14098 Federal Register / Vol. 85, No. 47 / Tuesday, March 10, 2020 / Proposed Rules

ENVIRONMENTAL PROTECTION • Federal eRulemaking Portal: making effective comments, please visit AGENCY https://www.regulations.gov/ (our https://www.epa.gov/dockets/ preferred method). Follow the online commenting-epa-dockets. 40 CFR Part 141 instructions for submitting comments. When submitting comments, • Mail: Water Docket, Environmental remember to: [EPA–HQ–OW–2019–0583; FRL–10005–88– Protection Agency, Mail Code: [28221T], • Identify the rulemaking by docket OW] 1200 Pennsylvania Ave. NW, number and other identifying Announcement of Preliminary Washington, DC 20460. information (subject heading, Federal • Hand Delivery: EPA Docket Center, Regulatory Determinations for Register date, and page number). [EPA/DC] EPA West, Room 3334, 1301 • Contaminants on the Fourth Drinking Explain why you agree or disagree Constitution Ave. NW, Washington, DC. Water Contaminant Candidate List and suggest alternatives. Such deliveries are only accepted • Describe any assumptions and AGENCY: Environmental Protection during the Docket’s normal hours of provide any technical information and/ Agency (EPA). operation, and special arrangements or data that you used. • ACTION: Request for public comment. should be made for deliveries of boxed Provide specific examples to information. illustrate your concerns and suggest SUMMARY: The Safe Drinking Water Act Instructions: All submissions received alternatives. (SDWA), as amended in 1996, requires must include the Docket ID No. for this • Explain your views as clearly as the Environmental Protection Agency rulemaking. Comments received may be possible. (EPA) to make regulatory posted without change to https:// • Make sure to submit your determinations every five years on at www.regulations.gov/, including any comments by the comment period least five unregulated contaminants. A personal information provided. For deadline identified. regulatory determination is a decision detailed instructions on sending B. Does this action apply to me? about whether or not to begin the comments and additional information process to propose and promulgate a on the rulemaking process, see the Neither these preliminary regulatory national primary drinking water ‘‘Written Comments’’ heading of the determinations nor the final regulatory regulation (NPDWR) for an unregulated SUPPLEMENTARY INFORMATION section of determinations, when published, contaminant. A preliminary regulatory this document. impose any requirements on anyone. determination lays out and takes FOR FURTHER INFORMATION CONTACT: Instead, this action notifies interested comment on EPA’s view about whether Richard Weisman, Standards and Risk parties of the EPA’s preliminary certain unregulated contaminants meet Management Division, Office of Ground regulatory determinations for eight three statutory criteria. After EPA Water and Drinking Water, MC: 4607M, unregulated contaminants for comment. considers public comment, EPA makes Environmental Protection Agency, 1200 Abbreviations Used in This Document a final determination. The unregulated Pennsylvania Ave. NW; telephone contaminants included in a regulatory number: (202) 564–2822; email address: Abbreviation Meaning determination are chosen from the [email protected]. ADAF ...... Age Dependent Adjustment Fac- Contaminant Candidate List (CCL), SUPPLEMENTARY INFORMATION: tor which the SDWA requires the EPA to ADONA ...... 4,8-dioxa-3H-perfluorononanoic publish every five years. The EPA I. General Information acid ALT ...... Alanine Aminotransferase published the fourth CCL (CCL 4) in the A. Written Comments AM ...... Assessment Monitoring Federal Register on November 17, 2016. Submit your comments, identified by AOP ...... Advanced Oxidative Process This document presents the preliminary ASDWA ...... Association of State Drinking Docket ID No. EPA–HQ–OW–2019– Water Administrators regulatory determinations and 0583, at https://www.regulations.gov supporting rationale for the following ATSDR ...... Agency for Toxic Substances and (our preferred method), or the other Disease Registry eight of the 109 contaminants listed on methods identified in the ADDRESSES AWIA ...... America’s Water Infrastructure CCL 4: Perfluorooctanesulfonic acid Act section. Once submitted, comments BAT ...... Best Available Technology (PFOS), perfluorooctanoic acid (PFOA), cannot be edited or removed from the 1,1-dichloroethane, acetochlor, methyl BMD ...... Benchmark Dose docket. The EPA may publish any BMDL ...... Benchmark Dose Level bromide (bromomethane), metolachlor, comment received to its public docket. BMDS ...... Benchmark Dose Software nitrobenzene, and Royal Demolition BMR ...... Benchmark Response Do not submit electronically any BW ...... Body Weight eXplosive (RDX). The Agency is making information you consider to be preliminary determinations to regulate CAR ...... Constitutive Androstane Recep- Confidential Business Information (CBI) tor two contaminants (i.e., PFOS and or other information whose disclosure is CBI ...... Confidential Business Informa- PFOA) and to not regulate six tion restricted by statute. Multimedia CCL ...... Contaminant Candidate List contaminants (i.e., 1,1-dichloroethane, submissions (audio, video, etc.) must be acetochlor, methyl bromide, CCL 1 ...... First Contaminant Candidate List accompanied by a written comment. CCL 2 ...... Second Contaminant Candidate metolachlor, nitrobenzene, and RDX). The written comment is considered the List The EPA seeks comment on these CCL 3 ...... Third Contaminant Candidate official comment and should include List preliminary determinations. The EPA is discussion of all points you wish to also presenting an update on three other CCL 4 ...... Fourth Contaminant Candidate make. The EPA will generally not List CCL 4 contaminants (strontium, 1,4- consider comments or comment CDPHE ...... Colorado Department of Public dioxane, and 1,2,3-trichloropropane). Health and Environment contents located outside of the primary CDR ...... Chemical Data Reporting DATES: Comments must be received on submission (i.e., on the web, cloud, or CIIT ...... Chemical Industry Institute of or before May 11, 2020. other file sharing system). For Toxicology ADDRESSES: You may send comments, additional submission methods, the full CNS ...... Central Nervous System cPAD ...... Chronic Population Adjusted identified by Docket ID No. EPA–HQ– EPA public comment policy, Dose OW–2019–0583, by any of the following information about CBI or multimedia CRL ...... Cancer Risk Level methods: submissions, and general guidance on CSF ...... Cancer Slope Factor

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Abbreviation Meaning Abbreviation Meaning Abbreviation Meaning

CWS ...... Community Water System NPYR ...... N-Nitrosopyrrolidine WQX ...... Water Quality Exchange CWSS ...... Community Water System Sur- NRC ...... National Research Council 5:3 acid ...... 2H,2H,3H,3H-Perfluorooctanoic vey NTP ...... National Toxicology Program acid D/DBP ...... Disinfectants/Disinfection By- NWIS ...... National Water Information Sys- 6:2 diPAP ...... Bis[2-(perfluorohexyl)ethyl] products tem phosphate DBP ...... Disinfection Byproduct OA ...... Oxanilic Acid 6:2 monoPAP .. Mono[2-(perfluorohexyl)ethyl] DDE ...... 1,1-Dichloro-2,2-bis(p- OPP ...... Office of Pesticides Program phosphate chlorophenyl)ethylene ORD ...... Office of Research and Develop- 6:2/8:2 diPAP 6:2/8:2 Fluorotelomer phosphate DWI ...... Drinking Water Intake ment diester EPA ...... Environmental Protection Agen- OTC ...... Ornithine Carbamoyl Transferase 8:2 diPAP ...... Bis[2-(perfluorooctyl)ethyl] phos- cy OW ...... Office of Water phate EPCRA ...... Emergency Planning and Com- PCCL ...... Preliminary Contaminant Can- 8:2 monoPAP .. Mono[2-(perfluorooctyl)ethyl] munity Right-To-Know Act didate List phosphate EPTC ...... S-Ethyl dipropylthiocarbamate PDP ...... Pesticide Data Program ESA ...... Ethanesulfonic Acid PFAA ...... Perfluorinated Alkyl Acids FtOH 6:2 ...... 6:2 Fluorotelomer Alcohol PFAS ...... Per- and Polyfluoroalkyl Sub- Table of Contents FtOH 8:2 ...... 8:2 Fluorotelomer Alcohol stances FtS 6:2 ...... 6:2 Fluorotelomer Sulfonic Acid PFBA ...... Perfluorobutanoic Acid I. General Information FtS 8:2 ...... 8:2 Fluorotelomer Sulfonic Acid PFBS ...... Perfluorobutanesulfonic Acid A. Written Comments FQPA ...... Food Quality Protection Act PFDA ...... Perfluorodecanoic Acid B. Does this action apply to me? FR ...... Federal Register PFDS ...... Perfluorodecanesulfonic Acid II. Purpose and Background HA ...... Health Advisory PFHpA ...... Perfluoroheptanoic Acid A. What is the purpose of this action? HDL ...... High-Density Lipoprotein PFHpS ...... Perfluoroheptanesulfonic Acid HED ...... Human Equivalent Dose PFHxA ...... Perfluorohexanoic Acid B. Background on the CCL and Regulatory HERO ...... Health and Environmental Re- PFHxS ...... Perfluorohexanesulfonic Acid Determinations search Online PFNA ...... Perfluorononanoic Acid 1. Statutory Requirements for CCL and HESD ...... Health Effects Support Document PFNS ...... Perfluorononanesulfonic Acid Regulatory Determinations HFPO ...... Hexafluoropropylene Oxide PFOA ...... Perfluorooctanoic Acid 2. The First Contaminant Candidate List HHRA ...... Human Health Risk Assessment PFOS ...... Perfluorooctanesulfonic Acid (CCL 1) and Regulatory Determination HRL ...... Health Reference Level PFOSA ...... Perfluorooctanesulfonamide IARC ...... International Agency for Re- PFPeA ...... Perfluoropentanoic Acid (RD 1) search on Cancer PFPeS ...... Perfluoropentanesulfonic Acid 3. The Second Contaminant Candidate List ICR ...... Information Collection Rule PFTeDA ...... Perfluorotetradecanoic Acid (CCL 2) and Regulatory Determination IOC ...... Inorganic Compound PFUnA ...... Perfluoroundecanoic Acid (RD 2) IRED ...... Interim Reregistration Eligibility PMP ...... Pesticide Monitoring Program 4. The Third Contaminant Candidate List Decision POD ...... Point of Departure (CCL 3) and Regulatory Determination IRIS ...... Integrated Risk Information Sys- PPRTV ...... Provisional Peer-Reviewed Tox- tem icity Value (RD 3) IUR ...... Inventory Update Reporting PST ...... Pre-Screen Testing 5. The Fourth Contaminant Candidate List KH ...... Henry’s Law Constant PWS ...... Public Water System (CCL 4) and Regulatory Determination Koc ...... Organic Carbon Partitioning Co- QA ...... Quality Assurance (RD 4) efficients RD 1 ...... Regulatory Determination 1 III. Approach and Overall Outcomes for LOAEL ...... Lowest Observed Adverse Effect RD 2 ...... Regulatory Determination 2 RD 4 Level RD 3 ...... Regulatory Determination 3 A. Summary of the Approach and Overall log Kow ...... Octanol-Water Partitioning Coef- RD 4 ...... Regulatory Determination 4 ficient RDX ...... Royal Demolition eXplosive Outcomes for RD 4 MCL ...... Maximum Contaminant Level RED ...... Reregistration Eligibility Decision 1. Phase 1 (Data Availability Phase) MCLG ...... Maximum Contaminant Level RfD ...... Reference Dose 2. Phase 2 (Data Evaluation Phase) Goal RSC ...... Relative Source Contribution 3. Phase 3 (Regulatory Determination metHB ...... Methemoglobin SD ...... Standard Deviation Assessment Phase) MOA ...... Mode of Action SDWA ...... Safe Drinking Water Act MRL ...... Minimum Reporting Level SS ...... Screening Survey B. Supporting Documentation for EPA’s NAM ...... New Approach Method SSCT ...... Small System Compliance Tech- Preliminary Determination NAS ...... National Academy of Sciences nology C. Analyses Used To Support the NAWQA ...... National Water Quality Assess- STORET ...... Storage and Retrieval Data Sys- Preliminary Regulatory Determinations ment tem 1. Evaluation of Adverse Health Effects NCDEQ ...... North Carolina Department of TOF ...... Total Organic Fluorine 2. Evaluation of Contaminant Occurrence Environmental Quality TOP ...... Total Organic Precursor NCFAP ...... National Center for Food and Ag- TPTH ...... Triphenyltin Hydroxide and Exposure ricultural Policy TRED ...... Tolerance Reassessment Progress IV. Contaminant-Specific Discussions for the NCI ...... National Cancer Institute and Risk Management Decision RD 4 Preliminary Determination NDEA ...... N-Nitrosodiethylamine TRI ...... Toxic Release Inventory A. Summary of the Preliminary Regulatory NDMA ...... N-Nitrosodimethylamine TSCA ...... Toxic Substances Control Act Determination NDPA ...... N-Nitroso-di-n-propylamine TT ...... Treatment Technique B. Contaminant Profiles NDPhA ...... N-Nitrosodiphenylamine UCM ...... Unregulated Contaminant Moni- NDWAC ...... National Drinking Water Advi- toring 1. PFOA and PFOS sory Council UCMR ...... Unregulated Contaminant Moni- 2. 1,1-Dichloroethane NEtFOSAA ..... 2-(N- toring Rule 3. Acetochlor Ethylperfluorooctanesulfonam- UCMR 1 ...... First Unregulated Contaminant 4. Methyl Bromide (Bromomethane) ido) acetic acid Monitoring Rule 5. Metolachlor NHDES ...... New Hampshire Department of UCMR 2 ...... Second Unregulated Contami- 6. Nitrobenzene Environmental Services nant Monitoring Rule NIEHS ...... National Institute of Environ- UCMR 3 ...... Third Unregulated Contaminant 7. RDX mental Health Sciences Monitoring Rule V. Status of the Agency’s Evaluation of NIRS ...... National Inorganics and Radio- UF ...... Uncertainty Factor Strontium, 1,4-Dioxane, and 1,2,3- nuclides Survey UNEP ...... United Nations Environmental Trichloropropane NMeFOSAA .... 2-(N- Programme A. Strontium Methylperfluorooctanesulfona- USDA ...... United States Department of Ag- B. 1,4-Dioxane mido) Acetic Acid riculture C. 1,2,3-Trichloropropane NOAEL ...... No Observed Adverse Effect USGS ...... United States Geological Survey Level VOC ...... Volatile Organic Compound VI. EPA’s Request for Comments and Next NPDWR ...... National Primary Drinking Water WHO ...... World Health Organization Steps Regulation WQP ...... Water Quality Portal VII. References

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II. Purpose and Background B. Background on the CCL and process builds upon the previous Regulatory Determinations process, including the collection of data This section briefly summarizes the and analyses conducted. The Agency’s 1. Statutory Requirements for CCL and purpose of this action, the statutory improvements in developing CCLs 3 Regulatory Determinations requirements, and previous activities and 4 provided a foundation for RD 4 related to the CCL and regulatory Section 1412(b)(1)(B)(i) of the SDWA by enhancing the EPA’s ability to determinations. requires the EPA to publish the CCL identify contaminants of concern for every five years after public notice and A. What is the purpose of this action? drinking water. Sections III and IV in an opportunity to comment. The CCL is this document provide more detailed The purpose of this action is to a list of contaminants which are not information about the approach and request comment on the Environmental subject to any proposed or promulgated outcomes for RD 4 and the contaminant- Protection Agency’s (EPA’s) preliminary NPDWRs but are known or anticipated specific regulatory determinations. to occur in public water systems (PWSs) regulatory determinations for the 2. The First Contaminant Candidate List and may require regulation under the following eight unregulated (CCL 1) and Regulatory Determination SDWA. SDWA section 1412(b)(1)(B)(ii) contaminants: Perfluorooctanesulfonic (RD 1) acid (PFOS), perfluorooctanoic acid directs the EPA to determine, after The EPA published the final CCL 1, (PFOA), 1,1-dichloroethane, acetochlor, public notice and an opportunity to comment, whether to regulate at least which contained 60 chemical and methyl bromide (bromomethane), microbiological contaminants, in the metolachlor, nitrobenzene, and RDX. five contaminants from the CCL every five years. Under Section 1412(b)(1)(A) Federal Register (FR) on March 2, 1998 The Agency is making preliminary of SDWA, the EPA makes a (63 FR 10273; USEPA, 1998). The determinations to regulate two determination to regulate a contaminant Agency published the final regulatory contaminants (PFOS and PFOA) and to in drinking water if the Administrator determinations for nine of the 60 CCL 1 not regulate the remaining six determines that: contaminants in the FR on July 18, contaminants (1,1-dichloroethane, (a) The contaminant may have an 2003. The Agency determined that acetochlor, methyl bromide, adverse effect on the health of persons; NPDWRs were not necessary for nine metolachlor, nitrobenzene, and RDX). (b) the contaminant is known to occur contaminants: Acanthamoeba, aldrin, As described in Section III.A.3, if the or there is substantial likelihood that the dieldrin, hexachlorobutadiene, EPA finalizes these preliminary contaminant will occur in public water manganese, metribuzin, naphthalene, regulatory determinations, it would systems with a frequency and at levels sodium, and sulfate (68 FR 42898; represent the beginning of the Agency’s of public health concern; and USEPA, 2003a). The Agency posted regulatory development process, not the (c) in the sole judgment of the information about Acanthamoeba 4 on end. As required by SDWA, the EPA Administrator, regulation of such the EPA’s website and issued health seeks comment on these preliminary contaminant presents a meaningful advisories 5 (HAs) for manganese, determinations and is asking for opportunity for health risk reduction for sodium, and sulfate. information and comment on other per- persons served by public water systems. 3. The Second Contaminant Candidate and polyfluoroalkyl substances (PFAS) If the EPA determines that these three List (CCL 2) and Regulatory and potential regulatory approaches. statutory criteria are met and makes a Determination (RD 2) The Agency is also requesting comment final determination to regulate a on the process and analyses used for contaminant (i.e., a positive The Agency published the final CCL this round of regulatory determinations determination), the Agency must 2 in the FR on February 24, 2005 (70 FR (i.e., RD 4), the supporting information, publish a proposed Maximum 9071; USEPA, 2005a) and carried forward the 51 remaining chemical and additional studies or sources of Contaminant Level Goal (MCLG) 1 and microbial contaminants listed on CCL 1. information the Agency should NPDWR 2 within 24 months. After the The Agency published the final consider, and the rationale used to make proposal, the Agency must publish a regulatory determinations for 11 of the these preliminary decisions. The EPA is final MCLG and promulgate a final 51 CCL 2 contaminants in the FR on also presenting an update on strontium NPDWR (SDWA section 1412(b)(1)(E)) July 30, 2008. The Agency determined (from the third regulatory within 18 months.3 that NPDWRs were not necessary for 11 determination) and two other CCL 4 The development of the CCL, contaminants: Boron, the dacthal mono- contaminants for which the Agency is regulatory determinations, and any and di-acid degradates, 1,1-dichloro-2,2- subsequent rulemaking should be not making preliminary determinations bis(p-chlorophenyl)ethylene (DDE), 1,3- viewed as a progression where each today (1,4-dioxane and 1,2,3- dichloropropene (Telone), 2,4- trichloropropane). dinitrotoluene, 2,6-dinitrotoluene, s- 1 An MCLG is the maximum level of a It should be noted that the analyses contaminant in drinking water at which no known ethyl dipropylthiocarbamate (EPTC), associated with a regulatory or anticipated adverse effect on the health of fonofos, terbacil, and 1,1,2,2- determination process are distinct from persons would occur, and which allows an the analyses needed to develop a adequate margin of safety. MCLGs are non- 4 Consumer information about Acanthamoeba for National Primary Drinking Water enforceable health goals. (40 CFR 141.2; 42 U.S.C. people who wear contact lenses can be found at 300g–1) http://water.epa.gov/action/advisories/ Regulation (NPDWR). Thus, a decision 2 An NPDWR is a legally enforceable standard acanthamoeba/index.cfm. to regulate is the beginning of the that applies to public water systems. An NPDWR 5 Health advisories provide information on Agency’s regulatory development sets a legal limit (called a maximum contaminant contaminants that can cause human health effects process, not the end. For example, the level or MCL) or specifies a certain treatment and are known or anticipated to occur in drinking technique (TT) for public water systems for a water. The EPA’s health advisories are non- EPA may find at a later point in the specific contaminant or group of contaminants. The enforceable and provide technical guidance to regulatory development process, and MCL is the highest level of a contaminant that is states agencies and other public health officials on based on additional or new information, allowed in drinking water and is set as close to the health effects, analytical methodologies, and that a contaminant does not meet the MCLG as feasible using the best available treatment treatment technologies associated with drinking technology and taking cost into consideration. water contamination. Health advisories can be three statutory criteria for finalizing a 3 The statute authorizes a nine-month extension found at http://water.epa.gov/drink/standards/ NPDWR. of this promulgation date. hascience.cfm.

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tetrachloroethane (73 FR 44251; USEPA, delay in issuing a final regulatory A. Summary of the Approach and 2008a). The Agency issued new or determination on strontium in order to Overall Outcomes for RD 4 updated health advisories for boron, consider additional data. Additional The approach taken under RD 4 is dacthal degradates, 2,4-dinitrotoluene, discussion on strontium is provided in similar to that used in previous rounds 2,6-dinitrotoluene, and 1,1,2,2- Section V of this document. of Regulatory Determination and tetrachloroethane. The EPA also published an off-cycle formalized in a written Protocol under 4. The Third Contaminant Candidate final determination to regulate one CCL Regulatory Determination 3. The List (CCL 3) and Regulatory 3 contaminant, perchlorate, on February Regulatory Determination 4 Protocol, Determination (RD 3) 11, 2011 (76 FR 7762; USEPA, 2011a) found in Appendix E of the Regulatory The Agency published the final CCL during the RD 3 cycle (bringing the total Determination 4 Support Document 3, which listed 116 contaminants, in the number of final determinations to five). (USEPA, 2019a), like the Regulatory FR on October 8, 2009 (74 FR 51850; Additional information about the Determination 3 protocol, specifies a USEPA, 2009a). In developing CCL 3, perchlorate determination can be found three-phase process. The three phases the EPA improved and built upon the in that document. are: (1) The Data Availability Phase, (2) process that was used for CCL 1 and the Data Evaluation Phase, and (3) the CCL 2. The CCL 3 process was based on 5. The Fourth Contaminant Candidate Regulatory Determination Assessment substantial expert input and List (CCL 4) and Regulatory Phase. Figure 1 provides an overview of recommendations from the National Determination (RD 4) the process the EPA uses to identify Academy of Science’s (NAS) National which CCL 4 contaminants are The final CCL 4 was published on Research Council (NRC) and the candidates for regulatory determinations National Drinking Water Advisory November 17, 2016 (81 FR 81099; and the SDWA statutory criteria Council (NDWAC) as well as input from USEPA, 2016b) and is the latest CCL considered in making the regulatory the public. Based on these consultations published by EPA. The final CCL 4 determinations. For more detailed and input, the EPA developed a multi- consists of 97 chemicals or chemical information on the three phases of the step process to select candidates for the groups and 12 microbiological RD 4 process please refer to the final CCL 3, which included the contaminants. Most CCL 4 contaminants Regulatory Determination 4 Protocol following key steps: were carried over from CCL 3 (which, as (Appendix E to USEPA, 2019a). (a) Identification of a broad universe described above, was developed SDWA 1412 (b)(1)(C) requires that the of ∼7,500 potential drinking water according to a rigorous process with Administrator prioritize selection of contaminants (the CCL 3 Universe); input from multiple stakeholders over contaminants that present the greatest (b) screening the CCL 3 Universe to a the course of multiple years). The EPA public health concern. The preliminary CCL (PCCL) of ∼600 added two contaminants (manganese Administrator, in making such contaminants based on the potential to and nonylphenol) to the CCL 4 list selections, shall take into consideration, occur in PWSs and the potential for based on nominations. The EPA among other factors of public health public health concern; and removed from the list those CCL 3 concern, the effect of such contaminants (c) evaluation of the PCCL contaminants that had been subject to upon subgroups that comprise a contaminants based on a more detailed recent preliminary and/or final meaningful portion of the general review of the occurrence and health regulatory determinations (perchlorate, population (such as infants, children, effects data to identify a list of 116 CCL dimethoate, 1,3-dinitrobenzene, pregnant women, the elderly, 3 contaminants. terbufos, terbufos sulfone, and individuals with a history of serious The Agency published its preliminary strontium) and three pesticides with illness, or other subpopulations) that are regulatory determinations for cancelled registrations (disulfoton, identifiable as being at greater risk of contaminants listed on the CCL 3 in the fenamiphos, and molinate). adverse health effects due to exposure to FR on October 20, 2014 (79 FR 62715; contaminants in drinking water than the USEPA, 2014a). In that document, the III. Approach and Overall Outcomes general population. Because the RD 4 EPA made preliminary determinations for RD 4 process includes consideration of for 5 of the 116 contaminants listed on human health effects, the Agency’s the CCL 3 including a preliminary This section describes (a) the Policy on Evaluating Health Risks to positive determination for strontium approach the EPA used to identify and Children (USEPA, 1995a) to consistently and preliminary negative evaluate contaminants for the Agency’s and comprehensively address children’s determinations for dimethoate, 1,3- fourth round of Regulatory unique vulnerabilities, recently dinitrobenzene, terbufos, and terbufos Determination (RD 4) along with the reaffirmed by Administrator Wheeler sulfone. On January 4, 2016 (81 FR 13; overall outcome of applying this (USEPA, 2018a), applies to this action. USEPA, 2016a), the EPA finalized the approach, (b) the supporting RD 4 We have explicitly considered negative determinations for dimethoate, documentation, and (c) the technical children’s health in the RD 4 process by 1,3-dinitrobenzene, terbufos, and analyses and sources of health and reviewing all the available children’s terbufos sulfone. The EPA announced a occurrence information. exposure and health effects information.

