&EPA United States Environmental Protection Agency Public Meeting and Webinar: Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations Held June 25, 2014 USEPA, Office of Ground Water and Drinking Water Office of Water (MLK 140) EPA 815-A-14-001 June 2014 ------- Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) for Public Water Systems Public Meeting and Webinar June 25th, 2014 Meeting starts at 9:00 a.m. E.T. USEPA Office of Ground Water and Drinking Water June 25, 2014 U.S. Environmental Protection Agency If you are participating by webinar... You will be in listen-only mode. Submit question/comment by clicking on "+" on the Questions tab in the control panel (Figure 1). Type question in the box; press send (Figure 2). Submit questions as soon as possible. We will answer as many questions as possible at the end of each presentation. 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Figure 5 View in Fullscreen mode Figure 6 (!) | -: " ' :: ' : June 25, 2014 U.S. Environmental Protection Agency ------- Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations WELCOME Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) for Public Water Systems Public Stakeholder Meeting and Webinar June 25, 2014 U.S. Environmental Protection Agency General Meeting Information Purpose o Review the status of EPA's efforts in the areas of analyte selection, analytical methods, sampling design, determination of minimum reporting levels, and other possible revisions relative to the rule Webinar lines are muted to minimize background noise. On-site attendees: o Please mute electronic devices/cell phones. o Bathrooms in hall, follow signs; need door key cards, which should be returned after use. o Lunch break will be at 11:45; list of restaurants available at registration table. June 25, 2014 U.S. Environmental Protection Agency ------- Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations Agenda 8:30-9:00 9:00-9:20 9:20-9:50 9:50-10:30 10:30-10:45 Stakeholder Sign-in Welcome - Introduction and Agenda Overview of the UCMR Program UCMR 3 Status BREAK 10:45-11:30 UCMR 4 Potential Sampling Design Change Relative to UCMR 3 11:30-11:45 Discussion 11:45-1:15 LUNCH 1:15-3:00 UCMR 4 Candidate Selections and Rationale 3:00-3:15 BREAK 3:15-3:45 Approval of Laboratories Supporting UCMR 4 3:45-5:00 Discussion June 25, 2014 U.S. Environmental Protection Agency Overview of the Unregulated Contaminant Monitoring Program Public Meeting and Webinar Washington D.C. June 25th, 2014-9:20 a.m. Brenda Parris USEPA, OGWDW, SRMD Technical Support Center Cincinnati, Ohio ------- Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations Overview Unregulated Contaminant Monitoring (UCM) program Regulatory background for UCMR - Safe Drinking Water Act (SDWA) authority - Relationship to Contaminant Candidate List (CCL) Unregulated Contaminant Monitoring Rule (UCMR) approach - UCMR cycles - UCMR implementation June 25, 2014 U.S. Environmental Protection Agency Safe Drinking Water Act Passed in 1974, amended in 1986 and 1996 Authorized EPA to set enforceable health standards for contaminants in drinking water - National Primary Drinking Water Standards (NPDWS) Outlined a sound science approach to NPDWS development that required consideration of: - Occurrence Data - Health Effects Data - Cost Benefit Analysis June 25, 2014 U.S. Environmental Protection Agency 10 ------- Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations Unregulated Contaminant Monitoring 1986 SDWA amendments were the basis for the original UCM program UCM Rounds 1 (1988-1992, 62 contaminants) & 2 (1993-1997, 48 contaminants) - State drinking water programs managed the original UCM program - Public water systems (PWSs) serving > 500 people were required to monitor June 25, 2014 U.S. Environmental Protection Agency 11 Safe Drinking Water Act 1996 SDWA amendments changed the process of developing and reviewing NPDWS - Contaminant Candidate List - Unregulated Contaminant Monitoring Rule - Regulatory Determination - Six-Year Review June 25, 2014 U.S. Environmental Protection Agency 12 ------- Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations General Flow of Regulatory Process Draft CCL J | Final CCL L Draft UCMR Final UCMR No further action if make decision not to regulate (may develop health adv:-;o. > , Proposed Rule (NPDWR) 1 Final Rule (NPDWR) Six Year Review of Existing NPDWRs At each stage, need increased specificity and confidence in the type of supporting data used (e.g. health and occurrence). June 25, 2014 U.S. Environmental Protection Agency 13 Contaminant Candidate List SDWA requires EPA to list unregulated contaminants that may require a national drinking water regulation in the future Every five years CCL defines unregulated contaminants for which EPA needs - Occurrence data - Analytical methods - Potential health effects - Evaluation of treatment techniques June 25, 2014 U.S. Environmental Protection Agency 14 ------- Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations Contaminant Candidate List EPA considered approximately 7,500 potential chemical and microbial contaminants Screening process based on a contaminant's potential to occur in public water systems (PWSs) and the potential for public health concerns Further detailed evaluations, public input, and expert judgment and review are used in the final contaminant selection Final CCL 3 published October 8, 2009 - 104 chemicals or chemical groups and 12 microbiological contaminants CCL 4 is in development June 25, 2014 U.S. Environmental Protection Agency 15 Unregulated Contaminant Monitoring Rule 1996 Safe Drinking Water Act Amendments - Redesigned the UCM program and included these requirements: Monitor no more than 30 contaminants per 5-year cycle Monitor only a representative sample of PWSs serving 10,000 or fewer people Store analytical results in the National Contaminant Occurrence Database (NCOD) Direct implementation - EPA managed program in partnership with States EPA funds testing/analytical costs for small PWSs June 25, 2014 U.S. Environmental Protection Agency 16 ------- Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations Objective of UCMR Program Develop a list of contaminants, largely based on CCL, every five years Collect occurrence data for suspected drinking water contaminants that do not have health-based standards set under SDWA Occurrence information is used to support future regulatory decision-making Supports the Administrator's determination of whether (or not) to regulate a contaminant under the drinking water program June 25, 2014 U.S. Environmental Protection Agency 17 Unregulated Contaminant Monitoring Rule UCMR groups contaminants into three tiers based on their priority and analytical methodologies - Assessment Monitoring (List 1) - Employs commonly used analytical techniques - Screening Survey (List 2) - Uses more recently developed analytical techniques - Pre-Screen Testing (List 3) - Utilizes new or specialized techniques June 25, 2014 U.S. Environmental Protection Agency 18 ------- Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations UCMR1 UCMR 1 (2001-2005, 26 contaminants) - Published in Federal Register (FR) on September 17, 1999 - Required all large PWSs and a nationally representative sample of small PWSs serving <10,000 people to monitor for contaminants on List 1 - Required a random selection of 300 large and small PWSs to monitor for contaminants on List 2 June 25, 2014 U.S. Environmental Protection Agency 19 UCMR 2 UCMR 2 (2007-2011, 25 contaminants) - Published in Federal Register (FR) on January 4, 2007 - More PWSs included under List 2 Screening Survey than for UCMR 1 to provide more representative results - Define monitoring schedules to improve compliance June 25, 2014 U.S. Environmental Protection Agency 20 10 ------- Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations UCMR 3 UCMR 3 (2012-2016, 30 contaminants) - Currently ongoing - monitoring ends in 2015, data review will occur in 2016 - Published in Federal Register (FR) on April 16, 2012 June 25, 2014 U.S. Environmental Protection Agency 21 UCMR Implementation OGWDW, SRMD, Technical Support Center (Cincinnati) - Review and track PWS applicability and monitoring progress - Coordinate Laboratory Approval Program - Provide technical support for Regions, States, PWSs and laboratories - Coordinate outreach - Assist and support Regional compliance efforts June 25, 2014 U.S. Environmental Protection Agency 22 11 ------- Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations UCMR Implementation OGWDW, SRMD, Technical Support Center (Cincinnati) - Small PWS support - Maintain lab and implementation contracts to support UCMR - Manage sample kit distribution - Responsible for data review and reporting - Prepare data for NCOD - Large PWS support - Extract data from the Safe Drinking Water Accession and Review System (SDWARS) for evaluation and reporting to NCOD - Support SDWARS reporting system and users June 25, 2014 U.S. Environmental Protection Agency 23 Extended UCMR Implementation Team OGWDW, DWPD, Infrastructure Branch - Responsible for SDWARS EPA Regional Offices - Coordinate State partnership agreements - Assist States and PWSs with UCMR requirements, compliance and enforcement Partnering States - Support various levels of monitoring coordination June 25, 2014 U.S. Environmental Protection Agency 24 12 ------- Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations Status of the Third Unregulated Contaminant Monitoring Rule (UCMR 3) Public Meeting and Webinar Washington D.C. June 25th, 2014-9:50 a.m. Gregory J. Carroll USEPA, OGWDW, SRMD Technical Support Center Cincinnati, Ohio 25 Overview Timing, Activities and Applicability Monitoring -Listl, List2, Lists Reporting - Current Status Occurrence Data -NCOD Preparation for UCMR 4 June 25, 2014 U.S. Environmental Protection Agency 26 13 ------- Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations Time Line of UCMR 3 Activities 2012 Pre-monitonng Implementation Lab Approval Notifications SDWARS Registration Inventory Schedule 2013 2014 2015 Sampling and Reporting Period One consecutive 12-month period during January 2013 - December 2015 (monitoring can span more than one calendar year, as long as conducted during a consecutive 12-month period). 