed.nlm.nih.gov/dailymed/. 161 Scott, T. M., Phillips, P. J., Kolpin, D. W., Colella, K. M., Furlong, E. T., Foreman, W. T., & Gray, J. L. (2018). Pharmaceutical manufacturing facility discharges can substantially increase the pharmaceutical load to US wastewaters. Science of the Total Environment, 636, 69-79. A-576 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Morphine-3-Glucuronide CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Mo rph in e-3-G lu cu ron id e CASRN: 20290-09-9 DTXSID: DTXSID80174157 Use: Central Nervous System Stimulants Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANTSUMMARY& DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT IN FORMATION Potency Severity Prevalence Magnitude Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-577 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Morphine-3-GIucuronide CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Measured Data and Assessment Results I Value I Measured Data and Assessment Results I I Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Modeled Data LD50 TEST QSAR Ames mutagenicity test TEST QSAR Developmental toxin test TEST QSAR A-578 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Morphine-3-Glucuronide CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contam nant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contam nant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contam nant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contam nant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contam nant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contam nant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev(NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Ambient Water Prevalence Magnitude Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR Boiling point OPERA QSAR Boiling point TEST QSAR Vapor pressure OPERA QSAR Vapor pressure TEST QSAR Solubility in water OPERA QSAR Solubility in water TEST QSAR Bioconcentration factor OPERA QSAR Bioconcentration factor TEST QSAR Henry's Law constant OPERA QSAR 0 eta no l/water partitioning coeff. (log Kow) OPERA QSAR A-579 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Morphine-3-Glucuronide CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference A-580 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Myclobutanil CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Myclobutanil CASRN: 88671-89-0 DTXSID: DTXSID8024315 Use: Fungicide used on fruit Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro X Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Not List ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 5 reproductive and developmental effects 9 3 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value («"gA) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 100 decreased testicular weights and increased testicular atrophy general population OPP 2019 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.04 90th Percentile All Ambient Water NAWQA 1991-2017 Final Hazard Quotient (HQ) 0.0004 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-581 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Myclobutanil CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDW and OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg- HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.025 mg/kg/day OPP 2019 Wolfe 1993; Shellenberger etal. 1986 decreased testicular weights and increased testicular atrophy general population 33.8 148 [421] Cancer Classification (CC) E OPP 2019 [4211 Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg- CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title- abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Acute Human Health Benchmark 20 mg/L EPA HHBP Acute PAD 0.6 mg/kg/day EPA HHBP Chronic Human Health Benchmark 0.16 mg/L EPA HHBP Health-Based Screening Level 0.16 mg/L Health-based screening levels from Population-Ad justed Dose (PAD) 0.025 mg/kg/dav EPA HHBP Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element | Value | Units | Source | Notes Measured Data and Assessment Results LD50 1600 mg/kg NIH HSDB min LD50 2290 mg/kg NIH HSDB max LOAEL 393.5 mg/kg/day EPA Toxicity Reference Database max LOAEL 9.8400002 mg/kg/day EPA Toxicity Reference Database min NOAEL 2.5 mg/kg/day EPA Toxicity Reference Database min NOAEL 93.77 mg/kg/day EPA Toxicity Reference Database max Percent of active toxcast in vitro assays tested 13.57 percent EPA Chemistry Dashboard Subchronic LOAEL 150 mg/kg/day EPA Toxicity Reference Database max Subchronic LOAEL 5 mg/kg/day EPA Toxicity Reference Database min Subchronic NOAEL 0.25 mg/kg/day EPA Toxicity Reference Database min Subchronic NOAEL 50 mg/kg/day EPA Toxicity Reference Database max Data Element Value Units Source Notes Modeled Data LD50 0.0057677 mol/kg TEST QSAR Ames mutagenicity test 0.709 no units TEST QSAR Developmental toxin test 0.554 no units TEST QSAR A-582 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Myclobutanil CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev(NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 4,941 170 Sites 3.44 0.00033 0.011 0.04 0.668 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 581 150 Sites 26 0.00033 0.011 0.04 0.668 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 4.360 20 Sites 0.46 0.00468 0.012 0.0346 0.266 Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) 40 103,368 2016 Toxic Release Inventory (TRI) Program (EPA) (2016) 6 0.98 Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude USDA Pesticide Data Program (PDP) (Finished) 2001-2013 17 2 Sites 12 0.0027 0.0188 0.0188 0.0188 ug/L USGS, Sioux Falls Area, 2012 (Finished) [153] 2009-2010 1 0 Sites 0 Ambient Water Prevalence Magnitude National Water Information System (USGS NWIS) (Surface Water) 2008-2017 903 106 Sites 12 0.00092 0.013 0.309 24 ug/L National Water information System (USGS NWIS) (Groundwater) 2008-2017 2,510 10 Sites 0.4 0.008 0.0127 0.0822 0.146 ug/L National Water information System (USGS NWIS) (All Water) 2008-2017 3,412 116 Sites 3.4 0.00092 0.013 0.282 24 ug/L USDA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001-2013 229 6 Sites 2.62 0.0027 0.0188 0.083 0.083 ug/L USDA Pesticide Data Program (PDP) (Groundwater) 2001-2013 219 2 Sites 0.91 0.004828 0.0439 0.0752 0.083 ug/L USDA Pesticide Data Program (PDP) (Untreated) 2001-2013 12 4 Sites 33 0.0027 0.0188 0.083 0.083 ug/L Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990-2018 24 0 Sites 0 Bradley et al. 2017 (Ambient) [52] 2012-2014 38 2 Sites 5.26 0.0497 0.161 0.251 0.273 ug/L Arnold et al. 2016 (Filtered) [7] 2012-2013 690 3 Sites 0.43 0.0061 0.0098 0.0116 0.012 ug/L USGS, Sioux Falls Area, 2012 (Ambient) [153] 2009-2010 2 0 Sites 0 Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 8.75E-08 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 3.35213 days Boiling point OPERA QSAR 337.658 degree C Boiling point TEST QSAR 396.923 degree C Vapor pressure OPERA QSAR 0.00000101 mmHg Vapor pressure TEST QSAR 0.000000126 mmHg Solubility in water OPERA QSAR 0.000735975 mol/L Solubility in water TEST QSAR 0.0000383 mol/L Bioconcentration factor OPERA QSAR 33.7291 no units Bioconcentration factor TEST QSAR 103.514 no units Henry's Law constant OPERA QSAR 0.000000439 atm-mA3/mol 0 eta no 1/water partitioning coeff. (log Kow) OPERA QSAR 2.98801 no units A-583 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Myclobutanil CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 153 Occurrence of anthropogenic organic compounds and nutrients in source and finished water in the Sioux Falls area, South Dakota, 2009-10: U.S. Geological Survey Scientific Investigations Report 2012-5098, 21 p. plus appendixes. 421 USEPA. 2019. Myclobutanil: Human Health Risk Assessment for Registration Review. E PA-HQ-OPP-2015-0053-0018. DP No. D448816. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticide in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. A-584 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 N^N-Diethyl-m-toluamide (DEET) CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: N,N-Diethyl-m-toluamide (DEET) CASRN: 134-62-3 DTXSID: DTXSID2021995 Use: Broad-spectrum insect re pel la nt Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts X Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 10 4 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.22 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-585 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 N,N-Diethyl-m-toluamide (DEET) CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWandOST Assessment Source Critical Study Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Reference Dose (RfD) or Equivalent mg/kg/day EPA. 1989. [EPA memorandum 007645 from Whang Phang, Subject: Review of a two-generation reproduction on DEET, dated 13 December 1989] reduced body weight in F1 and F2 male and female pups on lactation day 21 lactating women [35] [331] NOTE: There is no HRL for DEET because there are no toxicity values provided in the OPP assessment. The document states "no dietary or occupational exposures are anticipated, residential and aggregate were not risks of concern due to the lack of hazard." An ATSDR Toxicological Profile exists for this compound. See entry in "other qualifying information" Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Acute Health-Based Guidance Value 0.2 mg/L MN DOH Chronic Health-Based Guidance Value 0.2 mg/L MN DOH Short-Term/Subchronic Health-Based Guidance 0.2 mg/L MN DOH Value Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Measured Data and Assessment Results LD50 1584 mg/kg NIH HSDB min LD50 1950 mg/kg NIH HSDB max LOAEL 1000 mg/kg/day EPA Toxicity Reference Database max LOAEL 25 mg/kg/day EPA Toxicity Reference Database min NOAEL 100 mg/kg/day EPA Toxicity Reference Database min NOAEL 500 mg/kg/day EPA Toxicity Reference Database max Percent of active toxcast in 1.51 percent EPA Chemistry Dashboard vitro assays tested Subchronic LOAEL 304 mg/kg/day EPA Toxicity Reference Database Subchronic NOAEL 61 mg/kg/day EPA Toxicity Reference Database Data Element Value Units Source Notes Modeled Data LD50 0.0091411 mo l/kg TEST QSAR Ames mutagenicity test -0.042 no units TEST QSAR Developmental toxin test 0.57 no units TEST QSAR A-586 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 N,N-Dietiiyl-m-toluamide (DEET) CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev(NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 538 114 Sites 21 0.01 0.06 0.22 2.2 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 60 43 Sites 72 0.01 0.07 0.24 2.2 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 478 71 Sites 15 0.01 0.02 0.094 0.29 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Glassmeyer et al 2017 (Finished) [86] 2007-2012 25 NA Sites 0 ug/L Padhye et al. 2013 (Finished) [155] 2009-2010 8 8 Samples 100 5e-07 +/- le-07 1.19e-05 2.4e-05 +/- 8.2e- 06 ug/L USGS, Sioux Falls Area, 2012 (Finished) [153] 2009-2010 1 1 Sites 100 0.1 0.1 0.1 0.1 ug/L Ambient Water Prevalence Magnitude National Water Information System (USGS NWIS) (Surface Water) 2008-2017 710 522 Sites 74 0.01 0.05 0.22 5.07 ug/L National Water information System (USGS NWIS) (Groundwater) 2008-2017 683 244 Sites 36 0.01 0.03 0.358 7.9 ug/L National Water information System (USGS NWIS) (All Water) 2008-2017 1,393 766 Sites 55 0.01 0.05 0.23 7.9 ug/L Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990-2018 26 12 Sites 46 0.0106 0.146 0.473 0.912 ug/L Glassmeyer et a 1 2017 (Ambient) [86] 2007-2012 25 NA Sites 4 0.098 0.098 ug/L Bradley et al. 2017 (Ambient) [52] 2012-2014 38 22 Sites 58 0.0035 0.0311 0.0899 0.119 ug/L Padhye et al. 2013 (Ambient) [155] 2009-2010 8 8 Samples 100 2.33e-05 +/- 3e- 06 0.0001224 0.0002557 +/- 6.25e-05 ug/L USGS, Sioux Falls Area, 2012 (Ambient) [153] 2009-2010 2 2 Sites 100 Waste Water Effluent Prevalence Magnitude Scott et al. 2018 (Wastewater) [161] 2011-2017 21 17 Sites 81 0.085 0.195 0.449 1 ug/L Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/ day) Notes Expocast exposure 0.00000017 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) < LOD ug/l Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 3.35701 days Boiling point OPERA QSAR 287.874 degree C Boiling point TEST QSAR 307.376 degree C Vapor pressure OPERA QSAR 0.0019251 mmHg Vapor pressure TEST QSAR 0.00031989 mmHg Solubility in water OPERA QSAR 0.00200679 mol/L Solubility in water TEST QSAR 0.0209894 mol/L Bioconcentration factor OPERA QSAR 3.31548 no units Bioconcentration factor TEST QSAR 10.3276 no units Henry's Law constant OPERA QSAR 0.000000145 atm-mA3/mol 0 eta no 1/water partitioning coeff. (log Kow) OPERA QSAR 2.25645 no units A-587 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 N,N-Diethyl-m-toluamide (DEET) CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 35 ATSDR. 2017. Toxicological Profile for DEET (N,N-Diethyl-Meta-Toluamide). U.S. Department of Health and Human Services, Public Health Service, Agency for Toxic Substances and Disease Registry (ATSDR), Atlanta, GA. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 86 Glassmeyer, S.T., Furlong, E.T., Kolpin, D.W., Batt, A.L., Benson, R., Boone, J.S.,... & Wilson, V.S. (2017). Nationwide reconnaissance of contaminants of emerging concern in source and treated drinking waters of the United States. Science of The Total Environment. v581-582, (909-922). 153 Occurrence of anthropogenic organic compounds and nutrients in source and finished water in the Sioux Falls area, South Dakota, 2009-10: U.S. Geological Survey Scientific Investigations Report 2012-5098, 21 p. plus appendixes. 155 Padhye, L.P., Yao, H., Kung'u, F.T., and Huang, C.H. Year-long evaluation on the occurrence and fate of pharmaceuticals, personal care products, and endocrine disrupting chemicals in an urban drinking water treatment plant. 2014. Water Research 51 (2014) 266-276. 161 Scott, T. M., Phillips, P. J., Kolpin, D. W., Colella, K. M., Furlong, E. T., Foreman, W. T., & Gray, J. L. (2018). Pharmaceutical manufacturing facility discharges can substantially increase the pharmaceutical load to US wastewaters. Science of the Total Environment, 636, 69-79. 331 USEPA. 2014. DEET (N,N-diethyl-meta-toluamide). Revised Human Health Risk Assessment in Support of Registration Review. EPA-HQ-OPP-2012-0162-0003. DP No. D413872. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticide in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. A-588 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Naled CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Chemical Notes: DTXSID1024209 Is the contaminant on any lists? CERCLA X FIFRA X Human Neurotoxicants X PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANTSUMMARY& DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 6 non-cancer effects 3 3 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 10 brain chol in esterase inhibition general population OPP 2009 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.1972 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-589 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Naled CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.002 mg/kg/day OPP 2006 Bath am et a 1.1984 brain cholinesterase inhibition general population 33.8 11.8 [266] Cancer Classification (CC) E OPP 2006 [2661 Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Acute Human Health Benchmark 0.07 mg/L EPA HHBP Acute PAD 0.01 mg/kg/day EPA HHBP Chronic Human Health Benchmark 0.01 mg/L EPA HHBP Health-Based Screening Level 0.01 mg/L Health-based screening levels from USGS Population-Adjusted Dose (PAD) 0.002 mg/kg/day EPA H HBP Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Measured Data and Assessment Results LD50 430 mg/kg NIH HSDB max LD50 92 mg/kg NIH HSDB min LOAEL 2 mg/kg/day EPA Toxicity Reference Database min LOAEL 40 mg/kg/day EPA Toxicity Reference Database max NOAEL 0.2 mg/kg/day EPA Toxicity Reference Database min NOAEL 10 mg/kg/day EPA Toxicity Reference Database max Percent of active toxcast in 24.11 percent EPA Chemistry Dashboard vitro assays tested Data Element Value Units Source Notes Modeled Data LD50 0.0002851 mo l/kg TEST QSAR Ames mutagenicity test 0.559 no units TEST QSAR Developmental toxin test TEST QSAR A-590 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Naled CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 1.698 4 Sites 0.24 0.004 0.0221 0.197 0.367 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 322 3 Sites 0.93 0.004 0.0173 0.0253 0.0274 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 1.376 1 Sites 0.07 0.367 0.367 0.367 0.367 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) 6 293,220 2016 Toxic Release Inventory (TRI) Program (EPA) (2016) 1 10 Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Finished) 2006 - 2020 1 0 Sites 0 Ambient Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Source) 2006 - 2020 3 0 Sites 0 National Water information System (USGS NWIS) (Surface Water) 2008-2017 299 2 Sites 0.67 0.0578 0.0595 0.0605 0.0612 ug/L National Water information System (USGS NWIS) (Groundwater) 2008-2017 528 0 Sites 0 National Water information System (USGS NWIS) (All Water) 2008-2017 827 2 Sites 0.24 0.0578 0.0595 0.0605 0.0612 ug/L Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990-2018 2,547 0 Sites 0 Arnold et al. 2016 (Filtered) [7] 2012-2013 584 0 Sites 0 Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 0.000000122 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 4.13863 days Boiling point OPERA QSAR 275.202 degree C Boiling point TEST QSAR 291.332 degree C Vapor pressure OPERA QSAR 0.000367639 mmHg Vapor pressure TEST QSAR 0.0069024 mmHg Solubility in water OPERA QSAR 0.00699769 mol/L Solubility in water TEST QSAR 0.00360579 mol/L Bioconcentration factor OPERA QSAR 3.99441 no units Bioconcentration factor TEST QSAR 5.90201 no units Henry's Law constant OPERA QSAR 0.00000793 atm-mA3/mol 0 eta no l/water partitioning coeff. (log Kow) OPERA QSAR 1.56699 no units A-591 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Naled CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 266 USEPA. 2006. Finalization of Interim Reregistration Eligibility Decisions (IREDs) and Interim Tolerance Reassessment and Risk Management Decisions (TREDs) for the Organophosphate Pesticides, and Completion of the Tolerance Reassessment and Reregistration Eligibility Process for the Organophosphate Pesticides. Interim Reregistration Eligibility Decision for Naled. EPA-HQ-OPP-2002-0307-0002. EPA 738-R-02-008. U.S. Environmental Protection Agency, Office of Prevention, Pesticides and Toxic Substances, Washington, D.C. 301 USEPA. 2009. Naled. Human Health Assessment Scoping Document in Support of Registration Review. EPA-HQ-OPP-2009-0053-0005. DP No. D356244. Office of Prevention, Pesticides and Toxic Substances, United States Environmental Protection Agency, Washington, D.C. 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticide in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. A-592 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Naphthalene CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Naphthalene CASRN: 91-20-3 DTXSID: DTXSID8020913 Use: Former pesticide; chemical intermediate; moth repellant Chemical Notes: Is the contaminant on any lists? CERCLA X FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts X Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUM MARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT IN FORMATION Potency Severity Prevalence Magnitude 4 non-cancer effects 7 6 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 600 decreases in body weights and body weight gains, renal effects general population OPP 2018 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 7.4 90th Percentile Finished Water UCM1 1988-1992 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Naphthalene regulation does not represent a meaningful opportunity for health risk reduction in persons served by public water systems. While there is evidence that naphthalene may cause adverse health effects in humans at high doses, specifically hemolytic anemia [a,b], it likely that it will occur in drinking water at frequencies or con cent rations that are of public health concern. The UCM Round 2 survey data estimates only 0.002% of the population served by PWS e exposed to concentrations greater than the HRL and no posures at concentrations greater than an HRLof 140 pg/L [c]. iidron & Leu rer, 1956 [84]; [b] ATSDR, 1995 [3]; [ [232]; as cited in USE PA, 2001 [182] ] US EPA, 1999 Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-593 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Naphthalene CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.1 mg/kg/day OPP 2018 N TP 1980 decreases in body weights and renal effects general population 33.8 592 [4051 Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results 10-day Health Advisory 0.5 mg/L EPA DWSHA 2018 Acute Health-Based Guidance Value 0.07 mg/L MN DOH Acute Health-Based Guidance Value 0.07 mg/L MN DOH Acute Minimal Risk Level (MRL) 0.6 mg/kg/day CDC ATSDR Benchmark 0.017 mg/L CalEPAOEHHA Chemical Database Cancer Slope Factor (CSF) 0.12 (mg/kg/day) A-1 CalEPAOEHHA Chemical Database Chronic Health-Based Guidance Value 0.07 mg/L MN DOH Chronic inhalation Minimal Risk Level (MRL) 0.0007 ppm CDC ATSDR Inhalation Unit Risk (IUR) 0.000034 ug/mA3 CalEPAOEHHA Chemical Database Intermediate Minimal Risk Level (MRL) 0.6 mg/kg/day CDC ATSDR Lifetime Health Advisory 0.1 mg/L EPA DWSHA 2018 Reference Concentration (RfC) 0.003 mg/mA3 EPA IRIS Reference Concentration (RfC) 9 ug/mA3 CalEPAOEHHA Chemical Database Short-Term/Subchronic Health-Based Guidance Value 0.07 mg/L MN DOH Cancer Classification (CC) 2B no units WHO IARC Cancer Classification (CC) Female.Mice NT no units HHSNTP Cancer Classification (CC) Female.Mice SE no units HHSNTP Cancer Classification (CC) Female.Rats NT no units HHSNTP Cancer Classification (CC) Female.Rats P no units HHSNTP Cancer Classification (CC) Male.Mice NE no units HHSNTP Cancer Classification (CC) Male.Mice NT no units HHSNTP Cancer Classification (CC) Male.Rats NT no units HHSNTP Cancer Classification (CC) Male.Rats P no units HHS NTP Data Element Value Units Source Notes Measured Data and Assessment Results LD50 2600 mg/kg NIH HSDB max LD50 490 mg/kg NIH HSDB min LOAEL 50 mg/kg/day EPA Toxicity Reference Database Percent of active toxcast in 2.54 percent EPA Chemistry Dashboard vitro assays tested Data Element Value Units Source Notes Modeled Data LD50 0.0109648 mo l/kg TEST QSAR Ames mutagenicity test -0.01 no units TEST QSAR Developmental toxin test 0.32 no units TEST QSAR Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. A-594 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Naphthalene CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 OCCURRENCE DATA Scorin£Data_ Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018 - 2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013 - 2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008 - 2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 22,923 173 Sites 0.75 0.07 0.73 3.08 90 ug/L Unregulated Contaminant Monitoring-St ate (UCM-State) Round 1 1988 -1992 13,452 159 Sites 1.18 0.03 1 7.4 906 ug/L National Inorganics and Radionuclides Survey (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991 - 2017 7,850 68 Sites 0.87 0.008 0.2 1.02 70 ug/L National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991 - 2017 310 30 Sites 9.68 0.008 0.1 0.3 1.12 ug/L National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991 - 2017 7,540 38 Sites 0.5 0.048 0.42 5.69 70 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) 49 2,359,983 Chemical Data Reporting(CDR) Results (EPA) (2016) 100M - 250M Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Finished) 2006 - 2020 366 3 Sites 0.82 0.003 0.0105 0.93 7 ug/L Drinking Water Monitoring Data - MA (Finished) 2006 - 2020 887 14 Sites 1.58 0.5 1.3 2.03 3.1 ug/L Drinking Water Monitoring Data - WA (Finished) 2006 - 2011 1,188 0 Sites 0 USGS, Sioux Falls Area, 2012 (Finished) [153] 2009 - 2010 1 0 Sites 0 Ambient Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Source) 2006 - 2020 3,888 21 Sites 0.54 0.001 0.565 3.21 5.8 ug/L Drinking Water Monitoring Data - MA (Source) 2006 - 2020 131 5 Sites 3.82 0.5 1.2 2.58 4.5 ug/L Drinking Water Monitoring Data - PA (Source) 2006 - 2011 15 1 Sites 6.67 1.08 1.16 1.23 1.25 ug/L Drinking Water Monitoring Data - WA (Source) 2006 - 2011 1,665 2 Sites 0.12 0.66 34.4 35.8 36 ug/L Drinking Water Monitoring Data - Wl (Source) 2012-2019 101 0 Sites 0 National Water Information System (USGS NWIS) (Surface Water) 2008 - 2017 978 159 Sites 16 0.008 0.02 0.07 6 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008 - 2017 4,211 87 Sites 2.07 0.007 0.096 43.4 16000 ug/L National Water Information System (USGS NWIS) (All Water) 2008 - 2017 5,186 246 Sites 4.74 0.007 0.0205 0.282 16000 ug/L Bradley et al. 2017 (Ambient) [52] 2012 - 2014 38 3 Sites 7.89 0.0162 0.025 0.0277 0.0284 ug/L Arnold et al. 2016 (Unfiltered) [7] 2012 - 2013 685 1 Sites 0.15 0.78 0.78 0.78 0.78 ug/L USGS, Sioux Falls Area, 2012 (Ambient) [153] 2009 - 2010 2 0 Sites 0 Waste Water Effluent Prevalence Magnitude Scott et al. 2018 (Wastewater) [161] 2011-2017 21 2 Sites 9.52 0.021 0.025 0.0282 0.029 ug/L Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg- bw/day) Notes Expocast exposure 0.0000737 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES bio monitoring detect ion in blood (1999-2016) NHANES bio monitoring detect ion in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biode gradation ha If-life OPERA QSAR 5.12244 days Boiling point OPERA QSAR 221.854 degree C Boiling point TEST QSAR 233.31 degree C Vapor pressure OPERA QSAR 0.0632206 mmHg Vapor pressure TEST QSAR 0.057544 mmHg Solubility in water OPERA QSAR 0.000165649 mol/L Solubility in water TEST QSAR 0.00030903 mol/L Bioconcentration factor OPERA QSAR 89.6573 no units Bioconcentration factor TEST QSAR 244.67 no units Flenry's Law constant OPERA QSAR 0.000415844 atm-mA3/mol Octanol/water partitioningcoeff. (log Kow) OPERA QSAR 3.32388 no units A-595 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Naphthalene CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 3 Agency for Toxic Substances and Disease Registry (ATSDR). 1995. Toxicological Profile for Naphthalene (Update). Atlanta: Agency for Toxic Substances and Disease Registry. 200pp. 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 84 Gidron, E. and J. Leurer. 1956. Naphthalene Poisoning. Lancet. 4:228-230 (as cited in ATSDR, 1995). 153 Occurrence of anthropogenic organic compounds and nutrients in source and finished water in the Sioux Falls area, South Dakota, 2009-10: U.S. Geological Survey Scientific Investigations Report 2012-5098, 21 p. plus appendixes. 161 Scott, T. M., Phillips, P. J., Kolpin, D. W., Colella, K. M., Furlong, E. T., Foreman, W. T., & Gray, J. L. (2018). Pharmaceutical manufacturing facility discharges can substantially increase the pharmaceutical load to US wastewaters. Science of the Total Environment, 636, 69-79. 182 USE PA, 2001. Regulatory Determination Support Document for Naphthalene. EPA 815 R-01-008. 232 USEPA. 1999. A Review of Contaminant Occurrence in Public Water Systems. Office of Water. EPA Report 816-R-99-006. 78 pp. 405 USEPA. 2018. Naphthalene: Human Health Risk Assessment in Support of Registration Review. EPA-HQ-OPP-2016-0113-0018. DP No. D440842. U.S. Environmental Protection Agency, Office of Chemica Safety and Pollution Prevention, Washington, D.C. A-596 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Nicotine CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Nicotine CASRN: 54-11-5 DTXSID: DTXSID1020930 Use: Restricted use pesticide; component in cigarettes Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants X PubMed Neu rotoxica nts Neu rode v. Disruptors X Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 X CONTAMINANTSUMMARY& DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT IN FORMATION Potency Severity Prevalence Magnitude 8 non-cancer effects 10 3 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date SL 0.2 lowest therapeutic dose: smoking cessation/reduceswithdrawalsymptoms, including nicotine craving associated with quitting smoking bottle-fed infants FDA; NIH 2018; 2018 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.1566 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-597 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Nicotine CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.000025 mg/kg/day FDA 2018; NIH 2018 Wal-Mart Stores Inc lowest therapeutic dose:smoking cessation/reduces withdrawal symptoms, including nicotine craving associated with quitting smoking bottle-fed infants 151 0.170 [77] [150] NOTE: (Lowest Therapeutic Dose/3000x UF) is used in place of an RfD; LTDs were obtained from FDA-approved drug labels Reference Dose (RfD) or Equivalent 0.000025 mg/kg/day FDA 2018; NIH 2018 Wal-Mart Stores Inc lowest therapeutic dose:smoking cessation/reduces withdrawal symptoms, including nicotine craving associated with quitting smoking general population 33.8 0.590 [77] [150] NOTE: (Lowest Therapeutic Dose/3000x UF) is used in place of an RfD; LTDs were obtained from FDA-approved drug labels Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Screening level for pharmaceutical - general 0.000588235 mg/L EPA Office of Water population Screening level for pharmaceutical - infants 0.000166667 mg/L EPA Office of Water Data Element Value Units Source Notes Measured Data and Assessment Results LD50 188 mg/kg NIH HSDB max LD50 24 mg/kg NIH HSDB min Percent of active toxcast in vitro assavs tested 2.39 percent EPA Chemistry Dashboard Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Modeled Data LD50 0.0053088 mo l/kg TEST QSAR Ames mutagenicity test 0.047 no units TEST QSAR Developmental toxin test 0.645 no units TEST QSAR A-598 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Nicotine CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev(NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 557 127 Sites 23 0.00295 0.0258 0.157 1.71 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 75 64 Sites 85 0.00314 0.0381 0.21 1.71 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 482 63 Sites 13 0.00295 0.0141 0.0465 0.0991 Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) 14 684,575 Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Bradley et al. 2018 (Finished) [53] 2016 26 3 Sites 12 0.0226154 0.0229 0.0795 0.0935951 ug/L Glassmeyer et al 2017 (Finished) [86] 2007-2012 25 NA Sites 0 ug/L IL EPA (2008) via Uslu et al. (2013) (Finished) [433] 2008 NA NA 0.011 ug/L Ambient Water Prevalence Magnitude National Water Information System (USGS NWIS) (Surface Water) 2008-2017 202 143 Sites 71 0.00391 0.0358 0.152 14.6 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008-2017 401 67 Sites 17 0.00297 0.0181 0.0579 0.337 ug/L National Water Information System (USGS NWIS) (All Water) 2008-2017 603 210 Sites 35 0.00297 0.033 0.127 14.6 ug/L Glassmeyer et al 2017 (Ambient) [86] 2007-2012 25 NA Sites 0 ug/L Bradley etal. 2017 (Ambient) [52] 2012-2014 38 11 Sites 29 0.0034862 0.0586 0.272 0.3776463 ug/L IL EPA(2008) via Uslu etal. (2013) (Ambient) [433] 2008 NA NA 0.059 ug/L Waste Water Effluent Prevalence Magnitude Scott et al. 2018 (Wastewater) [161] 2011 - 2017 21 5 Sites 24 0.0346125 0.0664 0.103 0.1070941 ug/L Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 0.000000708 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 3.36018 days Boiling point OPERA QSAR 250.979 degree C Boiling point TEST QSAR 244.899 degree C Vapor pressure OPERA QSAR 0.018167 mmHg Vapor pressure TEST QSAR 0.02208 mmHg Solubility in water OPERA QSAR 4.52635 mol/L Solubility in water TEST QSAR 0.0799834 mol/L Bioconcentration factor OPERA QSAR 6.524 no units Bioconcentration factor TEST QSAR 11.995 no units Henry's Law constant OPERA QSAR 0.00000666 o E E Octanol/water partitioning coeff. (log Kow) OPERA QSAR 1.23608 no units A-599 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Nicotine CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 53 Bradley, P. M., Kolpin, D. W., Romanok, K. M., Smalling, K. L., Focazio, M. J., Brown, J. B.,... & Dietze, J. E. (2018). Reconnaissance of mixed organic and inorganic chemicals in private and public supply tapwaters at selected residential and workplace sites in the United States. Environmental science & technology, 52(23), 13972-13985. 77 FDA. 2018. Drugs @ FDA: FDA Approved Drug Products. U.S. Food and Drug Administration (FDA), https://www.accessdata.fda.gov/scripts/cder/daf/. 86 Glassmeyer, S.T., Furlong, E.T., Kolpin, D.W., Batt, A.L., Benson, R., Boone, J.S.,... & Wilson, V.S. (2017). Nationwide reconnaissance of contaminants of emerging concern in source and treated drinking waters of the United States. Science of The Total Environment. v581-582, (909-922). 150 NIH. 2018. DailyMed Database. U.S. National Library of Medicine, National Institutes of Health (NIH). https://dailymed.nlm.nih.gov/dailymed/. 161 Scott, T. M., Phillips, P. J., Kolpin, D. W., Colella, K. M., Furlong, E. T., Foreman, W. T., & Gray, J. L. (2018). Pharmaceutical manufacturing facility discharges can substantially increase the pharmaceutical load to US wastewaters. Science of the Total Environment, 636, 69-79. 433 Uslu, M., Jasim, S., Arvai, A., Bewtra, J. and Biswas, N., 2013. A Survey of Occurrence and Risk Assessment of Pharmaceutical Substances in the Great Lakes Basin. Ozone: Science & Engineering, 35(4), pp.249-262. A-600 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Nonylphenol CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Nonylphenol CASRN: 25154-52-3 DTXSID: DTXSID3021857 Use: In the preparation of lubricating oil additives, resins, plasticizers, surface active agents; antioxidants for plastics and rubber Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro X Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANTSUMMARY& DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT IN FORMATION Potency Severity Prevalence Magnitude 6 non-cancer effects 9 7 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date SL 30 renal mineralization general population MDH 2015 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 4.4 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-601 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Nonylphenol CCL 5 Contaminant Information Sheet EPA-OGWDWand OST October 2022 HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.0049 mg/kg/day MDH 2015 NTP, 1997/Chapi n, 1999 Renal Mineralization general population 33.8 29.0 [136] Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Metabolic, Systemic 0.00002 Yu, 2018 Endocrine 456 Masutomi, 2004 2020-01-28 2685 64 16 50 Other Health Data Data Element Value Units Source Notes Data Element Value Units Source Notes Measured Data and Assessment Results Measured Data and Assessment Results Acute Health-Based Guidance Value 0.1 mg/L MN DOH LD50 1600 mg/kg NIH HSDB min Chronic Health-Based Guidance Value 0.02 mg/L MN DOH LD50 1620 mg/kg NIH HSDB max Short-Term/Subchronic Health-Based Guidance 0.04 mg/L MN DOH Percent of active toxcast in 26.88 percent EPA Chemistry Dashboard min Value vitro assays tested Percent of active toxcast in 38.23 percent EPA Chemistry Dashboard max Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Modeled Data LD50 0.0116681 mo l/kg TEST QSAR Ames mutagenicity test -0.104 no units TEST QSAR Developmental toxin test 0.533 no units TEST QSAR A-602 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Nonylphenol CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contam nant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contam nant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contam nant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contam nant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contam nant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contam nant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 567 45 Sites 7.94 0.3 1.85 4.4 13 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 88 43 Sites 49 0.3 1.85 4.4 13 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 479 2 Sites 0.42 1.5 2.35 2.86 3.2 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Data Number of States Amount Released (lbs/year) Toxic Release Inventory (TRI) Program (EPA) (2016) 24 42,754 Chemical Production Data Production Volume (lbs/year) Chemical Data Reporting (CDR) Results (EPA) (2016) 100M - 250M Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Glassmeyer et al 2017 (Finished) [86] 2007-2012 25 NA Sites 0 ug/L Padhye et al. 2013 (Finished) [155] 2009-2010 8 8 Samples 100 1.24e-05 +/- 5.3e-06 1.95e-05 6.06e-05 +/- 1.92e-05 ug/L USGS, Sioux Falls Area, 2012 (Finished) [153] 2009-2010 1 0 Sites 0 Ambient Water Prevalence Magnitude Glassmeyer et al 2017 (Ambient) [86] 2007-2012 25 NA Sites 0 ug/L Bradley et al. 2017 (Ambient) [52] 2012-2014 38 10 Sites 26 0.105 0.278 0.448 0.461 ug/L Padhye et al. 2013 (Ambient) [155] 2009-2010 8 8 Samples 100 5.34e-05 +/- 5.8e-06 8.32e-05 0.0001856 +/- 2e-05 ug/L USGS, Sioux Falls Area, 2012 (Ambient) [153] 2009-2010 2 0 Sites 0 Waste Water Effluent Prevalence Magnitude Scott et al. 2018 (Wastewater) [161] 2011-2017 21 17 Sites 81 1.1 1.1 1.1 1.1 ug/L Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/ day) Notes Expocast exposure 0.000000872 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR4 data used in the CCL5 is a partial datasetand will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 3.94705 days Boiling point OPERA QSAR 269.167 degree C Boiling point TEST QSAR 316.679 degree C Vapor pressure OPERA QSAR 0.00114475 mmHg Vapor pressure TEST QSAR 0.000034 mmHg Solubility in water OPERA QSAR 0.0000344 mol/L Solubility in water TEST QSAR 0.00000575 mol/L Bioconcentration factor OPERA QSAR 431.548 no units Bioconcentration factor TEST QSAR 96.8278 no units Henry's Law constant OPERA QSAR 0.0000106 o E E 0 eta no l/water partitioning coeff. (log Kow) OPERA QSAR 5.68641 no units A-603 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Nonylphenol CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 86 Glassmeyer, S.T., Furlong, E.T., Kolpin, D.W., Batt, A.L., Benson, R., Boone, J.S.,... & Wilson, V.S. (2017). Nationwide reconnaissance of contaminants of emerging concern in source and treated drinking waters of the United States. Science of The Total Environment. v581-582, (909-922). 136 MDH. 2015. Toxicological Summary for p-Nonylphenol, branched isomers. Minnesota Department of Health (MDH), Environmental Health Division, Health Risk Assessment Unit, St Paul, MN. 153 Occurrence of anthropogenic organic compounds and nutrients in source and finished water in the Sioux Falls area, South Dakota, 2009-10: U.S. Geological Survey Scientific Investigations Report 2012-5098, 21 p. plus appendixes. 155 Padhye, L.P., Yao, H., Kung'u, F.T., and Huang, C.H. Year-long evaluation on the occurrence and fate of pharmaceuticals, personal care products, and endocrine disrupting chemicals in an urban drinking water treatment plant. 2014. Water Research 51 (2014) 266-276. 161 Scott, T. M., Phillips, P. J., Kolpin, D. W., Colella, K. M., Furlong, E. T., Foreman, W. T., & Gray, J. L. (2018). Pharmaceutical manufacturing facility discharges can substantially increase the pharmaceutical load to US wastewaters. Science of the Total Environment, 636, 69-79. A-604 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Norflurazon CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Chemical Notes: DTXSID8024234 Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 6 non-cancer effects 9 3 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 9 increased incidence of thyroid co No id/vacuoles and epithelial desquamation, increased liver weight, ALP, and cholesterol in males general population OPP 2017 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.44 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-605 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Norflurazon CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDW and OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg- HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.0015 mg/kg/day OPP 2017 Klotzsche etal. 1973 increased incidence of thyroid colloid/vacuoles and epithelial desquamation, increased liver weight, ALP, and cholesterol in males general population 33.8 8.88 [387] Cancer Classification (CC) C OPP 2017 [3871 Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg- CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title- abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Acute Human Health Benchmark 0.8 mg/L EPA HHBP Acute PAD 0.03 mg/kg/day EPA HHBP Chronic Human Health Benchmark 0.096 mg/L EPA HHBP Health-Based Screening Level 0.096 mg/L Health-based screening levels from USGS Population-Ad justed Dose (PAD) 0.015 mg/kg/day EPA HHBP Data Element Value Units Source Notes Measured Data and Assessment Results LD50 8000 mg/kg NIH HSDB LOAEL 102.5 mg/kg/day EPA Toxicity Reference Database max LOAEL 4.77 mg/kg/day EPA Toxicity Reference Database min NOAEL 1.58 mg/kg/day EPA Toxicity Reference Database min NOAEL 81.7 mg/kg/day EPA Toxicity Reference Database max Percent of active toxcast in 7.86 percent EPA Chemistry Dashboard vitro assavs tested Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Modeled Data LD50 0.0101391 mol/kg TEST QSAR Ames mutagenicity test 0.227 no units TEST QSAR Developmental toxin test 0.941 no units TEST QSAR A-606 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Norflurazon CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev(NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 7.803 217 Sites 2.78 0.00025 0.021 0.44 26.5 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 1.222 107 Sites 8.76 0.00025 0.02 0.36 7.3 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 6.581 110 Sites 1.67 0.00029 0.042 1.06 26.5 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) 19 202,807 2016 Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Drinking Water Monitoring Data - WA (Finished) 2006-2011 1 0 Sites 0 USDA Pesticide Data Program (PDP) (Finished) 2001-2013 17 2 Sites 12 0.0313 0.0313 0.0928 0.096 ug/L Ambient Water Prevalence Magnitude Drinking Water Monitoring Data - WA (Source) 2006-2011 4 0 Sites 0 National Water Information System (USGS NWIS) (Surface Water) 2008-2017 475 21 Sites 4.42 0.00035 0.00798 0.155 0.53 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008-2017 1,056 19 Sites 1.8 3.00E - 04 0.03 0.828 1.49 ug/L National Water Information System (USGS NWIS) (All Water) 2008-2017 1,531 40 Sites 2.61 3.00E - 04 0.02 0.53 1.49 ug/L USDA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001-2013 229 9 Sites 3.93 0.007992 0.0313 0.0992 0.352 ug/L USDA Pesticide Data Program (PDP) (Groundwater) 2001-2013 219 6 Sites 2.74 0.007992 0.0248 0.222 0.352 ug/L USDA Pesticide Data Program (PDP) (Untreated) 2001-2013 12 3 Sites 25 0.0313 0.0313 0.09 0.132 ug/L Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990-2018 1,090 125 Sites 11 0.05 0.13 0.424 1.49 ug/L Bradley et al. 2017 (Ambient) [52] 2012-2014 38 2 Sites 5.26 0.0137 0.0206 0.026 0.0274 ug/L Arnold et al. 2016 (Filtered) [7] 2012-2013 690 12 Sites 1.74 3e-04 0.00195 0.045 0.0563 ug/L Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 0.000000108 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 3.54354 days Boiling point OPERA QSAR 329.74 degree C Boiling point TEST QSAR 355.301 degree C Vapor pressure OPERA QSAR 0.00016561 mmHg Vapor pressure TEST QSAR 0.000000708 mmHg Solubility in water OPERA QSAR 0.000311995 mol/L Solubility in water TEST QSAR 0.0000906 mol/L Bioconcentration factor OPERA QSAR 22.9102 no units Bioconcentration factor TEST QSAR Henry's Law constant OPERA QSAR 1.18E-09 atm-mA3/mol 0 eta no 1/water partitioning coeff. (log Kow) OPERA QSAR 2.43139 no units A-607 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Norflurazon CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 387 USEPA. 2017. Norflurazon: Draft Human Health Risk Assessment in Support of Registration Review. EPA-HQ-OPP-2012-0565-0025. DP No. D432685. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticide in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. A-608 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 o-Toluidine CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: o-Toluidine CASRN: 95-53-4 DTXSID: DTXSID1026164 Use: Intermediate in the manufacture of dyes, rubber, pharmaceuticals and pesticides Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANTSUMMARY& DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT IN FORMATION Potency Severity Prevalence Magnitude 4 carcinogen with linear MOA 8 3 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 2 subcutaneous fibromas and fibrosarcomas general population PPRTV 2012 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.06164 90th Percentile Finished Water UCMR4 2018-2019 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-609 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 o-Toluidine CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Cancer Slope Factor (CSF) 0.016 (mg/kg/day)A-l PPRTV 2012 Weisburger eta 1.1978 subcutaneous fibromas and fibromasarcomas in males general population 33.8 1.85 [328] Cancer Classification (CC) L PPRTV 2012 [328] Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Systemic 226.6 Toyoda, 2019 Renal 226.6 Toyoda, 2019 2011-12-01 2020-04-06 73 1 5 1 Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Cancer Classification (CC) 1 no units WHO IARC Cancer Slope Factor (CSF) 0.18 (mg/kg/day)A-l CalEPA OEHHA Chemical Database Inhalation Unit Risk (IUR) 0.000051 ug/mA3 CalEPA OEHHA Chemical Database Subchronic Provisional RfD 0.02 mg/kg/day EPA PPRTV Data Element Value Units Source Notes Measured Data and Assessment Results LD50 300 mg/kg NIH HSDB min LD50 940 mg/kg NIH HSDB max Percent of active toxcast in vitro assays tested 1.47 percent EPA Chemistry Dashboard Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Modeled Data LD50 0.0067298 mo l/kg TEST QSAR Ames mutagenicity test 0.335 no units TEST QSAR Developmental toxin test 0.559 no units TEST QSAR A-610 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 o-Toluidine CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 OCCURRENCE DATA Scoring_Data_ Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contam nant Monitoring Rule (UCMR) 4 2018-2019 3.678 67 Sites 1.82 0.007 0.012 0.0616 0.38 Unregulated Contam nant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contam nant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contam nant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contam nant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contam nant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survey (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 National Water Qua lity Assessment (USGS NAWQA) (Surface Water) 1991-2017 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) 10 6,328 Chemical Data Reporting (CDR) Results (EPA) (2016) 50M - 100M Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Ambient Water Prevalence Magnitude National Water Information System (USGS NWIS) (Surface Water) 2008-2017 21 0 Sites 0 National Water Information System (USGS NWIS) (Groundwater) 2008-2017 15 0 Sites 0 National Water Information System (USGS NWIS) (All Water) 2008-2017 36 0 Sites 0 Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 0.00000421 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 3.81183 days Boiling point OPERA QSAR 212.346 degree C Boiling point TEST QSAR 206.895 degree C Vapor pressure OPERA QSAR 0.177328 mmHg Vapor pressure TEST QSAR 0.134586 mmHg Solubility in water OPERA QSAR 0.182954 mol/L Solubility in water TEST QSAR 0.0475335 mol/L Bioconcentration factor OPERA QSAR 4.90019 no units Bioconcentration factor TEST QSAR 6.54636 no units Henry's Law constant OPERA QSAR 0.0000019 atm-mA3/mol 0 eta no l/water partitioning coeff. (log Kow) OPERA QSAR 1.4043 no units A-611 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 o-Toluidine CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 328 USEPA. 2012. Provisional Peer-Reviewed Toxicity Values for o-Toluidine. U.S. Environmental Protection Agency, Office of Research and Development, National Center for Environmental Assessment, Superfund Health Risk Technical Support Center, Cincinnati, OH. A-612 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Oxadiazon CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Chemical Notes: DTXSID3024239 Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 4 carcinogen with linear MOA 1 1 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 0.4 increase in liver adenomas and/or carcinomas combined in males general population OPP 2014 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 46.3 EDWCSW Chronic OPP 2020 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-613 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Oxadiazon CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Cancer Slope Factor (CSF) 0.0711 (mg/kg/day)A-l OPP 2014 Shirasu 1987 increase in liver adenomas and/or carcinomas combined in males general population 33.8 0.416 [333] NOTE: a non-cancer toxicity value was not provided in this assessment because there are no food or feed uses of oxadiazon Cancer Classification (CC) L OPP 2014 [333] NOTE: a non-cancer toxicity value was not provided in this assessment because there are no food or feed uses of oxadiazon Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Measured Data and Assessment Results Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Measured Data and Assessment Results LD50 3500 mg/kg NIH HSDB min LD50 5000 mg/kg NIH HSDB max LOAEL 180 mg/kg/day EPA Toxicity Reference Database max LOAEL 3.5 mg/kg/day EPA Toxicity Reference Database min NOAEL 0.44 mg/kg/day EPA Toxicity Reference Database min NOAEL 60 mg/kg/day EPA Toxicity Reference Database max Percent of active toxcast in 21.59 percent EPA Chemistry Dashboard vitro assays tested Subchronic LOAEL 100 mg/kg/day EPA Toxicity Reference Database max Subchronic LOAEL 25 mg/kg/day EPA Toxicity Reference Database min Subchronic NOAEL 25 mg/kg/day EPA Toxicity Reference Database Data Element Value Units Source Notes Modeled Data LD50 0.0017989 mo l/kg TEST QSAR Ames mutagenicity test 0.434 no units TEST QSAR Developmental toxin test 0.874 no units TEST QSAR A-614 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Oxadiazon CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 OCCURRENCE DATA Scoring_Data_ Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 National Water Qua lity Assessment (USGS NAWQA) (Surface Water) 1991-2017 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) 1 1,328 2016 Toxic Release Inventory (TRI) Program (EPA) (2016) 5 58 Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude USDA Pesticide Data Program (PDP) (Finished) 2001-2013 15 1 Sites 6.67 0.025 0.0945 0.15 0.164 ug/L Ambient Water Prevalence Magnitude National Water Information System (USGS NWIS) (Surface Water) 2008-2017 57 11 Sites 19 0.0047 0.0218 0.248 1.53 ug/L National Water Information System (USGS NWIS) (All Water) 2008-2017 57 11 Sites 19 0.0047 0.0218 0.248 1.53 ug/L USDA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001-2013 120 1 Sites 0.83 0.086 0.086 0.086 0.086 ug/L USDA Pesticide Data Program (PDP) (Groundwater) 2001-2013 113 0 Sites 0 USDA Pesticide Data Program (PDP) (Untreated) 2001-2013 8 1 Sites 12 0.086 0.086 0.086 0.086 ug/L Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990 - 2018 3,008 1,250 Sites 42 8e-07 0.000202 0.0191 2.6219 ug/L Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Estimated Drinking Water Concentration (EDWC) in Surface Water, Chronic (cancer) 2020 OPP 46.3 ug/L Pesticide in Water Calculator (PWC), vl.52 The modeled surface water chronic, cancer concentration provided by the most recent available EPA OPP exposure assessment was selected as the occurrence concentration for oxadiazon. This value coincides with the critical effects of liver adenomas and carcinomas provided within the health effects report. Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 0.000000141 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 4.7926 days Boiling point OPERA QSAR 343.796 degree C Boiling point TEST QSAR 356.765 degree C Vapor pressure OPERA QSAR 0.000000128 mmHg Vapor pressure TEST QSAR 8.81E-08 mmHg Solubility in water OPERA QSAR 0.00000508 mol/L Solubility in water TEST QSAR 0.00000867 mol/L Bioconcentration factor OPERA QSAR 1204.35 no units Bioconcentration factor TEST QSAR 94.189 no units Henry's Law constant OPERA QSAR 7.72E-08 atm-mA3/mol 0 eta no l/water partitioning coeff. (log Kow) OPERA QSAR 4.67306 no units A-615 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Oxadiazon CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 333 USEPA. 2014. Oxadiazon. Human Health Assessment Scoping Document in Support of Registration Review. EPA-HQ-OPP-2014-0782-0004. DP No. D420616. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticide in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. A-616 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Oxyfluorfen CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Oxyfluorfen CASRN: 42874-03-3 DTXSID: DTXSID7024241 Use: Pesticide; herbicide Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 4 carcinogen with linear MOA 2 4 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 0.4 hepatocellular adenomas and carcinomas general population OPP 2019 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.2415 90th Percentile Finished Water UCMR4 2018-2019 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-617 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Oxyfluorfen CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg- HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.04 mg/kg/day OPP 2019 Goldenthal and Wazeter 1977 multiple signs of liver toxicity general population 33.8 237 [422] Cancer Slope Factor (CSF) 0.0732 (mg/kg/day)A-l OPP 2019 Goldenthal & Wazeter 1977 hepatocellular adenomas and carcinomas general population 33.8 0.404 [422] Cancer Classification (CC) C OPP 2019 [422] Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg- CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title- abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Cancer Slope Factor (CSF) 0.0732 (mg/kg/day) A-1 EPA HHBP Chronic Human Health Benchmark 0.2 mg/L EPA HHBP Chronic Human Health Benchmark 0.000437 mg/L EPA HHBP Health-Based Screening Level 0.2 mg/L Health-based screening levels from USGS Health-Based Screening Level 0.000437 mg/L Health-based screening levels from USGS Population-Ad justed Dose (PAD) 0.03 mg/kg/dav EPA HHBP Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Measured Data and Assessment Results LOAEL 18.5 mg/kg/day EPA Toxicity Reference Database min LOAEL 183 mg/kg/day EPA Toxicity Reference Database max NOAEL 3.1 mg/kg/day EPA Toxicity Reference Database min NOAEL 36.4 mg/kg/day EPA Toxicity Reference Database max Percent of active toxcast in 13.39 percent EPA Chemistry Dashboard vitro assays tested Subchronic LOAEL 51.400002 mg/kg/day EPA Toxicity Reference Database min Subchronic LOAEL 585 mg/kg/day EPA Toxicity Reference Database max Subchronic NOAEL 150.5 mg/kg/day EPA Toxicity Reference Database max Subchronic NOAEL 18 mg/kg/day EPA Toxicity Reference Database min Data Element Value Units Source Notes Modeled Data LD50 0.0087498 mol/kg TEST QSAR Ames mutagenicity test 0.253 no units TEST QSAR Developmental toxin test 0.864 no units TEST QSAR A-618 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Oxyfluorfen CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contam nant Monitoring Rule (UCMR) 4 2018-2019 3.649 6 Sites 0.16 0.053 0.0717 0.242 0.38 Unregulated Contam nant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contam nant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contam nant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contam nant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contam nant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 4.284 24 Sites 0.56 0.001 0.011 0.045 0.852 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 406 22 Sites 5.42 0.001 0.011 0.0442 0.605 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 3.878 2 Sites 0.05 0.002 0.427 0.682 0.852 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) 29 969,226 2016 Toxic Release Inventory (TRI) Program (EPA) (2016) 5 3,643 Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude USDA Pesticide Data Program (PDP) (Finished) 2001-2013 13 0 Sites 0 Ambient Water Prevalence Magnitude National Water Information System (USGS NWIS) (Surface Water) 2008-2017 759 28 Sites 3.69 0.001 0.0447 0.188 4.27 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008-2017 1,453 1 Sites 0.07 0.008 0.008 0.008 0.008 ug/L National Water Information System (USGS NWIS) (All Water) 2008-2017 2,211 29 Sites 1.31 0.001 0.0426 0.183 4.27 ug/L USDA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001-2013 8 0 Sites 0 USDA Pesticide Data Program (PDP) (Groundwater) 2001-2013 2 0 Sites 0 USDA Pesticide Data Program (PDP) (Untreated) 2001-2013 6 0 Sites 0 Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990-2018 1,939 208 Sites 11 0.0038 0.0995 0.481 9.23 ug/L Bradley et al. 2017 (Ambient) [52] 2012-2014 38 6 Sites 16 0.00147 0.00482 0.0487 0.0864 ug/L Arnold et al. 2016 (Filtered) [7] 2012-2013 690 0 Sites 0 Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 0.00000013 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 3.54009 days Boiling point OPERA QSAR 358.749 degree C Boiling point TEST QSAR 366.917 degree C Vapor pressure OPERA QSAR 0.000000254 mmHg Vapor pressure TEST QSAR 0.000000226 mmHg Solubility in water OPERA QSAR 0.000000308 mol/L Solubility in water TEST QSAR 0.00000334 mol/L Bioconcentration factor OPERA QSAR 12909 no units Bioconcentration factor TEST QSAR 320.627 no units Henry's Law constant OPERA QSAR 0.00000347 atm-mA3/mol 0 eta no l/water partitioning coeff. (log Kow) OPERA QSAR 4.70955 no units A-619 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Oxyfluorfen CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 422 USEPA. 2019. Oxyfluorfen: Draft Human Health Risk Assessment for Registration Review. EPA-HQ-OPP-2014-0778-0025. DP No. D445742. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticide in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. A-620 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 p^p'-DDE CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: p,p'-DDE CASRN: 72-55-9 DTXSID: DTXSID9020374 Use: Product of degradation of DDT Chemical Notes: Is the contaminant on any lists? CERCLA X FIFRA Human Neurotoxicants PubMed Neu rotoxica nts X Neu rode v. Disruptors Androgen Receptors in vitro X Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 5 carcinogen with linear MOA 1 7 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 0.09 hepatocellular carcinomas, hepatomas; increased incidence of livertumors including carcinomas in two strains of mice and in hamsters and of thyroid tumors in female rats by diet general population IRIS 1988 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 3 90th Percentile Finished Water UCMR1 2001 - 2003 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS DDE appears to occur infrequently at levels of concern in PWSs. DDE ¦as detected in only one of the PWSs monitored under the UCMR lat level greater than the MRL(0.8 pg/L) [a]. The MRL is greater than the HRLof 0.2 pg/L but represents a concentration that is within the 10-4 the 10-6 cancer risk range targeted by EPA [b]. In addition, ambient iter data from the USGS indicate that the maximum concentrations detected in surface and ground water were less than the HRL [c,d]. USE PA, 2008 [297]; [b] US EPA, 2000 [238]; [c] Martin, Crawford, & son, 2003 [134]; [d] Kolpin & Martin, 2003 [123]; as cited in USE PA, 2008 [296] Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-621 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 p,p'-DDE CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg- HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 1 mg/kg/day PPRTV 2017 Yamasaki etal., 2009 increased relative liver weight in adult male offspring exposed during gestation and via lactation bottle-fed infants 151 1320 [391] Cancer Slope Factor (CSF) 0.34 (mg/kg/day)A-l IRIS 1988 Rossi et al. 1983; NCI 1978; Tomatis et al. 1974 "hepatocellular carcinomas, hepatomas"; "increased incidence of liver tumors including carcinomas in two strains of mice and in hamsters and of thyroid tumors in female rats by diet." general population 33.8 0.0870 [200] NOTE: the 2017 PPRTV assessment declines to derive a cancer slope factor for DDE because a carcinogenicity assessment is available on IRIS Cancer Classification (CC) B2 IRIS 1988 [200] NOTE: the 2017 PPRTV assessment declines to derive a cancer slope factor for DDE because a carcinogenicity assessment is Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (m L/kg- CCL Screening Level ("g/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Titie- abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Metabolic, Svstemic 0.834 Mvrmel.2016 2016-09-01 2019-10-22 563 10 112 1 Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Cancer Slope Factor (CSF) 0.34 (mg/kg/day)A-l CalEPA OEHHA Chemical Database Chronic Health-Based Guidance Value 0.0001 mg/L MN DOH Human Health Ambient Water Quality Criteria 0.000000018 mg/L EPA Human Health Criteria for CWA Inhalation Unit Risk(IUR) 0.000097 ug/mA3 CalEPA OEHHA Chemical Database Subchronic Provisional RfD 0.0003 mg/kg/day EPA PPRTV Cancer Classification (CC) Female.Mice P no units HHS NTP Cancer Classification (CC) Female.Rats N no units HHS NTP Cancer Classification (CC) Male.Mice P no units HHS NTP Cancer Classification (CC) Male.Rats N no units HHSNTP Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. The full citation forthe critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Modeled Data LD50 0.001219 mol/kg TEST QSAR Ames mutagenicity test -0.248 no units TEST QSAR Developmental toxin test 0.419 no units TEST QSAR Data Element Value Units Source Notes Measured Data and Assessment Results LD50 700 mg/kg NIH HSDB min LD50 880 mg/kg NIH HSDB max Percent of active toxcast in 28.17 percent EPA Chemistry Dashboard vitro assays tested TD50 119 mg/kg/dav NIH CPDB max TD50 7.48 mg/kg/day NIH CPDB min A-622 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 p,p'-DDE CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 3.874 1 Sites 0.03 3 3 3 3 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 8.246 458 Sites 5.55 0 0.002 0.01 0.062 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 1.836 251 Sites 14 0 0.003 0.011 0.062 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 6.411 207 Sites 3.23 0 0.001 0.003 0.008 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Finished) 2006 - 2020 47 0 Sites 0 USDA Pesticide Data Program (PDP) (Finished) 2001-2013 13 0 Sites 0 Ambient Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Source) 2006 - 2020 294 0 Sites 0 National Water Information System (USGS NWIS) (Surface Water) 2008-2017 464 21 Sites 4.53 4.00E - 04 0.00466 0.0162 0.068 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008-2017 886 12 Sites 1.35 0.001 0.003 0.0446 0.08 ug/L National Water Information System (USGS NWIS) (All Water) 2008-2017 1,350 33 Sites 2.44 4.00E - 04 0.0046 0.0261 0.08 ug/L USDA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001 - 2013 8 0 Sites 0 USDA Pesticide Data Program (PDP) (Groundwater) 2001 - 2013 2 0 Sites 0 USDA Pesticide Data Program (PDP) (Untreated) 2001 - 2013 6 0 Sites 0 Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990 - 2018 600 47 Sites 7.83 0.003 0.01 0.0428 0.57 ug/L Bradley et al. 2017 (Ambient) [52] 2012 - 2014 38 5 Sites 13 0.000848 0.0032 0.0159 0.0238 ug/L Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 9.84E-08 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) 1170 ng/g NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 13.4608 days Boiling point OPERA QSAR 338.523 degree C Boiling point TEST QSAR 360.317 degree C Vapor pressure OPERA QSAR 0.00000416 mmHg Vapor pressure TEST QSAR 0.00000353 mmHg Solubility in water OPERA QSAR 0.000000159 mol/L Solubility in water TEST QSAR 0.000000262 mol/L Bioconcentration factor OPERA QSAR 12264.3 no units Bioconcentration factor TEST QSAR 17298.2 no units Henry's Law constant OPERA QSAR 0.0000268 o E E 0 eta no l/water partitioning coeff. (log Kow) OPERA QSAR 6.45816 no units A-623 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 p,p'-DDE CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 123 Kolpin, D.W. and J.D. Martin. 