&EPA Screening Document United States .^ -rkx^x^T Environmental Protection fOf the Draft PCCL 4 Agency Nominated Contaminants ------- Office of Water (4607M) EPA815-R-15-002 January 2015 ------- EPA-OGWDW Screening Document for the Draft EPA 815-R-15-002 PCCL 4 Nominated Contaminants Contents 1.0 Introduction 1 2.0 Summary of the CCL 3 Chemicals Screening Process 3 2.1 Health Effects Data Elements 4 2.2 Occurrence Data Elements 6 2.3 Selection of the PCCL 7 3.0 Screening the Nominated Chemicals from the CCL 4 Universe to the PCCL 8 4.0 Summary of the CCL 3 Microbes Screening Process and Screening of the Nominated Microbes from the CCL 4 Universe to the PCCL 4 8 5.0 References 10 6.0 Appendices Al Appendix 1. Screening data for the Nominated Chemicals in the CCL 4 Universe Al Page i of vi ------- EPA-OGWDW Screening Document for the Draft EPA 815-R-15-002 PCCL 4 Nominated Contaminants Page ii of vi ------- EPA-OGWDW Screening Document for the Draft EPA 815-R-15-002 PCCL 4 Nominated Contaminants Exhibits Exhibit 1: Partition for Screening the Universe 4 Exhibit 2: Potency Measures for Universe Data Element Partitioned Based on Toxicity (mg/kg/day ormg/kg) 5 Exhibit 3: Partitioning of Cancer Data Based on TD50 Values and Weight of Evidence 6 Exhibit 4: Criteria for a Chemical to Pass to the PCCL 7 Page ill of vi ------- EPA-OGWDW Screening Document for the Draft EPA 815-R-15-002 PCCL 4 Nominated Contaminants Page iv of vi ------- EPA-OGWDW Screening Document for the Draft PCCL 4 Nominated Contaminants EPA 815-R-15-002 Acronyms and Abbreviations < Less than < Less than or equal to > Greater than > Greater than or equal to |i Microgram, one |ig/L Micrograms per liter ADI Acceptable Daily Intake AWWARF American Water Works Association Research Foundation 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 CE Clear evidence of carcinogenicity CUS/IUR Chemical Update System/Inventory Update Rule DBF-CAN EPA Water Disinfection By-Products with Carcinogenicity Estimates DSSTOX Distributed Structure-Searchable Toxicity Database Network E Equivocal EE Equivocal evidence of carcinogenicity EPA United States Environmental Protection Agency EPA HA EPA Health Advisory FR Federal Register g Gram H High probability of causing cancer HM High moderate probability of causing cancer IARC International Agency for Research on Cancer ITER International Toxicity Estimates for Risk JECFA Joint FAO/WHO Expert Committee on Food Additives kg Kilogram L Liter LDso Lethal dose 50; an estimate of a single dose that is expected to cause the death of 50 percent of the exposed animals; it is derived from experimental data. M Moderate probability of causing cancer LM Low moderate probability of causing cancer LOAEL Lowest Observed Adverse Effect Level MCL Maximum Contaminant Level Page v of vi ------- EPA-OGWDW Screening Document for the Draft PCCL 4 Nominated Contaminants EPA 815-R-15-002 MCLG mg/kg mg/kg/day mg/L MRDD N NAWQA NE MRS NOAEL NCI NCFAP NDWAC NRC NREC NTP OPP P PFOA PWS QSAR RfD RAIS RTECS SDWA SE TDso TRI UCM Round 1 US WHO yr Maximum Contaminant Level Goal Milligrams per kilogram body weight Milligrams per kilogram body weight per day Milligrams per liter Maximum Recommended Daily Dose Negative National Water Quality Assessment No evidence of carcinogenicity National Inorganics and Radionuclides Survey No Observed Adverse Effect Level National Cancer Institute National Center for Food and Agricultural Policy National Drinking Water Advisory Council National Academy of Science's National Research Council National Reconnaissance of Emerging Contaminants National Toxicology Program Office of Pesticide Programs Positive Perfluorooctanoic acid Public water system Quantitative Structure Activity Relationship Reference dose Risk Assessment Information System Registry of Toxic Effects of Chemical Substances Safe Drinking Water Act Some evidence of carcinogenicity Tumorigenic dose 50; The dose-rate which if administered chronically for the standard life-span of the species will have a 50% probability of causing tumors at some point during that period. Toxics Release Inventory Unregulated Contaminant Monitoring Round 1 United States of America World Health Organization Year Page vi of vi ------- EPA-OGWDW Screening Document for the Draft EPA 815-R-15-002 PCCL 4 Nominated Contaminants 1.0 Introduction Section 1412(b)(l) of the Safe Drinking Water Act (SOWA), as amended in 1996, requires EPA to publish the Contaminant Candidate List (CCL) every five years. The SDWA specifies that the list must include contaminants that 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. EPA uses this list of unregulated contaminants to help the agency identify priority contaminants for regulatory decision making and to prioritize research and data collection efforts. SDWA also requires the agency to consult with the scientific community, including the Science Advisory Board, and provide notice and opportunity for public comment prior to the publication of the Final CCL. In addition, SDWA directs the agency to consider the health effects and occurrence information for unregulated contaminants to identify those contaminants that present the greatest public health concern related to exposure from drinking water. EPA published the third CCL (CCL 3), which listed 116 contaminants on October 8, 2009 (74 FR 51850 (USEPA, 2009a)). In developing the CCL 3, EPA implemented a multi-step process to select contaminants