2016 June 25, 2014 U.S. Environmental Protection Agency Post-monitoring Phase Complete Resampling Conclude Data Reporting Finalize NCOD Continue Enforcement 27 System Definitions and Sizes Public water system (PWS) provides water for human consumption through pipes or other constructed conveyances to at least 15 service connections or serves an average of at least 25 people for at least 60 days a year. - Community Water System (CWS) supplies water to the same population year-round. - Non-Transient Non-Community Water System (NTNCWS) regularly supplies water to at least 25 of the same people at least six months per year, but not year-round. Examples include schools, factories, office buildings, and hospitals that have their own water systems. - Transient Non-Community Water System (TNCWS) provides water in a place such as a gas station or campground where people do not remain for long periods of time. June 25, 2014 U.S. Environmental Protection Agency 28 14 ------- Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations UCMR 3 System Applicability 800 randomly selected systems CWS & NTNCWS TNCWS All systems(~410) serving more than 100,000, and -320 randomly selected systems serving 10,001 to 100,000 No requirements 480 randomly selected systems No requirements Pre-Screen Testing (List 3 Contaminants) ;WS, TNCWS & NTNCWS ms Servina > 1.000 ems Servina < 1.000 No requirements 800 randomly selected systems June 25, 2014 U.S. Environmental Protection Agency 29 UCMR 3 Monitoring PWSs must monitor during a consecutive 12-month period between 2013 - 2015 Number of times a PWS samples is directly related to the sample point source - Surface water and ground water under the direct influence of surface water - must monitor quarterly during their 12-month schedule (sample three months apart) - Ground water - must monitor twice during their 12-month schedule (sample five to seven months apart) June 25, 2014 U.S. Environmental Protection Agency 30 15 ------- Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations UCMR 3 Monitoring Lists Assessment Monitoring (List 1 Contaminants) relies on common analytical method technologies used by drinking water laboratories Screening Survey (List 2 Contaminants) monitoring uses more specialized analytical method technologies Pre-Screen Testing (List 3 Contaminants) relies on newer method technologies not as commonly used by drinking water laboratories UCMR 3 Pre-Screen Testing involves ground water systems that: - Serve less than 1,000 people - Do not disinfect - Are located in vulnerable areas of karst or fractured bedrock June 25, 2014 U.S. Environmental Protection Agency 31 UCMR 3 Sampling Locations Contaminant Type Volatile Organic Compounds Synthetic Organic Compound (1,4-dioxane) Perfluorinated Compounds Oxyhalide Anion (chlorate) Metals Chromium-6 Sampling Location Type EPTDS EPTDS EPTDS EPTDS and EPTDS and EPTDS and DSMRT DSMRT DSMRT Screening Survey: List 2 Contaminants Hormones | EPTDS Viruses EPTDS June 25, 2014 U.S. Environmental Protection Agency 32 16 ------- Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations UCMR 3 List 1 Contaminants Assessment Monitoring: List 1 Contaminants Volatile Organic Compounds - EPA Method chloromethane (methyl chloride) bromomethane (methyl bromide) chlorodifluoromethane (HCFC-22) bromochloromethane (halon 1011) 1,1-dichloroethane 1,2,3-trichloropropane 1,3-butadiene 0.2 0.2 0.08 0.06 0.03 0.03 0.1 Synthetic Organic Compound - EPA Method 52 1,4-dioxane 0.07 EPA will pay for all analytical and shipping costs associated with List 1 monitoring at small systems (< 10,000). June 25,2014 U.S. Environmental Protection Agency 33 UCMR 3 List 1 Contaminants Assessment Monitoring: List 1 Contaminants Perfluorinated Compounds- EPA Method 537 perfluorooctane sulfonic acid (PFOS) perfluorooctanoic acid (PFOA) perfluorononanoic acid (PFNA) perfluorohexane sulfonic acid (PFHxS) perfluoroheptanoic acid (PFHpA) perfluorobutanesulfonic acid (PFBS) 0.04 0.02 0.02 0.03 0.01 0.09 Oxyhalide Anion - EPA Method 300.1 ; SM 4110D; ASTM D658-08 chlorate 20 EPA will pay for all analytical and shipping costs associated with List 1 monitoring at small systems (< 10,000). June 25,2014 U.S. Environmental Protection Agency 34 17 ------- Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations UCMR 3 List 1 Contaminants cobalt molybdenum strontium vanadium chromium Chromium-6 - EPA Method 218.7 chromium-6 0.3 0.2 0.2 0.03 EPA will pay for all analytical and shipping costs associated with List 1 monitoring at small systems (< 10,000). June 25,2014 U.S. Environmental Protection Agency 35 UCMR 3 List 2 Contaminants 17-(3-estradiol 17-a-ethynylestradiol (ethinyl estradiol) 16-a-hydroxyestradiol (estriol) equilin estrone testosterone 4-androstene-3,17-dione 0.0004 0.0009 0.0008 0.004 0.002 0.0001 0.0003 EPA will pay for all analytical and shipping costs associated with List 2 monitoring at small systems (< 10,000). June 25, 2014 U.S. Environmental Protection Agency 36 18 ------- Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations UCMR 3 List 3 Contaminants ^^ Pre-Screen Testing: List 3 Contaminants ^^HHMi g^H ^_ Detection Assay 1 Microbiological Contaminants - EPA Method 1615 enterovirus norovirus Cell culture; qPCR qPCR Microbiological Indicators total coliforms £. co// Enterococci bacteriophage aerobic spores EPA will collect the samples from List 3 sampling locations, and will pay for all analytical and shipping costs associated with viruses and indicators at these small systems (< 1 ,000). June 25, 2014 U.S. Environmental Protection Agency 37 UCMR 3 Responsibilities Small PWSs serving 10,000 or fewer people are not responsible for the costs associated with analyses and shipping - EPA engages States and PWSs to collect samples for List 1 and List 2 - EPA collects samples for List 3 - EPA coordinates sample analyses with contracted laboratories and funds the analyses - EPA examines the results along with quality control data and generates reports June 25, 2014 U.S. Environmental Protection Agency 38 19 ------- Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations UCMR 3 Responsibilities Large PWSs serving more than 10,000 people are responsible for the costs associated with analyses - PWS coordinates sample analyses with an approved laboratory - Laboratories post the data to the Safe Drinking Water Accession and Review System (SDWARS 3) - PWS reviews and can act upon (e.g., approve) data in SDWARS 3 States and EPA review results June 25, 2014 U.S. Environmental Protection Agency 39 UCMR 3 Occurrence Data - Updated quarterly and posted in the National Contaminant Occurrence Database (NCOD) - Quarterly updates can be accessed from - http://water.epa.gov/lawsregs/rulesregs/sdwa/ucmr/data.cfm* ucmr2013 - Zipped file contains a summary document (PDF), occurrence data (.txt), disinfectant residual type (.txt) and U.S. postal service zip code(s) for all areas served by a PWS (.txt) - Data will continue to be added and may be corrected on further review - Use caution when interpreting the data before the dataset is complete (mid-late 2016) June 25, 2014 U.S. Environmental Protection Agency 40 20 ------- Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations UCMR 3 Results To-Date OGWDW posted PWS results (submitted through April 2014) to the web (NCOD) Chemicals are studied at levels that are often significantly below those in previous UCMRs The detection of a UCMR 3 analyte above the MRL does not represent cause for concern, in and of itself The data should be judged considering health effects information (reference concentration) June 25, 2014 U.S. Environmental Protection Agency 41 UCMR 3 Preliminary Results -3500 sample results from -400 PWSs for hormones -18,000 sample results from -1900 PWSs for metals, chlorate -11,000 sample results from 1800-1900 PWSs for other chemicals -1/3 of data that will ultimately be collected June 25, 2014 U.S. Environmental Protection Agency 42 21 ------- Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations Preliminary Data Summary Points Metals - Many PWSs had detections of metals (i.e., above the MRL) - Between 0-3% of sample results were above the Reference Concentration (Ref Cone) - Vanadium above the Ref Cone at ~3% of PWSs; strontium above the Ref Cone at 1%; other metals measured above the Ref Cone by less than 1 % of PWSs Chlorate - Many of the PWSs (-10,000 of-18,000) had detections of chlorate - 35% of the PWSs had chlorate measurements above the Ref Cone June 25, 2014 U.S. Environmental Protection Agency 43 Preliminary Data Summary Points 1,4-dioxane - -400 of -1800 PWSs had detections of 1,4-dioxane - -7% above the 1Q-6 Ref Cone of 0.35 ug/L; none above the 1Q-4 Ref Cone of 35 |jg/L Volatile Organic Compounds (VOCs) - One or more VOCs detected by 104 of the -1800 PWSs that reported data - Relatively few VOC measurements above the Ref Cone - 1,2,3-trichloropropane measured by -1.4% of PWSs above the 1Q-4 Ref Cone; detected above MRL by -1.7% (MRL > 10-6 Ref Cone) June 25, 2014 U.S. Environmental Protection Agency 44 22 ------- Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations Preliminary Data Summary Points - Perfluorinated Compounds (PFCs) 36 of the -1900 PWSs detected one or more PFCs 6 PWSs measured PFOS above the Ref Cone Ref Cone currently only available for PFOA and PFOS - Hormones 17 of the -400 PWSs detected one or more hormones Ref Cone available for the 5 estrogenic hormones, not the 2 androgenic hormones None of the PWSs had (estrogenic) hormone measurements above the Ref Cone June 25, 2014 U.S. Environmental Protection Agency 45 Preliminary Virus Data Pre-Screen Testing at 800 small GW systems for norovirus, enterovirus, and "indicator" organisms Field samples collected from ~376 PWSs; data available for ~173 133 indicator detections - 26 enterococci - 9 bacteriophage - 84 aerobic spores - 2 E. coli - 12 total coliform 3 norovirus detections June 25, 2014 U.S. Environmental Protection Agency 46 23 ------- Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations Timing for UCMR 3 and UCMR 4 > UCMR 3 monitoring activities are scheduled to end in December 2015 UCMR 3 data will be finalized in 2016 > EPA anticipates proposing UCMR 4 in mid 2015 UCMR 4 is anticipated to be final in late 2016 Implementation activity for UCMR 4 expected to begin in 2017 with monitoring expected to begin in January 2018 June 25, 2014 U.S. Environmental Protection Agency 47 Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) for Public Water Systems Public Stakeholder Meeting and Webinar June 25, 2014 Morning Break Resume at 10:45 a.m. U.S. Environmental Protection Agency 48 24 ------- Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations UCMR 4 Potential Sampling Design Changes Relative to UCMR 3 Public Meeting and Webinar Washington D.C. June 25th, 2014-10:45 a.m. Brenda Parris USEPA, OGWDW, SRMD Technical Support Center Cincinnati, OH 49 Overview Background for the Unregulated Contaminant Monitoring Rule (UCMR) sampling design UCMR 4 sampling design considerations Approach to tiered monitoring - Assessment Monitoring (List 1) - Screening Survey (List 2) - Pre-Screen Testing (List 3) Potential changes between UCMR 3 and UCMR 4 Implementation considerations June 25, 2014 U.S. Environmental Protection Agency 50 25 ------- Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations UCMR Background UCMR program designed for Safe Drinking Water Act (SDWA) specifications Under § 1445(a)(2)(A) of SDWA, as amended in 1996, EPA required to: - "vary the frequency and schedule for monitoring ...based on the number of persons served by the system, the source of supply, and the contaminants likely to be found;" - ensure "that only a representative sample of systems serving 10,000 persons or fewer are required to monitor;" and - "pay the reasonable cost of such testing and laboratory analysis..." for small systems June 25, 2014 U.S. Environmental Protection Agency 51 PWS Types Community water system - Public Water System (PWS) that supplies water to the same population year-round Non-transient non-community water system - PWS that supplies water to at least 25 of the same people at least six months per year, but not year- round - Schools Transient non-community water system - PWS that provides water where people do not remain for long periods of time - Gas stations and campgrounds June 25, 2014 U.S. Environmental Protection Agency 52 26 ------- Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations PWS Sizes Small PWSs serve 10,000 people or less Large PWSs serve 10,001-100,000 people "Extra large" PWSs serve over 100,001 people June 25, 2014 U.S. Environmental Protection Agency 53 Sampling Design Considerations UCMR 4 expected to be based on the sampling and statistical design used in UCMR 1,2 and 3 -Vetted with stakeholders - Peer reviewed -Three rounds of public comment June 25, 2014 U.S. Environmental Protection Agency 54 27 ------- Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations Sampling Design Considerations Data Quality Objectives Unbiased national exposure estimates; small margin of error Account for differential occurrence Stratify across system size and source water type to account for differences Multiple sample events over multiple years to address temporal variability Allocation across states proportional to population served; at least two per state June 25, 2014 U.S. Environmental Protection Agency 55 Assessment Monitoring (List 1): Statistical Approach Expect to maintain same statistical design for Assessment Monitoring used in UCMR 1, 2 and 3 - Nationally representative sample of 800 small systems - Census of large water systems Small system statistical sample combined with large