2003. Pesticides in Ground Water: Summary Statistics; Preliminary Results from Cycle 1 of the National Water Quality Assessment Program (NAWQA), 1992-2001. Available on the Internet at: http://ca.water.usgs.gov/pnsp/pestgw/Pest-GW_2001_Text.html. 134 Martin, J.D., C.G. Crawford, and S.J. Larson. 2003. Pesticides in Streams: Summary Statistics; Preliminary Results from Cycle 1 of the National Water Quality Assessment Program (NAWQA), 1992-2001. Available on the Internet at: http://ca.water.usgs.gov/pnsp/pestsw/Pest-SW_2001_Text.html. 200 USEPA. 1988. p,p'-Dichlorodiphenyldichloroethylene (DDE); CASRN 72-55-9. U.S. Environmental Protection Agency, National Center for Environmental Assessment, Integrated Risk Information System (IRIS), Washington, DC. 238 USEPA. 2000. Unregulated Contaminant Monitoring Regulation Analytical Methods and Quality Control Manual. EPA 815-R-00-006. 296 USEPA. 2008. Regulatory Determinations Support Document for Selected Contaminants from the Second Drinking Water Contaminant Candidate List (CCL 2). EPA Report 815-R-08-012. June 2008. 297 USEPA. 2008. The Analysis of Occurrence Data from the First Unregulated Contaminant Monitoring Regulation (UCMR 1) in Support of Regulatory Determinations for the Second Drinking Water Contaminant Candidate List. EPA 815-R-08-013. June. 391 USEPA. 2017. Provisional Peer-Reviewed Toxicity Values for p,p'-Dichlorodiphenyldichloroethylene (p,p'-DDE) (CASRN 72-55-9). EPA/690/R-17/007. U.S. Environmental Protection Agency, Office of Research and Development, National Center for Environmental Assessment, Superfund Health Risk Technical Support Center, Cincinnati, OH. 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticide in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. A-624 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 p-Cresol CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: p-Cresol CASRN: 106-44-5 DTXSID: DTXSID7021869 Use: Chemical intermediate making synthetic resins; in disinfectants and fumigants; as industrial solvent. Chemical Notes: Is the contaminant on any lists? CERCLA X FIFRA Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro X Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 5 reproductive and developmental effects 9 3 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value («"gA) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 100 neurotoxicity and mortality in pregnant rabbits women of child bearing age PPRTV 2010 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.181 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-625 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 p-Cresol CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDW and OST Data Element Value Assessment Source Critical Study Target Population Exposure Factor (mL/kg- HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent ng/kg/day neurotoxicity and mortality in pregnant rabbits women of childbearing age NOTE: Though the critical effects in this study are not reproductive or developmental effects, they were observed in a study of pregnant rabbits. The assessment notes that no chronic studies were available to calculate a chronic duration RfD. Given the data gaps in non- pregnant adult animals, we make the conservative assumption that the effects observed in the 2-gen study are pregnancy related. For this reason we use the exposure factors for n/nman of Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg- CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title- abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review 2009-09-01 2019-12-17 433 0 9 Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Chronic Health-Based Guidance Value 0.003 mg/L MN DOH Subchronic Provisional RfD 0.02 mg/kg/dav EPA PPRTV Data Element Value Units Source Notes Measured Data and Assessment Results LD50 1800 mg/kg NIH HSDB max LD50 207 mg/kg NIH HSDB min Percent of active toxcast in 1.59 percent EPA Chemistry Dashboard vitro assays tested Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Modeled Data LD50 0.0048306 mol/kg TEST QSAR Ames mutagenicity test 0.06 no units TEST QSAR Developmental toxin test 0.214 no units TEST QSAR A-626 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 p-Cresol CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contam nant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contam nant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contam nant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contam nant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contam nant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contam nant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev(NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 566 45 Sites 7.95 0.01 0.03 0.181 73 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 88 37 Sites 42 0.01 0.04 0.177 73 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 478 8 Sites 1.67 0.01 0.02 0.078 0.19 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) 8 421,441 Chemical Data Reporting (CDR) Results (EPA) (2016) 50M - 100M Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Glassmeyer et al 2017 (Finished) [86] 2007-2012 25 NA Sites 0 ug/L USGS, Sioux Falls Area, 2012 (Finished) [153] 2009-2010 1 0 Sites 0 Ambient Water Prevalence Magnitude National Water Information System (USGS NWIS) (Surface Water) 2008-2017 722 305 Sites 42 0.01 0.03 0.186 91.1 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008-2017 771 52 Sites 6.74 0.01 0.05 0.47 11.6 ug/L National Water Information System (USGS NWIS) (All Water) 2008-2017 1,493 357 Sites 24 0.01 0.03 0.19 91.1 ug/L Glassmeyer et a 1 2017 (Ambient) [86] 2007-2012 25 NA Sites 0 ug/L Bradley et al. 2017 (Ambient) [52] 2012-2014 38 21 Sites 55 0.0086 0.0219 0.0391 0.135 ug/L USGS, Sioux Falls Area, 2012 (Ambient) [153] 2009-2010 2 2 Sites 100 Waste Water Effluent Prevalence Magnitude Scott et al. 2018 (Wastewater) [161] 2011-2017 21 13 Sites 62 0.046 0.3 1.1 1.2 ug/L Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 0.00000396 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 5.33885 days Boiling point OPERA QSAR 200.232 degree C Boiling point TEST QSAR 185.666 degree C Vapor pressure OPERA QSAR 0.0992564 mmHg Vapor pressure TEST QSAR 0.21677 mmHg Solubility in water OPERA QSAR 0.168658 mol/L Solubility in water TEST QSAR 0.141579 mol/L Bioconcentration factor OPERA QSAR 15.2284 no units Bioconcentration factor TEST QSAR 9.39723 no units Henry's Law constant OPERA QSAR 0.000000807 atm-mA3/mol 0 eta no 1/water partitioning coeff. (log Kow) OPERA QSAR 1.94663 no units A-627 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 p-Cresol CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 86 Glassmeyer, S.T., Furlong, E.T., Kolpin, D.W., Batt, A.L., Benson, R., Boone, J.S.,... & Wilson, V.S. (2017). Nationwide reconnaissance of contaminants of emerging concern in source and treated drinking waters of the United States. Science of The Total Environment. v581-582, (909-922). 153 Occurrence of anthropogenic organic compounds and nutrients in source and finished water in the Sioux Falls area, South Dakota, 2009-10: U.S. Geological Survey Scientific Investigations Report 2012-5098, 21 p. plus appendixes. 161 Scott, T. M., Phillips, P. J., Kolpin, D. W., Colella, K. M., Furlong, E. T., Foreman, W. T., & Gray, J. L. (2018). Pharmaceutical manufacturing facility discharges can substantially increase the pharmaceutical load to US wastewaters. Science of the Total Environment, 636, 69-79. 315 USEPA. 2010. Provisional Peer-Reviewed Toxicity Values for 4-Methylphenol (p-Cresol) (CASRN 106-44-5). EPA/690/R-10/019F. U.S. Environmental Protection Agency, Office of Research and Development, National Center for Environmental Assessment, Superfund Health Risk Technical Support Center, Cincinnati, OH. A-628 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Pendimethalin CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Pendimethalin CASRN: 40487-42-1 DTXSID: DTXSID7024245 Use: Selective herbicide for control of broad leaf weeds and grassy weed species Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 4 reproductive and developmental effects 9 3 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value («"gA) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 2000 hormonal and histopat ho logical changes in the thyroid women of child bearing age OPP 2019 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.088 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-629 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Pendimethalin CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.3 mg/kg/day OPP 2019 Fischer 1991 and 1993; Devito and Bra verm an 1993 hormonal and histopathological changes in the thyroid women of child bearing age 35.4 1690 [423] Cancer Classification (CC) C OPP 2019 [4231 Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Acute Human Health Benchmark 7 mg/L EPA HHBP Acute PAD 1 mg/kg/day EPA HHBP Chronic Human Health Benchmark 2 mg/L EPA HHBP Drinking Water Guideline Value 0.02 mg/L WHO Drinking Water Quality Guidelines Health-Based Screening Level 2 mg/L Health-based screening levels from USGS Population-Adjusted Dose (PAD) 0.3 mg/kg/day EPA HHBP Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Measured Data and Assessment Results LD50 1050 mg/kg NIH HSDB min LD50 5000 mg/kg NIH HSDB max LOAEL 51 mg/kg/day EPA Toxicity Reference Database min LOAEL 622.09998 mg/kg/day EPA Toxicity Reference Database max NOAEL 46 mg/kg/day EPA Toxicity Reference Database min NOAEL 78.3 mg/kg/day EPA Toxicity Reference Database max Percent of active toxcast in 15.43 percent EPA Chemistry Dashboard vitro assays tested Subchronic LOAEL 250 mg/kg/day EPA Toxicity Reference Database Subchronic NOAEL 25 mg/kg/day EPA Toxicity Reference Database Data Element Value Units Source Notes Modeled Data LD50 0.0067453 mo l/kg TEST QSAR Ames mutagenicity test 0.117 no units TEST QSAR Developmental toxin test 0.948 no units TEST QSAR A-630 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Pendimethalin CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST October 2022 Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018 - 2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013 - 2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008 - 2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survey (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991 - 2017 11,234 412 Sites 3.67 2.00E - 04 0.019 0.088 42 ug/L National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991 - 2017 2,224 387 Sites 17 2.00E - 04 0.019 0.0871 42 ug/L National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991 - 2017 9,010 25 Sites 0.28 7.00E - 04 0.0185 0.107 0.824 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) 48 17,968,965 2016 Toxic Release Inventory (TRI) Program (EPA) (2016) 11 5,858 Chemical Data Reporting(CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Finished) 2006 - 2020 1 0 Sites 0 USDA Pesticide Data Program (PDP) (Finished) 2001 - 2013 15 2 Sites 13 0.007492 0.008 0.0664 0.076 ug/L USGS, Sioux Falls Area, 2012 (Finished) [153] 2009 - 2010 1 0 Sites 0 Ambient Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Source) 2006 - 2020 2 0 Sites 0 National Water Information System (USGS NWIS) (Surface Water) 2008 - 2017 1,006 109 Sites 11 0.001 0.024 0.118 2.46 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008 - 2017 3,066 2 Sites 0.07 0.011 0.0175 0.0384 0.048 ug/L National Water Information System (USGS NWIS) (All Water) 2008 - 2017 4,071 111 Sites 2.73 0.001 0.024 0.115 2.46 ug/L USDA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001 - 2013 225 0 Sites 0 USDA Pesticide Data Program (PDP) (Groundwater) 2001 - 2013 218 0 Sites 0 USDA Pesticide Data Program (PDP) (Untreated) 2001 - 2013 8 0 Sites 0 Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990 - 2018 4,405 416 Sites 9.44 0.005 0.191 1.28 8.35 ug/L Bradley et al. 2017 (Ambient) [52] 2012 - 2014 38 13 Sites 34 0.000319 0.0039 0.0301 0.578 ug/L Arnold et al. 2016 (Filtered) [7] 2012 - 2013 690 4 Sites 0.58 7e-04 0.00145 0.00437 0.0056 ug/L USGS, Sioux Falls Area, 2012 (Ambient) [153] 2009 - 2010 2 0 Sites 0 lA/osfe Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg- bw/day) Notes Expo cast exposure 1.66E-08 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES bio monitoring detect ion in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR4data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biode gradation ha If-life OPERA QSAR 3.53725 days Boiling point OPERA QSAR 330.972 degree C Boiling point TEST QSAR 363.278 degree C Vapor pressure OPERA QSAR 0.0000268 mmHg Vapor pressure TEST QSAR 0.000000621 mmHg Solubility in water OPERA QSAR 0.00000164 mol/L Solubility in water TEST QSAR 0.00000984 mol/L Bioconcentration factor OPERA QSAR 979.509 no units Bioconcentration factor TEST QSAR 59.5662 no units Flenry's Law constant OPERA QSAR 0.00000168 atm-mA3/mol Octanol/water partitioning coeff. (log Kow) OPERA QSAR 5.0582 no units A-631 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Pendimethalin CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 153 Occurrence of anthropogenic organic compounds and nutrients in source and finished water in the Sioux Falls area, South Dakota, 2009-10: U.S. Geological Survey Scientific Investigations Report 2012-5098, 21 p. plus appendixes. 423 USEPA. 2019. Pendimethalin - Human Health Risk Assessment to Support the Proposed New Uses on Leaf Petiole Vegetable Subgroup 22B, Monarda and Rosemary. EPA-HQ-OPP-2018-0619-0008. DP No. D448588. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticide in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. A-632 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Permethrin CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Chemical Notes: DTXSID8022292 Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro X Compounds with neu rod ev effects, Mundy et a 12015 X CONTAMINANT SUMMARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 4 carcinogen with linear MOA 4 4 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 3 lung adenomas and/or carcinomas in female general population OPP 2017 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.1558 90th Percentile Finished Water UCMR4 2018-2019 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-633 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Permethrin CCL 5 Contaminant Information Sheet EPA-OGWDWand OST October 2022 HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.147 mg/kg/day OPP 2017 Wolansky et al., 2006 reduced motor activity bottle-fed infants 151 195 [388] Cancer Slope Factor (CSF) 0.009567 (mg/kg/day)A-l OPP 2017 Ellison, 1979; Barton, 2000 lung adenomas and/or carcinomas in female mice general population 33.8 3.09 [388] Cancer Classification (CC) L OPP 2017 [388] Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Acute Human Health Benchmark 1.7 mg/L EPA HHBP Acute Minimal Risk Level (MRL) 0.3 mg/kg/day CDC ATSDR Acute PAD 0.25 mg/kg/day EPA HHBP Cancer Classification (CC) 3 no units WHO IARC Cancer Slope Factor (CSF) 0.009567 (mg/kg/day) A-1 EPA HHBP Chronic Human Health Benchmark 1.6 mg/L EPA HHBP Chronic Human Health Benchmark 0.003344 mg/L EPA HHBP Health-Based Screening Level 1.6 mg/L Health-based screening levels from USGS Health-Based Screening Level 0.003344 mg/L Health-based screening levels from USGS Intermediate Minimal Risk Level (MRL) 0.2 mg/kg/day CDC ATSDR Population-Adjusted Dose (PAD) 0.25 mg/kg/day EPAHHBP Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Measured Data and Assessment Results LD50 250 mg/kg NIH HSDB min LD50 6000 mg/kg NIH HSDB max LOAEL 1200 mg/kg/day EPA Toxicity Reference Database max LOAEL 91.5 mg/kg/day EPA Toxicity Reference Database min NOAEL 5 mg/kg/day EPA Toxicity Reference Database min NOAEL 600 mg/kg/day EPA Toxicity Reference Database max Percent of active toxcast in 8.43 percent EPA Chemistry Dashboard vitro assays tested Data Element Value Units Source Notes Modeled Data LD50 0.0018578 mo l/kg TEST QSAR Ames mutagenicity test 0.272 no units TEST QSAR Developmental toxin test 0.816 no units TEST QSAR A-634 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Permetiirin CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 OCCURRENCE DATA Scoring_Data_ Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 3.649 10 Sites 0.27 0.04 0.054 0.156 0.212 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 14 2 Sites 14 0.0077 0.00885 0.00954 0.01 National Water Qua lity Assessment (USGS NAWQA) (Surface Water) 1991-2017 14 2 Sites 14 0.0077 0.00885 0.00954 0.01 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) 45 604,727 2016 Toxic Release Inventory (TRI) Program (EPA) (2016) 9 20,106 Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Finished) 2006 - 2020 3 0 Sites 0 Ambient Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Source) 2006 - 2020 9 0 Sites 0 National Water Information System (USGS NWIS) (Surface Water) 2008-2017 140 5 Sites 3.57 0.0044 0.0053 0.0108 0.0146 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008-2017 3 0 Sites 0 National Water Information System (USGS NWIS) (All Water) 2008-2017 143 5 Sites 3.5 0.0044 0.0053 0.0108 0.0146 ug/L Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990-2018 6,049 452 Sites 7.47 0.000608 0.0169 0.113 180.9 ug/L Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 0.000002 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 3.34923 days Boiling point OPERA QSAR 401.477 degree C Boiling point TEST QSAR 412.391 degree C Vapor pressure OPERA QSAR 3.02E-08 mmHg Vapor pressure TEST QSAR 0.00000001 mmHg Solubility in water OPERA QSAR 0.000000627 mol/L Solubility in water TEST QSAR 5.13E-08 mol/L Bioconcentration factor OPERA QSAR 469.919 no units Bioconcentration factor TEST QSAR 727.78 no units Henry's Law constant OPERA QSAR 4.13E-09 atm-mA3/mol 0 eta no l/water partitioning coeff. (log Kow) OPERA QSAR 6.4075 no units A-635 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Permethrin CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 388 USEPA. 2017. Permethrin: Human Health Draft Risk Assessment for Registration Review. EPA-HQ-OPP-2011-0039-0088. DP No. 414137. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticide in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. A-636 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Phenanthrene CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Phenanthrene CASRN: 85-01-8 DTXSID: DTXSID6024254 Use: Dyestuffs, explosives, synthesis of drugs, biochemical research, manufacturing phenanthrenequinone. Chemical Notes: Is the contaminant on any lists? CERCLA X FIFRA Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 9 3 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.048 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-637 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Phenanthrene CCL 5 Contaminant Information Sheet EPA-OGWDWand OST October 2022 HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Cancer Classification (CC) D IRIS 1990 [208] Cancer Classification (CC) D OW1991 [212] Cancer Classification (CC) I PPRTV 2009 [303] ATSDR1995 [10] Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review 2008-03-08 2020-03-16 2319 0 16 Other Health Data Data Element I Value Units 1 Source I Notes Measured Data and Assessment Results Cancer Classification (CC) 1 3 no units IWHO IARC I Data Element Value Units Source Notes Measured Data and Assessment Results LD50 700 mg/kg NIH HSDB Percent of active toxcast in 5.92 percent EPA Chemistry Dashboard vitro assays tested Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Modeled Data LD50 0.0089331 mo l/kg TEST QSAR Ames mutagenicity test 0.629 no units TEST QSAR Developmental toxin test 0.651 no units TEST QSAR A-638 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Phenanthrene CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev(NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 593 39 Sites 6.58 0.003 0.014 0.048 0.13 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 101 29 Sites 29 0.003 0.0145 0.05 0.13 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 492 10 Sites 2.03 0.008 0.013 0.017 0.044 Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) 27 287,091 Chemical Data Reporting (CDR) Results (EPA) (2016) 500K-1M Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Finished) 2006 - 2020 28 1 Sites 3.57 0.001 0.002 0.002 0.002 ug/L Drinking Water Monitoring Data - WA (Finished) 2006-2011 481 0 Sites 0 Glassmeyer et al 2017 (Finished) [86] 2007-2012 25 NA Sites 0 ug/L USGS, Sioux Falls Area, 2012 (Finished) [153] 2009-2010 1 0 Sites 0 Ambient Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Source) 2006 - 2020 233 2 Sites 0.86 0.1 0.3 0.356 0.37 ug/L Drinking Water Monitoring Data - WA (Source) 2006-2011 634 0 Sites 0 National Water information System (USGS NWIS) (Surface Water) 2008-2017 866 258 Sites 30 0.003 0.02 0.255 26.3 ug/L National Water information System (USGS NWIS) (Groundwater) 2008-2017 1,099 98 Sites 8.92 0.002 0.017 0.0818 140 ug/L National Water information System (USGS NWIS) (All Water) 2008-2017 1,965 356 Sites 18 0.002 0.02 0.24 140 ug/L Glassmeyer et a 1 2017 (Ambient) [86] 2007-2012 25 NA Sites 0 ug/L Bradley et al. 2017 (Ambient) [52] 2012-2014 38 6 Sites 16 0.0074 0.0176 0.0239 0.0241 ug/L USGS, Sioux Falls Area, 2012 (Ambient) [153] 2009-2010 2 0 Sites 0 Waste Water Effluent Prevalence Magnitude Scott et al. 2018 (Wastewater) [161] 2011-2017 21 2 Sites 9.52 0.0086 0.0087 0.00878 0.0088 ug/L Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 0.00000121 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 63.7756 days Boiling point OPERA QSAR 340.536 degree C Boiling point TEST QSAR 340.522 degree C Vapor pressure OPERA QSAR 0.0000303 mmHg Vapor pressure TEST QSAR 0.000049 mmHg Solubility in water OPERA QSAR 0.00000116 mol/L Solubility in water TEST QSAR 0.00000355 mol/L Bioconcentration factor OPERA QSAR 2227.32 no units Bioconcentration factor TEST QSAR 633.87 no units Henry's Law constant OPERA QSAR 0.0000518 atm-mA3/mol 0 eta no l/water partitioning coeff. (log Kow) OPERA QSAR 4.52256 no units A-639 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Phenanthrene CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 10 ATSDR. 1995. Toxicological Profile for Polycyclic Aromatic Hydrocarbons. U.S. Department of Health and Human Services, Public Health Service, Agency for Toxic Substances and Disease Registry (ATSDR), Atlanta, GA. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 86 Glassmeyer, S.T., Furlong, E.T., Kolpin, D.W., Batt, A.L., Benson, R., Boone, J.S.,... & Wilson, V.S. (2017). Nationwide reconnaissance of contaminants of emerging concern in source and treated drinking waters of the United States. Science of The Total Environment. v581-582, (909-922). 153 Occurrence of anthropogenic organic compounds and nutrients in source and finished water in the Sioux Falls area, South Dakota, 2009-10: U.S. Geological Survey Scientific Investigations Report 2012-5098, 21 p. plus appendixes. 161 Scott, T. M., Phillips, P. J., Kolpin, D. W., Colella, K. M., Furlong, E. T., Foreman, W. T., & Gray, J. L. (2018). Pharmaceutical manufacturing facility discharges can substantially increase the pharmaceutical load to US wastewaters. Science of the Total Environment, 636, 69-79. 208 USEPA. 1990. Chemical Assessment Summary, Phenanthrene. U.S. Environmental Protection Agency, National Center for Environmental Protection, Integrated Risk Information System (IRIS), Washington, D.C. 212 USEPA. 1991. Drinking Water Criteria Document for Polycyclic Aromatic Hydrocarbons (PAHs). U.S. Environmental Protection Agency, Office of Health and Environmental Assessment, Environmental Criteria and Assessment Office, Cincinnati, OH. 303 USEPA. 2009. Provisional Peer-Reviewed Toxicity Values for Phenanthrene. U.S. Environmental Protection Agency, Office of Research and Development, National Center for Environmental Assessment, Superfund Health Risk Technical Support Center, Cincinnati, OH. A-640 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Phenol CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Phenol CASRN: 108-95-2 DTXSID: DTXSID5021124 Use: Pestcide; chemical intermediate Chemical Notes: Is the contaminant on any lists? CERCLA X FIFRA X Human Neurotoxicants X PubMed Neu rotoxica nts X Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 3 reproductive and developmental effects 10 6 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value («"gA) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 3000 reductions in mean fetal body weight per litter women of child bearing age OPP 2019 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.864 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-641 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Phenol CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.6 mg/kg/day OPP 2019 Jones-Price and Ledoux 1983 reductions in mean fetal body weight per litter women of childbearingage 35.4 3390 [426] Cancer Classification (CC) I OPP 2019 [4261 Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results 10-day Health Advisory 6 mg/L EPA DWSHA 2018 Acute Minimal Risk Level (MRL) 1 mg/kg/day CDC ATSDR Cancer Classification (CC) 3 no units WHO IARC Chronic Health-Based Guidance Value 4 mg/L MN DOH Human Health Ambient Water Quality Criteria 4 mg/L EPA Human Health Criteria forCWA Lifetime Health Advisory 2 mg/L EPA DWSHA 2018 Reference Concentration (RfC) 200 ug/mA3 CalEPA OEHHA Chemical Database Cancer Classification (CC) Female.Mice N no units HHSNTP Cancer Classification (CC) Female.Rats N no units HHSNTP Cancer Classification (CC) Male.Mice N no units HHSNTP Cancer Classification (CC) Male.Rats N no units HHSNTP Data Element Value Units Source Notes Measured Data and Assessment Results LD50 100 mg/kg NIH HSDB min LD50 530 mg/kg NIH HSDB max Percent of active toxcast in 0.44 percent EPA Chemistry Dashboard vitro assays tested TD50 133 mg/kg/day NIHCPDB min TD50 18500 mg/kg/day NIHCPDB max Data Element Value Units Source Notes Modeled Data LD50 0.0046132 mo l/kg TEST QSAR Ames mutagenicity test 0.246 no units TEST QSAR Developmental toxin test 0.58 no units TEST QSAR Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. A-642 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Phenol CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contam nant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contam nant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contam nant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contam nant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contam nant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contam nant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev(NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 462 98 Sites 21 0.08 0.34 0.864 12 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 93 43 Sites 46 0.09 0.29 0.652 12 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 369 55 Sites 15 0.08 0.41 1.16 2.5 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Data Number of States Amount Released (lbs/year) Toxic Release Inventory (TRI) Program (EPA) (2016) 44 5,965,893 Chemical Production Data Production Volume (lbs/year) Chemical Data Reporting (CDR) Results (EPA) (2016) 1B-5B Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Finished) 2006 - 2020 7 0 Sites 0 USGS, Sioux Falls Area, 2012 (Finished) [153] 2009-2010 1 0 Sites 0 Ambient Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Source) 2006 - 2020 34 0 Sites 0 National Water Information System (USGS NWIS) (Surface Water) 2008-2017 833 183 Sites 22 0.02 0.14 0.888 54.3 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008-2017 1,018 85 Sites 8.35 0.03 0.15 1.06 35.7 ug/L National Water Information System (USGS NWIS) (All Water) 2008-2017 1,851 268 Sites 14 0.02 0.14 1.04 54.3 ug/L Bradley et al. 2017 (Ambient) [52] 2012-2014 38 4 Sites 11 0.0548 0.0674 0.13 0.151 ug/L USGS, Sioux Falls Area, 2012 (Ambient) [153] 2009-2010 2 2 Sites 100 0.1 0.45 0.73 0.8 ug/L Waste Water Effluent Prevalence Magnitude Scott et al. 2018 (Wastewater) [161] 2011-2017 21 11 Sites 52 1 1.6 3.55 5.4 ug/L Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 0.0000876 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicatethere were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 4.58026 days Boiling point OPERA QSAR 187.496 degree C Boiling point TEST QSAR 176.783 degree C Vapor pressure OPERA QSAR 0.256635 mmHg Vapor pressure TEST QSAR 0.151356 mmHg Solubility in water OPERA QSAR 0.647838 mol/L Solubility in water TEST QSAR 0.294442 mol/L Bioconcentration factor OPERA QSAR 16.2785 no units Bioconcentration factor TEST QSAR 7.60326 no units Henry's Law constant OPERA QSAR 0.000000495 atm-mA3/mol 0 eta no 1/water partitioning coeff. (log Kow) OPERA QSAR 1.57532 no units A-643 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Phenol CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 153 Occurrence of anthropogenic organic compounds and nutrients in source and finished water in the Sioux Falls area, South Dakota, 2009-10: U.S. Geological Survey Scientific Investigations Report 2012-5098, 21 p. plus appendixes. 161 Scott, T. M., Phillips, P. J., Kolpin, D. W., Colella, K. M., Furlong, E. T., Foreman, W. T., & Gray, J. L. (2018). Pharmaceutical manufacturing facility discharges can substantially increase the pharmaceutical load to US wastewaters. Science of the Total Environment, 636, 69-79. 426 USEPA. 2019. Registration Review Draft Risk Assessment for Phenol and Salts. EPA-HQ-OPP-2012-0810-0007. DP No. 453361. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. A-644 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Phenol, 4-( 1,1,3,3-tetramethylbutyl)- CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Ph e no 1, 4-( 1,1,3,3-tetra methy 1 buty 1 )- CASRN: 140-66-9 DTXSID: DTXSID9022360 Use: Used in nonionic surfactants, plasticizers, antioxidants, fuel oil stabilizer, intermediate for resins,fungicides, bactericides, dyestuffs, adhesives, rubber chemicals Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro X Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 5 reproductive and developmental effects 9 4 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value («"gA) Critical Effect Target Pop. Assessment Assessment Pub. Date SL 70 decreased uterine weight, decreased pup body weight, increased time to preputial separation, decreased adult body weight bottle-fed infants MDH 2015 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.099 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-645 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Phenol, 4-( 1,1,3,3-tetramethylbutyl)- CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.051 mg/kg/day MDH 2015 Tyl etal. 1999 decreased uterine weight, decreased pup body weight, increased time to preputial separation, decreased adult body weight bottle-fed infants 151 67.6 [137] Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Reproductive 0.0000275 Blake, 2004 Systemic 450 Bian, 2006 2020-04-07 538 17 6 12 Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Acute Health-Based Guidance Value 0.1 mg/L MN DOH Chronic Health-Based Guidance Value 0.1 mg/L MN DOH Short-Term/Subchronic Health-Based Guidance 0.1 mg/L MN DOH Value Data Element Value Units Source Notes Measured Data and Assessment Results LD50 2000 mg/kg NIH HSDB min LD50 3210 mg/kg NIH HSDB max Percent of active toxcast in 40.93 percent EPA Chemistry Dashboard vitro assays tested Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Modeled Data LD50 0.0070146 mo l/kg TEST QSAR Ames mutagenicity test 0.049 no units TEST QSAR Developmental toxin test 0.75 no units TEST QSAR A-646 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Phenol, 4-( 1,1,3,3-tetram eth yi butyi )- CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev(NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 567 38 Sites 6.7 0.01 0.04 0.099 0.59 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 88 22 Sites 25 0.01 0.02 0.12 0.19 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 479 16 Sites 3.34 0.02 0.05 0.09 0.59 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) 50M - 100M Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude USGS, Sioux Falls Area, 2012 (Finished) [153] 2009-2010 1 0 Sites 0 Ambient Water Prevalence Magnitude National Water information System (USGS NWIS) (Surface Water) 2008-2017 717 61 Sites 8.51 0.01 0.1 0.1 1 ug/L National Water information System (USGS NWIS) (Groundwater) 2008-2017 689 29 Sites 4.21 0.01 0.25 1.32 42.6 ug/L National Water information System (USGS NWIS) (All Water) 2008-2017 1,406 90 Sites 6.4 0.01 0.1 0.2 42.6 ug/L Bradley et al. 2017 (Ambient) [52] 2012-2014 38 8 Sites 21 0.0204 0.0374 0.286 0.355 ug/L USGS, Sioux Falls Area, 2012 (Ambient) [153] 2009-2010 2 0 Sites 0 Waste Water Effluent Prevalence Magnitude Scott et al. 2018 (Wastewater) [161] 2011-2017 21 14 Sites 67 0.1 0.19 0.223 0.23 ug/L Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 0.0000755 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) 0.2 ug/l Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 4.08153 days Boiling point OPERA QSAR 263.357 degree C Boiling point TEST QSAR 293.064 degree C Vapor pressure OPERA QSAR 0.00142088 mmHg Vapor pressure TEST QSAR 0.00156315 mmHg Solubility in water OPERA QSAR 0.000088 mol/L Solubility in water TEST QSAR 0.000132434 mol/L Bioconcentration factor OPERA QSAR 344.461 no units Bioconcentration factor TEST QSAR 139.637 no units Henry's Law constant OPERA QSAR 0.00000786 atm-mA3/mol 0 eta no 1/water partitioning coeff. (log Kow) OPERA QSAR 4.86646 no units A-647 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Phenol, 4-(l,l,3,3-tetramethylbutyl)- CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 137 MDH. 2015. Toxicological Summary for: 4-tert-Octylphenol. Minnesota Department of Health (MDH), Environmental Health Division, Health Risk Assessment Unit, St Paul, MN. 153 Occurrence of anthropogenic organic compounds and nutrients in source and finished water in the Sioux Falls area, South Dakota, 2009-10: U.S. Geological Survey Scientific Investigations Report 2012-5098, 21 p. plus appendixes. 161 Scott, T. M., Phillips, P. J., Kolpin, D. W., Colella, K. M., Furlong, E. T., Foreman, W. T., & Gray, J. L. (2018). Pharmaceutical manufacturing facility discharges can substantially increase the pharmaceutical load to US wastewaters. Science of the Total Environment, 636, 69-79. A-648 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Phorate CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Phorate CASRN: 298-02-2 DTXSID: DTXSID4032459 Use: Insecticide used on corn, sugar beets, cotton, brassicas, and coffee Chemical Notes: Is the contaminant on any lists? CERCLA X FIFRA X Human Neurotoxicants X PubMed Neu rotoxica nts X Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 7 reproductive and developmental effects 3 3 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value («"gA) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 0.2 red blood cell and brain cholinesterase inhibition bottle-fed infants OPP 2006 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.0848 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-649 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Ph orate CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWandOST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.00017 mg/kg/day OPP 2006 Shellenberger and Tegeris, 1987 red blood cell and brain cholinesterase inhibition bottle-fed infants 151 0.225 [273] NOTE: this compound is a organophosphate pesticide. EPA has created a cumulative risk assessment regarding the common mechanisms of organophosphate compounds. Cancer Classification (CC) E OPP 2006 [273] NOTE: this compound is a organophosphate pesticide. EPA has created a cumulative risk assessment regarding the common mechanisms of organophosphate compounds. Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAE L (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Acute Human Health Benchmark 0.005 mg/L EPA HHBP Acute PAD 0.0008 mg/kg/day EPAHHBP Chronic Human Health Benchmark 0.0011 mg/L EPA HHBP Health-Based Screening Level 0.0011 mg/L Health-based screening levels from USGS Maximum Allowable Concentration (MAC) 0.002 mg/L Canadian Drinking Water Guidelines Population-Adjusted Dose (PAD) 0.00017 mg/kg/day EPA HHBP Data Element Value Units Source Notes Measured Data and Assessment Results LD50 1.1 mg/kg NIH HSDB min LD50 3.7 mg/kg NIH HSDB max LOAEL 0.8 mg/kg/day EPA Toxicity Reference Database max LOAEL 0.05 mg/kg/day EPA Toxicity Reference Database min NOAEL 0.01 mg/kg/day EPA Toxicity Reference Database min NOAEL 0.4 mg/kg/day EPA Toxicity Reference Database max Percent of active toxcast in 5.26 percent EPA Chemistry Dashboard Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Modeled Data LD50 7.83E-06 mo l/kg TEST QSAR Ames mutagenicity test -0.017 no units TEST QSAR Developmental toxin test -0.176 no units TEST QSAR A-650 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Phorate CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev(NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 11.241 24 Sites 0.21 0.002 0.012 0.0848 0.6 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 2.230 21 Sites 0.94 0.002 0.0125 0.082 0.6 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 9.012 3 Sites 0.03 0.00317 0.006 0.147 0.208 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) 19 945,534 2016 Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Finished) 2006 - 2020 1 0 Sites 0 USDA Pesticide Data Program (PDP) (Finished) 2001-2013 17 1 Sites 5.88 0.078 0.078 0.078 0.078 ug/L USGS, Sioux Falls Area, 2012 (Finished) [153] 2009-2010 1 0 Sites 0 Ambient Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Source) 2006 - 2020 4 0 Sites 0 USDA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001-2013 229 1 Sites 0.44 0.062 0.062 0.062 0.062 ug/L USDA Pesticide Data Program (PDP) (Groundwater) 2001-2013 219 0 Sites 0 USDA Pesticide Data Program (PDP) (Untreated) 2001-2013 12 1 Sites 8.33 0.062 0.062 0.062 0.062 ug/L Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990-2018 11,178 13 Sites 0.12 0.016 0.075 0.129 0.22 ug/L Arnold et al. 2016 (Filtered) [7] 2012-2013 690 1 Sites 0.14 0.0032 0.0032 0.0032 0.0032 ug/L USGS, Sioux Falls Area, 2012 (Ambient) [153] 2009-2010 2 0 Sites 0 Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 1.23E-08 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 139.463 days Boiling point OPERA QSAR 285.229 degree C Boiling point TEST QSAR Vapor pressure OPERA QSAR 0.000319476 mmHg Vapor pressure TEST QSAR 0.000179473 mmHg Solubility in water OPERA QSAR 0.000199114 mol/L Solubility in water TEST QSAR 0.000233346 mol/L Bioconcentration factor OPERA QSAR 71.5592 no units Bioconcentration factor TEST QSAR 55.5904 no units Henry's Law constant OPERA QSAR 0.00000156 atm-mA3/mol 0 eta no 1/water partitioning coeff. (log Kow) OPERA QSAR 3.43867 no units A-651 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Phorate CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 153 Occurrence of anthropogenic organic compounds and nutrients in source and finished water in the Sioux Falls area, South Dakota, 2009-10: U.S. Geological Survey Scientific Investigations Report 2012-5098, 21 p. plus appendixes. 273 USEPA. 2006. Reregistration Eligibility Decision for Phorate. EPA-HQ-OPP-2008-0174-0003. U.S. Environmental Protection Agency, Office of Prevention, Pesticides and Toxic Substances, Washington, D.C. 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticide in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. A-652 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Phosmet CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Chemical Notes: DTXSID5024261 Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUM MARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT IN FORMATION Potency Severity Prevalence Magnitude 7 reproductive and developmental effects 2 3 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value («"gA) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 0.2 pup red blood cell acetylcholinesterase inhibition bottle-fed infants OPP 2016 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.045 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-653 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Phosmet CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDW and OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg- HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.00016 mg/kg/day OPP 2016 Barnett 2009 pup red blood cell acetylcholinesterase inhibition bottle-fed infants 151 0.212 [371] Cancer Classification (CC) S OPP 2016 [3711 Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg- CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title- abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Acute Human Health Benchmark 0.08 mg/L EPA HHBP Acute PAD 0.012 mg/kg/day EPA HHBP Chronic Human Health Benchmark 0.003 mg/L EPA HHBP Health-Based Screening Level 0.003 mg/L Health-based screening levels from USGS Population-Ad justed Dose (PAD) 0.0006 mg/kg/dav EPA HHBP Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Measured Data and Assessment Results LD50 160 mg/kg NIH HSDB max LD50 26 mg/kg NIH HSDB min Percent of active toxcast in 6.25 percent EPA Chemistry Dashboard vitro assavs tested Data Element Value Units Source Notes Modeled Data LD50 0.0001349 mol/kg TEST QSAR Ames mutagenicity test 0.722 no units TEST QSAR Developmental toxin test 0.568 no units TEST QSAR A-654 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Phosmet CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev(NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 3.376 4 Sites 0.12 0.006 0.0125 0.045 0.063 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 380 3 Sites 0.79 0.006 0.018 0.0495 0.063 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 2.996 1 Sites 0.03 0.007 0.007 0.007 0.007 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) 40 844,617 2016 Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude USDA Pesticide Data Program (PDP) (Finished) 2001-2013 15 0 Sites 0 USGS, Sioux Falls Area, 2012 (Finished) [153] 2009-2010 1 0 Sites 0 Ambient Water Prevalence Magnitude National Water Information System (USGS NWIS) (Surface Water) 2008-2017 569 2 Sites 0.35 0.017 0.0945 0.141 0.172 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008-2017 1,971 0 Sites 0 National Water Information System (USGS NWIS) (All Water) 2008 - 2017 2,539 2 Sites 0.08 0.017 0.0945 0.141 0.172 ug/L USDA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001 - 2013 119 0 Sites 0 USDA Pesticide Data Program (PDP) (Groundwater) 2001 - 2013 111 0 Sites 0 USDA Pesticide Data Program (PDP) (Untreated) 2001 - 2013 8 0 Sites 0 Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990 - 2018 9,749 7 Sites 0.07 0.0535 0.375 0.978 1.5 ug/L Arnold et al. 2016 (Filtered) [7] 2012 - 2013 106 0 Sites 0 Southeast Stream Quality Assessment (SESQA) (Ambient) [102] 2014 1 0 Sites 0 USGS, Sioux Falls Area, 2012 (Ambient) [153] 2009 - 2010 2 0 Sites 0 Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 9.34E-08 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR4 data used in the CCL5 is a partial datasetand will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 125.261 days Boiling point OPERA QSAR 403.932 degree C Boiling point TEST QSAR Vapor pressure OPERA QSAR 0.000000516 mmHg Vapor pressure TEST QSAR 0.000000668 mmHg Solubility in water OPERA QSAR 0.0000549 mol/L Solubility in water TEST QSAR 0.0000598 mol/L Bioconcentration factor OPERA QSAR 2.48955 no units Bioconcentration factor TEST QSAR 9.18333 no units Henry's Law constant OPERA QSAR 3.84E-10 o E E Octanol/water partitioning coeff. (log Kow) OPERA QSAR 2.89029 no units A-655 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Phosmet CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 102 https://webapps.usgs.gOv/rsqa/#l/region/SESQA 153 Occurrence of anthropogenic organic compounds and nutrients in source and finished water in the Sioux Falls area, South Dakota, 2009-10: U.S. Geological Survey Scientific Investigations Report 2012-5098, 21 p. plus appendixes. 371 USEPA. 2016. Phosmet. Draft Human Health Risk Assessment to Support Registration Review. EPA-HQ-OPP-2009-0316-0022. DP No. D420736. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticide in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. A-656 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Phosphorus CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Phosphorus CASRN: 7723-14-0 DTXSID: DTXSID1024382 Use: Former pesticide; chemical intermediate; as Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants X PubMed Neu rotoxica nts X Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude no adverse effects 10 10 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date SL 300000 no adverse effects pregnant women IOM 1997 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 381 90th Percentile Finished Water NIRS 1984-1986 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-657 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Phosphorus CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDW and OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg- HRL (ug/L) Assessment Full Citation Notes Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg- CCL Screening Level (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 4000 mg/day IOM 1997 There is no evidence that individuals consuming this intake may experience adverse effects. lactating women 2720 294000 [107] NOTE: IOM identifies Upper Tolerable Intake values for many populations. The lowest UTI was for pregnant women, which is the group used for this CCL Screening Level - this value is reported as mg/day as opposed to mg/kg/day. For this reason, the DWI for pregnant women in units of ml/day is used as opposed to the intake in mg/kg/day. Reference Dose (RfD) or Equivalent 3500 mg/day IOM 1997 There is no evidence that individuals consuming this intake may experience adverse effects. pregnant women 2642 265000 [107] NOTE: IOM identifies Upper Tolerable Intake values for many populations. The lowest UTI was for pregnant women, which is the group used for this CCL Screening Level - this value is reported as mg/day as opposed to mg/kg/day. For this reason, the DWI for pregnant women in units of ml/day is used as opposed to the Reference Dose (RfD) or Equivalent 4000 mg/day IOM 1997 metastatic calcification, skeletal porosity, interference with calcium absorption general population 2413 332000 [107] NOTE: IOM identifies Upper Tolerable Intake values for many populations. The lowest UTI was for pregnant women, which is the group used for this CCL Screening Level - this value is reported as mg/day as opposed to mg/kg/day. For this reason, the DWI for pregnant women in units of ml/day is used as opposed to the intakp in mg/kg/Hay. Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title- abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Measured Data and Assessment Results Data Element Value Units Source Notes Measured Data and Assessment Results LD50 3.03 mg/kg NIH HSDB min LD50 4.85 mg/kg NIH HSDB max Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. Data Element Value Units Source Notes PECO = Population, Exposure, Comparator, Outcome. Modeled Data LD50 TEST QSAR Ames mutagenicity test TEST QSAR Developmental toxin test TEST QSAR A-658 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Phosphorus CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 OCCURRENCE DATA Scoring_Data_ Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contam nant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contam nant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contam nant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contam nant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contam nant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contam nant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev (NIRS) 1984 -1986 987 392 Sites 40 42 104 381 5546 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 3.889 185 Sites 4.76 3 92 680 10100 National Water Qua lity Assessment (USGS NAWQA) (Surface Water) 1991-2017 1.278 165 Sites 13 3 92 681 10100 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 2.613 20 Sites 0.77 10 70 523 1400 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) 250M - 500M Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Glassmeyer et al 2017 (Finished) [86] 2007-2012 25 NA Sites 68 200 700 ug/L Community Water System Survey (CWSS) (Finished) [178] 2006 1 NA Sites 380 380 ug/L Ambient Water Prevalence Magnitude Drinking Water Monitoring Data - Wl (Source) 2012-2019 1 0 Sites 0 National Water Information System (USGS NWIS) (Surface Water) 2008 - 2017 2,063 466 Sites 23 1 61 399 15900 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008-2017 1,357 345 Sites 25 1 101 631 380000 ug/L National Water Information System (USGS NWIS) (All Water) 2008 - 2017 3,413 811 Sites 24 1 61 408 380000 ug/L Glassmeyer et al 2017 (Ambient) [86] 2007 - 2012 25 NA Sites 88 70 220 ug/L Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR4 data used in the CCL5 is a partial datasetand will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR Boiling point OPERA QSAR Boiling point TEST QSAR Vapor pressure OPERA QSAR Vapor pressure TEST QSAR Solubility in water OPERA QSAR Solubility in water TEST QSAR Bioconcentration factor OPERA QSAR Bioconcentration factor TEST QSAR Henry's Law constant OPERA QSAR 0 eta no l/water partitioning coeff. (log Kow) OPERA QSAR A-659 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Phosphorus CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 86 Glassmeyer, S.T., Furlong, E.T., Kolpin, D.W., Batt, A.L., Benson, R., Boone, J.S.,... & Wilson, V.S. (2017). Nationwide reconnaissance of contaminants of emerging concern in source and treated drinking waters of the United States. Science of The Total Environment. v581-582, (909-922). 107 IOM. 1997. Standing Committee on the Scientific Evaluation of Dietary Reference Intakes, Food and Nutrition Board. Dietary Reference Intakes for calcium, phosphorus, magnesium, vitamin D, and fluoride. Institute of Medicine (IOM), National Academy Press, Washington, DC. 178 USEPA (US Environmental Protection Agency). (2009). 2006 Community Water System Survey. Overview, 57. A-660 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Phostebupirim CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Phostebupirim CASRN: 96182-53-5 DTXSID: DTXSID1032482 Use: Insecticide used on corn Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants X PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 8 reproductive and developmental effects 8 1 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value («"gA) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 0.03 plasma, red blood cell, and brain cholinesterase inhibition bottle-fed infants OPP 2009 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.006258 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-661 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Phostebupirim CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDW and OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg- HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.00002 mg/kg/day OPP 2009 Porter et al. 1991 plasma, red blood cell, and brain cholinesterase inhibition bottle-fed infants 151 0.0265 [306] Cancer Classification (CC) E OPP 2009 [3061 Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg- CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title- abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Acute Human Health Benchmark 0.001 mg/L EPA HHBP Acute PAD 0.00017 mg/kg/day EPA HHBP Chronic Human Health Benchmark 0.0001 mg/L EPA HHBP Health-Based Screening Level 0.0001 mg/L Health-based screening levels from USGS Population-Ad justed Dose (PAD) 0.00002 mg/kg/dav EPA HHBP Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element | Value | Units | Source | Notes Measured Data and Assessment Results LD50 1.3 mg/kg NIH HSDB min LD50 14 mg/kg NIH HSDB max LOAEL 0.125 mg/kg/day EPA Toxicity Reference Database min LOAEL 38.779999 mg/kg/day EPA Toxicity Reference Database max NOAEL 0.0175 mg/kg/day EPA Toxicity Reference Database min NOAEL 5.32 mg/kg/day EPA Toxicity Reference Database max Percent of active toxcast in vitro assays tested 18.87 percent EPA Chemistry Dashboard Subchronic LOAEL 1 mg/kg/day EPA Toxicity Reference Database min Subchronic LOAEL 3.5999999 mg/kg/day EPA Toxicity Reference Database max Subchronic NOAEL 0.3 mg/kg/day EPA Toxicity Reference Database min Subchronic NOAEL 1 mg/kg/day EPA Toxicity Reference Database max Data Element Value Units Source Notes Modeled Data LD50 0.000278 mol/kg TEST QSAR Ames mutagenicity test -0.032 no units TEST QSAR Developmental toxin test 0.634 no units TEST QSAR A-662 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Phostebupirim CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contam nant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contam nant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contam nant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contam nant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contam nant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contam nant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 1.994 48 Sites 2.41 7.00E - 05 0.00144 0.00626 0.232 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 338 46 Sites 14 7.00E - 05 0.00143 0.00581 0.191 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 1.656 2 Sites 0.12 0.00029 0.222 0.229 0.232 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) 19 296,550 2016 Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude USDA Pesticide Data Program (PDP) (Finished) 2001-2013 15 0 Sites 0 Ambient Water Prevalence Magnitude National Water Information System (USGS NWIS) (Surface Water) 2008-2017 359 15 Sites 4.18 0.00032 0.00141 0.241 0.266 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008-2017 528 0 Sites 0 National Water Information System (USGS NWIS) (All Water) 2008-2017 887 15 Sites 1.69 0.00032 0.00141 0.241 0.266 ug/L USDA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001-2013 225 0 Sites 0 USDA Pesticide Data Program (PDP) (Groundwater) 2001-2013 218 0 Sites 0 USDA Pesticide Data Program (PDP) (Untreated) 2001-2013 8 0 Sites 0 Arnold et al. 2016 (Filtered) [7] 2012-2013 584 1 Sites 0.17 3e-04 3e-04 3e-04 3e-04 ug/L Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 0.000000109 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 4.75549 days Boiling point OPERA QSAR 343.127 degree C Boiling point TEST QSAR Vapor pressure OPERA QSAR 0.0000536 mmHg Vapor pressure TEST QSAR 0.0000449 mmHg Solubility in water OPERA QSAR 0.0000241 mol/L Solubility in water TEST QSAR 0.0000417 mol/L Bioconcentration factor OPERA QSAR 33.1025 no units Bioconcentration factor TEST QSAR 174.582 no units Henry's Law constant OPERA QSAR 0.000000466 atm-mA3/mol 0 eta no l/water partitioning coeff. (log Kow) OPERA QSAR 3.53897 no units A-663 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Phostebupirim CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 306 USEPA. 2009. Tebupirimphos (Phostebupirim) in/on Corn, field, pop, sweet. Health Effects Division (HED) Risk Assessment. EPA-HQ-OPP-2008-0940-0010. DP No. D368530. U.S. Environmental Protection Agency, Office of Prevention, Pesticides and Toxic Substances, Washington, D.C. A-664 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Piperonyl butoxide CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Piperonyl butoxide CASRN: 51-03-6 DTXSID: DTXSID1021166 Use: Synergist for the pyrethrins and related insecticides Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 4 non-cancer effects 9 2 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 900 decrease in body weight gain, and increases in alkaline phosphatase activity, liver weight and hepatocellular hypertrophy general population OPP 2017 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.0202 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-665 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Piperonyl butoxide CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.16 mg/kg/day OPP 2017 Goldenthal 1993a and b decrease in body weight pin, and increases in alkaline phosphatase activity, liver weight and hepatocellular hypertrophy, decreased body weight general population 33.8 947 [389] Cancer Classification (CC) C OPP 2017 [3891 Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Acute Human Health Benchmark 42 mg/L EPA HHBP Acute PAD 6.3 mg/kg/day EPA HHBP Cancer Classification (CC) 3 no units WHO IARC Chronic Human Health Benchmark 0.992 mg/L EPA HHBP Health-Based Screening Level 0.992 mg/L Health-based screening levels from USGS Population-Adjusted Dose (PAD) 0.155 mg/kg/day EPA HHBP Cancer Classification (CC) Female.Mice N no units HHSNTP Cancer Classification (CC) Female.Rats N no units HHSNTP Cancer Classification (CC) Male.Mice N no units HHSNTP Cancer Classification (CC) Male.Rats N no units HHSNTP Data Element Value Units Source Notes Measured Data and Assessment Results LD50 11500 mg/kg NIH HSDB max LD50 2600 mg/kg NIH HSDB min LOAEL 15.5 mg/kg/day EPA Toxicity Reference Database min LOAEL 500 mg/kg/day EPA Toxicity Reference Database max NOAEL 2.9 mg/kg/day EPA Toxicity Reference Database min NOAEL 200 mg/kg/day EPA Toxicity Reference Database max Percent of active toxcast in 13.43 percent EPA Chemistry Dashboard TD50 1180 mg/kg/day NIH CPDB min TD50 7820 mg/kg/day NIH CPDB max Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Modeled Data LD50 0.0074131 mo l/kg TEST QSAR Ames mutagenicity test 0.08 no units TEST QSAR Developmental toxin test 0.43 no units TEST QSAR A-666 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Piperonyl butoxide CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 1.891 115 Sites 6.08 1.00E - 04 0.0054 0.0202 0.369 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 324 107 Sites 33 1.00E - 04 0.00545 0.0202 0.369 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 1.567 8 Sites 0.51 0.0015 0.0023 0.0635 0.239 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) 3 9,087 2016 Toxic Release Inventory (TRI) Program (EPA) (2016) 8 27 Chemical Data Reporting (CDR) Results (EPA) (2016) 500K-1M Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude USDA Pesticide Data Program (PDP) (Finished) 2001-2013 11 1 Sites 9.09 0.095 0.095 0.095 0.095 ug/L Glassmeyer et al 2017 (Finished) [86] 2007-2012 25 NA Sites 0 ug/L Ambient Water Prevalence Magnitude National Water Information System (USGS NWIS) (Surface Water) 2008-2017 555 90 Sites 16 0.00022 0.0058 0.064 0.47 ug/L National Water information System (USGS NWIS) (Groundwater) 2008-2017 731 7 Sites 0.96 0.00021 0.00172 0.0222 0.0934 ug/L National Water information System (USGS NWIS) (All Water) 2008-2017 1,286 97 Sites 7.54 0.00021 0.0053 0.0642 0.47 ug/L USDA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001-2013 6 1 Sites 17 0.062 0.062 0.062 0.062 ug/L USDA Pesticide Data Program (PDP) (Groundwater) 2001-2013 2 0 Sites 0 USDA Pesticide Data Program (PDP) (Untreated) 2001-2013 4 1 Sites 25 0.062 0.062 0.062 0.062 ug/L Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990-2018 267 78 Sites 29 0.000676 0.0184 1.18 11.2 ug/L Glassmeyer et a 1 2017 (Ambient) [86] 2007-2012 25 NA Sites 0 ug/L Bradley et al. 2017 (Ambient) [52] 2012-2014 38 12 Sites 32 0.0084 0.064 0.118 0.2049 ug/L Arnold et al. 2016 (Filtered) [7] 2012-2013 584 5 Sites 0.86 0.0021 0.0024 0.014 0.0196 ug/L Waste Water Effluent Prevalence Magnitude Scott et al. 2018 (Wastewater) [161] 2011-2017 21 17 Sites 81 0.0015966 0.0254 0.094 0.0989808 ug/L Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 2.25E-08 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 4.73603 days Boiling point OPERA QSAR 324.392 degree C Boiling point TEST QSAR 393.28 degree C Vapor pressure OPERA QSAR 8.18E-08 mmHg Vapor pressure TEST QSAR 0.000000708 mmHg Solubility in water OPERA QSAR 0.0000389 mol/L Solubility in water TEST QSAR 0.0000724 mol/L Bioconcentration factor OPERA QSAR 126.704 no units Bioconcentration factor TEST QSAR 18.55 no units Henry's Law constant OPERA QSAR 0.00000225 atm-mA3/mol 0 eta no l/water partitioning coeff. (log Kow) OPERA QSAR 4.39613 no units A-667 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Piperonyl butoxide CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 86 Glassmeyer, S.T., Furlong, E.T., Kolpin, D.W., Batt, A.L., Benson, R., Boone, J.S.,... & Wilson, V.S. (2017). Nationwide reconnaissance of contaminants of emerging concern in source and treated drinking waters of the United States. Science of The Total Environment. v581-582, (909-922). 161 Scott, T. M., Phillips, P. J., Kolpin, D. W., Colella, K. M., Furlong, E. T., Foreman, W. T., & Gray, J. L. (2018). Pharmaceutical manufacturing facility discharges can substantially increase the pharmaceutical load to US wastewaters. Science of the Total Environment, 636, 69-79. 389 USEPA. 2017. Piperonyl Butoxide (PBO). Draft Human Health Risk Assessment Registration Review and for Proposed New Use on Edible Fungi Crop Group 21. EPA-HQ-OPP-2010-0498-0021. DP Nos. D434163 D439507. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticide in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. A-668 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Potassium CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Potassium CASRN: 7440-09-7 DTXSID: DTXSID9049748 Use: Metal, laboratory reagent Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA Human Neurotoxicants PubMed Neu rotoxica nts X Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANTSUMMARY& DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT IN FORMATION Potency Severity Prevalence Magnitude 10 10 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 5939 90th Percentile Finished Water NIRS 1984-1986 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-669 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Potassium CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDW and OST October 2022 Data Element Value Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kR-day) Assessment Full Citation NOTE: assessment states"no RfD derived because potassium intake from drinking water is well below the level at which adverse health effects may occur." Additional information from the 2019 IOM report for potassium and sodium: Short-term potassium supplementation of approximately 2,500 mg/d (64 mmol/d) on the background of a usual diet appears to be safe for generally healthy individuals. This level of potassium intake would likely be below the ULfor individuals without kidney disease, diabetes, heart failure, adrenal insufficiency, or individuals using ACE-ls, ARBs, or other medications that may raise blood potassium concentrations to levels that could lead to adverse effects. There is evidence that very high doses of supplemental potassium ingestion can lead to adverse events, and in extreme cases has led to death, even in the absence of kidney disease or other factor: that alter potassium excretion. However, without a specific indicator ol a toxicological effect of high potassium intake, a potassium UL cannot be established." Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor CCL Screening Level Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 4700 mg/d ay IOM 2005 arrhythmias and hyperkalemia in individuals with impaired potassium excretion, detrimental for individuals with impaired kidney function general population 2413 390000 [109] IOM 2019 [1121 Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Data Element Value Units Source Notes Measured Data and Assessment Results Measured Data and Assessment Results III 1 III 1 Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Modeled Data LD50 TEST QSAR Ames mutagenicity test TEST QSAR Developmental toxin test TEST QSAR A-670 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Potassium CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contam nant Monitoring Rule (UCMR)4 2018-2019 Unregulated Contam nant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contam nant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contam nant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contam nant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contam nant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev(NIRS) 1984 -1986 989 958 Sites 97 311 1855 5939 23955 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 12.092 12.058 Sites 100 30 2500 7100 640000 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 2.585 2.573 Sites 100 30 2670 6940 180000 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 9.508 9.486 Sites 100 60 1960 7520 640000 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Glassmeyer et al 2017 (Finished) [86] 2007-2012 25 NA Sites 100 3070 6870 ug/L Community Water System Survey (CWSS) (Finished) [178] 2006 10 NA Sites 2510 4100 ug/L Ambient Water Prevalence Magnitude Glassmeyer et a 1 2017 (Ambient) [86] 2007-2012 25 NA Sites 100 2720 6930 ug/L Arnold et al. 2016 (Filtered) [7] 2012-2013 758 757 Sites 100 80 2300 8618 61200 ug/L Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. A-671 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Potassium CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 86 Glassmeyer, S.T., Furlong, E.T., Kolpin, D.W., Batt, A.L., Benson, R., Boone, J.S.,... & Wilson, V.S. (2017). Nationwide reconnaissance of contaminants of emerging concern in source and treated drinking waters of the United States. Science of The Total Environment. v581-582, (909-922). 93 HC. 2008. Guidance on Potassium from Water Softeners. Health Canada (HC), Water, Air and Climate Change Bureau, Healthy Environments and Consumer Safety Branch, Ottawa, Ontario, Canada. 109 IOM. 2005. Dietary Reference Intakes for Water, Potassium, Sodium, Chloride, and Sulfate. Institute of Medicine (IOM), National Academies of Science, Washington, D.C. 112 IOM. 2019. Dietary Reference Intakes for Sodium and Potassium (2019). Institute of Medicine (IOM), National Academies of Science, Washington, D.C. 178 USEPA (US Environmental Protection Agency). (2009). 2006 Community Water System Survey. Overview, 57. A-672 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Profenofos CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Chemical Notes: DTXSID3032464 Pesticide, insecticide, Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 7 reproductive and developmental effects 1 6 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value («"gA) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 0.2 inhibition of brain acetylcholinesterase bottle-fed infants OPP 2015 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.5144 90th Percentile Finished Water UCMR4 2018-2019 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-673 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Profenofos CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.00012 mg/kg/day OPP 2015 Burdock et al. 1981 inhibition of brain acetylcholinesterase bottle-fed infants 151 0.159 [351] Cancer Classification (CC) E OPP 2015 [3511 Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Acute Human Health Benchmark 0.03 mg/L EPA HHBP Acute PAD 0.005 mg/kg/day EPA HHBP Chronic Human Health Benchmark 0.0003 mg/L EPA HHBP Health-Based Screening Level 0.0003 mg/L Health-based screening levels from USGS Population-Adjusted Dose (PAD) 0.00005 mg/kg/day EPAHHBP Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element I Value I Units I Source I Notes Measured Data and Assessment Results LD50 1.9 mg/kg NIH HSDB min LD50 700 mg/kg NIH HSDB max LOAEL 1 mg/kg/day EPA Toxicity Reference Database min LOAEL 120 mg/kg/day EPA Toxicity Reference Database max NOAEL 0.03 mg/kg/day EPA Toxicity Reference Database min NOAEL 30 mg/kg/day EPA Toxicity Reference Database max Percent of active toxcast in vitro assays tested 15.19 percent EPA Chemistry Dashboard Subchronic LOAEL 0.05 mg/kg/day EPA Toxicity Reference Database Subchronic NOAEL 0.005 mg/kg/day EPA Toxicity Reference Database Data Element Value Units Source Notes Modeled Data LD50 0.0004498 mo l/kg TEST QSAR Ames mutagenicity test 0.137 no units TEST QSAR Developmental toxin test 0.615 no units TEST QSAR A-674 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Profenofos CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 3.649 2 Sites 0.05 0.464 0.492 0.514 0.52 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 1.953 7 Sites 0.36 0.00019 0.00128 0.144 0.21 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 338 5 Sites 1.48 0.00019 0.00128 0.0522 0.128 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 1.615 2 Sites 0.12 0.00072 0.105 0.168 0.21 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) 1 58 2012 Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude USDA Pesticide Data Program (PDP) (Finished) 2001-2013 13 0 Sites 0 Ambient Water Prevalence Magnitude National Water Information System (USGS NWIS) (Surface Water) 2008-2017 303 2 Sites 0.66 0.209 0.214 0.217 0.219 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008-2017 528 0 Sites 0 National Water Information System (USGS NWIS) (All Water) 2008-2017 831 2 Sites 0.24 0.209 0.214 0.217 0.219 ug/L USDA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001-2013 8 0 Sites 0 USDA Pesticide Data Program (PDP) (Groundwater) 2001-2013 2 0 Sites 0 USDA Pesticide Data Program (PDP) (Untreated) 2001-2013 6 0 Sites 0 Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990-2018 809 0 Sites 0 Arnold et al. 2016 (Filtered) [7] 2012-2013 584 1 Sites 0.17 7e-04 7e-04 7e-04 7e-04 ug/L Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 0.000000144 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 3.35324 days Boiling point OPERA QSAR 364.071 degree C Boiling point TEST QSAR Vapor pressure OPERA QSAR 0.00000174 mmHg Vapor pressure TEST QSAR 0.00000244 mmHg Solubility in water OPERA QSAR 0.0000653 mol/L Solubility in water TEST QSAR 0.0000518 mol/L Bioconcentration factor OPERA QSAR 1513.33 no units Bioconcentration factor TEST QSAR 55.0808 no units Henry's Law constant OPERA QSAR 0.0000089 atm-mA3/mol 0 eta no l/water partitioning coeff. (log Kow) OPERA QSAR 4.76488 no units A-675 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Profenofos CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 351 USEPA. 2015. Profenofos: Human Health Draft Risk Assessment (DRA) for Registration Review. EPA-HQ-OP P-2008-0345-0024. DP No. D414150. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticide in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. A-676 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Prometon CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Chemical Notes: DTXSID6022341 Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 5 non-cancer effects 1 1 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 300 emesis and decreased body weight general population OPP 2017 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.046 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-677 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Prometon CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.05 mg/kg/day OPP 2017 Brecken ridge and Green 1986; Tisdel 1992; Salamon 1987 emesis and decreased body weight general population 33.8 296 [390] Cancer Classification (CC) NL OPP 2017 [3901 Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results 10-day Health Advisory 0.2 mg/L EPA DWSHA2018 Chronic Health-Based Guidance Value 0.1 mg/L MN DOH Lifetime Health Advisory 0.4 mg/L EPA DWSHA 2018 Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Measured Data and Assessment Results LD50 2980 mg/kg NIH HSDB max LD50 503 mg/kg NIH HSDB min LOAEL 23.299999 mg/kg/day EPA Toxicity Reference Database min LOAEL 737 mg/kg/day EPA Toxicity Reference Database max NOAEL 1.18 mg/kg/day EPA Toxicity Reference Database min NOAEL 120 mg/kg/day EPA Toxicity Reference Database max Percent of active toxcast in 4.59 percent EPA Chemistry Dashboard vitro assays tested Data Element Value Units Source Notes Modeled Data LD50 0.0026915 mo l/kg TEST QSAR Ames mutagenicity test 0.106 no units TEST QSAR Developmental toxin test 0.947 no units TEST QSAR A-678 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Prometon CCL5 Contaminant Informatio OCCURRENCE DATA EPA-OGWDWand OST Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018 - 2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013 - 2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008 - 2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 295 0 Sites 0 ug/L Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survey (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991 - 2017 11,365 2,286 Sites 20 0 0.01 0.046 40 ug/L National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991 - 2017 2,297 1,377 Sites 60 0 0.01 0.044 25.1 ug/L National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991 - 2017 9,069 909 Sites 10 0.00033 0.011 0.078 40 ug/L PesticideApplication Data Number of States Amount Applied (lbs/year) Date Estimated Annual Agricultural Pesticide Use (USGS) 1 0.22 2016 Toxic Release Data Number of States Amount Released (lbs/year) Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Production Data Production Volume (lbs/year) Chemical Data Reporting (CDR) Results (EPA) (2016) Noil-Nation ally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Drinking Water Monitoring Data -CA (Finished) 2006 - 2020 49 0 Sites 0 USDA Pesticide Data Program (PDP) (Finished) 2001 - 2013 17 11 Sites 65 0.00028 0.0025 0.009 0.092 ug/L Bradley et al. 2018 (Finished) [53] 2016 26 1 Sites 3.85 0.0084 0.0084 0.0084 0.0084 ug/L USGS, Sioux Falls Area, 2012 (Finished) [153] 2009 - 2010 1 1 Sites 100 0.01 0.01 0.01 0.01 ug/L Ambient Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Source) 2006 - 2020 450 4 Sites 0.89 0.1 0.11 0.12 0.12 ug/L National Water Information System (USGS NWIS) (Surface Water) 2008 - 2017 1,613 594 Sites 37 0.00015 0.009 0.05 6.51 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008 - 2017 3,729 320 Sites 8.58 0.00059 0.01 0.05 0.495 ug/L National Water Information System (USGS NWIS) (All Water) 2008 - 2017 5,341 914 Sites 17 0.00015 0.009 0.05 6.51 ug/L USDA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001 - 2013 229 82 Sites 36 0.00028 0.0025 0.013 0.891 ug/L USDA Pesticide Data Program (PDP) (Groundwater) 2001 - 2013 219 74 Sites 34 0.00028 0.0011 0.0056 0.054 ug/L USDA Pesticide Data Program (PDP) (Untreated) 2001 - 2013 12 8 Sites 67 0.00028 0.0025 0.013 0.891 ug/L Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990 - 2018 4,469 98 Sites 2.19 0.006 0.0873 0.276 1.6 ug/L Bradley et al. 2017 (Ambient) [52] 2012 - 2014 38 18 Sites 47 0.0049 0.00695 0.0295 0.133 ug/L Arnold et al. 2016 (Filtered) [7] 2012 - 2013 690 64 Sites 9.28 4e-04 0.0036 0.0126 0.0438 ug/L USGS, Sioux Falls Area, 2012 (Ambient) [153] 2009 - 2010 2 2 Sites 100 0.01 0.01 0.015 0.02 ug/L USGS, McKenzie River, Oregon, 2012 (Ambient) [158] 2002 - 2010 133 19 Samples 14 0.06 ug/L Waste Water Effluent Prevalence Magnitude Scott et al. 2018 (Wastewater) [161] 2011 - 2017 21 0 Sites 0 Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 7.95E-08 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR4 data used in the CCL5 is a partial data set and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Value Units Notes Biodegradation half-life OPERA QSAR 3.81769 days Boiling point OPERA QSAR 336.341 degree C Boiling point TEST QSAR 329.884 degree C Vapor pressure OPERA QSAR 0.00000249 mmHg Vapor pressure TEST QSAR 0.000000752 mmHg Solubility in water OPERA QSAR 0.00205423 mol/L Solubility in water TEST QSAR 0.00400867 mol/L Bioconeentration factor OPERA QSAR 3.05344 no units Bioconeentration factor TEST QSAR 7.8886 no units Henry's Law constant OPERA QSAR 1.75E-08 atm-mA3/mol Octanol/water partitioning coeff. (log Kow) OPERA QSAR 3.05368 no units A-679 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Prometon CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 53 Bradley, P. M., Kolpin, D. W., Romanok, K. M., Smalling, K. L., Focazio, M. J., Brown, J. B.,... & Dietze, J. E. (2018). Reconnaissance of mixed organic and inorganic chemicals in private and public supply tapwaters at selected residential and workplace sites in the United States. Environmental science & technology, 52(23), 13972-13985. 153 Occurrence of anthropogenic organic compounds and nutrients in source and finished water in the Sioux Falls area, South Dakota, 2009-10: U.S. Geological Survey Scientific Investigations Report 2012-5098, 21 p. plus appendixes. 158 Reconnaissance of Land-Use Sources of Pesticides in Drinking Water, McKenzie River, Oregon. U.S. Geological Survey Scientific Investigations Report 2012-5091, 46 p. plus appendixes. 161 Scott, T. M., Phillips, P. J., Kolpin, D. W., Colella, K. M., Furlong, E. T., Foreman, W. T., & Gray, J. L. (2018). Pharmaceutical manufacturing facility discharges can substantially increase the pharmaceutical load to US wastewaters. Science of the Total Environment, 636, 69-79. 390 USEPA. 2017. Prometon. Chronic Dietary (Drinking Water Only) Exposure and Risk Assessment for the Registration Review Draft Risk Assessment. EPA-HQ-OPP-2013-0068-0015. DP No. D443014. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticide in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. A-680 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Prometryn CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Prometryn CASRN: 7287-19-6 DTXSID: DTXSID4024272 Use: Herbicide for most annual grasses, broad leaf weeds in cotton and celery Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 5 non-cancer effects 9 2 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 200 renal and hepatic degenerative changes, bone marrow atrophy general population OPP 2013 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.051 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-681 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Prometryn CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.04 mg/kg/day OPP 2013 Woodard et al. 1965 renal and hepatic degenerative changes, bone marrow atrophy general population 33.8 237 [329] Cancer Classification (CC) E OPP 2013 [3291 Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Acute Human Health Benchmark 3.3 mg/L EPA HHBP Acute PAD 0.12 mg/kg/day EPA HHBP Chronic Human Health Benchmark 0.3 mg/L EPA HHBP Health-Based Screening Level 0.3 mg/L Health-based screening levels from USGS Population-Adjusted Dose (PAD) 0.04 mg/kg/day EPAHHBP Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Measured Data and Assessment Results LD50 1265 mg/kg NIH HSDB min LD50 5233 mg/kg NIH HSDB max LOAEL 37.5 mg/kg/day EPA Toxicity Reference Database min LOAEL 72 mg/kg/day EPA Toxicity Reference Database max NOAEL 0.7 mg/kg/day EPA Toxicity Reference Database min NOAEL 37.25 mg/kg/day EPA Toxicity Reference Database max Percent of active toxcast in 7.17 percent EPA Chemistry Dashboard vitro assays tested Data Element Value Units Source Notes Modeled Data LD50 0.0075858 mo l/kg TEST QSAR Ames mutagenicity test 0.177 no units TEST QSAR Developmental toxin test 0.57 no units TEST QSAR A-682 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Prometryn CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev(NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 5.273 139 Sites 2.64 0.00017 0.007 0.051 3.73 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 712 106 Sites 15 0.00017 0.007 0.053 3.73 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 4.561 33 Sites 0.72 0.00048 0.006 0.0279 0.277 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) 20 1,458,440 2016 Toxic Release Inventory (TRI) Program (EPA) (2016) 2 860 Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Finished) 2006 - 2020 99 0 Sites 0 USDA Pesticide Data Program (PDP) (Finished) 2001-2013 17 5 Sites 29 0.00028 0.025 0.0866 0.231 ug/L USGS, Sioux Falls Area, 2012 (Finished) [153] 2009-2010 1 0 Sites 0 Ambient Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Source) 2006 - 2020 1,207 0 Sites 0 National Water information System (USGS NWIS) (Surface Water) 2008-2017 880 53 Sites 6.02 0.00017 0.009 0.119 0.658 ug/L National Water information System (USGS NWIS) (Groundwater) 2008-2017 2,579 15 Sites 0.58 0.00015 0.006 0.0108 0.037 ug/L National Water information System (USGS NWIS) (All Water) 2008-2017 3,458 68 Sites 1.97 0.00015 0.008 0.0993 0.658 ug/L USDA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001-2013 229 8 Sites 3.49 0.00028 0.00028 0.00552 0.118 ug/L USDA Pesticide Data Program (PDP) (Groundwater) 2001-2013 219 0 Sites 0 USDA Pesticide Data Program (PDP) (Untreated) 2001-2013 12 8 Sites 67 0.00028 0.00028 0.00552 0.118 ug/L Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990-2018 3,433 92 Sites 2.68 0.0031 0.122 0.756 20 ug/L Bradley et al. 2017 (Ambient) [52] 2012-2014 38 2 Sites 5.26 0.0032 0.0159 0.0261 0.0286 ug/L Arnold et al. 2016 (Filtered) [7] 2012-2013 690 0 Sites 0 USGS, Sioux Falls Area, 2012 (Ambient) [153] 2009-2010 2 0 Sites 0 Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 0.000000069 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 4.74373 days Boiling point OPERA QSAR 338.854 degree C Boiling point TEST QSAR Vapor pressure OPERA QSAR 0.00000143 mmHg Vapor pressure TEST QSAR 0.000000959 mmHg Solubility in water OPERA QSAR 0.000138089 mol/L Solubility in water TEST QSAR 0.000322849 mol/L Bioconcentration factor OPERA QSAR 12.3056 no units Bioconcentration factor TEST QSAR 9.35406 no units Henry's Law constant OPERA QSAR 2.33E-08 atm-mA3/mol 0 eta no 1/water partitioning coeff. (log Kow) OPERA QSAR 3.60968 no units A-683 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Prometryn CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 153 Occurrence of anthropogenic organic compounds and nutrients in source and finished water in the Sioux Falls area, South Dakota, 2009-10: U.S. Geological Survey Scientific Investigations Report 2012-5098, 21 p. plus appendixes. 329 USEPA. 2013. Prometryn. Human-Health Assessment Scoping Document in Support of Registration Review. EPA-HQ-OPP-2013-0032-0006. DP No. D407422. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticide in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. A-684 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Pronamide CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Chemical Notes: DTXSID2020420 Selective herbicide used o Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro X Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 5 reproductive and developmental effects 7 2 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value («"gA) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 200 decreases in body weight, weight gain, and food consumption; increased liver weight and lesions in liver, thyroid, and ovaries women of child bearing age OPP 2015 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.052 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-685 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Pronamide CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.04 mg/kg/day OPP 2015 Andrus and Hukkanen 2011 decreases in body weight, weight gain, and food consumption; increased liver weight; lesions in liver, thyroid, and ovaries women of child bearing age 35.4 226 [352] Cancer Classification (CC) NL OPP 2015 [3521 Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results 10-day Health Advisory 0.8 mg/L EPA DWSHA2018 Acute Human Health Benchmark 0.3 mg/L EPA HHBP Acute PAD 0.04 mg/kg/day EPA HHBP Chronic Human Health Benchmark 0.3 mg/L EPA HHBP Health-Based Screening Level 0.3 mg/L Health-based screening levels from USGS Lifetime Health Advisory 0.001 mg/L EPA DWSHA 2018 Population-Adjusted Dose (PAD) 0.04 mg/kg/day EPA H HBP Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Modeled Data LD50 0.0070632 mo l/kg TEST QSAR Ames mutagenicity test 0.667 no units TEST QSAR Developmental toxin test 0.574 no units TEST QSAR Data Element Value Units Source Notes Measured Data and Assessment Results LD50 5600 mg/kg NIH HSDB min LD50 8350 mg/kg NIH HSDB max LOAEL 123.2 mg/kg/day EPA Toxicity Reference Database max LOAEL 20 mg/kg/day EPA Toxicity Reference Database min NOAEL 17.5 mg/kg/day EPA Toxicity Reference Database max NOAEL 5 mg/kg/day EPA Toxicity Reference Database min Percent of active toxcast in 8.08 percent EPA Chemistry Dashboard vitro assays tested Subchronic LOAEL 60 mg/kg/day EPA Toxicity Reference Database Subchronic NOAEL 15 mg/kg/day EPA Toxicity Reference Database A-686 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Pronamide CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 11.233 143 Sites 1.27 0.00021 0.009 0.052 1.35 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 2.224 133 Sites 5.98 0.00021 0.009 0.0512 1.35 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 9.009 10 Sites 0.11 0.0012 0.00695 0.23 0.82 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) 3 137,018 2016 Toxic Release Inventory (TRI) Program (EPA) (2016) 4 0.35 Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude USDA Pesticide Data Program (PDP) (Finished) 2001-2013 13 0 Sites 0 USGS, Sioux Falls Area, 2012 (Finished) [153] 2009-2010 1 0 Sites 0 Ambient Water Prevalence Magnitude National Water Information System (USGS NWIS) (Surface Water) 2008-2017 1,020 22 Sites 2.16 7.00E - 04 0.0104 0.24 5.75 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008-2017 3,065 2 Sites 0.07 0.0075 0.0146 0.0188 0.0216 ug/L National Water Information System (USGS NWIS) (All Water) 2008-2017 4,084 24 Sites 0.59 7.00E - 04 0.0104 0.234 5.75 ug/L USDA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001-2013 8 0 Sites 0 USDA Pesticide Data Program (PDP) (Groundwater) 2001-2013 2 0 Sites 0 USDA Pesticide Data Program (PDP) (Untreated) 2001-2013 6 0 Sites 0 Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990-2018 641 49 Sites 7.64 0.005 0.017 0.0448 0.25 ug/L Bradley et al. 2017 (Ambient) [52] 2012-2014 38 1 Sites 2.63 0.1134 0.113 0.113 0.1134 ug/L Arnold et al. 2016 (Filtered) [7] 2012-2013 690 0 Sites 0 USGS, Sioux Falls Area, 2012 (Ambient) [153] 2009-2010 2 0 Sites 0 USGS, McKenzie River, Oregon, 2012 (Ambient) [158] 2002-2010 133 1 Samples 0.8 0.014 ug/L Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/ dav) Notes Expocast exposure 1.59E-08 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 3.30719 days Boiling point OPERA QSAR 312.471 degree C Boiling point TEST QSAR 339.245 degree C Vapor pressure OPERA QSAR 0.000000538 mmHg Vapor pressure TEST QSAR 0.00000364 mmHg Solubility in water OPERA QSAR 0.0000887 mol/L Solubility in water TEST QSAR 0.000169044 mol/L Bioconcentration factor OPERA QSAR 56.9152 no units Bioconcentration factor TEST QSAR Henry's Law constant OPERA QSAR 1.53E-09 atm-mA3/mol 0 eta no l/water partitioning coeff. (log Kow) OPERA QSAR 3.32595 no units A-687 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Pronamide CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 153 Occurrence of anthropogenic organic compounds and nutrients in source and finished water in the Sioux Falls area, South Dakota, 2009-10: U.S. Geological Survey Scientific Investigations Report 2012-5098, 21 p. plus appendixes. 158 Reconnaissance of Land-Use Sources of Pesticides in Drinking Water, McKenzie River, Oregon. U.S. Geological Survey Scientific Investigations Report 2012-5091, 46 p. plus appendixes. 352 USEPA. 2015. Pronamide. Human Health Risk Assessment for Registration Review and to Support New Section 3 Use on Leaf Lettuce (Revised). EPA-HQ-OPP-2009-0326-0017. DP Nos. D422207 D410291. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticide in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. A-688 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Propachlor CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Propachlor CASRN: 1918-16-7 DTXSID: DTXSID4024274 Use: selective herbicide used for pree merge nee weed control of annual grasses and broad leaf weeds Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUM MARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT IN FORMATION Potency Severity Prevalence Magnitude 4 carcinogen with linear MOA 1 5 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 0.9 general population OPP 1998 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 1.18 90th Percentile Finished Water UCM2 1993-1997 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-689 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Propachlor CCL 5 Contaminant Information Sheet EPA-OGWDWand OST October 2022 HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.054 mg/kg/day OPP1998 Naylorand Thake 1996 stomach lesions in males and liver lesions in both sexes general population 33.8 320 [231] Cancer Slope Factor (CSF) 0.032 (mg/kg/day)A-l OPP1998 Hamada 1987 ovarian tumors general population 33.8 0.925 [231] Cancer Classification (CC) L OPP1998 [231] Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results 10-day Health Advisory 0.5 mg/L EPA DWSHA 2018 Chronic Health-Based Guidance Value 0.09 mg/L MN DOH Lifetime Health Advisory 0.001 mg/L EPA DWSHA 2018 Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Measured Data and Assessment Results LD50 1800 mg/kg NIH HSDB max LD50 290 mg/kg NIH HSDB min LOAEL 125.3 mg/kg/day EPA Toxicity Reference Database max LOAEL 25 mg/kg/day EPA Toxicity Reference Database min NOAEL 5 mg/kg/day EPA Toxicity Reference Database min NOAEL 65.5 mg/kg/day EPA Toxicity Reference Database max Percent of active toxcast in 37.97 percent EPA Chemistry Dashboard vitro assays tested Data Element Value Units Source Notes Modeled Data LD50 0.0016181 mo l/kg TEST QSAR Ames mutagenicity test 0.347 no units TEST QSAR Developmental toxin test 0.777 no units TEST QSAR A-690 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Propachlor CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST October 2022 Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018 - 2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013 - 2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008 - 2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 12,050 6 Sites 0.05 0.1 0.11 1.18 2.5 ug/L Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survey (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991 - 2017 8,480 98 Sites 1.16 0.001 0.008 0.0912 2.99 ug/L National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991 - 2017 1,867 92 Sites 4.93 0.001 0.0085 0.0918 2.99 ug/L National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991 - 2017 6,614 6 Sites 0.09 0.002 0.0055 0.033 0.057 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) 4 120,862 2005 Toxic Release Inventory (TRI) Program (EPA) (2016) 2 15 Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Finished) 2006 - 2020 180 0 Sites 0 Drinking Water Monitoring Data - MA (Finished) 2006 - 2020 822 1 Sites 0.12 0.093 0.093 0.093 0.093 ug/L Drinking Water Monitoring Data - WA (Finished) 2006 - 2011 822 0 Sites 0 USDA Pesticide Data Program (PDP) (Finished) 2001 - 2013 17 3 Sites 18 0.00107 0.00107 0.145 0.287 ug/L Ambient Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Source) 2006 - 2020 2,047 0 Sites 0 Drinking Water Monitoring Data - MA (Source) 2006 - 2020 78 0 Sites 0 Drinking Water Monitoring Data - WA (Source) 2006 - 2011 997 0 Sites 0 Drinking Water Monitoring Data - Wl (Source) 2012-2019 92 0 Sites 0 National Water Information System (USGS NWIS) (Surface Water) 2008 - 2017 313 2 Sites 0.64 0.002 0.041 0.0644 0.08 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008 - 2017 812 0 Sites 0 National Water Information System (USGS NWIS) (All Water) 2008 - 2017 1,125 2 Sites 0.18 0.002 0.041 0.0644 0.08 ug/L USDA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001 - 2013 229 2 Sites 0.87 0.00107 0.00298 0.00452 0.0049 ug/L USDA Pesticide Data Program (PDP) (Groundwater) 2001 - 2013 219 0 Sites 0 USDA Pesticide Data Program (PDP) (Untreated) 2001 - 2013 12 2 Sites 17 0.00107 0.00298 0.00452 0.0049 ug/L Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990 - 2018 707 0 Sites 0 lA/osfe Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg- bw/day) Notes Expocast exposure 6.56E-08 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation ha If-life OPERA QSAR 3.36055 days Boiling point OPERA QSAR 292.103 degree C Boiling point TEST QSAR 300.836 degree C Vapor pressure OPERA QSAR 0.000341887 mmHg Vapor pressure TEST QSAR 0.000100925 mmHg Solubility in water OPERA QSAR 0.00447549 mol/L Solubility in water TEST QSAR 0.00156675 mol/L Bioconcentration factor OPERA QSAR 32.0372 no units Bioconcentration factor TEST QSAR 20.797 no units Flenry's Law constant OPERA QSAR 0.000000124 atm-mA3/mol Octanol/water partitioning coeff. (log Kow) OPERA QSAR 2.28865 no units A-691 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Propachlor CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 231 USEPA. 1998. Reregistration Eligibility Decision (RED) Propachlor. EPA 738-R-015. U.S. Environmental Protection Agency, Office of Prevention, Pesticides and Toxic Substances, Washington, D.C. 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticide in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. A-692 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Propanil CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Propanil CASRN: 709-98-8 DTXSID: DTXSID8022111 Use: Post emergent herbicide Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 5 reproductive and developmental effects 7 8 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value («"gA) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 50 increased methemoglobin; increased spleen weight in females; and enlarged seminal vesicles/prostates in males general population OPP 2006 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 72 EEC SW 30-Year OPP 2006 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-693 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Propanil CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.009 mg/kg/day OPP 2006 Bellringer 1994 increased methemoglobin; increased spleen weight in females; and enlarged seminal vesicles/prostates in males general population 33.8 53.3 [264] Cancer Classification (CC) S OPP 2006 [2641 Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Chronic Human Health Benchmark 0.06 mg/L EPA HHBP Health-Based Screening Level 0.06 mg/L Health-based screening levels from USGS Population-Adjusted Dose (PAD) 0.009 mg/kg/day EPA HHBP Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element I Value I Units I Source I Notes Measured Data and Assessment Results LD50 1384 mg/kg NIH HSDB max LD50 360 mg/kg NIH HSDB min LOAEL 100 mg/kg/day EPA Toxicity Reference Database max LOAEL 5 mg/kg/day EPA Toxicity Reference Database min NOAEL 15 mg/kg/day EPA Toxicity Reference Database min NOAEL 20 mg/kg/day EPA Toxicity Reference Database max Percent of active toxcast in vitro assays tested 12.91 percent EPA Chemistry Dashboard Subchronic LOAEL 49 mg/kg/day EPA Toxicity Reference Database Subchronic NOAEL 9.6 mg/kg/day EPA Toxicity Reference Database Data Element Value Units Source Notes Modeled Data LD50 0.003767 mo l/kg TEST QSAR Ames mutagenicity test -0.006 no units TEST QSAR Developmental toxin test 0.688 no units TEST QSAR A-694 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Propanil CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev(NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 Pesticide Application Data Number of States Amount Applied (lbs/year) Date Estimated Annual Agricultural Pesticide Use (USGS) 7 6,860,055 2016 Toxic Release Data Number of States Amount Released (lbs/year) Toxic Release Inventory (TRI) Program (EPA) (2016) 4 79,889 Chemical Production Data Production Volume (lbs/year) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Finished) 2006 - 2020 1 0 Sites 0 USDA Pesticide Data Program (PDP) (Finished) 2001-2013 16 6 Sites 38 0.0112 0.042 0.116 0.17 ug/L Ambient Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Source) 2006 - 2020 1 0 Sites 0 National Water Information System (USGS NWIS) (Surface Water) 2008-2017 936 23 Sites 2.46 0.00188 0.0354 0.574 6.5 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008-2017 2,045 0 Sites 0 National Water Information System (USGS NWIS) (All Water) 2008-2017 2,980 23 Sites 0.77 0.00188 0.0354 0.574 6.5 ug/L USDA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001-2013 228 0 Sites 0 USDA Pesticide Data Program (PDP) (Groundwater) 2001-2013 219 0 Sites 0 USDA Pesticide Data Program (PDP) (Untreated) 2001-2013 11 0 Sites 0 Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990-2018 1,424 201 Sites 14 0.004 0.591 5.68 57.6 ug/L Bradley et al. 2017 (Ambient) [52] 2012-2014 38 1 Sites 2.63 3.0096 3.01 3.01 3.0096 ug/L Arnold et al. 2016 (Filtered) [7] 2012-2013 690 0 Sites 0 Southeast Stream Quality Assessment (SESQA) (Ambient) [102] 2014 77 1 Sites 1.3 0.0020539 0.00205 0.00205 0.0020539 ug/L Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Estimated Environmental Concentration (EEC) in Surface Water, 30-Year Mean 2006 OPP 72 ug/L Exposure Analysis Modeling System (EXAMS) The modeled surface water 30-year mean estimated environmental concentration provided by the EPA OPP health assessment was selected as the occurrence value for propanil.This value coincides with the chronic health effects data and was considered the most Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 6.68E-08 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 3.50968 days Boiling point OPERA QSAR 341.956 degree C Boiling point TEST QSAR 325.947 degree C Vapor pressure OPERA QSAR 0.00000055 mmHg Vapor pressure TEST QSAR 0.00000265 mmHg Solubility in water OPERA QSAR 0.000730631 mol/L Solubility in water TEST QSAR 0.000447713 mol/L Bioconcentration factor OPERA QSAR 53.3998 no units Bioconcentration factor TEST QSAR 16.9824 no units Henry's Law constant OPERA QSAR 1.79E-09 atm-mA3/mol 0 eta no 1/water partitioning coeff. (log Kow) OPERA QSAR 3.219 no units A-695 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Propanil CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 102 https://webapps.usgs.gOv/rsqa/#l/region/SESQA 264 USEPA. 2006. Amendment to the Reregistration Eligibility Decision (RED) for Propanil (March 2006) and the Propanil RED (October 2003). EPA-HQ-OPP-2003-0348. U.S. Environmental Protection Agency, Office of Prevention, Pesticides and Toxic Substances, Washington, D.C. 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticide in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. A-696 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Propargite CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Propargite CASRN: 2312-35-8 DTXSID: DTXSID4024276 Use: Insecticide Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 5 carcinogen with linear MOA 6 4 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 0.2 jejunal tumors general population OPP 2019 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.5508 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-697 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Propargite CCL 5 Contaminant Information Sheet EPA-OGWDWand OST October 2022 HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.04 mg/kg/day OPP 2019 Trutter 1991; Goldenthal 1993 decreased pup weight in all generations bottle-fed infants 151 53.0 [424] Cancer Slope Factor (CSF) 0.192 (mg/kg/day)A-l OPP 2019 Goldenthal 1993 jejunal tumors general population 33.8 0.154 [424] Cancer Classification (CC) B2 OPP 2019 [424] Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Health-Based Screening Level 0.3 mg/L Health-based screening levels from USGS Health-Based Screening Level 0.000167 mg/L Health-based screening levels from USGS Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Measured Data and Assessment Results LD50 1480 mg/kg NIH HSDB min LD50 2947 mg/kg NIH HSDB max LOAEL 105 mg/kg/day EPA Toxicity Reference Database max LOAEL 6 mg/kg/day EPA Toxicity Reference Database min NOAEL 2 mg/kg/day EPA Toxicity Reference Database min NOAEL 25 mg/kg/day EPA Toxicity Reference Database max Percent of active toxcast in 32.06 percent EPA Chemistry Dashboard vitro assays tested Data Element Value Units Source Notes Modeled Data LD50 0.011885 mo l/kg TEST QSAR Ames mutagenicity test TEST QSAR Developmental toxin test 0.793 no units TEST QSAR A-698 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Propargite CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 10,698 73 Sites 0.68 6.00E - 04 0.044 0.551 20 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 2.055 70 Sites 3.41 6.00E - 04 0.044 0.56 20 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 8.643 3 Sites 0.03 0.008 0.009 0.174 0.245 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) 18 8,790,953 2016 Toxic Release Inventory (TRI) Program (EPA) (2016) 2 165 Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude USDA Pesticide Data Program (PDP) (Finished) 2001-2013 13 0 Sites 0 Ambient Water Prevalence Magnitude National Water Information System (USGS NWIS) (Surface Water) 2008-2017 891 7 Sites 0.79 0.00169 0.106 0.199 0.212 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008-2017 2,018 0 Sites 0 National Water Information System (USGS NWIS) (All Water) 2008-2017 2,908 7 Sites 0.24 0.00169 0.106 0.199 0.212 ug/L USDA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001-2013 8 0 Sites 0 USDA Pesticide Data Program (PDP) (Groundwater) 2001-2013 2 0 Sites 0 USDA Pesticide Data Program (PDP) (Untreated) 2001-2013 6 0 Sites 0 Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990-2018 1,146 65 Sites 5.67 0.0084 0.086 1.45 20 ug/L Arnold et al. 2016 (Filtered) [7] 2012 - 2013 690 0 Sites 0 Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/ day) Notes Expocast exposure 0.000000139 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR4 data used in the CCL5 is a partial datasetand will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 5.67573 days Boiling point OPERA QSAR 362.004 degree C Boiling point TEST QSAR 325.241 degree C Vapor pressure OPERA QSAR 0.000000359 mmHg Vapor pressure TEST QSAR 0.00000018 mmHg Solubility in water OPERA QSAR 0.00000239 mol/L Solubility in water TEST QSAR 0.0000271 mol/L Bioconcentration factor OPERA QSAR 10.8905 no units Bioconcentration factor TEST QSAR Henry's Law constant OPERA QSAR 0.00000979 o E E 0 eta no l/water partitioning coeff. (log Kow) OPERA QSAR 4.882 no units A-699 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Propargite CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 424 USEPA. 2019. Propargite: Draft Human Health Risk Assessment in Support of Registration Review. EPA-HQ-OPP-2014-0131-0051. DP No. D449759. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticide in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. A-700 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Propazine CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Propazine CASRN: 139-40-2 DTXSID: DTXSID3021196 Use: Selective post-e merge nee herbicide Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Ust ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 5 reproductive and developmental effects 10 2 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value («"gA) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 100 attenuation of LH surge women of child bearing age OPP 2015 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.05 90th Percentile All Ambient Water NAWQA 1991-2017 Final Hazard Quotient (HQ) 0.0005 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-701 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Propazine CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDW and OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg- HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.0242 mg/kg/day OPP 2015 national health and environmental effects research laboratory; Morales and attenuation of LH surge women of childbearing age 35.4 137 [353] Cancer Classification (CC) NL OPP 2015 [3531 Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg- CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title- abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Lifetime Health Advisory 0.01 mg/L EPA DWSHA 2018 Maximum Allowable Dailv Level 100 us/dav CalEPA OEH HA Chemical Database Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Measured Data and Assessment Results LD50 1200 mg/kg NIH HSDB min LD50 15380 mg/kg NIH HSDB max LOAEL 450 mg/kg/day EPA Toxicity Reference Database max LOAEL 50 mg/kg/day EPA Toxicity Reference Database min NOAEL 150 mg/kg/day EPA Toxicity Reference Database max NOAEL 5 mg/kg/day EPA Toxicity Reference Database min Percent of active toxcast 3.67 percent EPA Chemistry Dashboard in vitro assavs tested Data Element Value Units Source Notes Modeled Data LD50 0.006368 mol/kg TEST QSAR Ames mutagenicity test 0.045 no units TEST QSAR Developmental toxin test 0.695 no units TEST QSAR A-702 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Propazine CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev(NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 2.165 260 Sites 12 2.00E - 04 0.0051 0.05 1.79 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 462 209 Sites 45 2.00E - 04 0.00514 0.05 1.79 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 1.703 51 Sites 2.99 0.00025 0.00246 0.265 1.69 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) 7 637,396 2016 Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Finished) 2006 - 2020 4 0 Sites 0 USDA Pesticide Data Program (PDP) (Finished) 2001-2013 10 7 Sites 70 7e-04 0.0028 0.013 0.032 ug/L Ambient Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Source) 2006 - 2020 19 0 Sites 0 National Water Information System (USGS NWIS) (Surface Water) 2008-2017 426 115 Sites 27 0.00021 0.007 0.05 0.39 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008-2017 817 44 Sites 5.39 0.00026 0.01 0.03 0.0894 ug/L National Water Information System (USGS NWIS) (All Water) 2008-2017 1,243 159 Sites 13 0.00021 0.00716 0.05 0.39 ug/L USDA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001-2013 227 14 Sites 6.17 7e-04 0.0055 0.013 0.071 ug/L USDA Pesticide Data Program (PDP) (Groundwater) 2001-2013 219 7 Sites 3.2 7e-04 0.00105 0.0111 0.023 ug/L USDA Pesticide Data Program (PDP) (Untreated) 2001-2013 10 7 Sites 70 7e-04 0.0055 0.013 0.071 ug/L Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990-2018 68 2 Sites 2.94 1.1 1.55 1.91 2 ug/L Bradley et al. 2017 (Ambient) [52] 2012-2014 38 3 Sites 7.89 0.03 0.036 0.04 0.041 ug/L Arnold et al. 2016 (Filtered) [7] 2012-2013 584 9 Sites 1.54 5e-04 0.001 0.00266 0.0029 ug/L Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 7.85E-08 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicatethere were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 4.96717 days Boiling point OPERA QSAR 338.333 degree C Boiling point TEST QSAR 318.777 degree C Vapor pressure OPERA QSAR 0.000000183 mmHg Vapor pressure TEST QSAR 0.000000593 mmHg Solubility in water OPERA QSAR 0.000053 mol/L Solubility in water TEST QSAR 0.000355631 mol/L Bioconcentration factor OPERA QSAR 13.2841 no units Bioconcentration factor TEST QSAR 13.3352 no units Henry's Law constant OPERA QSAR 1.24E-08 atm-mA3/mol 0 eta no 1/water partitioning coeff. (log Kow) OPERA QSAR 3.08299 no units A-703 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Propazine CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 353 USEPA. 2015. Propazine. Acute and Chronic Dietary (Food Only) Exposure Assessments for Registration Review. EPA-HQ-OPP-2013-0250-0070. DP D428624. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticide in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. A-704 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Propiconazole CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Propiconazole CASRN: 60207-90-1 DTXSID: DTXSID8024280 Use: Fungicide Chemical Notes: This CIS also contains some data for the following: -C is-p rop icon azo le -Tra ns-p rop icon azo le Isthe contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants Pub Med Neurotoxicants Neurodev. Disruptors Androgen Receptors in vitro Compounds with neurodev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 4 non-cancer effects 9 2 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value ("g/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 600 Liver toxicity; increased liver weight in males, and increase in liver lesions (masses/raised areas/ swellings/nodular areas) general population OPP 2019 Cone, in water for HQ ("g/L) 90th Percentile or Maximum (if measured cone) Finished or Ambient (FW, SW, GW, WW) Source Date 0.039 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS RD1 RD 2 RD 3 Not Applicable Not Applicable Not Applicable Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. Green highlighting indicates a change made between the draft and final CCL 5. A-705 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Propiconazole CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.1 mg/kg/day OPP 2019 Ciba Geigy Corporation 1982 Liver toxicity; increased liver weight in males, and increase in liver lesions (masses/raisedareas/ swe llings/nodularareas) general population 33.8 592 [425] Cancer Classification (CC) C OPP 2019 [4251 Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mgAg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Acute Human Health Benchmark 2 mg/L EPA HHBP Acute PAD 0.3 mg/kg/day EPA HHBP Chronic Human Health Benchmark 0.6 mg/L EPA HHBP Health-Based Screening Level 0.6 mg/L Health-based screening levels from USGS Propiconazole Health-Based Screening Level 0.6 mg/L Health-based screening levels from USGS cis-Propiconazole Health-Based Screening Level 0.6 mg/L Health-based screening levels from USGS trans-Propiconazole Population-Adjusted Dose (PAD) 0.1 mg/kg/day EPA H HBP Notes: Yellow highlighted data indicate value was used in attribute scoring. Green highlighted data indicates a change made between the draft and final CCL 5. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element | Value I Units I Source I Notes Measured Data and Assessment Results LD50 1490 mg/kg NIH HSDB min LD50 1517 mg/kg NIH HSDB max LOAEL 300 mg/kg/day EPA Toxicity Reference Database max LOAEL 8.39999962 mg/kg/day EPA Toxicity Reference Database min NOAEL 1.9 mg/kg/day EPA Toxicity Reference Database min NOAEL 100 mg/kg/day EPA Toxicity Reference Database max Percent of active toxcast in vitro assays tested 19.93 percent EPA Chemistry Dashboard Subchronic LOAEL 6.25 mg/kg/day EPA Toxicity Reference Database min Subchronic LOAEL 77.5899963 mg/kg/day EPA Toxicity Reference Database max Subchronic NOAEL 1.25 mg/kg/day EPA Toxicity Reference Database min Subchronic NOAEL 16.82 mg/kg/day EPA Toxicity Reference Database max Data Element Value Units Source Notes Modeled Data LD50 0.00405509 mo l/kg TEST QSAR Ames mutagenicity test 0.333 no units TEST QSAR Developmental toxin test 0.484 no units TEST QSAR A-706 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Propiconazole CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST October 2022 Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018 - 2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013 - 2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008 - 2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitor ing-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survey (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991 - 2017 3,055 101 Sites 3.31 0.001 0.009 0.039 1.23 ug/L National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991 - 2017 190 95 Sites 50 0.001 0.009 0.039 1.23 ug/L National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991 - 2017 2.865 6 Sites 0.21 0.003 0.0075 0.018 0.024 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) 48 2,454,476 2016 Toxic Release Inventory (TRI) Program (EPA) (2016) 11 40,199 Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes finished Water Prev alence Magnitude US DA Pesticide Data Program (PDP) (Finished) 2001 - 2013 17 5 Sites 29 0.0057 0.0057 0.012 0.029 ug/L US DA Pesticide Data Program (PDP) (Finished) 2001 - 2013 11 0 Sites 0 US DA Pesticide Data Program (PDP) (Finished) 2001 - 2013 11 0 Sites 0 Bradley et al. 2018 (Finished) [53] 2016 26 2 Sites 7.69 0.0141 0.0154 0.0165 0.0168 ug/L Ambient Water Prev alence Magnitude National Water Information System (USGS NWIS) (Surface Water) 2008 - 2017 832 187 Sites 22 0.00041 0.0116 0.103 3.72 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008 - 2017 1,796 11 Sites 0.61 0.003 0.0065 0.0331 0.075 ug/L National Water Information System (USGS NWIS) (All Water) 2008 - 2017 2,627 198 Sites 7.54 0.00041 0.0112 0.1 3.72 ug/L US DA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001 - 2013 229 10 Sites 4.37 0.005661 0.01 0.027 0.1916 ug/L US DA Pesticide Data Program (PDP) (Groundwater) 2001 - 2013 219 5 Sites 2.28 0.005661 0.0057 0.134 0.1916 ug/L US DA Pesticide Data Program (PDP) (Untreated) 2001 - 2013 12 5 Sites 42 0.0057 0.01 0.0195 0.07 ug/L Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990 - 2018 134 13 Sites 9.7 0.02 0.0298 0.0452 0.051 ug/L Bradley et al. 2017 (Ambient) [52] 2012 - 2014 38 8 Sites 21 0.0029 0.0127 0.0662 0.13 ug/L cis-propiconazole Bradley et al. 2017 (Ambient) [52] 2012 - 2014 38 6 Sites 16 0.0202 0.0644 0.271 0.4045 ug/L Bradley et al. 2017 (Ambient) [52] 2012 - 2014 38 8 Sites 21 0.005 0.0174 0.115 0.217 ug/L trans-propiconazole Arnold et al. 2016 (Filtered) [7] 2012 - 2013 902 6 Sites 0.67 0.0023 0.00845 0.0225 0.031 ug/L USGS, McKenzie River, Oregon, 2012 (Ambient) [158] 2002 - 2010 42 3 Samples 7.1 0.051 ug/L cis-propiconazole USGS, McKenzie River, Oregon, 2012 (Ambient) [158] 2002 - 2010 42 3 Samples 7.1 0.08 ug/L t ra ns- p ro p ico nazo le Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data Date Total Predicted Notes Modeled Environmental Fate Parameters Source Value Units Notes (EPA CompTox Dashboard) Exposure (mg/kg bw/day) (EPA CompTox Dashboard) Expocast exposure 1.63 E-08 Biodegradation half-life OPERA QSAR 3.35915 days Boiling point OPERA QSAR 350.158 degree C Biomonitoring Data Detection at 90th Percentile Units Notes Boiling point TEST QSAR 366.386 degree C NHANES biomonitoring detection in serum (1999-2016) Vapor pressure OPERA QSAR 0.000000409 mmHg NHANES bio monitoring detect ion in blood (1999-2016) Vapor pressure TEST QSAR 7.08 E-08 mmHg NHANES bio monitoring detect ion in urine (1999-2016) Solubility in water OPERA QSAR 0.000222763 mol/L Solubility in water TEST QSAR 0.000192309 mol/L Notes: Highlighted data indicate value was used in attribute scoring. Green highlighted data indicates a change made between the draft and final CCL 5. Bioconcentration factor OPERA QSAR 45.858 no units Blank fields indicate there were no data available. Bioconcentration factor TEST QSAR 102.094 no units "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Henry's Law constant OPERA QSAR 0.00000378 atm-mA3/mol Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. Octanol/water partitioning coeff. (log Kow) OPERA QSAR 3.54562 no units State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. A-707 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Propiconazole CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 53 Bradley, P. M., Kolpin, D. W., Romanok, K. M., Smalling, K. L., Focazio, M. J., Brown, J. B.,... & Dietze, J. E. (2018). Reconnaissance of mixed organic and inorganic chemicals in private and public supply tapwaters at selected residential and workplace sites in the United States. Environmental science & technology, 52(23), 13972-13985. 158 Reconnaissance of Land-Use Sources of Pesticides in Drinking Water, McKenzie River, Oregon. U.S. Geological Survey Scientific Investigations Report 2012-5091,46 p. plus appendixes. 425 USEPA. 2019. Propiconazole Human Health Risk Assessment for the New Use of Propiconazole on Avocado, along with Conversion to Brassica, leafy greens, subgroup 4-16B, except watercress, Leaf petiole vegetable subgroup 22B, Celtuce, Florence fennel, Swiss chard, and the expansion to Vegetable, root, except sugar beet, subgroup IB. EPA-HQ-OPP-2018-0127-0007. DP No. D446376. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticides in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. A-708 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Propoxur CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Propoxur CASRN: 114-26-1 DTXSID: DTXSID7021948 Use: Insecticide used on cane, cocoa, fruit grapes, maize, rice, sugar, vegetables, cotton, lucerne, and ornamentals, etc Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants X PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 7 reproductive and developmental effects 1 1 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value («"gA) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 0.5 red blood cell acetylcholinesterase inhibition in pups bottle-fed infants OPP 2015 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.01 90th Percentile All Ambient Water NWIS 2008-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-709 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Propoxur CCL 5 Contaminant Information Sheet EPA-OGWDWand OST October 2022 HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.00038 mg/kg/day OPP 2015 Toot 2012 a and b red blood cell acetylcholinesterase inhibition in pups bottle-fed infants 151 0.503 [354] Cancer Slope Factor (CSF) 0.00352 (mg/kg/day)A-l OPP 2015 Subergand Loeserl984 urinary bladder papillomas and carcinomas, borderline significant increased incidence of uterine carcinomas general population 33.8 8.41 [354] Cancer Classification (CC) B2 OPP2015 [354] Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results 10-day Health Advisory 0.04 mg/L EPA DWSHA2018 Lifetime Health Advisory 0.003 mg/L EPA DWSHA 2018 Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Measured Data and Assessment Results LD50 23.5 mg/kg NIH HSDB min LD50 800 mg/kg NIH HSDB max LOAEL 472.39999 mg/kg/day EPA Toxicity Reference Database max LOAEL 9 mg/kg/day EPA Toxicity Reference Database min NOAEL 150.4 mg/kg/day EPA Toxicity Reference Database max NOAEL 3 mg/kg/day EPA Toxicity Reference Database min Percent of active toxcast in 2.68 percent EPA Chemistry Dashboard vitro assays tested Data Element Value Units Source Notes Modeled Data LD50 0.0009886 mo l/kg TEST QSAR Ames mutagenicity test 0.614 no units TEST QSAR Developmental toxin test 0.684 no units TEST QSAR A-710 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Propoxur CCL5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 OCCURRENCE DATA Scoring_Data_ Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018 - 2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013 - 2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008 - 2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survey (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991 - 2017 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991 - 2017 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991 - 2017 PesticideApplication Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) 0 Toxic Release Inventory (TRI) Program (EPA) (2016) 1 0.57 Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Drinking Water Monitoring Data -CA (Finished) 2006 - 2020 105 0 Sites 0 Drinking Water Monitoring Data - WA (Finished) 2006 - 2011 227 0 Sites 0 USDA Pesticide Data Program (PDP) (Finished) 2001 - 2013 13 0 Sites 0 Ambient Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Source) 2006 - 2020 868 0 Sites 0 Drinking Water Monitoring Data - WA (Source) 2006 - 2011 373 0 Sites 0 National Water Information System (USGS NWIS) (Surface Water) 2008 - 2017 475 51 Sites 11 0.00038 0.00296 0.011 0.367 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008 - 2017 1,045 28 Sites 2.68 4.00E-04 0.00224 0.00352 0.00579 ug/L National Water Information System (USGS NWIS) (All Water) 2008 - 2017 1,520 79 Sites 5.2 0.00038 0.00274 0.01 0.367 ug/L USDA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001 - 2013 223 1 Sites 0.45 0.005 0.005 0.005 0.005 ug/L USDA Pesticide Data Program (PDP) (Groundwater) 2001 - 2013 218 1 Sites 0.46 0.005 0.005 0.005 0.005 ug/L USDA Pesticide Data Program (PDP) (Untreated) 2001 - 2013 6 0 Sites 0 Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990 - 2018 1,584 0 Sites 0 Bradley et a 1. 2017 (Ambient) [52] 2012 - 2014 38 2 Sites 5.26 0.0093 0.0095 0.00966 0.0097 ug/L Arnold et al. 2016 (Filtered) [7] 2012 - 2013 690 3 Sites 0.43 0.0014 0.0029 0.0033 0.0034 ug/L Southeast Stream Quality Assessment (SESQA) (Ambient) [102] 2014 77 29 Sites 38 0.0003306 0.00197 0.00616 0.0126086 ug/L USGS, McKenzie River, Oregon, 2012 (Ambient) [158] 2002 - 2010 126 1 Samples 0.8 0.007 ug/L Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes 2015 OPP ug/L Drinking water exposure modeling was not conducted in the most recent available EPA OPP health assessment because propoxur's use patterns and registrations suggest it is unlikely to be found in drinking water resources. Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 7.16E-08 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for aII years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR4 data used in the CCL5 is a partial data set and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Value Units Notes Biodegradation half-life OPERA QSAR 4.65857 days Boiling point OPERA QSAR 284.046 degree C Boiling point TEST QSAR 285.351 degree C Vapor pressure OPERA QSAR 0.00000821 mmHg Vapor pressure TEST QSAR 0.0000306 mmHg Solubility in water OPERA QSAR 0.00570894 mol/L Solubility in water TEST QSAR 0.00252348 mol/L Biocon cent ration factor OPERA QSAR 6.97685 no units Biocon cent ration factor TEST QSAR 4.9545 no units Henry's Law constant OPERA QSAR 1.38E-09 atm-mA3/mol Octanol/water partitioning coeff. (log Kow) OPERA QSAR 1.70194 no units A-711 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Propoxur CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 102 https://webapps.usgs.gOv/rsqa/#l/region/SESQA 158 Reconnaissance of Land-Use Sources of Pesticides in Drinking Water, McKenzie River, Oregon. U.S. Geological Survey Scientific Investigations Report 2012-5091, 46 p. plus appendixes. 354 USEPA. 2015. Propoxur: Human Health Draft Risk Assessment for Registration Review. EPA-HQ-OPP-2009-0806-0023. DP No. D414135. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticide in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. A-712 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Prosulfuron CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Prosulfuron CASRN: 94125-34-5 DTXSID: DTXSID9034868 Use: Post-emergent herbicide Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANTSUMMARY& DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 4 non-cancer effects 6 2 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 300 decreased feed efficiency, hematological findings and hepatotoxicity general population OPP 2015 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.03224 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-713 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Prosulfuron CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.053 mg/kg/day OPP 2015 Chow and Richter 1992 decreased feed efficiency, hematological findings and hepatotoxicity general population 33.8 314 [355] Cancer Classification (CC) NL OPP 2015 [3551 Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Acute Human Health Benchmark 0.7 mg/L EPA HHBP Acute PAD 0.1 mg/kg/day EPA HHBP Chronic Human Health Benchmark 0.34 mg/L EPA HHBP Health-Based Screening Level 0.34 mg/L Health-based screening levels from USGS Population-Adjusted Dose (PAD) 0.053 mg/kg/day EPA HHBP Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element I Value I Units I Source I Notes Measured Data and Assessment Results LD50 546 mg/kg NIH HSDB LOAEL 18.6 mg/kg/day EPA Toxicity Reference Database min LOAEL 508 mg/kg/day EPA Toxicity Reference Database max NOAEL 1.95 mg/kg/day EPA Toxicity Reference Database min NOAEL 200 mg/kg/day EPA Toxicity Reference Database max Percent of active toxcast in vitro assays tested 2.29 percent EPA Chemistry Dashboard Subchronic LOAEL 31 mg/kg/day EPA Toxicity Reference Database min Subchronic LOAEL 69.300003 mg/kg/day EPA Toxicity Reference Database max Subchronic NOAEL 2.88 mg/kg/day EPA Toxicity Reference Database min Subchronic NOAEL 6.5 mg/kg/day EPA Toxicity Reference Database max Data Element Value Units Source Notes Modeled Data LD50 0.0170608 mo l/kg TEST QSAR Ames mutagenicity test TEST QSAR Developmental toxin test 1.087 no units TEST QSAR A-714 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Prosulfuron CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contam nant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contam nant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contam nant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contam nant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contam nant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contam nant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev(NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 1.760 16 Sites 0.91 7.00E - 04 0.00635 0.0322 0.274 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 322 13 Sites 4.04 7.00E - 04 0.0062 0.0222 0.173 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 1.438 3 Sites 0.21 0.0018 0.0065 0.194 0.274 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) 29 25,349 2016 Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude USDA Pesticide Data Program (PDP) (Finished) 2001-2013 8 1 Sites 12 0.0025 0.0025 0.0025 0.0025 ug/L Ambient Water Prevalence Magnitude National Water Information System (USGS NWIS) (Surface Water) 2008-2017 306 4 Sites 1.31 0.0055 0.114 0.192 0.197 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008-2017 528 0 Sites 0 National Water Information System (USGS NWIS) (All Water) 2008-2017 834 4 Sites 0.48 0.0055 0.114 0.192 0.197 ug/L USDA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001-2013 121 1 Sites 0.83 0.0025 0.0025 0.0025 0.0025 ug/L USDA Pesticide Data Program (PDP) (Groundwater) 2001-2013 113 0 Sites 0 USDA Pesticide Data Program (PDP) (Untreated) 2001-2013 8 1 Sites 12 0.0025 0.0025 0.0025 0.0025 ug/L Arnold et al. 2016 (Filtered) [7] 2012-2013 584 0 Sites 0 Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 0.000000157 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) < LOD ug/l Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 4.63586 days Boiling point OPERA QSAR 264.577 degree C Boiling point TEST QSAR Vapor pressure OPERA QSAR 3.93E-11 mmHg Vapor pressure TEST QSAR 5.45E-11 mmHg Solubility in water OPERA QSAR 0.0000576 mol/L Solubility in water TEST QSAR 0.000104472 mol/L Bioconcentration factor OPERA QSAR 2.58961 no units Bioconcentration factor TEST QSAR 1.15345 no units Henry's Law constant OPERA QSAR 2.63E-11 atm-mA3/mol 0 eta no 1/water partitioning coeff. (log Kow) OPERA QSAR 2.02925 no units A-715 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Prosulfuron CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 355 USEPA. 