for the final CCL 3, which included the following key steps: (1) The identification of a broad universe of potential drinking water contaminants (CCL 3 Universe); (2) Screening the CCL 3 Universe to a Preliminary CCL (PCCL) using screening criteria based on the potential to occur in PWSs and the potential for public health concern; (3) Evaluation of the PCCL contaminants based on a more detailed review of the occurrence and health effects data using a scoring and classification system to identify a final list of 116 CCL 3 contaminants; and (4) Incorporating public input and expert review in the CCL 3 process. Steps 1, 2 and 3 in the process are described in detail in the CCL 3 support documents: Final CCL 3 Chemicals: Identifying the Universe (USEPA, 2009b); Final CCL 3 Chemicals: Screening to a PCCL (USEPA, 2009c); Final Contaminant Candidate List 3 Chemicals: Classification of the PCCL to the CCL (USEPA, 2009d); Final CCL 3 Microbes: Identifying the Universe (USEPA, 2009e); Final CCL 3 Microbes: Screening to the PCCL (USEPA, 2009f); and Final CCL 3 Microbes: PCCL to CCL Process (USEPA, 2009g). These documents can be found on the EPA web site at: http://www2.epa.gov/ccl/contaminant- candidate-list-3-ccl-3 or at http://www.regulations.gov (docket ID: EPA-HQ-OW-2007-1189). After a Final CCL is published, SDWA section 1412(b)(l)(B)(ii) as amended in 1996, requires EPA at five year intervals to make determinations of whether to regulate or not to regulate no fewer than five contaminants from the CCL in a process called regulatory determinations. This is Page 1 of 11 ------- EPA-OGWDW Screening Document for the Draft EPA 815-R-15-002 PCCL 4 Nominated Contaminants a separate process from the listing of contaminants on the CCL. The 1996 SDWA Amendments specify three criteria to determine whether a contaminant may require regulation: the contaminant may have an adverse effect on the health of persons; the contaminant is known to occur or there is a substantial likelihood that the contaminant will occur in PWSs with a frequency and at levels of public health concern; and in the sole judgment of the Administrator, regulation of such contaminant presents a meaningful opportunity for health risk reduction for persons served by PWSs. If EPA determines that these three statutory criteria are met and makes a final determination to regulate a contaminant, the agency has 24 months to publish a proposed Maximum Contaminant Level Goal1 (MCLG) and NPDWR2. After the proposal, the agency has 18 months to publish and promulgate a final MCLG and NPDWR (SDWA section 1412(b)(l)(E))3. On February 11, 2011, as a separate action, the agency issued a positive regulatory determination for perchlorate, a chemical listed in CCL 1, CCL 2 and CCL 3 (76 FR 7762 (USEPA, 2011)). Recently, EPA has published preliminary regulatory determinations for five unregulated contaminants on the CCL 3 (79 FR 62716 (USEPA, 2014)). The five contaminants include: dimethoate; 1,3-dinitrobenzene; strontium; terbufos and terbufos sulfone. The agency is making preliminary determinations to regulate one contaminant (strontium) and to not regulate four contaminants (dimethoate; 1,3-dinitrobenzene; terbufos; and terbufos sulfone). Therefore, the agency is removing perchlorate and these five contaminants from the Draft Fourth CCL (CCL 4), pending the result of the final regulatory determinations for CCL 3. EPA conducted an abbreviated evaluation and selection process for the CCL 4. This abbreviated CCL 4 process includes a three pronged approach: (1) carrying forward CCL 3 contaminants (minus those with regulatory determinations), (2) seeking and evaluating nominations from the public for additional contaminants to consider and (3) evaluating any new data for those contaminants with previous negative regulatory determinations from CCL 1 or CCL 2 for potential inclusion on the CCL 4. As part of the process to develop the CCL 4, EPA published a Federal Register notice (77 FR 27057 (USEPA, 2012)) requesting that the public submit nominations for chemical and microbial contaminants to be considered for inclusion in the CCL 4. EPA also requested supporting information that has been made available since the development of the CCL 3, or existing information that was not considered in the development of the CCL 3, which shows that the nominated contaminant may have an adverse health effect on people, and occurs or is likely 1 The MCLG is the "maximum level of a contaminant in drinking water at which no known or anticipated adverse effect on the health of persons would occur, and which allows an adequate margin of safety. Maximum contaminant level goals are non-enforceable health goals." (40 C.F.R. 141.2; 42 U.S.C. 300g-l) 2 An NPDWR is a legally enforceable standard that applies to public water systems. An NPDWR sets a legal limit (called a maximum contaminant level or MCL) or specifies a certain treatment technique (TT) for public water systems for a specific contaminant or group of contaminants. The MCL is the highest level of a contaminant that is allowed in drinking water and is set as close to the MCLG as feasible using the best available treatment technology and analytical methods and taking cost into consideration. 