system census data provides a powerful tool for assessing contaminant occurrence June 25, 2014 U.S. Environmental Protection Agency 56 28 ------- Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations Sample Allocation for Small Systems in Assessment Monitoring (List 1) Size Category 500 and under 501 to 3,300 3,301 to 10, 000 Total Ground Water Surface Water Systems Systems 85 223 220 528 10 83 179 272 95 306 399 800 June 25, 2014 U.S. Environmental Protection Agency 57 Screening Survey (List 2): Statistical Approach Designed to ensure the data can be used to support regulatory determinations and rule development (if warranted) Account for possible laboratory capacity issues related to use of recently developed or technically complex methods June 25, 2014 U.S. Environmental Protection Agency 58 29 ------- Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations Screening Survey (List 2): Statistical Approach Considering similar approach as UCMR 2 and 3: - National sample of 800 systems, allocated across systems serving 100,000 or fewer: - Small system (serving 10,000 or fewer) sample would not overlap with Assessment Monitoring - Sample again allocated across strata of system size and source water type - Census of all systems serving 100,001 and over (~400 systems) - Adds further confidence in the sampling results by including a census of the largest systems Total number of systems ~1,200 June 25, 2014 U.S. Environmental Protection Agency 59 UCMR Pre-Screen Testing (List 3) Envisioned for use with methods that are in the early stages of development, and/or very specialized (such as those for viruses or DMA/microchips) May be conducted by limited number of PWSs identified as vulnerable (by EPA and/or State agencies) Not currently anticipated to be utilized for UCMR 4 June 25, 2014 U.S. Environmental Protection Agency 60 30 ------- Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations UCMR 4 Implementation Considerations The same sampling frequency used in UCMR 3 for Assessment Monitoring (AM) and Screening Survey (SS) is expected to be utilized for the majority of potential UCMR 4 analytes - Surface water systems (including groundwater under the direct influence of surface water) would sample four times during their year of monitoring - Ground water systems would sample two times during their year of monitoring Considering altering the sampling frequency for selected AM and/or SS analytes in UCMR 4 June 25, 2014 U.S. Environmental Protection Agency 61 Potential Change Between UCMR 3 and UCMR 4: Monitoring Selective monitoring for List 1 and 2 contaminants, such as cyanotoxins and pesticides? - UCMR 3: Selective monitoring was conducted with List 3 viruses but has not been conducted with List 1 or 2 contaminants - UCMR 4 potential change: Target the monitoring of cyanotoxins and potentially pesticides by sampling in the warmer months of the year and only sampling surface water or ground water under the direct influence of surface water? - Reason for considering change: - To obtain more accurate occurrence data on contaminants whose concentrations fluctuate - Target timeframes when the contaminant is most likely to found, vulnerable period(s) June 25, 2014 U.S. Environmental Protection Agency 62 31 ------- Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations UCMR 4 Implementation Considerations Same monitoring schedule anticipated for AM andSS - Months assigned to ensure coverage of temporal vulnerability and variability - System monitoring spread across 3-year period to provide temporal coverage and to accommodate lab capacity Year and months of monitoring assigned to small systems Large systems can re-define their year and month(s) of monitoring June 25, 2014 U.S. Environmental Protection Agency 63 Potential Change Between UCMR 3 and UCMR 4: Monitoring Reduce the period of UCMR monitoring? - UCMR 3: 3 years were allocated for sample monitoring - UCMR 4 potential change: Compress the monitoring period to 2 years? - Reason for considering change: - UCMR data would be available earlier to support regulatory determinations June 25, 2014 U.S. Environmental Protection Agency 64 32 ------- Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations UCMR 4 Implementation Considerations Sampling locations for potential AM and SS chemicals - All chemicals would be sampled at the entry points to the distribution systems (EPTDSs) - Metals, if any, would also be sampled at the distribution maximum residence time (DSMRT) location in the distribution systems - Some adjustment in sampling locations may be warranted depending on the final selection of UCMR 4 contaminants June 25, 2014 U.S. Environmental Protection Agency 65 Potential Change Between UCMR 3 and UCMR 4: QC Data Collect additional quality control (QC) data in SDWARS? - UCMR 3: EPA collects more extensive small system QC data from contract laboratories, large systems report limited QC data - UCMR 4 potential change: Require similar QC data to be submitted for both large and small systems? - Reason for considering change: - Ensure a more robust dataset June 25, 2014 U.S. Environmental Protection Agency 66 33 ------- Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations Potential Change Between UCMR 3 and UCMR 4: SDWARS Improve SDWARS reporting functionality? - UCMR 3: Compliance reports offer a summary of the reporting status of individual PWSs and if they have fulfilled their monitoring requirements - UCMR 4 potential change: Update the functionality of SDWARS to include compliance reports for multiple PWSs simultaneously? - Reason for considering change: - Facilitates compliance tracking by the Regions and States June 25, 2014 U.S. Environmental Protection Agency 67 Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) for Public Water Systems Discussion 11:30 a.m. - 11:45 a.m. June 25, 2014 U.S. Environmental Protection Agency 68 34 ------- Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) for Public Water Systems Public Stakeholder Meeting and Webinar Lunch Break Meeting will resume at 1:15 p.m. June 25, 2014 U.S. Environmental Protection Agency UCMR 4 Candidate Selection, Rationale and Method Considerations Public Meeting and Webinar Washington D.C. June 25th, 2014-1:15 p.m. Melissa Simic and Steve Wendelken United States Environmental Protection Agency Office of Ground Water and Drinking Water Technical Support Center 35 ------- Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations Overview UCMR 4 Schedule Candidate Selection Process and Rationale Method Considerations Health and Occurrence Data with Sources Contaminant Specific Information by Method Other UCMR 4 Contaminants Under Consideration UCMR 4 Schedule Public Comment Period Begins UCMR Method Development Stakeholder Meeting May 15, 2013 June 25, 2014 Publish UCMR 4 Proposal U.S. Environmental Protection Agency UCMR 4 monitoring tentatively starting in 2018 72 36 ------- Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations UCMR 4 Prioritization Process CCL 3 [106 chemicals +12 microbes] + 48 CCL 4 nominations1 = 166 contaminants 45 CCL + 48 related non-CCL analytes [16 methods] Propose up to 30 contaminants for comment Z Not currently regulated or previous regulatory determination Not monitored for on UCMR 2 or UCMR 3 Low national occurrence is not anticipated Have a completed drinking water method UCMR4 Candidates: 31 CCL + 18 related non-CCL analytes [9 methods] + other contaminants under t consideration2 Most contaminants in method group: Have an available health assessment to facilitate regulatory determinations and/or high public concern Have critical health endpoints, probable carcinogens, active pesticides Have an occurrence data gap Workgroup and stakeholder input Cost-effective method group Implementation considerations After considering comments, publish up to 30 contaminants for UCMR 4 monitoring tentatively starting in 2018 159 unique CCL 4 nominations; 11 removed because already on CCL 3 or regulated 2 Nitrate/Nitrite, 4 unregulated brominated DBFs June 25, 2014 U.S. Environmental Protection Agency 73 CCL an Assessment Monitoring (List 1) iermanium Manganese (CCL 4 nomination) ithoprop Ipha-Hexachlorocyclohexane 'ermethrin,trans- 'ermethrin, cis- Oxyfluorfen Dimethipin (Method 530) 2-Propen-l-ol 2-Methoxyethanol Irythromycin friclosan (CCL4 nomination) Carbamazepine Diazepam Sulfamethoxazole rrimethoprim Diclofenac Naproxen Gemfibrozil Fluoxetine Enalapril Phenytoin :ormaldehyde Acetaldehvde Screening Survey (List 2) Vlicrocystin-LR Vlicrocystin-YR Vlicrocystin-RR ^icrocystin-LA Anatoxin-a Microcystin-LF Microcystin-LY Nodularin Cylindrospermopsin Under Evaluation LegioneHo pneumophHo The candidates highlighted in gray are related non-CCL3 analytes June 25, 2014 U.S. Environmental Protection Agency 74 37 ------- Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations Potential EPA Methods Assessment Monitoring (List 1) Screening Survey (List 2) Method 200. 8 (ICP-MS) Method 525. 3 (GC/MS) Method 530 (GC/MS) Method 538 (DAI-LC/MS/MS) Method 541 (GC/MS) Method 542 (LC/MS/MS) Method 556.1 (FastGC) Inductively Coupled Plasma (ICP) Gas Chromatography (GC) Direct Aqueous Injection (DAI) Method 544 (LC/MS/MS) Method 545 (LC/ESI-MS/MS) Mass Spectrometry (MS) Liquid Chromatography (LC) Electrospray lonization (ESI) The monitoring location(s) are still being determined June 25, 2014 U.S. Environmental Protection Agency 75 Health Effects Data Identify health effects information compiled during CCL 3 + CCL 4 nominations - Potential health effects - Reference Dose (RfD) or other non-cancer health value - Cancer Slope Factor (CSF) - Health Reference Levels (HRLs)* - Cancellation Status for Pesticides Determine health assessment status: (1) Available health assessment from an EPA (i.e., IRIS, OPP, OW) or comparable non-EPA source (e.g., ATSDR) (2) Available health assessment from an EPA or comparable non-EPA source needs to be updated (3) A health assessment is not currently available but sufficient information may exist to conduct a health assessment (4) A health assessment is not currently available and there are substantial data needs *Note: HRLs are risk-derived concentrations against which to evaluate the occurrence data to determine if contaminants occur at levels of potential public health concern. HRLs are not final determinations about the level of a contaminant in drinking water that must not be exceeded to protect any particular population. June 25, 2014 U.S. Environmental Protection Agency 76 38 ------- Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations Health Effects Data Sources EPA - Office of Pesticide Programs (OPP) - Integrated Risk Information System (IRIS) - Office of Water Health Advisory (HA) Agency for Toxic Substances and Disease Registry (ATSDR) California Office of Environmental Health and Hazard Assessment (OEHHA) Risk Assessment Information System (RAIS) Registry of Toxic Effects of Chemical Substances (RTECS) Joint FAO/WHO Expert Committee on Food Additives (JECFA) - Food and Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO) Center for Disease Control (CDC) Single Studies Note: The health values are derived using the health effects information available during CCL 3. The health values are subject to change as health assessments are completed or updated based on more recent health effects information. June 25, 2014 U.S. Environmental Protection Agency 77 Calculating CCL 3 Health Reference Levels Non-Cancer CCL3 HRL (mg/L) = [(RfD x BW)/DWI] x RSC] Where: RfD = Reference Dose (mg/kg-day) RfD = Point of Departure (POD) -^Uncertainty Factors (UF) Point of Departure = the dose (e.g., No Observed Adverse Effect Level (NOAEL) or Lowest Observed Adverse Effect level (LOAEL)) BW = Body Weight for an adult, assumed to be 70 kilograms (kg) DWI = Drinking Water Intake for an adult, assumed to be 2 L/day (90th percentile) RSC = 20% Relative Source Contribution, assumed to be the level of exposure from drinking water when compared to other sources. June 