2015. Prosulfuron. Draft Human Health Risk Assessment in Support of Registration Review. EPA-HQ-OPP-2011-1010-0019. DP No. D426092. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. A-716 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Pymetrozine CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Pymetrozine CASRN: 123312-89-0 DTXSID: DTXSID2032637 Use: Pesticide used to control aphids and whiteflies in vegetables, ornamentals, cotton,field crops, deciduous and citrus fruit; control of plant hoppers in Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 4 carcinogen with linear MOA 3 2 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 2 liver benign hepatoma and hepatocarcinoma general population OPP 2017 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.01384 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-717 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Pymetrozine CCL 5 Contaminant Information Sheet EPA-OGWDWand OST October 2022 HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.008 mg/kg/day OPP 2017 Pinto 2003 morphometric changes in brains of pups bottle-fed infants 151 10.6 [392] Cancer Slope Factor (CSF) 0.0119 (mg/kg/day)A-l OPP 2017 Gerspach 1995 liver benign hepatoma and hepatocarcinoma general population 33.8 2.49 [392] Cancer Classification (CC) L OPP 2017 [392] Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Acute Human Health Benchmark 0.05 mg/L EPA HHBP Acute PAD 0.008 mg/kg/day EPA HHBP Cancer Slope Factor (CSF) 0.0119 (mg/kg/day)A-l EPA HHBP Chronic Human Health Benchmark 0.05 mg/L EPA HHBP Chronic Human Health Benchmark 0.00269 mg/L EPA HHBP Health-Based Screening Level 0.05 mg/L Health-based screening levels from USGS Health-Based Screening Level 0.00269 mg/L Health-based screening levels from USGS Population-Adjusted Dose (PAD) 0.008 mg/kg/day EPA HHBP Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Measured Data and Assessment Results LD50 5693 mg/kg NIH HSDB min LD50 5955 mg/kg NIH HSDB max LOAEL 3.76 mg/kg/day EPA Toxicity Reference Database min LOAEL 300 mg/kg/day EPA Toxicity Reference Database max NOAEL 0.454 mg/kg/day EPA Toxicity Reference Database min NOAEL 100 mg/kg/day EPA Toxicity Reference Database max Percent of active toxcast in 1.26 percent EPA Chemistry Dashboard vitro assays tested Subchronic LOAEL 14 mg/kg/day EPA Toxicity Reference Database min Subchronic LOAEL 360 mg/kg/day EPA Toxicity Reference Database max Subchronic NOAEL 3.12 mg/kg/day EPA Toxicity Reference Database min Subchronic NOAEL 34.5 mg/kg/day EPA Toxicity Reference Database max Data Element Value Units Source Notes Modeled Data LD50 0.0028445 mo l/kg TEST QSAR Ames mutagenicity test 0.37 no units TEST QSAR Developmental toxin test 0.66 no units TEST QSAR A-718 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Pymetrozine CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev(NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 844 2 Sites 0.24 0.0032 0.00985 0.0138 0.0165 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 276 1 Sites 0.36 0.0032 0.0032 0.0032 0.0032 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 568 1 Sites 0.18 0.0165 0.0165 0.0165 0.0165 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) 21 21,675 2016 Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Ambient Water Prevalence Magnitude National Water Information System (USGS NWIS) (Surface Water) 2008-2017 88 0 Sites 0 National Water Information System (USGS NWIS) (Groundwater) 2008-2017 28 0 Sites 0 National Water Information System (USGS NWIS) (All Water) 2008-2017 116 0 Sites 0 Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990-2018 3 0 Sites 0 Arnold et al. 2016 (Filtered) [7] 2012-2013 584 1 Sites 0.17 0.0165 0.0165 0.0165 0.0165 ug/L Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 1.15E-08 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicatethere were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 3.35411 days Boiling point OPERA QSAR 258.726 degree C Boiling point TEST QSAR Vapor pressure OPERA QSAR 0.0000821 mmHg Vapor pressure TEST QSAR 0.000000504 mmHg Solubility in water OPERA QSAR 0.00388089 mol/L Solubility in water TEST QSAR 0.00295801 mol/L Bioconcentration factor OPERA QSAR 2.35119 no units Bioconcentration factor TEST QSAR Henry's Law constant OPERA QSAR 0.000000712 atm-mA3/mol 0 eta no 1/water partitioning coeff. (log Kow) OPERA QSAR 1.0895 no units A-719 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Pymetrozine CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 392 USEPA. 2017. Pymetrozine. Draft Human Health Risk Assessment for Registration Review. EPA-HQ-OPP-2013-0368-0017. DP No. D439601. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticide in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. A-720 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Pyraclost robin CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Pyraclost robin CASRN: 175013-18-0 DTXSID: DTXSID7032638 Use: Very broad spectrum fungicide Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Not List ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 5 non-cancer effects 9 1 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 200 decreased body weight, kidney tubular casts and atrophy in both sexes; increased incidence of liver necrosis and erosion/u Ice ration of the glandular-stomach and fore-stomach in males general population OPP 2018 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.00825 90th Percentile All Ambient Water NAWQA 1991-2017 Final Hazard Quotient (HQ) 0.000041 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-721 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Pyraclostrobin CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.034 mg/kg/day OPP 2018 Mellert et al. 1999 decreased body weight, kidney tubular casts and atrophy in both sexes; increased incidence of liver necrosis and erosion/ulceration of the glandular- stomach and fore-stomach in males general population 33.8 201 [406] Cancer Classification (CC) NL OPP 2018 [4061 Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Acute Health-Based Guidance Value 0.1 mg/L MN DOH Acute Health-Based Guidance Value 0.3 mg/L MN DOH Acute Human Health Benchmark 1 mg/L EPA HHBP Acute PAD 0.05 mg/kg/day EPA HHBP Chronic Health-Based Guidance Value 0.1 mg/L MN DOH Chronic Human Health Benchmark 0.22 mg/L EPA HHBP Health-Based Screening Level 0.22 mg/L Health-based screening levels from USGS Population-Adjusted Dose (PAD) 0.034 mg/kg/day EPA HHBP Short-Term/Subchronic Health-Based Guidance Value 0.1 mg/L MN DOH Data Element Value Units Source Notes Measured Data and Assessment Results LD50 5000 mg/kg NIH HSDB LOAEL 50 mg/kg/day EPA Toxicity Reference Database max LOAEL 9.1999998 mg/kg/day EPA Toxicity Reference Database min NOAEL 25 mg/kg/day EPA Toxicity Reference Database max NOAEL 4.7 mg/kg/day EPA Toxicity Reference Database min Percent of active toxcast in 28.72 percent EPA Chemistry Dashboard vitro assays tested Subchronic LOAEL 10.8 mg/kg/day EPA Toxicity Reference Database min Subchronic LOAEL 34.700001 mg/kg/day EPA Toxicity Reference Database max Subchronic NOAEL 12.9 mg/kg/day EPA Toxicity Reference Database max Subchronic NOAEL 5.4 mg/kg/day EPA Toxicity Reference Database min Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Modeled Data LD50 TEST QSAR Ames mutagenicity test 0.587 no units TEST QSAR Developmental toxin test 0.41 no units TEST QSAR A-722 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Pyraclostrobin CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev(NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 1.763 138 Sites 7.83 0.00011 0.00182 0.00825 0.389 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 324 136 Sites 42 0.00011 0.00182 0.00807 0.389 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 1.439 2 Sites 0.14 0.00021 0.123 0.196 0.245 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) 48 2,471,066 2016 Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Ambient Water Prevalence Magnitude National Water Information System (USGS NWIS) (Surface Water) 2008-2017 434 52 Sites 12 0.00025 0.00339 0.0782 3.33 ug/L National Water information System (USGS NWIS) (Groundwater) 2008-2017 531 1 Sites 0.19 0.00441 0.00441 0.00441 0.00441 ug/L National Water information System (USGS NWIS) (All Water) 2008-2017 965 53 Sites 5.49 0.00025 0.00341 0.0774 3.33 ug/L Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990-2018 244 50 Sites 20 0.02 0.096 0.245 1.37 ug/L Bradley et al. 2017 (Ambient) [52] 2012-2014 38 1 Sites 2.63 0.0383 0.0383 0.0383 0.0383 ug/L Arnold et al. 2016 (Filtered) [7] 2012-2013 584 1 Sites 0.17 2e-04 2e-04 2e-04 2e-04 ug/L Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 2.01E-08 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 4.89847 days Boiling point OPERA QSAR 336.014 degree C Boiling point TEST QSAR 465.144 degree C Vapor pressure OPERA QSAR 8.44E-09 mmHg Vapor pressure TEST QSAR 1.5E-09 mmHg Solubility in water OPERA QSAR 0.0000103 mol/L Solubility in water TEST QSAR 0.0000209 mol/L Bioconcentration factor OPERA QSAR 174.72 no units Bioconcentration factor TEST QSAR Henry's Law constant OPERA QSAR 0.000000108 atm-mA3/mol 0 eta no 1/water partitioning coeff. (log Kow) OPERA QSAR 4.00245 no units A-723 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Pyraclostrobin CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 406 USEPA. 2018. Pyraclostrobin. Human Health Risk Assessment for a Petition for the Establishment of Use on Greenhouse-Grown Leafy Greens, Except Head Lettuce, Subgroup 4- 16A; Cucurbit Vegetable: Group 9; and Fruiting Vegetables, Group 8-10 and Crop Group Conversions and Expansion of Tolerances for Brassica, Leafy Greens, Subgroup 4-16B; Celtuce; Florence Fennel; Kohlrabi; Leaf Petiole Vegetables, Subgroup 22B; Tropical and Subtropical, Medium to Large Fruit, Inedible Peel, Subgroup 23B; and Brassica Head and Stem, Group 5-16 and a Revised Tolerance Level for Leafy Greens, 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticide in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. A-724 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Pyrene CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Pyrene CASRN: 129-00-0 DTXSID: DTXSID3024289 Use: Occurs as a result of incomplete burning Chemical Notes: Is the contaminant on any lists? CERCLA X FIFRA Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANTSUMMARY& DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 5 non-cancer effects 9 2 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 100 n ep h ro pat hy (re na 1 tu bu la r pat ho logy, decreased kidney weights) general population OW 1991 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.046 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-725 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Pyrene CCL 5 Contaminant Information Sheet EPA-OGWDWand OST October 2022 HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.03 mg/kg/day IRIS 1990 USE PA 1989 renal tubular pathology, decreased kidney weights general population 33.8 178 [209] Reference Dose (RfD) or Equivalent 0.025 mg/kg/day OW1991 USE PA 1989 nephropathy (renal tubular pathology, decreased kidney weights) general population 33.8 148 [212] Cancer Classification (CC) NL PPRTV 2007 [282] Cancer Classification (CC) D IRIS 1990 [209] Cancer Classification (CC) D OW 1991 [212] ATSDR1995 [10] Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Reproductive 0.0075 Paltaviciene, 2006 Reproductive 0.00075 Paltaviciene, 2006 2006-09-01 2020-03-25 6765 2 16 1 Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Cancer Classification (CC) 3 no units WHO IARC Chronic Health-Based Guidance Value 0.05 mg/L MN DOH Chronic Health-Based Guidance Value 0.2 mg/L MN DOH Human Health Ambient Water Quality Criteria 0.02 mg/L EPA Human Health Criteria for CWA Short-Term/Subchronic Health-Based Guidance Value 0.09 mg/L MN DOH Subchronic Provisional RfD 0.3 mg/kg/day EPA PPRTV Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Measured Data and Assessment Results LD50 2700 mg/kg NIH HSDB Percent of active toxcast in 6.19 percent EPA Chemistry Dashboard vitro assavs tested Data Element Value Units Source Notes Modeled Data LD50 0.0070469 mo l/kg TEST QSAR Ames mutagenicity test 0.842 no units TEST QSAR Developmental toxin test 0.342 no units TEST QSAR A-726 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Pyrene CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 588 38 Sites 6.46 0.003 0.01 0.046 0.14 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 101 30 Sites 30 0.003 0.01 0.0475 0.14 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 487 8 Sites 1.64 0.004 0.009 0.0388 0.046 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) 100K - 500K Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Finished) 2006 - 2020 28 1 Sites 3.57 0.001 0.001 0.001 0.001 ug/L Drinking Water Monitoring Data - WA (Finished) 2006-2011 481 0 Sites 0 Glassmeyer et al 2017 (Finished) [86] 2007-2012 25 NA Sites 0 ug/L USGS, Sioux Falls Area, 2012 (Finished) [153] 2009-2010 1 0 Sites 0 Ambient Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Source) 2006 - 2020 231 8 Sites 3.46 0.1 0.16 0.28 0.3 ug/L Drinking Water Monitoring Data - WA (Source) 2006-2011 634 0 Sites 0 National Water Information System (USGS NWIS) (Surface Water) 2008-2017 867 275 Sites 32 0.002 0.03 0.37 25.6 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008-2017 1,095 71 Sites 6.48 0.001 0.0155 0.072 1.28 ug/L National Water Information System (USGS NWIS) (All Water) 2008-2017 1,962 346 Sites 18 0.001 0.0295 0.34 25.6 ug/L Glassmeyer et a 1 2017 (Ambient) [86] 2007 - 2012 25 NA Sites 0 ug/L Bradley et al. 2017 (Ambient) [52] 2012 - 2014 38 14 Sites 37 0.0034 0.0092 0.0242 0.0447 ug/L USGS, Sioux Falls Area, 2012 (Ambient) [153] 2009 - 2010 2 0 Sites 0 Waste Water Effluent Prevalence Magnitude Scott et al. 2018 (Wastewater) [161] 2011 - 2017 21 5 Sites 24 Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 0.00000147 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 255.189 days Boiling point OPERA QSAR 392.038 degree C Boiling point TEST QSAR 415.21 degree C Vapor pressure OPERA QSAR 0.00000288 mmHg Vapor pressure TEST QSAR 8.69E-08 mmHg Solubility in water OPERA QSAR 0.000000659 mol/L Solubility in water TEST QSAR 0.000000121 mol/L Bioconcentration factor OPERA QSAR 2230.1 no units Bioconcentration factor TEST QSAR 529.663 no units Henry's Law constant OPERA QSAR 0.0000116 o E E 0 eta no l/water partitioning coeff. (log Kow) OPERA QSAR 5.05118 no units A-727 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Pyrene CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 10 ATSDR. 1995. Toxicological Profile for Polycyclic Aromatic Hydrocarbons. U.S. Department of Health and Human Services, Public Health Service, Agency for Toxic Substances and Disease Registry (ATSDR), Atlanta, GA. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 86 Glassmeyer, S.T., Furlong, E.T., Kolpin, D.W., Batt, A.L., Benson, R., Boone, J.S.,... & Wilson, V.S. (2017). Nationwide reconnaissance of contaminants of emerging concern in source and treated drinking waters of the United States. Science of The Total Environment. v581-582, (909-922). 153 Occurrence of anthropogenic organic compounds and nutrients in source and finished water in the Sioux Falls area, South Dakota, 2009-10: U.S. Geological Survey Scientific Investigations Report 2012-5098, 21 p. plus appendixes. 161 Scott, T. M., Phillips, P. J., Kolpin, D. W., Colella, K. M., Furlong, E. T., Foreman, W. T., & Gray, J. L. (2018). Pharmaceutical manufacturing facility discharges can substantially increase the pharmaceutical load to US wastewaters. Science of the Total Environment, 636, 69-79. 209 USEPA. 1990. Chemical Assessment Summary, Pyrene. U.S. Environmental Protection Agency, National Center for Environmental Assessment, Integrated Risk Information System (IRIS), Washington, D.C 212 USEPA. 1991. Drinking Water Criteria Document for Polycyclic Aromatic Hydrocarbons (PAHs). U.S. Environmental Protection Agency, Office of Health and Environmental Assessment, Environmental Criteria and Assessment Office, Cincinnati, OH. 282 USEPA. 2007. Provisional Peer-Reviewed Toxicity Values for Pyrene. U.S. Environmental Protection Agency, Office of Research and Development, National Center for Environmental Assessment, Superfund Health Risk Technical Support Center, Cincinnati, OH. A-728 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Pyridaben CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Pyridaben CASRN: 96489-71-3 DTXSID: DTXSID5032573 Use: Insecticide Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Not List ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 5 reproductive and developmental effects 5 1 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value («"gA) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 30 decreased parental and pup body weight bottle-fed infants OPP 2018 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.1614 90th Percentile All Ambient Water NAWQA 1991-2017 Final Hazard Quotient (HQ) 0.0054 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-729 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Pyridaben CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.022 mg/kg/day OPP 2018 Tesh et al. 1989; Willoughby 1990 decreased parental and pup body weight bottle-fed infants 151 29.1 [407] Cancer Classification (CC) NL OPP 2018 [4071 Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Acute Human Health Benchmark 2.9 mg/L EPA HHBP Acute PAD 0.44 mg/kg/day EPA HHBP Chronic Human Health Benchmark 0.03 mg/L EPA HHBP Health-Based Screening Level 0.03 mg/L Health-based screening levels from USGS Population-Adjusted Dose (PAD) 0.005 mg/kg/day EPA HHBP Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element I Value I Units I Source I Notes Measured Data and Assessment Results LD50 1100 mg/kg NIH HSDB max LD50 383 mg/kg NIH HSDB min LOAEL 0.5 mg/kg/day EPA Toxicity Reference Database min LOAEL 30 mg/kg/day EPA Toxicity Reference Database max NOAEL 13 mg/kg/day EPA Toxicity Reference Database max NOAEL 2.41 mg/kg/day EPA Toxicity Reference Database min Percent of active toxcast in vitro assays tested 21.96 percent EPA Chemistry Dashboard Subchronic LOAEL 13.02 mg/kg/day EPA Toxicity Reference Database max Subchronic LOAEL 4 mg/kg/day EPA Toxicity Reference Database min Subchronic NOAEL 1 mg/kg/day EPA Toxicity Reference Database min Subchronic NOAEL 4.92 mg/kg/day EPA Toxicity Reference Database max Data Element Value Units Source Notes Modeled Data LD50 0.0015417 mo l/kg TEST QSAR Ames mutagenicity test 0.255 no units TEST QSAR Developmental toxin test 0.152 no units TEST QSAR A-730 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Pyridaben CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 OCCURRENCE DATA Scoring_Data_ Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 1.761 9 Sites 0.51 0.00033 0.00096 0.161 0.219 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 322 7 Sites 2.17 0.00038 0.00096 0.0475 0.155 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 1.439 2 Sites 0.14 0.00033 0.11 0.175 0.219 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) 11 35,107 2016 Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Ambient Water Prevalence Magnitude National Water Information System (USGS NWIS) (Surface Water) 2008-2017 359 3 Sites 0.84 0.0042 0.195 0.215 0.223 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008-2017 528 0 Sites 0 National Water Information System (USGS NWIS) (All Water) 2008-2017 887 3 Sites 0.34 0.0042 0.195 0.215 0.223 ug/L Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990-2018 99 0 Sites 0 Arnold et al. 2016 (Filtered) [7] 2012-2013 584 0 Sites 0 Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/ day) Notes Expocast exposure 0.000000139 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 12.6613 days Boiling point OPERA QSAR 364.625 degree C Boiling point TEST QSAR 421.721 degree C Vapor pressure OPERA QSAR 0.00000141 mmHg Vapor pressure TEST QSAR 8.67E-08 mmHg Solubility in water OPERA QSAR 7.08E-08 mol/L Solubility in water TEST QSAR 0.000000585 mol/L Bioconcentration factor OPERA QSAR 599.145 no units Bioconcentration factor TEST QSAR Henry's Law constant OPERA QSAR 4.99E-08 atm-mA3/mol 0 eta no l/water partitioning coeff. (log Kow) OPERA QSAR 6.11525 no units A-731 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Pyridaben CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 407 USEPA. 2018. Pyridaben. Human Health Draft Risk Assessment in Support of Registration Review. EPA-HQ-OPP-2010-0214-0015. DP No. D440297. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticide in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. A-732 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Quinoline CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Quinoline CASRN: 91-22-5 DTXSID: DTXSID1021798 Use: Chemical intermediate; pharmaceutical (anti-malarial); Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANTSUMMARY& DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT IN FORMATION Potency Severity Prevalence Magnitude 6 carcinogen with linear MOA 6 3 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 0.01 hepatic hemangioendotheliomas or general population IRIS 2001 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.09312 90th Percentile Finished Water UCMR4 2018-2019 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-733 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Quinoline CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Cancer Slope Factor (CSF) 3 (mg/kg/day)A-l IRIS 2001 Hirao et al. 1976 hepatic hemangioendotheliomas or hemangiosarcomas general population 33.8 0.00986 [244] Cancer Classification (CC) B2 IRIS 2001 [244] Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Renal, Immune, Hepatic, Carcinogenicity, Systemic 8.8 Matsumoto, 2018 Hepatic 30 Uno, 2015 2005-07-01 2020-03-16 2041 2 2 2 Other Health Data Measured Data and Assessment Results I Value I Units I ~ I I I Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Measured Data and Assessment Results LD50 331 mg/kg NIH HSDB min LD50 460 mg/kg NIH HSDB max Percent of active toxcast in 0.89 percent EPA Chemistry Dashboard vitro assays tested Data Element Value Units Source Notes Modeled Data LD50 0.0046559 mo l/kg TEST QSAR Ames mutagenicity test 0.888 no units TEST QSAR Developmental toxin test 0.468 no units TEST QSAR A-734 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Quinoline CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 OCCURRENCE DATA Scoring_Data_ Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contam nant Monitoring Rule (UCMR) 4 2018-2019 3.675 36 Sites 0.98 0.0201 0.0288 0.0931 1.5 Unregulated Contam nant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contam nant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contam nant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contam nant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contam nant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survey (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 National Water Qua lity Assessment (USGS NAWQA) (Surface Water) 1991-2017 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) 9 2,474 Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Ambient Water Prevalence Magnitude Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/ dav) Notes Expocast exposure 0.00000309 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR4 data used in the CCL5 is a partial datasetand will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 13.3246 days Boiling point OPERA QSAR 243.313 degree C Boiling point TEST QSAR 239.117 degree C Vapor pressure OPERA QSAR 0.0417085 mmHg Vapor pressure TEST QSAR 0.0293765 mmHg Solubility in water OPERA QSAR 0.0339207 mol/L Solubility in water TEST QSAR 0.0323594 mol/L Bioconcentration factor OPERA QSAR 4.69938 no units Bioconcentration factor TEST QSAR 17.1396 no units Henry's Law constant OPERA QSAR 0.0000365 atm-mA3/mol 0 eta no l/water partitioning coeff. (log Kow) OPERA QSAR 2.11472 no units A-735 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Quinoline CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 244 USEPA. 2001. Chemical Assessment Summary, Quinoline. U.S. Environmental Protection Agency, National Center for Environmental Assessment, Integrated Risk Information System (IRIS), Washington, D.C. A-736 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Silicon CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Silicon CASRN: 7440-21-3 DTXSID: DTXSID0051441 Use: Chemical intermediate; alloys Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA Human Neurotoxicants PubMed Neu rotoxica nts X Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUM MARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT IN FORMATION Potency Severity Prevalence Magnitude 10 10 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 42069 90th Percentile Finished Water NIRS 1984-1986 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-737 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Silicon CCL 5 Contaminant Information Sheet EPA-OGWDWand OST October 2022 HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes IOM 2001 [108] NOTE: No health assessments found, "there is no evidence that the silicon that naturally occurs in food and water produces adverse health outcomes" Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element | Value | Units | Source I NoteT Measured Data and Assessment Results LD50 | 3160 | mg/kg |N!H HSDB I Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Measured Data and Assessment Results Data Element Value Units Source Notes Modeled Data LD50 TEST QSAR Ames mutagenicity test TEST QSAR Developmental toxin test TEST QSAR A-738 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Silicon CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 OCCURRENCE DATA Scoring_Data_ Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contam nant Monitoring Rule (UCMR)4 2018-2019 Unregulated Contam nant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contam nant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contam nant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contam nant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contam nant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev(NIRS) 1984 -1986 989 989 Sites 100 260 18139 42069 98916 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) 1B-5B Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Glassmeyer et al 2017 (Finished) [86] 2007-2012 25 NA Sites 100 2930 22300 ug/L Community Water System Survey (CWSS) (Finished) [178] 2006 1 NA Sites 5280 5280 ug/L Ambient Water Prevalence Magnitude National Water Information System (USGS NWIS) (Surface Water) 2008-2017 49 49 Sites 100 2 2800 5900 61000 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008-2017 81 78 Sites 96 8 4600 6190 23000 ug/L National Water Information System (USGS NWIS) (All Water) 2008-2017 130 127 Sites 98 2 3800 6150 61000 ug/L Glassmeyer et a 1 2017 (Ambient) [86] 2007-2012 25 NA Sites 100 2750 22400 ug/L Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/ day) Notes Expocast exposure Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. A-739 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Silicon CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 86 Glassmeyer, S.T., Furlong, E.T., Kolpin, D.W., Batt, A.L., Benson, R., Boone, J.S.,... & Wilson, V.S. (2017). Nationwide reconnaissance of contaminants of emerging concern in source and treated drinking waters of the United States. Science of The Total Environment. v581-582, (909-922). 108 IOM. 2001. Dietary Reference Intakes for Vitamin A, Vitamin K, Arsenic, Boron, Chromium, Copper, Iodine, Iron, Manganese, Molybdenum, Nickel, Silicon, Vanadium, and Zinc. Institute of Medicine (IOM), National Academies of Science, Washington, D.C. 178 USEPA (US Environmental Protection Agency). (2009). 2006 Community Water System Survey. Overview, 57. A-740 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Sitagliptin CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Sitagliptin CASRN: 486460-32-6 DTXSID: DTXSID70197572 Use: Hypoglycemic agents Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 7 non-cancer effects 8 3 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date SL 3 lowest therapeutic dose: improved glycemic control for patients with type 2 diabetes bottle-fed infants FDA; NIH 2018; 2018 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.08453 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-741 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Sitagliptin CCL 5 Contaminant Information Sheet EPA-OGWDWand OST October 2022 HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.000416667 mg/kg/day FDA 2018; NIH 2018 Merck Sharp & Dohme Corp. lowest therapeutic dose:improve glycemic control for patients with type 2 diabetes bottle-fed infants 151 2.80 [77] [150] NOTE: (Lowest Therapeutic Dose/3000x UF) is used in place of an RfD; LTDs were obtained from FDA-approved drug labels Reference Dose (RfD) or Equivalent 0.000416667 mg/kg/day FDA 2018; NIH 2018 Merck Sharp & Dohme Corp. lowest therapeutic dose:improve glycemic control for patients with type 2 diabetes general population 33.8 9.80 [77] [150] NOTE: (Lowest Therapeutic Dose/3000x UF) is used in place of an RfD; LTDs were obtained from FDA-approved drug la bels Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Screening level for pharmaceutical - general 0.009803922 mg/L EPA Office of Water population Screening level for pharmaceutical - infants 0.002777778 mg/L EPA Office of Water Data Element Value Units Source Notes Measured Data and Assessment Results LD50 3000 mg/kg NIH HSDB min LD50 4000 mg/kg NIH HSDB max Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Modeled Data LD50 0.0016596 mo l/kg TEST QSAR Ames mutagenicity test 0.299 no units TEST QSAR Developmental toxin test 0.869 no units TEST QSAR A-742 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Sitagliptin CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 557 12 Sites 2.15 0.00365 0.0268 0.0845 0.184 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 75 12 Sites 16 0.00365 0.0268 0.0845 0.184 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 482 0 Sites 0 Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Glassmeyer et al 2017 (Finished) [86] 2007-2012 25 NA Sites 0 ug/L Ambient Water Prevalence Magnitude National Water Information System (USGS NWIS) (Surface Water) 2008-2017 205 41 Sites 20 0.00263 0.0333 0.117 0.484 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008-2017 401 2 Sites 0.5 0.0432 0.219 0.325 0.395 ug/L National Water Information System (USGS NWIS) (All Water) 2008-2017 606 43 Sites 7.1 0.00263 0.0369 0.12 0.484 ug/L Glassmeyer et al 2017 (Ambient) [86] 2007-2012 25 NA Sites 0 ug/L Bradley et al. 2017 (Ambient) [52] 2012-2014 38 12 Sites 32 0.002071 0.00841 0.153 0.2267841 ug/L Bexfield et al. 2019 (Groundwater) [49] 2013 - 2015 1,106 0 Sites 0 Waste Water Effluent Prevalence Magnitude Scott et al. 2018 (Wastewater) [161] 2011 - 2017 21 20 Sites 95 0.0242164 0.261 4.9 5.184601 ug/L Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR4 data used in the CCL5 is a partial datasetand will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 3.54479 days Boiling point OPERA QSAR 328.816 degree C Boiling point TEST QSAR 403.649 degree C Vapor pressure OPERA QSAR 9.8E-10 mmHg Vapor pressure TEST QSAR 2.52E-09 mmHg Solubility in water OPERA QSAR 0.00000549 mol/L Solubility in water TEST QSAR 0.00000646 mol/L Bioconcentration factor OPERA QSAR 6.6312 no units Bioconcentration factor TEST QSAR 22.6986 no units Henry's Law constant OPERA QSAR 6.26E-11 o E E Octanol/water partitioning coeff. (log Kow) OPERA QSAR 1.82307 no units A-743 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Sitagliptin CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 49 Bexfield, L.M., P.L. Toccalino, K. Belitz, W.T. Foreman, and E.T. Furlong. 2019. Hormones and pharmaceuticals in groundwater used as a source of drinking water across the United States. Environmental Science and Technology 53: 2950-2960. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 77 FDA. 2018. Drugs @ FDA: FDA Approved Drug Products. U.S. Food and Drug Administration (FDA), https://www.accessdata.fda.gov/scripts/cder/daf/. 86 Glassmeyer, S.T., Furlong, E.T., Kolpin, D.W., Batt, A.L., Benson, R., Boone, J.S.,... & Wilson, V.S. (2017). Nationwide reconnaissance of contaminants of emerging concern in source and treated drinking waters of the United States. Science of The Total Environment. v581-582, (909-922). 150 NIH. 2018. DailyMed Database. U.S. National Library of Medicine, National Institutes of Health (NIH). https://dailymed.nlm.nih.gov/dailymed/. 161 Scott, T. M., Phillips, P. J., Kolpin, D. W., Colella, K. M., Furlong, E. T., Foreman, W. T., & Gray, J. L. (2018). Pharmaceutical manufacturing facility discharges can substantially increase the pharmaceutical load to US wastewaters. Science of the Total Environment, 636, 69-79. A-744 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Sodium CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Sodium CASRN: 7440-23-5 DTXSID: DTXSID1049774 Use: Chemical intermediate; alloys; semiconductors Chemical Notes: EPA requires periodic monitoring of sodium at the entry point to the distribution system. Monitoring is to be conducted annually for surface water systems and every 3 years for ground water systems (40 CFR:141.41). The water supplier must report sodium test results to local and State public health officials by direct mail within 3 months of the analysis unless this responsibility is assumed by the State. Is the contaminant on any lists? CERCLA FIFRA Human Neurotoxicants PubMed Neu rotoxica nts X Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT IN FORMATION Potency Severity Prevalence Magnitude non-cancer effects 10 10 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 20000 organoleptic effects, risk to adults under strict low-sodium diets general population OW 2003 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 160240 90th Percentile Finished Water NIRS 1984-1986 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Sodium generally occurs at low levels in drinking water, and when it at high levels the taste may be expected to cause people to reduce their consumption [a,b]. In addition, drinking water is only a nor source of dietary sodium compared with food, and sodium is ly one factor among many that contributes to hypertension and heart disease. Therefore, regulation of sodium in drinking water is unlikely to represent a meaningful opportunity for health risk reduction [a,c]. The most effective means to protect the health of PWS identify groups who are more sensitive than the general population, and provide dietary guidance through the public health ity [c]. Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-745 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Sodium CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDW and OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg- HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 6.25 mg/kg/day HC 1992 WHO 1984 organoleptic effects, risk to adults under strict low-sodium general population 33.8 37000 [91] Drinking Water Advisory 20 mg/L OW 2003 USE PA 1996 organoleptic effects, risk to adults under strict low-sodium general population 33.8 20000 [256] OW 2003 [256] Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg- CCL Screening Level (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 2300 mg/day IOM 2005 Johnson et al., 2001; MacGregor et al., 1989; Sacks et al., 2001 increased blood pressure lactating women 2720 169000 [110] Reference Dose (RfD) or Equivalent 2300 mg/day IOM 2005 Johnson et al., 2001; MacGregor et al., 1989; Sacks et al., 2001 hypertensive disorders pregnant women 2642 174000 [110] Reference Dose (RfD) or Equivalent 2300 mg/day IOM 2005 Johnson et al., 2001; MacGregor et al., 1989; Sacks et al., 2001 increased blood pressure general population 2413 191000 [110] Reference Dose (RfD) or Equivalent 2300 mg/day IOM 2005 Johnson et al., 2001; MacGregor et al., 1989; Sacks et al., 2001 increased blood pressure women of childbearing age 2430 189000 [110] IOM 2019 [112] Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title- abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Measured Data and Assessment Results Data Element I Value I Units I Measured Data and Assessment Results I I I Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Modeled Data LD50 TEST QSAR Ames mutagenicity TEST QSAR Developmental TEST QSAR A-746 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 CCL5 Contaminant Informatio OCCURRENCE DATA EPA-OGWDWand OST Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018 - 2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013 - 2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008 - 2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monito ring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survey (NIRS) 1984 -1986 989 989 Sites 100 907 16355 160240 1541000 ug/L Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991 - 2017 12,093 12,092 Sites 100 70 13300 84600 1.90 E+07 ug/L National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991 - 2017 2,592 2,592 Sites 100 70 13100 76600 6.00 E+06 ug/L National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991 - 2017 9,502 9,501 Sites 100 80 14000 107000 1.90 E+07 ug/L PesticideApplication Data Number of States Amount Applied (lbs/year) Date Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Data Number of States Amount Released (lbs/year) Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Production Data Production Volume (lbs/year) Chemical Data Reporting (CDR) Results (EPA) (2016) 50M - 100M Noil-Nation ally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Drinking Water Monitoring Data -CA (Finished) 2006 - 2020 589 588 Sites 100 500 50000 103000 3.7e+07 ug/L Drinking Water Monitoring Data - DC (Finished) 2008 - 2009 1 1 Sites 100 10000 15500 19300 22000 ug/L Drinking Water Monitoring Data - MA (Finished) 2006 - 2020 1,778 1,777 Sites 100 190 23000 88260 5100000 ug/L Drinking Water Monitoring Data -WA (Finished) 2006 - 2011 936 893 Sites 95 710 9800 37240 830000 ug/L Glassmeyer et a 12017 (Finished) [86] 2007 - 2012 25 NA Sites 100 27800 128000 ug/L Community Water System Survey (CWSS) (Finished) [178] 2006 27 NA Sites 19500 83000 ug/L Ambient Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Source) 2006 - 2020 5,409 5,400 Sites 100 400 35000 120000 203500000 ug/L Drinking Water Monitoring Data - FL (Source) 2006 - 2011 105 100 Sites 95 7 9165 80860 860000 ug/L Drinking Water Monitoring Data - MA (Source) 2006 - 2020 159 159 Sites 100 2600 49000 196790 4100000 ug/L Drinking Water Monitoring Data - PA (Source) 2006 - 2011 1 1 Sites 100 18900 18900 18900 18900 ug/L Drinking Water Monitoring Data - WA (Source) 2006 - 2011 1,498 1,303 Sites 87 700 8900 37400 950000 ug/L Drinking Water Monitoring Data -Wl (Source) 2012-2019 142 141 Sites 99 450 6500 36000 210000 ug/L Glassmeyer et a 12017 (Ambient) [86] 2007 - 2012 25 NA Sites 100 24000 128000 ug/L Arnold et al. 2016 (Filtered) [7] 2012 - 2013 758 757 Sites 100 450 15800 164000 682000 ug/L Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial data set and will be complete in Dec. 2020. A-747 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Sodium CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 86 Glassmeyer, S.T., Furlong, E.T., Kolpin, D.W., Batt, A.L., Benson, R., Boone, J.S.,... & Wilson, V.S. (2017). Nationwide reconnaissance of contaminants of emerging concern in source and treated drinking waters of the United States. Science of The Total Environment. v581-582, (909-922). 91 HC. 1992. Guideline Technical Document - Sodium. Health Canada (HC), Water and Air Quality Bureau, Healthy Environments and Consumer Safety Branch, Ottawa, Ontario, Canada. 110 IOM. 2005. Dietary Reference Intakes for Water, Potassium, Sodium, Chloride, and Sulfate. Institute of Medicine (IOM), National Academy of Science, Washington, D.C. 112 IOM. 2019. Dietary Reference Intakes for Sodium and Potassium (2019). Institute of Medicine (IOM), National Academies of Science, Washington, D.C. 152 NRC. 1989. Recommended Dietary Allowances. Washington, DC: National Academy of Sciences,National Academy Press, pp. 247-261. 178 USEPA (US Environmental Protection Agency). (2009). 2006 Community Water System Survey. Overview, 57. 183 USEPA, 2001. Regulatory Determination Support Document for Sodium. EPA 815 R-01-014. 185 USEPA. 2003. Drinking Water Advisory: Consumer Acceptability Advice and Health Effects Analysis on Sodium. EPA 822-R-03-006. February 2003. 232 USEPA. 1999. A Review of Contaminant Occurrence in Public Water Systems. Office of Water. EPA Report 816-R-99-006. 78 pp. 256 USEPA. 2003. Drinking Water Advisory: Consumer Acceptability Advice and Health Effects Analysis on Sodium. U.S. Environmental Protection Agency, Office of Water, Health and Ecological Criteria Division, Washington, D.C. A-748 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Sulfamethoxazole CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Sulfamethoxazole CASRN: 723-46-6 DTXSID: DTXSID8026064 Use: Antibacterial; antipneumocystic Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA Human Neurotoxicants PubMed Neu rotoxica nts X Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUM MARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT IN FORMATION Potency Severity Prevalence Magnitude 6 non-cancer effects 9 4 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date SL 20 lowest therapeutic dose: treat or prevent bacterial infections: urinary tract infections/acute otitis media/acute exacerbations of chronic b ron ch it is/Sh ige llos is/P neu mo cyst is j iro veci Pneumonia/Traveler's Diarrhea in Adults bottle-fed infants FDA; NIH 2018; 2018 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.1968 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-749 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Sulfamethoxazole CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) HRL (ug/L) Assessment Full Citation Notes Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.003333333 mg/kg/day FDA 2018; NIH 2018 Mutual Pharmaceutical Company, Inc. lowest therapeutic dose:treat or prevent bacterial infections: urinary tract infections/acute otitis media/acute exacerbations of chronic branch it is/Shigellosis/Pneumocyst is jiroveci Pneumonia/Traveler's Diarrhea in Adults bottle-fed infants 151 22.0 [77] [150] NOTE: (Lowest Therapeutic Dose/3000x UF) is used in place of an RfD; LTDs were obtained from FDA-approved drug labels Reference Dose (RfD) or Equivalent 0.003333333 mg/kg/day FDA 2018; NIH 2018 Mutual Pharmaceutical Company, Inc. lowest therapeutic dose:treat or prevent bacterial infections: urinary tract infections/acute otitis media/acute exacerbations of chronic branchitis/Shigellosis/Pneumocystis jiroveci Pneumonia/Traveler's Diarrhea in Adults general population 33.8 78.0 [77] [150] NOTE: (Lowest Therapeutic Dose/3000x UF) is used in place of an RfD; LTDs were obtained from FDA-approved drug labels Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Acute Health-Based Guidance Value 0.1 mg/L MN DOH Cancer Classification (CC) 3 no units WHO IARC Chronic Health-Based Guidance Value 0.1 mg/L MN DOH Screening level for pharmaceutical - general population 0.078431373 mg/L EPA Office of Water Screening level for pharmaceutical - infants 0.022222222 mg/L EPA Office of Water Short-Term/Subchronic Health-Based Guidance Value 0.1 mg/L MN DOH Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Measured Data and Assessment Results LD50 2650 mg/kg NIH HSDB min LD50 6370 mg/kg NIH HSDB max Percent of active toxcast in 1.28 percent EPA Chemistry Dashboard vitro assays tested Data Element Value Units Source Notes Modeled Data LD50 0.0337287 mo l/kg TEST QSAR Ames mutagenicity test -0.038 no units TEST QSAR Developmental toxin test 0.853 no units TEST QSAR A-750 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Sulfamethoxazole CCL5 Contaminant Informatio OCCURRENCE DATA EPA-OGWDWand OST Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018 - 2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013 - 2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008 - 2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survey (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991 - 2017 619 30 Sites 4.85 0.0016 0.0408 0.197 1.46 ug/L National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991 - 2017 75 15 Sites 20 0.0016 0.0527 0.305 1.46 ug/L National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991 - 2017 544 15 Sites 2.76 0.00483 0.0169 0.0814 0.12 ug/L PesticideApplication Data Number of States Amount Applied (lbs/year) Date Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Data Number of States Amount Released (lbs/year) Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Production Data Production Volume (lbs/year) Chemical Data Reporting (CDR) Results (EPA) (2016) Noil-Nationally Representative Water Data Date Number of Number of PWS/Sites/ Percent with Minimum Cone. Median Cone. 90th Percentile Maximum Cone. Cone. Units Notes PWS/ Sites/ Detects Samples Detects (Detects) (Detects) (Detects) (Detects) Samples Finished Water Prevalence Magnitude Bradley et al. 2018 (Finished) [53] 2016 26 1 Sites 3.85 0.005 0.005 0.005 0.005 ug/L Glassmeyer et al 2017 (Finished) [86] 2007 - 2012 25 NA Sites 4 0.0082 0.0082 ug/L Community Water System Survey (CWSS) (Finished) [178] 2006 1 NA Sites 0.002 0.002 ug/L Padhye et al. 2013 (Finished) [155] 2009 - 2010 8 1 Samples 12 0 0 1.27e-05 +/- 3.6e-06 ug/L USGS, Sioux Falls Area, 2012 (Finished) [153] 2009 - 2010 1 0 Sites 0 Kleywegt et al. (2011) via Uslu et a 1. (2013) (Finished) [433] 2011 NA NA 0.002 ug/L IL EPA (2008) via Uslu et al. (2013) (Finished) [433] 2008 NA NA 0.005 ug/L Ambient Water Prevalence Magnitude National Water Information System (USGS NWIS) (Surface Water) 2008 - 2017 502 179 Sites 36 0.00171 0.029 0.216 1.58 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008 - 2017 940 73 Sites 7.77 0.00275 0.0245 0.2 0.965 ug/L National Water Information System (USGS NWIS) (All Water) 2008 - 2017 1,441 252 Sites 17 0.00171 0.029 0.202 1.58 ug/L Glassmeyer et a 12017 (Ambient) [86] 2007 - 2012 25 NA Sites 40 0.0501 0.1611 ug/L Batt et al. 2016 (Ambient) [46] 2008 - 2009 182 141 Sites 77 0.0016 0.0289 0.11 0.5764 ug/L Bradley et a 1. 2017 (Ambient) [52] 2012 - 2014 38 20 Sites 53 0.005 0.115 0.895 1.5 ug/L Bexfield et al. 2019 (Groundwater) [49] 2013 - 2015 1,100 12 Sites 1.09 0.019022 0.0338 0.0644 0.1198271 ug/L Padhye et al. 2013 (Ambient) [155] 2009 - 2010 8 7 Samples 88 0 2.4e-06 7.4e-06+/-8e- 07 ug/L USGS, Sioux Falls Area, 2012 (Ambient) [153] 2009 - 2010 2 2 Sites 100 0.006 0.022 0.0448 0.052 ug/L Kleywegt et al. (2011) via Uslu et a 1. (2013) (Ambient) [433] 2011 NA NA 0.284 ug/L Tabe et al. (2009) via Uslu et al. (2013) (Ambient) [433] 2009 NA NA 0.002 ug/L Kormos et al. (2007) via Uslu et a 1. (2013) (Ambient) [433] 2007 NA NA 0.035 ug/L IL EPA (2008) via Uslu et al. (2013) (Ambient) [433] 2008 NA NA 0.012 ug/L Alverez et a1. (2005) via Kostich et al. 2010 (Ambient) [127] 2010 NA NA 0.034 ug/L Barnes et al. (2008) via Kostich et al. 2010 (Ambient) [127] 2010 NA NA 1.11 ug/L Batt et al. (2006) via Kostich et al. 2010 (Ambient) [127] 2010 NA NA 0.45 ug/L Batt et al. (2008) via Kostich et al. 2010 (Ambient) [127] 2010 NA NA 0.14 ug/L Benotti et al. (2007) via Kostich et al. 2010 (Ambient) [127] 2010 NA NA 0.081 ug/L Benotti et al. (2009) via Kostich et al. 2010 (Ambient) [127] 2010 NA NA 0.11 ug/L Brown et al. (2006) via Kostich et al. 2010 (Ambient) [127] 2010 NA NA 0.3 ug/L Conkle et al. (2008) via Kostich et al. 2010 (Ambient) [127] 2010 NA NA 0.369 ug/L Con ley et al. (2008) via Kostich et al. 2010 (Ambient) [127] 2010 NA NA 0.033 ug/L Con ley et al. (2008b) via Kostich et al. 2010 (Ambient) [127] 2010 NA NA 0.01 ug/L Focazio et al. (2008) via Kostich et al. 2010 (Ambient) [127] 2010 NA NA 0.023 ug/L A-751 ------- EPA 815-R-22-003 October 2022 N on-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Glassmeyer et a I. (2005) via Kostich et a I. 2010 (Ambient) [127] 2010 NA NA 0.763 ug/L Haggard et al. (2006) via Kostich et al. 2010 (Ambient) [127] 2010 NA NA 0.5 ug/L Karthikeyan et al. (2006) via Kostich et al. 2010 (Ambient) [127] 2010 NA NA 0.08 ug/L Kim et al. (2007) via Kostich et al. 2010 (Ambient) [127] 2010 NA NA 0.32 ug/L Kolpin et al. (2002) via Kostich et al. 2010 (Ambient) [127] 2010 NA NA 1.9 ug/L Kolpin et al. (2004) via Kostich et al. 2010 (Ambient) [127] 2010 NA NA 0.07 ug/L Lindsey et al. (2001) via Kostich et al. 2010 (Ambient) [127] 2010 NA NA 1.02 ug/L Shelver et al. (2008) via Kostich et al. 2010 (Ambient) [127] 2010 NA NA 0.09 ug/L Stackelberg et al. (2004) via Kostich et al. 2010 (Ambient) [127] 2010 NA NA 0.05 ug/L Stackelberg et al. (2007) via Kostich et al. 2010 (Ambient) [127] 2010 NA NA 0.06 ug/L Stand ley et al. (2008) via Kostich et al. 2010 (Ambient) [127] 2010 NA NA 0.0022 ug/L Trenholm et al. (2006) via Kostich et al. 2010 (Ambient) [127] 2010 NA NA 0.0049 ug/L Vanderford et al. (2003) via Kostich et al. 2010 (Ambient) [127] 2010 NA NA 0.033 ug/L Vanderford et al. (2006) via Kostich et al. 2010 (Ambient) [127] 2010 NA NA 0.672 ug/L Yang et al. (2003) via Kostich et al. 2010 (Ambient) [127] 2010 NA NA 0.16 ug/L Waste Water Effluent Prevalence Magnitude Scott et al. 2018 (Wastewater) [161] 2011 -2017 21 20 Sites 95 0.014029 0.474 0.945 2.082509 ug/L Kostich etal. 2014 (Wastewater) [126] not reported 50 48 Sites 96 0.0026 0.447 1.32 2.8725 ug/L Batt et al. (2005) via Kostich et al. 2010 (Wastewater) [127] 2010 NA NA 1.3 ug/L Batt et al. (2006) via Kostich et al. 2010 (Wastewater) [127] 2010 NA NA 6 ug/L Batt et al. (2007) via Kostich et al. 2010 (Wastewater) [127] 2010 NA NA 2.8 ug/L Batt et al. (2008) via Kostich et al. 2010 (Wastewater) [127] 2010 NA NA 2.2 ug/L Benotti et al. (2007) via Kostich et al. 2010 (Wastewater) [127] 2010 NA NA 0.626 ug/L Conkle et al. (2008) via Kostich et al. 2010 (Wastewater) [127] 2010 NA NA 4.09 ug/L Glassmeyer et al. (2005) via Kostich et al. 2010 (Wastewater) [127] 2010 NA NA 0.589 ug/L Karthikeyan et al. (2006) via Kostich et al. 2010 (Wastewater) [127] 2010 NA NA 1.25 ug/L Renew et al. (2004) via Kostich et al. 2010 (Wastewater) [127] 2010 NA NA 2.14 ug/L Shelver et al. (2008) via Kostich et al. 2010 (Wastewater) [127] 2010 NA NA 3.1 ug/L Spongberg et al. (2008) via Kostich et al. 2010 (Wastewater) [127] 2010 NA NA 0.472 ug/L Trenholm et al. (2006) via Kostich et al. 2010 (Wastewater) [127] 2010 NA NA 0.36 ug/L Vanderford et al. (2006) via Kostich et al. 2010 (Wastewater) [127] 2010 NA NA 2.06 ug/L Yang et al. (2003) via Kostich et al. 2010 (Wastewater) [127] 2010 NA NA 0.52 ug/L Estimated Concentration in Water Date Source Value Units Model Notes EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg- bw/ day) Notes Expocast exposure 2.48E-08 Biomonftoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection n serum (1999-2016) NHANES biomonitoring detection n blood (1999-2016) NHANES biomonitoring detection n urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 3.34495 days Boiling point OPERA QSAR 290.681 degree C Boiling point TEST QSAR Vapor pressure OPERA QSAR 6.8E-10 mmHg Vapor pressure TEST QSAR 4.63E-09 mmHg Solubility in water OPERA QSAR 0.000989291 mol/L Solubility in water TEST QSAR 0.00126183 mol/L Bioconcentration factor OPERA QSAR 2.73669 no units Bioconcentration factor TEST QSAR 17.1002 no units Henry's Law constant OPERA QSAR 7.84E-11 atm-mA3/mol Octanol/water partitioning coeff. (log Kow) OPERA QSAR 0.948532 no units A-752 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Sulfamethoxazole CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 46 Batt, A. L., Kincaid, T. M., Kostich, M. S., Lazorchak, J. M., & Olsen, A. R. (2016). Evaluating the extent of pharmaceuticals in surface waters of the United States using a Nationaicale Rivers and Streams Assessment survey. Environmental toxicology and chemistry, 35(4), 874-881. 49 Bexfield, L.M., P.L. Toccalino, K. Belitz, W.T. Foreman, and E.T. Furlong. 2019. Hormones and pharmaceuticals in groundwater used as a source of drinking water across the United States. Environmental Science and Technology 53: 2950-2960. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 53 Bradley, P. M., Kolpin, D. W., Romanok, K. M., Smalling, K. L., Focazio, M. J., Brown, J. B.,... & Dietze, J. E. (2018). Reconnaissance of mixed organic and inorganic chemicals in private and public supply tapwaters at selected residential and workplace sites in the United States. Environmental science & technology, 52(23), 13972-13985. 77 FDA. 2018. Drugs @ FDA: FDA Approved Drug Products. U.S. Food and Drug Administration (FDA), https://www.accessdata.fda.gov/scripts/cder/daf/. 86 Glassmeyer, S.T., Furlong, E.T., Kolpin, D.W., Batt, A.L., Benson, R., Boone, J.S.,... & Wilson, V.S. (2017). Nationwide reconnaissance of contaminants of emerging concern in source and treated drinking waters of the United States. Science of The Total Environment. v581-582, (909-922). 126 Kostich MS, et al. 2014 Concentrations of prioritized pharmaceuticals in effluents from 50 large wastewater treatment plants in the US and implications for risk estimation. Environ Pollut. 2014 Jan;184:354-9. doi: 10.1016/j.envpol.2013.09.013. Epub 2013 Oct 3. PMID: 24095705. 127 Kostich, MS, et al., 2010. Predicting variability of aquatic concentrations of human pharmaceuticals. Sci. Total Environ. 408 (20), 4504e4510. 150 NIH. 2018. DailyMed Database. U.S. National Library of Medicine, National Institutes of Health (NIH). https://dailymed.nlm.nih.gov/dailymed/. 153 Occurrence of anthropogenic organic compounds and nutrients in source and finished water in the Sioux Falls area, South Dakota, 2009-10: U.S. Geological Survey Scientific Investigations Report 2012-5098, 21 p. plus appendixes. 155 Padhye, L.P., Yao, H., Kung'u, F.T., and Huang, C.H. Year-long evaluation on the occurrence and fate of pharmaceuticals, personal care products, and endocrine disrupting chemicals in an urban drinking water treatment plant. 2014. Water Research 51 (2014) 266-276. 161 Scott, T. M., Phillips, P. J., Kolpin, D. W., Colella, K. M., Furlong, E. T., Foreman, W. T., & Gray, J. L. (2018). Pharmaceutical manufacturing facility discharges can substantially increase the pharmaceutical load to US wastewaters. Science of the Total Environment, 636, 69-79. 178 USEPA (US Environmental Protection Agency). (2009). 2006 Community Water System Survey. Overview, 57. 433 Uslu, M., Jasim, S., Arvai, A., Bewtra, J. and Biswas, N., 2013. A Survey of Occurrence and Risk Assessment of Pharmaceutical Substances in the Great Lakes Basin. Ozone: Science & Engineering, 35(4), pp.249-262. A-753 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Sulfentrazone CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Chemical Notes: DTXSID6032645 Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 4 reduced longevity 10 3 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 200 reduced prenatal viability (fetal and litter), reduced litter size, increased number of stillborn pups, reduced pup and litter postnatal survival, decreased pup body weights throughout lactation bottle-fed infants OPP 2018 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.1793 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-754 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Sulfentrazone CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.14 mg/kg/day OPP 2018 Ponnock 1994 reduced prenatal viability (fetal and litter), reduced litter size, increased number of stillborn pups, reduced pup and litter postnatal survival, decreased pup body weights throughout lactation bottle-fed infants 151 185 [409] Cancer Classification (CC) NL OPP 2018 [4091 Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Acute Human Health Benchmark 3.9 mg/L EPA HHBP Acute PAD 0.14 mg/kg/day EPA HHBP Chronic Human Health Benchmark 0.9 mg/L EPA HHBP Health-Based Screening Level 0.9 mg/L Health-based screening levels from USGS Population-Adjusted Dose (PAD) 0.14 mg/kg/day EPA HHBP Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element I Value I Units I Source I Notes Measured Data and Assessment Results LD50 2855 mg/kg NIH HSDB LOAEL 25 mg/kg/day EPA Toxicity Reference Database min LOAEL 250 mg/kg/day EPA Toxicity Reference Database max NOAEL 10 mg/kg/day EPA Toxicity Reference Database min NOAEL 116.9 mg/kg/day EPA Toxicity Reference Database max Percent of active toxcast in vitro assays tested 2.79 percent EPA Chemistry Dashboard Subchronic LOAEL 108.4 mg/kg/day EPA Toxicity Reference Database max Subchronic LOAEL 57 mg/kg/day EPA Toxicity Reference Database min Subchronic NOAEL 23.1 mg/kg/day EPA Toxicity Reference Database min Subchronic NOAEL 79.8 mg/kg/day EPA Toxicity Reference Database max Data Element Value Units Source Notes Modeled Data LD50 0.0012274 mo l/kg TEST QSAR Ames mutagenicity test 0.709 no units TEST QSAR Developmental toxin test 1.271 no units TEST QSAR A-755 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Sulfentrazone CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contam nant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contam nant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contam nant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contam nant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contam nant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contam nant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 1.762 230 Sites 13 0.00055 0.0224 0.179 4.1 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 322 198 Sites 61 0.00055 0.0224 0.178 4.1 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 1.440 32 Sites 2.22 0.0015 0.0166 0.201 0.26 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) 39 4,031,687 2016 Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Ambient Water Prevalence Magnitude National Water Information System (USGS NWIS) (Surface Water) 2008-2017 307 72 Sites 23 0.00133 0.0226 0.25 2.42 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008-2017 530 15 Sites 2.83 0.00548 0.0158 0.0304 0.0594 ug/L National Water Information System (USGS NWIS) (All Water) 2008-2017 837 87 Sites 10 0.00133 0.0215 0.244 2.42 ug/L Arnold et al. 2016 (Filtered) [7] 2012-2013 584 6 Sites 1.03 0.0015 0.007 0.109 0.199 ug/L Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 0.000000118 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 4.65135 days Boiling point OPERA QSAR 342.454 degree C Boiling point TEST QSAR Vapor pressure OPERA QSAR 7.86E-10 mmHg Vapor pressure TEST QSAR 2.59E-08 mmHg Solubility in water OPERA QSAR 0.0001917 mol/L Solubility in water TEST QSAR 0.000125314 mol/L Bioconcentration factor OPERA QSAR 7.66859 no units Bioconcentration factor TEST QSAR 6.91831 no units Henry's Law constant OPERA QSAR 8.59E-11 atm-mA3/mol 0 eta no l/water partitioning coeff. (log Kow) OPERA QSAR 1.3198 no units A-756 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Sulfentrazone CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 409 USEPA. 2018. Sulfentrazone - Human Health Risk Assessment for a Section 3 Registration Request to Add New Uses on Chia and Teff; an Amended Use on Mint; and Crop Group Conversions for Tree Nu Group 14-12, Stalk and Stem Vegetable Subgroup 22A; Vegetable, Brassica, Head and Stem, Group 5-16; and Brassica, Leafy Greens, Subgroup 4-16B. EPA-HQ-OPP-2017-0072-0009. DP No. D443993. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. A-757 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Sulfometuron methyl CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Sulfometuron methyl CASRN: 74222-97-2 DTXSID: DTXSID0034936 Use: Herbicide for annual, biennial, and perennial grasses and annual broad leaf weeds Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANTSUMMARY& DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 4 non-cancer effects 9 2 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 2000 decreased body weight gain, hemolytic anemia, increase in alkaline phosphatase general population OPP 2015 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.03624 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-758 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Sulfometuron methyl CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.275 mg/kg/day OPP 2015 Wood and O'Neal 1983 decreased body weight gain, hemolytic anemia, increase in alkaline phosphatase - decreased body weight gain seen at beginning of 4 weeks of exposure in adult dogs general population 33.8 1630 [357] Cancer Classification (CC) NL OPP 2015 [3571 Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Acute Human Health Benchmark 1.83 mg/L EPA HHBP Acute PAD 0.275 mg/kg/day EPA HHBP Chronic Human Health Benchmark 1.76 mg/L EPA HHBP Health-Based Screening Level 1.76 mg/L Health-based screening levels from USGS Population-Adjusted Dose (PAD) 0.275 mg/kg/day EPAHHBP Data Element Value Units Source Notes Measured Data and Assessment Results LD50 5000 mg/kg NIH HSDB Percent of active toxcast in 0.75 percent EPA Chemistry Dashboard vitro assavs tested Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Modeled Data LD50 TEST QSAR Ames mutagenicity test 0.116 no units TEST QSAR Developmental toxin test 1.056 no units TEST QSAR A-759 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Sulfometuron methyl CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contam nant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contam nant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contam nant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contam nant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contam nant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contam nant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 4,167 261 Sites 6.26 9.00E - 05 0.00454 0.0362 3.51 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 471 228 Sites 48 2.00E - 04 0.00455 0.0363 3.51 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 3.696 33 Sites 0.89 9.00E - 05 0.004 0.0336 0.284 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude USDA Pesticide Data Program (PDP) (Finished) 2001-2013 12 7 Sites 58 0.00127 0.0032 0.012 0.025 ug/L Ambient Water Prevalence Magnitude National Water Information System (USGS NWIS) (Surface Water) 2008-2017 475 119 Sites 25 2.00E - 04 0.00645 0.0348 1.79 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008-2017 1,057 16 Sites 1.51 0.00137 0.0055 0.0474 0.101 ug/L National Water Information System (USGS NWIS) (All Water) 2008-2017 1,532 135 Sites 8.81 2.00E - 04 0.00645 0.0352 1.79 ug/L USDA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001-2013 229 9 Sites 3.93 0.00127 0.0038 0.0192 0.059 ug/L USDA Pesticide Data Program (PDP) (Groundwater) 2001-2013 219 2 Sites 0.91 0.00863 0.0105 0.0281 0.035 ug/L USDA Pesticide Data Program (PDP) (Untreated) 2001-2013 12 7 Sites 58 0.00127 0.0032 0.0187 0.059 ug/L Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990-2018 26 0 Sites 0 Bradley et al. 2017 (Ambient) [52] 2012-2014 38 5 Sites 13 0.0252 0.0349 0.177 0.248 ug/L Arnold et al. 2016 (Filtered) [7] 2012-2013 690 8 Sites 1.16 le-04 0.00095 0.00325 0.0064 ug/L USGS, McKenzie River, Oregon, 2012 (Ambient) [158] 2002-2010 126 18 Samples 14 1.61 ug/L Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/ day) Notes Expocast exposure 0.000000106 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) < LOD ug/l Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 4.63689 days Boiling point OPERA QSAR 264.401 degree C Boiling point TEST QSAR Vapor pressure OPERA QSAR 1.3E-10 mmHg Vapor pressure TEST QSAR 2.21E-11 mmHg Solubility in water OPERA QSAR 0.000446592 mol/L Solubility in water TEST QSAR 0.000406443 mol/L Bioconcentration factor OPERA QSAR 3.45799 no units Bioconcentration factor TEST QSAR 0.907821 no units Henry's Law constant OPERA QSAR 6.36E-10 atm-mA3/mol 0 eta no l/water partitioning coeff. (log Kow) OPERA QSAR 1.21447 no units A-760 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Sulfometuron methyl CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 158 Reconnaissance of Land-Use Sources of Pesticides in Drinking Water, McKenzie River, Oregon. U.S. Geological Survey Scientific Investigations Report 2012-5091, 46 p. plus appendixes. 