3 The statute authorizes a nine month extension of this promulgation date. Page 2 of 11 ------- EPA-OGWDW Screening Document for the Draft EPA 815-R-15-002 PCCL 4 Nominated Contaminants to occur in public water systems. EPA reviewed the nominations and supporting information provided by nominators to determine if any new data were provided that had not been previously evaluated for CCL 3. The agency also collected additional data for the nominated contaminants, when it was available, from both CCL 3 data sources that had been updated and from new data sources that were not available at the time of CCL 3. A complete list of references provided by nominators can be found in the support document Summary of Nominations for the Fourth CCL (USEPA, 2015a). A more detailed description of the CCL data sources collected by EPA may be found in the support document Data Sources for the CCL 4 (USEPA, 2015b). EPA evaluated the nominated contaminants utilizing the best available health effects and occurrence data and the same process for screening and scoring contaminants that was used for CCL 3. This document focuses on describing the second step in the CCL 4 process, in which EPA applied screening criteria to the nominated contaminants in the CCL 4 Universe to identify a Preliminary CCL (PCCL) based on a contaminant's potential to occur in public water systems and the potential for public health concern. Appendix 1 shows the health effects and occurrence data used to screen the nominated chemicals in the CCL 4 Universe to the PCCL 4. 2.0 Summary of the CCL 3 Chemicals Screening Process The agency evaluated the nominated contaminants for CCL 4 utilizing the best available health effects and occurrence data and the same process for screening and scoring contaminants that was used for CCL 3. This section summarizes the process developed under CCL 3 to screen chemicals from the Universe to the PCCL. A more detailed description of the screening process can be found in the CCL 3 support document: Final CCL 3 Chemicals: Screening to a PCCL (USEPA, 2009c). EPA developed criteria to screen chemicals from the CCL 3 Universe to the PCCL 3. These screening criteria utilized available data (e.g., occurrence and health) to examine a chemical's health effects relative to its occurrence. The health effects information used included quantitative, descriptive or categorical information. Within the aforementioned categories, there were various types of reported health related values (e.g., RfD, LOAEL, NOAEL, LD50 or cancer classifications) from several data sources. A list and detailed description of the data sources used in CCL 3 can be found in Final CCL 3 Chemicals: Identifying the Universe (USEPA, 2009b). The occurrence information also included many types of available data representative of a chemical's potential to occur in water. Occurrence data ranged from concentrations in finished drinking water from PWSs, to concentrations of a chemical in ambient water, to environmental release and production data. The basic framework EPA used in screening is shown in Exhibit 1. EPA categorized the CCL Chemical Universe contaminants by their toxicity along the vertical axis and by their occurrence on the horizontal axis. This allows for separation of chemicals into those that move to the PCCL based on their toxicity and occurrence properties (e.g., upper right in Exhibit 1) and those that are not further evaluated and remain in the CCL Chemical Universe (e.g., lower left in Exhibit 1). EPA used a set of test chemicals to develop the screening criteria. This set of chemicals included regulated and unregulated chemicals that provided comprehensive information on health effects and occurrence in finished and/or ambient water as well as Page 3 of 11 ------- EPA-OGWDW Screening Document for the Draft PCCL 4 Nominated Contaminants EPA 815-R-15-002 environmental release and production volume. EPA then used these criteria to select chemicals for the PCCL for further consideration. Exhibit 1: Partition for Screening the Universe Health Effects Occurrence Low to High Occurrence Increasing Toxicity Do not pass to PCCL Lass to the PCCL 2.1 Health Effects Data Elements EPA evaluated the toxicity information and health effects data compiled from the data sources in the Universe and these data varied greatly. Some of these data are quantitative (e.g., RfD, LOAEL, NOAEL, LDso) and some are descriptive (e.g., cancer classifications or predictions). EPA designed the screening process to accommodate both types of health effects data. EPA divided the chemicals in the Universe into five toxicity categories for screening based upon the distribution of the toxicity value for each type of quantitative data element and/or the qualitative information on cancer weight-of-evidence. The five toxicity categories are designated 1 through 5, with Toxicity Category 1 containing chemicals in the most toxic grouping and Toxicity Category 5 the least toxic grouping. Based upon the distribution of the chemicals for each quantitative data element, EPA selected ranges of toxicity values for each toxicity category that differed based upon the type of data element used. For example, the range of toxicity values that places a LOAEL in Toxicity Category 1 differs from the values used to place LDso values into Toxicity Category 1. Placing contaminants into Toxicity Categories allows for a comparison of the relative toxicity of contaminants that have different types of available data. Exhibit 2 displays the ranges for each non-cancer health effects data element and their respective Toxicity Categories. Page 4 of 11 ------- EPA-OGWDW Screening Document