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1. Phase 1 (Data Availability Phase) sufficient to inform a regulatory Values (PPRTVs); (d) EPA’s Office of determination can be derived. (See Pesticide Programs (OPP) health In Phase 1, the Data Availability Section III.C.1 of this document for assessments: Reregistration Eligibility Phase, the Agency identifies information about how HRLs are Decisions (REDs), Interim Reregistration contaminants that have sufficient health derived.) Consistent with SDWA Eligibility Decisions (IREDs), Tolerance and occurrence data to proceed to Phase 1412.b.(3)(A)(i), EPA used health Reassessment Progress and Risk 2 and be listed on a ‘‘short list’’ for assessments to derive an HRL that the Management Decisions (TREDs), and further evaluation. SDWA Agency has concluded are the best Health Effects Division Human Health 1412(b)(1)(B)(ii)(II) requires that the available peer reviewed science Risk Assessments (HED HHRAs); (e) EPA consider the best available public finalized before March 1, 2019. EPA U.S. Department of Health and Human health information in making the establishes a cutoff date where it no Services’ Agency for Toxic Substances regulatory determination. longer considers new health-based and Disease Registry (ATSDR) To identify contaminant health effects information in order to allow for timely Toxicological Profiles; (f) Health Canada data that are sufficient to make a determinations and reviews. The EPA Guidelines for Drinking Water; (g) the regulatory determination regarding did not use draft health assessments to World Health Organization (WHO) potential adverse health effect(s), the derive HRLs. Sources of health Drinking Water Guidelines; and (h) Agency considers whether an EPA assessments may include: (a) EPA’s publicly available state assessments that health assessment or an externally peer- Office of Water (OW) health have been externally peer-reviewed and reviewed health assessment from assessments: Health Advisory (HA) provide new science not considered in another Agency is available, from which Documents and Health Effects Support the other RD 4 assessment sources listed a health reference level (HRL) 6 Documents (HESDs); (b) EPA’s Office of above. To support a regulatory Research and Development (ORD) determination, the EPA evaluates 6 An HRL is a health-based concentration against Integrated Risk Information System whether a health assessment used which the Agency evaluates occurrence data when (IRIS) assessments; (c) EPA’s ORD methods, standards, and guidelines making decisions about preliminary regulatory comparable to those of current EPA determinations. An HRL is not a final determination Provisional Peer-Reviewed Toxicity on establishing a protective level of a contaminant guidelines and guidance documents. If a in drinking water for a particular population; it is and exposure assessment and can be considered a suitable health assessment is not derived prior to development of a complete health screening value. available for a contaminant, the

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contaminant will not proceed to Phase regulatory determinations but may also After conducting the health and 2. The EPA is aware of draft health use other sources of finished water data occurrence data availability assessments that have not yet been to address the occurrence-related assessments, the Agency identifies those finalized for contaminants on which the aspects of the statutory criteria when contaminants and contaminant groups EPA is making a preliminary deciding to regulate a contaminant. In that meet the following Phase 1 data determination today. Once finalized, the Phase 1, the Agency does this by availability criteria: EPA will consider these new sources of assessing whether the non-nationally- (a) An EPA health assessment or an information in future regulatory representative finished water externally peer-reviewed health decision making. occurrence data show at least one assessment from another Agency that To identify contaminant occurrence detection in finished water at levels >1⁄2 conforms with the current EPA data that are sufficient to make a the HRL 9 for the critical endpoint. If a guidelines is available, from which an regulatory determination regarding the contaminant has nationally HRL can be derived; frequency and level of occurrence in representative or non-nationally (b) Either nationally representative PWSs, the Agency considers nationally representative finished water finished water occurrence data are representative finished water data occurrence data showing at least one available, or other finished water (samples are collected after the water 1 detection > ⁄2 HRL, the contaminant occurrence data show occurrence at undergoes treatment). The following passes the Occurrence Data Availability levels >1⁄2 the HRL; and sources, administered or overseen by Assessment and proceeds to the next (c) A widely available analytical the EPA, include finished water phase of analysis. However, it is occurrence data that are considered method for monitoring is available. difficult to determine that a If a contaminant or group meets these nationally representative: (a) The Third contaminant is not occurring or not Unregulated Contaminant Monitoring three criteria, it is placed on a ‘‘short likely to occur based on sources of non- list’’ and proceeds to Phase 2. After Rule (UCMR 3); (b) the Second nationally representative finished water Unregulated Contaminant Monitoring evaluating the 109 CCL 4 contaminants occurrence data because the data are and two additional contaminants (4- Rule (UCMR 2); (c) the First limited in scope and the contaminant Unregulated Contaminant Monitoring androstene-3,17-dione and could be occurring in other parts of the testosterone) 10 in Phase 1, the Agency Rule (UCMR 1); (d) the Unregulated country that were not monitored. Contaminant Monitoring (UCM) identified 25 CCL 4 contaminants to program; and (e) the National Inorganics In certain limited cases, a evaluate further in Phase 2 and Radionuclides Survey (NIRS).7 contaminant’s occurrence data may (contaminants listed in Table 1). If nationally representative data are have been gathered using a specialized not available, the EPA identifies and or experimental method that is not in TABLE 1—CONTAMINANTS PRO- evaluates other finished water data, general use. If a widely available CEEDING FROM PHASE 1 TO PHASE which may include other national analytical method does not exist, the 2 assessments, regional data, state, and contaminant will not be a viable more localized finished water candidate for regulation with a 1,1,1,2-Tetrachloroethane. assessments. These other finished water Maximum Contaminant Level (MCL). 1,1-Dichloroethane. data may include assessments that are With that in mind, in the Analytical 1,2,3-Trichloropropane. geographically distributed across the Methods Availability Assessment, the 1,4-Dioxane. nation but not intended to be EPA determines for each contaminant Acephate. Acetochlor. statistically representative of the nation. whether a widely available analytical method for monitoring exists. (A widely alpha-Hexachlorocyclohexane. These other finished water data include: Aniline. (a) Finished water assessments for available analytical method is a method Chlorate. Federal agencies (e.g., EPA and the employing technology that is commonly Cobalt. United States Geological Survey in use at numerous drinking water Cyanotoxins. (USGS)); 8 (b) state-level finished water laboratories.) If a widely available Legionella pneumophila. monitoring data; (c) research performed analytical method exists, the Manganese. by institutions, universities, and contaminant passes the Analytical Methyl bromide (Bromomethane). government scientists (information Methods Availability Assessment. If a Metolachlor. Molybdenum. published in the scientific literature); widely available analytical method does not exist, the EPA may advance the Nitrobenzene. and/or (d) other supplemental finished N-Nitrosodiethylamine (NDEA). water monitoring surveys (e.g., Pesticide contaminant to Phase 2 if the Agency N-Nitrosodimethylamine (NDMA). Monitoring Program (PMP), and other determines that indicator or surrogate N-Nitroso-di-n-propylamine (NDPA). targeted surveys or localized state/ monitoring, or use of a treatment N-Nitrosopyrrolidine (NPYR). federal monitoring surveys). technique (TT), could allow for effective Perfluorooctanesulfonic acid (PFOS). The EPA prefers to have nationally regulation and there is compelling Perfluorooctanoic acid (PFOA). representative data when making evidence of occurrence. RDX. Vanadium. In addition to considering 7 Specific types of UCMR monitoring (e.g., contaminants individually, the EPA also assessment monitoring and sometimes the The remaining 84 CCL 4 contaminants screening survey) are considered nationally may consider issuing a regulatory determination for groups of and two additional contaminants (4- representative. These are described further in androstene-3,17-dione and testosterone) Section III.C.2.a.1 of this document. contaminants. The EPA has regulated (listed in Table 2) did not meet one or 8 These may be assessments that are certain contaminants in drinking water geographically distributed across the nation but not collectively. more of the Phase 1 data availability intended to be statistically representative of the criteria above and were not considered nation. Examples include the EPA’s 1996 further for RD 4. Monitoring Requirements for Public Drinking Water 9 Note that the 1⁄2 HRL threshold is based on a Supplies, also known as the Information Collection recommendation from the NDWAC working group Rule (USEPA, 1996), and various USGS water that provided recommendations on the first 10 Contaminants monitored under UCMR 3 but quality surveys. regulatory determination effort (USEPA, 2000). not included in CCL 3 or CCL 4.

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TABLE 2—CONTAMINANTS NOT PRO- TABLE 2—CONTAMINANTS NOT PRO- analyses, such as the age of the dataset, CEEDING FROM PHASE 1 TO PHASE CEEDING FROM PHASE 1 TO PHASE the detection limit level (i.e., minimum 2 2—Continued reporting level [MRL11] > HRL), and/or representativeness of the data (e.g., Does not have nationally representative or Has nationally representative finished limited to a specific region) that may other finished water data water data but no health assessment cause misestimation of occurrence in 2-Methoxyethanol. 1,3-Butadiene. finished water at levels and frequency of 2-Propen-1-ol. public health concern? 3-Hydroxycarbofuran. 4,4′-Methylenedianiline. 4-Androstene-3,17-dione. After identifying contaminants that Acetamide. are occurring at levels and frequencies Acetochlor ethanesulfonic acid (ESA). Campylobacter jejuni. Acetochlor oxanilic acid (OA). Clethodim. of public health concern to proceed to Alachlor ESA. Cumene hydroperoxide. Phase 3, the Agency evaluates the Alachlor OA. Dimethipin. remaining contaminants on the ‘‘short Chloromethane (Methyl chloride). Escherichia coli (O157). list’’ to determine which contaminants Equilin. Ethylene oxide. have no or low occurrence at levels of Estradiol (17-beta estradiol). Helicobacter pylori. health concern that should proceed to Estriol. Hepatitis A virus. Phase 3 for a potential negative Estrone. Hydrazine. determination. Because the primary goal Ethinyl Estradiol (17-alpha ethynyl estradiol). Nitroglycerin. of RD 4 is to focus on contaminants of Germanium. N-Methyl-2-pyrrolidone. Halon 1011 (bromochloromethane). o-Toluidine. public health concern, potential HCFC–22. Oxirane, methyl-. negative determinations are a lower Methyl tert-butyl ether. Quinoline. priority than potential positive Metolachlor ESA. Salmonella enterica. determinations. The Agency considers Metolachlor OA. Shigella sonnei. the following information in selecting n-Propylbenzene. Tebufenozide. contaminants of no or low potential for sec-Butylbenzene. Thiodicarb. public health concern to proceed to Tellurium. Thiophanate-methyl. Phase 3: Testosterone. Toluene diisocyanate. (a) Does the contaminant have Triethylamine. nationally representative finished water Has available or in process health assess- Triphenyltin hydroxide (TPTH). ment and other finished drinking water Urethane. data showing no or low number or data but no occurrence at levels >1⁄2 percent of detections > HRL? HRL * Does not have a widely available analytical (b) If a contaminant has other finished method for occurrence monitoring. water data in addition to nationally 1-Butanol. 2. Phase 2 (Data Evaluation Phase) representative finished water data, does Acrolein. it support no or low potential for Bensulide. In Phase 2, the Agency collects occurrence in drinking water? 12 Benzyl chloride. additional data on occurrence Captan. (c) Does additional occurrence (including finished water data; ambient information of high quality support the Dicrotophos. water data; data on use, production, and Diuron. conclusion that there is low or no release; and information on occurrence or potential for occurrence Ethoprop. environmental fate and transport), and Ethylene glycol. in drinking water? For example, is the Ethylene thiourea (Maneb 12427382). more thoroughly evaluates this occurrence in ambient/source water at Formaldehyde. information (based on factors below) to levels below the HRL? How are releases Methamidophos. identify contaminants that should to the environment or use/production Methanol. proceed to Phase 3. changing over time? In Phase 2, the Agency focuses its N-Nitrosodiphenylamine (NDPhA) *. (d) Are critical gaps in health and efforts to identify those contaminants or Oxydemeton-methyl. occurrence information/data minimal? Oxyfluorfen. contaminant groups that are occurring After evaluating the ‘‘short list’’ Permethrin. or have substantial likelihood to occur Profenofos. contaminants (listed in Table 1), the at levels and frequencies of public Agency identified 10 CCL 4 Tebuconazole. health concern. As noted in Section Tribufos. contaminants to proceed to Phase 3 III.A, SDWA 1412.b.1.C requires that the (listed in Table 3). The contaminants are Vinclozolin. Administrator select contaminants that Ziram. within one of the following Phase 2 data present the greatest public health evaluation categories: Has other finished drinking water data but concern. To identify such contaminants, no health assessment (a) A contaminant or part of a the Agency considers the following contaminant group occurring or likely to 17alpha-estradiol. information: Acetaldehyde. (a) How many samples (number and 11 Adenovirus *. The MRL is the minimum concentration that is percentage) have detections > HRL and required to be reported quantitatively in a study. Butylated hydroxyanisole. 1⁄2 HRL in the nationally representative The MRL is set at a value that takes into account Caliciviruses *. and other finished water occurrence typical laboratory capabilities to reliably and cost- Enterovirus *. data? effectively detect and quantify a compound. Equilenin. 12 Note that other finished water data (i.e., non- Erythromycin. (b) How many systems (number and nationally-representative occurrence data) tend to Hexane. percentage) have detections > HRL and be limited in scope and the EPA does not use these 1 Mestranol. ⁄2 HRL in the nationally representative data alone to support a determination that the Mycobacterium avium *. and other finished water occurrence contaminant is not or is not substantially likely to ‘‘occur in PWSs with a frequency and at levels of Naegleria fowleri *. data? public health concern,’’ which would therefore be Nonylphenol. (c) Are there uncertainties or a decision ‘‘not to regulate’’ (i.e., negative Norethindrone (19-Norethisterone). limitations with the data and/or determination).

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occur at levels and frequencies of public concern requires a consideration of a (a) An updated health assessment health concern, or number of factors, some of which completed by March 1, 2019 was not (b) A contaminant not occurring or include the health effect(s), the potency identified; not likely to occur at levels and of the contaminant, the level at which (b) Critical health effects gap (e.g., frequencies of public health concern the contaminant is found in drinking lack of data to support quantification for water, the frequency at which the and no data gaps. the oral route of exposure); contaminant is found, the geographic (c) Lack of nationally representative TABLE 3—CONTAMINANTS PROCEED- distribution (national, regional, or local finished water occurrence data and lack ING FROM PHASE 2 TO PHASE 3 occurrence), other possible sources of exposure, and potential impacts on of sufficient other data to demonstrate occurrence at levels and frequencies of 1,1-Dichloroethane. sensitive populations or lifestages. 1,4-Dioxane. Given the many possible combinations public health concern; and 1,2,3-Trichloropropane. of factors, a simple threshold is not (d) Critical occurrence data limitation Acetochlor. viable. In the end, a determination of or gap (e.g., inconsistent results and/or Methyl Bromide. whether there is a meaningful trends in occurrence data requiring Metolachlor. opportunity for health risk reduction by further research; significant uncertainty Nitrobenzene. regulation of a contaminant in drinking in occurrence analyses and/or data). PFOA. water is a highly contaminant-specific PFOS. decision that takes into consideration Table 4 identifies the health, RDX. multiple factors. occurrence, and/or other data gaps that The remaining 15 CCL 4 contaminants prevented the following 15 Note that the Agency does not have a (listed in Table 4) did not proceed to contaminants from moving forward for threshold for occurrence in drinking Phase 3 and were not considered for RD RD 4. The Agency continues to conduct water that triggers whether a 4 because of one or more of the research and collect information to fill contaminant is of public health concern. following critical health, occurrence, the data and information gaps identified A determination of public health and/or other data gaps: in Table 4.

TABLE 4—DATA AND RATIONALE SUMMARY OF THE 15 CONTAMINANTS IN PHASE 2 NOT PROCEEDING TO PHASE 3

Health Occurrence Number Contaminant data data Rationale available available

1 ...... 1,1,1,2-Tetrachloroethane ...... Yes ...... Yes ...... Health data gap (a review of the current literature is needed to decide if an update to the 1987 IRIS health assessment is warranted). 2 ...... Acephate ...... Yes ...... No ...... Occurrence data gaps (no nationally representative finished water data or sufficient other finished water data). 3 ...... alpha-Hexachlorocyclohexane ..... Yes ...... No ...... Occurrence data gaps (no nationally representative finished water data or sufficient other finished water data). 4 ...... Aniline ...... Yes ...... No ...... Occurrence data gaps (no nationally representative finished water data or sufficient other finished water data). 5 ...... Chlorate ...... Will be evaluated and considered as part of the review of the existing Disinfectants/Disinfection Byproducts (D/DBP) rules.13 14 6 ...... Cobalt ...... Yes ...... Yes ...... Health data gap (updated health assessment needed to con- sider new subchronic and developmental studies). 7 ...... Cyanotoxins ...... Yes ...... No ...... Health advisories available for some specific cyanotoxins (microcystins and cylindrospermopsin); occurrence data gaps (insufficient nationally representative finished water data or other finished water data). Certain cyanotoxins are being monitored under UCMR 4 but final UCMR 4 data will not be complete in time for preliminary determination. 8 ...... Legionella pneumophila ...... Yes ...... No ...... MCLG available; occurrence data gaps (no nationally rep- resentative finished water data or sufficient other finished water data). Will be evaluated and considered as part of the review of the existing SWTR.14 9 ...... Manganese ...... No ...... No ...... Health and occurrence data gaps (updated health assess- ment 15 not completed by RD 4 cutoff date). Manganese is being monitored for under UCMR 4 but final UCMR 4 data will not be complete in time for preliminary determination. 10 ...... Molybdenum ...... No ...... Yes ...... Health data gap (updated assessment needed to consider multiple new studies). 11 ...... N-Nitrosodiethylamine (NDEA) ...... Will be evaluated and considered as part of the review of the existing D/DBP rules.13 12 ...... N-Nitrosodimethylamine (NDMA) ...... Will be evaluated and considered as part of the review of the existing D/DBP rules.13 13 ...... N-Nitroso-di-n-propylamine ...... Will be evaluated and considered as part of the review of the (NDPA). existing D/DBP rules.13 14 ...... N-Nitrosopyrrolidine (NPYR) ...... Will be evaluated and considered as part of the review of the existing D/DBP rules.13

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TABLE 4—DATA AND RATIONALE SUMMARY OF THE 15 CONTAMINANTS IN PHASE 2 NOT PROCEEDING TO PHASE 3— Continued

Health Occurrence Number Contaminant data data Rationale available available

15 ...... Vanadium ...... Yes ...... Yes ...... Health data gap; undergoing assessment by EPA IRIS: https://www.epa.gov/sites/production/files/2019-04/docu- ments/iris_program_outlook_apr2019.pdf.

3. Phase 3 (Regulatory Determination protective level of a contaminant in data (e.g., limited in scope to a specific Assessment Phase) drinking water for any particular region)? Phase 3, the Regulatory Determination population. HRLs are derived prior to Additional, less important factors that Assessment Phase, involves a complete the development of a complete health the Agency considers when identifying evaluation of the statutory criteria for and exposure assessment and can be contaminants or contaminant groups each contaminant or group of considered screening-level values. that are occurring at frequencies and contaminants that proceed from Phase 2 If an acceptable health assessment levels of public health concern also that demonstrates adverse health effects include: and have sufficient information and • data for making a regulatory is available, the Agency answers ‘‘yes’’ How many samples (number and 1 determination. In this phase, the Agency to the first statutory criterion. percentage) have detections > ⁄2 HRL in evaluates the following statutory criteria Otherwise, the Agency answers ‘‘no’’ to the nationally representative and other (SDWA 1412(b)(1)(A)): the first statutory criterion. (In practice, finished water occurrence data? • (a) Statutory Criterion #1—The it is expected that any contaminant that How many systems (number and contaminant may have an adverse effect reaches Phase 3 would receive a ‘‘yes’’ percentage) have detections > 1⁄2 HRL in on the health of persons. To evaluate to the first criterion.) the nationally representative and other criterion #1, the EPA evaluates whether (b) Statutory Criterion #2—The finished water occurrence data? • a contaminant has an EPA health contaminant is known to occur or there How many samples (number and assessment, or an externally peer- is a substantial likelihood that the percentage) have detections > HRL and 1 reviewed health assessment from contaminant will occur in public water ⁄2 HRL in the ambient/source water another Agency that is publicly occurrence data? systems with a frequency and at levels • available and conforms with current the of public health concern. The EPA How many monitoring sites EPA guidelines, from which an HRL can compares the occurrence data for each (number and percentage) have 1 be derived. The HRL derived in or from contaminant to the HRL to determine if detections > HRL and ⁄2 HRL in the the health assessment takes into account ambient/source water occurrence data? the contaminant occurs at a frequency • the MOA, the critical health effect(s), and levels of public health concern. The Are production and use trends for the dose-response relationship for types of occurrence data used at this the contaminant increasing or critical health effect(s), and impacts on decreasing? stage are described in section III.C.2, • sensitive population(s) or lifestages. Evaluation of Contaminant Occurrence How many pounds are discharged HRLs are preliminary health-based and Exposure. The Agency may annually to surface water and/or concentrations against which released to the environment? consider the following factors when • occurrence data is evaluated to identifying contaminants or Do the environmental fate and determine if contaminants may occur at contaminant groups that are occurring at transport parameters indicate that the levels of potential public health frequencies and levels of public health contaminant would persist and/or be concern. HRLs are not final mobile in water? concern: • determinations on establishing a • Is the contaminant introduced by How many samples (number and water treatment processes that provide percentage) have detections > HRL in 13 public health benefits such that it is Under RD 3 (79 FR 62716), the EPA noted that the nationally representative and other disinfection byproducts (DBPs) need to be relevant to risk-balancing evaluated collectively, because the potential exists finished water occurrence data? considerations? that the treatment used to control a specific DBP • How many systems (number and • could affect the concentrations of other DBPs and Are there additional uncertainties potentially microorganisms. percentage) have detections > HRL in or limitations with the data and/or 14 Under the Six-Year Review 3 (82 FR 3518, the nationally representative and other analyses that should be considered? USEPA, 2016c), the Agency completed a detailed finished water occurrence data? If a contaminant is known to occur or review of 76 NPDWRs and determined that eight • Is the geographic distribution of the NPDWRs were candidates for regulatory revision. substantially likely to occur at a The eight NPDWRs are included in the Stage 1 and contaminant occurrence national, frequency and level of health concern in the Stage 2 Disinfectants and Disinfection regional, or localized? public water systems based on Byproducts Rules, the Surface Water Treatment • In addition to the number of Rule (SWTR), the Interim Enhanced Surface Water consideration of the factors listed above, Treatment Rule, and the Long Term 1 Enhanced systems, what type of systems does the then the Agency answers ‘‘yes’’ to the Surface Water Treatment Rule. contaminant occur in? Does the second statutory criterion. 15 Health Canada finalized their Manganese contaminant occur in large or small (c) Statutory Criterion #3—In the sole Guideline for Canadian Drinking Water Quality in systems? Does the contaminant occur in judgment of the Administrator, June 2019. The Guideline summarizes new health effects information published since the EPA’s surface or groundwater systems? regulation of the contaminant presents a manganese health assessment in 2004 (https:// • Are there significant uncertainties meaningful opportunity for health risk www.canada.ca/content/dam/hc-sc/documents/ or limitations with the data and/or reduction for persons served by public services/publications/healthy-living/guidelines- analyses, such as the age of the dataset, water systems. The EPA evaluates the canadian-drinking-water-quality-guideline- technical-document-manganese/pub-manganese- the detection limit level (i.e., MRL > population exposed at the health level 0212-2019-eng.pdf). HRL), and/or representativeness of the of concern along with several other

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factors to determine if regulation particular contaminant, then the Agency public health officials on health effects, presents a meaningful opportunity for makes a positive preliminary analytical methodologies, and treatment health risk reduction. Among other determination. Additionally, after technologies associated with drinking things, the EPA may consider the identifying compounds occurring at water contamination. following factors in evaluating statutory frequencies and levels of public health While a negative determination is criterion #3: concern, if any, the Agency may initiate considered a final Agency action under • What is the nature of the health a systematic literature review to identify SDWA for a round of regulatory effect(s) identified in statutory criterion new studies that may influence the determinations, the contaminant may be #1? derivation of a Reference Dose (RfD) relisted on a future CCL based on newly • Are there sensitive populations that and/or Cancer Slope Factor (CSF). The available health and/or occurrence may be affected (evaluated either list of potentially relevant health effect information. qualitatively or quantitatively 16)? studies that could affect the derivation At this time, the Agency is not making • Based on the occurrence of an RfD or CSF identified through the preliminary regulatory determinations information for statutory criterion #2, systematic review process would then for two of the ten contaminants that including the number of systems be placed in the docket at the time of proceeded to Phase 3. After evaluating potentially affected, what is the national the Preliminary Determination for the remaining CCL 4 contaminants in population exposed or served by public comment (discussed further in Table 3 against the three SDWA criteria systems with levels > HRL and 1⁄2 HRL? Section IV of this document). • and considering the factors listed for For non-carcinogens, are there other If, after considering input provided each, the Agency is making a sources of exposure that should be during the public comment period, the preliminary regulatory determination considered (i.e., what is the relative Agency again answers ‘‘yes’’ to all three for these eight CCL 4 contaminants. source contribution (RSC) from drinking statutory criteria, the Agency then Table 5 provides a summary of the 10 water)? makes a positive final determination • contaminants evaluated for Phase 3 and What is the geographic distribution that regulation is necessary and of occurrence (e.g., local, regional, the preliminary regulatory proceeds to develop an MCLG and determination outcome for each. The national)? NPDWR. The Agency has 24 months to • Are there any uncertainties and/or Agency seeks comment on the publish a proposed MCLG and NPDWR preliminary determination to regulate limitations in the health and occurrence and an additional 18 months to publish information or analyses that should be two contaminants (PFOS and PFOA) a final MCLG and promulgate a final and to not regulate six contaminants considered? 18 • NPDWR. It should be noted that the (1,1-dichloroethane, acetochlor, methyl Are there any limiting analyses associated with a regulatory considerations related to technology bromide, metolachlor, nitrobenzene, determination process are distinct from and RDX). Section IV.B of this (e.g., lack of available treatment or the more detailed analyses needed to 17 document provides a more detailed analytical methods )? develop an NPDWR. Thus, a decision to If the Administrator, in his or her sole summary of the information and the regulate is the beginning of the Agency’s judgement, determines that there is a rationale used by the Agency to reach its regulatory development process, not the meaningful opportunity to reduce risk preliminary decisions for these end. For example, the EPA may find at by regulating the contaminant in contaminants. Section V of this a later point in the regulatory drinking water, then the Agency document provides more information development process, and based on answers ‘‘yes’’ to the third statutory about 1,4-dioxane and 1,2,3- additional or new information, that the criterion. trichloropropane, the two Phase 3 If the Agency answers ‘‘yes’’ to all contaminant no longer meets the three contaminants for which the EPA is not three statutory criteria in Phase 3 for a statutory criteria and may, as a result, making a preliminary regulatory withdraw the determination to regulate. determination at this time. If a contaminant has sufficient 16 If appropriate and available, the Agency information and the Agency answers quantitatively takes into account exposure data TABLE 5—CONTAMINANTS EVALUATED applicable to sensitive populations or lifestages ‘‘no’’ to any of the three statutory when deriving HRLs for regulatory determinations. criteria, based on the available data, IN PHASE 3 AND THE REGULATORY When data are not available on sensitive DETERMINATION OUTCOME populations, the derivation of the RfD typically then the Agency considers making a includes an uncertainty factor to account for the negative determination that an NPDWR Preliminary weakness in the database. Additionally, the EPA is not necessary for that contaminant at Number RD 3 contaminants determination will use exposure factors relevant to the sensitive that time. A final determination not to outcome population in deriving the HRL. See section III.C.1. Sensitive populations are also qualitatively regulate a contaminant is, by statute, a 1 ...... 1,1-Dichloroethane Do Not Regulate. considered by providing national prevalence final Agency action and is subject to 2 ...... 1,4-Dioxane ...... No Determination. estimates for a particular sensitive population, if judicial review. If a negative 3 ...... 1,2,3- No Determination. available. determination or no determination is Trichloropropane. 17 If the Agency decides to regulate a 4 ...... Acetochlor ...... Do Not Regulate. contaminant, the SDWA requires that the EPA issue made for a contaminant, the Agency 5 ...... Methyl Bromide .... Do Not Regulate. a proposed regulation within two years of the final may decide to develop a HA, which 6 ...... Metolachlor ...... Do Not Regulate. determination. As part of the proposal, the Agency provides non-regulatory concentration 7 ...... Nitrobenzene ...... Do Not Regulate. must list best available technologies (BATs), small values for drinking water contaminants 8 ...... PFOA ...... Regulate. system compliance technologies (SSCTs), and 9 ...... PFOS ...... Regulate. approved analytical methods if it proposes an at which adverse health effects are not 10 ...... RDX ...... Do Not Regulate. enforceable MCL. Alternatively, if the EPA proposes anticipated to occur over specific a TT instead of an MCL, the Agency must identify exposure durations (e.g., one-day, ten- the TT. The EPA must also prepare a health risk B. Supporting Documentation for EPA’s reduction and cost analysis. This analysis includes days, several years, and a lifetime). The Preliminary Determination an extensive evaluation of the treatment costs and EPA’s HAs are non-enforceable and monitoring costs at a system level and aggregated non-regulatory and provide technical For this action, the EPA prepared at the national level. To date, treatment information information to states agencies and other several supporting documents that are and approved analytical methods have not been available for review and comment in the significant factors in regulatory determinations but are important considerations for regulation 18 The statute authorizes a nine-month extension EPA Water Docket. These support development. of this promulgation date. documents include:

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• The comprehensive regulatory second general approach is used for serious illness, or other subpopulations) support document, Regulatory chemicals that exhibit a linear, non- that are identifiable as being at greater Determination 4 Support Document threshold response to dose (as is typical risk of adverse health effects due to (USEPA, 2019a), summarizes the of carcinogens). A variant of the second exposure to contaminants in drinking information and data on the physical approach is used when a carcinogen water compared to the general and chemical properties, uses and with a linear dose-response has a known population.’’ If appropriate and if environmental release, environmental mutagenic MOA (USEPA, 2019a). adequate data are available, the Agency fate, potential health effects, occurrence HRLs for contaminants with a will use data from sensitive populations and exposure estimates, analytical threshold dose-response (typically non- and lifestages quantitatively when methods, treatment technologies, and cancer endpoints) are calculated as deriving HRLs for regulatory preliminary determinations. follows: determinations in the following manner: Additionally, Appendix E of the (a) For non-carcinogens, an HRL can Regulatory Determinations 4 Support be developed for a sensitive population Document describes the approach if data are available to associate implemented by the Agency to evaluate HRLs for contaminants with a linear exposure with the critical health the CCL 4 contaminants in a three-phase dose-response (typically cancer endpoint in a specific group or during process and select the contaminants for endpoints) are calculated as follows: a specific period of sensitivity. Age- preliminary determinations for RD 4. specific drinking water intake (DWI) to • A comprehensive technical body weight (BW) ratio values from the occurrence support document for UCMR Exposure Factors Handbook (USEPA, 3, Occurrence Data from the Third 2011b) can be used to reflect the period Unregulated Contaminant Monitoring HRLs for carcinogenic contaminants of exposure more accurately. The Rule (UCMR 3) (USEPA, 2019b). This with a known mutagenic MOA are Agency can also apply specific occurrence support document includes calculated as follows: uncertainty factors (UFs) when deriving more detailed information about UCMR the RfD if toxicological data are lacking 3, how the EPA assessed the data for a sensitive population. Two common quality, completeness, and justifications for UFs that can be applied representativeness, and how the data to account for sensitive populations are: were used to generate estimates of Where: (1) Variation in sensitivity among the members of the human population (i.e., drinking water contaminant occurrence HRL = Health Reference Level (mg/L) in support of these regulatory RfD = Reference Dose (mg/kg/day) intraspecies variability) and (2) determinations. DWI = Drinking Water Intake (L) uncertainty associated with an BW = Body weight (kg) incomplete database. C. Analyses Used To Support the CSF = Cancer Slope Factor (mg/kg/day)¥1 (b) For HRLs developed for Preliminary Regulatory Determinations CRL = Cancer risk level, assumed to be 1 in carcinogens with a mutagenic MOA, the Sections III.C.1 and 2 of this action a million (1 × 10¥6) 2005 Cancer Guidelines require outline the health effects and ADAF = The Age Dependent Adjustment consideration of increased risks due to occurrence/exposure evaluation process Factor for the age group i (by default, early-life exposure. When chemical- the EPA used to support these ADAF = 10 from birth to two years of specific data to quantify the increased age; ADAF = 3 from two to sixteen years risk are lacking, Age Dependent preliminary determinations. of age; ADAF = 1 from sixteen to seventy Adjustment Factors (ADAFs) are 1. Evaluation of Adverse Health Effects years of age) f = fraction of applicable period of exposure applied, generally with a 10-fold This section describes the approach (by default, lifetime of seventy years) adjustment for early life exposures, a 3- for deriving the HRL for the represented by age group i fold adjustment for childhood/ contaminants under consideration for RSC = Relative Source Contribution, which is adolescent exposures, and no additional regulatory determinations. HRLs are the portion (percentage) of an adjustment for exposures later in life (as health-based drinking water individual’s exposure attributed to shown above). Age-specific drinking- concentrations against which the EPA drinking water rather than other sources water-intake-to-body-weight ratio values evaluates occurrence data to determine (e.g., food, ambient air). In Regulatory are also applied from the Exposure if contaminants occur at levels of Determination, a 20% RSC is used for Factors Handbook (USEPA, 2011b). In HRL derivation because (1) HRLs are potential public health concern. HRLs developed prior to a complete exposure cases where the data on the MOA are are not final determinations on assessment, and (2) 20% is the lowest lacking, the default low-dose linear establishing a protective level of a and most conservative RSC used in the extrapolation approach without ADAFs contaminant in drinking water for any derivation of an MCLG for drinking is used. particular population and are derived water. While this action is not subject to prior to the development of a complete Executive Order 13045: Protection of b. Protection of Sensitive health and exposure assessment. More Children from Environmental Health Subpopulations specific information about the potential and Safety Risks, the Agency’s Policy on for adverse health effects for each In prioritizing the contaminants of Evaluating Health Risks to Children contaminant is presented in section IV.B greatest public health concern for (USEPA, 1995a), recently reaffirmed by of this action. regulatory determination, Section Administrator Wheeler (USEPA, 2018a), 1412(b)(1)(C) of SDWA requires the was still applied for the RD 4 a. Derivation of an HRL Agency to consider ‘‘among other preliminary determination. The EPA’s There are two general approaches to factors of public health concern, the policy (USEPA, 1995a) requires the EPA the derivation of an HRL. One general effect of such contaminants upon to consistently and comprehensively approach is used for chemicals with a subgroups that comprise a meaningful address children’s unique threshold dose-response (usually portion of the general population (such vulnerabilities. For example, if exposure involving non-cancer endpoints, and as infants, children, pregnant women, to a contaminant considered for RD 4 occasionally cancer endpoints). The the elderly, individuals with a history of was associated with a developmental

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effect, the EPA derived HRLs using the produced by other agencies. The criteria published literature to supplement the exposure factors for a bottle-fed infant to for accepting a health assessment for RD health assessment (Note that the two be protective of children, assuming that 4 are described in Section III.A.1, above. Phase 3 contaminants that are not the adverse effect identified could occur Table 6 summarizes the sources of the receiving a preliminary determination during the window of time when the health assessment data for each are not discussed here. They are 1,4- infant is formula-fed (see metolachlor in chemical with a preliminary dioxane and 1,2,3-trichloropropane. See Section IV.B as an example). determination under RD 4. As noted in section V of this document for more on c. Sources of Data/Information for Section III.A.3, in the case of potential those two contaminants.) Health Effects positive determinations, the EPA The EPA relies on health assessments searches for and evaluates additional produced by the Agency itself and data and information from the

2. Evaluation of Contaminant The Agency also evaluates provide the results of monitoring efforts Occurrence and Exposure supplemental sources of information on in limited geographic areas. A summary occurrence in drinking water, of the occurrence data and the results or The EPA uses data from many sources occurrence in ambient and source water, findings for each of the contaminants to evaluate occurrence and exposure considered for regulatory determination from drinking water contaminants. The and information on contaminant is presented in section IV.B, the following comprise the primary sources production and release to augment and contaminant profiles section, and the of finished drinking water occurrence complement these primary sources of data are described in further detail in data discussed in this Federal Register drinking water occurrence data. Section the Regulatory Determination 4 Support document: III.C.2.a. of this action provides a brief summary of the primary sources of Document (see USEPA, 2019a). • Unregulated Contaminant Monitoring finished water occurrence data, and a. Primary Sources of Finished Drinking Rules (UCMR 1, 2, and 3) sections III.C.2.b and II.C.2.c provide • Water Occurrence Data UCM Program Rounds 1 and 2, and brief summary descriptions of some of • Data collected by states. the supplemental sources of occurrence The following sections provide a brief Several of the primary sources of information and/or data. These summary of the finished water finished water occurrence data are descriptions do not cover all the sources occurrence data sources used in RD 4. designed to be statistically that the EPA reviews and evaluates. For Table 8 in section IV lists the primary representative of the nation. These data individual contaminants, the EPA data source/finding used to evaluate sources include UCMR 1, UCMR 2, and reviews additional published reports each of the eight contaminants UCMR 3. and peer-reviewed studies that may considered for regulatory

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determinations. Section V of this possible laboratory capacity issues for estimates (99% confidence level with document provides more information the analytical methods required. Pre- ±1% error tolerance, at 1% exposure), about 1,4-dioxane and 1,2,3- Screen Testing (PST) is generally used while providing more precise trichloropropane, the two Phase 3 to collect monitoring information for occurrence estimates for categories of contaminants for which the EPA is not contaminants with analytical methods small systems). The UCMR AM program making a preliminary regulatory that are in an early stage of includes systems from all 50 states, the determination at this time. The development, and/or very limited District of Columbia, all five U.S. contaminant-specific discussions in laboratory availability. territories, and tribal lands across all of section IV provide more detailed The EPA designed the AM sampling the EPA regions. With contaminant information about the primary data frame to ensure that sample results monitoring data from all large PWSs— source findings as well as any would support a high level of a census of large systems—and a supplemental occurrence information. confidence and a low margin of error statistical, nationally representative (see USEPA, 1999 and 2001a, for UCMR sample of small PWSs, the UCMR AM (1) The Unregulated Contaminant design details). AM is required for all program provides a robust dataset for Monitoring Rules (UCMR 1, UCMR 2, large and very large PWSs, those serving evaluating national drinking water and UCMR 3) between 10,001 and 100,000 people and contaminant occurrence. The UCMR is the EPA’s primary serving more than 100,000 people, UCMR 1 AM was conducted by vehicle for collecting monitoring data respectively (i.e., a census of all large approximately 3,090 large systems and on the occurrence of unregulated and very large systems) and a national 797 small systems. Approximately contaminants in PWSs. SDWA section statistically representative sample of 33,800 samples were collected for each 1412(b)(1)(B)(ii)(II) requires that the 800 small PWSs, those serving 10,000 or contaminant. In UCMR 2, sampling was EPA include consideration of the data fewer people.19 PWSs that purchase conducted by over 3,300 large systems produced by the UCMR program in 100% of their water were not required and 800 small systems and resulted in making regulatory determinations. The to participate in UCMR 1 and UCMR 2. over 32,000 sample results for each UCMR list is published every five years However, those systems were not contaminant. and is designed to collect nationally excluded under UCMR 3. All systems As noted, in addition to AM, SS representative occurrence data that is that purchase 100% of their water and monitoring was required for developed in coordination with the CCL serve more than 10,000 people were contaminants. For UCMR 1, the SS was and Regulatory Determination subject to UCMR 3. Systems that conducted at 300 PWSs (120 large and processes. The UCMR sampling is purchase 100% of their water and serve 180 small systems) selected at random limited by statute to no more than 30 a retail population of 10,000 or fewer from the pool of systems required to contaminants every five years (SDWA customers were only required to conduct AM. Samples from the 300 section 1445(a)(2)). PWSs and state monitor if they were selected as part of PWSs from throughout the nation primacy agencies are required to report the UCMR 3 nationally representative provided approximately 2,300 analyses the data to the EPA. The EPA published sample of small systems. for each contaminant. While the the lists and requirements for the UCMR Each system conducts UCMR statistical design of the SS is national in 1 on September 17, 1999 (64 FR 50556, assessment monitoring for 12- scope, the uncertainty in the results for September 17, 1999, USEPA, 1999), and consecutive months (during the three- contaminants that have low occurrence the monitoring was conducted primarily year monitoring period). The rules is relatively high. Therefore, the EPA during 2001–2003. UCMR 2 was typically require quarterly monitoring looked for additional data to published on January 4, 2007 (72 FR for surface water systems and twice-a- supplement the SS data for regulatory 367; USEPA, 2007a), with monitoring year, six-month interval monitoring for determinations. conducted primarily during 2008–2010. groundwater systems. At least one For the UCMR 2 SS, the EPA UCMR 3 was published on May 2, 2012 sampling event must occur during a improved the design to include a census (77 FR 26071; USEPA, 2012a), with specified vulnerable period. Differing of all systems serving more than 100,000 monitoring conducted primarily during sampling points within the PWS may be people (approximately 400 PWSs—but 2013–2015. (The complete analytical specified for each contaminant related the largest portion of the national monitoring lists are available at: http:// to the contaminants source(s). population served by PWSs) and a water.epa.gov/lawsregs/rulesregs/sdwa/ The objective of the UCMR sampling nationally representative, statistically ucmr/.) UCMR 4 was published on approach for small systems was to selected sample of 320 PWSs serving December 20, 2016 (81 FR 92666), with collect contaminant occurrence data between 10,001 and 100,000 people, monitoring conducted between 2018 from a statistically-selected, nationally and 480 small PWSs serving 10,000 or and 2020 (final UCMR 4 data is not representative sample of small systems. fewer people (72 FR 367, January 4, complete in time for this RD 4 The small system sample was stratified 2007, USEPA, 2007a). With preliminary determination). and population-weighted, and included approximately 1,200 systems The UCMR program is designed as a some other sampling adjustments such participating in the SS, sufficient data three-tiered approach for monitoring as allocating a selection of at least two were generated to provide a confident contaminants related to the availability systems from each state for spatial national estimate of contaminant and complexity of analytical methods, coverage (the design meets the data occurrence and population exposure. In laboratory capacity, sampling frequency, quality objective for overall exposure UCMR 2, the 1,200 PWSs provided more relevant universe of PWSs, and other than 11,000 to 18,000 analyses considerations (e.g., cost/burden). 19 Section 1445 of the Safe Drinking Water Act (depending on the sampling design for Assessment Monitoring (AM) includes was recently amended by Public Law 115–270, the different contaminants). America’s Water Infrastructure Act of 2018 (AWIA), the largest number of PWSs and is and now specifies that, effective October 23, 2021, For UCMR 3, all large and very large generally used when there is sufficient subject to the availability of appropriations for such PWSs (serving between 10,001 and laboratory capacity. The Screening purpose and appropriate laboratory capacity, the 100,000 people and serving more than Survey (SS) includes a smaller number EPA must require all systems serving between 3,300 100,000 people, respectively), plus a and 10,000 persons to monitor and ensure that only of PWSs to conduct monitoring and may a representative sample of systems serving fewer statistically representative national be used, for example, when there are than 3,300 persons are required to monitor. sample of 800 small PWSs (serving

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10,000 people or fewer), conducted AM. conditions, as the presence of IOCs in Agency in public comment or suggested UCMR 3 SS monitoring was conducted aquifers depends in large part on by stakeholders during previous CCL by all large systems serving more than equilibrium with stable natural sources and Regulatory Determination efforts. 100,000 people, a nationally in contiguous rock formations. These supplemental data are useful to representative sample of 320 large evaluate the likelihood of contaminant (3) Unregulated Contaminant systems serving 10,001 to 100,000 occurrence in drinking water and/or to Monitoring (UCM) Program Rounds 1 people, and a nationally representative more fully characterize a contaminant’s and 2 sample of 480 small water systems presence in the environment and serving 10,000 or fewer people. In In 1987, the EPA initiated the UCM potentially in source water, and to contrast to implementation of UCMR 1 program to fulfill a 1986 SDWA evaluate any possible trends or spatial and 2 monitoring, transient Amendment requirement to monitor for patterns that may need further review. noncommunity water systems that specified unregulated contaminants. The descriptions that follow do not purchase all their finished water from The UCM required PWSs serving more cover all the sources that the EPA used. another system were not excluded from than 500 people to conduct monitoring. For individual contaminants, the EPA the requirements of UCMR 3 (this was The EPA implemented the UCM reviewed additional published reports applicable only to PST). See USEPA program in two phases or rounds. The and peer-reviewed studies that may (2012a) and USEPA (2019b) for more first round of UCM monitoring generally have provided the results of monitoring information on the UCMR 3 study extended from 1988 to 1992 and is efforts in limited geographic areas. A design and data analysis. referred to as UCM Round 1 monitoring. more detailed discussion of the As previously noted, the details of the The second round of UCM monitoring supplemental sources of information/ occurrence data and the results or generally extended from 1993 to 1997 data that the EPA evaluated and the findings for each of the contaminants and is referred to as UCM Round 2 occurrence data for each contaminant considered for regulatory determination monitoring. Information about UCM can be found in the Regulatory are presented in Section IV.B, the monitoring and data analysis is Determination 4 Support Document contaminant profiles section, and are available in The Analysis of Occurrence (USEPA, 2019a). described in further detail in the Data from the Unregulated Contaminant Regulatory Determination 4 Support Monitoring (UCM) Program and (1) Individual States’ Data Document (USEPA, 2019a). The National Inorganics and Radionuclides For RD 4, the Agency evaluated data national design, statistical sampling Survey (NIRS) in Support of Regulatory for unregulated contaminants from the frame, any new analytical methods, and Determinations for the Second Drinking second Six-Year Review of regulated the data analysis approach for the Water Contaminant Candidate List contaminants (USEPA, 2009b), the third UCMR program has been peer-reviewed (USEPA, 2008c). Six-Year Review of regulated at different stages of development (see The UCM-State Round 1 dataset contaminants (USEPA, 2016c), and USEPA, 2001b, 2008b, 2015a, 2019b). contains PWS monitoring results for 62 individual state websites. then-unregulated contaminants (some To support the second Six-Year (2) National Inorganics and have since been regulated). These data Review of regulated contaminants Radionuclides Survey (NIRS) were collected by 40 states and primacy (USEPA, 2009b), the EPA issued an The EPA conducted the NIRS to entities between 1988 and 1992. The Information Collection Rule (ICR) to provide a statistically representative Round 2 dataset contains PWS collect compliance monitoring data sample of the national occurrence of 36 monitoring results for 48 then- from PWSs for the time period covering selected inorganic compounds (IOCs) unregulated contaminants. These data 1998–2005. After issuing the ICR, the and 6 radionuclides in CWSs served by were collected by 35 states and primacy EPA received monitoring data from 45 groundwater. The sample was stratified entities between 1993 and 1997. Since states plus Region 8 and Region 9 by system size and 989 groundwater UCM Round 1 and Round 2 data Tribes. Six states and Region 9 tribes CWSs were selected at random represent different time periods and also provided monitoring data for representing 49 states (all except include occurrence data from different unregulated contaminants along with Hawaii) as well as Puerto Rico. The states, the EPA developed separate their compliance monitoring data. The survey focused on groundwater systems, national cross-sections for each data set. EPA further collected additional in part because IOCs tend to occur more The UCM Round 1 national cross- unregulated contaminant data from two frequently and at higher concentrations section, consisting of data from 24 additional States that provide in groundwater than in surface water. states, includes approximately 3.3 monitoring data through their websites. Each of the selected CWSs was sampled million records from approximately To support the third Six-Year Review at a single time between 1984 and 1986. 22,000 unique PWSs. The UCM Round of regulated contaminants (USEPA, One limitation of the NIRS is a lack 2 national cross-section, consisting of 2016c), the EPA issued an ICR to collect of occurrence data for surface water data from 20 states, includes compliance monitoring data from PWSs systems. Information about NIRS approximately 3.7 million records from for 2006–2011. After issuing the ICR, 46 monitoring and data analysis is slightly more than 27,000 unique PWSs. states and 8 other primacy agencies available in The Analysis of Occurrence provided compliance monitoring data. Data from the Unregulated Contaminant b. Supplemental Sources of Finished Nine states, three tribes, Washington, Monitoring (UCM) Program and Drinking and Ambient Water DC, and American Samoa also provided National Inorganics and Radionuclides Occurrence Data monitoring data for unregulated Survey (NIRS) in Support of Regulatory The Agency evaluates several sources contaminants along with their Determinations for the Second Drinking of supplemental information related to compliance monitoring data. Water Contaminant Candidate List contaminant occurrence in finished The EPA supplemented these (USEPA, 2008c). Another potential water and ambient and source waters to occurrence data for unregulated limitation of the NIRS is the age of the augment the primary drinking water contaminants by downloading data. Although the NIRS monitoring occurrence data. Some of these sources additional and more recent publicly occurred nearly 35 years ago, results were part of other Agency information available monitoring data from state may still provide insight into current gathering efforts or submitted to the websites. Drinking water monitoring

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data for select contaminants were among different sampling periods. The sampling points. Cycle 2 monitoring available online from several states, EPA reviewed the PDP data on the covers the period from 2002 through including California, Colorado, occurrence of select contaminants in 2012, with various design changes from Michigan, New Hampshire, New Jersey, untreated and treated water (USDA, Cycle 1 (see Hamilton et al., 2004). and North Carolina. Very limited data 2018). Sampling for Cycle 3 is currently were also available from Pennsylvania underway (2013–2023). Surface water (4) USGS Pilot Monitoring Program and Washington. The available state monitoring will be conducted at 313 (PMP) data are varied in terms of quantity and sites while groundwater assessments coverage. In many cases they represent In 1999, USGS and the EPA will be designed to evaluate status and targeted monitoring. conducted the PMP to provide trends at the principal aquifer and These datasets vary from state to state information on pesticide concentrations national scales. Refer to Rowe et al. in the contaminants included, the in small drinking water supply (2010; 2013) for more details. number of samples, and the reservoirs in areas with high pesticide The EPA performed a summary completeness of monitoring. They were use (Blomquist et al., 2001). The study analysis of the Cycle 1, Cycle 2, and reviewed and used to augment the was undertaken, in part, to test and available Cycle 3 water monitoring data national data and assessed if they refine the sampling approach for for the Regulatory Determination provide supportive observations or any pesticides in such reservoirs and related process. The surface water data unique occurrence results that might drinking water sources. Sampling sites consisted of river and stream samples; warrant further review. represent a variety of geographic for groundwater, all well data were regions, as well as different cropping used. (2) Community Water System Survey patterns. Twelve water supply For RD 4, the EPA used and evaluated (CWSS) reservoirs considered vulnerable to many USGS NAWQA reports to review The EPA periodically conducts the pesticide contamination were included causal or spatial factors that USGS may CWSS to collect data on the financial in the study. Samples were collected have presented in their interpretations. and operating characteristics from a quarterly throughout the year and at In particular, the EPA evaluated many nationally representative sample of weekly or biweekly intervals following reports from the Pesticide National CWSs. As part of the CWSS, all systems the primary pesticide-application Synthesis Programs (e.g., Gilliom et al., serving more than 500,000 people periods. Water samples were collected 2007) and the VOC National Synthesis receive the survey. In the 2000 and 2006 from the raw water intake and from (e.g., Delzer and Ivahnenko, 2003). CWSS, these very large systems were finished drinking water taps prior to While there is overlap in the data used asked questions about the occurrence entering the distribution system. At in the USGS reports and the EPA and concentrations of unregulated some sites, samples were also collected analysis, the USGS reports can provide contaminants in their raw and finished at the reservoir outflow. unique observations related to their water. The 2000 CWSS (USEPA, 2002a, synthesis of additional data. (5) USGS National Water Quality 2002b) requested data from 83 very large For RD 4, the EPA also supplemented Assessment (NAWQA) CWSs and the 2006 CWSS (USEPA, these data with information from recent 2009c, 2009d) requested data from 94 The USGS instituted the National special USGS reports that also used very large CWSs. Not all systems Water Quality Assessment (NAWQA) additional data from other programs, answered every question or provided program in 1991 to examine ambient particularly reports that focused on complete information on the water quality status and trends in the contaminant occurrence in source unregulated contaminants. Because United States. The NAWQA program is waters for PWSs, such as: Organic reported results are incomplete, they are designed to apply nationally consistent compounds in source water of selected illustrative, not representative, and are methods to provide a consistent basis CWSs (Hopple et al., 2009 and only used as supplemental information. for comparisons over time and among Kingsbury et al., 2008); water quality in significant watersheds and aquifers public-supply wells (Toccalino et al., (3) United States Department of across the country. These occurrence 2010); water quality in domestic wells Agriculture (USDA) Pesticide Data assessments serve to facilitate and principal aquifers (DeSimone, 2009 Program (PDP) interpretation of natural and and DeSimone et al., 2014); nationwide Since 1991, the USDA PDP has anthropogenic factors affecting national reconnaissance of contaminants of gathered data on pesticide residues in water quality. The NAWQA program emerging concern (Glassmeyer et al., food. In 2001 the program expanded to monitors the occurrence of chemicals 2017); water quality in select CWSs include sampling of pesticide residues such as pesticides, nutrients, volatile (Grady and Casey, 2001); water quality in treated drinking water, and in 2004 organic compounds (VOCs), trace in carbonate aquifers (Lindsey et al., some sampling of raw water was elements, radionuclides, hormones and 2008); VOCs in domestic wells (Moran incorporated as well. The PDP drinking pharmaceuticals, and the condition of et al., 2002 and Rowe et al., 2007); and water project continued until 2013 aquatic habitats and fish, insects, and VOCs in the nation’s groundwater (USDA, 2018). The CWSs selected for algal communities. For more detailed (Zogorski et al., 2006). sampling tended to be small and information on the NAWQA program medium-sized surface water systems design and implementation, please refer (6) National Water Information System (serving under 50,000 people) located in to Leahy and Thompson (1994), (NWIS) regions of heavy agriculture. The Hamilton et al. (2004), and NRC (2012). For RD 4, the EPA evaluated sampling frame was designed to monitor The NAWQA program has been contaminant monitoring results from the in regions of interest for at least two designed in ten-year cycles to enable non-NAWQA data in the National Water years to reflect the seasonal and climatic national coverage that can be used for Information System (NWIS) (USGS, variability during growing seasons. PDP trends and causal assessments. In the 2016). NWIS houses the NAWQA data worked with the EPA to identify Cycle 1 monitoring period, which was (described above) and includes other specific water treatment facilities where conducted from 1991 through 2001, USGS data from unspecified projects. monitoring data were collected. The NAWQA collected data from over 6,400 The non-NAWQA NWIS data were number of sites and samples varied surface water and 6,300 groundwater analyzed separately from NAWQA data.