357 USEPA. 2015. Sulfometuron Methyl. Draft Human Health Risk Assessment in Support of Registration Review. EPA-HQ-OPP-2012-0433-0026. DP No. D427028. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticide in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. A-761 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Tamoxifen CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Tamoxifen CASRN: 10540-29-1 DTXSID: DTXSID1034187 Use: Antiestrogen; antineoplastic (hormonal) Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro X Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANTSUMMARY& DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT IN FORMATION Potency Severity Prevalence Magnitude 7 non-cancer effects 1 1 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date SL 0.6 lowest therapeutic dose: nonsteroidal antiestrogen/treatment of metastatic breast cancer/adjuvant breast cancer treat me nt/du eta 1 carcinoma in situ/prophylaxis in women at high risk for bottle-fed infants FDA; NIH 2018; 2018 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.187 90th Percentile All Ambient Water NWIS 2008-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-762 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Tamoxifen CCL 5 Contaminant Information Sheet EPA-OGWDWand OST October 2022 HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 8.33333E-05 mg/kg/day FDA 2018; NIH 2018 Andrx Pharmaceut icals, Inc. lowest therapeutic dose:nonsteroidal antiestrogen/treatment of metastatic breast cancer/adjuvant breast cancertreatment/ductal carcinoma in situ/prophylaxis in women at high risk for cancer bottle-fed infants 151 0.560 [77] [150] NOTE: (Lowest Therapeutic Dose/3000x UF) is used in place of an RfD; LTDs were obtained from FDA-approved drug labels Reference Dose (RfD) or Equivalent 8.33333E-05 mg/kg/day FDA 2018; NIH 2018 Andrx Pharmaceut icals, Inc. lowest therapeutic dose: nonsteroidal a ntiestrogen/treatment of metastatic breast cancer/adjuvant breast cancertreatment/ductal carcinoma in situ/prophylaxis in women at high risk for cancer general population 33.8 2.00 [77] [150] NOTE: (Lowest Therapeutic Dose/3000x UF) is used in place of an RfD; LTDs were obtained from FDA-approved drug labels Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Cancer Classification (CC) 1 no units WHO IARC Screening level for pharmaceutical - general population 0.001960784 mg/L EPA Office of Water Screening level for pharmaceutical - infants 0.000555556 mg/L EPA Office of Water Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Measured Data and Assessment Results Percent of active toxcast in 40.13 percent EPA Chemistry Dashboard vitro assays tested Data Element Value Units Source Notes Modeled Data LD50 0.0058345 mo l/kg TEST QSAR Ames mutagenicity test 0.096 no units TEST QSAR Developmental toxin test 0.788 no units TEST QSAR A-763 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Tamoxifen CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contam nant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contam nant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contam nant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contam nant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contam nant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contam nant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev(NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 531 0 Sites 0 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 75 0 Sites 0 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 456 0 Sites 0 Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Glassmeyer et al 2017 (Finished) [86] 2007-2012 25 NA Sites 0 ug/L Ambient Water Prevalence Magnitude National Water Information System (USGS NWIS) (Surface Water) 2008-2017 193 1 Sites 0.52 0.187 0.187 0.187 0.187 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008-2017 333 0 Sites 0 National Water Information System (USGS NWIS) (All Water) 2008-2017 526 1 Sites 0.19 0.187 0.187 0.187 0.187 ug/L Glassmeyer et al 2017 (Ambient) [86] 2007-2012 25 NA Sites 0 ug/L Bexfieid et al. 2019 (Groundwater) [49] 2013-2015 1,097 0 Sites 0 Waste Water Effluent Prevalence Magnitude Scott et al. 2018 (Wastewater) [161] 2011-2017 20 0 Sites 0 Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 4.05E-08 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR4 data used in the CCL5 is a partial datasetand will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 3.36164 days Boiling point OPERA QSAR 419.341 degree C Boiling point TEST QSAR 428.393 degree C Vapor pressure OPERA QSAR 2.07E-08 mmHg Vapor pressure TEST QSAR 5.27E-09 mmHg Solubility in water OPERA QSAR 0.00000858 mol/L Solubility in water TEST QSAR 0.00000274 mol/L Bioconcentration factor OPERA QSAR 1210.92 no units Bioconcentration factor TEST QSAR 345.144 no units Henry's Law constant OPERA QSAR 2.21E-08 atm-mA3/mol Octanol/water partitioning coeff. (log Kow) OPERA QSAR 6.2335 no units A-764 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Tamoxifen CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 49 Bexfield, L.M., P.L. Toccalino, K. Belitz, W.T. Foreman, and E.T. Furlong. 2019. Hormones and pharmaceuticals in groundwater used as a source of drinking water across the United States. Environmental Science and Technology 53: 2950-2960. 77 FDA. 2018. Drugs @ FDA: FDA Approved Drug Products. U.S. Food and Drug Administration (FDA), https://www.accessdata.fda.gov/scripts/cder/daf/. 86 Glassmeyer, S.T., Furlong, E.T., Kolpin, D.W., Batt, A.L., Benson, R., Boone, J.S.,... & Wilson, V.S. (2017). Nationwide reconnaissance of contaminants of emerging concern in source and treated drinking waters of the United States. Science of The Total Environment. v581-582, (909-922). 150 NIH. 2018. DailyMed Database. U.S. National Library of Medicine, National Institutes of Health (NIH). https://dailymed.nlm.nih.gov/dailymed/. 161 Scott, T. M., Phillips, P. J., Kolpin, D. W., Colella, K. M., Furlong, E. T., Foreman, W. T., & Gray, J. L. (2018). Pharmaceutical manufacturing facility discharges can substantially increase the pharmaceutical load to US wastewaters. Science of the Total Environment, 636, 69-79. A-765 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Tebuconazole CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Tebuconazole CASRN: 107534-96-3 DTXSID: DTXSID9032113 Use: Fungicide Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 X CONTAMINANT SUMMARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 5 reproductive and developmental effects 1 5 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value («"gA) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 40 decreases in body weights, absolute brain weights, brain measurements, and motor activity in offspring bottle-fed infants OPP 2019 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.2307 90th Percentile Finished Water UCMR4 2018-2019 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-766 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Tebuconazole CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.029 mg/kg/day OPP 2019 Parker 2000 decreases in body weights, absolute brain weights, brain measurements, and motor activity in offspring bottle-fed infants 151 38.4 [427] Cancer Classification (CC) C OPP 2019 [4271 Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Acute Human Health Benchmark 0.19 mg/L EPA HHBP Acute PAD 0.029 mg/kg/day EPA HHBP Chronic Human Health Benchmark 0.19 mg/L EPA HHBP Health-Based Screening Level 0.19 mg/L Health-based screening levels from USGS Population-Adjusted Dose (PAD) 0.029 mg/kg/day EPAHHBP Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Measured Data and Assessment Results LD50 5000 mg/kg NIH HSDB max LD50 625 mg/kg NIH HSDB min Percent of active toxcast in 17.05 percent EPA Chemistry Dashboard vitro assays tested Data Element Value Units Source Notes Modeled Data LD50 0.0101391 mo l/kg TEST QSAR Ames mutagenicity test 0.499 no units TEST QSAR Developmental toxin test 0.483 no units TEST QSAR A-767 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Tebuconazole CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contam nant Monitoring Rule (UCMR) 4 2018-2019 3.648 2 Sites 0.05 0.21 0.222 0.231 0.233 Unregulated Contam nant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contam nant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contam nant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contam nant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contam nant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev(NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 1.788 165 Sites 9.23 0.00024 0.00735 0.0285 0.93 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 328 163 Sites 50 0.00024 0.00735 0.0284 0.93 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 1.460 2 Sites 0.14 0.00035 0.13 0.207 0.259 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) 47 2,111,268 2016 Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude USDA Pesticide Data Program (PDP) (Finished) 2001-2013 17 7 Sites 41 0.0035 0.0035 0.0165 0.15 ug/L Ambient Water Prevalence Magnitude National Water Information System (USGS NWIS) (Surface Water) 2008-2017 435 69 Sites 16 0.00044 0.0118 0.0784 3.24 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008-2017 536 2 Sites 0.37 0.00584 0.0103 0.0702 0.0959 ug/L National Water Information System (USGS NWIS) (All Water) 2008-2017 971 71 Sites 7.31 0.00044 0.0118 0.0859 3.24 ug/L USDA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001-2013 229 12 Sites 5.24 0.0035 0.0058 0.0377 0.15 ug/L USDA Pesticide Data Program (PDP) (Groundwater) 2001-2013 219 6 Sites 2.74 0.0035 0.014 0.061 0.083 ug/L USDA Pesticide Data Program (PDP) (Untreated) 2001-2013 12 6 Sites 50 0.0035 0.00465 0.026 0.15 ug/L Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990-2018 50 0 Sites 0 Bradley et al. 2017 (Ambient) [52] 2012-2014 38 7 Sites 18 0.0173 0.0255 0.041 0.0421 ug/L Arnold et al. 2016 (Filtered) [7] 2012-2013 690 0 Sites 0 Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 1.58E-08 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicatethere were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 3.17404 days Boiling point OPERA QSAR 321.712 degree C Boiling point TEST QSAR 344.862 degree C Vapor pressure OPERA QSAR 0.000000022 mmHg Vapor pressure TEST QSAR 9.29E-08 mmHg Solubility in water OPERA QSAR 0.00010626 mol/L Solubility in water TEST QSAR 0.0000893 mol/L Bioconcentration factor OPERA QSAR 243.826 no units Bioconcentration factor TEST QSAR 49.204 no units Henry's Law constant OPERA QSAR 0.000000329 atm-mA3/mol 0 eta no 1/water partitioning coeff. (log Kow) OPERA QSAR 3.68215 no units A-768 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Tebuconazole CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 427 USEPA. 2019. Tebuconazole: Acute and Chronic Aggregate Dietary Exposure and Risk Assessments for Petition for the Establishment of Registrations and Permanent Tolerances for Residues in/on Watercress; Add Green-House Grown Tomato to Label and Crop Group Conversions/Expansions for Brassica Leafy Greens, Subgroup 4-16B, Except Watercress; Cottonseed, Subgroup 20C; Pome Fruit, Group 11-10; Stone Fruit, Group 12-12, Except Cherry; Small Vine Climbing Fruit, Except Fuzzy Kiwifruit, Subgroup 13-07F; Tropical and Subtropical Small Fruit, Inedible Peel, Subgroup 24A; Tree Nut, 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticide in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. A-769 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Tebuthiuron CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Chemical Notes: DTXSID3024316 Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 4 reproductive and developmental effects 10 3 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value («"gA) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 200 decreased body weights in F1 females; decreased up body weights in Fland F2 generations bottle-fed infants OPP 2014 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.048 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-770 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Tebuthiuron CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.14 mg/kg/day OPP 2014 Hoyt et al. 1981 decreased body weights in F1 females; decreased pup body weights in F1 and F2 generations bottle-fed infants 151 185 [336] Cancer Classification (CC) D OPP 2014 [3361 Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results 10-day Health Advisory 3 mg/L EPA DWSHA 2018 Lifetime Health Advisory 0.5 mg/L EPA DWSHA 2018 Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Measured Data and Assessment Results LD50 200 mg/kg NIH HSDB min LD50 644 mg/kg NIH HSDB max LOAEL 110 mg/kg/day EPA Toxicity Reference Database max LOAEL 31 mg/kg/day EPA Toxicity Reference Database min NOAEL 15 mg/kg/day EPA Toxicity Reference Database min NOAEL 72 mg/kg/day EPA Toxicity Reference Database max Percent of active toxcast in 1.28 percent EPA Chemistry Dashboard vitro assays tested Data Element Value Units Source Notes Modeled Data LD50 0.0068865 mo l/kg TEST QSAR Ames mutagenicity test TEST QSAR Developmental toxin test 0.583 no units TEST QSAR A-771 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Tebuthiuron CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST October 2022 Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR)4 2018 - 2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013 - 2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008 - 2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survey (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991 - 2017 11,243 1,134 Sites 10 0 0.0106 0.048 17.3 ug/L National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991 - 2017 2,224 813 Sites 37 0 0.01 0.044 6.4 ug/L National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991 - 2017 9,019 321 Sites 3.56 0.00024 0.0205 0.146 17.3 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) 13 22,610 2015 Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting(CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Finished) 2006 - 2020 2 0 Sites 0 USDA Pesticide Data Program (PDP) (Finished) 2001 - 2013 17 10 Sites 59 0.00035 0.001 0.0037 0.055 ug/L USGS, Sioux Falls Area, 2012 (Finished) [153] 2009 - 2010 1 0 Sites 0 Ambient Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Source) 2006 - 2020 1 0 Sites 0 National Water Information System (USGS NWIS) (Surface Water) 2008 - 2017 918 185 Sites 20 0.00031 0.00667 0.0449 1.4 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008 - 2017 3,084 130 Sites 4.22 3.00E - 04 0.016 0.13 0.516 ug/L National Water Information System (USGS NWIS) (All Water) 2008 - 2017 4,001 315 Sites 7.87 3.00E - 04 0.00857 0.0603 1.4 ug/L USDA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001 - 2013 229 47 Sites 21 0.00035 0.001 0.0046 0.43 ug/L USDA Pesticide Data Program (PDP) (Groundwater) 2001 - 2013 219 41 Sites 19 0.00035 0.0011 0.05 0.43 ug/L USDA Pesticide Data Program (PDP) (Untreated) 2001 - 2013 12 6 Sites 50 0.00035 0.001 0.0044 0.22 ug/L Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990 - 2018 1,757 31 Sites 1.76 0.0127 0.052 1.3 3 ug/L Bradley et al. 2017 (Ambient) [52] 2012 - 2014 38 3 Sites 7.89 0.0125 0.015 0.0316 0.0358 ug/L Arnold et al. 2016 (Filtered) [7] 2012 - 2013 690 24 Sites 3.48 5e-04 0.0026 0.0145 0.0317 ug/L USGS, Sioux Falls Area, 2012 (Ambient) [153] 2009 - 2010 2 0 Sites 0 USGS, McKenzie River, Oregon, 2012 (Ambient) [158] 2002 - 2010 134 6 Samples 4.5 3.47 ug/L lA/osfe Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg- Notes Expo cast exposure 8.13E-08 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES bio monitoring detect ion in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR4data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biode gradation ha If-life OPERA QSAR 4.57479 days Boiling point OPERA QSAR 334.1 degree C Boiling point TEST QSAR 340.382 degree C Vapor pressure OPERA QSAR 0.00000229 mmHg Vapor pressure TEST QSAR 0.000000564 mmHg Solubility in water OPERA QSAR 0.0110523 mol/L Solubility in water TEST QSAR 0.00409261 mol/L Bioconcentration factor OPERA QSAR 2.60494 no units Bioconcentration factor TEST QSAR 9.18333 no units Flenry's Law constant OPERA QSAR 1.38E-10 atm-mA3/mol Octanol/water partitioning coeff. (log Kow) OPERA QSAR 1.65206 no units A-772 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Tebuthiuron CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 153 Occurrence of anthropogenic organic compounds and nutrients in source and finished water in the Sioux Falls area, South Dakota, 2009-10: U.S. Geological Survey Scientific Investigations Report 2012-5098, 21 p. plus appendixes. 158 Reconnaissance of Land-Use Sources of Pesticides in Drinking Water, McKenzie River, Oregon. U.S. Geological Survey Scientific Investigations Report 2012-5091, 46 p. plus appendixes. 336 USEPA. 2014. Tebuthiuron: Draft Human Risk Assessment. EPA-HQ-OPP-2009-0327-0041. DP Nos. D414218 D418910 D418911. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticide in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. A-773 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Tefluthrin CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Chemical Notes: DTXSID5032577 Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants X PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANTSUMMARY& DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 6 non-cancer effects 3 2 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 10 increased incidence of tremors general population OPP 2019 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.0101 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-774 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Tefluthrin CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.0017 mg/kg/day OPP 2019 Stonard 1986 increased incidence of tremors general population 33.8 10.1 [428] Cancer Classification (CC) NL OPP 2019 [4281 Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Acute Human Health Benchmark 0.011 mg/L EPA HHBP Acute PAD 0.0017 mg/kg/day EPA HHBP Health-Based Screening Level 0.011 mg/L Health-based screening levels from USGS Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element I Value I Units I Source I Notes Measured Data and Assessment Results LD50 22 mg/kg NIH HSDB min LD50 57 mg/kg NIH HSDB max LOAEL 3 mg/kg/day EPA Toxicity Reference Database min LOAEL 54.400002 mg/kg/day EPA Toxicity Reference Database max NOAEL 1 mg/kg/day EPA Toxicity Reference Database min NOAEL 13.5 mg/kg/day EPA Toxicity Reference Database max Percent of active toxcast in vitro assays tested 9.38 percent EPA Chemistry Dashboard Subchronic LOAEL 7.5 mg/kg/day EPA Toxicity Reference Database Subchronic NOAEL 2.5 mg/kg/day EPA Toxicity Reference Database Data Element Value Units Source Notes Modeled Data LD50 0.0001941 mo l/kg TEST QSAR Ames mutagenicity test 0.654 no units TEST QSAR Developmental toxin test 0.96 no units TEST QSAR A-775 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Tefluthrin CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contam nant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contam nant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contam nant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contam nant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contam nant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contam nant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 3.062 7 Sites 0.23 0.004 0.005 0.0101 0.015 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 197 6 Sites 3.05 0.004 0.005 0.0108 0.015 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 2.865 1 Sites 0.03 0.006 0.006 0.006 0.006 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) 36 350,395 2016 Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude USDA Pesticide Data Program (PDP) (Finished) 2001-2013 10 0 Sites 0 Ambient Water Prevalence Magnitude National Water Information System (USGS NWIS) (Surface Water) 2008-2017 508 1 Sites 0.2 0.062 0.062 0.062 0.062 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008-2017 956 4 Sites 0.42 0.002 0.0035 0.004 0.004 ug/L National Water Information System (USGS NWIS) (All Water) 2008-2017 1,463 5 Sites 0.34 0.002 0.004 0.033 0.062 ug/L USDA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001-2013 123 0 Sites 0 USDA Pesticide Data Program (PDP) (Groundwater) 2001-2013 113 0 Sites 0 USDA Pesticide Data Program (PDP) (Untreated) 2001-2013 10 0 Sites 0 Arnold et al. 2016 (Filtered) [7] 2012-2013 106 0 Sites 0 Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/ day) Notes Expocast exposure 0.000000183 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 3.53756 days Boiling point OPERA QSAR 306.216 degree C Boiling point TEST QSAR 289.657 degree C Vapor pressure OPERA QSAR 0.000042 mmHg Vapor pressure TEST QSAR 0.00000345 mmHg Solubility in water OPERA QSAR 8.52E-08 mol/L Solubility in water TEST QSAR 0.000000104 mol/L Bioconcentration factor OPERA QSAR 1246.21 no units Bioconcentration factor TEST QSAR 567.545 no units Henry's Law constant OPERA QSAR 4.43E-08 atm-mA3/mol 0 eta no l/water partitioning coeff. (log Kow) OPERA QSAR 6.47305 no units A-776 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Tefluthrin CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 428 USEPA. 2019. Tefluthrin: Updated Human Health Draft Risk Assessment in Support of Registration Review. DP No. D453462. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. A-777 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Terbacil CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION DTXSID8024317 Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Not List ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT IN FORMATION Potency Severity Prevalence Magnitude 4 reproductive and developmental effects 1 1 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value («"gA) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 400 decreased pup body weights pnd 7-21 bottle-fed infants OPP 2019 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.1418 90th Percentile All Ambient Water NAWQA 1991-2017 Final Hazard Quotient (HQ) 0.00035 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Terbacil does not appear to occur at health levels of concern in PWSs nd EPA has made a determiniation that terbacil does not present a neaningful opportunity for health risk reduction. While terbacil has been found in ambient waters at the levels less than the HRLof 90 pg/L(as well as the HRL) [a,b], it was not found in the UCMR1 survey of public water supplies [c]. Kolpin & Martin, 2003 [123]; [b] Martin, Crawford, & Lars [134]; [c] USE PA, 2008 [297]; as cited in USE PA, 2008 [296] i, 2003 Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-778 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Terbacil CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.33 mg/kg/day OPP 2019 Edwards 2017 decreased pup body weights pnd 7-21 bottle-fed infants 151 437 [429] Cancer Classification (CC) NL OPP 2019 [4291 Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results 10-day Health Advisory 0.3 mg/L EPA DWSHA 2018 Lifetime Health Advisory 0.09 mg/L EPA DWSHA 2018 Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Measured Data and Assessment Results LD50 5000 mg/kg NIH HSDB min LD50 7500 mg/kg NIH HSDB max LOAEL 6.25 mg/kg/day EPA Toxicity Reference Database NOAEL 1.25 mg/kg/day EPA Toxicity Reference Database Percent of active toxcast in 5.54 percent EPA Chemistry Dashboard vitro assays tested Data Element Value Units Source Notes Modeled Data LD50 0.0100231 mo l/kg TEST QSAR Ames mutagenicity test 0.196 no units TEST QSAR Developmental toxin test 0.982 no units TEST QSAR A-779 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Terbacil CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contam nant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contam nant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contam nant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contam nant Monitoring Rule (UCMR) 1 2001 - 2003 3.873 0 Sites 0 Unregulated Contam nant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contam nant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev(NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 10.088 235 Sites 2.33 0.0018 0.024 0.142 1.52 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 2.037 181 Sites 8.89 0.0018 0.024 0.126 1.52 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 8.052 54 Sites 0.67 0.003 0.0195 0.27 1.05 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) 17 13,550 2016 Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Finished) 2006 - 2020 67 0 Sites 0 USDA Pesticide Data Program (PDP) (Finished) 2001-2013 13 0 Sites 0 Ambient Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Source) 2006 - 2020 402 0 Sites 0 National Water Information System (USGS NWIS) (Surface Water) 2008-2017 671 8 Sites 1.19 0.0129 0.0255 0.135 0.275 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008-2017 1,587 6 Sites 0.38 0.006 0.063 0.177 0.245 ug/L National Water Information System (USGS NWIS) (All Water) 2008-2017 2,258 14 Sites 0.62 0.006 0.0264 0.192 0.275 ug/L USDA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001-2013 121 3 Sites 2.48 0.00118 0.00118 0.00237 0.002664 ug/L USDA Pesticide Data Program (PDP) (Groundwater) 2001-2013 114 1 Sites 0.88 0.002664 0.00266 0.00266 0.002664 ug/L USDA Pesticide Data Program (PDP) (Untreated) 2001-2013 8 2 Sites 25 0.00118 0.00118 0.00118 0.00118 ug/L Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990-2018 501 2 Sites 0.4 0.008 0.021 0.0314 0.034 ug/L Bradley etal. 2017 (Ambient) [52] 2012 - 2014 38 1 Sites 2.63 0.0154 0.0154 0.0154 0.0154 ug/L Arnold et al. 2016 (Filtered) [7] 2012 - 2013 690 1 Sites 0.14 0.0072 0.0072 0.0072 0.0072 ug/L Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/ dav) Notes Expocast exposure 7.54E-08 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR4 data used in the CCL5 is a partial datasetand will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 4.32238 days Boiling point OPERA QSAR 277.667 degree C Boiling point TEST QSAR 300.294 degree C Vapor pressure OPERA QSAR 0.00607559 mmHg Vapor pressure TEST QSAR 0.000000202 mmHg Solubility in water OPERA QSAR 0.0968241 mol/L Solubility in water TEST QSAR 0.0038815 mol/L Bioconcentration factor OPERA QSAR 2.47838 no units Bioconcentration factor TEST QSAR 4.57088 no units Henry's Law constant OPERA QSAR 0.00000155 o E E Octanol/water partitioning coeff. (log Kow) OPERA QSAR 2.05194 no units A-780 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Terbacil CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 123 Kolpin, D.W. and J.D. Martin. 2003. Pesticides in Ground Water: Summary Statistics; Preliminary Results from Cycle 1 of the National Water Quality Assessment Program (NAWQA), 1992-2001. Available on the Internet at: http://ca.water.usgs.gov/pnsp/pestgw/Pest-GW_2001_Text.html. 134 Martin, J.D., C.G. Crawford, and S.J. Larson. 2003. Pesticides in Streams: Summary Statistics; Preliminary Results from Cycle 1 of the National Water Quality Assessment Program (NAWQA), 1992-2001. Available on the Internet at: http://ca.water.usgs.gov/pnsp/pestsw/Pest-SW_2001_Text.html. 296 USEPA. 2008. Regulatory Determinations Support Document for Selected Contaminants from the Second Drinking Water Contaminant Candidate List (CCL 2). EPA Report 815-R-08-012. June 2008. 297 USEPA. 2008. The Analysis of Occurrence Data from the First Unregulated Contaminant Monitoring Regulation (UCMR 1) in Support of Regulatory Determinations for the Second Drinking Water Contaminant Candidate List. EPA 815-R-08-013. June. 429 USEPA. 2019. Terbacil: Human Health Draft Risk Assessment for Registration Review. EPA-HQ-OPP-2011-0054-0038. DP No. D446169. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticide in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. A-781 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Terbufos CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Chemical Notes: DTXSID2022254 Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants X PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUM MARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT IN FORMATION Potency Severity Prevalence Magnitude 8 non-cancer effects 1 1 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 0.3 plasma chol in esterase inhibition general population OPP 2006 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.1984 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Terbufos regulation does not represent a meaningful opportunity for health risk reduction for persons served by PWSs. Although terbufos has the potential to cause adverse health effects, including ChE hibition and reproductive effects [a,b,c], it does not appear to occur PWSs with a frequency and at levels of public health concern [c,d]. Terbufos was not detected in any UCMR 1 samples collected by PWSs, using an MRLof 0.5 pg/L, which is slightly higher than the HRL(0.35 Hg/L) [e,f,g,h], Shellenberger, 1984 [163]; [b] Shellenberger& Billups, 1986 [164]; USE PA, 2006 [274]; [d] Baiey, 1988 [39]; [e] USE PA, 2007 [284]; [f] USE PA, 2008 [297]; [g] USE PA, 2010 [310]; [h] USE PA, 2015 [350]; as cited in USE PA, 2014 [334] Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-782 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Terbufos CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.00005 mg/kg/day OPP 2006 American Cyanamid Co. 1986; Shellenberg er1984 plasma cholinesterase inhibition general population 33.8 0.296 [267] Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results 10-day Health Advisory 0.005 mg/L EPA DWSHA 2018 Lifetime Health Advisory 0.0004 mg/L EPA DWSHA 2018 Maximum Allowable Concentration (MAC) 0.001 mg/L Canadian Drinking Water Guidelines Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Measured Data and Assessment Results LD50 2 mg/kg NIH HSDB min LD50 9.2 mg/kg NIH HSDB max LOAEL 0.2188 mg/kg/day EPA Toxicity Reference Database max LOAEL 0.015 mg/kg/day EPA Toxicity Reference Database min NOAEL 0.0854 mg/kg/day EPA Toxicity Reference Database Percent of active toxcast in 8.45 percent EPA Chemistry Dashboard vitro assays tested Data Element Value Units Source Notes Modeled Data LD50 5.78E-06 mo l/kg TEST QSAR Ames mutagenicity test 0.005 no units TEST QSAR Developmental toxin test -0.779 no units TEST QSAR A-783 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Terbufos CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 295 0 Sites 0 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev(NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 11.234 33 Sites 0.29 0.002 0.017 0.198 0.56 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 2.224 29 Sites 1.3 0.002 0.023 0.194 0.56 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 9.010 4 Sites 0.04 0.007 0.01 0.126 0.202 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) 23 2,259,511 2016 Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Finished) 2006 - 2020 4 0 Sites 0 USDA Pesticide Data Program (PDP) (Finished) 2001-2013 17 1 Sites 5.88 0.089 0.089 0.089 0.089 ug/L USGS, Sioux Falls Area, 2012 (Finished) [153] 2009-2010 1 0 Sites 0 Ambient Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Source) 2006 - 2020 44 0 Sites 0 National Water Information System (USGS NWIS) (Surface Water) 2008-2017 898 4 Sites 0.45 0.006 0.146 0.212 0.226 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008-2017 3,037 1 Sites 0.03 0.009 0.009 0.009 0.009 ug/L National Water Information System (USGS NWIS) (All Water) 2008-2017 3,934 5 Sites 0.13 0.006 0.103 0.208 0.226 ug/L USDA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001-2013 229 0 Sites 0 USDA Pesticide Data Program (PDP) (Groundwater) 2001-2013 219 0 Sites 0 USDA Pesticide Data Program (PDP) (Untreated) 2001-2013 12 0 Sites 0 Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990-2018 495 1 Sites 0.2 0.04 0.04 0.04 0.04 ug/L Arnold et al. 2016 (Filtered) [7] 2012-2013 690 0 Sites 0 USGS, Sioux Falls Area, 2012 (Ambient) [153] 2009-2010 2 0 Sites 0 Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/ dav) Notes Expocast exposure 0.00000011 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR4 data used in the CCL5 is a partial datasetand will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 403.714 days Boiling point OPERA QSAR 315.407 degree C Boiling point TEST QSAR Vapor pressure OPERA QSAR 0.000228304 mmHg Vapor pressure TEST QSAR 0.000148594 mmHg Solubility in water OPERA QSAR 0.0000298 mol/L Solubility in water TEST QSAR 0.0000625 mol/L Bioconcentration factor OPERA QSAR 64.5795 no units Bioconcentration factor TEST QSAR 125.893 no units Henry's Law constant OPERA QSAR 0.00000263 atm-mA3/mol Octanol/water partitioning coeff. (log Kow) OPERA QSAR 4.32209 no units A-784 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Terbufos CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulorigoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 39 Bailey, D.E. 1988. 14-Day oral toxicity study in the dog with AC 92 100 and its metabolites, CL94 301 and CL94320. Unpublished report on HLA Study No. 362-190 (BASF RDI No.TE-420-007) from Hazleton Laboratories America, Inc., Vienna, VA, USA (as cited in USEPA, 2003). 153 Occurrence of anthropogenic organic compounds and nutrients in source and finished water in the Sioux Falls area, South Dakota, 2009-10: U.S. Geological Survey Scientific Investigations Report 2012-5098, 21 p. plus appendixes. 163 Shellenberger, T. 1984. 28-Day Oral Toxicity in the Dog with AC 92,100: Report No. 87019. Unpublished study prepared by Tegeris Laboratories Inc. 89 p. (as cited in USEPA,2006). 164 Shellenberger, T., and L.H. Billups. 1986. One-year oral toxicity study in purebred beagle dogs with AC 92 100. Unpublished report No. 8414 (BASF RDI No. TE-427-002) from Tegeris Laboratories, Inc., Laurel, MD, USA (as cited in USEPA, 2003). 267 USEPA. 2006. Finalization of Interim Reregistration Eligibility Decisions (IREDs) and Interim Tolerance Reassessment and Risk Management Decisions (TREDs) for the Organophosphate Pesticides, and Completion of the Tolerance Reassessment and Reregistration Eligibility Process for the Organophosphate Pesticides. Reregistration Eligibility Decision for Terbufos. U.S. Environmental Protection Agency, Office of Prevention, Pesticides and Toxic Substances, Washington, D.C. 274 USEPA. 2006. Reregistration Eligibility Decision for Terbufos. Office of Pesticide Programs. Available on the Internet at: http://www.epa.gov/pesticides/reregistration/REDs/terbufos_red.pdf. 284 USEPA. 2007. Unregulated Contaminant Monitoring Regulation (UCMR) for Public Water Systems Revisions. Federal Register. Vol. 72, No. 2, p. 367, January 4, 2007. 297 USEPA. 2008. The Analysis of Occurrence Data from the First Unregulated Contaminant Monitoring Regulation (UCMR 1) in Support of Regulatory Determinations for the Second Drinking Water Contaminant Candidate List. EPA 815-R-08-013. June. 310 USEPA. 2010. Data Management and Analytical Plan for the Second Unregulated Contaminant Monitoring Regulation (UCMR 2) Data. June 2010 Draft Report Submitted to EPA. 334 USEPA. 2014. Regulatory Determinations 3 Support Document. April 2014. EPA Publication # 815-R14-003. 350 USEPA. 2015. Occurrence Data from the Second Unregulated Contaminant Monitoring Regulation (UCMR 2). Including Appendices A-C. EPA 815-R-15-013. December 2015. 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticide in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. A-785 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Testosterone CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Testosterone CASRN: 58-22-0 DTXSID: DTXSID8022371 Use: Medication (human and veterinary) and in research Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro X Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 8 non-cancer effects 9 1 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date SL 0.3 lowest therapeutic dose: replacement therapy in conditions associated with deficiency or absence of endogenous testoste ro ne/a nt iest roge n th e ra py bottle-fed infants FDA; NIH 2018; 2018 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.000527 90th Percentile Finished Water UCMR3 2013-2015 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-786 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Testosterone CCL 5 Contaminant Information Sheet EPA-OGWDWand OST October 2022 HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 4.16667 E-05 mg/kg/day FDA 2018; NIH 2018 Impax Generics lowest therapeutic dose: replacement therapy in conditions associated with deficiency or absence of endogenous testosterone/antiestrogen therapy bottle-fed infants 151 0.280 [77] [150] NOTE: (Lowest Therapeutic Dose/3000x UF) is used in place of an RfD; LTDs were obtained from FDA-approved drug labels Reference Dose (RfD) or Equivalent 4.16667 E-05 mg/kg/day FDA 2018; NIH 2018 Impax Generics lowest therapeutic dose: replacement therapy in conditions associated with deficiency or absence of endogenous testosterone/a ntiestrogen therapy general population 33.8 0.980 [77] [150] NOTE: (Lowest Therapeutic Dose/3000x UF) is used in place of an RfD; LTDs were obtained from FDA-approved drug labels Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Screening level for pharmaceutical - general 0.000980392 mg/L EPA Office of Water population Screening level for pharmaceutical - infants 0.000277778 mg/L EPA Office of Water Data Element Value Units Source Notes Measured Data and Assessment Results Percent of active toxcast in 15.74 percent EPA Chemistry Dashboard vitro assays tested Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Modeled Data LD50 0.0135207 mo l/kg TEST QSAR Ames mutagenicity test -0.018 no units TEST QSAR Developmental toxin test 1.04 no units TEST QSAR A-787 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Testosterone CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contam nant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contam nant Monitoring Rule (UCMR) 3 2013-2015 1.201 65 Sites 5.41 1.00E - 04 0.00017 0.000527 0.0053 Unregulated Contam nant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contam nant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contam nant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contam nant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev(NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 527 4 Sites 0.76 0.00042 0.00069 0.00122 0.00149 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 29 0 Sites 0 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 498 4 Sites 0.8 0.00042 0.00069 0.00122 0.00149 U*/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Glassmeyer et al 2017 (Finished) [86] 2007-2012 25 NA Sites 0 ug/L USGS, Sioux Falls Area, 2012 (Finished) [153] 2009-2010 1 0 Sites 0 Ambient Water Prevalence Magnitude Glassmeyer et a 1 2017 (Ambient) [86] 2007-2012 25 NA Sites 4 0.00015 0.00015 ug/L Batt et al. 2016 (Ambient) [46] 2008 - 2009 182 3 Sites 1.65 0.0037 0.0064 0.29 0.3614 ug/L Bradley et al. 2017 (Ambient) [52] 2012-2014 38 1 Sites 2.63 0.0011 0.0011 0.0011 0.0011 ug/L Bexfield et al. 2019 (Groundwater) [49] 2013-2015 1,091 1 Sites 0.09 0.003038 0.00304 0.00304 0.003038 ug/L USGS, Sioux Falls Area, 2012 (Ambient) [153] 2009-2010 2 0 Sites 0 Waste Water Effluent Prevalence Magnitude Scott et al. 2018 (Wastewater) [161] 2011-2017 21 2 Sites 9.52 0.000973 0.000973 0.000973 0.000973 ug/L Kostich et al. 2014 (Wastewater) [126] not reported 50 0 Sites 0 Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/ dav) Notes Expocast exposure 3.14E-08 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 68.9239 days Boiling point OPERA QSAR 295.416 degree C Boiling point TEST QSAR 357.585 degree C Vapor pressure OPERA QSAR 0.000000187 mmHg Vapor pressure TEST QSAR 0.000000245 mmHg Solubility in water OPERA QSAR 0.000277495 mol/L Solubility in water TEST QSAR 0.000130317 mol/L Bioconcentration factor OPERA QSAR 52.7161 no units Bioconcentration factor TEST QSAR 80.5378 no units Henry's Law constant OPERA QSAR 2.46E-08 atm-mA3/mol 0 eta no 1/water partitioning coeff. (log Kow) OPERA QSAR 3.24993 no units A-788 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Testosterone CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 46 Batt, A. L., Kincaid, T. M., Kostich, M. S., Lazorchak, J. M., & Olsen, A. R. (2016). Evaluating the extent of pharmaceuticals in surface waters of the United States using a Nationaicale Rivers and Streams Assessment survey. Environmental toxicology and chemistry, 35(4), 874-881. 49 Bexfield, L.M., P.L. Toccalino, K. Belitz, W.T. Foreman, and E.T. Furlong. 2019. Hormones and pharmaceuticals in groundwater used as a source of drinking water across the United States. Environmental Science and Technology 53: 2950-2960. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 77 FDA. 2018. Drugs @ FDA: FDA Approved Drug Products. U.S. Food and Drug Administration (FDA), https://www.accessdata.fda.gov/scripts/cder/daf/. 86 Glassmeyer, S.T., Furlong, E.T., Kolpin, D.W., Batt, A.L., Benson, R., Boone, J.S.,... & Wilson, V.S. (2017). Nationwide reconnaissance of contaminants of emerging concern in source and treated drinking waters of the United States. Science of The Total Environment. v581-582, (909-922). 126 Kostich MS, et al. 2014 Concentrations of prioritized pharmaceuticals in effluents from 50 large wastewater treatment plants in the US and implications for risk estimation. Environ Pollut. 2014 Jan;184:354-9. doi: 10.1016/j.envpol.2013.09.013. Epub 2013 Oct 3. PMID: 24095705. 150 NIH. 2018. DailyMed Database. U.S. National Library of Medicine, National Institutes of Health (NIH). https://dailymed.nlm.nih.gov/dailymed/. 153 Occurrence of anthropogenic organic compounds and nutrients in source and finished water in the Sioux Falls area, South Dakota, 2009-10: U.S. Geological Survey Scientific Investigations Report 2012-5098, 21 p. plus appendixes. 161 Scott, T. M., Phillips, P. J., Kolpin, D. W., Colella, K. M., Furlong, E. T., Foreman, W. T., & Gray, J. L. (2018). Pharmaceutical manufacturing facility discharges can substantially increase the pharmaceutical load to US wastewaters. Science of the Total Environment, 636, 69-79. A-789 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Tetraconazole CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Tetraconazole CASRN: 112281-77-3 DTXSID: DTXSID8034956 Use: Fungicide used on blueberries, cereals, grapes, ornamentals, peanuts among others Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANTSUMMARY& DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 5 non-cancer effects 9 2 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 40 increased kidney weight and altered histopathology of the kidney general population OPP 2018 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.02644 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-790 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Tetraconazole CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.0073 mg/kg/day OPP 2018 Makin et al. 1990 increased kidney weight and altered histopathology of the kidney general population 33.8 43.2 [410] Cancer Classification (CC) NL OPP 2018 [4101 Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Acute Human Health Benchmark 3 mg/L EPA HHBP Acute PAD 0.5 mg/kg/day EPA HHBP Chronic Human Health Benchmark 0.047 mg/L EPA HHBP Health-Based Screening Level 0.047 mg/L Health-based screening levels from USGS Population-Adjusted Dose (PAD) 0.0073 mg/kg/day EPA H HBP Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Modeled Data LD50 TEST QSAR Ames mutagenicity test 0.138 no units TEST QSAR Developmental toxin test 0.626 no units TEST QSAR Data Element Value Units Source Notes Measured Data and Assessment Results LOAEL 100 mg/kg/day EPA Toxicity Reference Database max LOAEL 2.95 mg/kg/day EPA Toxicity Reference Database min NOAEL 0.8 mg/kg/day EPA Toxicity Reference Database min NOAEL 30 mg/kg/day EPA Toxicity Reference Database max Percent of active toxcast in 28.78 percent EPA Chemistry Dashboard vitro assavs tested Subchronic LOAEL 23.9 mg/kg/day EPA Toxicity Reference Database Subchronic NOAEL 5.5 mg/kg/day EPA Toxicity Reference Database A-791 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Tetraconazole CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contam nant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contam nant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contam nant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contam nant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contam nant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contam nant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev(NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 1.763 60 Sites 3.4 0.00035 0.00509 0.0264 0.254 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 324 55 Sites 17 0.00035 0.00514 0.026 0.208 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 1.439 5 Sites 0.35 0.00075 0.00158 0.13 0.254 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) 31 134,273 2016 Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude USDA Pesticide Data Program (PDP) (Finished) 2001-2013 15 6 Sites 40 0.002 0.0032 0.0096 0.084 ug/L Ambient Water Prevalence Magnitude National Water Information System (USGS NWIS) (Surface Water) 2008-2017 433 19 Sites 4.39 1.00E - 04 0.0089 0.206 0.462 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008-2017 531 1 Sites 0.19 0.00359 0.00359 0.00359 0.00359 ug/L National Water Information System (USGS NWIS) (All Water) 2008-2017 964 20 Sites 2.07 1.00E - 04 0.0082 0.204 0.462 ug/L USDA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001-2013 227 6 Sites 2.64 0.002 0.0047 0.0178 0.03 ug/L USDA Pesticide Data Program (PDP) (Groundwater) 2001-2013 219 1 Sites 0.46 0.003164 0.00316 0.00316 0.003164 ug/L USDA Pesticide Data Program (PDP) (Untreated) 2001-2013 10 5 Sites 50 0.002 0.0062 0.018 0.03 ug/L Bradley et al. 2017 (Ambient) [52] 2012-2014 38 1 Sites 2.63 0.0219 0.0219 0.0219 0.0219 ug/L Arnold et al. 2016 (Filtered) [7] 2012-2013 584 4 Sites 0.68 8e-04 0.00135 0.00454 0.0058 ug/L Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 0.000000105 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 4.48195 days Boiling point OPERA QSAR 339.08 degree C Boiling point TEST QSAR 344.772 degree C Vapor pressure OPERA QSAR 0.00000175 mmHg Vapor pressure TEST QSAR 0.000000171 mmHg Solubility in water OPERA QSAR 0.000928927 mol/L Solubility in water TEST QSAR 0.0000151 mol/L Bioconcentration factor OPERA QSAR 309.071 no units Bioconcentration factor TEST QSAR 131.22 no units Henry's Law constant OPERA QSAR 0.00000273 atm-mA3/mol 0 eta no 1/water partitioning coeff. (log Kow) OPERA QSAR 3.52679 no units A-792 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Tetraconazole CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 410 USEPA. 2018. Tetraconazole: Human Health Risk Assessment for the Section 3 Registration for Application to add Crop Subgroup 6C; Dried Shelled Pea and Bean (except soybean) Subgroup 6C; Barley; Rapeseed Subgroup 20A; Wheat; and Forage, Fodder, and Straw of Cereal Grains Group 16. EPA-HQ-OPP-2016-0573-0005. DP No. D435706. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. A-793 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Thiabendazole CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Thiabendazole CASRN: 148-79-8 DTXSID: DTXSID0021337 Use: Fungicide Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts X Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Not List ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 4 non-cancer effects 9 2 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 600 decreased body weight in males general population OPP 2019 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.0164 90th Percentile All Ambient Water NAWQA 1991-2017 Final Hazard Quotient (HQ) 0.000027 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-794 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Thiabendazole CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.1 mg/kg/day OPP 2019 Merck Research Labs. 1993 decreased body weight in males general population 33.8 592 [430] Cancer Classification (CC) L/NL OPP 2019 [4301 Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Acute Human Health Benchmark 0.3 mg/L EPA HHBP Acute PAD 0.05 mg/kg/day EPA HHBP Chronic Human Health Benchmark 0.21 mg/L EPA HHBP Health-Based Screening Level 0.21 mg/L Health-based screening levels from USGS Population-Adjusted Dose (PAD) 0.033 mg/kg/day EPA HHBP Screening level for pharmaceutical - general population 0.156862745 mg/L EPA Office of Water Screening level for pharmaceutical - infants 0.044444444 mg/L EPA Office of Water Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Measured Data and Assessment Results LD50 1300 mg/kg NIH HSDB min LD50 4000 mg/kg NIH HSDB max LOAEL 28.1 mg/kg/day EPA Toxicity Reference Database min LOAEL 600 mg/kg/day EPA Toxicity Reference Database max NOAEL 150 mg/kg/day EPA Toxicity Reference Database max NOAEL 9.8 mg/kg/day EPA Toxicity Reference Database min Percent of active toxcast in 6.87 percent EPA Chemistry Dashboard vitro assays tested Subchronic LOAEL 100 mg/kg/day EPA Toxicity Reference Database max Subchronic LOAEL 37 mg/kg/day EPA Toxicity Reference Database min Subchronic NOAEL 25 mg/kg/day EPA Toxicity Reference Database max Subchronic NOAEL 9.4 mg/kg/day EPA Toxicity Reference Database min Data Element Value Units Source Notes Modeled Data LD50 TEST QSAR Ames mutagenicity test 0.575 no units TEST QSAR Developmental toxin test 0.486 no units TEST QSAR A-795 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Thiabendazole CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST October 2022 Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018 - 2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013 - 2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008 - 2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survey (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991 - 2017 627 20 Sites 3.19 0.00098 0.00488 0.0164 0.115 ug/L National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991 - 2017 76 17 Sites 22 0.00098 0.00453 0.0168 0.115 ug/L National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991 - 2017 551 3 Sites 0.54 0.00187 0.00673 0.00774 0.00818 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) 1 23,140 2016 Toxic Release Inventory (TRI) Program (EPA) (2016) 5 13,653 Chemical Data Reporting(CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Furlong et al 2017 (Finished) [83] 2007 - 2012 NA NA Sites 0 ug/L Glassmeyer et a 1 2017 (Finished) [86] 2007 - 2012 25 NA Sites 0 ug/L USGS, Sioux Falls Area, 2012 (Finished) [153] 2009 - 2010 1 0 Sites 0 Ambient Water Prevalence Magnitude National Water Information System (USGS NWIS) (Surface Water) 2008 - 2017 501 33 Sites 6.59 0.00101 0.00491 0.019 0.176 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008 - 2017 841 4 Sites 0.48 0.00641 0.015 0.0826 0.127 ug/L National Water Information System (USGS NWIS) (All Water) 2008 - 2017 1,341 37 Sites 2.76 0.00101 0.00518 0.0191 0.176 ug/L Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990 - 2018 41 0 Sites 0 Furlong et a 1 2017 (Ambient) [83] 2007 - 2012 NA NA Sites 0 ug/L Glassmeyer et a 1 2017 (Ambient) [86] 2007 - 2012 25 NA Sites 0 ug/L Bradley et al. 2017 (Ambient) [52] 2012 - 2014 38 12 Sites 32 0.0039721 0.0117 0.0161 0.0421837 ug/L Bexfield et al. 2019 (Groundwater) [49] 2013 - 2015 1,106 2 Sites 0.18 0.0064082 0.169 0.3 0.3324209 ug/L USGS, Sioux Falls Area, 2012 (Ambient) [153] 2009 - 2010 2 0 Sites 0 Stackelberg et al. (2004) via Kostich et al. 2010 (Ambient) [127] 2010 NA NA 0.011 ug/L Waste Water Effluent Prevalence Magnitude Scott et al. 2018 (Wastewater) [161] 2011 - 2017 21 19 Sites 90 0.0030236 0.0169 0.0262 0.1126352 ug/L Glassmeyer et al. (2005) via Kostich et al. 2010 (Wastewater) [127] 2010 NA NA 0.515 ug/L Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg- Notes Expocast exposure 7.28E-08 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES bio monitoring detect ion in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES bio monitoring detect ion in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR4data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biode gradation ha If-life OPERA QSAR 2.58879 days Boiling point OPERA QSAR 326.584 degree C Boiling point TEST QSAR 403.909 degree C Vapor pressure OPERA QSAR 6.6E-09 mmHg Vapor pressure TEST QSAR 0.000000706 mmHg Solubility in water OPERA QSAR 0.000311564 mol/L Solubility in water TEST QSAR 0.000156675 mol/L Bioconcentration factor OPERA QSAR 7.89835 no units Bioconcentration factor TEST QSAR 18.197 no units Henry's Law constant OPERA QSAR 6.93E-08 atm-mA3/mol Octanol/water partitioning coeff. (logKow) OPERA QSAR 2.37325 no units A-796 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Thiabendazole CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 49 Bexfield, L.M., P.L. Toccalino, K. Belitz, W.T. Foreman, and E.T. Furlong. 2019. Hormones and pharmaceuticals in groundwater used as a source of drinking water across the United States. Environmental Science and Technology 53: 2950-2960. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 83 Furlong, E.T., Batt, A.L., Glassmeyer, S.T., Noriega, M.C., Kolpin, D.W., Mash, H., Schenck, K.M. (2017). Nationwide reconnaissance of contaminants of emerging concern in source and treated drinking waters of the United States: Pharmaceuticals. Science of The Total Environment. 579 (1629-1642). 86 Glassmeyer, S.T., Furlong, E.T., Kolpin, D.W., Batt, A.L., Benson, R., Boone, J.S.,... & Wilson, V.S. (2017). Nationwide reconnaissance of contaminants of emerging concern in source and treated drinking waters of the United States. Science of The Total Environment. v581-582, (909-922). 127 Kostich, MS, etal., 2010. Predicting variability of aquatic concentrations of human pharmaceuticals. Sci. Total Environ. 408 (20), 4504e4510. 153 Occurrence of anthropogenic organic compounds and nutrients in source and finished water in the Sioux Falls area, South Dakota, 2009-10: U.S. Geological Survey Scientific Investigations Report 2012-5098, 21 p. plus appendixes. 161 Scott, T. M., Phillips, P. J., Kolpin, D. W., Colella, K. M., Furlong, E. T., Foreman, W. T., & Gray, J. L. (2018). Pharmaceutical manufacturing facility discharges can substantially increase the pharmaceutical load to US wastewaters. Science of the Total Environment, 636, 69-79. 430 USEPA. 2019. Thiabendazole. Acute and Chronic Aggregate (Food and Drinking Water) Dietary Exposure and Risk Assessments in Support of Registration Review. E PA-HQ-OPP-2014-0175-0028. DP No. D450527. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticide in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. A-797 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Thiamethoxam CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Chemical Notes: DTXSID2034962 Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUM MARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT IN FORMATION Potency Severity Prevalence Magnitude 5 reproductive and developmental effects 1 1 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value («"gA) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 20 increased incidence and severity of tubular atrophy in testes of F1 males, sperm abnormalities in F1 males bottle-fed infants OPP 2016 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 131.77 EDWC SW (acute) OPP 2016 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-798 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Thiamethoxam CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.012 mg/kg/day OPP 2016 Winkler et al. 1998 increased incidence and severity of tubular atrophy in testes of F1 males (pups) bottle-fed infants 151 15.9 [372] Cancer Classification (CC) NL OPP 2016 [3721 Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Acute Health-Based Guidance Value 0.4 mg/L MN DOH Acute Human Health Benchmark 2.3 mg/L EPA HHBP Acute PAD 0.35 mg/kg/day EPA HHBP Chronic Health-Based Guidance Value 0.2 mg/L MN DOH Chronic Human Health Benchmark 0.077 mg/L EPA HHBP Health-Based Screening Level 0.077 mg/L Health-based screening levels from USGS Population-Adjusted Dose (PAD) 0.012 mg/kg/day EPA HHBP Short-Term/Subchronic Health-Based Guidance Value 0.2 mg/L MN DOH Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Modeled Data LD50 0.003656 mo l/kg TEST QSAR Ames mutagenicity test 0.998 no units TEST QSAR Developmental toxin test 1.036 no units TEST QSAR Data Element I Value I Units I Source I Notes Measured Data and Assessment Results LD50 1563 mg/kg NIH HSDB LOAEL 1.84 mg/kg/day EPA Toxicity Reference Database min LOAEL 1000 mg/kg/day EPA Toxicity Reference Database max NOAEL 0.8 mg/kg/day EPA Toxicity Reference Database min NOAEL 500 mg/kg/day EPA Toxicity Reference Database max Percent of active toxcast in vitro assays tested 0.64 percent EPA Chemistry Dashboard Subchronic LOAEL 14.3 mg/kg/day EPA Toxicity Reference Database min Subchronic LOAEL 32 mg/kg/day EPA Toxicity Reference Database max Subchronic NOAEL 1.879 mg/kg/day EPA Toxicity Reference Database min Subchronic NOAEL 9.27 mg/kg/day EPA Toxicity Reference Database max A-799 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Thiamethoxam CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 OCCURRENCE DATA Scoring_Data_ Nationally Representative Water Data Date Number of Number of PWS/Sites/ Percent with Minimum Cone. Median Cone. 90th Percentile Maximum Cone. Cone. Units Notes PWS/ Sites/ Detects Samples Detects (Detects) (Detects) (Detects) (Detects) Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev(NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 5 0 Sites 0 National Water Qua lity Assessment (USGS NAWQA) (Surface Water) 1991-2017 5 0 Sites 0 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) 48 353,487 2016 Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude USDA Pesticide Data Program (PDP) (Finished) 2001-2013 10 3 Sites 30 0.0102 0.0102 0.0102 0.0102 ug/L Klarich etal. 2017 (Finished) [117] 2016 20 19 Sites 95 0.00026 0.00084 0.00215 0.00415 ug/L Ambient Water Prevalence Magnitude National Water Information System (USGS NWIS) (Surface Water) 2008-2017 131 49 Sites 37 9.00E - 04 0.007 0.126 4.37 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008-2017 12 1 Sites 8.33 0.0031 0.0031 0.0031 0.0031 ug/L National Water Information System (USGS NWIS) (All Water) 2008-2017 143 50 Sites 35 9.00E - 04 0.00695 0.126 4.37 ug/L USDA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001-2013 227 2 Sites 0.88 0.0102 0.0102 0.0102 0.025 ug/L USDA Pesticide Data Program (PDP) (Groundwater) 2001-2013 218 0 Sites 0 USDA Pesticide Data Program (PDP) (Untreated) 2001-2013 10 2 Sites 20 0.0102 0.0102 0.0102 0.025 ug/L Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990-2018 281 43 Sites 15 0.0068 0.113 0.407 2.06 ug/L Bradley etal. 2017 (Ambient) [52] 2012-2014 38 8 Sites 21 0.0019 0.016 0.0795 0.1904 ug/L Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Estimated Drinking Water Concentration (EDWC) in Surface Water (acute) 2016 OPP 131.77 ug/L Tier II Rice Model in Tailwater The critical effect of male reproductive issues in F1 generation pups is considered a less-th an-chronic response in a sensitive population. To be protective of this population, the modeled surface water acute concentration was selected as the occurrence Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/ day) Notes Expocast exposure 1.25E-08 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 3.54394 days Boiling point OPERA QSAR 278.329 degree C Boiling point TEST QSAR Vapor pressure OPERA QSAR 0.00000154 mmHg Vapor pressure TEST QSAR Solubility in water OPERA QSAR 0.000322793 mol/L Solubility in water TEST QSAR 0.00732825 mol/L Bioconcentration factor OPERA QSAR 16.1043 no units Bioconcentration factor TEST QSAR Henry's Law constant OPERA QSAR 6.73E-09 atm-mA3/mol 0 eta no l/water partitioning coeff. (log Kow) OPERA QSAR -0.144367 no units A-800 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Thiamethoxam CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 117 Klarich, K.L., Pflug, N.C., DeWald, E.M., Hladik, M.L., Kolpin, D.W., Cwiertny, D.M. and LeFevre, G.H., 2017. Occurrence of neonicotinoid insecticides in finished drinking water and fate during drinking water treatment. Environmental Science & Technology Letters, 4(5), pp. 168-173. 372 USEPA. 2016. Thiamethoxam. Acute and Chronic Aggregate Dietary (Food and Drinking Water) Exposure and Risk Assessments for Residues of Thiamethoxam on Imported Banana. EPA-HQ-OPP-2015- 0705-0007. DP No. D429717. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticide in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. A-801 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Thiobencarb CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Thiobencarb CASRN: 28249-77-6 DTXSID: DTXSID6024337 Use: Pre-emergentto early post-emergent herbicide Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Not List ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 5 non-cancer effects 6 3 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 60 decreased body weights general population OPP 2018 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.1156 90th Percentile All Ambient Water NAWQA 1991-2017 Final Hazard Quotient (HQ) 0.0019 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-802 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Thiobencarb CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.01 mg/kg/day OPP 2018 Cummins 1984 decreased body weights general population 33.8 59.2 [411] Cancer Classification (CC) D OPP 2018 [4111 Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Acute Human Health Benchmark 7 mg/L EPA HHBP Acute PAD 1 mg/kg/day EPA HHBP Chronic Human Health Benchmark 0.06 mg/L EPA HHBP Health-Based Screening Level 0.06 mg/L Health-based screening levels from USGS Population-Adjusted Dose (PAD) 0.01 mg/kg/day EPA HHBP Public Health Goal 0.042 mg/L CalEPA OEHHA Public Health Goals Data Element Value Units Source Notes Measured Data and Assessment Results LD50 1903 mg/kg NIH HSDB max LD50 560 mg/kg NIH HSDB min LOAEL 2 mg/kg/day EPA Toxicity Reference Database min LOAEL 200 mg/kg/day EPA Toxicity Reference Database max NOAEL 100 mg/kg/day EPA Toxicity Reference Database max NOAEL 25 mg/kg/day EPA Toxicity Reference Database min Percent of active toxcast in 9.39 percent EPA Chemistry Dashboard vitro assays tested Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Modeled Data LD50 0.0057412 mo l/kg TEST QSAR Ames mutagenicity test 0.269 no units TEST QSAR Developmental toxin test 0.403 no units TEST QSAR A-803 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Thiobencarb CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev(NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 10.703 84 Sites 0.78 2.00E - 05 0.011 0.116 4.38 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 2.055 76 Sites 3.7 2.00E - 05 0.011 0.115 4.38 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 8.648 8 Sites 0.09 0.004 0.014 0.056 0.25 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) 6 2,372,729 2016 Toxic Release Inventory (TRI) Program (EPA) (2016) 2 3,385 Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Finished) 2006 - 2020 265 0 Sites 0 USDA Pesticide Data Program (PDP) (Finished) 2001-2013 15 5 Sites 33 0.029 0.0745 0.151 0.19 ug/L Ambient Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Source) 2006 - 2020 2,975 2 Sites 0.07 0.097 0.848 1.45 1.6 ug/L National Water information System (USGS NWIS) (Surface Water) 2008-2017 936 33 Sites 3.53 0.00093 0.0369 0.346 12.4 ug/L National Water information System (USGS NWIS) (Groundwater) 2008-2017 2,045 2 Sites 0.1 0.003 0.007 0.0094 0.011 ug/L National Water information System (USGS NWIS) (All Water) 2008-2017 2,980 35 Sites 1.17 0.00093 0.0359 0.342 12.4 ug/L USDA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001-2013 227 0 Sites 0 USDA Pesticide Data Program (PDP) (Groundwater) 2001-2013 219 0 Sites 0 USDA Pesticide Data Program (PDP) (Untreated) 2001-2013 10 0 Sites 0 Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990-2018 7,197 635 Sites 8.82 0.004 0.949 4.84 150 ug/L Bradley et al. 2017 (Ambient) [52] 2012-2014 38 1 Sites 2.63 0.3429 0.343 0.343 0.3429 ug/L Arnold et al. 2016 (Filtered) [7] 2012-2013 690 0 Sites 0 Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 8.52E-08 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 2.94541 days Boiling point OPERA QSAR 305.691 degree C Boiling point TEST QSAR Vapor pressure OPERA QSAR 0.0000201 mmHg Vapor pressure TEST QSAR 0.000147571 mmHg Solubility in water OPERA QSAR 0.000168437 mol/L Solubility in water TEST QSAR 0.0000845 mol/L Bioconcentration factor OPERA QSAR 130.611 no units Bioconcentration factor TEST QSAR 25.0611 no units Henry's Law constant OPERA QSAR 0.000000019 atm-mA3/mol 0 eta no l/water partitioning coeff. (log Kow) OPERA QSAR 3.37599 no units A-804 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Thiobencarb CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 411 USEPA. 