for the Draft PCCL 4 Nominated Contaminants EPA 815-R-15-002 Exhibit 2: Potency Measures for Universe Data Element Partitioned Based on Toxicity (mg/kg/day or mg/kg) Toxicity Category 1 Toxicity Category 2 Toxicity Category 3 Toxicity Category 4 Toxicity Category 5 RfD <0.0001 0.0001 -<0.001 0.001 -<0.05 0.05 -<0.1 >0.1 NOAEL <0.01 0.01 -< 1 1 -<10 10 -< 1000 >1000 LOAEL <0.01 0.01 -<1 1 -<10 10-<1000 >1000 MRDD <0.01 0.01 -<1 1 -<10 10 -< 1000 >1000 LDso <1 1 -<50 50 - <500 500 - <5000 >5000 EPA used descriptive (or categorical) cancer data to group data elements into toxicity categories that provide gradation based upon the strength of the data. Sources for the descriptive cancer data included: US EPA Cancer Groupings International Agency for Research on Cancer (IARC) Cancer Groupings National Toxicology Program weight-of-evidence findings from cancer bioassays National Cancer Institute (NCI) weight-of-evidence findings from cancer bioassays EPA Water Disinfection By-Products with Carcinogenicity Estimates (DBF-CAN) groupings based on carcinogenic potential derived from Quantitative Structure Activity Relationship (QSAR) projections and expert judgment EPA partitioned the cancer-related data elements in the Universe as described in Exhibit 3. The cancer data placed chemicals in only the three highest Toxicity Categories. EPA did not use quantitative measures of dose-response for carcinogenicity in the screening criteria because more chemicals can be analyzed using the descriptive data than by cancer slope factors. In addition, EPA did not use descriptors indicating lack of carcinogenic potential or insufficient data to determine carcinogenic potential in categorizing chemicals because those descriptors apply only to the cancer endpoint and do not consider non-cancer effects associated with exposure to the chemical. Page 5 of 11 ------- EPA-OGWDW Screening Document for the Draft PCCL 4 Nominated Contaminants EPA 815-R-15-002 Exhibit 3: Partitioning of Cancer Data Based on TD50 Values and Weight of Evidence Toxicity Category 1 Toxicity Category 2 Toxicity Category 3 TDso <0.1 0.1 -100 >100 EPA Group A; Human Carcinogen Groups B1 and B2; Likely carcinogens Group C; Suggestive evidence of carcinogenicity IARC /HC Group 1 Group 2A Group 2B NTP CE 2 species/2 sexes; or 2 species; or 2 sexes Combinations of CE, SE, EE, and NE Combinations of SE, EE, and NE NCI P 2 species/2 sexes; or 2 species; or 2 sexes Combinations ofP, EandN Combinations of E and N DSS-Tox H HM M and LM ** Cancer data placed chemicals in only the three highest Toxicity Categories CE = clear evidence, SE = some evidence, EE = equivocal evidence, NE = no evidence P = positive, N = Negative, E = equivocal H = high probability, HM = high to medium probability, M = medium probability, LM = medium to low probability EPA chose a conservative approach to categorize each chemical's toxicity for screening and evaluated all the available health effects dose-response and categorical data elements for a given chemical in the screening process. Chemicals were assigned to the highest toxicity category indicated after an evaluation of all the available data. Accordingly, if a chemical had just one data element that places it in Toxicity Category 1, it was categorized as such even if some of the other data elements for that same chemical may place it in a lower toxicity category. For example, if a chemical is classified as a 2A carcinogen by IARC it will be placed in Toxicity Category 2 using the descriptive cancer data even if a quantified LOAEL from a different study places it in Toxicity Category 3. 2.2 Occurrence Data Elements EPA evaluated the occurrence data elements for each chemical and placed them on the horizontal axis of the screening table. In assessing the data, EPA found that the data elements that represent a chemical's potential to occur in drinking water vary greatly. EPA's goal was to determine which data elements best represented the potential to occur in drinking water. EPA considered and evaluated data elements in the following categories: Finished Water - measures of concentration and frequency of detections Ambient Water - measures of concentration and frequency of detections Total Releases in the Environment - pounds per year and number of states Pesticide Application Rates - pounds per year and number of states Production volume - pounds per year In addition to evaluating quantitative data elements listed above, EPA also considered chemicals with descriptive data based upon their likelihood of occurring in drinking water. Examples of Page 6 of 11 ------- EPA-OGWDW Screening Document for the Draft PCCL 4 Nominated Contaminants EPA 815-R-15-002 descriptive occurrence data elements include characterization as a disinfection by-product or a drinking water treatment chemical. EPA used the following hierarchal approach to select the occurrence data element used to screen a chemical: Finished Water = Ambient Water > Environmental Release Data > Production Data. The highest data elements in the hierarchy are the finished and ambient water data; the lowest is production data. Environmental release data from TRI and pesticide application data occupy the middle position in the hierarchy. EPA also decided that when multiple data values exist for the chemicals within a given component of the hierarchy, the most conservative data value is used. For example, in the case of a chemical that has finished water data and ambient water data, EPA selected the highest available numerical concentration value as the occurrence screening data element. 