25, 2014 U.S. Environmental Protection Agency 78 39 ------- Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations Calculating CCL 3 Health Reference Levels Cancer Unit Risk (|jg/L)-1 = CSF x [(DWI x CW)/BW] Where: ' CSF = Cancer Slope Factor (mg/kg/day)-1 DWI = Drinking Water Intake for an adult, assumed to be 2 L/day (90th percentile) CW = Unit risk concentration in drinking water of 0.001 mg/L (1 ug/L) BW = Body Weight for an adult, assumed to be 70 kilograms (kg) The cancer HRL is the concentration of a contaminant in drinking water corresponding to an excess estimated lifetime cancer risk of one-in-a-million (1x 10~6), calculated as follows: Cancer HRL (|jg/L) = Risk Level of 10-6 4- Unit Risk (M9/L)-1 June 25, 2014 U.S. Environmental Protection Agency 79 Occurrence Data and Information Sourc Finished Water Data Unregulated Contaminant Monitoring Rule (UCMR) - UCMR 1 Screening Survey/Assessment Monitoring (2001 - 2003) National Inorganics and Radionuclides Survey (NIRS) (1984 -1986) Disinfection By-Product Information Collection Rule (DBP-ICR) Data (1997 -1998) U.S. Department of Agriculture Pesticide Data Program (POP) Pesticides Pilot Monitoring Program (PPMP) California Department of Health Services (CAL DHS) Small-Scale Local Occurrence Studies Note: Occurrence results are presented as a number or percent of detects at systems/sites. Where available, a statement is included about the maximum concentration being above or belowthe health reference level (HRL). June 25, 2014 U.S. Environmental Protection Agency 80 40 ------- Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations Occurrence Data and Information Sources (cont.) Supplemental Drinking Water and Ambient Water Data United States Geological Survey (USGS), Ambient Water - National Water Quality Assessment Program (NAWQA) National Reconnaissance of Emerging Contaminants (NREC) National Random and Focused Source Water Surveys (with AWWARF) - Special reports Other specialized studies and literature Production, Release, Usage and Other Data Toxic Release Inventory (TRI) National Center for Food and Agricultural Policy (NCFAP) OPP Reregistration Eligibility Document (RED) Data from pesticide registrants Chemical Update System/Inventory Update Reporting Program (CUS/IUR) Cancellation Status for Pesticides Persistent, Bioaccumulative and Toxic (PBT) Profiler June 25, 2014 U.S. Environmental Protection Agency 81 Metals EPA Method 200.8 (ICP/MS), 1994 Determination of trace elements in waters by inductively coupled plasma - mass spectrometry, revision 5.4 Analytes Manganese (2) Nickel Germanium (4) Thorium June 25, 2014 U.S. Environmental Protection Agency 82 41 ------- Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations Manganese: Background Heavy metal element found in over 100 naturally occurring minerals, including silicates, carbonates, sulfides, oxides, phosphates and borates; ubiquitous in soil, water, food and air Small amounts found in foods are an essential nutrient for humans and animals Commercially imported manganese compounds include ferromanganese (used in the production of steel), manganese sulfate (fertilizer), manganese dioxide (matches, batteries, fireworks) and potassium permanganate (wastewater and drinking water treatment chemical) Common manganese compounds range from insoluble to moderately soluble in water June 25, 2014 U.S. Environmental Protection Agency 83 Manganese: Health Effects Health Assessment Status = 2 - 1995 IRIS Risk Assessment RfD = 0.047 mg/kg-day - Critical Effect = Central nervous system effects - NOAEL = 0.14 mg/kg-day; UF = 3 [Reflects a modifying factor of 3 to adjust for increased bioavailability when in drinking water] HRL: 300 ug/L (non-cancer) Sensitive populations: Children, the elderly, pregnant women, iron deficient individuals, and individuals with impaired liver function - Recent studies indicate concern for neurological effects in children and infants June 25, 2014 U.S. Environmental Protection Agency 84 42 ------- Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations Manganese: Occurrence National Inorganics and Radionuclides Survey (NIRS), Finished Water, 1984-1986 (MRL = 1 ug/L): - 672 detections (median = 11.96 ug/L) out of 989 sites; Maximum detect (1,341 ug/L) > HRL (300 ug/L) USGS, National Water-Quality Assessment Program (NAWQA), Ambient Water, 1992-2001: - 6,447 detections (median = 19 ug/L) out of 8,002 sites; Maximum detect (70,000 ug/L) > HRL (300 ug/L) USGS, Toccalino et al., 2010, Ambient Water: - 543 detections (median = 8.99 ug/L) out of 808 samples; Maximum detect (1,923 ug/L) > HRL (300 ug/L) Toxic Release Inventory - Total: - 15,872,968 Ibs/yr in 48 states in 2010 June 25, 2014 U.S. Environmental Protection Agency 85 Germanium: Background Naturally-occurring element in earth's crust and oceans, widely distributed in low concentrations in oxide and sulfide minerals; commercially available in combination with other elements and produced mainly as a byproduct of zinc ore processing Used primarily in infrared optics, fiber-optic systems, electronics and solar electric applications Some germanium compounds (e.g., germanium dioxide) are water soluble June 25, 2014 U.S. Environmental Protection Agency 86 43 ------- Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations Germanium: Health Effects Health Assessment Status = 4 - Registry of Toxic Effects of Chemical Substances (RTECS): Single Study (Obaraetal. 1991) RfD-like = 0.0001 mg/kg-day - Critical Effect = Kidney, Ureter, Bladder- changes in tubules (including acute renal failure, acute tubular necrosis) - LOAEL = 0.318 mg/kg-day*; Default UF = 3,000 CCL 3 HRL: 0.744 ug/L (non-cancer) Sensitive populations: Individuals with compromised renal function *OW did not obtain the same LOAEL as RTECS using the data in the identified paper. Based on OW's evaluation of the dose information in the report, the LOAEL should be about ten times larger (i.e., 3.18 mg/kg-day). June 25, 2014 U.S. Environmental Protection Agency 87 Germanium: Occurrence National Inorganics and Radionuclides Survey (NIRS), Finished Water, 1984-1986 (MRL = 22 ug/L): - 4 detections (median = 220 |jg/L) out of 989 PWSs; Minimum detection (26 ug/L) > HRL (0.744 ug/L) Chemical Update System / Inventory Update Reporting: - <500K Ibs/yr in 2006 Toxic Release Inventory - Total: - No data in 2004 or 2010 June 25, 2014 U.S. Environmental Protection Agency 44 ------- Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations Semivolatile Organic Chemicals EPA Method 525.3 (GC/MS), 2012 Determination of semivolatile organic chemicals in drinking water by solid phase extraction and capillary column gas chromatography/mass spectrometry, version 1.0 Analytes Disulfoton (1) Ethoprop (1) Alpha-Hexachlorocyclohexane (2) Permethrin, trans - (1) Permethrin, cis- (1) Tebuconazole (1) Tribufos (1) Prof en ofos (1) Oxyfluorfen (2) Vinclozolin (2) Dimethipin (method 530) (1) June 25, 2014 U.S. Environmental Protection Agency 89 Disulfoton: Background Organophosphate pesticide; used as an insecticide; currently registered for use on over 35 crops, plus domestic outdoor use on potted plants and ornamentals Production cancelled 2009 (74 FR 48551) Expected to be not very mobile to moderately mobile in water, based on physical and chemical properties Projected half-life in water is 7 - 41 days (PBT Profiler) The PBT Profiler (2009) predicts that 17% of disulfoton will partition to water when modeled in a four-compartment system (water, air, soil and sediment) Moderately persistent in the environment June 25, 2014 U.S. Environmental Protection Agency 90 45 ------- Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations Disulfoton: Health Effects Health Assessment Status = 1 - 2006 OPP Risk Assessment RfD = 0.00013 mg/kg-day - Critical Effect = Plasma, RBC, brain and corneal cholinesterase (ChE) inhibition - NOAEL = 0.013 mg/kg-day; UF = 100 CCL3 HRL: 0.91 ug/L (non-cancer) Sensitive populations: None identified June 25, 2014 U.S. Environmental Protection Agency 91 Disulfoton: Occurrence UCMR 1 Screening Survey, Finished Water, 2001-2003 (MRL = 0.5 M9/L): - No detections of 2k samples in 295 systems USDA, Pesticide Data Program (POP), Finished Water, 2001-2009 (min detect = N/A): - No detections in 4k samples USGS, Toccalino et al. 2010, Ambient Water (MRL = 0.01 - 0.02 ug/L) - No detections in 647 samples/systems National Center for Food and Agricultural Policy (NCFAP) Pesticide Application: - 1,196,066 I bs/yr i n 33 states i n 1997 June 25, 2014 U.S. Environmental Protection Agency 92 46 ------- Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations Ethoprop: Background A phosphorodithioate pesticide; used as an insecticide Expected to be moderately mobile in water, based on physical and chemical properties PBT Profiler (2009) predicts 23% of ethoprop will partition to water when modeled in a four-compartment system (water, air, soil and sediment) June 25, 2014 U.S. Environmental Protection Agency 93 Ethoprop: Health Effects Health Assessment Status = 1 - 2001 OPP Risk Assessment RfD = 0.0001 mg/kg-day* - Critical Effect = Plasma cholinesterase (ChE) inhibition - NOAEL = 0.01 mg/kg-day; UF = 100 CCL 3 HRL: 0.7 ug/L (non-cancer) Sensitive populations: None identified Note: 2006 OPP Risk Assessment; RfD = 0.0014 Brain ChE inhibition; Likely carcinogen, CSF = 0.0281 mg/kg-day-1 June 25, 2014 U.S. Environmental Protection Agency 94 47 ------- Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations Ethoprop: Occurrence USGS, National Water-Quality Assessment Program (NAWQA), Ambient Water, 1992-2001: - 84 detections (median = 0.011 ug/L)out of 7,118 sites; Maximum detection (1.95 ug/L) >HRL(0.7ug/L) Pesticide Pilot Monitoring Program (PPMP), Finished Water, 1999: - 0 detections out of 228 samples National Center for Food and Agricultural Policy (NCFAP) Pesticide Application: - 1,010,807 Ibs/yr in 28 states in 1997 EPA OPP estimate of pesticide usage: - 691,000 Ibs/yr (2006 estimate) Toxic Release Inventory - Total: - 77,786 Ibs/yr in 4 states in 2004; 35,660 Ibs/yr in 2 states in 2010 June 25, 2014 U.S. Environmental Protection Agency 95 alpha-Hexachlorocyclohexane: Background A cyclic halogenated alkane; component of lindane, formerly used as an insecticide Expected to be not very to moderately mobile in water, based on physical and chemical properties The PBT Profiler (2009) predicts that 6% of alpha- hexachlorocyclohexane will partition to water when modeled in a four-compartment system (water, air, soil and sediment) June 25, 2014 U.S. Environmental Protection Agency 96 48 ------- Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations alpha-Hexachlorocyclohexane: Health Effects Health Assessment Status = 2 - 1987 IRIS Risk Assessment Slope Factor = 6.3 (mg/kg-day)-1 Cancer Class = B2 - Sufficient evidence of carcinogenicity in animals CCL 3 HRL: 0.006 ug/L (cancer) Sensitive populations: Children may be more sensitive, but no definitive studies June 25, 2014 U.S. Environmental Protection Agency 97 alpha-Hexachlorocyclohexane: Occurrence USGS, National Water Quality Assessment Program (NAWQA), Ambient Water, 1992-2001 (MRL = 0.002 ug/L): - 21 detections (median = 0.011 ug/L) out of 7,119 sites; Maxim urn detection (0.21 ug/L) > HRL (0.006 ug/L) National Center for Food and Agricultural Policy (NCFAP) Pesticide Application: - No data in 1997 Chemical Update System / Inventory Update Reporting: - No Reports in 2002 Toxic Release Inventory - Total: - No data in 2004 or 2010 June 25, 2014 U.S. Environmental Protection Agency 49 ------- Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations Permethrin, cis- and trans-: Background Permethrin is a substituted diphenyl ether; used as an insecticide Expected to be not very to moderately mobile in water, based on physical and chemical properties The PBT Profiler (2009) predicts that 2% of permethrin will partition to water when modeled in a four- compartment system (water, air, soil and sediment) May or may not be persistent in the