2018. Thiobencarb - Registration Review Draft Human Health Risk Assessment. EPA-HQ-OPP-2011-0932-0037. DP No. D439288. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticide in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. A-805 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Thiram CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Thiram CASRN: 137-26-8 DTXSID: DTXSID5021332 Use: Pesticide; rubber accelerator; antiseptic Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants X PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Not List ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT IN FORMATION Potency Severity Prevalence Magnitude 5 non-cancer effects 3 5 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 90 changes in hematology, clinical chemistry, incidences of bile duct hyperplasia, reduction in mean body weight gain, elevated cholesterol levels and increased liver weight general population OPP 2015 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 2.5 EDWC SW 30-Year OPP 2015 1-nr Final Hazard Quotient (HQ) 0.028 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-806 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Thiram CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.015 mg/kg/day OPP 2015 Kehoe 1991a and 1991b changes in hematology, clinical chemistry, incidences of bile duct hyperplasia, reduction in mean body weight gain, elevated cholesterol levels and increased liver weight general population 33.8 88.8 [358] Cancer Classification (CC) NL OPP 2015 [3581 Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Acute Human Health Benchmark 0.39 mg/L EPA HHBP Acute PAD 0.014 mg/kg/day EPA HHBP Cancer Classification (CC) 3 no units WHO IARC Chronic Human Health Benchmark 0.096 mg/L EPA HHBP Population-Adjusted Dose (PAD) 0.015 mg/kg/day EPA HHBP Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element I Value I Units I Source I Notes Measured Data and Assessment Results LD50 1350 mg/kg NIH HSDB max LD50 210 mg/kg NIH HSDB min LOAEL 0.84 mg/kg/day EPA Toxicity Reference Database min LOAEL 24 mg/kg/day EPA Toxicity Reference Database max NOAEL 1.8 mg/kg/day EPA Toxicity Reference Database min NOAEL 7.5 mg/kg/day EPA Toxicity Reference Database max Percent of active toxcast in vitro assays tested 33.64 percent EPA Chemistry Dashboard Subchronic LOAEL 7.0100002 mg/kg/day EPA Toxicity Reference Database Subchronic NOAEL 2.35 mg/kg/day EPA Toxicity Reference Database Data Element Value Units Source Notes Modeled Data LD50 0.0038107 mo l/kg TEST QSAR Ames mutagenicity test 0.476 no units TEST QSAR Developmental toxin test 0.772 no units TEST QSAR A-807 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Thiram CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev(NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) 3 125,378 2016 Toxic Release Inventory (TRI) Program (EPA) (2016) 19 29,783 Chemical Data Reporting (CDR) Results (EPA) (2016) 1M - 10M Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Ambient Water Prevalence Magnitude Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990-2018 16 0 Sites 0 Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Estimated Drinking Water Concentration (EDWC) in Surface Water, 30-Year Mean (chronic, non-cancer) 2015 OPP 2.5 ug/L Pesticide Root Zone Model (PRZM) - Exposure Analysis Modeling System (EXAMS) The modeled surface water chronic, non-cancer con cent ration provided by the most recent available EPA OPP health assessment was selected as the occurrence concentration for thiram. This value coincides with the chronic critical effects of multiple signs of systemic toxicity and hematological alterations provided within the health effects report. Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 3.58E-08 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 90.9543 days Boiling point OPERA QSAR 305.681 degree C Boiling point TEST QSAR Vapor pressure OPERA QSAR 0.0000166 mmHg Vapor pressure TEST QSAR Solubility in water OPERA QSAR 0.000151428 mol/L Solubility in water TEST QSAR 0.000587489 mol/L Bioconcentration factor OPERA QSAR 3.67366 no units Bioconcentration factor TEST QSAR 10.4954 no units Henry's Law constant OPERA QSAR 2.01E-09 atm-mA3/mol 0 eta no l/water partitioning coeff. (log Kow) OPERA QSAR 1.65192 no units A-808 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Thiram CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 358 USEPA. 2015. Thiram. Revised Human Health Risk Assessment for the Import Use of Thiram on Avocado, PP#4E8250and Banana, PP#4E8268. EPA-HQ-OPP-2014-0249-0004. DP No. D427383. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticide in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. A-809 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Tin CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Tin CASRN: 7440-31-5 DTXSID: DTXSID1049801 Use: Metal; used in alloys and solder. Block tin is used to coat copper cooking utensils and lead sheet, or to line lead pipe for distilled water, beer, carbonated beverages, and some chemicals. Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA Human Neurotoxicants PubMed Neu rotoxica nts X Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Final Hazard Quotient (HQ) Potency Severity Prevalence Magnitude 8 8 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 23 90th Percentile Finished Water NIRS 1984-1986 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-810 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Tin CCL 5 Contaminant Information Sheet EPA-OGWDWand OST October 2022 HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes ATSDR2005 [24] NOTE: ATSDR declined to quantify chronic oral toxicity Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Developmental 2 El-Makawy, 2008 Reproductive 2 El-Makawy, 2008 2004-08-01 2020-03-25 3052 1 23 1 Data Element | Value | Units | Source I Notes Measured Data and Assessment Results Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Chronic Health-Based Guidance Value 4 mg/L MN DOH Intermediate Minimal Risk Level (MRL) 0.3 mg/kg/day CDC ATSDR Data Element Value Units Source Notes Modeled Data LD50 TEST QSAR Ames mutagenicity test TEST QSAR Developmental toxin test TEST QSAR A-811 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Tin CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 OCCURRENCE DATA Scoring_Data_ Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contam nant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contam nant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contam nant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contam nant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contam nant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contam nant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survey (NIRS) 1984 -1986 989 14 Sites 1.42 3 5 23 32 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 1 0 Sites 0 National Water Qua lity Assessment (USGS NAWQA) (Surface Water) 1991-2017 1 0 Sites 0 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) 10M - 50M Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Glassmeyer et al 2017 (Finished) [86] 2007-2012 25 NA Sites 36 6.4 15.9 ug/L Ambient Water Prevalence Magnitude National Water Information System (USGS NWIS) (Surface Water) 2008-2017 80 15 Sites 19 0.02 1.83 200 200 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008-2017 126 47 Sites 37 0.01 0.5 5.3 22 ug/L National Water Information System (USGS NWIS) (All Water) 2008-2017 206 62 Sites 30 0.01 1 20 200 ug/L Glassmeyer et a 1 2017 (Ambient) [86] 2007-2012 25 NA Sites 40 3.55 17.4 ug/L Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) 2.42 ug/l Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. A-812 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Tin CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 24 ATSDR. 2005. Toxicological Profile for Tin and Tin Compounds. U.S. Department of Health and Human Services, Public Health Service, Agency for Toxic Substances and Disease Registry (ATSDR), Atlanta, GA. 86 Glassmeyer, S.T., Furlong, E.T., Kolpin, D.W., Batt, A.L., Benson, R., Boone, J.S.,... & Wilson, V.S. (2017). Nationwide reconnaissance of contaminants of emerging concern in source and treated drinking waters of the United States. Science of The Total Environment. v581-582, (909-922). A-813 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Triallate CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Chemical Notes: DTXSID5024344 Pre-emergent selective herbicide Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 4 carcinogen with linear MOA 6 2 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 0.4 hepatocellular carcinomas and renal tubular general population OPP 2019 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.059 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-814 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Triallate CCL 5 Contaminant Information Sheet EPA-OGWDWand OST October 2022 HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.025 mg/kg/day OPP 2019 Stout and Thake 1987; Vigneault 1988 decreased survival; decreased mean body weights and increased adrenal weight in males general population 33.8 148 [431] Cancer Slope Factor (CSF) 0.0717 (mg/kg/day)A-l OPP 2019 Stout et al. 1983 hepatocellular carcinomas and renal tubular cell adenomas general population 33.8 0.413 [431] Cancer Classification (CC) C OPP 2019 [431] Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Acute Human Health Benchmark 1 mg/L EPA HHBP Acute PAD 0.05 mg/kg/day EPA HHBP Cancer Slope Factor (CSF) 0.0717 (mg/kg/day)A-l EPA HHBP Chronic Human Health Benchmark 0.16 mg/L EPA HHBP Chronic Human Health Benchmark 0.000446 mg/L EPA HHBP Health-Based Screening Level 0.16 mg/L Health-based screening levels from USGS Health-Based Screening Level 0.000446 mg/L Health-based screening levels from USGS Population-Adjusted Dose (PAD) 0.025 mg/kg/day EPA HHBP Data Element Value Units Source Notes Measured Data and Assessment Results LD50 2700 mg/kg NIH HSDB max LD50 800 mg/kg NIH HSDB min LOAEL 5 mg/kg/day EPA Toxicity Reference Database min LOAEL 90 mg/kg/day EPA Toxicity Reference Database max NOAEL 1.5 mg/kg/day EPA Toxicity Reference Database min NOAEL 30 mg/kg/day EPA Toxicity Reference Database max Percent of active toxcast in 15.9 percent EPA Chemistry Dashboard vitro assays tested Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Modeled Data LD50 0.0144544 mo l/kg TEST QSAR Ames mutagenicity test 0.687 no units TEST QSAR Developmental toxin test 0.189 no units TEST QSAR A-815 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Triallate CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev(NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 9.433 92 Sites 0.98 0.001 0.008 0.059 0.65 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 2.030 82 Sites 4.04 0.001 0.008 0.059 0.65 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 7.403 10 Sites 0.14 0.0011 0.002 0.021 0.23 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) 10 471,417 2016 Toxic Release Inventory (TRI) Program (EPA) (2016) 1 10 Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude USDA Pesticide Data Program (PDP) (Finished) 2001-2013 17 1 Sites 5.88 0.12 0.12 0.12 0.12 ug/L Ambient Water Prevalence Magnitude National Water Information System (USGS NWIS) (Surface Water) 2008-2017 549 2 Sites 0.36 0.219 0.236 0.247 0.254 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008-2017 1,094 0 Sites 0 National Water Information System (USGS NWIS) (All Water) 2008-2017 1,643 2 Sites 0.12 0.219 0.236 0.247 0.254 ug/L USDA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001-2013 229 0 Sites 0 USDA Pesticide Data Program (PDP) (Groundwater) 2001-2013 219 0 Sites 0 USDA Pesticide Data Program (PDP) (Untreated) 2001-2013 12 0 Sites 0 Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990-2018 590 1 Sites 0.17 0.003 0.003 0.003 0.003 ug/L Arnold et al. 2016 (Filtered) [7] 2012-2013 584 0 Sites 0 Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 0.000000102 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicatethere were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 4.39965 days Boiling point OPERA QSAR 293.256 degree C Boiling point TEST QSAR Vapor pressure OPERA QSAR 0.00012696 mmHg Vapor pressure TEST QSAR 0.000402717 mmHg Solubility in water OPERA QSAR 0.0000293 mol/L Solubility in water TEST QSAR 0.0000345 mol/L Bioconcentration factor OPERA QSAR 453.67 no units Bioconcentration factor TEST QSAR 90.7821 no units Henry's Law constant OPERA QSAR 0.000154671 atm-mA3/mol 0 eta no 1/water partitioning coeff. (log Kow) OPERA QSAR 4.51044 no units A-816 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Triallate CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 431 USEPA. 2019. Triallate. Human Health Draft Risk Assessment Scoping Document in Support of Registration Review. EPA-HQ-OPP-2014-0573-0018. DP No. D452964. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticide in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. A-817 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Tribufos CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Chemical Notes: DTXSID1024174 Insecticide; cotton defoliant Is the contaminant on any lists? CERCLA X FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts X Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANTSUMMARY& DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 7 non-cancer effects 1 5 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 0.3 inhibition of red blood cell chol in esterase in bottle-fed infants OPP 2015 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.36742 90th Percentile Finished Water UCMR4 2018-2019 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-818 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Tribufos CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.0002 mg/kg/day OPP 2015 Sheets and Gilmore 2001 inhibition of red blood cell cholinesterase in females bottle-fed infants 151 0.265 [359] Cancer Classification (CC) L/NL OPP 2015 [3591 Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Acute Human Health Benchmark 0.007 mg/L EPA HHBP Acute PAD 0.001 mg/kg/day EPA HHBP Chronic Human Health Benchmark 0.0006 mg/L EPA HHBP Health-Based Screening Level 0.0006 mg/L Health-based screening levels from USGS Population-Adjusted Dose (PAD) 0.0001 mg/kg/day EPAHHBP Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Measured Data and Assessment Results LD50 435 mg/kg NIH HSDB max LD50 77 mg/kg NIH HSDB min LOAEL 0.4 mg/kg/day EPA Toxicity Reference Database min LOAEL 9 mg/kg/day EPA Toxicity Reference Database max NOAEL 0.1 mg/kg/day EPA Toxicity Reference Database min NOAEL 3 mg/kg/day EPA Toxicity Reference Database max Percent of active toxcast in 15.68 percent EPA Chemistry Dashboard vitro assays tested Data Element Value Units Source Notes Modeled Data LD50 0.0004487 mo l/kg TEST QSAR Ames mutagenicity test 0.199 no units TEST QSAR Developmental toxin test 0.084 no units TEST QSAR A-819 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Tribufos CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 3.647 2 Sites 0.05 0.0742 0.237 0.367 0.4 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 4.417 21 Sites 0.48 0.00313 0.016 0.102 0.246 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 430 19 Sites 4.42 0.00313 0.016 0.0766 0.176 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 3.987 2 Sites 0.05 0.009 0.128 0.199 0.246 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) 17 2,903,908 2016 Toxic Release Inventory (TRI) Program (EPA) (2016) 1 10 Chemical Data Reporting (CDR) Results (EPA) (2016) < 25K Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Finished) 2006 - 2020 1 0 Sites 0 USDA Pesticide Data Program (PDP) (Finished) 2001-2013 13 0 Sites 0 USGS, Sioux Falls Area, 2012 (Finished) [153] 2009-2010 1 0 Sites 0 Ambient Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Source) 2006 - 2020 1 0 Sites 0 National Water Information System (USGS NWIS) (Surface Water) 2008-2017 779 8 Sites 1.03 0.005 0.0255 0.219 0.227 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008-2017 2,510 0 Sites 0 National Water Information System (USGS NWIS) (All Water) 2008-2017 3,288 8 Sites 0.24 0.005 0.0255 0.219 0.227 ug/L USDA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001-2013 6 0 Sites 0 USDA Pesticide Data Program (PDP) (Untreated) 2001-2013 6 0 Sites 0 Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990-2018 1,773 2 Sites 0.11 0.01 0.01 0.01 0.01 ug/L Arnold et al. 2016 (Filtered) [7] 2012-2013 690 0 Sites 0 USGS, Sioux Falls Area, 2012 (Ambient) [153] 2009-2010 2 0 Sites 0 Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/ day) Notes Expocast exposure 0.000000176 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 273.028 days Boiling point OPERA QSAR 343.854 degree C Boiling point TEST QSAR Vapor pressure OPERA QSAR 0.00000738 mmHg Vapor pressure TEST QSAR 0.0000101 mmHg Solubility in water OPERA QSAR 0.00000337 mol/L Solubility in water TEST QSAR 0.000178238 mol/L Bioconcentration factor OPERA QSAR 333.052 no units Bioconcentration factor TEST QSAR 42.462 no units Henry's Law constant OPERA QSAR 0.000000412 atm-mA3/mol 0 eta no l/water partitioning coeff. (log Kow) OPERA QSAR 5.67262 no units A-820 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Tribufos CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 153 Occurrence of anthropogenic organic compounds and nutrients in source and finished water in the Sioux Falls area, South Dakota, 2009-10: U.S. Geological Survey Scientific Investigations Report 2012-5098, 21 p. plus appendixes. 359 USEPA. 2015. Tribufos: Human Health Draft Risk Assessment for Registration Review. EPA-HQ-OPP-2008-0883-0011. DP No. D357537. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticide in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. A-821 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Tributyl phosphate (TNBP) CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Tributyl phosphate (TNBP) CASRN: 126-73-8 DTXSID: DTXSID3021986 Use: Flame-retardant component of aircraft hydraulic flu id; solvent Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA Human Neurotoxicants X PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 3 carcinogen with linear MOA 9 4 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 3 bladder neoplasia (combined incidence of transitional cell and squamous cell carcinomas, and papillomas) general population PPRTV 2010 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.17 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-822 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Tributyl phosphate (TNBP) CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.011 mg/kg/day PPRTV 2010 Bio/dynamic s Inc., 1991b "cholinergic salivation" general population 33.8 65.1 [316] Reference Dose (RfD) or Equivalent 0.08 mg/kg/day ATSDR2012 Arnold etal. 1997 "urinary bladder hyperplasia" general population 33.8 473 [31] Cancer Slope Factor (CSF) 0.009 (mg/kg/day)A-l PPRTV 2010 Auletta et al. 1998a bladder neoplasia (combined incidence of transitional cell and squamous cell carcinomas, and papillomas) general population 33.8 3.29 [316] Cancer Classification (CC) L PPRTV 2010 [316] Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review 2011-09-01 2019-12-17 454 0 0 Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Acute Minimal Risk Level (MRL) 1.1 mg/kg/day CDC ATSDR Intermediate Minimal Risk Level (MRL) 0.08 mg/kg/day CDC ATSDR Subchronic Provisional RfD 0.03 mg/kg/day EPA PPRTV Data Element Value Units Source Notes Measured Data and Assessment Results LD50 20000 mg/kg NIH HSDB max LD50 400 mg/kg NIH HSDB min Percent of active toxcast in 5.4 percent EPA Chemistry Dashboard vitro assays tested Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Modeled Data LD50 0.0151705 mo l/kg TEST QSAR Ames mutagenicity test 0.08 no units TEST QSAR Developmental toxin test 0.354 no units TEST QSAR A-823 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Tributyl phosphate (TNBP) CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contam nant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contam nant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contam nant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contam nant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contam nant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contam nant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 571 36 Sites 6.3 0.006 0.06 0.17 0.92 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 88 28 Sites 32 0.006 0.06 0.17 0.92 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 483 8 Sites 1.66 0.02 0.05 0.161 0.17 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) 1M - 10M Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Glassmeyer et al 2017 (Finished) [86] 2007-2012 25 NA Sites 0 ug/L USGS, Sioux Falls Area, 2012 (Finished) [153] 2009-2010 1 1 Sites 100 Ambient Water Prevalence Magnitude National Water Information System (USGS NWIS) (Surface Water) 2008-2017 724 233 Sites 32 0.004 0.027 0.092 4.69 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008-2017 692 47 Sites 6.79 0.007 0.0315 0.352 0.98 ug/L National Water Information System (USGS NWIS) (All Water) 2008-2017 1,416 280 Sites 20 0.004 0.027 0.1 4.69 ug/L Glassmeyer et a 1 2017 (Ambient) [86] 2007-2012 25 NA Sites 4 0.087 0.087 ug/L Bradley et al. 2017 (Ambient) [52] 2012-2014 38 14 Sites 37 0.0116 0.0601 0.114 0.503 ug/L USGS, Sioux Falls Area, 2012 (Ambient) [153] 2009-2010 2 2 Sites 100 0.1 0.1 0.1 0.1 ug/L Waste Water Effluent Prevalence Magnitude Scott et al. 2018 (Wastewater) [161] 2011-2017 21 20 Sites 95 0.082 0.14 0.27 1.1 ug/L Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/ dav) Notes Expocast exposure 0.0000471 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 3.67987 days Boiling point OPERA QSAR 284.939 degree C Boiling point TEST QSAR 281.321 degree C Vapor pressure OPERA QSAR 0.00171598 mmHg Vapor pressure TEST QSAR 0.000174985 mmHg Solubility in water OPERA QSAR 0.00139101 mol/L Solubility in water TEST QSAR 0.00312608 mol/L Bioconcentration factor OPERA QSAR 29.4881 no units Bioconcentration factor TEST QSAR 8.26038 no units Henry's Law constant OPERA QSAR 0.00000113 atm-mA3/mol 0 eta no l/water partitioning coeff. (log Kow) OPERA QSAR 3.76206 no units A-824 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Tributyl phosphate (TNBP) CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 31 ATSDR. 2012. Toxicological Profile for Phosphate Ester Flame Retardants. U.S. Department of Health and Human Services, Public Health Service, Agency for Toxic Substances and Disease Registry (ATSDR), Atlanta, GA. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 86 Glassmeyer, S.T., Furlong, E.T., Kolpin, D.W., Batt, A.L., Benson, R., Boone, J.S.,... & Wilson, V.S. (2017). Nationwide reconnaissance of contaminants of emerging concern in source and treated drinking waters of the United States. Science of The Total Environment. v581-582, (909-922). 153 Occurrence of anthropogenic organic compounds and nutrients in source and finished water in the Sioux Falls area, South Dakota, 2009-10: U.S. Geological Survey Scientific Investigations Report 2012-5098, 21 p. plus appendixes. 161 Scott, T. M., Phillips, P. J., Kolpin, D. W., Colella, K. M., Furlong, E. T., Foreman, W. T., & Gray, J. L. (2018). Pharmaceutical manufacturing facility discharges can substantially increase the pharmaceutical load to US wastewaters. Science of the Total Environment, 636, 69-79. 316 USEPA. 2010. Provisional Peer-Reviewed Toxicity Values for Tributyl phosphate. EPA/690/R-20/024F. U.S. Environmental Protection Agency, Office of Research and Development, National Center for Environmental Assessment, Superfund Health Risk Technical Support Center, Cincinnati, OH. A-825 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Triclopyr CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Triclopyr CASRN: 55335-06-3 DTXSID: DTXSID0032497 Use: Herbicide; woody plants and many broad-leaved weeds in grassland, uncultivated land, industrial areas, coniferous forests, plantation crops and rice fields. Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANTSUMMARY& DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT IN FORMATION Potency Severity Prevalence Magnitude 5 non-cancer effects 9 4 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 300 proximal renal tube degeneration general population OPP 2016 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.3 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-826 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Triclopyr CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.05 mg/kg/day OPP 2016 Vedula et al., 1995 proximal renal tube degeneration general population 33.8 296 [374] Cancer Classification (CC) D OPP 2016 [3741 Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Acute Human Health Benchmark 1 mg/L EPA HHBP Acute PAD 0.05 mg/kg/day EPA HHBP Chronic Human Health Benchmark 0.3 mg/L EPA HHBP Health-Based Screening Level 0.3 mg/L Health-based screening levels from USGS Population-Adjusted Dose (PAD) 0.05 mg/kg/day EPA HHBP Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Measured Data and Assessment Results LD50 2140 mg/kg NIH HSDB max LD50 310 mg/kg NIH HSDB min LOAEL 2.5 mg/kg/day EPA Toxicity Reference Database min LOAEL 200 mg/kg/day EPA Toxicity Reference Database max NOAEL 0.5 mg/kg/day EPA Toxicity Reference Database min NOAEL 100 mg/kg/day EPA Toxicity Reference Database max Percent of active toxcast in 1.89 percent EPA Chemistry Dashboard vitro assays tested Subchronic LOAEL 2.5 mg/kg/day EPA Toxicity Reference Database min Subchronic LOAEL 20 mg/kg/day EPA Toxicity Reference Database max Subchronic NOAEL 0.5 mg/kg/day EPA Toxicity Reference Database min Subchronic NOAEL 5 mg/kg/day EPA Toxicity Reference Database max Data Element Value Units Source Notes Modeled Data LD50 0.002729 mo l/kg TEST QSAR Ames mutagenicity test 0.049 no units TEST QSAR Developmental toxin test 0.559 no units TEST QSAR A-827 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Triclopyr CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contam nant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contam nant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contam nant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contam nant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contam nant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contam nant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 7.742 257 Sites 3.32 0.0028 0.075 0.3 16 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 1.196 248 Sites 21 0.0028 0.0748 0.3 16 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 6.546 9 Sites 0.14 0.01 0.16 0.362 1.1 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) 43 1,790,323 2016 Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude USDA Pesticide Data Program (PDP) (Finished) 2001-2013 17 7 Sites 41 0.0027 0.01 0.0393 0.566 ug/L Ambient Water Prevalence Magnitude National Water Information System (USGS NWIS) (Surface Water) 2008-2017 479 117 Sites 24 0.0057 0.0723 0.289 13 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008-2017 1,059 3 Sites 0.28 0.04 0.31 0.314 0.316 ug/L National Water Information System (USGS NWIS) (All Water) 2008-2017 1,538 120 Sites 7.8 0.0057 0.0728 0.299 13 ug/L USDA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001-2013 229 28 Sites 12 0.002664 0.00965 0.0493 3.6 ug/L USDA Pesticide Data Program (PDP) (Groundwater) 2001-2013 219 21 Sites 9.59 0.002664 0.00266 0.0164 3.6 ug/L USDA Pesticide Data Program (PDP) (Untreated) 2001-2013 12 7 Sites 58 0.0027 0.00999 0.0507 0.847 ug/L Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990-2018 1,372 524 Sites 38 0.05 0.208 1.8 250 ug/L Bradley et al. 2017 (Ambient) [52] 2012-2014 38 6 Sites 16 0.0198 0.148 2.9 5.6413 ug/L Arnold et al. 2016 (Filtered) [7] 2012-2013 690 1 Sites 0.14 0.246 0.246 0.246 0.246 ug/L USGS, McKenzie River, Oregon, 2012 (Ambient) [158] 2002-2010 126 13 Samples 10 3.1 ug/L Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/ day) Notes Expocast exposure 0.000000104 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 3.53784 days Boiling point OPERA QSAR 307.12 degree C Boiling point TEST QSAR 325.714 degree C Vapor pressure OPERA QSAR 0.00000216 mmHg Vapor pressure TEST QSAR 0.00000741 mmHg Solubility in water OPERA QSAR 0.00157866 mol/L Solubility in water TEST QSAR 0.00113501 mol/L Bioconcentration factor OPERA QSAR 3.14686 no units Bioconcentration factor TEST QSAR 6.223 no units Henry's Law constant OPERA QSAR 1.36E-09 atm-mA3/mol 0 eta no l/water partitioning coeff. (log Kow) OPERA QSAR 2.51566 no units A-828 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Triclopyr CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 158 Reconnaissance of Land-Use Sources of Pesticides in Drinking Water, McKenzie River, Oregon. U.S. Geological Survey Scientific Investigations Report 2012-5091, 46 p. plus appendixes. 374 USEPA. 2016. Triclopyr. Revised Human Health Risk Assessment for Section 18 Emergency Exemption Request for Use on Sugarcane in Louisiana (LA). EPA-HQ-OPP-2017-0036-0002. DP No. D436366. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticide in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. A-829 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Triclosan CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Triclosan CASRN: 3380-34-5 DTXSID: DTXSID5032498 Use: Antiseptic/disinfectant/antimicrobial in personal care products and household goods; pesticide Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro X Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 4 reproductive and developmental effects 9 4 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value («"gA) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 2000 20% decrease in T4 and associations with neu rode ve lop mental and cognitive deficits women of child bearing age OPP 2018 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.135 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-830 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Triclosan CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.27 mg/kg/day OPP 2018 Stoker et al., 2010; Zorilla et al., 2010 20% decrease in T4 and associations with neurodevelopmental and cognitive deficits women of child bearing age 35.4 1530 [408] Cancer Classification (CC) NL OPP 2018 [4081 Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Acute Health-Based Guidance Value 0.05 mg/L MN DOH Acute Human Health Benchmark 2 mg/L EPA HHBP Acute PAD 0.3 mg/kg/day EPA HHBP Chronic Health-Based Guidance Value 0.05 mg/L MN DOH Chronic Human Health Benchmark 2 mg/L EPA HHBP Health-Based Screening Level 2 mg/L Health-based screening levels from USGS Population-Adjusted Dose (PAD) 0.3 mg/kg/day EPA H HBP Short-Term/Subchronic Health-Based Guidance Value 0.05 mg/L MN DOH Data Element Value Units Source Notes Measured Data and Assessment Results LD50 3700 mg/kg NIH HSDB min LD50 4530 mg/kg NIH HSDB max LOAEL 15 mg/kg/day EPA Toxicity Reference Database min LOAEL 300 mg/kg/day EPA Toxicity Reference Database max NOAEL 100 mg/kg/day EPA Toxicity Reference Database max NOAEL 50 mg/kg/day EPA Toxicity Reference Database min Percent of active toxcast in 36.79 percent EPA Chemistry Dashboard vitro assays tested Subchronic LOAEL 25 mg/kg/day EPA Toxicity Reference Database Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Modeled Data LD50 0.0000468 mo l/kg TEST QSAR Ames mutagenicity test 0.402 no units TEST QSAR Developmental toxin test 0.627 no units TEST QSAR A-831 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Triclosan CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev(NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 567 31 Sites 5.47 0.01 0.04 0.135 0.56 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 88 29 Sites 33 0.01 0.04 0.149 0.56 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 479 2 Sites 0.42 0.02 0.045 0.06 0.07 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Finished) 2006 - 2020 2 1 Sites 50 3 3 3 3 ug/L Glassmeyer et al 2017 (Finished) [86] 2007-2012 25 NA Sites 0 ug/L Padhye et al. 2013 (Finished) [155] 2009-2010 8 5 Samples 62 0 1.4e-06 5.96e-05 +/- 2.57e-05 ug/L USGS, Sioux Falls Area, 2012 (Finished) [153] 2009-2010 1 0 Sites 0 Ambient Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Source) 2006 - 2020 3 1 Sites 33 3 3 3 3 ug/L National Water information System (USGS NWIS) (Surface Water) 2008-2017 725 117 Sites 16 0.02 0.09 0.26 15.6 ug/L National Water information System (USGS NWIS) (Groundwater) 2008-2017 690 9 Sites 1.3 0.03 0.06 0.071 0.08 ug/L National Water information System (USGS NWIS) (All Water) 2008-2017 1,415 126 Sites 8.9 0.02 0.09 0.254 15.6 ug/L Glassmeyer et a 1 2017 (Ambient) [86] 2007-2012 25 NA Sites 12 0.00271 0.0035 ug/L Bradley et al. 2017 (Ambient) [52] 2012-2014 38 23 Sites 61 0.00152 0.0146 0.0928 0.534 ug/L Padhye et al. 2013 (Ambient) [155] 2009-2010 8 5 Samples 62 0 3.3e-06 0.0001058 +/- 6.31e-05 ug/L USGS, Sioux Falls Area, 2012 (Ambient) [153] 2009-2010 2 0 Sites 0 Waste Water Effluent Prevalence Magnitude Scott et al. 2018 (Wastewater) [161] 2011-2017 21 8 Sites 38 0.12 0.28 0.949 0.97 ug/L Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 0.00000141 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) 172 ug/l Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 4.47143 days Boiling point OPERA QSAR 342.344 degree C Boiling point TEST QSAR 369.746 degree C Vapor pressure OPERA QSAR 0.000000453 mmHg Vapor pressure TEST QSAR 0.00000453 mmHg Solubility in water OPERA QSAR 0.0000298 mol/L Solubility in water TEST QSAR 0.00000454 mol/L Bioconcentration factor OPERA QSAR 94.8967 no units Bioconcentration factor TEST QSAR 1698.24 no units Henry's Law constant OPERA QSAR 6.29E-10 atm-mA3/mol 0 eta no 1/water partitioning coeff. (log Kow) OPERA QSAR 4.94675 no units A-832 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Triclosan CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 86 Glassmeyer, S.T., Furlong, E.T., Kolpin, D.W., Batt, A.L., Benson, R., Boone, J.S.,... & Wilson, V.S. (2017). Nationwide reconnaissance of contaminants of emerging concern in source and treated drinking waters of the United States. Science of The Total Environment. v581-582, (909-922). 153 Occurrence of anthropogenic organic compounds and nutrients in source and finished water in the Sioux Falls area, South Dakota, 2009-10: U.S. Geological Survey Scientific Investigations Report 2012-5098, 21 p. plus appendixes. 155 Padhye, L.P., Yao, H., Kung'u, F.T., and Huang, C.H. Year-long evaluation on the occurrence and fate of pharmaceuticals, personal care products, and endocrine disrupting chemicals in an urban drinking water treatment plant. 2014. Water Research 51 (2014) 266-276. 161 Scott, T. M., Phillips, P. J., Kolpin, D. W., Colella, K. M., Furlong, E. T., Foreman, W. T., & Gray, J. L. (2018). Pharmaceutical manufacturing facility discharges can substantially increase the pharmaceutical load to US wastewaters. Science of the Total Environment, 636, 69-79. 408 USEPA. 2018. Registration Review Draft Risk Assessment for Triclosan. EPA-HQ-OPP-2012-0811-0020. DP Nos. 449415, 449416. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. A-833 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Trifloxyst robin CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Trifloxyst rob in CASRN: 141517-21-7 DTXSID: DTXSID4032580 Use: Fungicide Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Not List ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 5 reproductive and developmental effects 9 1 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value («"gA) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 50 maternal decreased body weight and lesions in the liver, kidney and spleen; offspring decreased body weight during lactation bottle-fed infants OPP 2018 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.008552 90th Percentile All Ambient Water NAWQA 1991-2017 Final Hazard Quotient (HQ) 0.00017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-834 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Trifloxystrobin CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.038 mg/kg/day OPP 2018 Khalil 1997 maternal decreased body weight and lesions in the liver, kidney and spleen; offspring decreased body weight during lactation bottle-fed infants 151 50.3 [412] Cancer Classification (CC) NL OPP 2018 [4121 Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Acute Human Health Benchmark 69 mg/L EPA HHBP Acute PAD 2.5 mg/kg/day EPA HHBP Chronic Human Health Benchmark 0.24 mg/L EPA HHBP Health-Based Screening Level 0.24 mg/L Health-based screening levels from USGS Population-Adjusted Dose (PAD) 0.038 mg/kg/day EPAHHBP Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Measured Data and Assessment Results LD50 4000 mg/kg NIH HSDB min LD50 5000 mg/kg NIH HSDB max LOAEL 29.700001 mg/kg/day EPA Toxicity Reference Database min LOAEL 500 mg/kg/day EPA Toxicity Reference Database max NOAEL 250 mg/kg/day EPA Toxicity Reference Database max NOAEL 3.9 mg/kg/day EPA Toxicity Reference Database min Percent of active toxcast in 24.02 percent EPA Chemistry Dashboard vitro assays tested Subchronic LOAEL 127 mg/kg/day EPA Toxicity Reference Database min Subchronic LOAEL 150 mg/kg/day EPA Toxicity Reference Database max Subchronic NOAEL 30 mg/kg/day EPA Toxicity Reference Database min Subchronic NOAEL 32.8 mg/kg/day EPA Toxicity Reference Database max Data Element Value Units Source Notes Modeled Data LD50 0.0014555 mo l/kg TEST QSAR Ames mutagenicity test 0.189 no units TEST QSAR Developmental toxin test 0.886 no units TEST QSAR A-835 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Trifloxystrobin CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev(NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 1.763 100 Sites 5.67 0.00011 0.00115 0.00855 0.486 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 324 98 Sites 30 0.00011 0.00115 0.00807 0.486 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 1.439 2 Sites 0.14 0.00065 0.12 0.192 0.24 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) 48 796,042 2016 Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Ambient Water Prevalence Magnitude National Water Information System (USGS NWIS) (Surface Water) 2008-2017 433 14 Sites 3.23 0.00014 0.00475 0.0638 0.216 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008-2017 531 1 Sites 0.19 0.00226 0.00226 0.00226 0.00226 ug/L National Water Information System (USGS NWIS) (All Water) 2008-2017 964 15 Sites 1.56 0.00014 0.00468 0.0495 0.216 ug/L Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990-2018 254 1 Sites 0.39 0.067 0.067 0.067 0.067 ug/L Bradley et al. 2017 (Ambient) [52] 2012-2014 38 1 Sites 2.63 0.045 0.045 0.045 0.045 ug/L Arnold et al. 2016 (Filtered) [7] 2012-2013 584 1 Sites 0.17 6e-04 6e-04 6e-04 6e-04 ug/L Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/ day) Notes Expocast exposure 1.91E-08 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicatethere were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 3.54712 days Boiling point OPERA QSAR 358.422 degree C Boiling point TEST QSAR Vapor pressure OPERA QSAR 2.48E-08 mmHg Vapor pressure TEST QSAR 0.0000109 mmHg Solubility in water OPERA QSAR 0.00000387 mol/L Solubility in water TEST QSAR 0.00000448 mol/L Bioconcentration factor OPERA QSAR 99.2112 no units Bioconcentration factor TEST QSAR 83.1764 no units Henry's Law constant OPERA QSAR 1.28E-08 atm-mA3/mol 0 eta no 1/water partitioning coeff. (log Kow) OPERA QSAR 4.31154 no units A-836 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Trifloxystrobin CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 412 USEPA. 2018. Trifloxystrobin. Human Health Risk Assessment for the Proposed New Use on Flax Seed and Increase of Established Tolerance on Aspirated Grain Fractions. EPA-HQ-OPP-2013-0074-0049. DP Nos. D442038 D444241. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticide in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. A-837 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Trifluralin CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Chemical Notes: DTXSID4021395 Is the contaminant on any lists? CERCLA X FIFRA X Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 3 carcinogen with linear MOA 9 2 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 10 thyroid follicular cell combined adenoma, papillary adenoma, cystadenoma, and general population OPP 2018 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.025 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-838 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Trifluralin CCL 5 Contaminant Information Sheet EPA-OGWDWand OST October 2022 HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.024 mg/kg/day OPP 2018 Adams et al. 1992 increased frequency of abnormal stool, decreased body weight and weight gain, decreased erythrocyte and hemoglobin, increased thrombocytes general population 33.8 142 [413] Cancer Slope Factor (CSF) 0.00296 (mg/kg/day)A-l OPP 2018 Emmerson eta 1.1980 thyroid follicular cell combined adenoma, papillary adenoma, cystadenoma, and carcinoma in males general population 33.8 10.0 [413] Cancer Classification (CC) C OPP 2018 [413] Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results 10-day Health Advisory 0.08 mg/L EPA DWSHA2018 Cancer Classification (CC) 3 no units WHO IARC Drinking Water Guideline Value 0.02 mg/L WHO Drinking Water Quality Guidelines Lifetime Health Advisory 0.01 mg/L EPA DWSHA 2018 Lifetime Health Advisory 0.004 mg/L EPA DWSHA 2018 Maximum Allowable Concentration (MAC) 0.045 mg/L Canadian Drinking Water Guidelines Cancer Classification (CC) Female.Mice P no units HHSNTP Cancer Classification (CC) Female.Rats N no units HHSNTP Cancer Classification (CC) Male.Mice N no units HHSNTP Cancer Classification (CC) Male.Rats N no units HHS NTP Data Element I Value I Units I Source I Notes Measured Data and Assessment Results LD50 10000 mg/kg NIH HSDB max LD50 500 mg/kg NIH HSDB min LOAEL 3.8 mg/kg/day EPA Toxicity Reference Database min LOAEL 500 mg/kg/day EPA Toxicity Reference Database max NOAEL 0.8 mg/kg/day EPA Toxicity Reference Database min NOAEL 225 mg/kg/day EPA Toxicity Reference Database max Percent of active toxcast in vitro assays tested 10.44 percent EPA Chemistry Dashboard TD50 263 mg/kg/day NIH CPDB min TD50 5440 mg/kg/day NIH CPDB max Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Modeled Data LD50 0.0136773 mo l/kg TEST QSAR Ames mutagenicity test 0.445 no units TEST QSAR Developmental toxin test 1.145 no units TEST QSAR A-839 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Trifluralin CCL5 Contaminant Information Sheet EPA-OGWDW and OST October 2 OCCURRENCE DATA Scoring Data Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018 - 2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013 - 2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008 - 2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survey (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991 - 2017 10,201 485 Sites 4.75 0.001 0.005 0.025 1.74 ug/L National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991 - 2017 2,075 421 Sites 20 0.001 0.005 0.025 1.74 ug/L National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991 - 2017 8,127 64 Sites 0.79 0.001 0.005 0.014 0.057 u«/L PesticideApplication Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) 47 8,578,613 2016 Toxic Release Inventory (TRI) Program (EPA) (2016) 13 11,482 Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Drinking Water Monitoring Data -CA (Finished) 2006 - 2020 60 0 Sites 0 Drinking Water Monitoring Data -WA (Finished) 2006 - 2011 481 0 Sites 0 USDA Pesticide Data Program (PDP) (Finished) 2001 - 2013 15 1 Sites 6.67 0.0025 0.0025 0.0025 0.0025 ug/L USGS, Sioux Falls Area, 2012 (Finished) [153] 2009 - 2010 1 0 Sites 0 Ambient Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Source) 2006 - 2020 604 3 Sites 0.5 0.5 31 174 210 ug/L Drinking Water Monitoring Data - WA (Source) 2006 - 2011 635 0 Sites 0 National Water Information System (USGS NWIS) (Surface Water) 2008 - 2017 811 121 Sites 15 6.00E-05 0.003 0.0147 0.323 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008 - 2017 2,670 28 Sites 1.05 0.001 0.003 0.0164 0.113 ug/L National Water Information System (USGS NWIS) (All Water) 2008 - 2017 3,480 149 Sites 4.28 6.00E-05 0.003 0.015 0.323 ug/L USDA Pesticide Data Program (PDP) (Combined Groundwater And Untreated) 2001 - 2013 225 0 Sites 0 USDA Pesticide Data Program (PDP) (Groundwater) 2001 - 2013 218 0 Sites 0 USDA Pesticide Data Program (PDP) (Untreated) 2001-2013 8 0 Sites 0 Surface Water Database (SURF) California Dept. of Pesticide Regulation (Ambient) [451] 1990-2018 2,711 254 Sites 9.37 0.003 0.024 0.234 3.3 ug/L Bradley et al. 2017 (Ambient) [52] 2012-2014 38 15 Sites 39 2.75e-05 0.000138 0.0188 0.0473 ug/L Arnold et al. 2016 (Filtered) [7] 2012-2013 106 0 Sites 0 USGS, Sioux Falls Area, 2012 (Ambient) [153] 2009-2010 2 0 Sites 0 USGS, McKenzie River, Oregon, 2012 (Ambient) [158] 2002-2010 133 3 Samples 2.3 0.002 ug/L Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mgAg bw/day) Notes Expocast exposure 0.00000157 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. "All Water7' data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 3.54291 days Boiling point OPERA QSAR 365.036 degree C Boiling point TEST QSAR 369.442 degree C Vapor pressure OPERA QSAR 0.0000523 mmHg Vapor pressure TEST QSAR 0.00000292 mmHg Solubility in water OPERA QSAR 0.000000496 mol/L Solubility in water TEST QSAR 0.000002 mol/L Bioconeentration factor OPERA QSAR 1513.15 no units Bioconeentration factor TEST QSAR 149.624 no units Henry's Law constant OPERA QSAR 0.0000755 atm-mA3/mol Octanol/water partitioning coeff. (log Kow) OPERA QSAR 5.27633 no units A-840 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Trifluralin CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulorigoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 153 Occurrence of anthropogenic organic compounds and nutrients in source and finished water in the Sioux Falls area, South Dakota, 2009-10: U.S. Geological Survey Scientific Investigations Report 2012-5098, 21 p. plus appendixes. 158 Reconnaissance of Land-Use Sources of Pesticides in Drinking Water, McKenzie River, Oregon. U.S. Geological Survey Scientific Investigations Report 2012-5091, 46 p. plus appendixes. 413 USEPA. 2018. Trifluralin: Acute, Chronic, and Cancer Aggregate Dietary (Food and Drinking Water) Exposure and Risk Assessment for the Section 3 Registration Action on Rosemary and Crop Group Conversions to Support Registration Review. EPA-HQ-OPP-2017-0420-0006. DP Nos. D445916 D447175. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. 451 Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticide in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. A-841 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 tris(l,3-dichloro-2-propYl) phosphate (TDCP) CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: tris( 1,3-dichloro-2-propyl) phosphate (TDCP) CASRN: 13674-87-8 DTXSID: DTXSID9026261 Use: Flame-retardant in plastics and as a secondary Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANTSUMMARY& DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 5 non-cancer effects 9 4 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 100 renal tubule epithelial hyperplasia general population ATSDR 2012 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.157 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-842 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 tris(l,3-dichloro-2-propyI) phosphate (TDCP) CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.02 mg/kg/day ATSDR2012 Stauffer Chemical Co. 1981 renal tubule epithelial hyperplasia general population 33.8 118 [31] Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Hepatic 0.0026 Deng 2018 Cardiovascular, Respiratory 500 Wang 2019 2011-09-01 2020-02-13 233 5 8 5 Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Chronic Health-Based Guidance Value 0.00008 mg/L MN DOH Chronic Health-Based Guidance Value 0.009 mg/L MN DOH Intermediate Minimal Risk Level (MRL) 0.05 mg/kg/day CDC ATSDR Short-Term/Subchronic Health-Based Guidance Value 0.02 mg/L MN DOH Data Element Value Units Source Notes Measured Data and Assessment Results LD50 1850 mg/kg NIH HSDB min LD50 2670 mg/kg NIH HSDB max Percent of active toxcast in 24.79 percent EPA Chemistry Dashboard vitro assays tested Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Modeled Data LD50 0.004529 mo l/kg TEST QSAR Ames mutagenicity test 0.601 no units TEST QSAR Developmental toxin test 0.546 no units TEST QSAR A-843 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 tris(l,3-dichIoro-2-propyl) phosphate (TDCP) CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contam nant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contam nant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contam nant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contam nant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contam nant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contam nant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev(NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 567 39 Sites 6.88 0.01 0.07 0.157 0.52 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 88 33 Sites 38 0.01 0.08 0.163 0.52 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 479 6 Sites 1.25 0.02 0.03 0.068 0.08 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) 10M - 50M Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Glassmeyer et al 2017 (Finished) [86] 2007-2012 25 NA Sites 0 ug/L USGS, Sioux Falls Area, 2012 (Finished) [153] 2009-2010 1 0 Sites 0 Ambient Water Prevalence Magnitude National Water Information System (USGS NWIS) (Surface Water) 2008-2017 720 278 Sites 39 0.01 0.08 0.21 14.9 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008-2017 687 64 Sites 9.32 0.02 0.095 0.266 0.44 ug/L National Water Information System (USGS NWIS) (All Water) 2008-2017 1,407 342 Sites 24 0.01 0.08 0.23 14.9 ug/L Glassmeyer et a 1 2017 (Ambient) [86] 2007-2012 25 NA Sites 0 ug/L Bradley et al. 2017 (Ambient) [52] 2012-2014 38 12 Sites 32 0.11 0.336 0.501 0.583 ug/L USGS, Sioux Falls Area, 2012 (Ambient) [153] 2009-2010 2 0 Sites 0 Waste Water Effluent Prevalence Magnitude Scott et al. 2018 (Wastewater) [161] 2011-2017 21 19 Sites 90 0.13 0.22 0.317 0.4 ug/L Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 0.000000181 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicatethere were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 4.07587 days Boiling point OPERA QSAR 313.35 degree C Boiling point TEST QSAR 373.105 degree C Vapor pressure OPERA QSAR 0.00000524 mmHg Vapor pressure TEST QSAR 0.0000164 mmHg Solubility in water OPERA QSAR 0.0000446 mol/L Solubility in water TEST QSAR 0.0000881 mol/L Bioconcentration factor OPERA QSAR 12.6458 no units Bioconcentration factor TEST QSAR 14.9279 no units Henry's Law constant OPERA QSAR 0.00000168 atm-mA3/mol 0 eta no 1/water partitioning coeff. (log Kow) OPERA QSAR 3.64426 no units A-844 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 tris(l,3-dichloro-2-propyl) phosphate (TDCP) CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 31 ATSDR. 2012. Toxicological Profile for Phosphate Ester Flame Retardants. U.S. Department of Health and Human Services, Public Health Service, Agency for Toxic Substances and Disease Registry (ATSDR), Atlanta, GA. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 86 Glassmeyer, S.T., Furlong, E.T., Kolpin, D.W., Batt, A.L., Benson, R., Boone, J.S.,... & Wilson, V.S. (2017). Nationwide reconnaissance of contaminants of emerging concern in source and treated drinking waters of the United States. Science of The Total Environment. v581-582, (909-922). 153 Occurrence of anthropogenic organic compounds and nutrients in source and finished water in the Sioux Falls area, South Dakota, 2009-10: U.S. Geological Survey Scientific Investigations Report 2012-5098, 21 p. plus appendixes. 161 Scott, T. M., Phillips, P. J., Kolpin, D. W., Colella, K. M., Furlong, E. T., Foreman, W. T., & Gray, J. L. (2018). Pharmaceutical manufacturing facility discharges can substantially increase the pharmaceutical load to US wastewaters. Science of the Total Environment, 636, 69-79. A-845 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Tris(2-butozylethyl) phosphate (TBEP) CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Tris(2-butozylethyl) phosphate (TBEP) CASRN: 78-51-3 DTXSID: DTXSID5021758 Use: Primary plasticizerfor most resins and elastomers; floor finishes and waxes; flame-retarding agent. Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUM MARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT IN FORMATION Potency Severity Prevalence Magnitude 9 5 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.98 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-846 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Tris(2-butozylethyl) phosphate (TBEP) CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Assessment Source Critical Study Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes [31] NOTE: Though there is no chronic duration MRL available, the intermediate duration MRL is 0.09 mg/kg/day based on hepatocyte vacuolization seen in an 18-week rat study. The ECHADNELvalue appears to be based on the same subchronic duration study Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.25 mg/kg/day EC HA 2010 Reyna 1987 liver effects general population 33.8 1.48 [741 Literature Search Summary Lowest LOAEL Health Effects Lowest LOAE L (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review 2011-09-01 2019-10-22 148 0 4 Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Acute Minimal Risk Level (MRL) 4.8 mg/kg/day CDC ATSDR Intermediate Minimal Risk Level (MRL) 0.09 mg/kg/day CDC ATSDR Data Element Value Units Source Notes Measured Data and Assessment Results LD50 3000 mg/kg NIH HSDB Percent of active toxcast in 10.9 percent EPA Chemistry Dashboard vitro assays tested Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Modeled Data LD50 0.0127938 mo l/kg TEST QSAR Ames mutagenicity test 0.045 no units TEST QSAR Developmental toxin test 0.501 no units TEST QSAR A-847 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Tris(2-butozylethyl) phosphate (TBEP) CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev(NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 566 36 Sites 6.36 0.1 0.2 0.98 9.9 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 88 26 Sites 30 0.1 0.3 1.18 9.9 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 478 10 Sites 2.09 0.1 0.1 0.3 0.5 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) 1M - 10M Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Glassmeyer et al 2017 (Finished) [86] 2007-2012 25 NA Sites 0 ug/L USGS, Sioux Falls Area, 2012 (Finished) [153] 2009-2010 1 0 Sites 0 Ambient Water Prevalence Magnitude National Water Information System (USGS NWIS) (Surface Water) 2008-2017 725 291 Sites 40 0.04 0.36 1.03 31.9 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008-2017 690 58 Sites 8.41 0.07 0.4 0.9 8 ug/L National Water Information System (USGS NWIS) (All Water) 2008-2017 1,415 349 Sites 25 0.04 0.36 1.02 31.9 ug/L Glassmeyer et al 2017 (Ambient) [86] 2007-2012 25 NA Sites 4 0.47 0.47 ug/L Bradley etal. 2017 (Ambient) [52] 2012-2014 38 10 Sites 26 0.244 0.488 0.835 1.11 ug/L USGS, Sioux Falls Area, 2012 (Ambient) [153] 2009-2010 2 0 Sites 0 Waste Water Effluent Prevalence Magnitude Scott et al. 2018 (Wastewater) [161] 2011-2017 21 17 Sites 81 0.4 2.9 14.4 19 ug/L Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 0.0000929 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR4 data used in the CCL5 is a partial datasetand will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 3.67989 days Boiling point OPERA QSAR 345.446 degree C Boiling point TEST QSAR 353.92 degree C Vapor pressure OPERA QSAR 0.0000171 mmHg Vapor pressure TEST QSAR 0.00000378 mmHg Solubility in water OPERA QSAR 0.00231797 mol/L Solubility in water TEST QSAR 0.000592925 mol/L Bioconcentration factor OPERA QSAR 6.05572 no units Bioconcentration factor TEST QSAR 6.09537 no units Henry's Law constant OPERA QSAR 0.00000725 atm-mA3/mol Octanol/water partitioning coeff. (log Kow) OPERA QSAR 3.61399 no units A-848 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Tris(2-butozylethyl) phosphate (TBEP) CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 31 ATSDR. 2012. Toxicological Profile for Phosphate Ester Flame Retardants. U.S. Department of Health and Human Services, Public Health Service, Agency for Toxic Substances and Disease Registry (ATSDR), Atlanta, GA. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 74 ECHA. Registration Dossier for Tris(2-butoxyethyl) phosphate. European Chemicals Agency (ECHA), Helsinki, Finland. https://echa.europa.eu/registration-dossier/-/registered-dossier/14166/10 Accessed 2/5/2020. 86 Glassmeyer, S.T., Furlong, E.T., Kolpin, D.W., Batt, A.L., Benson, R., Boone, J.S.,... & Wilson, V.S. (2017). Nationwide reconnaissance of contaminants of emerging concern in source and treated drinking waters of the United States. Science of The Total Environment. v581-582, (909-922). 153 Occurrence of anthropogenic organic compounds and nutrients in source and finished water in the Sioux Falls area, South Dakota, 2009-10: U.S. Geological Survey Scientific Investigations Report 2012-5098, 21 p. plus appendixes. 161 Scott, T. M., Phillips, P. J., Kolpin, D. W., Colella, K. M., Furlong, E. T., Foreman, W. T., & Gray, J. L. (2018). Pharmaceutical manufacturing facility discharges can substantially increase the pharmaceutical load to US wastewaters. Science of the Total Environment, 636, 69-79. A-849 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Tris(chloroethyl)phosphate (TCEP) CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Tris(chloroethyl)phosphate(TCEP) CASRN: 115-96-8 DTXSID: DTXSID5021411 Use: Flame-retardant in plastics and urethanes Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 4 carcinogen with linear MOA 9 4 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 1 renal tubular cell adenomas and carcinomas general population PPRTV 2009 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.142 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-850 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Tris(chloroethyl)phosphate (TCEP) CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.2 mg/kg/day ATSDR2012 NTP 1991 renal tubule epithelial hyperplasia general population 33.8 1180 [31] Reference Dose (RfD) or Equivalent 0.007 mg/kg/day PPRTV 2009 Matthews etal., 1990; NTP, 1991 increased absolute and relative liver and kidney weights general population 33.8 41.4 [304] Cancer Slope Factor (CSF) 0.02 (mg/kg/day)A-l PPRTV 2009 NTP, 1991; Matthews etal., 1993 combined incidence of renal tubular cell adenomas and carcinomas general population 33.8 1.48 [304] Cancer Classification (CC) L PPRTV 2009 [304] Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Gastrointestinal, Hepatic 0.0256 Deng, 2018 Systemic 100 Yang, 2018 2011-09-01 2020-01-28 357 5 3 4 Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Acute Health-Based Guidance Value 0.3 mg/L MN DOH Cancer Classification (CC) 3 no units WHO IARC Chronic Health-Based Guidance Value 0.2 mg/L MN DOH Chronic Health-Based Guidance Value 0.0005 mg/L MN DOH Intermediate Minimal Risk Level (MRL) 0.6 mg/kg/day CDC ATSDR Short-Term/Subchronic Health-Based Guidance 0.2 mg/L MN DOH Value Subchronic Provisional RfD 0.02 mg/kg/day EPA PPRTV Cancer Classification (CC) Female.Mice EE no units HHSNTP Cancer Classification (CC) Female.Rats P no units HHSNTP Cancer Classification (CC) Male.Mice EE no units HHSNTP Cancer Classification (CC) Male.Rats P no units HHS NTP Data Element Value Units Source Notes Modeled Data LD50 0.0015704 mo l/kg TEST QSAR Ames mutagenicity test 0.976 no units TEST QSAR Developmental toxin test 0.483 no units TEST QSAR Data Element Value Units Source Notes Measured Data and Assessment Results LD50 1866 mg/kg NIH HSDB max LD50 430 mg/kg NIH HSDB min Percent of active toxcast in 0.29 percent EPA Chemistry Dashboard vitro assays tested TD50 23600000 mg/kg/day NIH CPDB max TD50 39.9 mg/kg/day NIH CPDB min Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. A-851 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Tris(chloroetiiyl)phosphate (TCEP) CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contam nant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contam nant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contam nant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contam nant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contam nant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contam nant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev(NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 567 56 Sites 9.88 0.01 0.07 0.142 0.44 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 88 42 Sites 48 0.01 0.07 0.16 0.44 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 479 14 Sites 2.92 0.01 0.04 0.086 0.13 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) 25K-100K Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Glassmeyer et al 2017 (Finished) [86] 2007-2012 25 NA Sites 0 ug/L Padhye et al. 2013 (Finished) [155] 2009-2010 8 7 Samples 88 0 3.7e-06 2.04e-05 +/- 5.8e-06 ug/L USGS, Sioux Falls Area, 2012 (Finished) [153] 2009-2010 1 0 Sites 0 Ambient Water Prevalence Magnitude National Water Information System (USGS NWIS) (Surface Water) 2008-2017 725 291 Sites 40 0.01 0.07 0.21 7.66 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008-2017 690 62 Sites 8.99 0.01 0.06 0.195 1.88 ug/L National Water Information System (USGS NWIS) (All Water) 2008-2017 1,415 353 Sites 25 0.01 0.07 0.21 7.66 ug/L Glassmeyer et a 1 2017 (Ambient) [86] 2007-2012 25 NA Sites 4 0.065 0.065 ug/L Bradley et al. 2017 (Ambient) [52] 2012-2014 38 15 Sites 39 0.0416 0.18 0.282 0.487 ug/L Padhye et al. 2013 (Ambient) [155] 2009-2010 8 7 Samples 88 0 5.6e-06 5.17e-05 +/- 1.9e-06 ug/L USGS, Sioux Falls Area, 2012 (Ambient) [153] 2009-2010 2 2 Sites 100 Waste Water Effluent Prevalence Magnitude Scott et al. 2018 (Wastewater) [161] 2011-2017 21 21 Sites 100 0.2 0.415 0.57 0.73 ug/L Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure 0.00000696 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 3.67993 days Boiling point OPERA QSAR 321.803 degree C Boiling point TEST QSAR 295.075 degree C Vapor pressure OPERA QSAR 0.0350806 mmHg Vapor pressure TEST QSAR 0.000645654 mmHg Solubility in water OPERA QSAR 0.0265137 mol/L Solubility in water TEST QSAR 0.00506991 mol/L Bioconcentration factor OPERA QSAR 1.32172 no units Bioconcentration factor TEST QSAR 5.01187 no units Henry's Law constant OPERA QSAR 0.000000128 atm-mA3/mol 0 eta no l/water partitioning coeff. (log Kow) OPERA QSAR 1.52722 no units A-852 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Tris(chloroethyl)phosphate (TCEP) CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 31 ATSDR. 