2.3 Selection of the PCCL The last step in the screening process used the health effects and occurrence data elements shown in Exhibit 4 to establish the PCCL. As mentioned earlier, the health data elements were grouped into 5 toxicity categories and the highest toxicity category indicated after an evaluation of all the available data for a particular chemical was used in screening. EPA selected the highest available data element in the occurrence hierarchy to screen the contaminant. Because the chemicals were evaluated using a hierarchical approach for their occurrence elements, EPA developed separate criteria for each of the occurrence elements. EPA tested the screening criteria using a set of 200 chemicals including regulated and prior CCL chemicals and some chemicals from the Universe that had fairly complete data for all of the occurrence data elements. EPA screened these test chemicals and then adjusted the position of the PCCL selection line. In general, the PCCL selection line was positioned so that regulated chemicals and most prior CCL chemicals would be selected for the PCCL. Exhibit 4: Criteria for a Chemical to Pass to the PCCL Health Effects Toxicity Category 1 Toxicity Category 2 Toxicity Category 3 Toxicity Category 4 Toxicity Category 5 Occurrence (by data type) Finished/Ambient Water Concentrations All Concentrations > 1 |jg/l >10ug/l >100ug/l >1000ug/l Release Amount (per year) All Amounts >1 0,000 Ibs/yr > 100, 000 Ibs/yr > 1 M Ibs/yr >10M Ibs/yr Production Volume (per year) All Amounts > 500,000 Ibs/yr >10M Ibs/yr > 50 M Ibs/yr >100M Ibs/yr Page 7 of 11 ------- EPA-OGWDW Screening Document for the Draft EPA 815-R-15-002 PCCL 4 Nominated Contaminants 3.0 Screening the Nominated Chemicals from the CCL 4 Universe to the PCCL 4 EPA received nominations for 59 unique contaminants for the CCL 4 including 54 chemicals and five microbials (see section 4.0). Forty three of the nominated chemicals were included in the CCL 4 Universe. Forty of the nominated chemicals were previously included in the CCL 3 Universe, and were carried forward to the CCL 4 Universe. In addition to these forty, EPA has added three nominated chemicals to the CCL 4 Universe (octylphenol ethoxylate, oxacillin and virginiamycin) based on health effects and/or occurrence data that was newly available since the development of the CCL 3. A complete list of the nominated contaminants for the CCL 4 can be found in the support document: Summary of Nominations for the Fourth CCL (USEPA, 2015a). EPA screened all of the nominated chemicals in the CCL 4 Universe according to the screening criteria developed for CCL 3, and based on that evaluation; twenty of the nominated chemicals were included in the PCCL 4. Eighteen of those 20 chemicals were also included in the PCCL 3, and EPA added two new chemicals (manganese and nonylphenol) to the PCCL 4. The data used to screen the nominated chemicals from the CCL 4 Universe to the PCCL 4, and whether or not the chemical moved from the Universe to the PCCL 4 is shown in Appendix 1 of this document. 4.0 Summary of the CCL 3 Microbes Screening Process and Screening of the Nominated Microbes from the CCL 4 Universe to the PCCL 4 The microbial CCL 3 Universe was defined as microbes that are known to cause disease in humans. A literature review identified a list of 1,415 known human pathogens including bacterial, viral, protozoan, helminth and fungal pathogens (Taylor et al., 2001). This list was recommended as the basis of the microbial CCL 3 Universe. EPA requested nominations from the public for additions to the microbial CCL 3 Universe, and two microbes and two viral groups were added to the list through the nomination process (USEPA, 2006; USEPA, 2009e). EPA also added six fungi that did not appear on the list of Taylor et al. (2001) but were identified in drinking water distribution systems, thus bringing the total number of microbes in the CCL 3 Universe to 1,425 pathogens. These microbes remain in the CCL 4 Universe. The National Academy of Science's National Research Council (NRC) workgroup report did not make specific recommendations for selection and screening of microbial contaminants to a PCCL, and because occurrence data for microbes are not readily available to support the screening process envisioned by the NRC workgroup, the agency requested further study of these issues by a workgroup convened by the National Drinking Water Advisory Council (NDWAC). NDWAC recommended selecting microbial contaminants for the PCCL based upon an assessment of occurrence attributes and health effects attributes relating to the plausibility of pathogen presence, survival, and transport through drinking water resulting in disease manifestations from drinking water exposure. These recommendations are described further in, Page 8 of 11 ------- EPA-OGWDW Screening Document for the Draft EPA 815-R-15-002 PCCL 4 Nominated Contaminants National Drinking Water Advisory Council Report on the CCL Classification Process (NDWAC, 2004). Selection of microbes from the CCL Universe for placement on the PCCL is based upon exclusionary screening criteria that assess the potential of water-related transmission (occurrence) and the plausibility of causing waterborne disease by ingestion, inhalation or dermal contact (health effects). Microbes