environment June 25, 2014 U.S. Environmental Protection Agency 99 Permethrin, cis- and trans-: Health Effects Health Assessment Status = 1 - 2009 OPP Risk Assessment Slope Factor = 0.0096 (mg/kg-day)-1 Cancer Class = L - Likely to be carcinogenic to humans CCL 3 HRL: 3.65 ug/L (cancer) Sensitive populations: None identified June 25, 2014 U.S. Environmental Protection Agency 100 50 ------- Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations Permethrin, cis- and trans-: Occurrence National Center for Food and Agricultural Policy (NCFAP) Pesticide Application: - 1,066,056 Ibs/yrin 48 states in 1997 EPA OPP estimate of pesticide usage: - 2 million Ibs/yr (2007 estimate) Chemical Update System / Inventory Update Reporting: - No data in 2002 or 2006 Toxic Release Inventory - Total: - 17,979 Ibs/yr in 7 states in 2004; 2,116 Ibs/yr in 5 states in 2010 June 25, 2014 U.S. Environmental Protection Agency 101 Tribufos: Background Alkylated phosphorotrithioate pesticide; used as an insecticide and cotton defoliant Mobility in water uncertain, physical and chemical properties provide conflicting indications The PBT Profiler (2009) predicts that 14% of tribufos will partition to water when modeled in a four-compartment system (water, air, soil and sediment) Not persistent in the environment June 25, 2014 U.S. Environmental Protection Agency 102 51 ------- Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations Tribufos: Health Effects Health Assessment Status = 1 - 2006 OPP Risk Assessment RfD = 0.001 mg/kg-day - Critical Effect = Plasma cholinesterase (ChE) inhibition - NOAEL = 0.1 mg/kg-day; UF = 100 CCL 3 HRL: 7 ug/L (non-cancer) Sensitive populations: None identified June 25, 2014 U.S. Environmental Protection Agency 103 Tribufos: Occurrence Pesticide Pilot Monitoring Program (PPMP), Finished Water, 1999: - 0 detections out of 221 samples National Center for Food and Agricultural Policy (NCFAP) Pesticide Application: - 4,918,265 Ibs/yr in 16 states in 1997 EPA OPP estimate of pesticide usage: - 4.5 million Ibs/yr (2006 estimate) Chemical Update System / Inventory Update Reporting: - 10K - 500K Ibs/yr in 2002; <500K Ibs/yr in 2006 Toxic Release Inventory - Total: - 7 Ibs/yr in 1 state in 2004; 9 Ibs/yr in 2 states in 2010 June 25, 2014 U.S. Environmental Protection Agency 104 52 ------- Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations Profenofos: Background A phosphorothioate pesticide, applied as an insecticide Mobility in water uncertain, physical and chemical properties provide conflicting indications The PBT Profiler (2009) predicts that 9% of profenofos will partition to water when modeled in a four- compartment system (water, air, soil and sediment) Persistent in the environment June 25, 2014 U.S. Environmental Protection Agency 105 Profenofos: Health Effects Health Assessment Status = 1 - 2006 OPP Risk Assessment RfD = 0.00005 mg/kg-day - Critical Effect = Plasma and RBC cholinesterase (ChE) inhibition - NOAEL = 0.005 mg/kg-day; UF = 100 CCL 3 HRL: 0.35 ug/L (non-cancer) Sensitive populations: None identified June 25, 2014 U.S. Environmental Protection Agency 106 53 ------- Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations Profenofos: Occurrence Pesticide Program Monitoring Program (PPMP), Finished Water, 1999: - 0 detections out of 221 samples National Center for Food and Agricultural Policy (NCFAP) Pesticide Application: - 879,776 Ibs/yrin 14 states in 1997 EPA OPP estimate of pesticide usage: - 775,000 Ibs/yr (2006 estimate) Chemical Update System / Inventory Update Reporting: - No data in 2002 or 2006 Toxic Release Inventory - Total: - 255 Ibs/yr in 1 state in 2004; no data 2010 June 25, 2014 U.S. Environmental Protection Agency 107 Oxyfluorfen: Background A substituted diphenyl ether; used as a herbicide Expected to be not very to moderately mobile in water, based on physical and chemical properties The PBT Profiler (2009) predicts that 5% of oxyfluorfen will partition to water when modeled in a four- compartment system (water, air, soil and sediment) Persistent in the environment June 25, 2014 U.S. Environmental Protection Agency 108 54 ------- Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations Oxyfluorfen: Health Effects Health Assessment Status = 2 - 1986 IRIS Risk Assessment RfD = 0.003 mg/kg-day - Critical Effect = Liver toxicity (e.g., increased liver weight and lesions) - NOAEL = 0.3 mg/kg-day; UF = 100 CCL 3 HRL: 21 ug/L (non-cancer) Sensitive populations: Individuals with pre- existing liver conditions Note: 2002 OPP Risk Assessment; RfD = 0.03 mg/kg-day based on liver toxicity June 25, 2014 U.S. Environmental Protection Agency 109 Oxyfluorfen: Occurrence Pesticide Pilot Monitoring Program (PPMP), Finished Water, 1999: - 0 detections out of 221 samples National Center for Food and Agricultural Policy (NCFAP) Pesticide Application: - 705,255 Ibs/yr in 37 states in 1997 EPA OPP estimate of pesticide usage: - 761,000 Ibs/yr on average between 1990 and 1999; usage increasing Chemical Update System / Inventory Update Reporting: - No data in 2002 or 2006 Toxic Release Inventory - Total: - 5 Ibs/yr in 2 states in 2004; 2,503 Ibs/yr in 1 state in 2010 June 25, 2014 U.S. Environmental Protection Agency 110 55 ------- Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations Vinclozolin: Background An oxazolidine pesticide; used as a fungicide Expected to be moderately to very mobile in water, based on physical and chemical properties The PBT Profiler (2009) predicts that 12% of vinclozolin will partition to water when modeled in a four- compartment system (water, air, soil and sediment) Persistent in the environment June 25, 2014 U.S. Environmental Protection Agency 111 Vinclozolin: Health Effects Health Assessment Status = 2 - 2000 OPP Risk Assessment RfD = 0.012 mg/kg-day - Critical Effect = Lesions in the lungs, liver, ovaries and eye - NOAEL = 1.2 mg/kg-day; UF = 100 CCL 3 HRL: 84 ug/L (non-cancer) Sensitive populations: Fetuses, neonates, and adolescents during puberty could be a sensitive population June 25, 2014 U.S. Environmental Protection Agency 112 56 ------- Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations Vinclozolin: Occurrence National Center for Food and Agricultural Policy (NCFAP) Pesticide Application: - 121,959 Ibs/yr in 26 states in 1997 EPA OPP estimate of pesticide usage: - 141,000 Ibs/yr in 2000; expected to drop to 71,000 Ibs/yr after the phase- out of several uses was completed in 2004 Chemical Update System / Inventory Update Reporting: - No data in 2002 or 2006 Toxic Release Inventory - Total: - No data in 2004 or 2010 June 25, 2014 U.S. Environmental Protection Agency 113 Dimethipin: Background A cyclic dithiane pesticide; used as an herbicide and plant growth regulator Expected to be very mobile in water, based on physical and chemical properties The PBT Profiler (2009) predicts that 46% of dimethipin will partition to water when modeled in a four- compartment system (water, air, soil and sediment) Moderately persistent in the environment June 25, 2014 U.S. Environmental Protection Agency 114 57 ------- Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations Dimethipin: Health Effects Health Assessment Status = 1 - 2005 OPP Risk Assessment RfD = 0.0218 mg/kg-day - Critical Effect = Kidney, lungs, duodenum, liver, glandular stomach, heart, aortic artery and testes toxicity. Decreased body weight gain - NOAEL = 2.18 mg/kg-day; UF = 100 CCL 3 HRL: 153 ug/L (non-cancer) Sensitive populations: Non identified June 25, 2014 U.S. Environmental Protection Agency 115 Dimethipin: Occurrence National Center for Food and Agricultural Policy (NCFAP) Pesticide Application: - 282,458 Ibs/yrin 14 states in 1997 Chemical Update System / Inventory Update Reporting: - No data in 2002 or 2006 Toxic Release Inventory - Total: - 250 Ibs/yr in 1 state in 2004; 87 Ibs/yr in 1 state in 2010 June 25, 2014 U.S. Environmental Protection Agency 116 58 ------- Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations Tebuconazole: Background A substituted triazole pesticide; used as a fungicide Expected to be moderately to very mobile in water, based on physical and chemical properties The PBT Profiler (2009) predicts that 9% of tebuconazole will partition to water when modeled in a four- compartment system (water, air, soil and sediment) Persistent in the environment June 25, 2014 U.S. Environmental Protection Agency 117 Tebuconazole: Health Effects Health Assessment Status = 1 - 2008 OPP Risk Assessment RfD = 0.03 mg/kg-day - Critical Effect = Decreased body weights, absolute brain weights, brain measurements and motor activity in offspring - LOAEL = 8.8 mg/kg-day; UF = 300 CCL 3 HRL: 210 ug/L (non-cancer) Sensitive populations: Infants and children June 25, 2014 U.S. Environmental Protection Agency 118 59 ------- Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations Tebuconazole: Occurrence National Center for Food and Agricultural Policy (NCFAP) Pesticide Application: - 478,568 Ibs/yrin 16 states in 1997 Chemical Update System / Inventory Update Reporting: - No data in 2002 or 2006 Toxic Release Inventory - Total: - No data in 2004 or 2010 June 25, 2014 U.S. Environmental Protection Agency 119 Semivolatile Organic Chemicals Draft EPA Method 530 (GC/MS) Anticipated Publication Year 2014 Determination of select semivolatile organic chemicals in drinking water by solid phase extraction and capillary column gas chromatography/mass spectrometry Quinoline (1) o-Toluidine (4) Butylated hydroxyanisole (3) Dimethipin (1) (method 525.3) June 25, 2014 U.S. Environmental Protection Agency 120 60 ------- Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations Quinoline: Background Fused aromatic amine; used as a pharmaceutical (anti- malarial) and flavoring agent, also produced as a chemical intermediate Mobility in water uncertain, physical and chemical properties provide conflicting indications PBT Profiler (2009) predicts 31 % of quinoline will partition to water when modeled in a four-compartment system (water, air, soil and sediment) Not persistent in the environment June 25, 2014 U.S. Environmental Protection Agency 121 Quinoline: Health Effects Health Assessment Status = 1 - 2001 IRIS Risk Assessment Slope Factor = 3 (mg/kg-day)-1 Cancer Class = B2 - Sufficient evidence of carcinogenicity in animals CCL 3 HRL: 0.01 ug/L (cancer) Sensitive populations: None identified June 25, 2014 U.S. Environmental Protection Agency 122 61 ------- Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations Quinoline: Occurrence Chemical Update System / Inventory Update Reporting: - 10K - 500K Ibs/yr in 2002; 1M - <1 OM Ibs/yr in 2006 Toxic Release Inventory - Total: - 28,629 Ibs/yr in 8 states in 2004; 15,789 Ibs/yr in 9 states in 2010 June 25, 2014 U.S. Environmental Protection Agency 123 o-Toluidine: Background Aminated aromatic compound; used in production of dyes, rubber, Pharmaceuticals and pesticides Expected to be moderately to very mobile in water based on physical and chemical properties PBT Profiler (2009) predicts 41 % of o-toluidine will partition to water when modeled in a four-compartment system (water, air, soil and sediment) Not persistent in the environment June 25, 2014 U.S. Environmental Protection Agency 124 62 ------- Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations o-Toluidine: Health Effects Health Assessment Status = 4 - California Office of Environmental Health and Hazard Assessment (OEHHA), 2008: Study not provided Slope Factor =0.18 (mg/kg-day)-1 I ARC Cancer Group = 2A - Probably carcinogenic to humans CCL3HRL: 0.194 ug/L (cancer) Sensitive populations: Infants and children June 25, 2014 U.S. Environmental Protection Agency 125 o-Toluidine: Occurrence Chemical Update System / Inventory Update Reporting: - >10M - 50M Ibs/yr in 2002; 10M - <50M Ibs/yr in 2006 Toxic Release Inventory - Total: - 10,774 Ibs/yr in 9 states in 2004; 6,623 Ibs/yr in 1 state in 2010 June 25, 2014 U.S. Environmental Protection Agency 126 63 ------- Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations Butylated hydroxyanisole: Background Alkylated methoxyphenol; used as an antioxidant in foods, particularly those with high fat content and packaged foods Expected to be moderately mobile to not very mobile in water, based on physical and chemical properties PBT Profiler (2009) predicts 15% of butylated hydroxyanisole will partition to water when modeled in a four-compartment system (water, air, soil and sediment) Projected half-life in water is 38 days (PBT Profiler) Moderately persistent in the water June 25, 2014 U.S. Environmental Protection Agency 127 Butylated hydroxyanisole: Health Effects Health Assessment Status = 3 - Registry of Toxic Effects of Chemical Substances (RTECS), 2006: Single Study (Adelaide, S.A., Australia 1959) RfD-like = 0.000083 mg/kg-day - Critical Effect = Changes in liver weight - LOAEL = 0.249 mg/kg-day; Default UF = 3,000 CCL 3 HRL: 0.581 ug/L (non-cancer) Sensitive populations: Fetus and neonate may be sensitive to neurodevelopmental effects from exposure to high levels June 25, 2014 U.S. Environmental Protection Agency 128 64 ------- Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations Butylated hydroxyanisole: Occurrence USGS, National Reconnaissance of Emerging Contaminants (NREC), Ambient Surface Water, 1999-2004: - 2 detections (median = 0.1 ug/L) in 85 sites; Median of detections < HRL (0.581 ug/L) USGS, Koplin, et al., 2002, Ambient Water: - 2.4% detection rate (median = 0.1 ug/L) out of 85 sites; Maximum detect (0.2 ug/L) < HRL USGS, Focazio, et al., 2008, Ambient Water: - No detects out of 73 sites Chemical Update System / Inventory Update Reporting: - 10K - 500K Ibs/yr in 2002; <500K Ibs/yr in 2006 Toxic Release Inventory - Total: - No data in 2004; No data in 2010 June 25, 2014 U.S. Environmental Protection Agency 129 Presenter Steve Wendelken, USEPA June 25, 2014 U.S. Environmental Protection Agency 130 65 ------- Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations Organic Contaminants EPA Method 538 (DAI-LC/MS/MS), 2009 Determination of selected organic contaminants in drinking water by direct aqueous injection-liquid chromatography/tandem mass spectrometry, version 1.0 Analytes Dicrotophos (1) Oxydemeton-methyl (1) Methamidiphos (1) Acephate (1) June 25, 2014 U.S. Environmental Protection Agency 131 Dicrotophos: Background Organophosphate pesticide; used as an insecticide on cotton Expected to be moderately mobile to very mobile in water, based on chemical and physical properties The PBT Profiler (2009) predicts that 39% of dicrotophos will partition to water when modeled in a four-compartment system (water, air, soil and sediment) Moderately persistent in the environment June 25, 2014 U.S. Environmental Protection Agency 132 66 ------- Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations Dicrotophos: Health Effects Health Assessment Status = 1 - 2006 OPP Risk Assessment RfD = 0.00007 mg/kg-day - Critical Effect = Plasma, RBC and brain cholinesterase (ChE) inhibition - LOAEL = 0.02 mg/kg-day; UF = 300 CCL 3 HRL: 0.49 ug/L (non-cancer) Sensitive populations: None identified June 25, 2014 U.S. Environmental Protection Agency 133 Dicrotophos: Occurrence Pesticide Pilot Monitoring Program (PPMP), Finished Water, 1999: - 0 detections National Center for Food and Agricultural Policy (NCFAP) Pesticide Application: - 359,726 Ibs/yr in 13 states in 1997 OPP Pesticide Usage Estimate - 500,000 Ibs/yr (2006 estimate) Chemical Update System / Inventory Update Reporting: - No data in 2002 or 2006 Toxic Release Inventory - Total: - No data in 2004 or 2010 June 25, 2014 U.S. Environmental Protection Agency 134 67 ------- Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations Oxydemeton-methyl: Background Thiophosphate pesticide, used as an insecticide on broccoli, lettuce and other crops Expected to be very mobile in water based on chemical and physical properties The PBT Profiler (2009) predicts that 39% of oxydemeton-methyl will partition to water when modeled in a four-compartment system (water, air, soil and sediment) Moderately persistent in the environment June 25, 2014 U.S. Environmental Protection Agency 135 Oxydemeton-methyl: Health Effects Health Assessment Status = 1 - 2006 OPP Risk Assessment RfD = 0.00013 mg/kg-day - Critical Effect = RBC and brain cholinesterase (ChE) inhibition - NOAEL = 0.013 mg/kg-day; UF = 100 CCL 3 HRL: 0.91 ug/L (non-cancer) Sensitive populations: None identified June 25, 2014 U.S. Environmental Protection Agency 136 68 ------- Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations Oxydemeton-methyl: Occurrence Pesticide Pilot Monitoring Program (PPMP) Finished Water, 1999: - 0 detections National Center for Food and Agricultural Policy (NCFAP) Pesticide Application: - 154,227 Ibs/yr in 19 states in 1997 OPP Pesticide Usage Estimate - 145,000 - 186,000 Ibs/yr (2006 estimate) Chemical Update System / Inventory Update Reporting: - No data in 2002 or 2006 Toxic Release Inventory - Total: - No data in 2004 or 2010 June 25, 2014 U.S. Environmental Protection Agency 137 Methamidophos: Background Phosphoramidothioate pesticide used as an insecticide on potatoes and other crops; also a degradation product of acephate, an organic phosphoramide insecticide Expected to be very mobile in water, based on chemical and physical properties The PBT Profiler (2009) predicts that 39% of methamidophos will partition to water when modeled in a four-compartment system (water, air, soil and sediment) Moderately persistent in the environment June 25, 2014 U.S. Environmental Protection Agency 138 69 ------- Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations Methamidophos: Health Effects Health Assessment Status = 1 - 2006 OPP Risk Assessment RfD = 0.0003 mg/kg-day - Critical Effect = Brain cholinesterase (ChE) inhibition - NOAEL = 0.03 mg/kg-day; UF = 100 CCL 3 HRL: 2.1 ug/L (non-cancer) Sensitive populations: None identified June 25, 2014 U.S. Environmental Protection Agency 139 Methamidophos: Occurrence National Center for Food and Agricultural Policy (NCFAP) Pesticide Application: - 965,584 Ibs/yr in 39 states in 1997 OPP Pesticide Usage Estimate - 640,000 Ibs/yr (2006 estimate) Chemical Update System / Inventory Update Reporting: - No data in 2002 or 2006 Toxic Release Inventory - Total: - No data in 2004 or 2010 June 25, 2014 U.S. Environmental Protection Agency 140 70 ------- Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations Acephate: Background Organic phosphoramide pesticide; used as an insecticide on cotton, tobacco and other crops Expected to be very mobile in water, based on chemical and physical properties Projected half-life in water of 38 days (PBT Profiler) PBT Profiler (2009) predicts 46% of acephate will partition to water when modeled in a four-compartment system (water, air, soil and sediment) Not persistent in the environment June 25, 2014 U.S. Environmental Protection Agency 141 Acephate: Health Effects Health Assessment Status = 1 - 2006 OPP Risk Assessment RfD = 0.0012 mg/kg-day - Critical Effect = Brain cholinesterase (ChE) inhibition - NOAEL = 0.12 mg/kg-day; UF = 100 CCL 3 HRL: 8.4 ug/L (non-cancer) Sensitive populations: None identified June 25, 2014 U.S. Environmental Protection Agency 142 71 ------- Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations Acephate: Occurrence National Center for Food and Agricultural Policy (NCFAP) Pesticide Application: - 2,462,354 Ibs/yr in 35 states in 1997 EPA OPP estimate of pesticide usage: - 4-5 million Ibs/yr (2006 estimate) Chemical Update System / Inventory Update Reporting: - No data in 2002 or 2006 Toxic Release Inventory - Total: - 20,751 Ibs/yr in 5 states in 2004; 5,816 Ibs/yr in 2 states in 2010 June 25, 2014 U.S. Environmental Protection Agency 143 Alcohols Draft EPA Method 541 (GC/MS) Anticipated Publication Year 2014 Analysis of low molecular weight alcohols in drinking water by gas chromatography mass spectrometry 1-Butanol(2) 2-Propen-1-ol(2) 2-Methoxyethanol (3) June 25, 2014 U.S. Environmental Protection Agency 144 72 ------- Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations 1-Butanol: Background Alkyl alcohol compound; used as a paint solvent and food additive, also formed as a chemical intermediate Expected to be moderately mobile to very mobile in water, based on chemical and physical properties PBT Profiler (2009) predicts 40% of 1-butanol will partition to water when modeled in a four-compartment system (water, air, soil and sediment) Not persistent in the environment June 25, 2014 U.S. Environmental Protection Agency 145 1-Butanol: Health Effects Health Assessment Status = 2 - 1987 IRIS Risk Assessment RfD = 0.1 mg/kg-day - Critical Effect = Abnormally diminished activity in the body/organs; inability to control muscles - NOAEL = 125 mg/kg-day; UF = 1,000 CCL 3 HRL: 700 ug/L (non-cancer) Sensitive populations: None identified June 25, 2014 U.S. Environmental Protection Agency 146 73 ------- Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations 1-Butanol: Occurrence Chemical Update System / Inventory Update Reporting: - >1 B Ibs/yr in 2002; >1 B Ibs/yr in 2006 Toxic Release Inventory - Total: - 17,648,846 Ibs/yr in 44 states in 2004; 11,093,815 Ibs/yr in 47 states in 2010 June 25, 2014 U.S. Environmental Protection Agency 147 2-Propen-1-ol: Background Alkene/alcohol compound; chemical intermediate used in the manufacturing of flavorings and perfumes Expected to be moderately mobile to very mobile in water, based on chemical and physical properties PBT Profiler (2009) predicts 48% of 2-propen-1-ol will partition to water when modeled in a four-compartment system (water, air, soil and sediment) Not persistent in the environment June 25, 2014 U.S. Environmental Protection Agency 148 74 ------- Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations 2-Propen-1-ol: Health Effects Health Assessment Status = 2 - 1987 IRIS Risk Assessment RfD = 0.005 mg/kg-day - Critical Effect = Impaired renal function and increased relative liver, spleen and kidney weights - NOAEL = 4.8 mg/kg-day; UF = 1,000 CCL 3 HRL: 35 ug/L (non-cancer) Sensitive populations: Individuals with impaired pulmonary function may be particularly sensitive to the toxic effects of allyl alcohol through inhalation June 25, 2014 U.S. Environmental Protection Agency 149 2-Propen-1-ol: Occurrence Chemical Update System / Inventory Update Reporting: - >100M - 500M Ibs/yr in 2002; 100M - <500M Ibs/yr in 2006 Toxic Release Inventory - Total: - 604,872 Ibs/yr in 13 states in 2004; 445,833 Ibs/yr in 13 states in 2010 June 25, 2014 U.S. Environmental Protection Agency 150 75 ------- Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations 2-Methoxyethanol: Background Monoalkylated alcohol; used in synthetic cosmetics, perfumes, fragrances, hair preparations, skin lotions and other consumer products Expected to be moderately mobile to very mobile in water, based on chemical and physical properties PBT Profiler (2009) predicts 45% of 2-methoxyethanol will partition to water when modeled in a four- compartment system (water, air, soil and sediment) Not persistent in the environment June 25, 2014 U.S. Environmental Protection Agency 151 2-Methoxyethanol: Health Effects Health Assessment Status = 3 - Risk Assessment Information System (RAISHE): Single Study (Gulati, etal. 1990) RfD-like = 0.003 mg/kg-day - Critical Effect = Reproductive effects - LOAEL = 9 mg/kg-day; Default UF = 3,000 CCL 3 HRL: 21 ug/L (non-cancer) Sensitive populations: None identified June 25, 2014 U.S. Environmental Protection Agency 152 76 ------- Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations 2-Methoxyethanol: Occurrence Chemical Update System / Inventory Update Reporting: - >1 OM - 50M Ibs/yr in 2002; 1M - <1 OM Ibs/yr in 2006 Toxic Release Inventory - Total: - 153,774 Ibs/yr in 16 states in 2004; 23,240 Ibs/yr in 16 states in 2010 June 25, 2014 U.S. Environmental Protection Agency 153 Pharmaceuticals Draft EPA Method 542 (LC/MS/MS) Anticipated Publication Year 2014 