2012. Toxicological Profile for Phosphate Ester Flame Retardants. U.S. Department of Health and Human Services, Public Health Service, Agency for Toxic Substances and Disease Registry (ATSDR), Atlanta, GA. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 86 Glassmeyer, S.T., Furlong, E.T., Kolpin, D.W., Batt, A.L., Benson, R., Boone, J.S.,... & Wilson, V.S. (2017). Nationwide reconnaissance of contaminants of emerging concern in source and treated drinking waters of the United States. Science of The Total Environment. v581-582, (909-922). 153 Occurrence of anthropogenic organic compounds and nutrients in source and finished water in the Sioux Falls area, South Dakota, 2009-10: U.S. Geological Survey Scientific Investigations Report 2012-5098, 21 p. plus appendixes. 155 Padhye, L.P., Yao, H., Kung'u, F.T., and Huang, C.H. Year-long evaluation on the occurrence and fate of pharmaceuticals, personal care products, and endocrine disrupting chemicals in an urban drinking water treatment plant. 2014. Water Research 51 (2014) 266-276. 161 Scott, T. M., Phillips, P. J., Kolpin, D. W., Colella, K. M., Furlong, E. T., Foreman, W. T., & Gray, J. L. (2018). Pharmaceutical manufacturing facility discharges can substantially increase the pharmaceutical load to US wastewaters. Science of the Total Environment, 636, 69-79. 304 USEPA. 2009. Provisional Peer-Reviewed Toxicity Values for Tris(2-chloroethyl)phosphate (TCEP) (CASRN 115-96-8). U.S. Environmental Protection Agency, Office of Research and Development, Nationa Center for Environmental Assessment, Superfund Health Risk Technical Support Center, Cincinnati, OH. A-853 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Tungsten CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Tungsten CASRN: 7440-33-7 DTXSID: DTXSID8052481 Use: Metal, in plating material and textiles Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA Human Neurotoxicants PubMed Neu rotoxica nts Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANTSUMMARY& DECISION CCL5 List Decision Final Hazard Quotient (HQ) ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Potency Severity Prevalence Magnitude 6 non-cancer effects 10 6 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 5 glandular stomach goblet cell metaplasia general population PPRTV 2015 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 3.99 90th Percentile All Ambient Water NAWQA 1991-2017 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-854 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Tungsten CCL 5 Contaminant Information Sheet EPA-OGWDWand OST October 2022 HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.0008 mg/kg/day PPRTV 2015 USACHPPM 2007a and b glandular stomach goblet cell metaplasia general population 33.8 4.73 [356] Cancer Classification (CC) I PPRTV 2015 [356] ATSDR2005 [25] Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Immune, Renal, Hematologic 17.7 Frawley, 2016 Respiratory, Systemic 284 Frawley, 2016 2014-09-01 2020-01-21 805 2 29 2 Other Health Data Data Element I Value Units 1 Source I Notes Measured Data and Assessment Results Subchronic Provisional RfD I 0.008 mg/kg/day I EPA PPRTV I Data Element I Value | Units | Source I Notes Measured Data and Assessment Results Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Modeled Data LD50 TEST QSAR Ames mutagenicity test TEST QSAR Developmental toxin test TEST QSAR A-855 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Tungsten CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contam nant Monitoring Rule (UCMR) 4 2018-2019 Unregulated Contam nant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contam nant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contam nant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contam nant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contam nant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev (NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 21 17 Sites 81 0.06 0.376 3.99 22.1 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 4 3 Sites 75 0.1 0.7 1.88 2.3 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 17 14 Sites 82 0.06 0.376 4.4 22.1 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) 10M - 50M Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Ambient Water Prevalence Magnitude National Water Information System (USGS NWIS) (Surface Water) 2008-2017 82 49 Sites 60 0.003 1.04 3.01 42.2 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008 - 2017 1,175 722 Sites 61 0.001 0.232 8.32 5060 ug/L National Water Information System (USGS NWIS) (All Water) 2008 - 2017 1,257 771 Sites 61 0.001 0.26 5.9 5060 ug/L Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) 0.263 ug/l Notes: Highlighted data indicate value was used in attribute scoring. Blankfields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. A-856 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Tungsten CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 25 ATSDR. 2005. Toxicological Profile for Tungsten. U.S. Department of Health and Human Services, Public Health Service, Agency for Toxic Substances and Disease Registry (ATSDR), Atlanta, GA. 356 USEPA. 2015. Provisional Peer-Reviewed Toxicity Values for Soluble Tungsten Compounds. U.S. Environmental Protection Agency, Office of Research and Development, National Center for Environmental Assessment, Superfund Health Risk Technical Support Center, Cincinnati, OH. A-857 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Vanadium CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Vanadium CASRN: 7440-62-2 DTXSID: DTXSID2040282 Use: Use data a re for vanadium pentoxide: Chemical intermediate; catalyst; naturally-occurring Chemical Notes: This CIS also contains some data for the following: -Vanadium, elemental -Vanadium compounds -Vanadium and compounds -Vanadium (except when contained in an alloy) -Vanadium, total -Vanadium pentoxide Isthe contaminant on any lists? CERCLA X FIFRA Human Neurotoxicants Pub Med Neurotoxicants X Neurodev. Disruptors Androgen Receptors in vitro Compounds with neurodev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT INFORMATION Final Hazard Quotient (HQ) Potency Severity Prevalence Magnitude 7 non-cancer effects 10 7 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value ("g/L) Critical Effect Target Pop. Assessment Assessment Pub. Date HRL 0.4 " kid ney toxicity" general population PPRTV 2009 Cone, in water for HQ ("g/L) 90th Percentile or Maximum (if measured cone) Finished or Ambient (FW, SW, GW, WW) Source Date 12.4 90th Percentile Finished Water UCMR3 2013-2015 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS RD1 RD 2 RD 3 Not Applicable Not Applicable Not Applicable Basis Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. Green highlighting indicates a change made between the draft and final CCL 5. A-858 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Vanadium CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mLAg-day) HRL (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.00007 mg/kg/day PPRTV 2009 Boscolo et al. 1994 "kidney toxicity" general population 33.8 0.414 [305] Cancer Classification (CC) I PPRTV2009 [3051 ATSDR2012 [321 Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Neurological 38.51 Sun,2017 Hepatic, Renal 83.7 Wang, 2016 2011-09-01 2019-10-22 1233 19 53 2 Other Health Data Data Element I Value I Units I Source I Notes Measured Data and Assessment Results Acute inhalation Minimal Risk Level (MRL) 0.0008 mg/mA3 CDC ATSDR Benchmark 0.015 mg/L CalEPA OEHHA Chemical Database vanadium and compounds otherthan vanadium pentoxide Chronic Health-Based Guidance Value 0.05 mg/L MN DOH Chronic inhalation Minimal Risk Level (MRL) 0.0001 mg/mA3 CDC ATSDR Intermediate Minimal Risk Level (MRL) 0.01 mg/kg/day CDC ATSDR Subchronic Provisional RfD 0.0007 mg/kg/day EPA PPRTV vanadium and soluble inorganic compounds other than vanadium pentoxide Notes: Yellow highlighted data indicate value was used in attribute scoring. Green highlighted data indicates a change made between the draft and final CCL 5. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Measured Data and Assessment Results LD50 2000 mg/kg NIH HSDB max; vanadium, elemental LD50 23 mg/kg NIH HSDB min; vanadium compounds Data Element Value Units Source Notes Modeled Data LD50 TEST QSAR Ames mutagenicity test TEST QSAR Developmental toxin test TEST QSAR A-859 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Vanadium CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDWand OST October 2022 Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevak nee Magnitude Unregulated Contaminant Monitoring Rule (UCMR) 4 2018 - 2019 Unregulated Contaminant Monitoring Rule (UCMR) 3 2013 - 2015 4.922 3.625 Sites 74 0.2 1.3 12.4 193 Unregulated Contaminant Monitoring Rule (UCMR) 2 2008 - 2010 Unregulated Contaminant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contaminant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contaminant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Sutvev (NIRS) 1984 -1986 989 146 Sites 15 3 7 23 70 Ambient Water Prevak nee Magnitude National Water Qualitv Assessment (USGS NAWQA) (All Water) 1991 - 2017 5.985 4.753 Sites 79 0.02 1.5 8.8 294 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991 - 2017 274 176 Sites 64 0.04 1.5 5.9 54.8 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991 - 2017 5.711 4.577 Sites 80 0.02 1.4 17.5 294 ug/L Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Notes Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) 12 692,638 vanadium (except when contained in an alloy) 45 33,542,802 vanadium compounds Chemical Production Data Production Volume (lbs/year) Chemical Data Reporting (CDR) Results (EPA) (2016) 10M -50M Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Finished) 2006 - 2020 213 123 Sites 58 0.844 5 12 76 ug/L vanadium, total Glassmeyeret al 2017 (Finished) [86] 2007 - 2012 25 NA Sites 16 3.4 4.9 ug/L Community WaterSystem Survey (CWSS) (Finished) [178] 2006 3 NA Sites 2.225 4.1 ug/L Ambient Water Prevalence Magnitude Drinking Water Monitoring Data - CA (Source) 2006 - 2020 1,704 1,279 Sites 75 0.0044 6.68 26 262 ug/L vanadium, total National Water Information System (USGS NWIS) (Surface Water) 2008 - 2017 1,056 964 Sites 91 0.01 1.8 8.3 801 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008 - 2017 5,214 3,986 Sites 76 0.01 3.7 27.2 1000 ug/L National Water Information System (USGS NWIS) (All Water) 2008 - 2017 6,258 4,941 Sites 79 0.01 2.4 17.7 1000 ug/L Glassmeyeret al 2017 (Ambient) [86] 2007 - 2012 25 NA Sites 44 2.3 5.8 ug/L Arnold et al. 2016 (Filtered) [7] 2012 - 2013 757 510 Sites 67 0.08 0.48 13 62.3 ug/L Waste Water Effluent Prevalence Magnitude Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/day) Notes Expocast exposure Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Green highlighted data indicates a change made between the draft and final CCL 5. Blank fields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. A-860 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Vanadium CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 7 Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. 32 ATSDR. 2012. Toxicological Profile for Vanadium. U.S. Department of Health and Human Services, Public Health Service, Agency for Toxic Substances and Disease Registry (ATSDR), Atlanta, GA. 86 Glassmeyer, S.T., Furlong, E.T., Kolpin, D.W., Batt, A.L., Benson, R., Boone, J.S.,... & Wilson, V.S. (2017). Nationwide reconnaissance of contaminants of emerging concern in source and treated drinking waters of the United States. Science of The Total Environment. v581-582, (909-922). 178 USEPA (US Environmental Protection Agency). (2009). 2006 Community Water System Survey. Overview, 57. 305 USEPA. 2009. Provisional Peer-Reviewed Toxicity Values for Vanadium and Its Soluble Inorganic Compounds Other Than Vanadium Pentoxide (CASRN 7440-62-2 and Others), Derivation of Subchronic and Chronic Oral RfDs. EPA/690/R-09/070F. U.S. Environmental Protection Agency, Office of Research and Development, National Center for Environmental Assessment, Superfund Health Risk Technical Support Center, Cincinnati, OH. A-861 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Verapamil CCL 5 Contaminant Information Sheet EPA-OGWDWand OST CONTAMINANT IDENTIFYING INFORMATION Name: Verapamil CASRN: 52-53-9 DTXSID: DTXSID9041152 Use: Anti-arrhythmia agent Chemical Notes: Is the contaminant on any lists? CERCLA FIFRA Human Neurotoxicants PubMed Neu rotoxica nts X Neu rode v. Disruptors Androgen Receptors in vitro Compounds with neu rod ev effects, Mundy et a 12015 CONTAMINANT SUMMARY & DECISION CCL5 List Decision Not List ATTRIBUTE SCORE & FINAL HAZARD QUOTIENT IN FORMATION Potency Severity Prevalence Magnitude 6 non-cancer effects 4 1 Health Reference Level (HRL) or CCL Screening Level (SL) HRL or SL value (ug/L) Critical Effect Target Pop. Assessment Assessment Pub. Date SL 5 lowest therapeutic dose: management of hypertension bottle-fed infants FDA; NIH 2018; 2018 Cone, in water for HQ (ug/L) 90th Percentile or Maximum (if measured cone) Finished orAmbient (FW, SW, GW, WW) Source Date 0.001886 90th Percentile All Ambient Water NAWQA 1991-2017 Final Hazard Quotient (HQ) 0.00038 PUBLIC NOMINATION STATUS Public Nomination PAST CCL STATUS PAST NEGATIVE REGULATORY DETERMINATION STATUS Notes: The final hazard quotient is the ratio of the contaminant's concentration in water to its Health Reference Level (HRL) or CCL Screening Level. The HRL or CCL Screening Level for carcinogens is equivalent to the one-in-a-million cancer risk expressed as a drinking water concentration. For non-carcinogens, the toxicity value (RfD or equivalent) is divided by an exposure factor (i.e. drinking water intake level) relevant to the target population and critical effect and multiplied by a Relative Source Contribution of 20%. A-862 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Verapamil CCL 5 Contaminant Information Sheet HEALTH EFFECTS DATA Qualifying Assessments, Exposure Factors, and HRL Determination EPA-OGWDWand OST Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) HRL (ug/L) Assessment Full Citation Notes Non-Qualifying Assessments, Exposure Factors, and CCL Screening Level Determinations Data Element Value Units Assessment Source Critical Study Critical Effect Target Population Exposure Factor (mL/kg-day) CCL Screening Level (ug/L) Assessment Full Citation Notes Reference Dose (RfD) or Equivalent 0.00075 mg/kg/day FDA 2018; NIH 2018 Ranbaxy Laboratories Inc. lowest therapeutic dose: management of hypertension bottle-fed infants 151 0.993 [77] [150] NOTE: (Lowest Therapeutic Dose/3000x UF) is used in place of an RfD; LTDs were obtained from FDA-approved drug labels Reference Dose (RfD) or Equivalent 0.00075 mg/kg/day FDA 2018; NIH 2018 Ranbaxy Laboratories Inc. lowest therapeutic dose: management of hypertension general population 33.8 4.44 [77] [150] NOTE: (Lowest Therapeutic Dose/3000x UF) is used in place of an RfD; LTDs were obtained from FDA-approved drug labels Literature Search Summary Lowest LOAEL Health Effects Lowest LOAEL (mg/kg bw/day) Lowest LOAEL Study Highest NOAEL Health Effects Highest NOAEL (mg/kg bw/day) Highest NOAEL Study Start Date of Search End Date of Search No. Unique References identified in lit search No. Animal Studies passed Title-abstract Screen No. Human Studies passed Title-abstract Screen No. PECO Relevant Studies passed full-text review Other Health Data Data Element Value Units Source Notes Measured Data and Assessment Results Screening level for pharmaceutical - general 0.017647059 mg/L EPA Office of Water population Screening level for pharmaceutical - infants 0.005 mg/L EPA Office of Water Data Element Value Units Source Notes Measured Data and Assessment Results LD50 108 mg/kg NIH HSDB min LD50 163 mg/kg NIH HSDB max Percent of active toxcast in vitro assays tested 14.04 percent EPA Chemistry Dashboard Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. The full citation for the critical study is provided in the corresponding health assessment. PECO = Population, Exposure, Comparator, Outcome. Data Element Value Units Source Notes Modeled Data LD50 0.0010568 mo l/kg TEST QSAR Ames mutagenicity test -0.173 no units TEST QSAR Developmental toxin test 0.641 no units TEST QSAR A-863 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Verapamil CCL 5 Contaminant Information Sheet OCCURRENCE DATA EPA-OGWDW and OST Nationally Representative Water Data Date Number of PWS/ Sites/ Number of Detects PWS/Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Unregulated Contam nant Monitoring Rule (UCMR)4 2018-2019 Unregulated Contam nant Monitoring Rule (UCMR) 3 2013-2015 Unregulated Contam nant Monitoring Rule (UCMR) 2 2008-2010 Unregulated Contam nant Monitoring Rule (UCMR) 1 2001 - 2003 Unregulated Contam nant Monitoring-State (UCM-State) Round 2 1993 -1997 Unregulated Contam nant Monitoring-State (UCM-State) Round 1 1988 -1992 National Inorganics and Radionuclides Survev(NIRS) 1984 -1986 Ambient Water Prevalence Magnitude National Water Quality Assessment (USGS NAWQA) (All Water) 1991-2017 557 2 Sites 0.36 0.00031 0.0013 0.00189 0.00228 National Water Quality Assessment (USGS NAWQA) (Surface Water) 1991-2017 75 2 Sites 2.67 0.00031 0.0013 0.00189 0.00228 National Water Quality Assessment (USGS NAWQA) (Ground Water) 1991-2017 482 0 Sites 0 Pesticide Application Data Number of States Amount Applied (lbs/year) Date Toxic Release Data Number of States Amount Released (lbs/year) Chemical Production Data Production Volume (lbs/year) Estimated Annual Agricultural Pesticide Use (USGS) Toxic Release Inventory (TRI) Program (EPA) (2016) Chemical Data Reporting (CDR) Results (EPA) (2016) Non-Scoring Data Non-Nationally Representative Water Data Date Number of PWS/ Sites/ Samples Number of Detects PWS/ Sites/ Samples Percent with Detects Minimum Cone. (Detects) Median Cone. (Detects) 90th Percentile (Detects) Maximum Cone. (Detects) Cone. Units Notes Finished Water Prevalence Magnitude Glassmeyer et al 2017 (Finished) [86] 2007-2012 25 NA Sites 4 0.0267 0.0267 ug/L Ambient Water Prevalence Magnitude National Water Information System (USGS NWIS) (Surface Water) 2008-2017 210 9 Sites 4.29 4.00E - 04 0.0184 0.0541 0.161 ug/L National Water Information System (USGS NWIS) (Groundwater) 2008-2017 401 0 Sites 0 National Water Information System (USGS NWIS) (All Water) 2008-2017 611 9 Sites 1.47 4.00E - 04 0.0184 0.0541 0.161 ug/L Glassmeyer et al 2017 (Ambient) [86] 2007-2012 25 NA Sites 4 0.0459 0.0459 ug/L Batt et al. 2016 (Ambient) [46] 2008 - 2009 182 39 Sites 21 9e-04 0.0032 0.015 0.0358 ug/L Bradley et al. 2017 (Ambient) [52] 2012-2014 38 6 Sites 16 0.0007812 0.00358 0.0099 0.0129033 ug/L Bexfieid et al. 2019 (Groundwater) [49] 2013-2015 1,106 0 Sites 0 Waste Water Effluent Prevalence Magnitude Scott et al. 2018 (Wastewater) [161] 2011-2017 21 12 Sites 57 0.0095317 0.0228 0.132 4.119285 ug/L Kostich et al. 2014 (Wastewater) [126] not reported 49 39 Sites 80 0.0053 0.021 0.0502 0.0971 ug/L Batt et al. (2008) via Kostich et al. 2010 (Wastewater) [127] 2010 NA NA 0.19 ug/L Estimated Concentration in Water Date Source Value Units Model Notes Predicted Exposure Data (EPA CompTox Dashboard) Date Total Predicted Exposure (mg/kg bw/ day) Notes Expocast exposure 0.000000276 Biomonitoring Data Detection at 90th Percentile Units Notes NHANES biomonitoring detection in serum (1999-2016) NHANES biomonitoring detection in blood (1999-2016) NHANES biomonitoring detection in urine (1999-2016) Notes: Highlighted data indicate value was used in attribute scoring. Blank fields indicate there were no data available. "All Water" data from NWIS and NAWQA are combined surface water and groundwater data. Monitoring dates for non-scoring data and NAWQA are not chemical-specific and may not contain samples for all years listed. State Drinking Water Monitoring Data with a max date range of 2020 may contain few samples from early 2020. UCMR 4 data used in the CCL5 is a partial dataset and will be complete in Dec. 2020. Modeled Environmental Fate Parameters (EPA CompTox Dashboard) Source Value Units Notes Biodegradation half-life OPERA QSAR 7.28169 days Boiling point OPERA QSAR 425.134 degree C Boiling point TEST QSAR 489.98 degree C Vapor pressure OPERA QSAR 6.02E-10 mmHg Vapor pressure TEST QSAR 1.22E-09 mmHg Solubility in water OPERA QSAR 0.000000569 mol/L Solubility in water TEST QSAR 0.000000891 mol/L Bioconcentration factor OPERA QSAR 200.744 no units Bioconcentration factor TEST QSAR 197.242 no units Henry's Law constant OPERA QSAR 0.000000428 atm-mA3/mol 0 eta no l/water partitioning coeff. (log Kow) OPERA QSAR 3.88495 no units A-864 ------- EPA - Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA 815-R-22-003 October 2022 Verapamil CCL 5 Contaminant Information Sheet EPA-OGWDW and OST October 2022 Reference Number Full Reference 46 Batt, A. L., Kincaid, T. M., Kostich, M. S., Lazorchak, J. M., & Olsen, A. R. (2016). Evaluating the extent of pharmaceuticals in surface waters of the United States using a Nationaicale Rivers and Streams Assessment survey. Environmental toxicology and chemistry, 35(4), 874-881. 49 Bexfield, L.M., P.L. Toccalino, K. Belitz, W.T. Foreman, and E.T. Furlong. 2019. Hormones and pharmaceuticals in groundwater used as a source of drinking water across the United States. Environmental Science and Technology 53: 2950-2960. 52 Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T.,... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. 77 FDA. 2018. Drugs @ FDA: FDA Approved Drug Products. U.S. Food and Drug Administration (FDA), https://www.accessdata.fda.gov/scripts/cder/daf/. 86 Glassmeyer, S.T., Furlong, E.T., Kolpin, D.W., Batt, A.L., Benson, R., Boone, J.S.,... & Wilson, V.S. (2017). Nationwide reconnaissance of contaminants of emerging concern in source and treated drinking waters of the United States. Science of The Total Environment. v581-582, (909-922). 126 Kostich MS, et al. 2014 Concentrations of prioritized pharmaceuticals in effluents from 50 large wastewater treatment plants in the US and implications for risk estimation. Environ Pollut. 2014 Jan;184:354-9. doi: 10.1016/j.envpol.2013.09.013. Epub 2013 Oct 3. PMID: 24095705. 127 Kostich, MS, et al., 2010. Predicting variability of aquatic concentrations of human pharmaceuticals. Sci. Total Environ. 408 (20), 4504e4510. 150 NIH. 2018. DailyMed Database. U.S. National Library of Medicine, National Institutes of Health (NIH). https://dailymed.nlm.nih.gov/dailymed/. 161 Scott, T. M., Phillips, P. J., Kolpin, D. W., Colella, K. M., Furlong, E. T., Foreman, W. T., & Gray, J. L. (2018). Pharmaceutical manufacturing facility discharges can substantially increase the pharmaceutical load to US wastewaters. Science of the Total Environment, 636, 69-79. A-865 ------- EPA-Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA815-R-22-003 October 2022 Appendix B Contaminant Information Sheet References [1] Agency for Toxic Substances and Disease Registry (ATSDR). 1993. Toxicological Profile for Aldrin/Dieldrin (update). Atlanta: Agency for Toxic Substances and Disease Registry. 184 pp [2] Agency for Toxic Substances and Disease Registry (ATSDR). 1993. Toxicological Profile for Aldrin/Dieldrin (update). Atlanta: Agency for Toxic Substances and Disease Registry. 184 pp. [3] Agency for Toxic Substances and Disease Registry (ATSDR). 1995. Toxicological Profile for Naphthalene (Update). Atlanta: Agency for Toxic Substances and Disease Registry. 200pp. [4] Agency for Toxic Substances and Disease Registry (ATSDR). 1996. Toxicological Profile for 1,1,2,2- Tetrachloroethane. Atlanta, GA: Agency for Toxic Substances and Disease Registry, Public Health Service, U.S. Department of Health and Human Services. Available on the Internet at: http://www.atsdr.cdc.gov/toxprofiles/tp93.html. [5] Alvarez DA, Stackelberg PE, Petty JD, Huckins JN, Furlong ET, Zaugg SD, Meyer MT., 2005. Comparison of a novel passive sampler to standard water-column sampling for organic contaminants associated with wastewater effluents entering a New Jersey stream. Chemosphere. 61(5), pp.610-22 [6] American Conference of Governmental Industrial Hygienists (ACGIH). 1984. Documentation of the Threshold Limit Values for Substances in Workroom Air. Third Edition. Cincinnati, OH: ACGIH. 139 pp. [7] Arnold, T.L., DeSimone, L.A., Bexfield, L.M., Lindsey, B.D., Barlow, J.R., Kulongoski, J.T., Musgrove, MaryLynn, Kingsbury, J.A., and Belitz, Kenneth, 2016, Groundwater quality data from the National Water-Quality Assessment Project, May 2012 through December 2013 (ver. 1.1, November 2016): U.S. Geological Survey Data Series 997, 56 p., http://dx.doi.org/10.3133/ds997. [8] ATSDR. 1992. Toxicological Profile for 1,2,3-Trichloropropane. U.S. Department of Health and Human Services, Public Health Service, Agency for Toxic Substances and Disease Registry (ATSDR), Atlanta, GA. [9] ATSDR. 1995. Toxicological Profile for Diethyl Phthalate. U.S. Department of Health and Human Services, Public Health Service, Agency for Toxic Substances and Disease Registry (ATSDR), Atlanta, GA. [10] ATSDR. 1995. Toxicological Profile for Polycyclic Aromatic Hydrocarbons. U.S. Department of Health and Human Services, Public Health Service, Agency for Toxic Substances and Disease Registry (ATSDR), Atlanta, GA. [11] ATSDR. 1996. Toxicological Profile for Carbon Disulfide. U.S. Department of Health and Human Services, Public Health Service, Agency for Toxic Substances and Disease Registry (ATSDR), Atlanta, GA. [12] ATSDR. 1996. Toxicological Profile for Methyl tert-Butyl Ether. U.S. Department of Health and Human Services, Public Health Service, Agency for Toxic Substances and Disease Registry (ATSDR), Atlanta, GA. [13] ATSDR. 1998. Toxicological Profile for Chloromethane. U.S. Department of Health and Human Services, Public Health Service, Agency for Toxic Substances and Disease Registry (ATSDR), Atlanta, GA. B-1 ------- EPA-Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA815-R-22-003 October 2022 [14] ATSDR. 1999. Toxicological Profile for Chlorophenols. U.S. Department of Health and Human Services, Public Health Service, Agency for Toxic Substances and Disease Registry (ATSDR), Atlanta, GA. [15] ATSDR. 1999. TOXICOLOGICAL PROFILE FOR MERCURY. U.S. Department of Health and Human Services, Public Health Service, Agency for Toxic Substances and Disease Registry (ATSDR), Atlanta, GA. [16] ATSDR. 2000. Toxicological Profile for Aldrin/Dieldrin (Update). Atlanta, GA: Agency for Toxic Substances and Disease Registry. 280 pp. [17] ATSDR. 2001. Toxicological Profile for Di-n-Butyl Phthalate. U.S. Department of Health and Human Services, Public Health Service, Agency for Toxic Substances and Disease Registry (ATSDR), Atlanta, GA. [18] ATSDR. 2002. Toxicological Profile for Aldrin/Dieldrin. U.S. Department of Health and Human Services, Public Health Service, Agency for Toxic Substances and Disease Registry (ATSDR), Atlanta, GA. [19] ATSDR. 2004. Toxicological Profile for Ammonia. U.S. Department of Health and Human Services, Public Health Service, Agency for Toxic Substances and Disease Registry (ATSDR), Atlanta, GA. [20] ATSDR. 2004. Toxicological Profile for Cobalt. U.S. Department of Health and Human Services, Public Health Service, Agency for Toxic Substances and Disease Registry (ATSDR), Atlanta, GA. [21] ATSDR. 2004. Toxicological Profile for Strontium. U.S. Department of Health and Human Services, Public Health Service, Agency for Toxic Substances and Disease Registry (ATSDR), Atlanta, GA. [22] ATSDR. 2005. Toxicological Profile for Alpha-, Beta-, Gamma-, and Delta-Hexachlorocyclohexane. U.S. Department of Health and Human Services, Public Health Service, Agency for Toxic Substances and Disease Registry (ATSDR), Atlanta, GA. [23] ATSDR. 2005. Toxicological Profile for Naphthalene, 1-Methylnaphthalene, and 2- Methylnaphthalene. U.S. Department of Health and Human Services, Public Health Service, Agency for Toxic Substances and Disease Registry (ATSDR), Atlanta, GA. [24] ATSDR. 2005. Toxicological Profile for Tin and Tin Compounds. U.S. Department of Health and Human Services, Public Health Service, Agency for Toxic Substances and Disease Registry (ATSDR), Atlanta, GA. [25] ATSDR. 2005. Toxicological Profile for Tungsten. U.S. Department of Health and Human Services, Public Health Service, Agency for Toxic Substances and Disease Registry (ATSDR), Atlanta, GA. [26] ATSDR. 2007. Toxicological Profile for Acrolein. U.S. Department of Health and Human Services, Public Health Service, Agency for Toxic Substances and Disease Registry (ATSDR), Atlanta, GA. [27] ATSDR. 2008. Toxicological Profile for 1,1,2,2-Tetrachloroethane. U.S. Department of Health and Human Services, Public Health Service, Agency for Toxic Substances and Disease Registry (ATSDR), Atlanta, GA. [28] ATSDR. 2010. Toxicological Profile for Boron. U.S. Department of Health and Human Services, Public Health Service, Agency for Toxic Substances and Disease Registry (ATSDR), Atlanta, GA. [29] ATSDR. 2012. Toxicological Profile for 1,3-Butadiene. U.S. Department of Health and Human Services, Agency for Toxic Substances and Disease Registry (ATSDR), Atlanta, GA. B-2 ------- EPA-Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA815-R-22-003 October 2022 [30] ATSDR. 2012. Toxicological Profile for 1,4-Dioxane. U.S. Department of Health and Human Services, Public Health Service, Agency for Toxic Substances and Disease Registry (ATSDR), Atlanta, GA. [31] ATSDR. 2012. Toxicological Profile for Phosphate Ester Flame Retardants. U.S. Department of Health and Human Services, Public Health Service, Agency for Toxic Substances and Disease Registry (ATSDR), Atlanta, GA. [32] ATSDR. 2012. Toxicological Profile for Vanadium. U.S. Department of Health and Human Services, Public Health Service, Agency for Toxic Substances and Disease Registry (ATSDR), Atlanta, GA. [33] ATSDR. 2013. Addendum to the Toxicological Profile for Mercury (Alkeyl and Dialkyl compounds). U.S. Department of Health and Human Services, Public Health Service, Agency for Toxic Substances and Disease Registry (ATSDR), Atlanta, GA [34] ATSDR. 2016. Toxicological Profile for Dinitrotoluenes. U.S. Department of Health and Human Services, Public Health Service, Agency for Toxic Substances and Disease Registry (ATSDR), Atlanta, GA. [35] ATSDR. 2017. Toxicological Profile for DEET (N,N-Diethyl-Meta-Toluamide). U.S. Department of Health and Human Services, Public Health Service, Agency for Toxic Substances and Disease Registry (ATSDR), Atlanta, GA. [36] ATSDR. 2018. Toxicological Profile for Isophorone. U.S. Department of Health and Human Services, Public Health Service, Agency for Toxic Substances and Disease Registry (ATSDR), Atlanta, GA. [37] ATSDR. 2019.Toxicological Profile for Dinitrophenols DRAFT FOR PUBLIC COMMENT. U.S. Department of Health and Human Services, Public Health Service, Agency for Toxic Substances and Disease Registry (ATSDR), Atlanta, GA. [38] Auriol M, Filali-Meknassi Y, Adams CD, Tyagi RD, Noguerol TN, Pina B., 2008. Removal of estrogenic activity of natural and synthetic hormones from a municipal wastewater: efficiency of horseradish peroxidase and laccase from Trametes versicolor. Chemosphere. 70(3), pp.445-52 [39] Bailey, D.E. 1988. 14-Day oral toxicity study in the dog with AC 92 100 and its metabolites, CL 94 301 and CL94320. Unpublished report on HLA Study No. 362-190 (BASF RDI No.TE-420-007) from Hazleton Laboratories America, Inc., Vienna, VA, USA (as cited in USEPA, 2003). [40] Barnes KK, Kolpin DW, Furlong ET, Zaugg SD, Meyer MT, Barber LB., 2008. A national reconnaissance of pharmaceuticals and other organic wastewater contaminants in the United States-I) groundwater. The Science of the total environment. 402(2-3), pp.192-200 [41] Batt AL, Aga DS., 2005. Simultaneous analysis of multiple classes of antibiotics by ion trap LC/MS/MS for assessing surface water and groundwater contamination. Analytical chemistry. 77(9), pp.2940-7 [42] Batt AL, Bruce IB, Aga DS, 2006 . Evaluating the vulnerability of surface waters to antibiotic contamination from varying wastewater treatment plant discharges. Environmental pollution. 142(2), pp.295-302 [43] Batt AL, Kim S, Aga DS., 2006 . Enhanced biodegradation of iopromide and trimethoprim in nitrifying activated sludge. Environmental science & technology. 40(23), pp.7367-73 B-3 ------- EPA-Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA815-R-22-003 October 2022 [44] Batt AL, Kim S, Aga DS., 2007 . Comparison of the occurrence of antibiotics in four full-scale wastewater treatment plants with varying designs and operations. Chemosphere. 68(3), pp.428-35 [45] Batt AL, Kostich MS, Lazorchak JM., 2008 . Analysis of ecologically relevant pharmaceuticals in wastewater and surface water using selective solid-phase extraction and UPLC-MS/MS. Analytical chemistry. 80(13), pp.5021-30 [46] Batt, A. L., Kincaid, T. M., Kostich, M. S., Lazorchak, J. M., & Olsen, A. R. (2016). Evaluating the extent of pharmaceuticals in surface waters of the United States using a National-scale Rivers and Streams Assessment survey. Environmental toxicology and chemistry, 35(4), 874-881. [47] Benotti MJ, Brownawell BJ., 2007 . Distributions of pharmaceuticals in an urban estuary during both dry- and wet-weather conditions. Environmental science & technology. 41(16), pp.5795-802 [48] Benotti MJ, Trenholm RA, Vanderford BJ, Holady JC, Stanford BD, Snyder SA., 2009 . Pharmaceuticals and endocrine disrupting compounds in U.S. drinking water. Environmental science & technology. 43(3), pp.597-603 [49] Bexfield, L.M., P.L. Toccalino, K. Belitz, W.T. Foreman, and E.T. Furlong. 2019. Hormones and pharmaceuticals in groundwater used as a source of drinking water across the United States. Environmental Science and Technology 53: 2950-2960. [50] Boyd GR, Palmeri JM, Zhang S, Grimm DA., 2004. Pharmaceuticals and personal care products (PPCPs) and endocrine disrupting chemicals (EDCs) in stormwater canals and Bayou St. John in New Orleans, Louisiana, USA. The Science of the total environment. 333(1-3), pp.137-48 [51] Boyd GR, Reemtsma H, Grimm DA, Mitra S., 2003 . Pharmaceuticals and personal care products (PPCPs) in surface and treated waters of Louisiana, USA and Ontario, Canada. The Science of the total environment. 311(1-3), pp.135-49 [52] Bradley, P. M., Journey, C. A., Romanok, K. M., Barber, L. B., Buxton, H. T., Foreman, W. T., ... & Jones, D. K. (2017). Expanded target-chemical analysis reveals extensive mixed-organic-contaminant exposure in US streams. Environmental science & technology, 51(9), 4792-4802. [53] Bradley, P. M., Kolpin, D. W., Romanok, K. M., Smalling, K. L., Focazio, M. J., Brown, J. B., ... & Dietze, J. E. (2018). Reconnaissance of mixed organic and inorganic chemicals in private and public supply tapwaters at selected residential and workplace sites in the United States. Environmental science & technology, 52(23), 13972-13985. [54] Brown KD, Kulis J, Thomson B, Chapman TH, Mawhinney DB., 2006. Occurrence of antibiotics in hospital, residential, and dairy effluent, municipal wastewater, and the Rio Grande in New Mexico. The Science of the total environment. 366(2-3), pp.772-83 [55] CalEPA. 1992. Expedited Cancer Potency Values and Proposed Regulatory Levels for Certain Proposition 65 Carcinogens. California Environmental Protection Agency (CalEPA), Office of Environmental Health Hazard Assessment, Reproductive and Cancer Hazard Assessment Section, Sacramento, CA. B-4 ------- EPA-Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA815-R-22-003 October 2022 [56] CalEPA. 1999. Public Health Goal for Methyl Tertiary Butyl Ether (MTBE) in Drinking Water. California Environmental Protection Agency (CalEPA), Office of Environmental Health Hazard Assessment, Pesticide and Environmental Toxicology Section, Sacramento, CA. [57] CalEPA. 2003. Public Health Goal for 1,1,2,2-Tetrachloroethane in Drinking Water. California Environmental Protection Agency (CalEPA), Office of Environmental Health Hazard Assessment, Sacramento, CA. [58] CalEPA. 2009. Development of a Reference Dose (RfD) for Methamphetamine. California Environmental Protection Agency (CalEPA), Office of Environmental Health Hazard Assessment, Integrated Risk Assessment Branch, Sacramento, CA. [59] CalEPA. 2009. Public Health Goals for Chemicals in Drinking Water, 1,2,3-Trichloropropane. California Environmental Protection Agency (CalEPA), Office of Environmental Health Hazard Assessment, Pesticide and Environmental Toxicology Branch, Sacramento, CA. [60] CalEPA. 2009. Technical Support Document for Cancer Potency Factors, Appendix B. California Environmental Protection Agency (CalEPA), Office of Environmental Health Hazard Assessment, Air Toxicology and Epidemiology Branch, Sacramento, CA. [61] CalEPA. 2017. Public Health Concentration: Metolachlor and Metolachlor Degradates Ethanesulfonic Acid and Oxanilic Acid in Groundwater. California Environmental Protection Agency (CalEPA), Office of Environmental Health Hazard Assessment, Pesticide and Environmental Toxicology Branch, Sacramento, CA. [62] Cha JM, Yang S, Carlson KH., 2006. Trace determination of beta-lactam antibiotics in surface water and urban wastewater using liquid chromatography combined with electrospray tandem mass spectrometry. Journal of chromatography. A. 1115(1-2), pp.46-57 [63] Chimchirian RF, Suri RP, Fu H., 2007 . Free synthetic and natural estrogen hormones in influent and effluent of three municipal wastewater treatment plants. Water environment research. 79(9), pp.969-74 [64] Conkle JL, White JR, Metcalfe CD., 2008 . Reduction of pharmaceutical^ active compounds by a lagoon wetland wastewater treatment system in Southeast Louisiana. Chemosphere. 73(11), pp.1741-8 [65] Conley JM, Symes SJ, Kindelberger SA, Richards SM., 2008 . Rapid liquid chromatography-tandem mass spectrometry method for the determination of a broad mixture of pharmaceuticals in surface water. Journal of chromatography. A. 1185(2), pp.206-15 [66] Conley JM, Symes SJ, Schorr MS, Richards SM., 2008 . Spatial and temporal analysis of pharmaceutical concentrations in the upper Tennessee River basin. Chemosphere. 73(8), pp.1178-87 [67] Danish Environmental Protection Agency. 2018. Substance Evaluation Conclusion as required by REACH Article 48 and Evaluation Report for Benzophenone EC No 204-337-6 CAS No 119-61-9. Copenhagen, Denmark. EC No 204-337-6 [68] Delzer, G.C. and T. Ivahnenko. 2003. Occurrence and Temporal Variability of Methyl tertButyl Ether (MTBE) and Other Volatile Organic Compounds in Select Sources of Drinking Water: Results of the Focused Survey. U.S. Geological Survey WaterResources Investigations Report 02-4084. 65 pp. Available on the Internet at: http://sd.water.usgs.gov/nawqa/pubs/wrir/wrir02_4084.pdf. B-5 ------- EPA-Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA815-R-22-003 October 2022 [69] Drewes JE, Heberer T, Reddersen K., 2002. Fate of pharmaceuticals during indirect potable reuse. Water science and technology. 46(3), pp.73-80 [70] ECHA. 2011. Registration Dossier for Androst-4-ene-3,17-dione. European Chemicals Agency (ECHA), Helsinki, Finland. https://echa.europa.eu/registration-dossier/-/registered-dossier/13632/l Accessed 5/14/2020. [71] ECHA. 2011. Registration Dossier: l,3,4,6,7,8-hexahydro-4,6,6,7,8,8-hexamethylindeno[5,6-c]pyran. European Chemicals Agency (ECHA), Helsinki, Finland, https://echa.europa.eu/registration-dossier/- /registered-dossier/14504/1. Accessed 03/03/2020 [72] ECHA. 2015. Committee for Risk Assessment (RAC) Opinion on an Annex XV dossier proposing restrictions on bisphenol A. European Chemicals Agency (ECHA), Helsinki, Finland. ECHA/RAC/RES-O- 0000001412-86-56/F. [73] ECHA. 2017. Registration Dossier: Strontium. European Chemicals Agency (ECHA), Helsinki, Finland. https://echa.europa.eu/registration-dossier/-/registered-dossier/19651/l. Accessed 03/09/2020 [74] ECHA. Registration Dossier for Tris(2-butoxyethyl) phosphate. European Chemicals Agency (ECHA), Helsinki, Finland. https://echa.europa.eu/registration-dossier/-/registered-dossier/14166/10 Accessed 2/5/2020. [75] EPA Region 4. Village Creek Dieldrin Screening. June 2015. https://www.birminghamal.gov/wp- content/uploads/2017/08/15-0308-Village-Creek-Dieldrin-Screening-Final-Report-v081015.pdf [76] FDA. 2000. Public Health Advisory. Subject: Safety of Phenylpropanolamine. Food and Drug Administration, Nonprescription Drugs Advisory Committee, Silver Spring, MD. [77] FDA. 2018. Drugs @ FDA: FDA Approved Drug Products. U.S. Food and Drug Administration (FDA). https://www.accessdata.fda.gov/scripts/cder/daf/. [78] Finkelstein M. and Gold, H. 1959. Toxicology of the citric acid esters: tributyl citrate, acetyl tributyl citrate, triethyl citrate, and acetyl triethyl citrate. Toxicology and applied pharmacology. 1(283-98). [79] Focazio MJ, Kolpin DW, Barnes KK, Furlong ET, Meyer MT, Zaugg SD, Barber LB, Thurman ME., 2008 . A national reconnaissance for pharmaceuticals and other organic wastewater contaminants in the United States-ll) untreated drinking water sources. The Science of the total environment. 402(2-3), pp.201-16 [80] Fono LJ, Kolodziej EP, Sedlak DL., 2006. Attenuation of wastewater-derived contaminants in an effluent-dominated river. Environmental science & technology. 40(23), pp.7257-62 [81] Fono LJ, Sedlak DL., 2005. Use of the chiral pharmaceutical propranolol to identify sewage discharges into surface waters. Environmental science & technology. 39(23), pp.9244-52 [82] Frey, M.M., C. Seidel, M. Edwards, J. Parks, and L. McNeill. 2004. Occurrence Survey for Boron and Hexavalent Chromium. AwwaRF Report 91044F. [83] Furlong, E.T., Batt, A.L., Glassmeyer, S.T., Noriega, M.C., Kolpin, D.W., Mash, H., Schenck, K.M. (2017). Nationwide reconnaissance of contaminants of emerging concern in source and treated drinking waters of the United States: Pharmaceuticals. Science of The Total Environment. 579 (1629-1642). B-6 ------- EPA-Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA815-R-22-003 October 2022 [84] Gidron, E. and J. Leurer. 1956. Naphthalene Poisoning. Lancet. 4:228-230 (as cited in ATSDR, 1995). [85] Glassmeyer ST, Furlong ET, Kolpin DW, Cahill JD, Zaugg SD, Werner SL, Meyer MT, Kryak DD., 2005. Transport of chemical and microbial compounds from known wastewater discharges: potential for use as indicators of human fecal contamination. Environmental science & technology. 39(14), pp.5157-69 [86] Glassmeyer, S.T., Furlong, E.T., Kolpin, D.W., Batt, A.L., Benson, R., Boone, J.S., ... & Wilson, V.S. (2017). Nationwide reconnaissance of contaminants of emerging concern in source and treated drinking waters of the United States. Science of The Total Environment. v581-582, (909-922). [87] Grady, S.J. 2003. A National Survey of Methyl tert-Butyl Ether and Other Volatile Organic Compounds in Drinking-Water Sources: Results of the Random Survey. U.S. Geological Survey Water- Resources Investigations Report 02-4079. 85 pp. Available on the Internet at: http://sd.water.usgs.gov/nawqa/pubs/wrir/wrir02 4079.pdf. [88] Gross B, Montgomery-Brown J, Naumann A, Reinhard M., 2004 . Occurrence and fate of pharmaceuticals and alkylphenol ethoxylate metabolites in an effluent-dominated river and wetland. Environmental toxicology and chemistry . 23(9), pp.2074-83 [89] Haggard BE, Galloway JM, Green WR, Meyer MT., 2006 . Pharmaceuticals and other organic chemicals in selected north-central and northwestern Arkansas streams. Journal of environmental quality. 35(4), pp.1078-87 [90] HC. 1990. Guideline Technical Document - Boron. Health Canada (HC), Water and Air Quality Bureau, Healthy Environments and Consumer Safety Branch, Ottawa, Ontario, Canada. [91] HC. 1992. Guideline Technical Document - Sodium. Health Canada (HC), Water and Air Quality Bureau, Healthy Environments and Consumer Safety Branch, Ottawa, Ontario, Canada. [92] HC. 2002. Guidelines for Canadian Drinking Water Quality: Supporting Documentation. Health Canada (HC), Ottawa, Ontario, Canada. [93] HC. 2008. Guidance on Potassium from Water Softeners. Health Canada (HC), Water, Air and Climate Change Bureau, Healthy Environments and Consumer Safety Branch, Ottawa, Ontario, Canada. [94] HC. 2017. Guidelines for Canadian Drinking Water Quality, Guideline Technical Document: Cyanobacterial Toxins. Health Canada (HC), Federal-Provincial-Territorial Committee on Drinking Water of the Federal-Provincial-Territorial Committee on Health and the Environment, Ottawa, Ontario, CA. [95] HC. 2018. Guideline Technical Document for Public Consultation, 1,4-Dioxane in Drinking Water. Health Canada (HC), Ottawa, Ontario, Canada. [96] HC. 2019. Guideline Technical Document - Strontium. Guidelines for Canadian Drinking Water Quality. Health Canada (HC), Water and Air Quality Bureau, Healthy Environments and Consumer Safety Branch, Ottawa, Ontario, Canada. [97] HC. 2019. Guidelines for Canadian Drinking Water Quality Summary Table. Health Canada (HC), Water and Air Quality Bureau, Health Environments and Consumer Safety Branch, Ottawa, Ontario, Canada. B-7 ------- EPA-Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA815-R-22-003 October 2022 [98] Health Canada. 1987. Guideline Technical Document - Chlorophenols. Health Canada (HC), Water and Air Quality Bureau, Healthy Environments and Consumer Safety Branch, Ottawa, Ontario, Canada. [99] Health Canada. 2006. Guidelines for Canadian Drinking Water Quality: Guidline Technical Document Methyl Tertiary-Butyl Ether. Health Canada (HC), Ottawa, Ontario, Canada. [100] Health Canada. 2013 Guideline Technical Document Ammonia. Health Canada (HC), Ottawa, Ontario, Canada. [101] Health Canada. 2019. Guideline Technical Document Manganese. Health Canada (HC), Ottawa, Ontario, Canada. [102] https://webapps.usgs.gOv/rsqa/#l/region/SESQA [103] Huang CH, Sedlak DL., 2001. Analysis of estrogenic hormones in municipal wastewater effluent and surface water using enzyme-linked immunosorbent assay and gas chromatography/tandem mass spectrometry. Environmental Toxicology and Chemistry. 20(1), pp.133-9 [104] Huggett DB, Khan IA, Foran CM, Schlenk D., 2003. Determination of beta-adrenergic receptor blocking pharmaceuticals in United States wastewater effluent. Environmental pollution . 121(2), pp.199-205 [105] Illinois Environment Protection Agency (EPA). 2008. "Report on Pharmaceutical Substances and Personal Care Products in Illinois Drinking Water Bureau of Water." Springfield, IL: Illinois EPA. [106] Institute of Medicine (IOM). 2001. Dietary Reference Intakes for Vitamin A, Vitamin K, Arsenic, Boron, Chromium, Copper, Iodine, Iron, Manganese, Molybdenum, Nickel, Silicon, Vanadium and Zinc: A Report of the Panel on Micronutrients, Subcommittees on Upper Reference Levels of Nutrients and of Interpretation and Use of Dietary Reference Intakes, and the Standing Committee on the Scientific Evaluation of Dietary Reference Intakes, Food and Nutrition Board, Institute of Medicine. Washington, DC: National Academy Press (prepublication version). Available on the Internet at: http://www.nap.edu/catalog/10026.html. [107] IOM. 1997. Standing Committee on the Scientific Evaluation of Dietary Reference Intakes, Food and Nutrition Board. Dietary Reference Intakes for calcium, phosphorus, magnesium, vitamin D, and fluoride. Institute of Medicine (IOM), National Academy Press, Washington, DC. [108] IOM. 2001. Dietary Reference Intakes for Vitamin A, Vitamin K, Arsenic, Boron, Chromium, Copper, Iodine, Iron, Manganese, Molybdenum, Nickel, Silicon, Vanadium, and Zinc. Institute of Medicine (IOM), National Academies of Science, Washington, D.C. [109] IOM. 2005. Dietary Reference Intakes for Water, Potassium, Sodium, Chloride, and Sulfate. Institute of Medicine (IOM), National Academies of Science, Washington, D.C. [110] IOM. 2005. Dietary Reference Intakes for Water, Potassium, Sodium, Chloride, and Sulfate. Institute of Medicine (IOM), National Academy of Science, Washington, D.C. [111] IOM. 2010. Dietary Reference Intakes for Calcium and Vitamin D. Institute of Medicine (IOM), National Academies of Science, Washington, D.C. B-8 ------- EPA-Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA815-R-22-003 October 2022 [112] IOM. 2019. Dietary Reference Intakes for Sodium and Potassium (2019). Institute of Medicine (IOM), National Academies of Science, Washington, D.C. [113] Jager, K.W. 1970. Aldrin, Dieldrin, Endrin and Telodrin: An Epidemiological and Toxicological Study of Long-Term Occupational Exposure. New York: Elsevier Publishing Company. 234 pp. [114] Jones-Lepp TL, Alvarez DA, Petty JD, Huckins JN., 2004 . Polar organic chemical integrative sampling and liquid chromatography-electrospray/ion-trap mass spectrometry for assessing selected prescription and illicit drugs in treated sewage effluents. Archives of environmental contamination and toxicology. 47(4), pp.427-39 [115] Karthikeyan KG, Meyer MT., 2006. Occurrence of antibiotics in wastewater treatment facilities in Wisconsin, USA. The Science of the total environment. 361(1-3), pp.196-207 [116] Kim SC, Carlson K., 2007. Temporal and spatial trends in the occurrence of human and veterinary antibiotics in aqueous and river sediment matrices. Environmental science & technology. 41(1), pp.50-7 [117] Klarich, K.L., Pflug, N.C., DeWald, E.M., Hladik, M.L., Kolpin, D.W., Cwiertny, D.M. and LeFevre, G.H., 2017. Occurrence of neonicotinoid insecticides in finished drinking water and fate during drinking water treatment. Environmental Science & Technology Letters, 4(5), pp.168-173. [118] Kleywegt, S., V. Pileggi, P. Yang, C. Hao, X. Zhao, C. Rocks, S. Thach, P. Cheung, and B. Whitehead. 2011. "Pharmaceutical Substances, Hormones and Bisphenol A in Untreated Source and Finished Drinking Water in Ontario, Canada Occurrence and Treatment Efficiency." Sci. Total Environ. 409: 1481-1488. [119] Koch DE, Bhandari A, Closb L, Hunter RP., 2005. Azithromycin extraction from municipal wastewater and quantitation using liquid chromatography/mass spectrometry. Journal of chromatography. A. 1074(1-2), pp.17-22 [120] Kolodziej EP, GrayJL, Sedlak DL., 2003 . Quantification of steroid hormones with pheromonal properties in municipal wastewater effluent. Environmental Toxicology and Chemistry. 22(11), pp.2622- 9 [121] Kolpin DW, Furlong ET, Meyer MT, Thurman EM, Zaugg SD, Barber LB, Buxton HT., 2002 . Pharmaceuticals, hormones, and other organic wastewater contaminants in U.S. streams, 1999-2000: a national reconnaissance. Environmental science & technology. 36(6), pp.1202-11 [122] Kolpin DW, Skopec M, Meyer MT, Furlong ET, Zaugg SD., 2004 . Urban contribution of pharmaceuticals and other organic wastewater contaminants to streams during differing flow conditions. The Science of the total environment. 328(1-3), pp.119-30 [123] Kolpin, D.W. and J.D. Martin. 2003. Pesticides in Ground Water: Summary Statistics; Preliminary Results from Cycle I of the National Water Quality Assessment Program (NAWQA), 1992-2001. Available on the Internet at: http://ca.water.usgs.gov/pnsp/pestgw/Pest-GW_2001_Text.html. [124] Kolpin, D.W., J.E. Barbash, and R.J. Gilliom. 1998. Occurrence of Pesticides in Shallow Groundwater of the United States: Initial Results from the National Water Quality Assessment Program. Env. Sci. Tech. 32:558-566. B-9 ------- EPA-Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA815-R-22-003 October 2022 [125] Kormos, J.L. 2007. "Occurrence and Seasonal Variability of Selected Pharmaceutical Substances in Southern Ontario Drinking Water Supplies." MSc. Thesis, Biology, University of Waterloo, Waterloo, Ontario, Canada. [126] Kostich MS, et al. 2014 Concentrations of prioritized pharmaceuticals in effluents from 50 large wastewater treatment plants in the US and implications for risk estimation. Environ Pollut. 2014 Jan;184:354-9. doi: 10.1016/j.envpol.2013.09.013. Epub 2013 Oct 3. PMID: 24095705. [127] Kostich, MS, et al., 2010. Predicting variability of aquatic concentrations of human pharmaceuticals. Sci. Total Environ. 408 (20), 4504e4510. [128] Kumar, A. and Xagoraraki, I., 2010. Human health risk assessment of pharmaceuticals in water: An uncertainty analysis for meprobamate, carbamazepine, and phenytoin. Regulatory Toxicology and Pharmacology, 57(2-3), pp.146-156. [129] Levine AD, Meyer MT, Kish G., 2006. Evaluation of the persistence of micropollutants through pure-oxygen activated sludge nitrification and denitrification. Water environment research. 78(11), pp.2276-85 [130] Lin AY, Plumlee MH, Reinhard M., 2006. Natural attenuation of pharmaceuticals and alkylphenol polyethoxylate metabolites during river transport: photochemical and biological transformation. Environmental Toxicology and Chemistry. 25(6), pp.1458-64 [131] Lindsey ME, Meyer TM, Thurman EM., 2001. Analysis of trace levels of sulfonamide and tetracycline antimicrobials in groundwater and surface water using solid-phase extraction and liquid chromatography/mass spectrometry. Analytical chemistry. 73(19), pp.4640-6 [132] Loganathan B, Phillips M, Mowery H, Jones-Lepp TL., 2009. Contamination profiles and mass loadings of macrolide antibiotics and illicit drugs from a small urban wastewater treatment plant. Chemosphere. 75(1), pp.70-7 [133] Loraine GA, Pettigrove ME., 2006. Seasonal variations in concentrations of pharmaceuticals and personal care products in drinking water and reclaimed wastewater in southern California. Environmental science & technology. 40(3), pp.687-95 [134] Martin, J.D., C.G. Crawford, and S.J. Larson. 2003. Pesticides in Streams: Summary Statistics; Preliminary Results from Cycle I of the National Water Quality Assessment Program (NAWQA), 1992- 2001. Available on the Internet at: http://ca.water.usgs.gov/pnsp/pestsw/Pest-SW_2001_Text.html. [135] MDH. 2013. Dimethenamid Degradates: ESA and OXA. Health Based Guidance for Water. Minnesota Department of Health (MDH), Environmental Health Division, Health Risk Assessment Unit, St Paul, MN. [136] MDH. 2015. Toxicological Summary for p-Nonylphenol, branched isomers. Minnesota Department of Health (MDH), Environmental Health Division, Health Risk Assessment Unit, St Paul, MN. [137] MDH. 2015. Toxicological Summary for: 4-tert-Octylphenol. Minnesota Department of Health (MDH), Environmental Health Division, Health Risk Assessment Unit, St Paul, MN. B-10 ------- EPA-Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA815-R-22-003 October 2022 [138] MDH. 2015. Toxicological Summary for: Bisphenol A. Minnesota Department of Health (MDH), Environmental Health Division, Health Risk Assessment Unit, St Paul, MN. [139] MDH. 2015. Toxicological Summary for: Microcystin LR. Minnesota Department of Health (MDH), Environmental Health Division, Health Risk Assessment Unit, St Paul, MN. [140] MDH. 2016. Toxicological Summary for: Alachlor ESA and Alachlor OXA. Health Based Guidance for Water. Minnesota Department of Health (MDH), Environmental Health Division, Health Risk Assessment Unit, St Paul, MN. [141] MDH. 2016. Toxicological Summary for: anatoxin-a. Minnesota Department of Health (MDH), Environmental Health Division, Health Risk Assessment Unit, St Paul, MN. [142] MDH. 2018. Toxicological Summary for: Acetochlor ESA. Health Based Guidance for Water. Minnesota Department of Health (MDH), Environmental Health Division, Health Risk Assessment Unit, St Paul, MN. [143] MDH. 2018. Toxicological Summary for: Acetochlor OXA. Health Based Guidance for Water. Minnesota Department of Health (MDH), Environmental Health Division, Health Risk Assessment Unit, St Paul, MN. [144] MDH. 2018. Toxicological Summary for: Metolachlor ESA. Health Based Guidance for Water. Minnesota Department of Health (MDH), Environmental Health Division, Health Risk Assessment Unit, St Paul, MN. [145] MDH. 2018. Toxicological Summary for: Metolachlor OXA. Health Based Guidance for Water. Minnesota Department of Health (MDH), Environmental Health Division, Health Risk Assessment Unit, St Paul, MN. [146] MDH. 2019 Toxicological Summary for Benzophenone. Minnesota Department of Health (MDH), Environmental Health Division, Health Risk Assessment Unit, St Paul, MN. [147] MDH. 2019. Toxicological Summary for: Strontium. Health Based Guidance for Water. Minnesota Department of Health (MDH), Environmental Health Division, Health Risk Assessment Unit, St Paul, MN. [148] MDH. 2019. Toxicological Summary for: Tolyltriazole and 5-Methyl-lH-Benzotriazole. Health Based Guidance for Water. Minnesota Department of Health (MDH), Environmental Health Division, Health Risk Assessment Unit, St Paul, MN. [149] Minnesota Department of Health. Dieldrin and Drinking Water. October 2016. https://www.health.state.mn.us/communities/environment/risk/docs/guidance/gw/dieldrininfo.pdf [150] NIH. 2018. DailyMed Database. U.S. National Library of Medicine, National Institutes of Health (NIH). https://dailymed.nlm.nih.gov/dailymed/. [151] NIRS. 2016. Summary of data provided in tabular form in docket; www.regulations.gov Docket ID EPA-HQ-OW-2007-1189. [152] NRC. 1989. Recommended Dietary Allowances. Washington, DC: National Academy of Sciences,National Academy Press, pp. 247-261. B-11 ------- EPA-Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA815-R-22-003 October 2022 [153] Occurrence of anthropogenic organic compounds and nutrients in source and finished water in the Sioux Falls area, South Dakota, 2009-10: U.S. Geological Survey Scientific Investigations Report 2012- 5098, 21 p. plus appendixes. [154] Oppenheimer J, Stephenson R, Burbano A, Liu L., 2007. Characterizing the passage of personal care products through wastewater treatment processes. Water environment research. 79(13), pp.2564-77 [155] Padhye, L.P., Yao, H., Kung'u, F.T., and Huang, C.H. Year-long evaluation on the occurrence and fate of pharmaceuticals, personal care products, and endocrine disrupting chemicals in an urban drinking water treatment plant. 2014. Water Research 51 (2014) 266-276. [156] Palmer PM, Wilson LR, O'Keefe P, Sheridan R, King T, Chen CY., 2008. Sources of pharmaceutical pollution in the New York City Watershed. The Science of the total environment. 394(1), pp.90-102 [157] Rahman, M.F., E.K. Yanful, S.Y. Jasim, L.M. Bragg, M.R. Servos, S. Ndiongue, and D. Borikar. 2010. "Advanced Oxidation Treatment of Drinking Water: Part 1. Occurrence and Removal of Pharmaceutical Substances and Endocrine Disrupting Compounds from Lake HuronWater." Ozone: Sci. Eng. 32: 217- 229. [158] Reconnaissance of Land-Use Sources of Pesticides in Drinking Water, McKenzie River, Oregon. U.S. Geological Survey Scientific Investigations Report 2012-5091, 46 p. plus appendixes. [159] Renew JE, Huang CH., 2004. Simultaneous determination of fluoroquinolone, sulfonamide, and trimethoprim antibiotics in wastewater using tandem solid phase extraction and liquid chromatography- electrospray mass spectrometry. Journal of chromatography. A. 1042(1-2), pp.113-21 [160] Schultz MM, Furlong ET., 2008. Trace analysis of antidepressant pharmaceuticals and their select degradates in aquatic matrixes by LC/ESI/MS/MS. Analytical chemistry. 80(5), pp.1756-62 [161] Scott, T. M., Phillips, P. J., Kolpin, D. W., Colella, K. M., Furlong, E. T., Foreman, W. T., & Gray, J. L. (2018). Pharmaceutical manufacturing facility discharges can substantially increase the pharmaceutical load to US wastewaters. Science of the Total Environment, 636, 69-79. [162] Seidel, C. 2006. Email Communication to Brent Ranalli at The Cadmus Group, Inc. [concerning boron data from an AwwaRF-sponsored study, with data in an attached spreadsheet], Denver, CO: McGuire Malcolm Pirnie. May 19. [163] Shellenberger, T. 1984. 28-Day Oral Toxicity in the Dog with AC 92,100: Report No. 87019. Unpublished study prepared by Tegeris Laboratories Inc. 89 p. (as cited in USEPA,2006). [164] Shellenberger, T., and L.H. Billups. 1986. One-year oral toxicity study in purebred beagle dogs with AC 92 100. Unpublished report No. 8414 (BASF RDI No. TE-427-002) from Tegeris Laboratories, Inc., Laurel, MD, USA (as cited in USEPA, 2003). [165] Shelver WL, Shappell NW, Franek M, Rubio FR., 2008. ELISA for sulfonamides and its application for screening in water contamination. Journal of agricultural and food chemistry. 56(15), pp.6609-15 [166] Snyder, et al., 2007. Removal of EDCs and Pharmaceuticals in Drinking and Reuse Treatment Processes. American Water Works Association. B-12 ------- EPA-Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA815-R-22-003 October 2022 [167] Soliman MA, Pedersen JA, Park H, Castaneda-Jimenez A, Stenstrom MK, Suffet IH., 2007. Human pharmaceuticals, antioxidants, and plasticizers in wastewater treatment plant and water reclamation plant effluents. Water environment research. 79(2), pp.156-67 [168] Spongberg AL, Witter JD., 2008. Pharmaceutical compounds in the wastewater process stream in Northwest Ohio. The Science of the total environment. 397(1-3), pp.148-57 [169] Stackelberg PE, Furlong ET, Meyer MT, Zaugg SD, Henderson AK, Reissman DB., 2004. Persistence of pharmaceutical compounds and other organic wastewater contaminants in a conventional drinking- water-treatment plant. The Science of the total environment. 329(1-3), pp.99-113 [170] Stackelberg PE, Gibs J, Furlong ET, Meyer MT, Zaugg SD, Lippincott RL., 2007. Efficiency of conventional drinking-water-treatment processes in removal of pharmaceuticals and other organic compounds. The Science of the total environment. 377(2-3), pp.255-72 [171] Standley U, Rudel RA, Swartz CH, Attfield KR, Christian J, Erickson M, Brody JG., 2008. Wastewater- contaminated groundwater as a source of endogenous hormones and pharmaceuticals to surface water ecosystems. Environmental Toxicology and Chemistry. 27(12), pp.2457-68 [172] State of Hawaii Department of Health. Trace levels of dieldrin and bromacil in two Oahu Water Systems. January 2015. https://health.hawaii.gov/news/files/2013/05/TRACE-LEVELS-OF-DIELDRIN- AND-BROMACIL-DETECTED-IN-TWO-OAHU-WATER-SYSTEMS.pdf [173] Sun, M., Arevalo, E., Strynar, M., Lindstrom, A., Richardson, M., Kearns, B., ... & Knappe, D. R. (2016). Legacy and emerging perfluoroalkyl substances are important drinking water contaminants in the Cape Fear River Watershed of North Carolina. Environmental science & technology letters, 3(12), 415-419. [174] Tabe, S., T. Jamal, R. Seth, C. Yue, P. Yang, X. Zhao, and L. Schweitzer. 2009. "PPCPs and EDCs Occurrence in the Detroit River and Their Removal by Ozonation." Final Report. Denver, CO: Water Research Foundation. [175] Thomas PM, Foster GD., 2004. Determination of nonsteroidal anti-inflammatory drugs, caffeine, and triclosan in wastewater by gas chromatography-mass spectrometry. Journal of environmental science and health. Part A, Toxic/hazardous substances & environmental engineering. 39(8), pp.1969-78 [176] Thomas PM, Foster GD., 2005. Tracking acidic pharmaceuticals, caffeine, and triclosan through the wastewater treatment process. Environmental Toxicology and Chemistry. 24(1), pp.25-30 [177] Trenholm RA, Vanderford BJ, Holady JC, Rexing DJ, Snyder SA., 2006. Broad range analysis of endocrine disruptors and pharmaceuticals using gas chromatography and liquid chromatography tandem mass spectrometry. Chemosphere. 