that met any of the exclusionary criteria were not included on the PCCL. The screening criteria developed for CCL 3, which are listed below, were also used for CCL 4. Criterion 1: Anaerobes (microorganisms that cannot survive in oxygenated environments) Criterion 2: Fastidious or obligate intracellular pathogens (environmental survival in water implausible) Criterion 3: Pathogens exclusively transmitted by direct or indirect contact with blood or body fluids (including sexually transmitted diseases) Criterion 4: Pathogens transmitted by vectors Criterion 5: Microflora indigenous to the gastrointestinal tract, skin and mucous membranes Criterion 6: Pathogens transmitted solely by respiratory secretions Criterion 7: Pathogens whose life cycle is incompatible with drinking water transmission Criterion 8: Pathogens where drinking water-related transmission is not implicated Criterion 9: Natural habitat is in the environment without epidemiological evidence of drinking water-related disease Criterion 10: Pathogens not endemic to North America Criterion 11: A genus and species or serotype may be chosen to represent a group of closely related organisms Criterion 12: Current taxonomy does not support the classification listed by Taylor et al. (2001). Four of the five nominated microbial contaminants, with the exception of heterotrophic plate count bacteria, (e.g. Vibrio cholerae, Toxoplasma gondii, Naegleria fowleri and Adenovirus) were on the PCCL 3 and are being carried forward to the PCCL 4 since no new data were found that would support a change to the contaminants listed in the PCCL 3. For additional information on the screening process please see Final Contaminant Candidate List 3 Microbes: Screening to the PCCL (USEPA, 2009f). For detailed information on the scoring protocols used to rank the nominated pathogens on the PCCL to produce a CCL please see Final Contaminant Candidate List 3 Microbes: PCCL to CCL Process (USEPA, 2009g) and for the most recent versions of the Page 9 of 11 ------- EPA-OGWDW Screening Document for the Draft EPA 815-R-15-002 PCCL 4 Nominated Contaminants contaminant information sheets, which summarize the data used for scoring the microbial contaminants nominated for CCL 4 see Contaminant Information Sheets for the Draft PCCL 4 Nominated Contaminants (USEPA, 2015c). 5.0 References National Drinking Water Advisory Council (NDWAC). 2004. National Drinking Water Advisory Council Report on the CCL Classification Process to the U. S. Environmental Protection Agency, May 19, 2004 Taylor, L. H., S. M. Latham, and M. E. Woolhouse. 2001. Risk factors for human disease emergence Philosophical Transactions of the Royal Society of London B. Vol. 356, pp. 983-989 (See electronic Appendix A, No. 1411, pp. 1-9). USEPA. 2006. Request for Nominations of Drinking Water Contaminants for the Contaminant Candidate List. Federal Register. Vol. 71. No. 199. p. 60704. October 16, 2006. USEPA. 2009a. Drinking Water Contaminant Candidate List 3Final Notice. Federal Register. Vol. 74. No 194. p. 51850. October 8, 2009. USEPA. 2009b. Final Contaminant Candidate List 3 Chemicals: Identifying the Universe. EPA 815-R-09-006. August, 2009. USEPA. 2009c. Final Contaminant Candidate List 3 Chemicals: Screening to a PCCL. EPA 815-R-09-007. August, 2009. USEPA. 2009d. Final Contaminant Candidate List 3 Chemicals: Classification of PCCL to the CCL. EPA 815-R-09-008. August 2009. USEPA. 2009e. Final Contaminant Candidate List 3 Microbes: Identifying the Universe. EPA 815-R-09-008. August 2009. USEPA. 2009f. Final Contaminant Candidate List 3 Microbes: Screening to the PCCL. EPA 815-R-09-008. August 2009. USEPA. 2009g. Final Contaminant Candidate List 3 Microbes: PCCL to CCL Process. EPA 815-R-09-009. August, 2009. USEPA, 2012. Request for Nominations of Drinking Water Contaminants for the Fourth Contaminant Candidate List. Federal Register. Vol. 77. No 89. p. 27057. May 8, 2012 USEPA. 2014. Announcement of Preliminary Regulatory Determination for Contaminants on the Third Drinking Water Contaminant Candidate List. Federal Register. Vol. 79, No. 202, p. 62716, October 20, 2014. Page 10 of 11 ------- EPA-OGWDW Screening Document for the Draft EPA 815-R-15-002 PCCL 4 Nominated Contaminants USEPA. 2015a. Summary of Nominations for the Fourth Contaminant Candidate List. EPA 815- R-l5-001. January, 2015. USEPA. 2015b. Data Sources for the CCL 4. EPA 815-R-15-004. January, 2015. USEPA. 2015c. Contaminant Information Sheets (CISs) for the Draft Fourth Preliminary Contaminant Candidate List (PCCL 4) Nominated Contaminants. EPA 815-R-15-003. January, 2015. Page 11 of 11 ------- EPA-OGWDW Screening Document for the Draft EPA 815-R-15-002 PCCL 4 Nominated Contaminants 6.0 Appendices Appendix 1. Screening data for the Nominated Chemicals in the CCL 4 Universe Appendix 1 presents the CASRN, names of the nominated contaminants in the CCL 4 Universe, the health effects and occurrence data elements that were used in their screening. The CCL 4 Screening Notes column includes a brief explanation of whether or not the chemical made the PCCL 4, and if it did not make the PCCL 4, the reason is included (i.e., the chemical failed based on the screening criteria, or incomplete data were available, so the chemical could not be screened). Some chemicals had some type of occurrence/ health information that allowed them to be included in the CCL 4 Universe, but this data was not sufficient for