Determination of Pharmaceuticals and personal care products (PPCP) in drinking water by solid phase extraction (SPE) and liquid chromatography electrospray ionization tandem mass spectrometry Analytes Erythromycin (3) Carbamazepine Diazepam Sulfamethoxazole Trimethoprim Diclofenac Triclosan (1) Naproxen Gemfibrozil Fluoxetine Enalapril Phenytoin June 25, 2014 U.S. Environmental Protection Agency 154 77 ------- Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations Erythromycin: Background Used in pharmaceutical formulations as an antibiotic Expected to be moderately mobile to very mobile in water, based on chemical and physical properties Projected half-life in water of 180 days (PBT Profiler) The PBT Profiler (2009) predicts that 6% of erythromycin will partition to water when modeled in a four-compartment system (water, air, soil and sediment) Persistent in the environment June 25, 2014 U.S. Environmental Protection Agency 155 Erythromycin: Health Effects Health Assessment Status = 3 - Joint FAO/WHO Expert Committee on Food Additives (JECFA), 2006 Acceptable Daily Intake (ADI) = 0.0007 mg/kg-day - Critical Effect = Inhibition of beneficial gastrointestinal bacteria CCL 3 HRL: 4.9 ug/L (non-cancer) Sensitive populations: None identified June 25, 2014 U.S. Environmental Protection Agency 156 78 ------- Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations Erythromycin: Occurrence USGS, National Reconnaissance of Emerging Contaminants (NREC), Ambient Surface Water, 1999-2004: - 22 detections (median = 0.1 ug/L) out of 104 sites; Maximum detect (1.7 ug/L) < HRL (4.9 ug/L) USGS, Focazio, et al., 2008, Ambient Water: - Maximum detect value = 0.3 ug/L; Maximum < HRL (4.9 ug/L) Chemical Update System / Inventory Update Reporting: - No data in 2002 or 2006 Toxic Release Inventory - Total: - No data in 2004 or 2010 June 25, 2014 U.S. Environmental Protection Agency 157 Triclosan: Background Antimicrobial agent found in many personal care products such as soaps, toothpaste; also used in many other products including clothing and plastics Expected to be not very mobile to immobile in water, based on chemical and physical properties Projected half-life in water of 60 days (PBT Profiler) The PBT Profiler (2009) predicts that 7% of triclosan will partition to water when modeled in a four-compartment system (water, air, soil and sediment) Persistent in the environment June 25, 2014 U.S. Environmental Protection Agency 158 79 ------- Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations Triclosan: Health Effects Health Assessment Status = 1 - 2008 OPP Risk Assessment RfD = 0.3 mg/kg-day - Critical Effect = Vomiting, diarrhea, loss of appetite - NOAEL = 30 mg/kg-day; UF = 100 HRL 2,100 ug/L (non-cancer) Sensitive populations: None identified June 25, 2014 U.S. Environmental Protection Agency 159 Triclosan: Occurrence USGS, National Reconnaissance of Emerging Contaminants (NREC), Ambient Ground Water, 1999-2004: - Median = 0.19 ug/L; < HRL (2,100 ug/L) USGS, NREC Ambient Surface Water, 1999-2004: - Median = 0.17 ug/L; < HRL (2,100 ug/L) USGS, Hopple, et al., 2008, Finished Water: - Maximum detect value = 0.065 ug/L; Maximum < HRL USGS, Kolpin , et al., 2002, Ambient Water: - 49 detections (maximum = 2.3 ug/L, median = 0.14 ug/L) out of 85 sites; Maximum detect (2.3 ug/L) < HRL (2,100 ug/L) June 25, 2014 U.S. Environmental Protection Agency 160 80 ------- Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations Carbonyl Compounds EPA Method 556.1 (Fast GC), 1999 Determination ofcarbonyl compounds in drinking water by fast gas chromatography, revision 1.0 Analytes Formaldehyde (2) Acetaldehyde (4) June 25, 2014 U.S. Environmental Protection Agency 161 Formaldehyde: Background Aliphatic aldehyde; used as a fungicide and tissue preservative Drinking water disinfection byproduct (from chlorination, ozonation) Present in smoked foods and in living systems as a metabolic intermediate Expected to be very mobile in water, based on chemical and physical properties The PBT Profiler (2009) predicts that 44% of formaldehyde will partition to water when modeled in a four-compartment system (water, air, soil and sediment) Not persistent in the environment June 25, 2014 U.S. Environmental Protection Agency 162 81 ------- Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations Formaldehyde: Health Effects Health Assessment Status = 2 - 1990 IRIS Risk Assessment RfD = 0.2 mg/kg-day - Critical Effect = Reduced weight gain; decreased absolute heart, liver, testes and kidney weights; increased relative brain weights - NOAEL = 15 mg/kg-day; UF = 100 CCL 3 HRL: 1,400 ug/L (non-cancer) Sensitive populations: Deficiencies of folic acid and factors causing low activity of aldehyde reductase may increase the toxicity of formaldehyde June 25, 2014 U.S. Environmental Protection Agency 163 Formaldehyde: Occurrence Disinfection By-product Information Collection Rule DBP-ICR, Finished Water, 1997-1998: - 126 detections (median = 7.6 ug/L) out of 227 sites using ozone; Maximum detect (30.6 ug/L) < HRL (1,400 ug/L) (only at plants with ozone) Chemical Update System / Inventory Update Reporting: - >1 B Ibs/yr in 2002; >1 B Ibs/yr in 2006 Toxic Release Inventory - Total: - 26,992,234 Ibs/yr in 46 states in 2004; 19,381,048 Ibs/yr in 45 states in 2010 June 25, 2014 U.S. Environmental Protection Agency 164 82 ------- Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations Acetaldehyde: Background Aliphatic aldehyde; used as a pesticide and a food additive, also formed as a chemical intermediate in production of other substances Drinking water disinfection byproduct (from chlorination, ozonation) Expected to be moderately mobile to very mobile in water, based on chemical and physical properties The PBT Profiler (2009) predicts that 49% of acetaldehyde will partition to water when modeled in a four-compartment system (water, air, soil and sediment) Not persistent in the environment June 25, 2014 U.S. Environmental Protection Agency 165 Acetaldehyde: Health Effects Health Assessment Status = 4 - Registry of Toxic Effects of Chemical Substances (RTECS), 2008 RfD-like = 0.00333 mg/kg-day - Critical Effect = Behavioral changes in motor activity (specific assay) - LOAEL 10 mg/kg-day; Default UF = 3,000 CCL 3 HRL: 23.3 ug/L (non-cancer) Sensitive populations: Individuals with polymorphism of the aldehyde dehydrogenase (ALDH) gene June 25, 2014 U.S. Environmental Protection Agency 166 83 ------- Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations Acetaldehyde: Occurrence Disinfection By-Product Information Collection Rule (DBP-ICR), Finished Water, 1997-1998: - 27 detections (median = 7.4 ug/L) out of 236 sites using ozone; Maximum detect (18.3 ug/L) < HRL (23.3 ug/L) California Department of Health Services, Finished Water (CAL DHS): - 3 detections (median = 2 ug/L) out of 8 sites; Maximum detect (24 ug/L) > HRL Chemical Update System / Inventory Update Reporting: - >100M - 500M Ibs/yr in 2002; 100M - <500M Ibs/yr in 2006 Toxic Release Inventory - Total: - 14,683,890 Ibs/yr in 38 states in 2004; 9,926,083 Ibs/yr in 38 states in 2010 June 25, 2014 U.S. Environmental Protection Agency 167 Cyanotoxins Draft EPA Method 544 (LC/MS/MS) Anticipated Publication Year 2014 Determination of microcystins and nodularin in drinking water by solid phase extraction and liquid chromatography/tandem mass spectrometry . Analytes Microcystin-LR (3) Microcystin-RR Microcystin-YR Microcystin-LA Microcystin-LF Microcystin-LY Nodularin June 25, 2014 U.S. Environmental Protection Agency 168 84 ------- Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations Microcystin-LR: Background Cyanotoxin (toxin produced and released by cyanobacteria) that targets the liver Insufficient data to characterize mobility in water or environmental persistence June 25, 2014 U.S. Environmental Protection Agency 169 Microcystin-LR: Health Effects Health Assessment Status = 3 - Single Study (Ueno, Makita, Nagata et al. 1999) RfD-like = 0.000003 mg/kg-day - Critical Effect = Liver effects - NOAEL = 0.003 mg/kg-day; Default UF = 1,000 CCL 3 HRL: 0.021 ug/L (non-cancer) Sensitive populations: None identified June 25, 2014 U.S. Environmental Protection Agency 170 85 ------- Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations Microcystin-LR: Occurrence US and Canadian drinking water (bloom area, source, finished water): - 542 detections out of 677 sites; Typical maximum (0.1 ug/L) < HRL (0.021 ug/L) Chemical Update System / Inventory Update Reporting: - No data in 2002 or 2006 Toxic Release Inventory - Total: - No data in 2004 or 2010 June 25, 2014 U.S. Environmental Protection Agency 171 Cyanotoxins Draft EPA Method 545 (LC/ESI-MS/MS) Anticipated Publication Year 2014 Determination of cylindrospermopsin and anatoxin-a in drinking water by liquid chromatography electrospray ionization tandem mass spectrometry Analyte Anatoxin-a (4) Cylindrospermopsin (3) June 25, 2014 U.S. Environmental Protection Agency 172 86 ------- Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations Anatoxin-a: Background Cyanotoxin (toxin produced and released by cyanobacteria) that targets the nervous system Insufficient data to characterize mobility in water or environmental persistence June 25, 2014 U.S. Environmental Protection Agency 173 Anatoxin-a: Health Effects Health Assessment Status = 4 - Single Study (Astrachan and Archer, 1981) RfD-like = 0.0005 mg/kg-day - Critical Effect = Mortality in rats (7-day) - NOAEL = 0.5 mg/kg-day; Default UF = 1,000 CCL 3 HRL: 3.5 ug/L (non-cancer) Sensitive populations: People using anticholinergic agents for therapeutic purposes could be at risk of increased side effects after exposure to anatoxin-a, due to the potential for the additivity of adverse effects June 25, 2014 U.S. Environmental Protection Agency 174 87 ------- Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations Anatoxin-a: Occurrence CyanoHABs - The Florida Experience, 2000: - Maximum detect (~10 |jg/L); Maximum detect > HRL (3.5 ug/L) UCMR 1 Meeting summary: - 4% detection rate in Lake Champlain Chemical Update System / Inventory Update Reporting: - No data in 2002 or 2006 Toxic Release Inventory - Total: - No data in 2004 or 2010 June 25, 2014 U.S. Environmental Protection Agency 175 Cylindrospermopsin: Background Cyanotoxin (toxin produced and released by cyanobacteria) that affects the liver and kidney Insufficient data to characterize mobility in water or environmental persistence June 25, 2014 U.S. Environmental Protection Agency 176 88 ------- Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations Cylindrospermopsin: Health Effects Health Assessment Status = 3 - Single Study (Humpage and Falconer, 2003) RfD-like = 0.00003 mg/kg-day - Critical Effect = Increased kidney weight - NOAEL = 0.03 mg/kg-day; Default UF = 1,000 CCL 3 HRL: 0.21 ug/L (non-cancer) Sensitive populations: Children; individuals with liver or kidney disease June 25, 2014 U.S. Environmental Protection Agency 177 Cylindrospermopsin: Occurrence CyanoHABs - The Florida Experience, 2000: - Maximum detect (-100 ug/L); Maximum detect > HRL (0.21 ug/L) UCMR 1 Meeting summary: - Maximum detect (90 ug/L); Maximum detect > HRL (0.21 ug/L) Chemical Update System / Inventory Update Reporting: - No data in 2002 or 2006 Toxic Release Inventory - Total: - No data in 2004 or 2010 June 25, 2014 U.S. Environmental Protection Agency 178 89 ------- Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations Legionella pneumophila Under Evaluation: Potential methods being investigated Legionella pneumophila June 25, 2014 U.S. Environmental Protection Agency 179 Legionella: Background Legionella bacteria are aerobic gram-negative rods associated with respiratory infections Legionella are ubiquitous in fresh and marine waters; exist in varied temperatures, pH levels and nutrient and oxygen contents EPA is leading a multi-agency taskforce to develop a document characterizing the effectiveness of available treatment technologies for control of Legionella as