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Although NWIS is comprised of the supplemental sources of pounds (40 CFR 372.28). Both the primarily ambient water data, some information/data that the EPA evaluated number and type of facilities required to finished drinking water data are and the occurrence data for each report has increased over time. included as well. The non-NAWQA data contaminant can be found in the Information from the TRI was housed in NWIS generally involve fewer Regulatory Determination 4 Support downloaded in 2017 (USEPA, 2017a). constituents per sample than the Document (USEPA, 2019a). Although TRI can provide a general NAWQA data. Unlike the NAQWA data, idea of release trends, these trends (1) Inventory Update Reporting (IUR) the non-NAWQA data are a should be interpreted with caution since and Chemical Data Reporting (CDR) miscellaneous collection, so they are not the list of chemicals with reporting Program as well-suited for making temporal and requirements has generally increased geographic comparisons. Most NWIS The IUR regulation required over time. In addition, only those data are available via the Water Quality manufacturers and importers of certain facilities that meet specific criteria are Portal (see below). chemical substances, included on the required to report to the TRI program. Toxic Substances Control Act (TSCA) Finally, data on releases cannot be used (7) Water Quality Exchange (WQX)/ Chemical Substance Inventory, to report as a direct measure of public exposure Water Quality Portal Data System site and manufacturing information and to a chemical in drinking water (USEPA, (Formerly STORET) the amount of chemicals produced or 2019a). The EPA’s Water Quality Exchange imported in amounts of 25,000 pounds (WQX) is the data format and or more at a single site. Additional (3) Pesticide Usage Estimates mechanism for publishing monitoring information on domestic processing and For the regulatory determinations data available through the Water Quality use was required to be reported for process, the Agency reviews various Portal. WQX replaces the Storage and chemicals produced or imported in sources of information about pesticide Retrieval Data System (STORET) as the amounts of 300,000 pounds or more at usage. Pesticide use and manufacturing mechanism for data partners to submit a single site. Prior to the 2003 TSCA information is considered confidential water monitoring data to the EPA. The Amendments (i.e., reporting from 2002 business information (CBI) and Water Quality Portal is the mechanism or earlier), information was collected for therefore, accurate measures of for anyone, including the public, to only organic chemicals that were production and use are not publicly retrieve water monitoring data from the produced or imported in amounts of available. As a result, the Agency EPA WQX/STORET, USDA 10,000 pounds or more, and was limited reviews various estimates of use as STEWARDS, and USGS NWIS/ to more basic manufacturing supplemental information in the BIODATA. The WQX database contains information such as production volume. deliberative process. raw biological, chemical, and physical In 2011 the Agency issued the CDR For some pesticides, the EPA presents data from surface and groundwater Rule, which replaced the IUR Rule and estimations of annual U.S. usage of sampling conducted by federal, state established a somewhat modified individual pesticides in its pesticide and local agencies, Native American program, including annual data reregistration documents (e.g., REDs, Tribes, volunteer groups, academics, gathering and periodic reporting. CDR IREDs, TREDs). The EPA also and others. WQX includes data from makes use of a two-tiered system of periodically issues Pesticides Industry monitoring locations in all 50 states as reporting thresholds, with 25,000 Sales and Usage reports. The reports well as multiple territories and pounds the threshold for some provide contemporary and historical jurisdictions of the United States. Most contaminants and 2,500 pounds the information on U.S. pesticide data are from ambient waters, but in threshold for others. Contaminants may production, imports, exports, usage, and some cases finished drinking water data have reports for some years but not sales, particularly with respect to dollar are included as well. Data owners are others (USEPA, 2008d; USEPA, 2016d). values and quantities of active responsible for providing data of ingredient (USEPA, 2004a; USEPA, (2) Toxics Release Inventory (TRI) documented quality, so that data users 2011c; USEPA, 2017b). can choose to access only those data The EPA established the Toxics The National Center for Food and collected and analyzed with data quality Release Inventory (TRI) in 1987 in Agricultural Policy (NCFAP), a private objectives that meet their study needs. response to Section 313 of the non-profit institution, has also produced For more general WQX data Emergency Planning and Community national pesticide use estimates based information, please refer to: https:// Right-to-Know Act (EPCRA). EPCRA on USDA state-level statistics and www.epa.gov/waterdata/water-quality- Section 313 requires facilities to report surveys for commercial agriculture data-wqx. To retrieve the data, please annual information on toxic chemical usage patterns and state-level crop refer to: https:// releases from facilities that meet acreage. The database contains estimates www.waterqualitydata.us/portal/. reporting criteria to both the EPA and of pounds applied and acres treated in the states. The TRI database details not each State for 220 active (pesticide) c. Supplemental Production, Use, and only the types and quantities of toxic ingredients and 87 crops. The majority Release Data chemicals released to the air, water, and of the chemicals monitored are The Agency reviews various sources land by facilities, but also provides herbicides, but the database also follows of information to assess if there are information on the quantities of significant numbers of fungicides and changes or trends in a contaminant’s chemicals sent to other facilities for insecticides (NCFAP, 2000). production, use, and release that may further management (USEPA, 2003b; The USGS produced usage estimates affect its presence in the environment USEPA, 2019c). Currently, for most and maps for over 200 pesticides used and potential occurrence in drinking chemicals, reporting of releases is in United States crop production, water. The cancellation of a pesticide or required if 25,000 pounds or more of the providing spatial insight to the regional a clear increase in production and use chemical are manufactured or processed use of many pesticides (USGS, 2018). of a contaminant are trends that can at a facility, or if 10,000 pounds or more These pesticide use estimates were inform the regulatory determination are used at the facility. For certain generated by the USGS using data from process. Several sources are described chemicals the reporting threshold is as proprietary surveys of farm operations, below. A more detailed discussion of low as 0.1 grams, 10 pounds, or 100 USDA Census of Agriculture, and other

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sources. USGS used two methods to IV. Contaminant-Specific Discussions effects, and associated reference dose estimate pesticide usage, since pesticide for the RD 4 Preliminary Determination and/or cancer slope factor used to derive an HRL. Following Table 7, Table usage information was not available in A. Summary of the Preliminary 8 summarizes the primary occurrence some districts. ‘‘EPest-High’’ estimates Regulatory Determination were generated by projecting usage information used to make these estimates for such districts based on Based on the EPA’s evaluation of the preliminary regulatory determinations. usage in neighboring districts. ‘‘EPest- three SDWA criteria (discussed in Section IV.B of this document provides Low’’ estimates were generated by section II.B.1), the Agency is making a more detailed summary of the assuming no usage in such districts. preliminary determinations to regulate information and the rationale used by two contaminants and to not regulate the Agency to reach its preliminary six contaminants. For each of the eight decisions for these eight contaminants. contaminants discussed in this section For more information about the two of this document, Table 7 summarizes Phase 3 contaminants that are not information about the health receiving a preliminary regulatory assessment, principle study, critical determination, see section V. TABLE 7—HEALTH EFFECTS INFORMATION FOR CONTAMINANTS DISCUSSED IN SECTION IV OF THIS DOCUMENT

RfD for Cancer slope RD 4 contaminant Health Principle study Critical effect noncancer factor, in HRL, in μg/L assessment effects, in ¥1 mg/kg/day (mg/kg/day)

PFOS ...... EPA OW HESD, Luebker et al. decreased neonatal rat body weight ...... 0.00002 n/a 0.07. 2016. 2005a and 2005b. PFOA ...... EPA OW HESD, Lau et al., 2006 reduced ossification in proximal phalanges and 0.00002 20 0.07 0.07. 2016. accelerated puberty in male pups, in mice. 1,1-Dichloroethane EPA ORD Muralidhara et increased urinary enzyme markers for renal dam- 0.2 n/a 1,000. PPRTV, 2006. al., 2001. age and central nervous system (CNS) depres- sion in rats. Acetochlor ...... EPA OPP ICI, Inc. 1988 .... increased salivation, increased alanine 0.02 n/a 100. HHRA, 2018. aminotransferase (ALT), ornithine carbamyl transferase and triglyceride levels; decreased blood glucose; and histopathological changes in the kidneys, liver and testes of males, in beagle dogs. Methyl Bromide EPA OPP Mertens, 1997 .. decreased body weight, decreased rate of body 0.022 n/a 100. (Bromomethane). HHRA, 2006. weight gain, and decreased food consumption in rats. Metolachlor ...... EPA OPP Page, 1981 ...... decreased pup body weight in rats ...... 0.26 n/a 300. HHRA, 2018. Nitrobenzene ...... EPA IRIS, 2009 NTP, 1983 ...... changes in absolute and relative organ weights, 0.002 n/a 10. splenic congestion, and increases in reticulocyte count and metHb concentration in rats. RDX ...... EPA IRIS, 2018 Crouse et al., convulsions in rats (noncancer); lung and liver tu- 0.004 0.08 30 (noncancer); 2006 (non- mors in mice (cancer). 0.4 (cancer). cancer); Lish et al. 1984 (cancer).

TABLE 8—OCCURRENCE FINDINGS FROM PRIMARY DATA SOURCES

Population Population served by served by RD 4 HRL, μg/L Primary PWSs with at least 1 PWSs with at least 1 PWSs with at least 1 PWSs with at contaminant database detection > 1⁄2 HRL detection > HRL detection > 1⁄2 HRL least 1 detec- tion > HRL

PFOS ...... 0.07 UCMR 3 AM ...... 95/4,920 (1.93%) ...... 10,427,193/241 M (4.32%) 46/4,920 (0.93%) ...... 3,789,831/241 M (1.57%). PFOA ...... 0.07 UCMR 3 AM ...... 53/4,920 (1.07%) ...... 3,652,995/241 M (1.51%) 13/4,920 (0.26%) ...... 490,480/241 M (0.20%). 1,1- 1,000 UCMR 3 AM ...... 0/4,916 (0.00%) ...... 0/241 M (0.00%) ...... 0/4,916 (0.00%) ...... 0/241 M Dichloroethane. (0.00%). Acetochlor ...... 100 UCMR 1 AM ...... 0/3,869 (0.00%)—UCMR 1 0/226 M (0.00%)—UCMR 0/3,869 (0.00%)—UCMR 1 0/226 M 1. (0.00%)— UCMR 1. UCMR 2 SS ...... 0/1,198 (0.00%)—UCMR 2 0/157 M (0.00%)—UCMR 0/1,198 (0.00%)—UCMR 2 0/157 M 2. (0.00%)— UCMR 2. Methyl Bromide 100 UCMR 3 AM ...... 0/4,916 (0.00%) ...... 0/241 M (0.00%) ...... 0/4,916 (0.00%) ...... 0/241 M (Bromometha- (0.00%). ne). Metolachlor ...... 300 UCMR 2 SS ...... 0/1,198 (0.00%) ...... 0/157 M (0.00%) ...... 0/1,198 (0.00%) ...... 0/157 M (0.00%). Nitrobenzene ..... 10 UCMR 1 AM ...... 2/3,861 (0.05%) ...... 255,358/226 M (0.11%) .... 2/3,861 (0.05%) ...... 255,358/226 M (0.11%). RDX ...... 30, 0.4 UCMR 2 AM ...... 0/4,139 (0.00%) > 15 μg/L 0/229 M (0.00%) > 15 μg/ 0/4,139 (0.00%) > 30 μg/L 0/229 M L. (0.00%) > 30 μg/L.

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TABLE 8—OCCURRENCE FINDINGS FROM PRIMARY DATA SOURCES—Continued

Population Population served by PWSs with at least 1 served by RD 4 HRL, μg/L Primary PWSs with at least 1 PWSs with at least 1 PWSs with at contaminant database detection > 1⁄2 HRL detection > HRL detection > 1⁄2 HRL least 1 detec- tion > HRL

3/4,139 (0.07%) > 0.2 μg/ 96,033/229 M (0.04%) > 3/4,139 (0.07%) > 0.4 μg/ 96,033/229 M L. 0.2 μg/L. L. (0.04%) > 0.4 μg/L.

B.Contaminant Profiles products and emissions from their (health effects support documents or facilities. All companies met the PFOA HESDs) for PFOA and PFOS based on 1. Perfluorooctane Sulfonate (PFOS) and Stewardship Program goals by 2015. Perfluorooctanoic Acid (PFOA) the Agency’s evaluation of the peer While companies participating in the reviewed science available at that time. a. Background PFOA Stewardship program report that This section presents a summary of the PFAS are a group of synthetic they no longer produce or use PFOA adverse health effects discussed in the chemicals that have been in use since domestically, PFOA may still be HESDs. For specific details on the the 1940s. PFAS are found in a wide produced domestically or imported or potential for adverse health effects and array of consumer and industrial used by companies not participating in approaches used to identify and products. PFAS manufacturing and the PFOA Stewardship Program. In evaluate information on hazard and processing facilities, facilities using addition, PFOA and PFOS can also be dose-response, please see USEPA PFAS in production of other products, present in imported articles (USEPA, (2016d), USEPA (2016e), USEPA airports, and military installations have 2017c). Due to the widespread use and (2016f), and USEPA (2016g). The been associated with PFAS releases into persistence of PFAS in the environment, lifetime HA of 0.07 mg/L is used as the the air, soil, and water (USEPA, 2016e; most people have been exposed to HRL for Regulatory Determination 4. USEPA, 2016f). PFAS, including PFOA and PFOS PFOS and PFOA—two of the most (USEPA, 2016e; USEPA, 2016f). Human epidemiology data report widely-studied and longest-used Production of PFOA and PFOS is associations between PFOA exposure PFAS—are part of a subset of PFAS subject to CDR reporting. Production and high cholesterol, increased liver known as perfluorinated alkyl acids volumes of PFOA and PFOS were enzymes, decreased vaccination (PFAA). These two compounds have claimed by reporting companies as response, thyroid disorders, pregnancy- been detected in up to 98% of serum confidential for the most recent induced hypertension and samples taken in biomonitoring studies reporting cycles. The last time preeclampsia, and cancer (testicular and that are representative of the U.S. production (including import) of PFOA kidney). The associations for most general population; however, since exceeded the CDR reporting threshold epidemiology endpoints are mixed. PFOA and PFOS have been voluntarily was during the 2016 reporting cycles Although mean serum values are phased out in the U.S., serum (which includes production information presented in the human studies, actual concentrations have been declining from 2012–2015) and it was phased out estimates of PFOA exposure (i.e., doses/ (CDC, 2019). The National Health and by companies participating in the 2010/ duration) are not currently available. Nutrition Examination Survey 2015 PFOA Stewardship Program in Thus, the serum level at which the (NHANES) data shows that 95th- 2013. Similarly, PFOS was phased out effects were first manifest and whether percentile serum PFOS concentrations by 3M in 2002 and the most recently the serum had achieved steady state at have decreased from 75.7 mg/L in the reported data for PFOS are from the the point the effect occurred cannot be 1999–2000 cycle to 18.3 mg/L in the 2002 reporting cycle (which includes determined. It is likely that some of the 2015–2016 cycle (CDC, 2019; Jain, 2018; production information from 2001 only) human exposures that contribute to Calafat et al., 2007; Calafat et al., 2019), (USEPA, 2019a). Absence of recent serum PFOA values come from PFOA reporting may indicate that production a decrease of over 75 percent. In early derivatives or precursors that break (including import) of PFOA and PFOS 2000, the EPA worked with the 3M down metabolically to PFOA. These has halted or has been below the CDR Company, which was the only major compounds could originate from PFOA reporting thresholds. Although PFOA manufacturer of PFOS in the United in diet and materials used in the home, and PFOS are not produced States at that time, to support the which creates potential for confounding. domestically or imported by the company’s voluntary phase-out and companies participating in the 2010/ In addition, most of the subjects of the elimination of PFOS production and 2015 PFOA Stewardship Program, epidemiology studies have many PFASs use. Under the EPA’s 2010/2015 PFOA PFOA and PFOS may still be produced and/or other contaminants in their Stewardship Program, eight major domestically or imported below the blood. Although the study designs chemical manufacturers and processors CDR reporting thresholds (i.e., 2,500 adjust for other potential toxicants as agreed to phase out the use of PFOA and pounds) by companies not participating confounding factors, their presence PFOA-related chemicals in their in the PFOA Stewardship Program. constitutes a level of uncertainty that is usually absent in the animal studies. 20 Using the CSF, the calculated concentration in b. Statutory Criterion #1 (Adverse Taken together, the weight of evidence drinking water with one-in-a-million risk for an Health Effects) increase in testicular tumors at levels greater than for human studies supports the background is 0.0005 mg/L. The EPA is preliminarily determining conclusion that PFOA exposure is a The equivalent concentration derived from the that PFOA and PFOS meet the SDWA human health hazard. At this time, EPA RfD is lower than the concentration of 0.0005 mg/ statutory criterion #1 for regulatory concludes that the human studies are L associated with a one-in-a-million risk for adequate for use qualitatively in the testicular cancer indicating that a guideline derived determinations: They may have adverse from the developmental endpoint will be protective effects on the health of persons. In 2016, identification hazard and are supportive for the cancer endpoint. (USEPA, 2016g). the EPA published health assessments of the findings in laboratory animals.

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For PFOA, oral animal studies of ratio for the 90th percentile 21 for higher serum glucose levels and short-term, subchronic, and chronic lactating women (0.054 L/kg/day) and a evidence of insulin resistance in adult duration are available in multiple calculated 20% RSC (USEPA, 2016f). offspring. Limited evidence suggests species including monkeys, rats and This RfD is protective of effects other immunological effects in mice. Short- mice. These animal studies report than those occurring during term and subchronic duration studies developmental effects (survival, body development such as kidney and are available in multiple animal species weight changes, reduced ossification, immune effects. Because of the potential including monkeys, rats and mice. delays in eye opening, altered puberty, for increased susceptibility during the These studies also found increased and retarded mammary gland time period of pregnancy and lactation serum glucose levels and insulin development), liver toxicity observed in this study, the EPA used resistance in adult animals exposed (hypertrophy, necrosis, and effects on DWI and BW parameters for lactating during development, developmental the metabolism and deposition of women in the calculation of a lifetime effects (decreased body weight and dietary lipids), kidney toxicity (weight), HA for this target population during this survival), reproductive effects (impacts immune effects, and cancer (liver, potential critical time period. The EPA on mating behavior), liver toxicity testicular, and pancreatic) (USEPA, also calculated a CSF of 0.07 (mg/kg/ ¥ (increased liver weight co-occurring 2016e). Overall, the animal toxicity day) 1 based on testicular tumors in with decreased serum cholesterol, studies available for PFOA demonstrate rats. The resultant HA using this CSF is hepatic steatosis), developmental that the developing fetus is particularly greater than the lifetime HA based on neurotoxicity (impaired spatial learning sensitive to PFOA-induced toxicity. noncancer effects, indicating that the and memory), suppressed Human epidemiology data report HA derived based on the developmental immunological responses, and cancer associations between PFOA exposure endpoint is protective for the cancer (thyroid and liver). Increased incidence and high cholesterol, increased liver endpoint (USEPA, 2016h). of hepatocellular adenomas in the male For PFOS, epidemiological studies enzymes, decreased vaccination (12% at the high dose) and female rats have reported associations between response, thyroid disorders, pregnancy- (8% at the high dose) and combined PFOS exposure and high serum induced hypertension and adenomas/carcinomas in the females cholesterol and reproductive and preeclampsia, and cancer (testicular and (10% at the high dose) were observed, kidney). Overall, the developmental developmental parameters. The but they did not display a clear dose- toxicity studies in animals available for strongest associations are related to related response; Thyroid tumors PFOA demonstrate that the developing serum lipids with increased total serum (adenomas and carcinomas) were seen rodent fetus and newborn rodent are cholesterol and high-density in males receiving 0, 0.5, 2, 5, or 20 ppm sensitive to PFOA-induced toxicity. lipoproteins (HDLs). As with PFOA, the and in females receiving 5 or 20 ppm in PFOA is known to be transmitted to associations for most epidemiology their diet. The tumor (adenomas + the fetus via cord blood and to the endpoints are inconsistent. Although carcinomas) prevalence for males was newborn, infant, and child via breast mean serum values are presented in the consistent across dose groups. In males milk (USEPA, 2016f). Under the EPA’s human studies, actual estimates of the incidence of thyroid tumors was Guidelines for Carcinogen Risk PFOS exposure (i.e., doses/duration) are significantly elevated only in the high- Assessment (USEPA, 2005b), there is not currently available. Thus, the serum dose, recovery group males exposed for ‘‘suggestive evidence of carcinogenic level at which the effects were first 52 weeks (10/39) but not in the animals potential’’ for PFOA. Similarly, the manifest and whether the serum had receiving the same dose at 105 weeks. International Agency for Research on achieved steady state at the point the There were very few follicular cell Cancer (IARC) classifies PFOA as effect occurred cannot be determined adenomas/carcinomas in the females (5 ‘‘possibly carcinogenic to humans’’ (USEPA, 2016e) Human epidemiological total) with no dose-response. The most (IARC, 2019a; IARC, 2019b). studies suggest an association between frequent thyroid tumor type in the The EPA calculated several candidate higher PFOS levels and decreases in females was C-cell adenomas, but the RfDs for PFOA in the 2016 HESD and female fecundity and fertility, decreased highest incidence was that for the selected the RfD of 0.00002 mg/kg/day birth weights in offspring and other controls and there was a lack of dose based on reduced ossification in measures of postnatal growth (e.g., small response among the exposed groups. C- proximal phalanges and accelerated for gestational age). cell adenomas were not observed in puberty in male pups following Short-term and chronic exposure males (Thomford 2002; Butenhoff et al. exposure during gestation and lactation studies in animals demonstrate 2012). Overall, the animal toxicity in a developmental toxicity study in increases in liver weight consistently. studies available for PFOS demonstrate mice (Lau et al., 2006) for the derivation Co-occurring effects in these studies that the developing fetus and newborn of a lifetime HA. The RfD for PFOA was include decreased cholesterol, hepatic rodent are sensitive to PFOS induced calculated by applying uncertainty steatosis, lower body weight, and liver toxicity. PFOS is known to be factors to account for interspecies histopathology. One and two generation transmitted to the fetus via cord blood variability (3), intraspecies differences toxicity studies also show decreased and to the newborn, infant, and child (10), and use of a LOAEL (3). The Health pup survival and body weights. via breast milk (USEPA, 2016f). Effects Support Document (USEPA, Additionally, developmental Applying the EPA Guidelines for 2016h) describes these uncertainties in neurotoxicity studies show increased Carcinogen Risk Assessment (USEPA, Section 4. Additionally, uncertainties motor activity and decreased 2005b), there is suggestive evidence of and limitations (i.e., human habituation and increased escape carcinogenic potential for PFOS. epidemiological data, immunological latency in the water maze test following However, the weight of evidence for and mammary gland endpoints, and in utero and lactational exposure to humans is too limited to support a exposure) are discussed in detail in PFOS. Gestational and lactational quantitative cancer assessment given Section 8 of the Health Advisory exposures were also associated with (USEPA, 2016f) document. The lifetime that there was no evidence for dose- m response from which to derive a slope HA of 0.07 g/L was calculated using 21 Consumers only estimate of combined direct the 0.00002 mg/kg/day RfD for and indirect community water ingestion; see Table factor for the tumor types identified in developmental effects, a DWI to BW 3–81 in USEPA, 2011b. animals.

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The EPA calculated multiple and consider public comment on any of PWSs (63 PWSs 22). Since UCMR 3 candidate RfDs for PFOS in the HESD proposed rule. Therefore, EPA monitoring occurred, certain sites where and selected the RfD of 0.00002 mg/kg/ anticipates further scientific review of elevated levels of PFOA and PFOS were day based on decreased neonatal rat new science prior to promulgation of detected may have installed treatment body weight from both the one- and any regulatory standard. for PFOA and PFOS, may have chosen two-generation studies by Luebker et al. to blend water from multiple sources, or (2005a, 2005b) for the derivation of a c. Statutory Criterion #2 (Occurrence at may have otherwise remediated known lifetime HA. The RfD for PFOS was Frequency and Levels of Public Health sources of contamination. Those 63 calculated by applying uncertainty Concern) PWSs serve a total population of factors to account for interspecies The EPA is preliminarily determining approximately 5.6 million people and variability (3) and intraspecies that PFOA and PFOS meet the SDWA are located in 25 states, tribes, or U.S. differences (10). The Health Effects statutory criterion #2 for regulatory territories (USEPA, 2019b). The HRLs Support Document (USEPA, 2016g) determinations: they occur with a for PFOA and PFOS are based on the describes these uncertainties in Section frequency and at levels of public health 2016 drinking water Health Advisories 4. Additionally, uncertainties and concern at PWSs based on the EPA’s and reflect concentrations of PFOA and limitations (i.e., human epidemiologic evaluation of the available occurrence PFOS in drinking water at which data, immunological and mammary information. The EPA is seeking public adverse health effects are not gland endpoints, and exposure) are comment on whether the data described anticipated to occur over a lifetime discussed in detail in Section 8 of the below support such a determination and (USEPA, 2016e; USEPA, 2016f). Health Advisory (USEPA, 2016e) whether additional data or studies exist Consistent with the Agency’s document. The lifetime HA of 0.07 mg/ which EPA should consider when commitment in the PFAS Action Plan L was calculated using the 0.00002 mg/ finalizing a determination. (USEPA, 2019d) to present information kg/day RfD for developmental effects, a EPA has made its preliminary about additional sampling for PFAS in DWI to BW ratio for the 90th determination based, in part, on the water systems, the EPA has percentile 21 for lactating women (0.054 UCMR 3 data (USEPA, 2019b). The EPA supplemented its UCMR data with data L/kg/day) and a 20% RSC (USEPA, has determined in accordance with collected by states who have made their 2016e). The lifetime HA of 0.07 mg/L is SDWA 1412(b)(1)(B)(ii)(II) that the data publicly available at this time. In used as the HRL for Regulatory UCMR 3 data are the best available some cases, EPA obtained the data Determination 4. occurrence information for the PFOA/ directly from the state’s public website The RfDs for both PFOA and PFOS PFOS regulatory determinations. UCMR while, in others, these data were are both based on developmental effects 3 monitoring occurred between 2013 provided to EPA. Specifically, the EPA and are numerically identical. Thus, and 2015and currently represents the evaluated publicly available monitoring when both chemicals co-occur at the only nationally-representative finished data that permitted summed PFOA and same time and location, the EPA water dataset for PFOA and PFOS. PFOS analyses from the state websites recommended a conservative and Under UCMR 3, 36,972 samples from of New Hampshire, Colorado, and health-protective approach of 0.07 mg/L 4,920 PWSs were analyzed for PFOA Michigan. Additional finished drinking for the PFOA/PFOS total combined and PFOS. The MRL for PFOA was 0.02 water monitoring data was provided to concentration (USEPA, 2016e). mg/L and the MRL for PFOS was 0.04 the EPA by the New Jersey Department The EPA has initiated a systematic mg/L. A total of 1.37% of samples had of Environmental Protection. These data literature review of peer-reviewed reported detections (greater than or are summarized in Table 9 below. The scientific literature for PFOA and PFOS equal to the MRL) of at least one of the EPA notes that some of these data are published since 2013 with the goal of two compounds. To examine the from targeted sampling efforts and thus identifying any new studies that may be occurrence of PFOS and PFOA in may not be representative of occurrence relevant to human health assessment. aggregate, the EPA summed the in the state. The EPA also notes that An annotated bibliography of identified states which chose to make their studies as well as the protocol used to concentrations detected in the same sample to calculate a total PFOS/PFOA occurrence data publicly available and identify the relevant publications can be the state that chose to provide its data found in Appendix D of the Regulatory concentration. The EPA notes that when these two to the EPA may not necessarily Determination 4 Support Document represent occurrence in other states. The (USEPA, 2019a), available in the docket chemicals co-occur at the same time and location in a drinking water source, a Regulatory Determination 4 Support for this document. Additional analyses Document presents a detailed of these new studies is needed to conservative and health-protective approach that EPA recommends would discussion of additional information confirm relevance, extract the data to from states on occurrence of these assess the weight of evidence, and be to compare the sum of the concentrations (USEPA, 2016g; USEPA, contaminants in drinking water systems identify critical studies in order to (USEPA, 2019a). The EPA is also aware inform future decision making. The EPA 2016h). The Regulatory Determination 4 Support Document presents a sample- that some of these states may have is seeking comment on any additional updated data available and that studies and information that it should level summary of the results for the individual contaminants (USEPA, additional states have or intend to consider. Should the EPA make a final conduct monitoring of finished drinking positive regulatory determination for 2019a). Concentrations of PFOS or PFOA below their respective MRLs were water, such as Illinois, Pennsylvania, PFOA and PFOS, the Agency will and Vermont. The EPA will consider undertake the SDWA rulemaking set equal to 0 mg/L when calculating the total PFOS/PFOA concentration for the any data submitted in response to this process to establish a National Primary proposal to inform future regulatory Drinking Water Regulation for those sample. The maximum summed concentration of PFOA and PFOS was decision making. The EPA is also aware contaminants. For that rulemaking of additional locations with drinking effort, in addition to using the best 7.22 mg/L and the median summed value was 0.05 mg/L. Summed PFOA available science, the SDWA requires 22 Sum of PFOA + PFOS results rounded to 2 that the Agency seek recommendations and PFOS concentrations exceeded the decimal places in those cases where a laboratory from the EPA Science Advisory Board, HRL (0.07 mg/L) at a minimum of 1.3% reported more digits.