screening. An example of this is a chemical that was an analyte in a supplemental occurrence study, but was not detected; therefore, no concentration value was available to be used in the screening process. Thus, this chemical would remain in the Universe. The screening process is summarized in the text of this report, and a detailed description of the screening process developed under CCL 3 can be found in the Final CCL 3 Chemicals: Screening to a PCCL (USEPA, 2009c). When the health effects data element is designated as Cancer Studies NTP, the results shown are from cancer assays for two species and two sexes (male rat/female rat/ male mouse/female mouse) The NTP cancer data were partitioned into Toxicity Categories as described in Exhibit 3 of this document and the data source is described further in USEPA, 2009b. For the occurrence data elements, the release data may be either national TRI data or pesticide application data. The notation "FW/AW" indicates the data are finished or ambient water data. Also noted, for some contaminants, supplemental data were used. Further data and information for the nominated contaminants that made the PCCL 4 are available in the Contaminant Information Sheets (USEPA, 2015c) available in the CCL 4 water docket and on the CCL 4 Web site at: http://www2.epa.gov/ccl/contaminant-candidate-list-4- ccl-4. PageA1-1 ------- EPA-OGWDW Screening Document for the Draft PCCL 4 Nominated Contaminants EPA 815-R-15-002 Appendix 1. Screening Data for the Nominated Chemicals in the CCL 4 Universe Substance Key 74233 6535 3200 28242 2918 12023 3168 2448 12375 14098 3122 5106 3114 CASRN 77439760 319846 86500 25057890 80057 1 689845 85687 63252 1 897456 2921882 84742 115322 84617 Common Name 3-chloro-4- dichloromethyl-5- hydroxy-2(5H)- furanone alpha- Hexachlorocyclohe xane Azinphos-methyl Bentazon Bisphenol A (BPA) Bromoxynil Butyl benzyl phthalate Carbaryl Chlorothalonil Chlorpyrifos Dibutyl phthalate Dicofol Dicyclohexyl phthalate Health Effect/Toxicity Data Used For CCL 4 Screening Health Effect Data Element Lethal Dose 50 (LD50) Risk Specific Dose (RSD) Lowest Observed Adverse Effect Level (LOAEL) Reference Dose (RfD) Lowest Observed Adverse Effect Level (LOAEL) Reference Dose (RfD) Cancer Studies, NTP Lowest Observed Adverse Effect Level (LOAEL) Cancer Studies, NTP Reference Dose (RfD) Tolerable Daily Intake (TDI) Tumorigenic Dose 50 (TD50) No HE data for screening Value 120 0.000002 0.91 0.03 2.5 0.015 IS/P/P/N 0.23 P/P/N/N 0.0003 0.063 32.9 Units mg/kg mg/kg-day mg/kg-day mg/kg-day mg/kg-day mg/kg-day mg/kg-day mg/kg-day mg/kg-day mg/kg-day Data Source RTECS ITER RTECS OPP RTECS OPP NTP RTECS NTP OPP ITER DSSTOX Toxicity Screening Category Toxicity Category 3 Toxicity Category 1 Toxicity Category 2 Toxicity Category 3 Toxicity Category 3 Toxicity Category 3 Toxicity Category 2 Toxicity Category 2 Toxicity Category 1 Toxicity Category 2 Toxicity Category 4 Toxicity Category 2 Occurrence Data Used For CCL 4 Screening Occurrence Data Element No Occurrence data for screening FW/AW-Max Value FW/AW-Max Value FW/AW-Max Value FW/AW-Max Value FW/AW-Max Value Production Volume FW/AW-Max Value FW/AW-Max Value FW/AW-Max Value Release Release Production Volume Value 0.21 3.37 11.46 12 6.1 >50M-100M 33.5 0.71 0.57 177,489 788,527 >500K- 1M Units ug/L ug/L ug/L ug/L ug/L Ibs/yr ug/L ug/L ug/L Ibs/yr Ibs/yr Ibs/yr Data Source NAWQA NAWQA NAWQA Kolpin et al., 2002 (Max) NAWQA CUS/IUR NAWQA NAWQA NAWQA TRI NCFAP CUS/IUR CCL 4 Screening Notes Incomplete data for screening/ remains in CCL 4 Universe Makes PCCL 4 Makes PCCL 4 Makes PCCL 4 Makes PCCL 4 Fails Screen/ remains in CCL 4 Universe Makes PCCL 4 Makes PCCL 4 Makes PCCL 4 Fails Screen/ remains in CCL 4 Universe Fails Screen/ remains in CCL 4 Universe Makes PCCL 4 Incomplete data for screening/ remains in CCL 4 Universe A1-2 ------- EPA-OGWDW Screening Document for the Draft PCCL 4 Nominated Contaminants EPA 815-R-15-002 Substance Key 3118 30533 5769 5200 5104 12839 6584 5402 18823 6419 11918 76859 28410 20331 CASRN 84662 28553120 131113 117840 115297 2164172 330552 1 21 755 7439965 298000 1 634044 1 01 043372 251 54523 901 6459 Common Name Diethyl phthalate Di-isononyl phthalate Dimethyl phthalate Di-n-octyl phthalate Endosulfan Fluometuron Linuron Malathion Manganese Methyl parathion Methyl tert-butyl ether Microcystin-LR Nonylphenol Nonylphenol ethoxylate Health Effect/Toxicity Data Used For CCL 4 Screening Health Effect Data Element No Observed Adverse Effect Level (NOAEL) Lowest Observed Adverse Effect Level (LOAEL) Reference Dose (RfD) Reference Dose (RfD) No Observed Adverse Effect Level (NOAEL) Reference Dose (RfD) Lowest Observed Effect Level (LOEL) No Observed Effect Level (NOEL) No Observed Adverse Effect Level (NOAEL) Reference Dose (RfD) Tolerable Daily Intake (TDI) Reference Dose (RfD) Lowest Observed Adverse Effect Level (LOAEL) Lethal Dose 50 (LD50) Value 750 402 10 0.04 0.7 0.01 0.63 0.23 0.14 0.0002 0.01 0.000003 2 1310 Units mg/kg-day mg/kg-day mg/kg-day mg/kg-day mg/kg-day mg/kg-day mg/kg-day mg/kg-day mg/kg-day mg/kg-day mg/kg-day mg/kg-day mg/kg-day mg/kg Data Source ITER RTECS RAIS RAIS ITER EPA HA ITER ITER ITER EPA HA ITER Ueno et al., 1999 RTECS RTECS Toxicity Screening Category Toxicity Category 4 Toxicity Category 4 Toxicity Category 5 Toxicity Category 3 Toxicity Category 2 Toxicity Category 3 Toxicity Category 2 Toxicity Category 2 Toxicity Category 2 Toxicity Category 2 Toxicity