well as the regulatory implications for consecutive systems that may become PWSs after installing additional treatment. The document is scheduled to be completed by Spring 2015 June 25, 2014 U.S. Environmental Protection Agency 180 90 ------- Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations Legionella: Health Effects Legionellosis - Major risk factors: immunosuppression, smoking, travel, use of undisinfected well water, chronic heart or lung disease and chronic renal failure - Community or hospital acquired legionellosis can occur - Approximately 1,000-2,000 cases are reported to CDC each year - Prompt diagnosis and treatment results in 95-99% recovery rates - Mortality in untreated cases is approximately 15% of previously healthy patients and 75% of severely immunocompromised patients Pontiac Fever - Resembles an acute allergic reaction - Self-limiting; no specific treatment is advised and hospitalization is not required June 25, 2014 U.S. Environmental Protection Agency 181 Legionella: Occurrence Can colonize plumbing fixtures, hot water tanks, warm water spas and cooling towers May have evolved a symbiotic relationship with free-living amoebae, which may facilitate movement and colonization of domestic and industrial water systems Colonization of hot water systems in hospitals has resulted in numerous hospital outbreaks Community acquired cases are typically associated with cooling towers or untreated well water exposures 52 documented waterborne disease outbreaks affecting 225 people caused by L. pneumophila as reported by CDC between 1990 and 2010 - Outbreaks associated with drinking water exposure mostly due to premise plumbing colonization, which is not under jurisdiction of the water utility June 25, 2014 U.S. Environmental Protection Agency 182 91 ------- Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations Other UCMR 4 Contaminants Under Consideration Presenter Melissa Simic, USEPA June 25, 2014 U.S. Environmental Protection Agency 183 Other UCMR 4 Contaminants Under Consideration Nitrate/Nitrite (currently regulated) - Nitrate and nitrite levels may increase in the distribution system, especially when chloramines are used as residual disinfectants - Currently, monitoring is only required at the entry point to the distribution system and is not required in the distribution system or for all consecutive systems - UCMR 4 data could be used to better characterize the exposure of nitrite and nitrate in the distribution system on a national scale June 25, 2014 U.S. Environmental Protection Agency 184 92 ------- Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations Other UCMR 4 Contaminants Under Consideration 4 unregulated brominated DBFs bromodichloroacetic acid, dibromochloroacetic acid, and tribromoacetic acid) - Monitor at Stage 2 DBPR compliance locations - Brominated haloacetic acids (HAAs) may pose higher health risks than chlorinated species - UCMR 4 data could help inform brominated HAA occurrence and exposure relative to the regulated HAAS (i.e., monochloroacetic acid, dichloroacetic acid, trichloroacetic acid, monobromoacetic acid, dibromoacetic acid) June 25, 2014 U.S. Environmental Protection Agency 185 Appendices June 25, 2014 U.S. Environmental Protection Agency 186 93 ------- Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations Appendix A: Unregulated CCL 3 Contaminants 106 Chemicals and 12 Microbes Tl^rfefrachloroethane Chloromethane (Methyl chloride) Methyl tert-butyl ether Tebuconazole l'l-Dichloroethane Clethodim Metolachlor Tebufenozide 1 '2 3-Trichloropropane Cobalt Metolachlor ethanesulfonic acid (ESA) Tellurium 1 3-Butadiene Cumene hydroperoxide Metolachlor oxanilic acid (OA) Terbufos 1 '" Dinitrobcn cnc CylindrospermoDsin Microcvstin-LR Terbufos sulfone 1 iJ-Scotane" '" Dicrotophos 17alpha-Estradiol DimethiPin 1-Butanol Dimethoate 2-Methoxvethanol Disulfoton 2-Propen-1-ol Diuron . S-Hydroxycarbofuran(degradate) Equilenm 4,4'-Methylenedianiline Equilm Acephate Erythromycin Acetaldehvde Estradiol (17-beta) Acetamide Estrid Acetochlor Estrone Acetochlor ethanesulfonic acid (ESA) Etniny' Estradio1 (17-alpha) Acetochlor oxanilic acid (OA) Ethoprop Acrolein Ethylene glycol Alachlor ethanesulfonic acid (ESA) Ethylene oxide Alachlor oxanilic acid (OA) Ethylene thiourea alpha-Hexachlorocvclohexane Fenamiphos Anatoxin-a Formaldehyde Bensulide Halon 1011 (Bromochloromethane) Benzyl chloride HCFC-22 Butvlated hvdroxvanisole Hexane Captan Hydrazine Chlorate (also D-DBP) Mestranol Methamidophos Methyl bromide (Bromom ethane) Molinate Thiodicarb Molybdenum Thiophanate-m ethyl Nitrobenzene Toluene diisocyanate Nitroglycerin Tribufos N-Methyl-2-pyrrolidone Triethylamine N-Nitrosodiethylamine (NDEA) Triphenyltin hydroxide (TPTH) N-nitrosodimethylamine(NDMA) Urethane N-Nitroso-di-n-propylamine NDPA) Vanadium N-Nitrosodiphenylamine Vinclozolin N-nitrosopyrrolidine (NPYR) Ziram Norethindrone (19-Norethisterone) n-Propylbenzene Microbes o-Toluidine Adenovirus Oxirane, methyl- Caliciviruses Oxydemeton-methyl Campylobacterjejuni Oxyfluorfen Enterovirus Perchlorate Escherichia coli (0157) Perfluorooctane sulfonic acid (PFOS) Helicobacter pylori Perfluorooctanoic acid (PFOA) Hepatitis A v rus Permethrin (cis. trans) LeaionellaDneumoDhila Profenofos Mycobacterium avium Quinoline Naegleria fowleri RDX Salmonella enterica sec- Butyl benzene Shigella sonnei Strontium UCMR 4 Candidates June 25, 2014 U.S. Environmental Protection Agency 187 Appendix B: CCL 4 Nominations 3-chloro-4-dichloromethyl-5-hydroxy-2(5H)- furanone1,1,1,2-Tetrachloroethane Alkylphenol mono- totri-oxylates Amoxicillin Azinphos-m ethyl Bacitracin zinc Bentazone Benzyl butyl phthalate Bisphenol A Bromoxynil Carbaryl Chlorothalonil Chlorpyrifos Dibutyl phthalate Dicamba Dichlorvos Dicofol Dicyclohexyl phthalate Diethyl phthalate Di-isononyl phthalate Dimethyl phthalate Di-n-octyl phthalate Endosulfan Fluometuron Linezolid Linuron Malathion Manganese Methicillin Methyl parathion Nonylphenol Nonylphenol ethoxylate Octylphenol Octylphenol ethoxylate Oxacillin Penicillin Phosmet Progesterone Spiramycin Testosterone Trichlorfon Triclocarban Triclosan Tylosin Vancomycin Virginiamycin Chlorate (also D-DBP) Chloromethane (Methyl chloride) Clethodim Cobalt Cumene hydroperoxide Microbes Toxoplasma gondii Vibrio cholerae UCMR 4 d ndidates Note: There were a total of 59 unique nominations for CCL 4. Only 48 are presented here because eleven contaminants were removed for either having an existing NPDWRorare already on CCL 3. June 25, 2014 U.S. Environmental Protection Agency 94 ------- Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) for Public Water Systems Public Stakeholder Meeting and Webinar Afternoon Break Resume at 3:15 p.m. June 25, 2014 U.S. Environmental Protection Agency 189 Approval of Laboratories Supporting UCMR 4 Public Meeting and Webinar Washington D.C. June 25th, 2014-3:15 p.m. Brenda Parris USEPA, OGWDW, SRMD Technical Support Center Cincinnati, OH 190 95 ------- Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations Overview Expected approach to the UCMR 4 Laboratory Approval Program Maintaining approval June 25, 2014 U.S. Environmental Protection Agency 191 General Expectations Laboratory Approval Program expected to be similar to the process used in UCMR 3 Water systems would need to use EPA UCMR- approved laboratories for analysis Labs would need to meet the required equipment, laboratory performance and data reporting criteria to become approved Labs would stilj need to be approved to support UCMR 4 even if already certified by state, primacy entity or accredited through the National Environmental Accreditation Program (NELAP) fora particular method being used for compliance monitoring June 25, 2014 U.S. Environmental Protection Agency 192 96 ------- Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations General Procedure Step 1: Request to participate and register Step 2: Application Step 3: EPA review of application Step 4: Proficiency Testing Step 5: EPA approval June 25, 2014 U.S. Environmental Protection Agency 193 Stepl Request to participate and register - Submit a written participation request to EPA Laboratory Approval Coordinator - EPA provides registration material - Submit complete registration material within 90 days of Final Rule publication in Federal Register - EPA provides a custom application package based on registration information June 25, 2014 U.S. Environmental Protection Agency 194 97 ------- Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations Step 2 Application Package - Separate application for each method - Lab would receive a copy of the Laboratory Approval Manual - Completed package would be submitted within 210 days of publication of the Final Rule in the Federal Register June 25, 2014 U.S. Environmental Protection Agency 195 Laboratory Approval Manual Procedures for obtaining UCMR approval and procedures for revocation of approval Quality Assurance requirements Quality Control requirements - Initial demonstration of capability - Initial calibration - Continuing calibration checks - Surrogate and internal standard criteria - Reagent blanks and fortified blanks - Quality control samples - Spiked field samples - Field blank criteria (if required by the method) Sample handling requirements June 25, 2014 U.S. Environmental Protection Agency 196 98 ------- Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations Step 2 continued Completed application package anticipated to include: - Precision, accuracy and minimum reporting level (MRL) studies with documentation - Documentation of certification or accreditation of drinking water compliance analyses/selected methods as requested - Personnel and quality assurance information - Description of analytical equipment and sample handling procedures June 25, 2014 U.S. Environmental Protection Agency 197 StepS Review of Application Package - EPA would review the package and could request more information - Email notifying lab would be sent following EPA's confirmation of successful completion of the application package - Once the application has been accepted, the lab could participate in the corresponding PT studies June 25, 2014 U.S. Environmental Protection Agency 198 99 ------- Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations Step 4 Proficiency Testing - EPA would provide PT samples - Labs would analyze PT sample(s) for each method - Labs would likely have several opportunities to analyze PT samples - Only one successful analysis of PT samples per method would be required June 25, 2014 U.S. Environmental Protection Agency 199 Step 5 EPA Approval - Once all steps are completed, EPA would grant formal written approval (for each method, as appropriate) June 25, 2014 U.S. Environmental Protection Agency 200 100 ------- Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations Maintaining Approval Adhere to quality assurance/quality control (QA/QC) measures in both the methods and the Laboratory Approval Manual Post occurrence data and required QC data via the Safe Drinking Water Accession and Review System (SDWARS) within prescribed timeframe Participate and pass on-site and/or paper audits Respond to requests for data outside of SDWARS June 25, 2014 U.S. Environmental Protection Agency 201 Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) for Public Water Systems Public Presentations - 3:45 p.m. Pre-registered speakers only June 25, 2014 U.S. Environmental Protection Agency 202 101 ------- Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) Meeting Presentations Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) for Public Water Systems Discussion June 25, 2014 U.S. Environmental Protection Agency 203 Closing Remarks On-site attendees must turn in any door keycards to the sign-in desk. Meeting materials were sent to all registered participants; if you did not receive a copy, please email UCMRwebinar@cadmusgroup.com and we will send you a copy. June 25, 2014 U.S. Environmental Protection Agency 204 102 ------- |