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water impacts (including private wells) Hampshire and New Jersey permitted data sets summarized in Table 9 had at from contaminated sites. These include combined analysis of PFOS and PFOA least one instance of summed PFOS and sites near production facilities, active occurrence (i.e., with paired PFOS and PFOA concentrations greater than the and former military bases, and other PFOA concentrations reported for each HRL of 0.07 mg/L. Additional details can point sources.23 individual water sample). In addition, be found in the Regulatory For the following summed PFOA and Colorado and Michigan directly Determination 4 Support Document PFOS analyses, monitoring data sets reported monitoring results for (USEPA, 2019a). from public water systems in New combined PFOS and PFOA. All states

TABLE 9—COMBINED PFOS AND PFOA OCCURRENCE: SUMMARY OF STATE MONITORING RESULTS 24

State Date Type of water (reference) range tested Notes on coverage Summary of results Survey type

Colorado 2013– Surface Water Data available from 28 ‘‘drinking water distribu- The maximum summed con- Targeted. (CDPHE, 2017. (Finished tion zones’’ (one or more per public water centration of PFOA and 2018) Water) and system) in targeted sampling efforts at a PFOS was 0.3 μg/L and the Drinking known contaminated aquifer region. Data median summed value was Water Dis- were collected by El Paso County Public 0.09 μg/L. Summed PFOA tribution Health, local water districts and utilities, and and PFOS concentrations ex- Samples. the Colorado Department of Public Health ceeded the EPA HRL (0.07 and Environment (CDPHE). Results rep- μg/L) at 25% of distribution resent data collected in a targeted region. zones (7 distribution zones). Detection limits ranged from 0.002 μg/L to 0.040 μg/L. Michigan 2018– Groundwater Data available from 1,119 public community The maximum summed con- Statewide. (Michigan 2019. and Surface water systems, downloaded in October 2019. centration of PFOA and EGLE, Water—Raw Results are from the Michigan Department of PFOS was 1.52 μg/L and the 2019) and Finished Environment, Great Lakes and Energy median summed value was Water (Com- (EGLE) statewide sampling efforts for PFAS 0.004 μg/L. Summed PFOA munity Water of drinking water from community water sup- and PFOS concentrations ex- Supplies). plies. Results are presented for the sum of ceeded the EPA HRL (0.07 PFOA and PFOS concentrations. Information μg/L) at 0.09% of PWSs (1 on detection limits was not available. PWS). New Hamp- 2013– Groundwater Data available online from 295 PWSs providing The maximum summed con- Targeted. shire 2017. and Surface results to NH, including PWSs near contami- centration of PFOA and (NHDES, Water. nated sites. Results represent all PFOA and PFOS was 0.242 μg/L and 2017) PFOS water quality data reported to New the median summed value Hampshire Department of Environmental was 0.006 μg/L. Summed Services (NHDES) through May 3, 2017. PFOA and PFOS concentra- There is no discussion of representativeness. tions exceeded the EPA HRL Detection limits ranged from 0.0005 μg/L to (0.07 μg/L) at 1.01% of 0.04 μg/L. PWSs (3 PWSs). New Jersey 2019 ... Groundwater Statewide sampling of finished drinking water The maximum summed con- Statewide. (NJDEP, and Surface data between January 1, 2019 and June 28, centration of PFOA and 2019) Water—Fin- 2019. These represent the first two quarters PFOS was 1.09 μg/L and the ished Water. of statewide efforts to sample of finished median summed value was drinking water. Under this sampling effort, 0.01 μg/L. Summed PFOA 2,459 water samples from 1,049 PWS were and PFOS concentrations ex- analyzed for PFOA and PFOS. Detection lim- ceeded the EPA HRL (0.07 its ranged from 0.0016 - 0.0046 (doesn’t μg/L) at 1.14% of PWSs (12 specify for which PFAS compound). PWSs).

In addition to the monitoring data private wells where the data may be identified that approximately 50% of available from public water systems, indicative of contaminants in aquifers samples with PFAS detections North Carolina has made data from 17 that are used as sources for public water contained ≥2 PFASs, and 72% of private wells associated with the system wells. detections occurred in groundwater. Chemours facility in Fayetteville UCMR 3 data have also been used by Large PWSs (>10,000 customers) were available (NCDEQ, 2018). The maximum researchers to evaluate co-occurrence of 5.6 times more likely than small PWSs combined PFOS and PFOA PFAS in drinking water at PWSs. For (≤10,000 customers) to exhibit PFAS concentration was 0.0319 mg/L, while example, Guelfo and Adamson (2018) detections; however, when detected, the median was 0.004 mg/L. Summed investigated PFAS data from UCMR 3 median total PFAS concentrations were PFOS and PFOA concentrations did not for occurrence and co-contaminant higher in small PWSs (0.12 mg/L) than exceed the EPA HRL (0.07 mg/L) at any mixtures, trends in PFAS detections in large (0.053 mg/L). Hu et al. (2016) of the sampling sites. Note that the EPA relative to PWS characteristics and presented spatial analysis of PFAS does not regulate private drinking water potential release types, and temporal concentrations under UCMR 3 and wells but may evaluate data from trends in PFAS occurrence. The study found that the number of industrial sites

23 Examples include Chemours Washington Michigan (active and former military bases), and 24 Some of these data in these tables are from Works Facility, West Virginia (production non-military firefighting activities (other point targeted sampling efforts and therefore, would be facilities), Horsham Air National Guard Station, sources). expected to have higher detection rates than a Pennsylvania and former Wurtsmith Air Force Base, random sample.

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that manufacture or use these (USEPA, 2019d). Through these environment, multiple localized areas of compounds, the number of military fire engagements, the EPA heard significant contamination across the country may training areas, and the number of concerns from the public on the be a significant contributor to drinking wastewater treatment plants are all challenges these contaminants pose for water contamination. The state data sets significant predictors of PFAS detection communities nationwide and the need summarized in Table 9 had at least one frequencies and concentrations in for uniform, protective drinking water instance of summed PFOS and PFOA public water supplies. The authors regulations across the United States. concentrations greater than the HRL of found that for PFAS monitored under Based on the significant public 0.07 mg/L. While many detections are UCMR 3, the detection frequency in interest in the potential risks posed by marginally above the EPA HA levels, drinking water sourced from PFOA and PFOS, and the information there are many instances where groundwater was more than twice that currently available to the EPA, the localized samples substantially exceed from surface water. Additionally, PFOA Administrator has made the preliminary the HA levels, sometimes by 2–3 orders and PFOS were more frequently determination that regulation of PFOA of magnitude (i.e., a maximum summed detected in groundwater whereas UCMR and PFOS presents a meaningful concentration as high as 1.52 mg/L). The 3 PFAS compounds with shorter chain opportunity for health risk reduction for EPA believes there is significant public lengths were detected more frequently persons served by PWSs. In determining health risk reduction potential in the in surface waters. Hu et al. (2016) noted that regulation of PFOA and PFOS localized areas with these significantly that this observation could be due to the presents a meaningful opportunity for elevated concentrations. To assess original mode of environmental release health risk reduction for sensitive communities with the highest (aerosol, application to soil, and populations, the EPA was particularly exposures, the ATSDR has begun to aqueous discharge). mindful that PFOA and PFOS are perform PFAS exposure assessments in The state data (as presented above and known to be transmitted to the fetus via communities near current or former discussed in the Regulatory cord blood and to the newborn, infant, military bases with elevated Determination 4 Support Document), and child via breast milk (USEPA, concentrations of PFAS detected in while some are from targeted sampling 2016f). drinking water (ATSDR, 2019a). efforts and therefore, would be expected Data from recent state monitoring Adverse effects observed following to have higher detection rates than a efforts validate the UCMR 3 monitoring exposures to PFOA and PFOS are the random sample, show occurrence in results (USEPA, 2019b; NJ DEP, 2019). same or similar and include effects in multiple geographic locations consistent Sun et al. observed similar temporal humans on serum lipids, birth weight, with what was observed during UCMR trends in their investigation in the Cape and serum antibodies. Some of the 3 monitoring. Additionally, some state Fear Watershed of North Carolina, animal studies show common effects on monitoring efforts show detections where PFAS concentrations remained the liver, neonate development, and above the EPA Health Advisory in water similar between 2006 and 2013 (Sun et responses to immunological challenges. systems that were not required to al., 2016). These observations suggest Both compounds were also associated conduct monitoring in the UCMR 3. that PFOA and PFOS can be persistent with tumors in long-term animal studies EPA believes that these data support the in the environment, lack attenuation (USEPA, 2016g; USEPA, 2016h). States Agency’s preliminary determination processes that would degrade these have taken action to reduce exposures that PFOA and PFOS occur with a compounds over time and may be (as further discussed below). Some frequency and at levels of public health subject to precursor transformations. states have established regulatory or concern in drinking water systems The EPA believes PFOA and PFOS guidance levels in drinking water for across the United States. Additional occur at a frequency and at levels of PFOA, PFOS, as well as other PFAS details of the EPA analyses of UCMR 3 public health concern. UCMR 3 (ASDWA, 2019). Moving forward with a monitoring data for PFAS can be found indicates 1.3% of PWSs (63 PWSs) national-level regulation for PFOA and in the Regulatory Determination 4 monitored reported combined PFOA/ PFOS may provide additional national Support Document (USEPA, 2019a). The PFOS above the HRL. These systems consistency and reduce regulatory EPA requests comment on whether serve a total population of uncertainty for stakeholders across the there are additional occurrence data sets approximately 5.6 million people. country. that it can use to supplement the While this preliminary regulatory PFOA and PFOS are resistant to analyses already performed and inform determination is based, in part, on the environmental degradation processes its determination, including more recent UCMR occurrence data, it is also based such as hydrolysis, photolysis, and data from specific data sets mentioned on additional factors discussed above. biodegradation and are thus highly above. State data (as described above and persistent in the environment (USEPA, discussed in the Regulatory 2019a). In addition, biotic and abiotic d. Statutory Criterion #3 (Meaningful Determination 4 Support Document) processes can degrade PFAS precursors Opportunity) support the UCMR results, and the to form PFAAs such as PFOA and PFOS The EPA conducted extensive public Agency’s determination that PFOA and over time and thus are also important outreach in the development of the PFOS occur with a frequency and at contributors to the presence and PFAS Action Plan, including gathering levels of public health concern in persistence of these chemicals in the diverse perspectives through the May finished drinking water across the environment (ITRC, 2018). Additionally, 2018 National Leadership Summit, United States, with some results PFOA and PFOS are expected to have a direct engagement with the public in substantially elevated above the EPA’s high likelihood of partitioning to water impacted communities in five states, HAs. These data have also identified based on their ionic nature at typical engagement with tribal partners, and PFAS contamination in other locations, environmental pH and their organic roundtables conducted with community such as in small, previously carbon partitioning coefficients (Koc). leaders near impacted sites. In addition, unmonitored systems, beyond where the PFOA has a high likelihood of the Agency reviewed approximately UCMR 3 required water systems to partitioning to water based on its water 120,000 comments in the public docket conduct monitoring. Due to the solubility while the water solubility of that was specifically established to anthropogenic nature of PFOA and PFOS anion indicates a moderate gather input for the Action Plan PFOS and their persistence in the likelihood of partitioning to water.

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Therefore, PFOA and PFOS have high it is important to consider the media The Regulatory Determination 4 mobility and persistence in soil and reactivation and replacement frequency, Support Document (USEPA, 2019a) and groundwater and are expected to form the cost of reactivation or disposal of the Occurrence Data from the Third larger plumes than less mobile and spent media, and the potential for Unregulated Contaminant Monitoring persistent contaminants in the same overshoot (i.e., higher concentrations of Rule (UCMR 3) (USEPA, 2019b) present hydrogeological setting (ITRC, 2018). In a contaminant in the effluent than the additional information and analyses addition, long-range atmospheric influent, due to preferential adsorption supporting the Agency’s evaluation of transport of PFOA and PFOS through of other contaminants) if a treatment PFOA and PFOS. industrial releases (e.g., stack emissions) system is operated improperly (Crone et The agency solicits comment on all can accumulate to measurable levels in al., 2019; Speth, 2019). Reverse osmosis aspects of this preliminary regulatory soils and surface waters away from their and nanofiltration are effective for determination. In particular, the EPA point of release (Young et al., 2007; removing a wide range of PFAS. requests comment on whether there are Wallington et al., 2006; Dreyer et al., However, they have high capital and any additional data the agency should 2010). Although some manufacturing operations costs (Crone et al., 2019; consider in making its final regulatory companies agreed to phase out Speth, 2019). Additionally, membrane determination and whether EPA has production of PFOA and PFOS in the fouling, corrosion control, and the appropriately considered the data. United States, other sources could still disposal or treatment of concentrate f. Considerations for Additional PFAS exist such as fire training and stream are issues that need to be emergency response sites, industrial addressed (Crone et al., 2019; Speth, As stated in the EPA’s PFAS Action sites, landfills, and wastewater 2019). Additional literature and Plan (USEPA, 2019d): ‘‘The Agency treatment plant biosolids as well as discussion on the efficacy of these recognizes that there is additional information that the EPA should imported in products (USEPA, 2017c; treatments can be found on the EPA’s evaluate regarding PFAS other than ITRC, 2018). Drinking water analytical Drinking Water Treatability Database PFOA and PFOS, including new methods are available to measure PFOA, (USEPA, 2019e). monitoring and occurrence data, recent PFOS, and other PFAS in drinking Considering the population exposed health effects data, and additional water. The EPA has published validated to PFOA and PFOS including sensitive information to be solicited from the methodology for detecting a total of 29 populations and lifestages, such as public, which will inform the unique PFAS in drinking water children, the potential adverse human development of a national drinking including EPA Method 537.1 (18 PFAS) health impacts of these contaminants at water regulation for a broader class of (USEPA, 2018b) and EPA Method 533 low concentrations, the environmental PFAS in the future.’’ (25 PFAS) (14 PFAS can be detected by persistence, the persistence in the human body, the availability of both The EPA is aware that many states, both methods). Therefore, new tribes, and local communities face information about the occurrence of methods to measure and treatment technologies to remove these challenges from PFAS other than PFOA PFAS in drinking water will become and PFOS. For example, in addition to available as the Agency further contaminants, and significant public concerns regarding PFOA and PFOS PFOA and PFOS, the EPA worked with evaluates regulatory action for these states and public water systems to contaminants. contamination, the Agency proposes the finding that regulation of PFOA and characterize the occurrence of four Available treatment technologies for PFOS presents a meaningful additional PFAS (perfluorononanoic removing PFAS from drinking water opportunity for health risk reduction for acid (PFNA), perfluorohexanesulfonic have been evaluated and reported in the infants, children, and adults, including acid (PFHxS), perfluoroheptanoic acid literature (e.g., Dickenson and Higgins, pregnant and nursing women, served by (PFHpA), and PFBS)) in the nation’s 2016). The EPA’s Drinking Water PWS. While SDWA specifies that the drinking water served by public water Treatability Database (USEPA, 2019e) determination of whether PFOA and systems under UCMR 3. The EPA found summarizes available technical PFOS present ‘‘a meaningful that 4.0% of PWSs reported results for literature on the efficacy of treatment opportunity for health risk reduction for which one or more of the six UCMR 3 technologies for a range of priority persons served by public water PFAS were measured at or above their drinking water contaminants, including systems’’ is made ‘‘in the sole respective MRL. The 4.0% figure is PFOA and PFOS. Conventional judgement of the Administrator,’’ the based on 198 PWSs reporting treatment (comprised of the unit EPA seeks public comment on the measurable PFAS results for one or processes coagulation, flocculation, information and analyses described more sampling events from one or more clarification, and filtration) is not above. of their sampling locations. Those 198 considered effective for the removal of PWS serve an estimated total population e. Preliminary Regulatory Determination PFOA. Granular activated carbon (GAC), of approximately 16 million. anion exchange resins, reverse osmosis for PFOA and PFOS With the voluntary phase-out of and nanofiltration are considered At this stage, the Agency is making a PFOA and PFOS, manufacturers are effective for the removal of PFOA. preliminary determination to regulate shifting to alternative PFAS compounds However, there are limitations and PFOA and PFOS with an NPDWR after (e.g., hexafluoropropylene oxide (HFPO) uncertainties pertaining to these evaluating health, occurrence, and other dimer acid and HFPO dimer acid removal processes for PFAS. For related information against the three ammonium salt (GenX chemicals), and example, the treatment efficacy of GAC SDWA statutory criteria. The EPA has perfluorobutanesulfonic acid (PFBS)). and anion exchange resins is strongly preliminarily determined that PFOA There is less publicly available dependent upon the type of PFAS and PFOS may have an adverse effect on information on the occurrence and present and physio-chemical properties human health; that PFOA and PFOS health effects of these replacements than of the solution matrix. When mixed occur in PWSs with a frequency and at for PFOA and PFOS and other members PFAS are in the source water, short- levels of public health concern; and that of the carboxylic acid and sulfonate chain PFAS will break through the regulation of PFOA and PFOS presents PFAS families (Brendel et al., 2018). adsorber more quickly. When a system a meaningful opportunity for health risk The EPA plans to consider available makes treatment technology decisions, reduction for persons served by PWSs. human health toxicity and occurrence

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information for other PFAS as they (HERO), which is a database of scientific available, which may be suitable to become available. The EPA is working studies and other references used to inform the evaluation of potential on hazard assessments for the following develop the EPA’s risk assessments human health effects. Other references PFAS: GenX chemicals; PFBS; PFNA; aimed at understanding the health and provide information on occurrence perfluorobutanoic acid (PFBA); environmental effects of pollutants and (both in humans and the environment). perfluorodecanoic acid (PFDA); chemicals. While HERO uses a variety Available references for the PFAS listed perfluorohexanoic acid (PFHxA); and of reference types, the majority are below can be accessed at: https:// PFHxS. original research published in peer- hero.epa.gov/hero/index.cfm/litbrowser/ The following PFAS have literature reviewed literature. For some PFAS, public/#PFAS. available in the EPA’s Health and there are epidemiological and/or Environmental Research Online experimental animal toxicity data

Chemical name Acronym CAS No.

Perfluorooctanoic acid ...... PFOA ...... 335–67–1 Perfluorooctanesulfonic acid ...... PFOS ...... 1763–23–1 2H,2H,3H,3H-Perfluorooctanoic acid ...... 5:3 acid ...... 914637–49–3 6:2/8:2 Fluorotelomer phosphate diester ...... 6:2/8:2 diPAP ...... 943913–15–3 Bis[2-(perfluorohexyl)ethyl] phosphate ...... 6:2 diPAP ...... 57677–95–9 Mono[2-(perfluorohexyl)ethyl] phosphate ...... 6:2 monoPAP ...... 57678–01–0 Bis[2-(perfluorooctyl)ethyl] phosphate ...... 8:2 diPAP ...... 678–41–1 Mono[2-(perfluorooctyl)ethyl] phosphate ...... 8:2 monoPAP ...... 57678–03–2 4,8-dioxa-3H-perfluorononanoic acid ...... ADONA ...... 919005–14–4 6:2 Fluorotelomer alcohol ...... FtOH 6:2 ...... 647–42–7 8:2 Fluorotelomer alcohol ...... FtOH 8:2 ...... 678–39–7 6:2 Fluorotelomer sulfonic acid ...... FtS 6:2 ...... 27619–97–2 8:2 Fluorotelomer sulfonic acid ...... FtS 8:2 ...... 39108–34–4 HFPO dimer acid ...... GenX chemicals ..... 13252–13–6 HFPO dimer acid ammonium salt ...... GenX chemicals ..... 62037–80–3 2-(N-Ethylperfluorooctanesulfonamido) acetic acid ...... NEtFOSAA ...... 2991–50–6 2-(N-Methylperfluorooctanesulfonamido) acetic acid ...... NMeFOSAA ...... 2355–31–9 Perfluorobutanoic acid ...... PFBA ...... 375–22–4 Perfluorobutanesulfonic acid ...... PFBS ...... 375–73–5 Perfluorodecanoic acid ...... PFDA ...... 335–76–2 Perfluorododecanoic acid ...... PFDoA ...... 307–55–1 Perfluorodecanesulfonic acid ...... PFDS ...... 335–77–3 Perfluoroheptanoic acid ...... PFHpA ...... 375–85–9 Perfluoroheptanesulfonic acid ...... PFHpS ...... 375–92–8 Perfluorohexanoic acid ...... PFHxA ...... 307–24–4 Perfluorohexanesulfonic acid ...... PFHxS ...... 355–46–4 Perfluorononanoic acid ...... PFNA ...... 375–95–1 Perfluorononanesulfonic acid ...... PFNS ...... 68259–12–1 Perfluorooctanesulfonamide ...... PFOSA ...... 754–91–6 Perfluoropentanoic acid ...... PFPeA ...... 2706–90–3 Perfluoropentanesulfonic acid ...... PFPeS ...... 2706–91–4 Perfluorotetradecanoic acid ...... PFTeDA ...... 376–06–7 Perfluoroundecanoic acid ...... PFUnA ...... 2058–94–8

The EPA continues to work towards methods-descriptions. To further conducting ongoing toxicological filling information gaps for human understand occurrence in drinking studies for multiple PFAS compounds health, toxicity and occurrence water and discussed in the EPA’s PFAS of varying length in rats, including 28- including through collaborations with Action Plan (USEPA, 2019d), the EPA day studies for 7 PFAS compounds (3 federal, state, tribal, and other will propose a nationwide drinking carboxylates and 4 sulfonates), and a 2- stakeholders. The EPA is generating water monitoring for PFAS under the year chronic toxicity and PFAS toxicology data through new next UCMR monitoring cycle (UCMR 5) carcinogenicity study for PFOA that is approaches such as high throughput utilizing newer methods available to currently undergoing peer-review. screening, computational toxicology detect more PFAS chemicals and at ATSDR developed a draft toxicological tools, and chemical informatics for lower MRLs than previous possible for profile that characterizes toxicologic chemical prioritization, screening, and the earlier UCMR monitoring. These and adverse health effects information risk assessment. This research can monitoring results will improve for PFOA, PFOS, and 10 other PFAS inform a more complete understanding understanding of the frequency and compounds which include PFBA, of PFAS toxicity for the large set of concentration of PFAS occurrence in the PFHxA, PFHpA, PFNA, PFDA, PFUnA, PFAS chemicals without conventional finished U.S. drinking water. PFDoA, PFBS, PFHxS, and PFOSA toxicity data and allow prioritization of The EPA is also aware of ongoing (ATSDR, 2018). Some states, including actions to potentially address groups of toxicity work and guideline California, Michigan, Minnesota, New PFAS. For additional information on the development by other federal agencies, Hampshire, New Jersey, New York and new approach methods for PFAS state governments, international Vermont, are also developing health- toxicity testing, please visit: https:// organizations, industry groups, and based guidance or drinking water www.epa.gov/chemical-research/pfas- other stakeholders. For example, the standards for individual targeted PFAS chemical-lists-and-tiered-testing- U.S. National Toxicology Program is or the sum for several targeted PFAS

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(California OEHHA, 2019; potential future regulatory actions using groups of PFAS to account for similar Commonwealth of Massachusetts, 2019; information completed prior to a physiochemical characteristics. The MDH, 2019; Michigan Science Advisory potential rule proposal. Examples of EPA’s ORD and the National Institute of Workgroup, 2019; NHDES, 2019; suitable information sources the EPA Environmental Health Sciences’ NJDOH, 2017; NYSDOH, 2018; VTDEC, could evaluate under future actions (NIEHS) National Toxicology Program 2019). PFAS that have been or are being include current and expected peer recently identified a subset of PFAS for evaluated by at least one state include reviewed toxicity assessments, testing with the goals of supporting Hexafluoropropylene Oxide (HFPO) nationwide drinking water monitoring read-across within structure-based Dimer Acid and its Ammonium Salt data, state drinking water monitoring subgroups and capturing the diversity of (GenX chemicals), PFBA, PFBS, PFHpA, data, and monitoring data from other the broader PFAS class (Helman et al., PFHxA, PFHxS, PFNA, PFOA, and Federal Agencies. This approach would 2019; Patlewicz et al., 2019a, 2019b). PFOS. The EPA will evaluate all be limited to those individual PFAS for The EPA is also exploring new available and reliable information to which sufficient health and occurrence approaches such as high throughput and inform future decision making for these information is available or can be computational approaches to explore PFAS contaminants. The EPA is also clearly and logically extrapolated. The different chemical categories of PFAS. aware of PFAS monitoring efforts by EPA is actively working to fill The EPA will continue research on states and local communities to better information gaps needed to support this methods for using these data to support understand PFAS occurrence in approach including developing toxicity risk assessments using new approach drinking water, including both assessments for PFBS, HFPO dimer acid methods such as read-across (i.e., an statewide drinking water monitoring and HFPO dimer acid ammonium salt or effort to predict biological activity based efforts and targeted sampling at GenX chemicals, PFBA, PFHxA, PFNA, on similarity in chemical structure) and locations that have potentially been and PFHxS, and PFDA. The EPA plans transcriptomics (i.e., a measure of impacted by releases or locations where to propose nationwide drinking water changes in gene expression in response PFAS-containing materials are known to monitoring for PFAS under the next to chemical exposure or other external have been used (Table 9). The EPA will UCMR monitoring cycle (UCMR 5) stressors), and to make inferences about consider these other information utilizing newer methods available to the toxicity of PFAS mixtures that sources to inform future decisions for measure more PFAS and at lower commonly occur in real world other PFAS. minimum reporting levels than previous exposures. Example classifications that UCMR monitoring. The EPA may also the EPA could consider in its group g. Potential Regulatory Approaches consider health assessments and evaluation include common adverse Since PFOA and PFOS raise occurrence data that are currently being effects, chain length (e.g., long chain complicated issues and since the developed by other federal, state and and short chain), functional groups (e.g., issuance of any NPDWR imposes costs international agencies. sulfonates, acids), degradation products on the public, the EPA is taking (i.e., some PFAS degrade to shorter Evaluate Additional PFAS by Different advantage of this document by chain PFAS), co-occurrence, or using a Grouping Approaches exploring and seeking comment on combination of physiochemical and fate potential regulatory constructs and Since the 1940s, over 4000 PFAS have characteristics (e.g., long chain monitoring requirements the Agency been manufactured and used in a perfluoroalkyl sulfonic acids). may consider for PFAS chemicals variety of industries across the world including PFOA and PFOS if it were to (Guelfo et al., 2018; OECD 2019). Evaluate PFAS Based on Drinking Water finalize positive regulatory Evaluations of the retrospective Treatment Techniques determinations. As noted above in the reporting requirements of the TSCA SDWA 1412(b)(7)(A) authorizes the EPA PFAS Action Plan (USEPA, 2019d), Inventory Notification Rule indicates EPA to promulgate a treatment the EPA is seeking information from the 602 PFAS are currently commercially technique rule rather than an MCL if the public to ‘‘inform the development of active in the United States. The EPA Agency determines it is not national drinking water regulation for a recognizes the challenges associated economically or technologically feasible broader class of PFAS in the future’’. with evaluating each PFAS that may to ascertain the level of the The EPA is seeking feedback on impact drinking water on an individual contaminant. The EPA continues to potential regulatory approaches to basis. The EPA has regulated develop reliable analytical methods to address PFAS to support the potential contaminants as a group in drinking monitor for PFAS including evaluating development of a PFOA and PFOS water, including, for example, methodologies to measure total PFAS. regulation (pending final regulatory disinfection byproducts (i.e., haloacetic However, the EPA does not anticipate determinations) or in future PFAS acids and total trihalomethanes). that reliable and validated methods that regulatory actions. The EPA is exploring In their study of organohalogen flame accurately and precisely capture all how to best use the available retardants, the National Academies of PFAS or total PFAS (and not other information when developing potential Sciences evaluated general approaches fluorinated, non-PFAS compounds) will regulatory approaches for PFAS. Three to forming chemical classes at be available for a number of years. potential regulatory approach options regulatory agencies and concluded that Therefore, the Agency is considering described below include (1) evaluate a ‘‘science-based class approach does whether a treatment technique each additional PFAS on an individual not necessarily require one to evaluate regulatory approach may be appropriate. basis; (2) evaluate additional PFAS by a large chemical group as a single entity The strength of the carbon-fluorine different grouping approaches; and (3) for hazard assessment. That is, an bond makes certain PFAS (such as evaluate PFAS based on drinking water approach that divides a large group into perfluoroalkyl acids) relatively stable treatment techniques. smaller units (or subclasses) to conduct compounds that are not removed by the hazard assessment is still a class conventional treatment such as Evaluate Each Additional PFAS on an approach for purposes of hazard or risk coagulation/flocculation/sedimentation. Individual Basis assessment’’ (NASEM, 2019). An Technologies that have reported This approach would focus on approach to exploring PFAS by groups removal efficiencies of greater than 90% evaluating PFAS individually for could, for example, include evaluating for certain PFAS include granulated