Category 3 Toxicity Category 1 Toxicity Category 3 Toxicity Category 4 Occurrence Data Used For CCL 4 Screening Occurrence Data Element FW/AW-Med Value Production Volume Release Production Volume Release FW/AW-Max Value FW/AW-Max Value FW/AW-Max Value FW/AW FW/AW-Max Value FW/AW-Max Value FW/AW FW/AW-Max Value FW/AW-Median Value Value 0.2 >10M-50M 41 4093 >1M-10M 1 ,604,700 37.8 1.4 9.58 1,314 0.521 23,000 1,200 40 1 Units ug/L Ibs/yr Ibs/yr Ibs/yr Ibs/yr ug/L ug/L ug/L ug/L ug/L ug/L ug/L ug/L ug/L Data Source NREC CUS/IUR TRI CUS/IUR NCFAP NAWQA NAWQA NAWQA NIRS NAWQA NAWQA AWWARF, 2001 (Max) Kolpin et al., 2002 (Max) NREC CCL 4 Screening Notes Fails Screen/ remains in CCL 4 Universe Fails Screen/ remains in CCL 4 Universe Fails Screen/ remains in CCL 4 Universe Fails Screen/ remains in CCL 4 Universe Makes PCCL 4 Makes PCCL 4 Makes PCCL 4 Makes PCCL 4 Makes PCCL 4 Fails Screen/ remains in CCL 4 Universe Makes PCCL 4 Makes PCCL 4 Makes PCCL 4 Fails Screen/ remains in CCL 4 Universe A1-3 ------- EPA-OGWDW Screening Document for the Draft PCCL 4 Nominated Contaminants EPA 815-R-15-002 Substance Key 29943 20418 81717 75565 6614 35815 9544 2334 2343 2202 4164 14798 CASRN 271 93288 90361 95 66795 61336 335671 52645531 732116 57830 58220 52686 1 01 202 3380345 Common Name Octylphenol Octylphenol ethoxylate Oxacillin Penicillin Perfluorooctanoic acid (PFOA) Permethrin Phosmet Progesterone Testosterone Trichlorfon Triclocarban Triclosan Health Effect/Toxicity Data Used For CCL 4 Screening Health Effect Data Element No HE data for screening Lethal Dose 50 (LD50) Maximum Recommended Daily Dose (MRDD) Maximum Recommended Daily Dose (MRDD) Lowest Observed Adverse Effect Level (LOAEL) No Observed Effect Level (NOEL) Lethal Dose 50 (LD50) Acceptable Daily Intake (ADI) Acceptable Daily Intake (ADI) Reference Dose (RfD) No Observed Adverse Effect Level (NOAEL) Lethal Dose 50 (LD50) Value 3500 100 25 0.46 5 26 0.03 0.002 0.002 25 3700 Units mg/kg mg/kg-day mg/kg-day mg/kg-day mg/kg-day mg/kg mg/kg-day mg/kg-day mg/kg-day mg/kg-day mg/kg Data Source RTECS DSSTOX DSSTOX Lau et al., 2006 ITER RTECS JECFA JECFA OPP OCSPP RTECS Toxicity Screening Category Toxicity Category 4 Toxicity Category 4 Toxicity Category 4 Toxicity Category 2 Toxicity Category 3 Toxicity Category 2 Toxicity Category 3 Toxicity Category 3 Toxicity Category 3 Toxicity Category 4 Toxicity Category 4 Occurrence Data Used For CCL 4 Screening Occurrence Data Element Production Volume Production Volume No Occurrence data for screening No Occurrence data for screening FW/AW Release Release FW/AW FW/AW Release Production Volume FW/AW-Median Value Value >10M-50M < 500,000 Ibs 7.2 1 ,068,390 1 ,336,387 0.199 0.214 861 >1M-10M 0.19 Units Ibs/yr Ibs/yr ug/L Ibs/yr Ibs/yr ug/L ug/L Ibs/yr Ibs/yr ug/L Data Source CUS/IUR CUS/IUR Emmett et al., 2006 (Max) NCFAP NCFAP Kolpin et al., 2002 (Max) Kolpin et al., 2002 (Max) TRI CUS/IUR NREC CCL 4 Screening Notes Incomplete data for screening/ remains in CCL 4 Universe Fails Screen/ remains in CCL 4 Universe Incomplete data for screening/ remains in CCL 4 Universe Incomplete data for screening/ remains in CCL 4 Universe Makes PCCL 4 Makes PCCL 4 Makes PCCL 4 Fails Screen/ remains in CCL 4 Universe Fails Screen/ remains in CCL 4 Universe Fails Screen/ remains in CCL 4 Universe Fails Screen/ remains in CCL 4 Universe Fails Screen/ remains in CCL 4 Universe A1-4 ------- EPA-OGWDW Screening Document for the Draft PCCL 4 Nominated Contaminants EPA 815-R-15-002 Substance Key 75792 75932 CASRN 1401690 11006761 Common Name Tylosin Virginiamycin Health Effect/Toxicity Data Used For CCL 4 Screening Health Effect Data Element Lethal Dose 50 (LD50) No HE data for screening Value 800 Units mg/kg Data Source RTECS Toxicity Screening Category Toxicity Category 4 Occurrence Data Used For CCL 4 Screening Occurrence Data Element FW/AW-Median Value No Occurrence data for screening Value 0.04 Units ug/L Data Source NREC CCL 4 Screening Notes Fails Screen/ remains in CCL 4 Universe Incomplete data for screening/ remains in CCL 4 Universe AWWARF - Carmichael, W.W. 2001. Assessment of Blue-Green Algal Toxins in Raw and Finished Drinking Water. Denver, CO: American Waterworks Association Research Foundation CUS/IUR - Chemical Update System/ Inventory Update Rule DSSTOX- Distributed Structure-Searchable Toxicity Database Network Emmett et al., 2006 - Emmett, et al., 2006. J. Occ. Env. Med. Little Hocking, OH EPA HA - EPA Health Advisory ITER - International Toxicity Estimates for Risk JECFA - Joint FAO/WHO Expert Committee on Food Additives Kolpinetal.,2002-Kolpin, D.W., etal.,2002. Env. Sci. STechnol., 36(6), pp. 1202-1211. Lau et al., 2006 - Lau, 2006. Tox. Sci., 90, 2, pp. 510-518. NAWQA - National Water Quality Assessment NCFAP - National Center for Food and Agricultural Policy NIRS - National Inorganics and Radionuclides Survey NREC - National Reconnaissance of Emerging Contaminants NTP - National Toxicology Program; Values: P=positive; N=negative; IS=insufficient study. Results for male rat/female rat/male mouse/female mouse. OCSPP - Office of Chemical Safety and Pollution Prevention OPP - Office of Pesticide Programs RAIS - Risk Assessment Information System RTECS - Registry of Toxic Effects of Chemical Substances TRI - Toxics Release Inventory UCM Round 1 - Unregulated Contaminant Monitoring Ueno et al., 1999 - Ueno, Y., Y. Makita, S. Nagata et al. 1999. Environ. Toxicol. 14(1):45-55 A1-5 ------- |