65(11), pp.1990-8 [178] USEPA (US Environmental Protection Agency). (2009). 2006 Community Water System Survey. Overview, 57. [179] USEPA, 2001. Regulatory Determination Support Document for Aldrin and Dieldrin. EPA 815 R-01- 011. [180] USEPA, 2001. Regulatory Determination Support Document for Manganese. EPA 815 R-01-013. B-13 ------- EPA-Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA815-R-22-003 October 2022 [181] USEPA, 2001. Regulatory Determination Support Document for Metribuzin. EPA 815 R-01-010. [182] USEPA, 2001. Regulatory Determination Support Document for Naphthalene. EPA 815 R-01-008. [183] USEPA, 2001. Regulatory Determination Support Document for Sodium. EPA 815 R-01-014. [184] USEPA. 1998. R.E.D. Facts: Metribuzin. EPA Report 738-F-96-006. 7 pp. Available on the Internet at: http://www.epa.gov/oppsrrdl/REDs/ Last modified: 8/29/2000. [185] USEPA. 2003. Drinking Water Advisory: Consumer Acceptability Advice and Health Effects Analysis on Sodium. EPA 822-R-03-006. February 2003. [186] USEPA. 2003. Health Effects Support Document for Metribuzin. Office of Water. EPA Report822- R-03-004. February 2003. 84 pp. [187] USEPA. 1987. Chemical Assessment Summary alpha-Hexachlorocyclohexane (alpha-HCH); CASRN 319-84-6. U.S. Environmental Protection Agency, National Center for Environmental Assessment, Integrated Risk Information System (IRIS), Washington, DC. [188] USEPA. 1987. Chemical Assessment Summary di-n-butyl phthalate. U.S. Environmental Protection Agency, National Center for Environmental Assessment, Integrated Risk Information System (IRIS), Washington, DC. [189] USEPA. 1987. Chemical Assessment Summary, 2,4-Dichlorophenol. U.S. Environmental Protection Agency, National Center for Environmental Assessment, Integrated Risk Information System (IRIS), Washington, D.C. [190] USEPA. 1987. Chemical Assessment Summary, Aldrin. U.S. Environmental Protection Agency, National Center for Environmental Assessment, Integrated Risk Information System (IRIS), Washington, DC. [191] USEPA. 1987. Chemical Assessment Summary, Carbon Disulfide. U.S. Environmental Protection Agency, National Center for Environmental Assessment, Integrated Risk Information System (IRIS), Washington, D.C. [192] USEPA. 1987. Chemical Assessment Summary, Diethyl Phthalate. U.S. Environmental Protection Agency, National Center for Environmental Assessment, Integrated Risk Information System (IRIS), Washington, DC. [193] USEPA. 1987. Chemical Assessment Summary, n-Butanol. U.S. Environmental Protection Agency, National Center for Environmental Assessment, Integrated Risk Information System (IRIS), Washington, D.C. [194] USEPA. 1987. Drinking Water Health Advisory for 1,2,4-trimethylbenzene. U.S. Environmental Protection Agency, Office of Health and Environmental Assessment, Environmental Criteria and Assessment Office, Cincinnati, OH. [195] USEPA. 1988. Chemical Assessment Summary benzoic acid U.S. Environmental Protection Agency, National Center for Environmental Assessment, Integrated Risk Information System (IRIS), Washington, DC. B-14 ------- EPA-Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA815-R-22-003 October 2022 [196] USEPA. 1988. Chemical Assessment Summary Bisphenol A. U.S. Environmental Protection Agency, National Center for Environmental Assessment, Integrated Risk Information System (IRIS), Washington, DC. [197] USEPA. 1988. Chemical Assessment Summary, Acetophenone. U.S. Environmental Protection Agency, National Center for Environmental Assessment, Integrated Risk Information System (IRIS), Washington, DC. [198] USEPA. 1988. Chemical Assessment Summary, Dieldrin. U.S. Environmental Protection Agency, National Center for Environmental Assessment, Integrated Risk Information System (IRIS), Washington, DC. [199] USEPA. 1988. Manganese; CASRN 7439-96-5. U.S. Environmental Protection Agency, National Center for Environmental Assessment, Integrated Risk Information System (IRIS), Washington, DC. [200] USEPA. 1988. p,p'-Dichlorodiphenyldichloroethylene (DDE); CASRN 72-55-9. U.S. Environmental Protection Agency, National Center for Environmental Assessment, Integrated Risk Information System (IRIS), Washington, DC. [201] USEPA. 1989. 1,2,3-Trichloropropane Drinking Water Health Adivsory. U.S. Environmental Protection Agency, Office of Water, Washington, D.C. [202] USEPA. 1989. Bromochloromethane Health Advisory. U.S. Environmental Protection Agency, Office of Water, Washington, D.C. [203] USEPA. 1989. Chemical Assessment Summary Butyl benzyl phthalate. U.S. Environmental Protection Agency, National Center for Environmental Assessment, Integrated Risk Information System (IRIS), Washington, DC. [204] USEPA. 1989. Chemical Assessment Summary, Isophorone. U.S. Environmental Protection Agency, National Center for Environmental Assessment, Integrated Risk Information System (IRIS), Washington, D.C. [205] USEPA. 1989. Chloromethane Health Advisory. U.S. Environmental Protection Agency, Office of Water, Washington, D.C. [206] USEPA. 1990. Chemical Assessment Summary, 2,4-/2,6-Dinitrotoluene mixture. U.S. Environmental Protection Agency, National Center for Environmental Assessment, Integrated Risk Information System (IRIS), Washington, D.C. [207] USEPA. 1990. Chemical Assessment Summary, Fluoranthene. U.S. Environmental Protection Agency, National Center for Environmental Assessment, Integrated Risk Information System (IRIS), Washington, D.C. [208] USEPA. 1990. Chemical Assessment Summary, Phenanthrene. U.S. Environmental Protection Agency, National Center for Environmental Protection, Integrated Risk Information System (IRIS), Washington, D.C. B-15 ------- EPA-Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA815-R-22-003 October 2022 [209] USEPA. 1990. Chemical Assessment Summary, Pyrene. U.S. Environmental Protection Agency, National Center for Environmental Assessment, Integrated Risk Information System (IRIS), Washington, D.C. [210] USEPA. 1991. Chemical Assessment Summary, Bromochloromethane. U.S. Environmental Protection Agency, National Center for Environmental Protection, Integrated Risk Information System (IRIS), Washington, D.C. [211] USEPA. 1991. Drinking Water Criteria Document for Phthalic Acid Esthers (PAES). U.S. Environmental Protection Agency, Office of Water, Health and Ecological Criteria Division, Washington, DC. [212] USEPA. 1991. Drinking Water Criteria Document for Polycyclic Aromatic Hydrocarbons (PAHs). U.S. Environmental Protection Agency, Office of Health and Environmental Assessment, Environmental Criteria and Assessment Office, Cincinnati, OH. [213] USEPA. 1991. Strontium Drinking Water Health Advisory. U.S. Environmental Protection Agency, Office of Water, Washington, D.C. [214] USEPA. 1992. Chemical Assessment Summary 2,4-Dinitrotoluene. U.S. Environmental Protection Agency, National Center for Environmental Assessment, Integrated Risk Information System (IRIS), Washington, DC. [215] USEPA. 1992. Chemical Assessment Summary, Molybdenum. U.S. Environmental Protection Agency, National Center for Environmental Assessment, Integrated Risk Information System (IRIS), Washington, D.C. [216] USEPA. 1992. Chemical Assessment Summary, Strontium. U.S. Environmental Protection Agency, National Center for Environmental Assessment, Integrated Risk Information System (IRIS), Washington, D.C. [217] USEPA. 1992. Cyanazine: Report of the RfD/Peer Review. U.S. Environmental Protection Agency, Office of Prevention, Pesticides and Toxic Substances, Washington, D.C. [218] USEPA. 1992. Drinking Water Criteria Document for Phthalic Acid Esters (PAEs). U.S. Environmental Protection Agency, Office of Health and Environmental Assessment, Environmental Criteria and Assessment Office, Cincinnati, OH. [219] USEPA. 1992. Drinking Water Health Advisories: Ammonia. U.S. Environmental Protection Agency, Office of Water, Health and Ecological Criteria Division, Washington, DC. [220] USEPA. 1992. Isophorone Drinking Water Health Advisory. U.S. Environmental Protection Agency, Office of Water, Washington, D.C. [221] USEPA. 1993. Chemical Assessment Summary, Chlorodifluoromethane. U.S. Environmental Protection Agency, National Center for Environmental Protection, Integrated Risk Information System (IRIS), Washington, D.C. B-16 ------- EPA-Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA815-R-22-003 October 2022 [222] USEPA. 1994. Chemical Assessment Summary, DCPA. U.S. Environmental Protection Agency, National Center for Environmental Assessment, Integrated Risk Information System (IRIS), Washington, D.C. [223] USEPA. 1994. R.E.D. Facts Mevinphos. EPA-738-F-94-020. EPA-738-R-94-023. Office of Prevention, Pesticides and Toxic Substances, United States Environmental Protection Agency, Washington, D.C. [224] USEPA. 1994. Revised Occupational and Residential Risk Assessment for the Triazines. U.S. Environmental Protection Agency, Office of Prevention, Pesticides and Toxic Substances, Washington, D.C. [225] USEPA. 1997. Chemical Assessment Summary, Cumene. U.S. Environmental Protection Agency, National Center for Environmental Assessment, Integrated Risk Information System (IRIS), Washington, D.C. [226] USEPA. 1997. Drinking Water Advisory: Consumer Acceptability Advice and Health Effects Analysis on Methyl Tertiary-Butyl Ether (MtBE). U.S. Environmental Protection Agency, Office of Water, Health and Ecological Criteria Division, Washington, DC. [227] USEPA. 1998. Ethyl Parathion. Dietary and Occupational Risk Assessments. U.S. Environmental Protection Agency, Office of Prevention, Pesticides and Toxic Substances, Washington, D.C. [228] USEPA. 1998. Isofenphos: HED Chapter for the Reregistration Eligibility Decision (RED) Document. DP No. D237260. U.S. Environmental Protection Agency, Office of Prevention, Pesticides and Toxic Substances, Washington, D.C. [229] USEPA. 1998. Reregistration Eligibility Decision (RED) DCPA. EPA 738-R-98-005. U.S. Environmental Protection Agency, Office of Prevention, Pesticides and Toxic Substances, Washington, D.C. [230] USEPA. 1998. Reregistration Eligibility Decision (RED) Dicofol. EPA 738-R-98-018. U.S. Environmental Protection Agency, Office of Prevention, Pesticides and Toxic Substances, Washington, D.C. [231] USEPA. 1998. Reregistration Eligibility Decision (RED) Propachlor. EPA 738-R-015. U.S. Environmental Protection Agency, Office of Prevention, Pesticides and Toxic Substances, Washington, D.C. [232] USEPA. 1999. A Review of Contaminant Occurrence in Public Water Systems. Office of Water. EPA Report 816-R-99-006. 78 pp. [233] USEPA. 1999. Ethyl Parathion: Revised Human Health Risk Assessment. DP No. D259500.U.S. Environmental Protection Agency, Office of Prevention, Pesticides and Toxic Substances, Washington, D.C. [234] USEPA. 1999. Isophorone - Report of the Hazard Identification Assessment Review Committee. U.S. Environmental Protection Agency, Office of Prevention, Pesticides, and Toxic Substances, Office of Pesticides Programs, Health Effects Division, Washington, D.C. [235] USEPA. 1999. R.E.D. Facts Isofenphos. EPA 738-F-99-019.U.S. Environmental Protection Agency, Office of Prevention, Pesticides and Toxic Substances, Washington, D.C. B-17 ------- EPA-Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA815-R-22-003 October 2022 [236] USEPA. 2000. Mevinphos: Revised Human Health Risk Assessment. DP No. D266026. Office of Prevention, Pesticides and Toxic Substances, United States Environmental Protection Agency, Washington, D.C. [237] USEPA. 2000. R.E.D. Facts Ethyl Parathion. EPA-738-F00-009. U.S. Environmental Protection Agency, Office of Prevention, Pesticides and Toxic Substances, Washington, D.C. [238] USEPA. 2000. Unregulated Contaminant Monitoring Regulation Analytical Methods and Quality Control Manual. EPA 815-R-00-006. [239] USEPA. 2001. Analysis of National Occurrence of the 1998 Contaminant Candidate List Regulatory Determination Priority Contaminants in Public Water Systems. Office of Water. EPA report 815-D-01- 002. 77 pp. [240] USEPA. 2001. Benomyl RED Facts. EPA-738-F-02-001. U.S. Environmental Protection Agency, Office of Prevention, Pesticides and Toxic Substances, Washington, D.C. [241] USEPA. 2001. Benomyl: HED Revised Preliminary Risk Assessment for the Reregistration Eligibility Decision (RED) Document. DP No. D267478.U.S. Environmental Protection Agency, Office of Prevention, Pesticides and Toxic Substances, Washington, D.C. [242] USEPA. 2001. Chemical Assessment Summary Methylmercury. U.S. Environmental Protection Agency, National Center for Environmental Assessment, Integrated Risk Information System (IRIS), Washington, DC. [243] USEPA. 2001. Chemical Assessment Summary, Chloromethane. U.S. Environmental Protection Agency, National Center for Environmental Assessment, Integrated Risk Information System (IRIS), Washington, D.C. [244] USEPA. 2001. Chemical Assessment Summary, Quinoline. U.S. Environmental Protection Agency, National Center for Environmental Assessment, Integrated Risk Information System (IRIS), Washington, D.C. [245] USEPA. 2001. Ethion RED. U.S. Environmental Protection Agency, Office of Prevention, Pesticides and Toxic Substances, Washington, D.C. [246] USEPA. 2001. Interim Reregistration Eligibility Decision for Fenthion. EPA 738-R-00-013. U.S. Environmental Protection Agency, Office of Prevention, Pesticides and Toxic Substances, Washington, D.C. [247] USEPA. 2001. Occurrence of Unregulated Contaminants in Public Water Systems: An Initial Assessment. Office of Water. EPA report 815-P-00-001. Office of Water. 50 pp. [248] USEPA. 2001. Propetamphos. Revised Human Health Risk Assessment. EPA-HQ-OPP-2007-1195- 0013. DP No. D272377. U.S. Environmental Protection Agency, Office of Prevention, Pesticides and Toxic Substances, Washington, D.C. [249] USEPA. 2002. Chemical Assessment Summary, 1,3-Butadiene. U.S. Environmental Protection Agency, National Center for Environmental Assessment, Integrated Risk Information System (IRIS), Washington, D.C. B-18 ------- EPA-Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA815-R-22-003 October 2022 [250] USEPA. 2002. Health Effects Division (HED) Risk Assessment for Imazethapyr. EPA-HQ-OPP-2002- 0189-0003. DP Nos. D232428 D269226 D277925. U.S. Environmental Protection Agency, Office of Prevention, Pesticides and Toxic Substances, Washington, D.C. [251] USEPA. 2002. Molinate - Review of 60-Day Comments and Revised Human Health Risk Assessment. EPA-HQ-OPP-2003-0397-0003. DP No. D286216. U.S. Environmental Protection Agency, Office of Prevention, Pesticides and Toxic Substances, Washington, D.C. [252] USEPA. 2002. Provisional Peer-Reviewed Toxicity Values for Acrolein. U.S. Environmental Protection Agency, Office of Research and Development, National Center for Environmental Assessment, Superfund Health Risk Technical Support Center, Cincinnati, OH. [253] USEPA. 2002. Provisional Peer Reviewed Toxicity Values for Butyl benzyl phthalate (CASRN 85-68- 7) Derivation of a Carcinogenicity Assessment. U.S. Environmental Protection Agency, Office of Research and Development, National Center for Environmental Assessment, Superfund Health Risk Technical Support Center, Cincinnati, OH. [254] USEPA. 2003. Chemical Assessment Summary, 2-Methylnaphthalene. U.S. Environmental Protection Agency, National Center for Environmental Protection, Integrated Risk Information System (IRIS), Washington, D.C. [255] USEPA. 2003. Contaminant Candidate List Regulatory Determination Support Document for Aldrin and Dieldrin. U.S Environmental Protection Agency, Office of Water, Standards and Risk Management Divison, Washington, D.C. [256] USEPA. 2003. Drinking Water Advisory: Consumer Acceptability Advice and Health Effects Analysis on Sodium. U.S. Environmental Protection Agency, Office of Water, Health and Ecological Criteria Division, Washington, D.C. [257] USEPA. 2003. Health Effects Support Document for Manganese. Office of Water. EPA Report 822- R-03-003. February 2003. 164pp. [258] USEPA. 2003. Toxicological Review of Acrolein (CAS No. 107-02-8). U.S. Environmental Protection Agency, National Center for Environmental Assessment, Integrated Risk Information System (IRIS), Washington, D.C. [259] USEPA. 2004. Chemical Assessment Summary, Boron. U.S. Environmental Protection Agency, National Center for Environmental Assessment, Integrated Risk Information System (IRIS), Washington, D.C. [260] USEPA. 2004. Drinking Water Health Advisory for Manganese. EPA-822-R-04-003. U.S. Environmental Protection Agency, Office of Water, Health and Ecological Criteria Division, Washington, DC. [261] USEPA. 2004. Integrated Risk Information System (IRIS), Boron and Compounds. August. Available on the Internet at: http://www.epa.gov/iris/subst/0410.htm. Accessed February 2, 2005. [262] USEPA. 2005. Chemical Assessment Summary 2,4-Dinitrophenol. U.S. Environmental Protection Agency, National Center for Environmental Assessment, Integrated Risk Information System (IRIS), Washington, DC. B-19 ------- EPA-Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA815-R-22-003 October 2022 [263] USEPA. 2005. Provisional Peer-Reviewed Toxicity Values for Ammonia. U.S. Environmental Protection Agency, Office of Research and Development, National Center for Environmental Assessment, Superfund Health Risk Technical Support Center, Cincinnati, OH. [264] USEPA. 2006. Amendment to the Reregistration Eligibility Decision (RED) for Propanil (March 2006) and the Propanil RED (September 2003). EPA-HQ-OPP-2003-0348. U.S. Environmental Protection Agency, Office of Prevention, Pesticides and Toxic Substances, Washington, D.C. [265] USEPA. 2006. Dichlorvos (DDVP) HED Chapter of the Reregistration Eligibility Decision Document (RED). EPA-HQ-OPP-2002-0302-0016. DP No. D330262. U.S. Environmental Protection Agency, Office of Prevention, Pesticides and Toxic Substances, Washington, D.C. [266] USEPA. 2006. Finalization of Interim Reregistration Eligibility Decisions (IREDs) and Interim Tolerance Reassessment and Risk Management Decisions (TREDs) for the Organophosphate Pesticides, and Completion of the Tolerance Reassessment and Reregistration Eligibility Process for the Organophosphate Pesticides. Interim Reregistration Eligibility Decision for Naled. EPA-HQ-OPP-2002- 0307-0002. EPA 738-R-02-008. U.S. Environmental Protection Agency, Office of Prevention, Pesticides and Toxic Substances, Washington, D.C. [267] USEPA. 2006. Finalization of Interim Reregistration Eligibility Decisions (IREDs) and Interim Tolerance Reassessment and Risk Management Decisions (TREDs) for the Organophosphate Pesticides, and Completion of the Tolerance Reassessment and Reregistration Eligibility Process for the Organophosphate Pesticides. Reregistration Eligibility Decision for Terbufos. U.S. Environmental Protection Agency, Office of Prevention, Pesticides and Toxic Substances, Washington, D.C. [268] USEPA. 2006. Reregistration Eligibility Decision (RED) for Inorganic Chlorates. EPA 738-R-06-014. U.S. Environmental Protection Agency, Office of Prevention, Pesticides and Toxic Substances, Washington, D.C. [269] USEPA. 2006. Reregistration Eligibility Decision for Azinphos-Methyl. Finalization of Interim Reregistration Eligibility Decisions (IREDs) and Interim Tolerance Reassessment and Risk Management Decisions (TREDs) for the Organophosphate Pesticides, and Completion of the Tolerance Reassessment and Reregistration Eligibility Process for the Organophosphate Pesticides. U.S. Environmental Protection Agency, Office of Prevention, Pesticides and Toxic Substances, Washington, D.C. [270] USEPA. 2006. Reregistration Eligibility Decision for Disulfoton. Finalization of Interim Reregistration Eligibility Decisions (IREDs) and Interim Tolerance Reassessment and Risk Management Decisions (TREDs) for the Organophosphate Pesticides, and Completion of the Tolerance Reassessment and Reregistration Eligibility Process for the Organophosphate Pesticides. U.S. Environmental Protection Agency, Office of Prevention, Pesticides and Toxic Substances, Washington, D.C. [271] USEPA. 2006. Reregistration Eligibility Decision for Imazapyr. EPA-HQ-OPP-2005-0495-0031. OPP- 2005-0495. U.S. Environmental Protection Agency, Office of Prevention, Pesticides and Toxic Substances, Washington, D.C. [272] USEPA. 2006. Reregistration Eligibility Decision for Methidathion. Office of Prevention, Pesticides and Toxic Substances, United States Environmental Protection Agency, Washington, D.C. B-20 ------- EPA-Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA815-R-22-003 October 2022 [273] USEPA. 2006. Reregistration Eligibility Decision for Phorate. EPA-HQ-OPP-2008-0174-0003. U.S. Environmental Protection Agency, Office of Prevention, Pesticides and Toxic Substances, Washington, D.C. [274] USEPA. 2006. Reregistration Eligibility Decision for Terbufos. Office of Pesticide Programs. Available on the Internet at: http://www.epa.gov/pesticides/reregistration/REDs/terbufos_red.pdf. [275] USEPA. 2006. Revised Section 18 Quarantine Exemption for the Application of Flusilazole to Soybeans. EPA-HQ-OPP-2007-0428-0002. DP No. 328024. U.S. Environmental Protection Agency, Office of Prevention, Pesticides and Toxic Substances, Washington, D.C. [276] USEPA. 2006. The Health Effects Division's Review of California's Methyl Parathion Risk Characterization Document on Dietary and Ambient Air Exposures. EPA-HQ-OPP-2003-0237-0029. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. [277] USEPA. 2007. Lactofen: Revised Human Health Risk Assessment for Proposed Uses on Fruiting Vegetables and Okra. EPA-HQ-OPP-2006-0178-0008. DP No. D339011. U.S. Environmental Protection Agency, Office of Prevention, Pesticides and Toxic Substances, Washington, D.C. [278] USEPA. 2007. Provisional Peer-Reviewed Toxicity Values for 1,2,4-Trimethylbenzene. U.S. Environmental Protection Agency, Office of Research and Development, National Center for Environmental Assessment, Superfund Health Risk Technical Support Center, Cincinnati, OH. [279] USEPA. 2007. Provisional Peer-Reviewed Toxicity Values for 2-Methylnaphthalene. U.S. Environmental Protection Agency, Office of Research and Development, National Center for Environmental Assessment, Superfund Health Risk Technical Support Center, Cincinnati, OH. [280] USEPA. 2007. Provisional Peer-Reviewed Toxicity Values for 2,4-Dichlorophenol. U.S. Environmental Protection Agency, Office of Research and Development, National Center for Environmental Assessment, Superfund Health Risk Technical Support Center, Cincinnati, OH. [281] USEPA. 2007. Provisional Peer-Reviewed Toxicity Values for 2,4-Dinitrotoluene. U.S. Environmental Protection Agency, Office of Research and Development, National Center for Environmental Assessment, Superfund Health Risk Technical Support Center, Cincinnati, OH. [282] USEPA. 2007. Provisional Peer-Reviewed Toxicity Values for Pyrene. U.S. Environmental Protection Agency, Office of Research and Development, National Center for Environmental Assessment, Superfund Health Risk Technical Support Center, Cincinnati, OH. [283] USEPA. 2007. Revised Interim Reregistration Decision for Dimethoate. Available on the Internet at: http://www.epa.gov/pesticides/reregistration/REDs/dimethoate_ired_revised.pdf. [284] USEPA. 2007. Unregulated Contaminant Monitoring Regulation (UCMR) for Public Water Systems Revisions. Federal Register. Vol. 72, No. 2, p. 367, January 4, 2007. [285] USEPA. 2008. 1,3-Dichloropropene: Proposed New Use for Drip Irrigation in Vineyards: Revised HED Human Health Risk Assessment. EPA-HQ-OPP-2013-0154-0006. DP No. D347789. U.S. Environmental Protection Agency, Office of Prevention, Pesticides and Toxic Substances, Washington, D.C. B-21 ------- EPA-Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA815-R-22-003 October 2022 [286] USEPA. 2008. Carbofuran. HED Revised Risk Assessment for the Notice of Intent to Cancel (NOIC). EPA-HQ-OW-2016-0627-0009. DP No. D347038. U.S. Environmental Protection Agency, Office of Prevention, Pesticides and Toxic Substances, Washington, D.C. [287] USEPA. 2008. Drinking Water Health Advisory for 1,1,2,2-Tetrachloroethane. U.S. Environmental Protection Agency, Office of Water, Office of Science and Technology, Health and Ecological Criteria Division, Washington, D.C. [288] USEPA. 2008. Drinking Water Health Advisory for 2,4-Dinitrotoluene and 2,6-Dinitrotoluene. EPA/822/R-08/010. U.S. Environmental Protection Agency, Office of Water, Health and Ecological Criteria Division, Washington, DC. [289] USEPA. 2008. Drinking Water Health Advisory for 2,4-Dinitrotoluene and 2,6-Dinitrotoluene. U.S. Environmental Protection Agency, Office of Water, Office of Science and Technology, Health and Ecological Criteria Division, Washington, D.C. [290] USEPA. 2008. Drinking Water Health Advisory For Dacthal and Dacthal Degradates: Tetrachloroterephthalic acid (TPA) and Monomethyl Tetrachloroterephthalic acid (MTP). U.S. Environmental Protection Agency, Office of Water, Washington, D.C. [291] USEPA. 2008. Health Effects Support Document for 1,1,2,2-Tetrachloroethane. U.S. Environmental Protection Agency, Office of Water, Health and Ecological Criteria Division, Washington, D.C. [292] USEPA. 2008. Health Effects Support Document for Boron. U.S. Environmental Protection Agency, Office of Water, Health and Ecological Criteria Division, Washington, D.C. [293] USEPA. 2008. Methamidophos. Revised Human Health Assessment Scoping Document in Support or Registration Review. EPA-HQ-OPP-2008-0842-0004. DP No. D358676. U.S. Environmental Protection Agency, Office of Prevention, Pesticides and Toxic Substances, Washington, D.C. [294] USEPA. 2008. Provisional Peer Reviewed Toxicity Values for Cobalt (CASRN 7440-48-4). EPA/690/R- 08/008F. U.S. Environmental Protection Agency, Office of Research and Development, National Center for Environmental Assessment, Superfund Health Risk Technical Support Center, Cincinnati, OH. [295] USEPA. 2008. Provisional Peer Reviewed Toxicity Values for Lithium (CASRN 7439-93-2). EPA/690/R-08/016F. U.S. Environmental Protection Agency, Office of Research and Development, National Center for Environmental Assessment, Superfund Health Risk Technical Support Center, Cincinnati, OH. [296] USEPA. 2008. Regulatory Determinations Support Document for Selected Contaminants from the Second Drinking Water Contaminant Candidate List (CCL 2). EPA Report 815-R-08-012. June 2008. [297] USEPA. 2008. The Analysis of Occurrence Data from the First Unregulated Contaminant Monitoring Regulation (UCMR 1) in Support of Regulatory Determinations for the Second Drinking Water Contaminant Candidate List. EPA 815-R-08-013. June. [298] USEPA. 2008. The Analysis of Occurrence Data from the Unregulated Contaminant Monitoring (UCM) Program and National Inorganics and Radionuclides Survey (NIRS) in Support of Regulatory Determinations for the Second Drinking Water Contaminant Candidate List. EPA 815-D-08-014. June. B-22 ------- EPA-Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA815-R-22-003 October 2022 [299] USEPA. 2009. Chemical Assessment Summary, 1,2,3-Trichloropropane. U.S. Environmental Protection Agency, National Center for Environmental Assessment, Integrated Risk Information System (IRIS), Washington, D.C. [300] USEPA. 2009. Chemical Assessment Summary, Chlordecone (Kepone). U.S. Environmental Protection Agency, National Center for Environmental Assessment, Integrated Risk Information System (IRIS), Washington, D.C. [301] USEPA. 2009. Naled. Human Health Assessment Scoping Document in Support of Registration Review. EPA-HQ-OPP-2009-0053-0005. DP No. D356244. Office of Prevention, Pesticides and Toxic Substances, United States Environmental Protection Agency, Washington, D.C. [302] USEPA. 2009. Provisional Peer-Reviewed Toxicity Values for Bromochloromethane. U.S. Environmental Protection Agency, Office of Research and Development, National Center for Environmental Assessment, Superfund Health Risk Technical Support Center, Cincinnati, OH. [303] USEPA. 2009. Provisional Peer-Reviewed Toxicity Values for Phenanthrene. U.S. Environmental Protection Agency, Office of Research and Development, National Center for Environmental Assessment, Superfund Health Risk Technical Support Center, Cincinnati, OH. [304] USEPA. 2009. Provisional Peer-Reviewed Toxicity Values for Tris(2-chloroethyl)phosphate (TCEP) (CASRN 115-96-8). U.S. Environmental Protection Agency, Office of Research and Development, National Center for Environmental Assessment, Superfund Health Risk Technical Support Center, Cincinnati, OH. [305] USEPA. 2009. Provisional Peer-Reviewed Toxicity Values for Vanadium and Its Soluble Inorganic Compounds Other Than Vanadium Pentoxide (CASRN 7440-62-2 and Others), Derivation of Subchronic and Chronic Oral RfDs. EPA/690/R-09/070F. U.S. Environmental Protection Agency, Office of Research and Development, National Center for Environmental Assessment, Superfund Health Risk Technical Support Center, Cincinnati, OH. [306] USEPA. 2009. Tebupirimphos (Phostebupirim) in/on Corn, field, pop, sweet. Health Effects Division (HED) Risk Assessment. EPA-HQ-OPP-2008-0940-0010. DP No. D368530. U.S. Environmental Protection Agency, Office of Prevention, Pesticides and Toxic Substances, Washington, D.C. [307] USEPA. 2010. Chemical Assessment Summary, 1,1,2,2-Tetrachloroethane. U.S. Environmental Protection Agency, National Center for Environmental Assessment, Integrated Risk Information System (IRIS), Washington, D.C. [308] USEPA. 2010. Chemical Assessment Summary, 1,4-Dioxane. U.S. Environmental Protection Agency, National Center for Environmental Assessment, Integrated Risk Information System (IRIS), Washington, D.C. [309] USEPA. 2010. Chlorothalonil. Registration Request for Use on Low-Growing Berry Subgroup 13- 07G; Bushberry Subgroup 13-07B; Onion, Bulb Subgroup 3-07A; and Onion, Green Subgroup 3-07B. Human Health Risk Assessment. EPA-HQ-OPP-2018-0517-0003. DP No. D370486. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. [310] USEPA. 2010. Data Management and Analytical Plan for the Second Unregulated Contaminant Monitoring Regulation (UCMR 2) Data. June 2010 Draft Report Submitted to EPA. B-23 ------- EPA-Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA815-R-22-003 October 2022 [311] USEPA. 2010. Endosulfan: Revised Human Health Risk Assessment. EPA-HQ-OPP-2002-0262-0180. DP No. D372569. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. [312] USEPA. 2010. Fenamiphos: Revised Human Health Risk Assessment for Imported Commodities. DP No. D377426. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. [313] USEPA. 2010. Fenitrothion. Risk Assessment to Support Final Registration Review Decision. EPA- HQ-OPP-2009-0172-0016. DP No. D383647. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. [314] USEPA. 2010. Methidathion Registration Review Final Decision September 2010. EPA-HQ-OPP- 2008-0723. United States Environmental Protection Agency, Washington, D.C. [315] USEPA. 2010. Provisional Peer-Reviewed Toxicity Values for 4-Methylphenol (p-Cresol) (CASRN 106-44-5). EPA/690/R-10/019F. U.S. Environmental Protection Agency, Office of Research and Development, National Center for Environmental Assessment, Superfund Health Risk Technical Support Center, Cincinnati, OH. [316] USEPA. 2010. Provisional Peer-Reviewed Toxicity Values for Tributyl phosphate. EPA/690/R- 20/024F. U.S. Environmental Protection Agency, Office of Research and Development, National Center for Environmental Assessment, Superfund Health Risk Technical Support Center, Cincinnati, OH. [317] USEPA. 2011. Benzoic acid Registration Review: Final Work Plan May 2011. EPA-HQ-OPP-2010- 0692-0005. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. [318] USEPA. 2011. Chlorpyrifos: Preliminary Human Health Risk Assessment for Registration Review. EPA-HQ-OPP-2008-0850-0025. DP No. D388070. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. [319] USEPA. 2011. Fipronil. Human Health Assessment Scoping Document in Support of Registration Review. EPA-HQ-OPP-2011-0448-0004. DP No. D387318. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. [320] USEPA. 2011. Isoxaflutole. Section 3 Registration for Use on Soybeans. Human Health Risk Assessment. EPA-HQ-OPP-2010-0845-0005. DP No. D382796. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. [321] USEPA. 2011. Propetamphos Registration Review Final Decision May 2011. EPA-HQ-OPP-2007- 1195-00023. U.S Environmental Protection Agency, Washington, D.C. [322] USEPA. 2011. Provisional Peer-Reviewed Toxicity Values for Acetophenone. U.S. Environmental Protection Agency, Office of Research and Development, National Center for Environmental Assessment, Superfund Health Risk Technical Support Center, Cincinnati, OH. [323] USEPA. 2011. Provisional Peer Reviewed Toxicity Values for 9,10-Anthraquinone(CASRN 84-65-1). EPA/690/R-11/007F. U.S. Environmental Protection Agency, Office of Research and Development, B-24 ------- EPA-Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA815-R-22-003 October 2022 National Center for Environmental Assessment, Superfund Health Risk Technical Support Center, Cincinnati, OH. [324] USEPA. 2012. Bifenthrin: Human Health Risk Assessment to Support Section 3 New Uses for a Bed Bug Treatment, Grass Grown for Seed, Tolerances for Imported Tea, and a Section 18 Emergency Exemption Use on Apple, Nectarine, and Peach. EPA-HQ-OPP-2016-0236-0007. DP No. D372550. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. [325] USEPA. 2012. Iprodione. Acute Probabilistic, Chronic and Cancer Aggregate (Food and Drinking Water) Dietary Exposure and Risk Assessments for Parent and 3,5-DCA to Support New Section 3 Registration Actions on Cucurbits (Crop Group 9) and Fruiting Vegetables (Crop Group 8-10) and to Support a Tolerance for Imported Canola. EPA-HQ-OPP-2012-0392-0008. DP No. D392706. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. [326] USEPA. 2012. Provisional Peer-Reviewed Toxicity Values for Chloromethane. U.S. Environmental Protection Agency, Office of Research and Development, National Center for Environmental Assessment, Superfund Health Risk Technical Support Center, Cincinnati, OH. [327] USEPA. 2012. Provisional Peer-Reviewed Toxicity Values for Fluoranthene. U.S. Environmental Protection Agency, Office of Research and Development, National Center for Environmental Assessment, Superfund Health Risk Technical Support Center, Cincinnati, OH. [328] USEPA. 2012. Provisional Peer-Reviewed Toxicity Values for o-Toluidine. U.S. Environmental Protection Agency, Office of Research and Development, National Center for Environmental Assessment, Superfund Health Risk Technical Support Center, Cincinnati, OH. [329] USEPA. 2013. Prometryn. Human-Health Assessment Scoping Document in Support of Registration Review. EPA-HQ-OPP-2013-0032-0006. DP No. D407422. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. [330] USEPA. 2013. Provisional Peer-Reviewed Toxicity Values for 2,6-Dinitrotoluene. U.S. Environmental Protection Agency, Office of Research and Development, National Center for Environmental Assessment, Superfund Health Risk Technical Support Center, Cincinnati, OH. [331] USEPA. 2014. DEET (N,N-diethyl-meta-toluamide). Revised Human Health Risk Assessment in Support of Registration Review. EPA-HQ-OPP-2012-0162-0003. DP No. D413872. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. [332] USEPA. 2014. Dimethenamid/Dimethenamid-P. Human Health Risk Assessment for Proposed New Use on Cotton Subgroup 20C. EPA-HQ-OPP-2013-0670-0005. DP No. D418118. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. [333] USEPA. 2014. Oxadiazon. Human Health Assessment Scoping Document in Support of Registration Review. EPA-HQ-OPP-2014-0782-0004. DP No. D420616. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. [334] USEPA. 2014. Regulatory Determinations 3 Support Document. April 2014. EPA Publication # 815- R14-003. B-25 ------- EPA-Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA815-R-22-003 October 2022 [335] USEPA. 2014. Sodium Bentazon - Preliminary Human Health Risk Assessment for Registration Review. EPA-HQ-OPP-2010-0117. DP No. D417312. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. [336] USEPA. 2014. Tebuthiuron: Draft Human Risk Assessment. EPA-HQ-OPP-2009-0327-0041. DP Nos. D414218 D418910 D418911. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. [337] USEPA. 2014. Thiophanate-Methyl and Carbendazim (MBC). Human Health Assessment Scoping Document in Support of Registration Review. EPA-HQ-OPP-2014-0004-0010. DP No. D413079. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. [338] USEPA. 2015. Acrolein: Human Health Assessment Scoping Document in Support of Registration Review. EPA-HQ-OPP-2015-0571-0005. DP No. D427578. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. [339] USEPA. 2015. Cycloate. Human Health Scoping Document in Support of Registration Review. EPA- HQ-OPP-2015-0288-0008. DP No. D424437. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. [340] USEPA. 2015. Cyprodinil. Human Health Risk Assessment for the Expansion of Existing Crop Group/Representative Commodity Uses to Stone Fruit Group 12-12, and Adding New Uses on the Artichoke, Guava, Pomegranate, Passionfruit, Feijoa, Jaboticaba, Wax Jambu, Starfruit, and Acerola and Amended Uses on Greenhouse Cucumbers and Small Tomatoes. EPA-HQ-OPP-2014-0506-0013. DP No. D425998. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. [341] USEPA. 2015. Dicrotophos: Revised Human Health Risk Assessment for Registration Review of Dicrotophos. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. [342] USEPA. 2015. Diuron. Human Health Assessment Scoping Document in Support of Registration Review. EPA-HQ-OPP-2015-0077-0004. DP No. D423231. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. [343] USEPA. 2015. Ethoprop. Preliminary Occupational and Residential Exposure/Risk Assessment for Registration Review. EPA-HQ-OPP-2008-0560-0056. DP No. D421954. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. [344] USEPA. 2015. Famoxadone. Human Health Assessment Scoping Document in Support of Registration Review. EPA-HQ-OPP-2015-0094-0002. DP No. D423286. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. [345] USEPA. 2015. Flufenacet: Human Health Draft Risk Assessment for Registration Review. EPA-HQ- OPP-2010-0863-0017. DP No. D416546. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. B-26 ------- EPA-Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA815-R-22-003 October 2022 [346] USEPA. 2015. Health Effects Support Document for the Cyanobacterial Toxin Anatoxin-A. U.S. Environmental Protection Agency, Office of Water, Health and Ecological Criteria Division, Washington, D.C. [347] USEPA. 2015. Health Effects Support Document for the Cyanobacterial Toxin Cylindrospermopsin. U.S. Environmental Protection Agency, Office of Water, Health and Ecological Criteria Division, Washington, D.C. [348] USEPA. 2015. Health effects support document for the cyanobacterial toxin microcystins. U.S. Environmental Protection Agency, Office of Water, Health and Ecological Criteria Division, Washington, DC. [349] USEPA. 2015. Hexazinone: Draft Human Health Risk Assessment for Registration Review. EPA-HQ- OPP-2009-0755-0019. DP No. D424526. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. [350] USEPA. 2015. Occurrence Data from the Second Unregulated Contaminant Monitoring Regulation (UCMR 2). Including Appendices A-C. EPA 815-R-15-013. December 2015. [351] USEPA. 2015. Profenofos: Human Health Draft Risk Assessment (DRA) for Registration Review. EPA-HQ-OPP-2008-0345-0024. DP No. D414150. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. [352] USEPA. 2015. Pronamide. Human Health Risk Assessment for Registration Review and to Support New Section 3 Use on Leaf Lettuce (Revised). EPA-HQ-OPP-2009-0326-0017. DP Nos. D422207 D410291. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. [353] USEPA. 2015. Propazine. Acute and Chronic Dietary (Food Only) Exposure Assessments for Registration Review. EPA-HQ-OPP-2013-0250-0070. DP D428624. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. [354] USEPA. 2015. Propoxur: Human Health Draft Risk Assessment for Registration Review. EPA-HQ- OPP-2009-0806-0023. DP No. D414135. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. [355] USEPA. 2015. Prosulfuron. Draft Human Health Risk Assessment in Support of Registration Review. EPA-HQ-OPP-2011-1010-0019. DP No. D426092. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. [356] USEPA. 2015. Provisional Peer-Reviewed Toxicity Values for Soluble Tungsten Compounds. U.S. Environmental Protection Agency, Office of Research and Development, National Center for Environmental Assessment, Superfund Health Risk Technical Support Center, Cincinnati, OH. [357] USEPA. 2015. Sulfometuron Methyl. Draft Human Health Risk Assessment in Support of Registration Review. EPA-HQ-OPP-2012-0433-0026. DP No. D427028. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. B-27 ------- EPA-Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA815-R-22-003 October 2022 [358] USEPA. 2015. Thiram. Revised Human Health Risk Assessment for the Import Use of Thiram on Avocado, PP#4E8250 and Banana, PP#4E8268. EPA-HQ-OPP-2014-0249-0004. DP No. D427383. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. [359] USEPA. 2015. Tribufos: Human Health Draft Risk Assessment for Registration Review. EPA-HQ- OPP-2008-0883-0011. DP No. D357537. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. [360] USEPA. 2015. Dimethoate: Human Health Risk Assessment for Registration Review. EPA-HQ-OPP- 2009-0059-0027. DP No. D416010. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. [361] USEPA. 2016. Bensulide: Human Health Risk Assessment to Support Registration Review. EPA-HQ- OPP-2008-0022-0019. DP No. D428598. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. [362] USEPA. 2016. Bromacil and its Lithium Salt - Draft Human Health Risk Assessment for Registration Review. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. [363] USEPA. 2016. Diazinon Draft Human Health Risk Assessment for Registration Review. EPA-HQ-OPP- 2008-0351-0093. DP No. D419216. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. [364] USEPA. 2016. Dicamba and Dicamba BAPMA Salt: Human-Health Risk Assessment for Proposed Section 3 New Uses on Dicamba-tolerant Cotton and Soybean. EPA-HQ-OPP-2012-0841-0052. DP Nos. D378366 D404917 D402514 D421306. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. [365] USEPA. 2016. Ethalfluralin: Human Health Draft Risk Assessment for Registration Review. EPA-HQ- OPP-2011-0094-0016. DP No. D429844. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. [366] USEPA. 2016. Fenpropathrin. Draft Human Health Risk Assessment for Registration Review. EPA- HQ-OPP-2010-0422-0017. DP No. D425768. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. [367] USEPA. 2016. Fluometuron. Human Health Assessment Scoping Document in Support of Registration Review. EPA-HQ-OPP-2015-0746-0009. DP No. D430248; D391415. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. [368] USEPA. 2016. Malathion: Human Health Draft Risk Assessment for Registration Review. EPA-HQ- OPP-2009-0317-0080. DP No. D414107. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. [369] USEPA. 2016. Mefenoxam. Human Health Risk Assessment for Proposed Use on the Rapeseed Subgroup 20A. EPA-HQ-OPP-2015-0014-0008. DP No. D424727. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. B-28 ------- EPA-Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA815-R-22-003 October 2022 [370] USEPA. 2016. Pentachloronitrobenzene (PCNB). Human Health Assessment Scoping Document in Support of Registration Review. EPA-HQ-OPP-2015-0348-0004. DP No. D429798. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. [371] USEPA. 2016. Phosmet. Draft Human Health Risk Assessment to Support Registration Review. EPA- HQ-OPP-2009-0316-0022. DP No. D420736. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. [372] USEPA. 2016. Thiamethoxam. Acute and Chronic Aggregate Dietary (Food and Drinking Water) Exposure and Risk Assessments for Residues of Thiamethoxam on Imported Banana. EPA-HQ-OPP-2015- 0705-0007. DP No. D429717. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. [373] USEPA. 2016. Toxicological Review of Trimethylbenzenes. U.S. Environmental Protection Agency, Office of Research and Development, National Center for Environmental Assessment, Integrated Risk Information System (IRIS), Washington, D.C. [374] USEPA. 2016. Triclopyr. Revised Human Health Risk Assessment for Section 18 Emergency Exemption Request for Use on Sugarcane in Louisiana (LA). EPA-HQ-OPP-2017-0036-0002. DP No. D436366. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. [375] USEPA. 2017. Acetamiprid. Acute and Chronic Dietary Exposure and Risk Assessment for Registration Review. EPA-HQ-OPP-2012-0329-0022. DP No. D443740. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. [376] USEPA. 2017. Ametryn - Preliminary Human Health Risk Assessment for Registration Review. EPA- HQ-OPP-2013-0249-0022. DP No. D440785. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. [377] USEPA. 2017. Benfluralin: Human Health Draft Risk Assessment for Registration Review. EPA-HQ- OPP-2011-0931-0039. DP No. D431028. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. [378] USEPA. 2017. Carbaryl: Draft Human Health Risk Assessment in Support of Registration Review. EPA-HQ-OPP-2010-0230-0034. DP No. D433668. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. [379] USEPA. 2017. Cyfluthrin and Beta-Cyfluthrin: Acute and Chronic Aggregate Dietary (Food and Drinking Water) Exposure and Risk Assessment for Registration Review. EPA-HQ-OPP-2010-0684-0101. DP No. D435057. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. [380] USEPA. 2017. Cypermethrin, Zeta-cypermethrin, and Alpha-cypermethrin. Draft Human Health Risk Assessment for Registration Review. EPA-HQ-OPP-2012-0167-0116. DP No. D425964. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. B-29 ------- EPA-Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA815-R-22-003 October 2022 [381] USEPA. 2017. Difenoconazole: human health risk assessment for proposed new foliar uses on cotton, rice and wild rice. EPA-HQ-OPP-2016-0254-0010. DP No. D432211. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. [382] USEPA. 2017. EPTC: (S-Ethyl dipropylthiocarbamate) Acute and Chronic Aggregate Dietary (Food and Drinking Water), Exposure and Risk Assessments for Registration Review. EPA-HQ-OPP-2012-0720- 0019. DP No. D439764. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. [383] USEPA. 2017. Esfenvalerate. Draft Human Health Risk Assessment for Registration Review. EPA- HQ-OPP-2009-0301-0074. DP No. D414149. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. [384] USEPA. 2017. Imidacloprid. Acute and Chronic Aggregate Dietary (Food and Drinking Water) Exposure and Risk Assessments for the Registration Review Risk Assessment. EPA-HQ-OPP-2008-0844- 1236. DP Nos. D438392 D438433. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. [385] USEPA. 2017. Lambda-& Gamma-Cyhalothrin: Human Health Draft Risk Assessment for Registration Review. EPA-HQ-OPP-2010-0480-0299. DP No. 426321. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. [386] USEPA. 2017. Metribuzin: Draft Risk Assessment for Registration Review. EPA-HQ-OPP-2012-0487- 0022. DP No. D432005. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. [387] USEPA. 2017. Norflurazon: Draft Human Health Risk Assessment in Support of Registration Review. EPA-HQ-OPP-2012-0565-0025. DP No. D432685. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. [388] USEPA. 2017. Permethrin: Human Health Draft Risk Assessment for Registration Review. EPA-HQ- OPP-2011-0039-0088. DP No. 414137. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. [389] USEPA. 2017. Piperonyl Butoxide (PBO). Draft Human Health Risk Assessment Registration Review and for Proposed New Use on Edible Fungi Crop Group 21. EPA-HQ-OPP-2010-0498-0021. DP Nos. D434163 D439507. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. [390] USEPA. 2017. Prometon. Chronic Dietary (Drinking Water Only) Exposure and Risk Assessment for the Registration Review Draft Risk Assessment. EPA-HQ-OPP-2013-0068-0015. DP No. D443014. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. [391] USEPA. 2017. Provisional Peer-Reviewed Toxicity Values for p,p'-Dichlorodiphenyldichloroethylene (p,p'-DDE) (CASRN 72-55-9). EPA/690/R-17/007. U.S. Environmental Protection Agency, Office of Research and Development, National Center for Environmental Assessment, Superfund Health Risk Technical Support Center, Cincinnati, OH. B-30 ------- EPA-Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA815-R-22-003 October 2022 [392] USEPA. 2017. Pymetrozine. Draft Human Health Risk Assessment for Registration Review. EPA-HQ- OPP-2013-0368-0017. DP No. D439601. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. [393] USEPA. 2018. 2,4-DB: Draft Human Health Risk Assessment in Support of Registration Review. EPA- HQ-OPP-2013-0661-0019. DP No. D448826. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. [394] USEPA. 2018. Acephate. Revised Draft Human Health Risk Assessment (DRA) in Support of Registration Review. EPA-HQ-OPP-2008-0915-0025. DP No. D446177. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. [395] USEPA. 2018. Atrazine. Draft Human Health Risk Assessment for Registration Review. EPQ-HQ- OPP-2013-0266-1159. DP No. D418316. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. [396] USEPA. 2018. Azoxystrobin: Revised Human Health Draft Risk Assessment for Registration Review. EPA-HQ-OPP-2009-0835-0043. DP No. D444164. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. [397] USEPA. 2018. Bromoxynil and Bromoxynil Esters: Human Health Draft Risk Assessment for Registration Review. EPA-HQ-OPP-2012-0896-0021. DP No. D444387. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. [398] USEPA. 2018. Clomazone: Human Health Risk Assessment for Proposed (1) New Uses on Cilantro, Dill, and Rapeseed Subgroup 20A; (2) Tolerance Revisions of Cucurbit Vegetable Group 9; (3) Tolerance Expansions of Representative Commodities to (i) Cottonseed Subgroup20C, (ii) Stalk and Stem Vegetable Subgroup 22A, except Kohlrabi, (iii) Dry Bean, and (iv)Succulent Bean; and (4) Tolerance Conversions from Crop Subgroup 5A (Head and Stem Brassica) to Crop Group 5-16 (Brassica Head and Stem Vegetable), Chinese Broccoli and Kohlrabi. EPA-HQ-OPP-2017-0372-0008. DP No. D445140. Office of Chemical Safety and Pollution Prevention, United States Environmental Protection Agency, Washington, D.C. [399] USEPA. 2018. Imazalil. Acute, Chronic, and Cancer Dietary (Food Only) Exposure and Risk Assessment in Support of the HED Draft Risk Assessment for Registration Review. EPA-HQ-OPP-2013- 0305-0026. DP No. D446973. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. [400] USEPA. 2018. Imazaquin: Draft Human Health Risk Assessment for Registration Review. EPA-HQ- OPP-2014-0224-0020. DP No. D445078. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. [401] USEPA. 2018. Indoxacarb: Update to the Human Health Draft Risk Assessment for Indoxacarbto Support Registration Review and the Proposed New Use for Controlling Ants at Ornamental Nurseries, Sod Farms, and Livestock Corrals of non-Food Bearing Animals. EPA-HQ-OPP-2013-0367-0050. DP No. D445517. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. B-31 ------- EPA-Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA815-R-22-003 October 2022 [402] USEPA. 2018. MCPA. Draft Human Health Risk Assessment in Support of Registration Review. EPA- HQ-OPP-2014-0180-0043. DP No. D446323. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. [403] USEPA. 2018. Methomyl and Thiodicarb: Draft Human Health Risk Assessment in Support of Registration Review. EPA-HQ-OPP-2009-0432-0017. DP Nos. D420613 D439094. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. [404] USEPA. 2018. Methyl Bromide. Draft Human Health Risk Assessment for Registration Review. EPA- HQ-OPP-2013-0269-0030. DP No. D449330. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. [405] USEPA. 2018. Naphthalene: Human Health Risk Assessment in Support of Registration Review. EPA-HQ-OPP-2016-0113-0018. DP No. D440842. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. [406] USEPA. 2018. Pyraclostrobin. Human Health Risk Assessment for a Petition for the Establishment of Use on Greenhouse-Grown Leafy Greens, Except Head Lettuce, Subgroup 4- 16A; Cucurbit Vegetables, Group 9; and Fruiting Vegetables, Group 8-10 and Crop Group Conversions and Expansion of Tolerances for Brassica, Leafy Greens, Subgroup 4-16B; Celtuce; Florence Fennel; Kohlrabi; Leaf Petiole Vegetables, Subgroup 22B; Tropical and Subtropical, Medium to Large Fruit, Inedible Peel, Subgroup 23B; and Brassica Head and Stem, Group 5-16 and a Revised Tolerance Level for Leafy Greens, Subgroup 4-16A.EPA-HQ-OPP-2017-0311-0008. EPA-HQ-OPP-2017-0311-0008. DP No. D440504. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. [407] USEPA. 2018. Pyridaben. Human Health Draft Risk Assessment in Support of Registration Review. EPA-HQ-OPP-2010-0214-0015. DP No. D440297. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. [408] USEPA. 2018. Registration Review Draft Risk Assessment for Triclosan. EPA-HQ-OPP-2012-0811- 0020. DP Nos. 449415, 449416. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. [409] USEPA. 2018. Sulfentrazone - Human Health Risk Assessment for a Section 3 Registration Request to Add New Uses on Chia and Teff; an Amended Use on Mint; and Crop Group Conversions for Tree Nut Group 14-12, Stalk and Stem Vegetable Subgroup 22A; Vegetable, Brassica, Head and Stem, Group 5-16; and Brassica, Leafy Greens, Subgroup 4-16B. EPA-HQ-OPP-2017-0072-0009. DP No. D443993. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. [410] USEPA. 2018. Tetraconazole: Human Health Risk Assessment for the Section 3 Registration for Application to add Crop Subgroup 6C; Dried Shelled Pea and Bean (except soybean) Subgroup 6C; Barley; Rapeseed Subgroup 20A; Wheat; and Forage, Fodder, and Straw of Cereal Grains Group 16. EPA-HQ- OPP-2016-0573-0005. DP No. D435706. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. [411] USEPA. 2018. Thiobencarb - Registration Review Draft Human Health Risk Assessment. EPA-HQ- OPP-2011-0932-0037. DP No. D439288. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. B-32 ------- EPA-Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA815-R-22-003 October 2022 [412] USEPA. 2018. Trifloxystrobin. Human Health Risk Assessment for the Proposed New Use on Flax Seed and Increase of Established Tolerance on Aspirated Grain Fractions. EPA-HQ-OPP-2013-0074-0049. DP Nos. D442038 D444241. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. [413] USEPA. 2018. Trifluralin: Acute, Chronic, and Cancer Aggregate Dietary (Food and Drinking Water) Exposure and Risk Assessment for the Section 3 Registration Action on Rosemary and Crop Group Conversions to Support Registration Review. EPA-HQ-OPP-2017-0420-0006. DP Nos. D445916 D447175. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. [414] USEPA. 2019. Boscalid. Human Health Risk Assessment for Registration Review. EPA-HQ-OPP- 2014-0199-0020. DP No. D451675. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. [415] USEPA. 2019. Clopyralid. Draft Human Health Risk Assessment for Registration Review of the Herbicide. EPA-HQ-OPP-2014-0167-0031. DP No. D442247. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. [416] USEPA. 2019. Clothianidin. Human Health Risk Assessment to Address Residues from New/Amended Uses of Thiamethoxam. EPA-HQ-OPP-2018-0779-0004. DP No. D446686. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. [417] USEPA. 2019. Fenbuconazole: Human Health Risk Assessment for Proposed Use on Imported Tea. EPA-HQ-OPP-2018-0300-0004. DP No. D446940. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. [418] USEPA. 2019. Linuron: Revised Human Health Draft Risk Assessment to Support Registration Review. EPA-HQ-OPP-2010-0228-0065. DP No. D444117. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. [419] USEPA. 2019. Mecoprop-p (MCPP-p): Acute, and Chronic Aggregate Dietary (Drinking Water Only) Exposure and Risk Assessments for the Registration Review Risk Assessment. EPA-HQ-OPP-2014-0361- 0021. DP No. D452571. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. [420] USEPA. 2019. Metolachlor and S-Metolachlor: Draft Human Health Risk Assessment for Registration Review. EPA-HQ-OPP-2014-0772-0030. DP No. 438094. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. [421] USEPA. 2019. Myclobutanil: Human Health Risk Assessment for Registration Review. EPA-HQ-OPP- 2015-0053-0018. DP No. D448816. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. [422] USEPA. 2019. Oxyfluorfen: Draft Human Health Risk Assessment for Registration Review. EPA-HQ- OPP-2014-0778-0025. DP No. D445742. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. B-33 ------- EPA-Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA815-R-22-003 October 2022 [423] USEPA. 2019. Pendimethalin - Human Health Risk Assessment to Support the Proposed New Uses on Leaf Petiole Vegetable Subgroup 22B, Monarda and Rosemary. EPA-HQ-OPP-2018-0619-0008. DP No. D448588. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. [424] USEPA. 2019. Propargite: Draft Human Health Risk Assessment in Support of Registration Review. EPA-HQ-OPP-2014-0131-0051. DP No. D449759. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. [425] USEPA. 2019. Propiconazole Human Health Risk Assessment for the New Use of Propiconazole on Avocado, along with Conversion to Brassica, leafy greens, subgroup 4-16B, except watercress, Leaf petiole vegetable subgroup 22B, Celtuce, Florence fennel, Swiss chard, and the expansion to Vegetable, root, except sugar beet, subgroup IB. EPA-HQ-OPP-2018-0127-0007. DP No. D446376. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. [426] USEPA. 2019. Registration Review Draft Risk Assessment for Phenol and Salts. EPA-HQ-OPP-2012- 0810-0007. DP No. 453361. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. [427] USEPA. 2019. Tebuconazole: Acute and Chronic Aggregate Dietary Exposure and Risk Assessments for Petition for the Establishment of Registrations and Permanent Tolerances for Residues in/on Watercress; Add Green-House Grown Tomato to Label and Crop Group Conversions/Expansions for Brassica Leafy Greens, Subgroup 4-16B, Except Watercress; Cottonseed, Subgroup 20C; Pome Fruit, Group 11-10; Stone Fruit, Group 12-12, Except Cherry; Small Vine Climbing Fruit, Except Fuzzy Kiwifruit, Subgroup 13-07F; Tropical and Subtropical Small Fruit, Inedible Peel, Subgroup 24A; Tree Nut, Group 14- 12; and Sunflower, Subgroup 20B. EPA-HQ-OPP-2018-0094-0006. DP No. D447613. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. [428] USEPA. 2019. Tefluthrin: Updated Human Health Draft Risk Assessment in Support of Registration Review. DP No. D453462. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. [429] USEPA. 2019. Terbacil: Human Health Draft Risk Assessment for Registration Review. EPA-HQ-OPP- 2011-0054-0038. DP No. D446169. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. [430] USEPA. 2019. Thiabendazole. Acute and Chronic Aggregate (Food and Drinking Water) Dietary Exposure and Risk Assessments in Support of Registration Review. EPA-HQ-OPP-2014-0175-0028. DP No. D450527. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. [431] USEPA. 2019. Triallate. Human Health Draft Risk Assessment Scoping Document in Support of Registration Review. EPA-HQ-OPP-2014-0573-0018. DP No. D452964. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. [432] USEPA. 2020. Acetochlor. Human Health Draft Risk Assessment to Support Registration Review. EPA-HQ-OPP-2016-0298-0019. DP No. D454826. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, D.C. B-34 ------- EPA-Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA815-R-22-003 October 2022 [433] Uslu, M., Jasim, S., Arvai, A., Bewtra, J. and Biswas, N., 2013. A Survey of Occurrence and Risk Assessment of Pharmaceutical Substances in the Great Lakes Basin. Ozone: Science & Engineering, 35(4), pp.249-262. [434] Vanderford BJ, Pearson RA, Rexing DJ, Snyder SA., 2003. Analysis of endocrine disruptors, pharmaceuticals, and personal care products in water using liquid chromatography/tandem mass spectrometry. Analytical chemistry. 75(22), pp.6265-74 [435] Vanderford BJ, Snyder SA., 2006. Analysis of pharmaceuticals in water by isotope dilution liquid chromatography/tandem mass spectrometry. Environmental science & technology. 40(23), pp.7312-20 [436] WHO. 1999. Concise International Chemical Assessment Document 18, Cumene. World Health Organization (WHO), Geneva, Switzerland. [437] WHO. 2003. Ammonia in Drinking-water. Background document for development of WHO Guidelines for Drinking-water Quality. World Health Organization (WHO), Geneva, Switzerland. [438] WHO. 2003. Guidelines for Drinking Water Quality: Polynyclear Aromatic Hydrocarbons (PAHs). World Health Organization (WHO), Geneva, Switzerland. [439] WHO. 2005. 1,4-Dioxane in Drinking-water. WHO Guidelines for Drinking-water Quality. World Health Organization (WHO), Geneva, Switzerland. [440] WHO. 2005. Methyl tertiary-Butyl Ether (MTBE) in Drinking-water Background document for development of WHO Guidelines for Drinking-water Quality. World Health Organization (WHO), Geneva, Switzerland. [441] WHO. 2009. Boron in Drinking-water. Background document for development of WHO Guidelines for Drinking-water Quality. World Health Organization (WHO), Geneva, Switzerland. [442] WHO. 2011. Molybdenum in Drinking-water. Background document for development of WHO Guidelines for Drinking-water Quality. World Health Organization (WHO), Geneva, Switzerland. [443] WHO. 2017. Guidelines for drinking water quality: 4th ed. World Health Organization (WHO), Geneva, Switzerland. [444] Willhite, C., Ball. G., and McLellan, C. 2008. Journal of Toxicology and Environmental Health, Part B. 11:69-146. [445] Yang S, Carlson K., 2003. Evolution of antibiotic occurrence in a river through pristine, urban and agricultural landscapes. Water research. 37(19), pp.4645-56 [446] Yang S, Carlson KH., 2004. Solid-phase extraction-high-performance liquid chromatography-ion trap mass spectrometry for analysis of trace concentrations of macrolide antibiotics in natural and waste water matrices. Journal of chromatography. A. 1038(1-2), pp.141-55 [447] Yang S, Cha J, Carlson K., 2005. Simultaneous extraction and analysis of 11 tetracycline and sulfonamide antibiotics in influent and effluent domestic wastewater by solid-phase extraction and liquid chromatography-electrospray ionization tandem mass spectrometry. Journal of chromatography. A. 1097(1-2), pp.40-53 B-35 ------- EPA-Office of Water Technical Support Document for the Final Fifth Contaminant Candidate List (CCL 5) Contaminant Information Sheets EPA815-R-22-003 October 2022 [448] Yang S, Cha J, Carlson K., 2006. Trace analysis and occurrence of anhydroerythromycin and tylosin in influent and effluent wastewater by liquid chromatography combined with electrospray tandem mass spectrometry. Analytical and bioanalytical chemistry. 385(3), pp.623-36 [449] Yu JT, Bouwer EJ, Coelhan M., 2006. Occurrence and biodegradability studies of selected pharmaceuticals and personal care products in sewage effluent Agricultural water management. 86(), pp.72-80 [450] Zhang S, Zhang Q, Darisaw S, Ehie O, Wang G., 2007. Simultaneous quantification of polycyclic aromatic hydrocarbons (PAHs), polychlorinated biphenyls (PCBs), and pharmaceuticals and personal care products (PPCPs) in Mississippi river water, in New Orleans, Louisiana, USA. Chemosphere. 66(6), pp.1057-69 [451] Zhang, X., Ensminger, M., Deng, X., Budd, R., Xie, Y., Wang, D.,... & Goh, K. S. (2019). The Surface Water Database (SURF): A California Database for Surface Water Pesticide Monitoring Data. In Pesticides in Surface Water: Monitoring, Modeling, Risk Assessment, and Management (pp. 215-232). American Chemical Society. [452] Zuo Y, Zhang K, Deng Y., 2006. Occurrence and photochemical degradation of 17alpha- ethinylestradiol in Acushnet River Estuary. Chemosphere. 63(9), pp.1583-90 B-36 ------- |