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activated carbon, powdered activated state specific characteristics and solubility. The octanol-water carbon, anion exchange resins, concerns. The Standardized Monitoring partitioning coefficient (log Kow) nanofiltration and reverse osmosis Framework for regulated synthetic indicates that 1,1-dichloroethane is (Crone et al., 2019; Dickenson and organic chemicals under 40 CFR expected to have a moderate likelihood Higgins, 2016; Ross et al., 2018; USEPA, 141.24(h) provides a framework for of partitioning to water, while the 2019e). Each of these technologies has determining compliance with a Henry’s Law Constant (KH) indicates benefits and limitations that need to be potential future MCL. Under this that this compound is expected to have considered if they are to be used when approach, monitoring frequency would a low likelihood of partitioning to water. treating PFAS contaminated drinking be dependent on whether the 1,1-Dichloroethane is expected to have water, such as cost and operational contaminant has been detected above a moderate to high persistence in certain feasibility (Speth, 2019). For example, certain ‘‘trigger level’’ and/or detected waters based on biodegradation half- nanofiltration and reverse osmosis are above an MCL, and whether a waiver lives (USEPA, 2019a). highly effective at removing PFAS but from monitoring has been granted by the b. Statutory Criterion #1 (Adverse are more costly options and generate Primacy Agency. Health Effects) large waste streams that may require An alternative approach to the additional treatment. Anion exchange is Standardized Monitoring Framework 1,1-Dichloroethane may have an effective at removing long-chain PFAS could be to require monitoring at public adverse effect on the health of persons. constituents but may be less effective at water systems only when data show the Based on a 13-week gavage study in rats removing short-chain PFAS. Granular presence of PFAS in finished drinking (Muralidhara et al., 2001), the kidney activated carbon has the advantage of water and those designated by the was identified as a sensitive target for being a less costly treatment technology Primacy Agency. Under this approach, 1,1-dichloroethane, and no-observed- and has the ability to be regenerated, monitoring would be required for public adverse-effect level (NOAEL) and however other organic matter present in water systems with PFAS monitoring lowest-observed-adverse-effect level the influent water may interact and data and/or vulnerable systems (LOAEL) values of 1,000 and 2,000 mg/ compete for adsorption sites with PFAS, designated by the state or Primacy kg/day, respectively, were identified potentially making treatment less Agency. For example, monitoring could based on increased urinary enzyme effective. In addition, unintended be required if a Primacy Agency is markers for renal damage and central consequences of PFAS treatment also aware of information indicating nervous system (CNS) depression need consideration given regional potential PFAS contamination of the (USEPA, 2006a). The only available reproductive or differences in source water quality and public water supply. Information that developmental study with 1,1- treatment strategies in the United States. could be considered includes proximity dichloroethane is an inhalation study Additional discussion on benefits and to facilities with historical or on-going where pregnant rats were exposed on limitations associated with drinking use of fire-fighting foam and proximity days 6 through 15 of gestation (Schwetz water treatment technologies for PFAS to facilities that use or manufacture et al., 1974). No effects on the fetuses can be found in the Regulatory PFAS. Determination Support Document were noted at 3,800 ppm. Delayed (USEPA, 2019a). 2. 1,1-Dichloroethane ossification of the sternum without accompanying malformations was A treatment technique regulation a. Background would address multiple PFAS with reported at a concentration of 6,000 similar characteristics that may be 1,1-Dichloroethane is a halogenated ppm. removed by similar treatment alkane. It is an industrial chemical and A cancer assessment for 1,1- technologies including some for which is used as a solvent and a chemical dichloroethane is available on IRIS validated drinking water methods are intermediate. Annual production and (USEPA, 1990a). That assessment currently available. importation of 1,1-dichloroethane in the classifies the chemical, according to the United States was last reported by IUR EPA’s 1986 Guidelines for Carcinogenic Monitoring Considerations in 2006 to be between 500,000 and 1 Risk Assessment (USEPA, 1986), as Should an MCL be established for million pounds. The data show that Group C, a possible human carcinogen. PFOA, PFOS, and/or other PFAS production of 1,1-dichloroethane in the This classification is based on no chemicals pursuant to section 1412 of United States has declined since human data and limited evidence of the SDWA, PWSs could be required to reporting began in 1986. Under CDR, carcinogenicity in two animal species monitor for these contaminants. The there were no reports of 1,1- (rats and mice), as shown by increased EPA may seek to minimize the dichloroethane production in 2012, incidences of hemangiosarcomas and monitoring burden on water systems 2013, 2014, or 2015 (USEPA, 2019a). mammary gland adenocarcinomas in while assuring public health protection. TRI data for 1,1-dichloroethane from female rats and hepatocellular Minimizing the monitoring burden to the years 1994–2016 show that an carcinomas and benign uterine polyps the maximum extent feasible and average of about 12,000 pounds per year in mice (NCI, 1978). The data were allowed by statute could reduce costs of reported releases have entered the considered inadequate to support for drinking water systems that have environment from 2003 onward. The quantitative assessment. The close other important risk-reduction resource number of states with releases of 1,1 structural relationship between 1,1- demands. The EPA is considering dichloroethane has stayed steady at dichloroethane and 1,2-dichloroethane, alternative approaches for this about five since 2004, while the number which is classified as a B2 probable monitoring that reduce monitoring of states with surface water discharges human carcinogen and produces tumors frequency for systems that are reliably has averaged two since 1994; surface at many of the same sites where and consistently below the MCL or do water discharges ranged from 0 to 235 marginal tumor increases were observed not detect the contaminant. This pounds per year over the approximately for 1,1-dichloroethane, supports the framework provides primacy agencies 20-year period (USEPA, 2019a). suggestion that the 1,1-isomer could with the flexibility to issue monitoring 1,1-Dichloroethane is expected to possibly be carcinogenic to humans. waivers, with the EPA’s approval, have a high likelihood of partitioning to Mixed results in initiation/promotion which take into account regional and water based on its Koc and water studies and genotoxicity assays are

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consistent with this classification. On on the EPA’s evaluation of the following e. Preliminary Regulatory Determination the other hand, the animals from the occurrence information. for 1,1-dichloroethane 1,1-dichloroethane National Cancer The primary occurrence data for 1,1- The Agency is making a preliminary Institute (NCI, 1978) study were housed dichloroethane are recent (2013–2015) determination to not regulate 1,1- with animals being exposed to 1,2- nationally-representative drinking water dichloroethane with an NPDWR after dichloroethane providing opportunities monitoring data generated through the evaluating health, occurrence, and other for possible co-exposure impacting the EPA’s UCMR 3. Under UCMR 3, 36,848 related information against the three 1,1-dichloroethane results. The samples were collected from 4,916 SDWA statutory criteria. While data following groups of individuals may PWSs and analyzed for 1,1- suggest that 1,1-dichloroethane may have an increased risk from exposure to dichloroethane. The contaminant was have an adverse effect on human health, 1,1-dichloroethane (NIOSH, 1978; not detected in any of the samples at the occurrence data indicate that 1,1- ATSDR, 2015): levels greater than 1⁄2 the HRL (500 mg/ dichloroethane is not occurring or is not • Those with chronic respiratory L) or the HRL (1,000 mg/L). 1,1- likely to occur in PWSs with a disease Dichloroethane was detected in about frequency and at levels of public health • Those with liver diseases that impact 2.3% samples at or above the MRL (0.03 concern. Therefore, the Agency has hepatic microsomal cytochrome P– mg/L) (USEPA, 2019a; USEPA, 2019b). determined that an NPDWR for 1,1- 450 functions Occurrence data for 1,1- dichloroethane would not present a • Individuals with impaired renal dichloroethane in finished drinking meaningful opportunity to reduce function and vulnerable to kidney water are also available from UCM health risk for persons served by PWSs. stones Rounds 1 and 2 (1988–1992 and 1993– The Regulatory Determination 4 • Individuals with skin disorders 1997). None of those samples exceeded Support Document (USEPA, 2019a) and vulnerable to irritation by solvents 1⁄2 the HRL or the HRL. In the Round 1 the Occurrence Data from the Third like 1,1- dichloroethane cross-section states, 1,1 dichloroethane Unregulated Contaminant Monitoring • Those who consume alcohol or use was detected at 233 PWSs (1.14% of Rule (UCMR 3) (USEPA, 2019b) present pharmaceuticals (e.g., phenobarbital) PWSs). Detected concentrations ranged additional information and analyses that alter the activity of cytochrome from 0.01 mg/L to 500 mg/L. In the supporting the Agency’s evaluation of P–450s Round 2 cross-section states, 1,1 1,1-dichloroethane. dichloroethane was detected at 184 A provisional chronic RfD was 3. Acetochlor derived from the 13-week gavage study PWSs (0.74% of PWSs). Detected in rats based on a NOAEL of 1,000 mg/ concentrations ranged from 0.00126 mg/ a. Background kg/day administered for five days/week L to 159 mg/L (USEPA, 2008c; USEPA, Acetochlor is a chloroacetanilide and adjusted to 714.3 mg/kg/day for 2019a). pesticide that is used as an herbicide for continuous exposure (an increase in Occurrence data for 1,1- pre-emergence control of weeds. It was urinary enzymes was the adverse impact dichloroethane in ambient water are first registered by the EPA in 1994. It is on the kidney). The chronic oral RfD of available from the NAWQA program. registered for use on corn crops (field 0.2 mg/kg/day was derived by dividing Those data show that 1,1- corn and popcorn); corn fields treated the normalized NOAEL of 714.3 mg/kg/ dichloroethane was detected in between with acetochlor may later be rotated to day in male Sprague-Dawley rats by a 2% and 4% of samples from between grain sorghum (milo), soybeans, wheat, combined UF of 3,000. The combined 2% and 4% of sites. No detections were and tobacco. In March of 2006, the EPA UF includes factors of 10 for greater than the HRL. The median released a Report of the Food Quality interspecies extrapolation, 10 for concentrations based on detections were Protection Act (FQPA) Tolerance extrapolation from a subchronic study, less than 0.06 mg/L (WQP, 2018). Reassessment Progress and Risk 10 for human variability, and 3 for Ambient water data for 1,1- Management Decision (TRED) for database deficiencies (including lack of dichloroethane analysis are also Acetochlor (USEPA, 2006b). In 2010, the reproductive and developmental available from the NWIS database. EPA approved the use of acetochlor on toxicity tests by the oral route). This Those data show that 1,1- cotton as a rotational crop (USEPA, assessment noted several limitations in dichloroethane was detected in 2010a). Synonyms for acetochlor the critical study and database as a approximately 5% of samples (1,152 out include 2-chloro-2′-methyl-6-ethyl-N- whole. Specifically, that the reporting of of 24,560) and at approximately 5% of ethoxymethylacetanilide (USEPA, the results in the critical study were sites (620 out of 12,057). The median 2019a). marginally adequate and that the concentration of detections was 0.380 According to the EPA Pesticide database lacks information on mg/L (USEPA, 2019a). Industry Sales and Usage reports, the reproductive and developmental and amount of acetochlor active ingredient d. Statutory Criterion #3 (Meaningful nervous system toxicity. used in the United States was between Opportunity) The EPA calculated an HRL for 1,1- 31 and 36 million pounds in 1997; dichloroethane of 1,000 mg/L, based on 1,1-Dichloroethane does not present a between 30 and 35 million pounds in the EPA oral RfD of 0.2 mg/kg/day, meaningful opportunity for health risk 1999, 2001 and 2003; between 26 and 31 using 2.5 L/day drinking water reduction through regulation for persons million pounds in 2005; between 28 and ingestion, 80 kg body weight and a 20% served by PWSs based on the estimated 33 million pounds in 2007; between 23 RSC factor. exposed population, including sensitive and 33 million pounds in 2009; and populations. UCMR 3 findings indicate between 28 and 38 million pounds in c. Statutory Criterion #2 (Occurrence at that the estimated population exposed 2012 (USEPA, 2019a). Frequency and Levels of Public Health to 1,1-dichloroethane at levels of public USGS pesticide use data show that Concern) health concern is 0%. As a result, the there has been an increase in the annual The EPA proposes to find that 1,1- Agency finds that an NPDWR for 1,1- usage of acetochlor, from about 32 dichloroethane does not occur with a dichloroethane does not present a million pounds per year in 2010 to over frequency and at levels of public health meaningful opportunity for health risk 45 million pounds in 2016. This concern in public water systems based reduction. increase can largely be attributed to the

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use of acetochlor on crops other than mg/kg/day, based on the NOAEL of 2 As a result, the Agency finds that an corn (USEPA, 2019a). mg/kg/day from the 1-year oral chronic NPDWR for acetochlor does not present If released to soil, acetochlor is feeding study in beagle dogs, is a meaningful opportunity for health risk expected to have moderate to high expected to be protective of both reduction. mobility (HSDB, 2012). Acetochlor is noncancer and cancer effects. expected to have a high likelihood of The EPA calculated an HRL of 100 mg/ e. Preliminary Regulatory Determination for Acetochlor partitioning to water based on its KH. L based on the EPA OPP RfD for non- The values for Koc indicate that cancer effects for acetochlor of 0.02 mg/ The Agency is making a preliminary acetochlor is expected to have a kg/day (USEPA, 2018c) using 2.5 L/day determination to not regulate acetochlor moderate to high likelihood of drinking water ingestion, 80 kg body with an NPDWR after evaluating health, partitioning to water. The water weight, and a 20% RSC factor. occurrence, and other related solubility indicates that acetochlor is c. Statutory Criterion #2 (Occurrence at information against the three SDWA expected to have a moderate likelihood Frequency and Levels of Public Health statutory criteria. While data suggest of partitioning to water. Acetochlor is Concern) that acetochlor may have an adverse expected to have low to moderate effect on human health, the occurrence persistence based on aerobic and The EPA proposes to find that data indicate that acetochlor is not anaerobic biodegradation/ acetochlor does not occur with a occurring or not likely to occur in PWSs biotransformation half-lives (USEPA, frequency and at levels of public health with a frequency and at levels of public 2019a). concern in public water systems based health concern. The EPA also noted that on the EPA’s evaluation of the following the use of acetochlor has increased since b. Statutory Criterion #1 (Adverse occurrence information. Health Effects) the nationally representative data The primary data for acetochlor are collection from finished water under Acetochlor may have an adverse effect from the UCMR 1 a.m. (2001–2003) and UCMR 2 (i.e., 2008–2010). A review of on the health of persons. Subchronic UCMR 2 SS (2008–2010). Acetochlor ambient and limited finished water and chronic oral studies have was not detected at or above the MRL monitoring data collected since 2010 in demonstrated adverse effects on the of 2 mg/L or above the HRL of 100 mg/ NAWQA and NWIS show no 90th liver, thyroid (secondary to the liver L in any of the 33,778 UCMR 1 a.m. percentile values exceeding 1 mg/L. effects), nervous system, kidney, lung, samples (USEPA, 2008b; USEPA, 2019a) Therefore, the Agency has determined testes, and erythrocytes in rats and mice or in any of the 11,193 UCMR 2 SS that an NPDWR for acetochlor would (USEPA, 2006c; USEPA, 2018c). There samples (USEPA, 2015a; USEPA, not present a meaningful opportunity to was evidence of carcinogenicity in 2019a). reduce health risk for persons served by To ascertain the impact of increased studies conducted with acetochlor in PWSs. The Regulatory Determination 4 usage of acetochlor since the end of rats and mice and a non-mutagenic Support Document (USEPA, 2019a), The mode of action was demonstrated for UCMR 2, the EPA assessed ambient Analysis of Occurrence Data from the nasal and thyroid tumors in rats water and limited finished water data First Unregulated Contaminant (USEPA, 2006c). Cancer effects include collected after 2010. Sources of such Monitoring Regulation (UCMR 1) in nasal tumors and thyroid tumors in rats, data include the NAWQA program and Support of Regulatory Determinations lung tumors and histocytic sarcomas in the NWIS database. Three cycles of for the Second Drinking Water mice, and liver tumors in both rats and NAWQA data show that acetochlor was Contaminant Candidate List (USEPA, mice (Ahmed and Seely, 1983; Ahmed detected in between 13% and 23% of 2008b), and the Occurrence Data from et al., 1983; Amyes, 1989; Hardisty, samples from between 3% and 10% of the Second Unregulated Contaminant 1997a; Hardisty, 1997b; Hardisty, 1997c; sites. While maximum values in Monitoring Regulation (UCMR 2) Naylor and Ribelin, 1986; Ribelin, 1987; NAWQA Cycle 2 (2002–2012) and Cycle (USEPA, 2015a) present additional USEPA, 2004b; USEPA, 2006c; and 3 (2013–2017) monitoring exceeded the information and analyses supporting the Virgo and Broadmeadow, 1988). No HRL (215 mg/L in 2004 and 137 mg/L in Agency’s evaluation of acetochlor. biologically sensitive human 2013) (only one sample in each of those subpopulations have been identified for two cycles exceeded the HRL), 90th 4. Methyl Bromide (Bromomethane) acetochlor. Developmental and percentile levels of acetochlor remained a. Background reproductive toxicity studies do not below 1 mg/L. More than 10,000 samples indicate increased susceptibility to were collected in each cycle. Non- Methyl bromide is a halogenated acetochlor exposure at early life stages NAWQA NWIS data (1991–2016), alkane and occurs as a gas. Methyl in test animals (USEPA, 2006c). which included limited finished water bromide has been used as a fumigant The study used to derive the oral RfD data in addition to the ambient water fungicide, applied to soil before is a 1-year oral chronic feeding study data, show no detected concentrations planting, to crops after harvest, to conducted in beagle dogs. This study greater than the HRL (USEPA, 2019a). vehicles and buildings, and for other describes a NOAEL of 2 mg/kg/day, and specialized purposes. a LOAEL of 10 mg/kg/day, based on the d. Statutory Criterion #3 (Meaningful Methyl bromide is an ozone-depleting critical effects of increased salivation; Opportunity) chemical regulated under the Montreal increased levels of alanine Acetochlor does not present a Protocol. Use of the chemical in the aminotransferase (ALT) and ornithine meaningful opportunity for health risk United States was phased out in 2005, carbamoyl transferase (OTC); increased reduction for persons served by PWSs except for specific critical use triglyceride levels; decreased blood based on the estimated exposed exemptions and quarantine and pre- glucose levels; and alterations in the population, including sensitive shipment exemptions. Critical use histopathology of the testes, kidneys, populations. The estimated population exemptions have included strawberry and liver of male beagle dogs (USEPA, exposed to acetochlor at levels of public cultivation and production of dry cured 2018c; ICI, Inc., 1988). The UF applied health concern is 0% based on UCMR pork. Additional information on the was 100 (10 for intraspecies variation 1 finished water data gathered from methyl bromide phase-out and and 10 for interspecies extrapolation). 2001 to 2003 and UCMR 2 finished exemptions in the United States can be The EPA OPP RfD for acetochlor of 0.02 water data gathered from 2008 to 2010. found on the EPA’s website: https://

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www.epa.gov/ods-phaseout/methyl- between 5 and 9 million pounds in (ATSDR, 1992a), a lower dose of 0.4 mg/ bromide. 2009; and between 2 and 6 million kg/day is selected as the NOAEL In August of 2006, the EPA released pounds in 2012 (USEPA, 2019a). because ‘‘mild focal hyperemia’’ was a TRED for methyl bromide and a RED USGS pesticide use data show that observed at the 1.4 mg/kg/day dose for commodity uses (USEPA, 2006d). A there has been a decrease of methyl level. It is worth noting that authors of RED for soil fumigant uses was released bromide use through 2016 down to this study reported neoplastic changes in July 2008, and amended in May 2009 about 2 million pounds from a high of in the forestomach. However, the EPA (USEPA, 2009e). In 2011, the EPA about 78 million pounds in 1995 (USGS, and others (USEPA, 1985; Schatzow, issued a cancellation order for certain 2018). 1984) re-evaluated the histological soil-related uses of methyl bromide, but If released to dry or moist soil, methyl results, concluding that the lesions were this order did not affect its use as a post- bromide is expected to be volatile hyperplasia and inflammation, not harvest fumigant (76 FR 29238; USEPA, (HSDB, 2019); its KH indicates that neoplasms. ATSDR notes that 2011d). Synonyms for methyl bromide methyl bromide is expected to have a histological diagnosis of epithelial include bromomethane, low likelihood of partitioning to water carcinomas in the presence of marked monobromomethane, curafume, Meth- from air. Methyl bromide is expected to hyperplasia is difficult (Wester and O-Gas, and Brom-O-Sol (HSDB, 2019). have a high likelihood of partitioning to Kroes 1988; ATSDR 1992a). A report by the United Nations water based on its Koc and water Additionally, the hyperplasia of the Environment Programme (UNEP, 2018) solubility. The log Kow indicates that forestomach observed after 13 weeks of indicates that critical use exemptions in methyl bromide is expected to have a exposure to bromomethane regressed the United States under the Montreal moderate likelihood of partitioning to when exposure ended (Boorman et al. Protocol declined steadily from 9,553 water. Methyl bromide is predicted to 1986; ATSDR 1992a). metric tons of methyl bromide in 2005 have low persistence in soil based on The EPA selected an OPP Human to 235 metric tons in 2016 and stood at experiments under simulated conditions Health Risk Assessment from 2006 as 0 in 2017 and 2018. A total 50 metric in reaction with aniline. Measured the basis for developing the HRL for tons were ‘‘on hand’’ in the United hydrolysis half-lives indicate moderate methyl bromide (USEPA, 2006e). As States at the end of 2016 (UNEP, 2018). persistence in water (USEPA, 2019a). described in the OPP document, the Exempted quarantine and pre-shipment b. Statutory Criterion #1 (Adverse study was of chronic duration (two uses continue. Production data for Health Effects) years) with four groups of male rats and methyl bromide are available from the four groups of female rats treated orally EPA’s IUR and CDR programs, and Methyl bromide may have an adverse via encapsulated methyl bromide. In the industrial release data are available from effect on the health of persons. The OPP assessment (USEPA, 2006e), the EPA’s TRI database, as described limited number of studies investigating Mertens (1997) was identified as the below. the oral toxicity of methyl bromide critical study and decreased body The most recent quantities of methyl indicate that the route of administration weight, decreased rate of body weight bromide produced and imported (in influences the toxic effects observed gain, and decreased food consumption 2013, 2014, and 2015, as reported in (USEPA, 2006e). The forestomach of rats were the critical effects in rats orally CDR) are classified as CBI. The last (forestomachs are not present in exposed to methyl bromide (USEPA, publicly available data for production of humans) appears to be the most 2006e). The NOAEL was 2.2 mg/kg/day methyl bromide are from 2006, under sensitive target of methyl bromide when and the LOAEL was 11.1 mg/kg/day. IUR, when production was in the range it is administered orally by gavage The RfD derived in the 2006 OPP of 10 to <50 million pounds (USEPA, (ATSDR, 1992a). Acute and subchronic Human Health Assessment is 0.022 mg/ 2019a). oral gavage studies in rats identified kg/day, based on the point of departure TRI data from 1988 to 2016 show a stomach lesions (Kaneda et al., 1998), (POD) of 2.2 mg/kg/day (the NOAEL) general long-term declining trend in hyperemia (excess blood) (Danse et al., and a combined uncertainty factor (UF) industrial releases of methyl bromide, 1984), and ulceration (Boorman et al., of 100 for interspecies variability (10) from over one million pounds per year 1986; Danse et al., 1984) of the and intraspecies variability (10). No in the 1990s to under 500,000 pounds forestomach. However, forestomach benchmark dose modeling was most years since 2010. Air emissions effects were not observed in rats and performed. have tended to dominate releases, with stomach effects were not observed in Neurological effects reported after the exception of 2015, when an dogs that were chronically exposed to inhalation exposures have not been anomalous large quantity (350,000 methyl bromide in the diet, potentially reported after oral exposures, indicating pounds) was reported released by because methyl bromide degrades to that route of exposure may influence the underground injection from a single other bromide compounds in the food most sensitive adverse health endpoint facility. In 2016, facilities in 11 states (Mertens, 1997). Decreases in food (USEPA, 1988). reported releases of any kind and consumption, body weight, and body Limited data are available regarding facilities in two states reported on-site weight gain were noted in the chronic the developmental or reproductive surface water discharges (USEPA, rat study when methyl bromide was toxicity of methyl bromide, especially 2019a). administered in capsules (Mertens, via the oral route of exposure. ATSDR According to the EPA’s Pesticide 1997). (1992a) found no information on Industry Sales and Usage reports, the In a subchronic (13-week) rat study developmental effects in humans with amount of methyl bromide active (Danse et al., 1984), a NOAEL of 1.4 mg/ methyl bromide exposure. An oral ingredient used in the United States was kg/day (a time weighted average, 5⁄7 developmental toxicity study of methyl between 38 and 45 million pounds in days, of the 2 mg/kg/day dose group) bromide in rats (doses of 3, 10, or 30 1997; between 28 and 33 million was selected in the EPA IRIS assessment mg/kg/day) and rabbits (doses of 1, 3, or pounds in 1999; between 20 and 25 based on severe hyperplasia of the 10 mg/kg/day) found that there were no million pounds in 2001; between 13 and stratified squamous epithelium in the treatment-related adverse effects in 17 million pounds in 2003; between 12 forestomach, in the next highest dose fetuses of the treated groups of either and 16 million pounds in 2005; between group of 7.1 mg/kg/day (USEPA, 1989a). species (Kaneda et al., 1998). ATSDR’s 11 and 15 million pounds in 2007; In ATSDR’s Toxicological Profile 1992 Toxicological Profile also did not

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identify any LOAELs for rats or rabbits risk among 7,814 applicators of methyl In all three NAWQA cycles, methyl in this study. In rats exposed to 30 mg/ bromide (Barry et al., 2012). In OPP’s bromide was detected in fewer than 1% kg/day, there was an increase in fetuses Draft HHRA for Methyl Bromide, OPP of samples from fewer than 2% of sites. having 25 presacral vertebrae; however, reviews all the epidemiological studies No detections were greater than the HRL ATSDR notes that there were no for methyl bromide, including the Barry in any of the three cycles. The median significant differences in the number of et al. (2012) Agricultural Health Study. concentration among detections were litters with this variation and the effect OPP concludes that ‘‘based on the 0.5 mg/L and 0.8 mg/L in Cycle 1 and was not exposure-related (ATSDR, review of these studies, there is Cycle 3, respectively. There were no 1992a). No significant alterations in insufficient evidence to suggest a clear detections in Cycle 2. The results of the resorptions or fetal deaths, number of associative or causal relationship non-NAWQA NWIS analysis show that live fetuses, sex ratio, or fetal body between exposure to methyl bromide methyl bromide was detected in weights were observed in rats and no and carcinogenic or non-carcinogenic approximately 0.1% of samples at alterations in the occurrence of external, health outcomes.’’ approximately 0.1% of sites. The visceral, or skeletal malformations or According to ATSDR (1992a) and the median concentration among detections variations were observed in the rabbits. EPA OPP assessment (USEPA, 2006e), was 0.6 mg/L. Some inhalation studies reported no no studies suggest that a specific d. Statutory Criterion #3 (Meaningful effects on development or reproduction, subpopulation may be more susceptible Opportunity) but other inhalation studies show to methyl bromide, though there is little adverse developmental effects. For information about susceptible lifestages Methyl bromide does not present a example, Hardin et al. (1981) and Sikov or subpopulations when exposed via the meaningful opportunity for health risk et al. (1980) conducted studies in rats oral route. Because the critical effects of reduction for persons served by PWSs based on the estimated exposed and rabbits and found no developmental decreased body weight, decreased rate population, including sensitive effects, even when maternal toxicity was of body weight gain, and decreased food populations. UCMR 3 findings indicate severe (ATSDR, 1992a). However, consumption in this study are not that the estimated population exposed another inhalation study of rabbits specific to a sensitive subpopulation or to methyl bromide at levels of public found increased incidence of life stage, the target population of the health concern is 0%. As a result, the gallbladder agenesis, fused vertebrae, general adult population was selected in Agency finds that an NPDWR for methyl and decreased fetal body weights in deriving the HRL for regulatory bromide does not present a meaningful offspring (Breslin et al., 1990). determination. EPA’s OPP assessment opportunity for health risk reduction. Decreased pup weights were noted in a conducted additional exposure multigeneration study in rats exposed to assessments for lifestages that may e. Preliminary Regulatory Determination 30 ppm (Enloe et al., 1986). increase exposure to methyl bromide for Methyl Bromide Reproductive effects were noted in and concluded that no lifestages have The Agency is making a preliminary intermediate-duration inhalation studies expected exposure greater than 10% of determination to not regulate methyl in rats and mice (Eustis et al., 1988; the chronic population-adjusted dose bromide with an NPDWR after Kato et al., 1986), which indicated that (cPAD), including children. evaluating health, occurrence, and other the testes may undergo degeneration The EPA calculated an HRL of 100 mg/ related information against the three and atrophy at high exposure levels. L (rounded from 140.8 mg/L) based on SDWA statutory criteria. While data In the OPP HHRA for methyl bromide an EPA OPP assessment cPAD of 0.022 suggest that methyl bromide may have (USEPA, 2006e), methyl bromide is mg/kg/day and using 2.5 L/day drinking an adverse effect on human health, the classified as ‘‘not likely to be water ingestion, 80 kg body weight, and occurrence data indicate that methyl carcinogenic to humans’’. In 2007, the a 20% RSC factor (USEPA, 2006d; bromide is not occurring or not likely to EPA published a PPRTV report which USEPA, 2011b, Table 8–1 and 3–33). occur in PWSs with a frequency and at stated that there is ‘‘inadequate c. Statutory Criterion #2 (Occurrence at levels of public health concern. information to assess the carcinogenic Frequency and Levels of Public Health Furthermore, in accordance with U.S. potential’’ of methyl bromide in humans Concern) obligations under the Montreal Protocol, (USEPA, 2007b). The PPRTV assessment production and importation of methyl agrees with earlier National Toxicology The EPA proposes to find that methyl bromide has steadily declined since Program (NTP) conclusions that the bromide does not occur with a 2005. available data indicate that methyl frequency and at levels of public health Therefore, the Agency has determined bromide can cause genotoxic and/or concern in PWSs based on the EPA’s that an NPDWR for methyl bromide mutagenic changes. The PPRTV evaluation of the following occurrence would not present a meaningful assessment states that the results in information. opportunity to reduce health risk for studies by Vogel and Nivard (1994) and The primary data for methyl bromide persons served by PWSs. The Gansewendt et al. (1991) clearly are from the UCMR 3 a.m., which was Regulatory Determination 4 Support indicate methyl bromide is distributed collected from January 2013 to Document (USEPA, 2019a) and the throughout the body and is capable of December 2015. A total of 36,848 Occurrence Data from the Third methylating DNA in vivo. However, the samples for methyl bromide were Unregulated Contaminant Monitoring PPRTV assessment also summarizes the collected from 4,916 systems. Of these Rule (UCMR 3) (USEPA, 2019b) present results of several studies in mice and systems, 49 (1.0% of systems) reported additional information and analyses rats that have not demonstrated at least one detection at or above the supporting the Agency’s evaluation of evidence of methyl bromide-induced MRL of 0.2 mg/L. A total of 0.31% of methyl bromide. carcinogenic changes (USEPA, 2007b; samples had concentrations greater than 5. Metolachlor NTP, 1992; Reuzel et al. 1987; ATSDR, or equal to the MRL (0.2 mg/L). Reported 1992a). In 2012, an epidemiology study methyl bromide concentrations range a. Background was published that concluded there was from 0.2 mg/L to 6.9 mg/L. There was no Metolachlor is a chloroacetanilide a significant monotonic exposure- occurrence above the 1⁄2 HRL or HRL pesticide that is used as an herbicide for dependent increase in stomach cancer thresholds. weed control. Initially registered in

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1976 for use on turf, metolachlor has USGS pesticide use data show that While some prenatal developmental more recently been used on corn, there has been a mild increase in studies in the rat and rabbit with both cotton, peanuts, pod crops, potatoes, metolachlor (racemic mixture) with a metolachlor and S-metolachlor revealed safflower, sorghum, soybeans, stone greater change in the amount of S- no evidence of a qualitative or fruits, tree nuts, non-bearing citrus, non- metolachlor relative to metolachlor. quantitative susceptibility in fetal bearing grapes, cabbage, certain Between 2010 and 2016, the increase in animals, decreased pup body weight peppers, buffalograss, guymon metolachlor usage is about 3 million was observed in a two-generation study bermudagrass for seed production, pounds, or about 30%, and for S- (Page, 1981, USEPA, 2018d). Though nurseries, hedgerows/fencerows, and metolachlor the increase is about 25 there was no evidence of maternal landscape plantings. In April of 1995, million pounds, or about 75% (USEPA, toxicity, decreased pup body weight in the EPA released a RED for metolachlor 2019a). the F1 and F2 litters was observed, (USEPA, 1995b) and a TRED was If released to soil, metolachlor is indicating developmental toxicity (Page, released in June of 2002 (USEPA, expected to have moderate to high 1981; USEPA, 1990b). Therefore, 2002c). In 2012, the EPA reinstated mobility. The EPA’s RED document sensitive lifestages to consider include tolerances for metolachlor on popcorn indicates that substantial leaching and/ infants, as well as pregnant women and to rectify an omission of these or runoff of metolachlor from soil is their fetus, and lactating women. tolerances in previous documentation expected to occur (USEPA, 1995b). Although treatment with metolachlor (USEPA, 2012b). The metolachlor Metolachlor is expected to have a high did not result in an increase in molecule can exist in right- and left- likelihood of partitioning to water based treatment-related tumors in male rats or handed versions (enantiomers), labeled on its KH, while its log Kow and water in mice (both sexes), metolachlor caused ‘‘R-’’ and ‘‘S-’’. (The chemical terms are solubility indicate that metolachlor is an increase in liver tumors in female dextrorotatory and levorotatory: the expected to have a moderate likelihood rats (USEPA, 2018d). There was no factor refers to the direction the of partitioning to water. The literature evidence of mutagenic or cytogenetic compound in solution rotates polarized provides a wide range of values for Koc effects in vivo or in vitro (USEPA, light.) The ‘‘S-’’ version is more potent (USEPA, 2019a provides additional 2018d). In 1994 (USEPA, 1995b), the as a pesticide. When manufacturers information). Metolachlor is expected to EPA classified metolachlor as a Group C found a way of producing metolachlor have moderate to high persistence in possible human carcinogen, in that was predominantly the ‘‘S-’’ soil and water under aerobic conditions accordance with the 1986 Guidelines for enantiomer in the late 1990s, they began based on aerobic biodegradation half- Carcinogen Risk Assessment (USEPA, marketing that as ‘‘S-metolachlor,’’ lives and high persistence in soil and 1986). In 2017 (USEPA, 2018d), the EPA while the racemic (roughly evenly water under anaerobic conditions based re-assessed the cancer classification for balanced) mixture continues to be sold on anaerobic biodegradation half-lives metolachlor in accordance with the as ‘‘metolachlor’’ (Hartzler, 2004). (USEPA, 2019a). EPA’s final Guidelines for Carcinogen Metolachlor and S-metolachlor are b. Statutory Criterion #1 (Adverse Risk Assessment (USEPA, 2005b), and under registration review (USEPA, Health Effects) reclassified metolachlor/S-metolachlor as ‘‘Not Likely to be Carcinogenic to 2014b). Synonyms for metolachlor Metolachlor may have an adverse include dual and bicep (USEPA, 2019a). effect on the health of persons. The Humans’’ at doses that do not induce Based on private market usage data, existing toxicological database includes cellular proliferation in the liver. This the EPA estimated that approximately 9 studies evaluating both metolachlor and classification was based on convincing million pounds of metolachlor active S-metolachlor. When combined with the evidence of a constitutive androstane ingredient and 28 million pounds of S- toxicology database for metolachlor, the receptor (CAR)-mediated mitogenic metolachlor active ingredient were toxicology database for S-metolachlor is MOA for liver tumors in female rats that applied annually between 1998 and considered complete for risk assessment supports a nonlinear approach when 2012, both mostly on corn (USEPA, purposes (USEPA, 2018d). In deriving a guideline that is protective 2014b). subchronic (metolachlor and S- for the tumor endpoint (USEPA, 2018d). According to the EPA’s Pesticide metolachlor) (USEPA, 1995b; USEPA, A recent OPP HHRA identified a two- Industry Sales and Usage reports, the 2018d) and chronic (metolachlor) generation reproduction study in rats as amount of metolachlor active ingredient (Hazelette, 1989; Tisdel, 1983; Page, the critical study (USEPA, 2018d). OPP (the racemic mixture) used in the 1981; USEPA, 2018d) toxicity studies in proposed an RfD for metolachlor of 0.26 United States was between 45 and 50 dogs and rats, decreased body weight mg/kg/day, derived from a NOAEL of 26 million pounds in 1987; between 63 and was the most commonly observed effect. mg/kg/day for decreased pup body 69 million pounds in 1997; between 26 Chronic exposure to metolachlor in rats weight in the F1 and F2 litters. A and 30 million pounds in 1999; between also resulted in increased liver weight combined UF of 100 was used based on 15 and 22 million pounds in 2001; and microscopic liver lesions in both interspecies extrapolation (10), between 1 and 5 million pounds on sexes (USEPA, 2018d). No systemic intraspecies variation (10), and an FQPA 24 2009; and between 4 and 8 million toxicity was observed in rabbits when Safety Factor of 1. This RfD is pounds in 2012. Furthermore, the metolachlor was administered dermally, 24 The EPA notes that for pesticide registrations amount of S-metolachlor active though dermal irritation was observed at under FIFRA, EPA’s Office of Pesticides derives ingredient used was between 16 and 19 lower doses (USEPA, 2018d). Portal of acute or chronic population adjusted doses (PADs) million pounds in 1999; between 20 and entry effects (e.g., hyperplasia of the using an FQPA Safety Factor mandated by the 24 million pounds in 2001; between 28 squamous epithelium and mucous cell) FQPA taking into consideration potential pre and/ or postnatal toxicity and completeness of the data and 33 million pounds in 2003; between occurred in the nasal cavity at lower with respect to exposure and toxicity to infants and 27 and 32 million pounds in 2005; doses in a 28-day inhalation study in children. In the majority of instances, the PAD and between 30 and 35 million pounds in rats (USEPA, 2018d). Systemic toxicity the RfD are the same. It is only in those few 2007; between 24 and 34 million effects were not observed in this study. instances when the FQPA Safety Factor is attributed to residual uncertainty with regard to exposure or pounds in 2009; and between 34 and 44 Immunotoxicity effects were not pre/postnatal toxicity that the RfD and PAD differ. million pounds in 2012 (USEPA, observed in mice exposed to S- More recently, FQPA Safety Factors can account for 2019a). metolachlor (USEPA, 2018d). uncertainties in the overall completeness of the

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considered protective of carcinogenic exceeded the HRL. The highest value in IUR data indicate that production of effects as well as effects observed in the NWIS data set (376 mg/L) exceeded nitrobenzene in the United States chronic toxicity studies (USEPA, the HRL, but the 99th percentile value increased between 1986 and 1990 and 2018d). The decreased F1 and F2 litter (13.3 mg/L) did not exceed the HRL25 stood at over 1 billion pounds per year pup body weights in the absence of (USEPA, 2019a). from 1990 to 2006. Data from the EPA’s maternal toxicity were considered CDR program indicate that production d. Statutory Criterion #3 (Meaningful indicative of increased susceptibility to of nitrobenzene was in the range of 1– Opportunity) the pups. Therefore, a rate of 0.15 L/kg/ 5 billion pounds per year in 2012, 2013, day was selected from the Exposure Metolachlor does not present a 2014, and 2015 (USEPA, 2019a). Factors Handbook (USEPA, 2011b) to meaningful opportunity for health risk TRI data for nitrobenzene show that represent the consumers-only estimate reduction for persons served by PWSs total releases were in the range of of DWI based on the combined direct based on the estimated exposed hundreds of thousands of pounds per and indirect community water ingestion population, including sensitive year from 1988 through 2016. at the 90th percentile for bottle fed populations. UCMR 2 findings indicate Underground injection dominated total infants. This estimate is more protective that the estimated population exposed reported releases, fluctuating between than the estimate for pregnant women to metolachlor at levels of public health approximately 191,000 pounds (in 2003) (0.033 L/kg/day) or lactating women concern is 0%. As a result, the Agency and over 860,000 pounds (in 1992). On- (0.054 L/kg/day). DWI and BW finds that an NPDWR for metolachlor site air emissions were in the range of parameters are further outlined in the does not present a meaningful tens of thousands of pounds annually. Exposure Factors Handbook (USEPA, opportunity for health risk reduction. Since 1999, surface water discharges of 2011b). nitrobenzene have not exceeded 500 The EPA OW calculated an HRL for e. Preliminary Regulatory Determination pounds per year (USEPA, 2019a). metolachlor of 300 mg/L (rounded from for Metolachlor Nitrobenzene is expected to have a high likelihood of partitioning to water 0.347 mg/L). The HRL was derived from The Agency is making a preliminary based on its water solubility. Multiple the oral RfD of 0.26 mg/kg/day for bottle determination to not regulate values for K indicate that nitrobenzene fed infants ingesting 0.15 L/kg/day metolachlor with an NPDWR after oc is expected to have a moderate to high water, with the application of a 20% evaluating health, occurrence, and other likelihood of partitioning to water, RSC. related information against the three while the log K and K indicate that SDWA statutory criteria. While data ow H c. Statutory Criterion #2 (Occurrence at nitrobenzene is expected to have a suggest that metolachlor may have an Frequency and Levels of Public Health moderate likelihood of partitioning to adverse effect on human health, the Concern) water. Nitrobenzene is expected to have occurrence data indicate that moderate persistence in water based on The EPA proposes to find that metolachlor is not occurring or not metolachlor does not occur with a its aerobic biodegradation half-life likely to occur in PWSs with a (USEPA, 2019a). frequency and at levels of public health frequency and at levels of public health concern in public water systems based concern. The EPA will continue to b. Statutory Criterion #1 (Adverse on the EPA’s evaluation of the following evaluate metolachlor as new finished Health Effects) occurrence information. water data become available. The primary data for metolachlor are Nitrobenzene may have an adverse Therefore, the Agency has determined from the UCMR 2 SS. A total of 11,192 effect on the health of persons. NTP that an NPDWR for metolachlor would (1983) conducted a 90-day oral gavage metolachlor samples were collected not present a meaningful opportunity to study of nitrobenzene in F344 rats and from 1,198 systems. Of these systems, reduce health risk for persons served by B6C3F1 mice. The rats were more three (0.25%) had metolachlor PWSs. The Regulatory Determination 4 sensitive to the effects of nitrobenzene detections and none of the detections Support Document (USEPA, 2019a) and exposure than the mice, and changes in were greater than 1⁄2 the HRL or the HRL the Occurrence Data from the Second absolute and relative organ weights, of 300 mg/L (USEPA, 2015a; USEPA, Unregulated Contaminant Monitoring hematologic parameters, splenic 2019a). Regulation (UCMR 2) (USEPA, 2015a) Nationally representative finished congestion, and histopathologic lesions present additional information and water occurrence data for metolachlor in the spleen, testis, and brain were analyses supporting the Agency’s are also available from the UCM Round reported. Based on statistically evaluation of metolachlor. 2 data set. In the Round 2 cross-section significant changes in absolute and relative organ weights, splenic states, metolachlor was detected at 108 6. Nitrobenzene congestion, and increases in reticulocyte PWSs (0.83% of PWSs). Detected a. Background concentrations ranged from 0.01 mg/L to count and methemoglobin (metHb) 13.8 mg/L. There were no exceedances of Nitrobenzene is a synthetic aromatic concentration, a LOAEL of 9.38 mg/kg/ day was identified for the subchronic 1⁄2 the HRL or the HRL of 300 mg/L nitro compound and occurs as an oily, (USEPA, 2008c; USEPA, 2019a). flammable liquid. It is commonly used oral effects of nitrobenzene in F344 To ascertain the impact of increased as a chemical intermediate in the male rats (USEPA, 2009f). This was the usage of metolachlor since the end of production of aniline and drugs such as lowest dose studied, so a NOAEL was UCMR 2, the EPA assessed ambient acetaminophen. Nitrobenzene is also not identified. The mice were treated water and limited finished water data used in the manufacturing of paints, with higher doses and were generally collected after 2010. Sources of such shoe polishes, floor polishes, metal more resistant to nitrobenzene toxicity, data include the NAWQA program and polishes, aniline dyes, and pesticides the toxic endpoints were similar in both the NWIS database. The EPA found no (USEPA, 2019a). species. The testis, epididymis, and values in the NAWQA data set that seminiferous tubules of the male 25 Approximately 99.9% of the metolachlor toxicity database, extrapolation from subchronic to samples in NWIS are from ambient water. The reproductive system are targets of a chronic study duration, and LOAEL to NOAEL highest finished water value in the NWIS data set nitrobenzene toxicity in rodents. In extrapolation. is 0.24 mg/L, which is much lower than the HRL. male rats (F344/N and CD) and mice

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(B6C3F1), nitrobenzene exposure via the assessment is 0.002 mg/kg/day. The 2,747). The median concentration oral and inhalation routes results in overall confidence in the RfD was among detections was 83.0 mg/L. histopathologic lesions of the testis and medium because the critical effect is d. Statutory Criterion #3 (Meaningful seminiferous tubules, testicular atrophy, supported by the overall database and is Opportunity) a large decrease in sperm count, and a thought to be protective of reproductive reduction of sperm motility and/or and immunological effects observed at Nitrobenzene does not present a viability, which contribute to a loss of higher doses; however, there are no meaningful opportunity for health risk fertility (NTP, 1983; Bond et al., 1981; chronic or multigenerational reduction for persons served by PWSs Koida et al., 1995; Matsuura et al., 1995; reproductive/developmental oral based on the estimated exposed Kawashima et al., 1995). These data studies available for nitrobenzene. population. UCMR 1 data indicate that suggest that nitrobenzene is a male- Because the critical effect in this study the estimated population exposed to specific reproductive toxicant (USEPA, (increased metHb in the adult rat) is not nitrobenzene above the HRL is 0.1%. As 2009f). specific to a sensitive subpopulation or a result, the Agency finds that an Under the Guidelines for Carcinogen lifestage, the general adult population NPDWR for nitrobenzene does not Risk Assessment (USEPA, 2005b), was selected in deriving the HRL for present a meaningful opportunity for nitrobenzene is classified as ‘‘likely to regulatory determination. health risk reduction. be carcinogenic to humans’’ by any The EPA calculated an HRL for the e. Preliminary Regulatory Determination route of exposure (USEPA, 2009f). A noncancer effects of nitrobenzene of 10 for Nitrobenzene two-year inhalation cancer bioassay in mg/L (rounded from 12.8 mg/L), based on The Agency is making a rats and mice (Cattley et al., 1994; CIIT, the RfD of 0.002 mg/kg/day, using 2.5 L/ 1993) reported an increase in several determination to not regulate day drinking water ingestion, 80 kg nitrobenzene with an NPDWR after tumor types in both species. However, body weight, and a 20% RSC factor. the lack of available data, including a evaluating health, occurrence, and other physiologically based biokinetic or c. Statutory Criterion #2 (Occurrence at related information against the three model that might predict the impact of Frequency and Levels of Public Health SDWA statutory criteria. While data the intestinal metabolism on serum Concern) suggest that nitrobenzene may have an levels of nitrobenzene and its adverse effect on human health, the The EPA proposes to find that occurrence data indicate that metabolites following oral exposures, nitrobenzene does not occur with a precluded the EPA’s IRIS program from nitrobenzene is not occurring or not frequency and at levels of public health likely to occur in PWSs with a deriving an oral CSF (USEPA, 2009f). concern in public water systems based Additionally, a metabolite of frequency and at levels of public health on the EPA’s evaluation of the following concern, and regulation of such nitrobenzene, aniline, is classified as a occurrence information. probable human carcinogen (B2) contaminant does not present a The primary data for nitrobenzene are (USEPA, 1988). meaningful opportunity for health risk Nitrobenzene has been shown to be nationally-representative drinking water reduction for persons served by PWSs. non-genotoxic in most studies and was monitoring data generated through the Therefore, the Agency has determined classified as, at most, weakly genotoxic EPA’s UCMR 1 (USEPA, 2008b), that an NPDWR for nitrobenzene would in the 2009 USEPA IRIS assessment collected from 2001 to 2003. UCMR 1 is not present a meaningful opportunity to (ATSDR, 1990; USEPA, 2009f). the only dataset with nationally- reduce health risk for persons served by Of the available animal studies with representative finished water data for PWSs. The Regulatory Determination 4 oral exposure to nitrobenzene, the 90- this contaminant. The EPA does not Support Document (USEPA, 2019a) and day gavage study conducted by NTP anticipate nitrobenzene occurrence the Occurrence Data from the First (1983) is the most relevant study for meaningfully changing from the UCMR Unregulated Contaminant Monitoring deriving an RfD for nitrobenzene. This 1 monitoring period given that reported Regulation (UCMR 1) (USEPA, 2008b) study used the longest exposure releases to surface water have generally present additional information and duration and multiple dose levels. decreased over time and detections of analyses supporting the Agency’s Benchmark dose software (BMDS) nitrobenzene in ambient waters and Six- evaluation of nitrobenzene. Year Review monitoring data are at low (version 1.4.1c; USEPA, 2007c) was 7. RDX applied to estimate candidate PODs for levels. UCMR 1 collected 33,576 deriving an RfD for nitrobenzene. Data nitrobenzene samples from 3,861 PWSs. a. Background for splenic congestion and increases in The contaminant was detected in only RDX is a nitrated triazine and is an reticulocyte count and metHb a small number of those samples explosive. The name RDX is an concentration were modeled. The POD (0.01%) above the HRL (10 mg/L), which abbreviation of ‘‘Royal Demolition derived from the male rat increased is the same as the MRL (10 mg/L). The eXplosive.’’ The formal chemical name metHb data with a benchmark response detections occurred in two large water is hexahydro-1,3,5-trinitro-1,3,5-triazine (BMR) of 1 standard deviation (SD) was systems (one surface water, the other (USEPA, 2019a). Annual production selected as the basis of the RfD (see groundwater); the maximum detected and importation of RDX in the United USEPA, 2009f for additional detail). concentration of nitrobenzene was 100 States was last reported by the EPA’s Therefore, the benchmark dose level mg/L. CDR program in 2015 to be in the range (BMDL) used as the POD is a BMDL1SD Occurrence data for nitrobenzene in of 1–10 million pounds. It appears to of 1.8 mg/kg/day. ambient water from the NAWQA have held steady in that range from In deriving the RfD, the EPA’s IRIS program show that nitrobenzene was 2002 onward (USEPA, 2019a). program applied a composite UF of not detected in any of the samples Studies have shown that this 1,000 to account for interspecies collected under any of the three compound is mobile in soil and extrapolation (10), intraspecies variation monitoring cycles. Non-NAWQA NWIS therefore likely to leach into (10), subchronic-to-chronic study data show that nitrobenzene was groundwater (ATSDR, 2012a). RDX is extrapolation (3), and database detected in approximately 1% of expected to have a high likelihood of deficiency (3) (USEPA, 2009f). Thus, the samples (60 out of 7,265) and at partitioning to water based on its log RfD calculated in the 2009 IRIS approximately 1% of sites (25 out of Kow and KH. Multiple values for Koc

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indicate that RDX is expected to have a was observed in males but not in presented in the 2018 EPA IRIS moderate to high likelihood of females (USEPA, 2018e). Although assessment. The slope factor is derived partitioning to water, while its water evidence of carcinogenicity included from the dose-response for lung and solubility indicates that RDX is dose-dependent increases in two liver tumors in the Lish et al. (1984) expected to have a moderate likelihood experimental animal species, two sexes, study, with elimination of the data for of partitioning to water. RDX is and two systems (liver and lungs), the high dose group due to high expected to have low to moderate evidence supporting carcinogenicity in mortality. The point of departure for the ¥1 persistence based on modeled addition to the B6C3F1 mouse study was slope factor of 0.08 (mg/kg/day) was biodegradation rates (USEPA, 2019a). not robust; this factor contributed to the the BMDL10 which was allometrically suggestive evidence of carcinogenic scaled to a HED. The EPA calculated an b. Statutory Criterion #1 (Adverse potential classification. The EPA oral cancer slope factor-derived HRL of Health Effects) considered both the Lish et al. (1984) 0.4 mg/L for RDX based on the cancer RDX may have adverse effects on the and Levine et al. (1983) studies to be slope factor of 0.08 (mg/kg/day)¥1, health of persons. Available health suitable for dose-response analysis using 2.5 L/day drinking water effects assessments include an IRIS because they were well conducted, ingestion, 80 kg body weight, and a 1 in toxicological review (USEPA, 2018e), using similar study designs with large a million cancer risk level. and older assessments including an numbers of animals at multiple dose The EPA’s (USEPA, 2018e) derivation ATSDR toxicological profile (ATSDR, levels (USEPA, 2018e). The EPA (2018e) of an oral slope factor for cancer is in 2012a) and an OW assessment concluded that insufficient information accordance with the Guidelines for published in the 1992 Drinking Water was available to evaluate male Carcinogen Risk Assessment (USEPA, Health Advisory: Munitions (USEPA, reproductive toxicity from experimental 2005b) while RDX is classified as having 1992). The EPA IRIS assessment (2018e) animals exposed to RDX. In addition, ‘‘suggestive evidence of carcinogenic presents an RfD of 0.004 mg/kg/day the EPA (2018e) concluded that potential.’’ Specifically, the guidelines based on convulsions as the critical inadequate information was available to state ‘‘when the evidence includes a effect observed in a subchronic study in assess developmental effects from well-conducted study, quantitative F–344 rats by Crouse et al. (2006). The experimental animals exposed to RDX. analyses may be useful for some POD for the derivation was a BMDL0.05 The EPA selected the 2018 EPA IRIS purposes, for example, providing a of 1.3 mg/kg/day derived using a assessment to derive two HRLs for RDX: sense of the magnitude and uncertainty pharmacokinetic model that identified The RfD-derived HRL (based on Crouse of potential risks, ranking potential the human equivalent dose (HED) based et al., 2006) and the oral cancer slope hazards, or setting research priorities’’ on arterial blood concentrations in the factor-derived HRL (based on Lish et al., (USEPA, 2005b). The EPA IRIS rats as the dose metric. A 300-fold UF 1984). The EPA has generally derived assessment concluded that the database (3 for extrapolation from animals to HRLs for ‘‘possible’’ or Group C for RDX contains well-conducted humans, 10 for interindividual carcinogens using the RfD approach in carcinogenicity studies (Lish et al., differences in human susceptibility, and past Regulatory Determinations. 1984; Levine et al., 1983) suitable for 10 for uncertainty in the database) was However, for RDX, the EPA decided to dose response and that the quantitative applied in determination of the RfD. show both an RfD-derived and oral- analysis may be useful for providing a Additionally, the EPA IRIS cancer-slope-factor-derived HRL since sense of the magnitude and uncertainty assessment (USEPA, 2018e) classified the mode of action for liver tumors is of potential carcinogenic risk (USEPA, data from the Lish et al. (1984) chronic unknown and the 1 × 10¥6 cancer risk 2018e). Therefore, the EPA felt it was study in B6C3F1 as providing suggestive level provides a more health protective important to evaluate the occurrence evidence of carcinogenic potential HRL to evaluate the occurrence information against both the RfD- following the EPA (USEPA, 2005b) information. derived HRL and the oral cancer slope guidelines. The slope factor was derived The RfD-derived HRL for RDX was factor-derived HRL. from the lung and liver tumors’ dose- calculated using the RfD of 0.004 mg/kg/ c. Statutory Criterion #2 (Occurrence at response in the Lish et al. (1984) study. day based on a subchronic study in F– Frequency and Levels of Public Health The POD for the slope factor was the 344 rats by Crouse et al. (2006) with Concern) BMDL10 allometrically scaled to a HED convulsions as the critical effect yielding a slope factor of 0.08 per mg/ (USEPA, 2018e). The point of departure The EPA proposes to find that RDX kg/day. for the RfD calculation was a human does not occur with a frequency and at In mice fed doses of 0 to 35 mg/kg/ equivalent BMDL0.05 of 1.3 mg/kg/day. levels of public health concern in public day for 24 months in the Lish et al. The HED was derived using a water systems based on the EPA’s (1984) study, there were dose- pharmacokinetic model based on evaluation of the following occurrence dependent increases in adenomas or arterial blood concentrations in the rats information. carcinomas of the lungs and liver in as the dose metric. A 300-fold The primary data for RDX are males and females (USEPA, 2018e). The uncertainty factor (3 for extrapolation nationally-representative drinking water formulation used contained 3 to 10% from animals to humans, 10 for monitoring data generated through the HMX, another munition ingredient. The interindividual differences in human EPA’s UCMR 2 a.m., collected from EPA assessed the toxicity of HMX susceptibility, and 10 for uncertainty in 2008 to 2010 (USEPA, 2015a). UCMR 2 (USEPA, 1988). No chronic-duration the database) was applied in is the only dataset with nationally- studies were available to evaluate the determination of the RfD. The EPA representative finished water data for carcinogenicity of HMX (USEPA, 1988). calculated a RfD-derived HRL of 30 mg/ this contaminant. Under UCMR 2, HMX is classified as Group D, or not L (rounded from 25.6 mg/L), for the 32,150 RDX samples were collected classifiable as to human carcinogenicity noncancer effects of RDX based on the from 4,139 PWSs. The contaminant was (USEPA, 1992; USEPA, 1988). In the RfD of 0.004 mg/kg/day, using 2.5 L/day detected in only a small number of Levine et al. (1983) RDX dietary drinking water ingestion, 80 kg body samples (0.01%) at or above the MRL (1 exposure study with Fischer 344 rats, a weight, and a 20% RSC factor. mg/L), which is about 2.5 times higher statistically significant increase in the The oral-cancer-slope-factor-derived than the oral cancer slope factor-derived incidence of hepatocellular carcinomas HRL for RDX was also based on values HRL (0.4 mg/L). The detections occurred

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in three large surface water systems; the Regulation (UCMR 2) (USEPA, 2015a) D. Infants, children and adolescents maximum detected concentration of present additional information and with low dietary intakes of bone RDX was 1.1 mg/L and the median analyses supporting the Agency’s forming nutrients are among the most detected value was 1.07 mg/L. evaluation of RDX. vulnerable to exposures to high levels of Occurrence data for RDX in ambient strontium during periods of bone water are not available from the V. Status of the Agency’s Evaluation of growth (USEPA, 2014c). Women who NAWQA program; however, non- Strontium, 1,4-Dioxane, and 1,2,3- are pregnant or lactating may also be NAWQA data are available from NWIS. Trichloropropane sensitive to strontium due to their The NWIS data show that RDX was A. Strontium increased requirement for bone-forming detected in approximately 46% of Strontium is an alkaline earth metal. nutrients and increased rates of bone samples (517 out of 1,115 samples) and On October 20, 2014 the Agency remodeling. Breast-fed infants (from at approximately 29% of sites (43 out of published its preliminary regulatory exposure to lactating mothers who have 147 sites). The median concentration an increased water intake), formula-fed determination to regulate strontium and based on detections was 26.0 mg/L (the infants (who will ingest a greater requested public comment on the 99th percentile was 120 mg/L and the volume of contaminated water), and the determination and supporting technical maximum value was 310 mg/L). While developing fetus (from exposure to information (USEPA, 2014a). Informed the NWIS data show that ambient pregnant women who have an increased by the public comments received, rather waters contain detectable levels of RDX, water intake) are other susceptible than making a final determination for the nationally-representative drinking subpopulations. In these populations strontium in 2016, the EPA delayed the water monitoring data indicate that only and lifestages, susceptibility is final determination to consider a small number of samples are at or enhanced by a combination of high additional data, and to decide whether above the MRL; Section III.a.3 notes that exposure and lifestage. ambient water data are a less important there is a meaningful opportunity for Toxicity studies indicate that factor in making a regulatory health risk reduction by regulating strontium can decrease the calcification determination. strontium in drinking water (USEPA, of the cartilaginous portion of bone. The 2016a). Specifically, the notification on results of animal studies show that the d. Statutory Criterion #3 (Meaningful the delayed final determination effects of strontium at doses from 400– Opportunity) mentioned that the EPA would evaluate 500 mg Sr/kg/day include small changes RDX does not present a meaningful additional studies on strontium in bone structure and inhibition of opportunity for health risk reduction for exposure and health studies related to calcification, consistent with early persons served by PWSs based on the strontium exposure. Since 2016, the development of osteomalacia and/or estimated exposed population, EPA has worked to identify and ‘‘strontium rickets.’’ Decreased levels of including sensitive populations. UCMR evaluate published studies on health osteoclasts and associated decreases in 2 findings indicate that the estimated effects associated with strontium bone resorption can also occur at these population exposed to RDX at or above exposure, sources of exposure to doses in animals. Higher doses of the MRL is 0.04%. As a result, the strontium, and treatment technologies to strontium can result in more severe Agency finds that an NPDWR for RDX remove strontium from drinking water. bone effects including reduced growth, does not present a meaningful In this document, the EPA is clarifying large areas of unmineralized bone, bone opportunity for health risk reduction. that it is continuing with its previous softening (‘‘strontium rickets’’ in young Based on the small number of samples 2016 decision (USEPA, 2016a) to delay animals, and osteomalacia in adults), measured at or marginally above the a final determination for strontium in excess growth of epiphyseal cartilage, MRL, the EPA does not believe that order to further consider additional and abnormal deposition of osteoid in there would be enough occurrence in studies related to strontium exposure. the metaphyses (USEPA, 2014c). More the narrow range between the HRL and With the preliminary regulatory recent information on strontium toxicity the MRL to change our meaningful determination in 2014, the EPA is now available in the peer reviewed opportunity determination. published a peer-reviewed HESD for literature. The EPA intends to do an strontium (USEPA, 2014c) and an HRL updated literature search and systematic e. Preliminary Regulatory Determination of 1,500 mg/L. That document addresses for RDX review before finalizing the assessment. exposure from drinking water and other The primary finished drinking water The Agency is making a preliminary media, toxicokinetics, hazard occurrence data for strontium are recent determination to not regulate RDX with identification, and dose-response (2013–2015) nationally-representative an NPDWR after evaluating health, assessment, and provides an overall drinking water monitoring data occurrence, and other related characterization of the risk from generated through the EPA’s UCMR 3. information against the three SDWA drinking water containing strontium. Under the UCMR 3, 62,913 samples statutory criteria. While data suggest The chemical similarity of strontium were analyzed for strontium; 2.8% of that RDX may have an adverse effect on to calcium allows it to exchange for those samples were found at human health, the occurrence data calcium in a variety of biological concentrations greater than the HRL indicate that RDX is not occurring or not processes, which could result in (potentially subject to change following likely to occur in PWSs with a detrimental health effects. The most examination of health studies), and frequency and at levels of public health important of these processes is the 99.8% of the samples were found at concern. Therefore, the Agency has substitution of calcium in bone, concentrations greater than the MRL determined that an NPDWR for RDX affecting skeletal development. Because (0.3 mg/L). In addition, approximately would not present a meaningful the mode of action for this adverse effect 5.8% of the PWSs had at least one opportunity to reduce health risk for is strontium uptake into bone, the detection greater than the HRL, persons served by PWSs. The toxicity of strontium depends on an corresponding to 6.2% of the U.S. Regulatory Determination 4 Support individual’s stage of bone development population. Document (USEPA, 2019a) and the and their intake of nutrients related to The EPA evaluated several treatment- Occurrence Data from the Second bone formation, such as calcium, related studies concerning strontium’s Unregulated Contaminant Monitoring magnesium, phosphorous and Vitamin removal from drinking water. A full-

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scale evaluation of strontium removal calcium in some drinking water systems performed with three strains of rats, two from groundwater sources at four lime and treatment technologies that remove strains of mice, and guinea pigs. The softening and four ion exchange strontium may also remove calcium. MOA by which 1,4-dioxane induces softening plants in Ohio was reported The agency is evaluating the tumors in animal models is not by Lytle et al. (2017). Raw waters effectiveness of treatment technologies conclusive, so a linear low dose contained between 13 and 28 mg/L, and under different water conditions, extrapolation was used to estimate 1.2 and 15 mg/L strontium at the ion including calcium concentrations. human carcinogenic risk (USEPA, exchange and lime softening plants, B. 1,4-Dioxane 2013). respectively. Ion exchange effectively For the HRL derivation, the EPA removed nearly all of the strontium, The EPA is not making a preliminary selected the oral cancer slope factor of although under typical operation, determination for 1,4-dioxane at this 0.10 (mg/kg/day)¥1 for 1,4-dioxane treated strontium levels were dictated time as the Agency has not determined derived by the EPA IRIS for by the percentage of water that by- whether there is a meaningful hepatocellular adenomas or carcinomas passed the ion exchange vessels. The opportunity for public health risk in female mice (2013). The principal amount of strontium that was removed reduction. As discussed in Section II.B.1 study selected for the derivation of an by lime softening ranged between 49 of this document, the EPA considers oral cancer slope factor was Kano et al., and 94% on average (or to final levels three statutory criteria mandated under 2009.26 The oral cancer slope factor was of between 0.2 and 3.6 mg/L) likely SDWA Section 1412(b)(1)(A) in making derived using linear extrapolation from dependent on treatment and water a decision to regulate a contaminant. the point of departure (POD) (i.e., the quality conditions. The EPA summarizes the current status 95% lower confidence limit on the dose O’Donnell et al. (2016) evaluated the of its evaluation of 1,4-dioxane below. associated with a benchmark response effectiveness of conventional treatment The EPA will continue to evaluate 1,4- near the lower end of the observed data) (i.e., coagulation/filtration) and lime- dioxane in the context of all three calculated by fitting a curve to the soda ash softening treatment methods to statutory criteria prior to making such a experimental dose-response data using remove strontium from drinking water. proposal as part of a future regulatory log-logistic benchmark dose modeling. The results indicated that coagulation/ determination. The EPA (USEPA, 2013) indicated that 1,4-Dioxane is used as a solvent in filtration was ineffective at removing a multistage model did not provide an cellulose formulations, resins, oils, strontium (6–12% removal) and lime- adequate fit because of the steep rise in waxes, and other organic substances; soda ash softening was more effective, the dose-response curve from the low- also used in wood pulping, textile with removal percentages as high as dose to the mid-dose followed by a processing, degreasing; in lacquers, 78%. Additionally, the authors noted plateau between the mid- and high-dose that the removal of strontium using paints, varnishes, and stains; and in paint and varnish removers. groups for the hepatocellular adenoma lime-soda ash softening in all of the or carcinoma incidence data in the softening jar tests was directly Health effects information for 1,4- dioxane are available from several female mice (USEPA, 2013). The EPA associated with substantial calcium performed a comparison of benchmark removal, typically at higher rates sources including EPA IRIS (USEPA, 2010b), ATSDR (2012b), and WHO dose (BMD) and benchmark dose limit compared to the removal of strontium. (BMDL) estimates derived for studies of Najm (2016) reviewed available (2005). The EPA’s IRIS assessment rats and mice and found that female literature for the removal of naturally (USEPA, 2010b) shows critical effects mice are more sensitive to 1,4-dioxane occurring stable strontium or for both noncancer (liver, kidney, and induced liver carcinogenicity than other anthropogenically produced radioactive nasal toxicity) and cancer species or types of tumors (USEPA, strontium from drinking water. The (hepatocellular adenoma and main conclusion was that precipitative carcinoma) endpoints. 2013). The EPA therefore derived an The EPA’s IRIS identified an oral oral cancer slope factor of 0.10 (mg/kg/ softening (i.e., lime-soda ash softening) ¥1 and cation-exchange are the most reference dose (RfD) for 1,4-dioxane of day) for 1,4-dioxane using the BMDL feasible options. Additionally, the 0.03 mg/kg/day based on the Kociba HED for hepatocellular adenomas or report highlights that chemical (1974) 2-year rat feeding study in which carcinomas in female mice with a precipitation is targeted for the removal hepatic and renal toxicity in male rats benchmark response of 50% as the POD of calcium or magnesium and it is were identified as critical effects (USEPA, 2013). The EPA calculated an unknown if targeted removal of (Kociba, 1974; USEPA, 2010b; USEPA, HRL for 1,4-dioxane of 0.32 mg/L based strontium can be achieved. Likewise, 2013). The LOAEL of 94 mg/kg/day was on the cancer slope factor of 0.1 (mg/kg/ ¥1 partial removal of calcium is based on hepatocellular degeneration day) , using 2.5 L/day drinking water unavoidable with cation exchange, even and necrosis as well as renal tubule ingestion, 80 kg body weight, and a 1 in in a process targeted for strontium epithelial cell degenerative changes and a million cancer risk level. The EPA removal. necrosis in male Sherman rats, with a recently released a draft risk evaluation While the EPA determined in 2014 NOAEL of 9.6 mg/kg/day. A composite for 1,4-dioxane (USEPA, 2019f) that that strontium may have adverse effects UF of 300 was applied to the RfD to includes an oral slope factor different on the health of persons including account for pharmacokinetic and than that provided by IRIS (USEPA, children, the Agency continues to pharmacodynamic differences between 2010b). Additionally, Health Canada consider additional data, consult rats and humans (10); interindividual released a guideline technical document existing assessments (such as ATSDR’s variability (10); and database for 1,4-dioxane for public consultation Toxicological Profile from 2004 and deficiencies (3) (USEPA, 2010b; USEPA, in 2018 (Health Canada, 2018). The Health Canada’s Drinking Water 2013). consultation period ended November 9, Guideline from 2018), and evaluate In 2013, the EPA IRIS classified 1,4- 2018 and a final publication is pending. whether there is a meaningful dioxane as ‘‘likely to be carcinogenic to opportunity for health risk reduction by humans’’ in accordance with the EPA’s 26 Note that the study results for the two-year drinking water study have been reported in regulating strontium in drinking water. 2005 Guidelines for Carcinogenic Risk multiple publications and/or communications Additionally, the EPA understands that Assessment, based on evidence of (Kano et al., 2009; Yamazaki et al., 1994; JBRC, strontium may co-occur with beneficial carcinogenicity in two-year studies 1998; and Yamazaki, 2006).

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Once completed, the EPA will consider systems where system averages of 1,4- factor for 1,2,3-trichloropropane of 30 whether either the newer EPA oral slope dioxane were greater than the HRL are (mg/kg/day)¥1 (USEPA, 2009g). The factor or Canadian guideline technical in California and New York. oral cancer slope factor was calculated document is appropriate to inform a The Agency is not making a for adult exposures and does not take regulatory determination. preliminary determination for 1,4- into account presumed early-life The primary occurrence data for 1,4- dioxane at this time as the Agency has susceptibility to 1,2,3-trichloropropane dioxane are recent (2013–2015) not determined whether there is a exposure. As outlined in the IRIS nationally-representative drinking water meaningful opportunity for public assessment, the evidence indicates that monitoring data generated through the health risk reduction. The Agency 1,2,3-trichloropropane carcinogenicity EPA’s UCMR 3. Under the UCMR 3, intends to complete its new risk occurs via a mutagenic MOA. The EPA 36,810 samples were analyzed for 1,4- evaluation for 1,4-dioxane that is provides guidance on assessing early dioxane; 3.4% of those samples were currently in draft (USEPA, 2019f) and life carcinogen exposure (USEPA, found at concentrations greater than the consider it and the Canadian guideline 2005b; USEPA, 2005c), and children HRL, and 11.4% of the samples were technical document and other relevant potentially exposed to mutagenic found at concentrations greater than the new science prior to making a carcinogens can be assumed to have the MRL (0.07 mg/L). In addition, regulatory determination. This potential for increased early-life approximately 7.8% of the PWSs had at evaluation may provide clarity as to susceptibility to carcinogens. Therefore, least one detection greater than the HRL. whether there is a meaningful for mutagenic carcinogens, the EPA While the health effects data suggest opportunity for an NPDWR to reduce recommends that risk assessors apply that 1,4-dioxane may have an adverse public health risk. The Regulatory special adjustment factors to a given effect on human health and the Determination 4 Support Document cancer slope factor which are dependent occurrence data indicate that 1,4- (USEPA, 2019a) and the Occurrence on age (ADAFs). Section 5.4.5 of the dioxane is occurring in finished Data from the Third Unregulated IRIS assessment for 1,2,3- drinking water above the HRL, the EPA Contaminant Monitoring Rule (UCMR 3) trichloropropane describes application continues to evaluate whether there is a (USEPA, 2019b) present additional of the ADAFs to the CSF. The EPA meaningful opportunity to reduce information and analyses supporting the recommends the application of these health risk for persons served by PWSs Agency’s evaluation of 1,4-dioxane. ADAFs when estimating cancer risks by establishing an NPDWR for 1,4- C. 1,2,3-Trichloropropane from early life (<16 years of age) dioxane. Based on UCMR 3 data, the exposure to 1,2,3-trichloropropane EPA derived a national estimate of less 1,2,3-Trichloropropane is a man-made (USEPA, 2009g). Thus, the EPA than two baseline cancer cases per year chemical used as an industrial solvent, calculated an HRL of 0.0004 mg/L (0.4 attributable to 1,4-dioxane in drinking cleaning and degreasing agent, and ng/L) using ADAFs and a cancer risk water. The EPA derived this estimate by synthesis intermediate. Due to level of one cancer case per million using the CSF from the IRIS assessment analytical method-based limitations, the people. (USEPA, 2013), a national extrapolation EPA is not making a preliminary The primary occurrence data for 1,2,3- of UCMR 3 population-weighted mean determination on 1,2,3-trichloropropane trichloropropane are nationally- exposure data, and the assumption that at this time. representative drinking water all UCMR 3 non-detect samples were Health effects information for 1,2,3- monitoring data generated through the equivalent to the MRL (0.07 mg/L), trichloropropane is available from EPA EPA’s UCMR 3 (2013–2015). Under the which was intended to result in a high- IRIS (USEPA, 2009g), EPA OW (USEPA, UCMR 3, an MRL of 0.03 mg/L was end estimate of the number of national 1989b), ATSDR (1992b; 2011), and identified for the method used to cancer cases. However, while the California OEHHA (2009). The most analyze that contaminant (EPA Method number of baseline cancer cases is recent health assessment is the EPA’s 524.3).29 For the 36,848 samples relatively low, other adverse health IRIS assessment (USEPA, 2009g), which collected during UCMR 3, 0.69% of the effects following exposure to 1,4- uses an NTP study (NTP, 1993) to derive samples exceeded the MRL. Further, dioxane may also contribute to potential both an RfD of 0.004 mg/kg/day for about 1.4% of PWSs had at least one risk to public health, and these analyses noncancer effects and a CSF of 30 (mg/ ¥1 detection over the MRL, corresponding have not yet been completed. kg/day) . The NTP (1993) chronic to 2.5% of the population. As the EPA evaluates whether there is duration oral bioassay gavage study of While the UCMR 3 data indicated a meaningful opportunity to protect rats and mice shows critical effects for 1,2,3-trichloropropane occurrence was public health by establishing a national- both noncancer (increased liver weight) relatively low at concentrations above level drinking water regulation for 1,4- and cancer endpoints (alimentary the MRL, the MRL (0.03 mg/L) is more dioxane, the Agency recognizes that system squamous cell neoplasms, liver than 75 times the HRL (0.0004 mg/L) for several states have ongoing activities hepatocellular adenomas or carcinomas, 1,2,3-trichloropropane. This relevant to control of 1,4-dioxane in Harderian gland adenoma, uterine/ discrepancy allows for a broad range of PWSs. For example, New York State has cervix adenomas or carcinomas) for oral 27 potential contaminant concentrations a recommended MCL of 1.0 mg/L, and exposure. 1,2,3-Trichloropropane that could be in exceedance of the HRL California has a notification level of 1 received a classification of ‘‘likely to be but below the MRL. Thus, the EPA m 28 g/L. Based on UCMR 3 data, 38% of carcinogenic to humans’’ based on needs additional lower-level occurrence statistically significant increases in 27 information prior to making a In December 2018, the New York State multiple tumors types in rats and mice. preliminary regulatory determination Departments of Health and Environmental The HRL for the cancer effects is Conservation announced that the New York State Drinking Water Quality Council has recommended based on the EPA IRIS cancer slope 29 Under UCMR 3, the MRL for an analyte, as that the Department of Health ‘‘adopt an MCL for determined by a specified analytical method, is a 1,4-dioxane of 1.0 part per billion’’ (i.e., 1.0 mg/L). level at which the source is removed from service, reporting threshold set at a level at which New York State approved Advanced Oxidative is 35 mg/L. The notification level is slightly greater quantitation is achievable, with 95% confidence, by Process (AOP) as an effective treatment technology than the de minimis (1 X 10E–6) level commonly a capable analyst/laboratory at least 75% of the time for 1,4-dioxane. used for notification levels based on cancer risk, when using the specified analytical method. This 28 The California drinking water notification level reflecting difficulty in monitoring 1,4-dioxane at simultaneously accounts for both precision and for 1,4-dioxane is 1 mg/L. The response level, the very low concentrations. accuracy.

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for 1,2,3-trichloropropane. The NPDWR for PFOA and PFOS beyond the information provided about the three Regulatory Determination 4 Support information described in this document. contaminants discussed in Section V to Document (USEPA, 2019a) and the The EPA notes that ongoing evaluations inform potential future regulatory Occurrence Data from the Third of PFOA and PFOS health effects determinations. Unregulated Contaminant Monitoring include the National Toxicology VII. References Rule (UCMR 3) (USEPA, 2019b) present Program’s Technical Report on the additional information and analyses Toxicology and Carcinogenesis Studies Ahmed, F.E. and J.C. Seely. 1983. Acetochlor: supporting the Agency’s evaluation of of PFOA, ATSDR toxicity assessments, Chronic Feeding Toxicity and 1,2,3-trichloropropane. as well as state health assessments. Oncogenicity Study in the Rat. • The EPA requests comment upon Pharmacopathics Research Laboratories, VI. EPA’s Request for Comments and Inc., Laurel, MD. Study No. PR–80–006. potential regulatory constructs, Next Steps May 20, 1983. Unpublished report (as grouping approaches, and potential cited in USEPA, 2006c). The EPA invites commenters to monitoring requirements described in Ahmed, F.E., A.S. Tegeris, and J.C. Seely. submit any relevant data or information Sections III.A.1. and IV.B.1.f of this 1983. MON 097: 24-Month Oncogenicity pertaining to the preliminary regulatory document. Study in the Mouse. Pharmacopathics determinations identified in this • The EPA requests additional studies Research Laboratories, Inc., Laurel, MD. document, as well as other relevant and data that characterizes the Report No. PR–80–007. May 4, 1983. comments. The EPA will consider the occurrence of PFAS in drinking water. Unpublished report (as cited in USEPA, public comments and/or any new, 2006c). The Agency is particularly interested in Amyes, S.J. 1989. SC–5676: 78 Week Feeding relevant data submitted for the datasets that include: Æ Study in CD–1 Mice. Life Science contaminants discussed in this Information on the sample data that Research Ltd., Suffolk, England. Study document and in the supporting includes: Location and sample type (raw No. 87/SUC0012/0702. June 9, 1989. rationale. or treated water; groundwater or surface Unpublished report (as cited in USEPA, The data and information requested water source); 2006c). by the EPA include peer-reviewed Æ Information on the measurement Association of State Drinking Water science and supporting studies results that includes: Specific analyte, Administrators (ASDWA). 2019. Per- and conducted in accordance with sound analytical method used; measurement Polyfluoroalkyl Substances (PFAS) State and objective scientific practices, and Drinking Water Program Challenges. results; units and qualifiers; detection https://www.asdwa.org/pfas/. Web page data collected by accepted methods or limit values (for non-detects); Æ copyright 2019. best available methods (if the reliability Sample collection dates for a given Agency for Toxic Substances and Disease of the method and the nature of the sample and analysis dates for each Registry (ATSDR). 1990. Toxicological review justifies use of the data). analytical result; Profile for Nitrobenzene. U.S. Peer-reviewed data are studies/ Æ Meta data that could include the Department of Health and Human analyses that have been reviewed by organization that created the dataset; Services, Public Health Service. qualified individuals (or organizations) contact information; the purpose of the Available on the internet at: https:// who are independent of those who data collection; the size of the dataset; www.atsdr.cdc.gov/toxprofiles/ performed the work, but who are tp.asp?id=532&tid=95. and indication of data quality (such as ATSDR. 1992a. Toxicological Profile for collectively equivalent in technical a quality assurance project plan); and Æ Bromomethane. U.S. Department of expertise (i.e., peers) to those who An accompanying data dictionary Health and Human Services, Public performed the original work. A peer and reference to Quality Assurance Health Service. review is an in-depth assessment of the processes for sample collection and ATSDR. 1992b. Toxicology Profile for 1,2,3- assumptions, calculations, analysis information. Trichloropropane. U.S. Department of extrapolations, alternate interpretations, • The EPA requests peer reviewed Health and Human Services, Public methodology, acceptance criteria, and health effects studies for PFAS other Health Service. September. conclusions pertaining to the specific than PFOA and PFOS that the Agency ATSDR. 2011. Addendum to the Toxicology Profile for 1,2,3-Trichloropropane. U.S. major scientific and/or technical work could consider in future regulatory Department of Health and Human products and the documentation that decision making. • Services, Agency for Toxic Substances supports them (USEPA, 2015b). Specific information about removal and Disease Registry. August. Specifically, the EPA is requesting of PFOA, PFOS, and other PFAS from ATSDR. 2012a. Toxicological Profile for RDX. comment and/or information related to drinking water under field conditions, U.S. Department of Health and Human the following aspects: including information about Services, Public Health Service. • The health effects information effectiveness and costs of various Available on the internet at: http:// considered by the Agency in making the treatment approaches and effectiveness www.atsdr.cdc.gov/ToxProfiles/ preliminary determinations described in of PFAS removal in the presence of tp.asp?id=412&tid=72. this document. The EPA requests ATSDR. 2012b. Toxicological Profile for 1,4- other contaminants and constituents. Dioxane. U.S. Department of Health and commenters identify any additional The EPA intends to carefully evaluate Human Services, Public Health Service. peer reviewed studies that could inform the public comments received on the Available on the internet at: https:// the final regulatory determination. eight preliminary determinations and www.atsdr.cdc.gov/toxprofiles/ • Drinking water occurrence issue its final regulatory determinations. tp187.pdf. information considered by the Agency If the Agency makes a final ATSDR. 2015. Toxicological Profile for 1,1- in making the preliminary determination to regulate any of the Dichloroethane. U.S. Department of determinations described in this contaminants, the EPA intends to Health and Human Services, Public Health Service. Available on the internet document. The EPA requests propose an NPDWR within 24 months commenters identify any additional data at: https://www.atsdr.cdc.gov/ and promulgate a final NPDWR within ToxProfiles/tp133.pdf. and studies upon the occurrence of 18 months following the proposal.30 In ATSDR. 2018. Toxicological Profile for these contaminants in drinking water. addition, the EPA will also consider • Perfluoroalkyls. Draft for Public The EPA requests comment on what Comment. U.S. Department of Health additional information the Agency 30 The statute authorizes a nine-month extension and Human Services, Public Health should consider in developing a of this promulgation date. Service. Available on the internet at:

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