Designation of Perfluorooctanoic Acid (PFOA) and Perfluorooctanesulfonic Acid (PFOS) as CERCLA Hazardous Substances, 54415-54442 [2022-18657]

Download as PDF Federal Register / Vol. 87, No. 171 / Tuesday, September 6, 2022 / Proposed Rules information, please see the information provided in the ADDRESSES section of this document. Dated: August 26, 2022. Daniel Blackman Regional Administrator, Region 4. [FR Doc. 2022–19202 Filed 9–2–22; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 302 [EPA–HQ–OLEM–2019–0341; FRL–7204– 02–OLEM] RIN 2050–AH09 Designation of Perfluorooctanoic Acid (PFOA) and Perfluorooctanesulfonic Acid (PFOS) as CERCLA Hazardous Substances Environmental Protection Agency (EPA). ACTION: Proposed rule. AGENCY: Under the Comprehensive Environmental Response, Compensation, and Liability Act of 1980, as amended (‘‘CERCLA’’ or ‘‘Superfund’’), the Environmental Protection Agency (EPA or the Agency) is proposing to designate perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS), including their salts and structural isomers, as hazardous substances. CERCLA authorizes the Administrator to promulgate regulations designating as hazardous substances such elements, compounds, mixtures, solutions, and substances which, when released into the environment, may present substantial danger to the public health or welfare or the environment. Such a designation would ultimately facilitate cleanup of contaminated sites and reduce human exposure to these ‘‘forever’’ chemicals. DATES: Comments must be received on or before November 7, 2022. Under the Paperwork Reduction Act, comments on the information collection provisions are best assured of consideration if the Office of Management and Budget (OMB) receives a copy of your comments on or before October 6, 2022. ADDRESSES: You may send comments, identified by Docket ID No. EPA–HQ– OLEM–2019–0341, by any of the following methods: • Federal eRulemaking Portal: https://www.regulations.gov (our preferred method). Follow the online instructions for submitting comments. • Mail: U.S. Environmental Protection Agency, EPA Docket Center, jspears on DSK121TN23PROD with PROPOSALS SUMMARY: VerDate Sep<11>2014 18:21 Sep 02, 2022 Jkt 256001 OLEM Docket, Mail Code 28221T, 1200 Pennsylvania Avenue NW, Washington, DC 20460. • Hand Delivery or Courier: EPA Docket Center, WJC West Building, Room 3334, 1301 Constitution Avenue NW, Washington, DC 20004. The Docket Center’s hours of operations are 8:30 a.m.–4:30 p.m., Monday–Friday (except Federal Holidays). Instructions: All submissions received must include the Docket ID No. for this rulemaking. Comments received may be posted without change to https:// www.regulations.gov/, including any personal information provided. For detailed instructions on sending comments and additional information on the rulemaking process, see the ‘‘Public Participation’’ heading of the SUPPLEMENTARY INFORMATION section of this document. For further information on EPA Docket Center services and the current status, please visit us online at https://www.epa.gov/dockets. FOR FURTHER INFORMATION CONTACT: Michelle Schutz, Office of Superfund Remediation and Technology Innovation (5202T), Environmental Protection Agency, 1200 Pennsylvania Avenue NW, Washington, DC 20460; telephone number 703–346–9536; email address: schutz.michelle@epa.gov. SUPPLEMENTARY INFORMATION: Acronyms and Abbreviations: We use multiple acronyms and terms in this preamble. While this list may not be exhaustive, to ease the reading of the preamble and for reference purposes, the EPA defines the following terms and acronyms here: ADEC Alaska Department of Environmental Conservation AFFF Aqueous film-forming foam APFO Ammonium perfluorooctanoate ATSDR Agency for Toxic Substances and Disease Registry CDC Center for Disease Control and Prevention CDR Chemical Data Reporting CERCLA Comprehensive Environmental Response, Compensation, and Liability Act CFR Code of Federal Regulations COP–9 9th Conference of Parties DoD Department of Defense DOE Department of Energy DNA Deoxyribonucleic acid EA Economic Analysis EALs Environmental action levels ECF Electrochemical fluorination EJ Environmental justice EPA Environmental Protection Agency EPCRA Emergency Planning and Community Right-to-Know Act EU European Union FAA Federal Aviation Administration FDA Food and Drug Administration FR Federal Register FSANZ Food Standards Australia New Zealand PO 00000 Frm 00003 Fmt 4702 Sfmt 4702 54415 IARC International Agency for Research of Cancer ICR Information Collection Request ILs Initiation levels LEPC Local Emergency Planning Committee LHA Lifetime health advisories MAC Maximum acceptable concentration MCL Maximum contaminant level MDH Minnesota Department of Health mg/kg milligram per kilogram mg/kg/day milligram per kilogram per day MRL Minimal risk level MSC Medium-specific concentration NAICS North American Industrial Classification System NCP National Oil and Hazardous Substances Pollution Contingency Plan ng/g nanograms per gram ng/L nanograms per liter NHANES National Health and Nutrition Examination Survey NJDEP New Jersey Department of Environmental Protection NPL National Priorities List NRC National Response Center OMB Office of Management and Budget PADEP Pennsylvania Department of Environmental Protection PBI Proprietary business information PCBs Polychlorinated biphenyls PCL Protective concentration level PER Perimeter Well Study PFAS Per- and polyfluoroalkyl substances PFBS Perfluorobutanesulfonic acid PFDA Perfluorodecanoic acid PFHpA Perfluoroheptanoic acid PFHxA Perfluorohexanoic acid PFHxS Perfluorohexanesulfonic acid PFNA Perfluorononanoic acid PFOA Perfluorooctanoic acid PFOS Perfluorooctanesulfonic acid PFOSA Perfluorooctanesulfonamide pg/m3 picogram per cubic meter PHGs Public health goals POSF Perfluorooctanesulfonyl fluoride ppt parts per trillion PRG Preliminary remediation goal PWS Public water system RAGs Remedial action guidelines RCRA Resource Conservation and Recovery Act REACH Registration Evaluation, Authorisation and Restriction of Chemicals RFA Regulatory Flexibility Act RfD Reference dose RIDEM Rhode Island Department of Environmental Management RML Regional removal management level RQ Reportable quantity RSL Regional screening level SAB Science Advisory Board SALs State action levels SDWA Safe Drinking Water Act SERC State Emergency Response Commission SNURs Significant New Use Rules TDI Tolerable daily intake TEPC Tribal Emergency Planning Committee TERC Tribal Emergency Response Commission TRI Toxic Release Inventory TSCA Toxic Substances Control Act UCMR Unregulated Contaminant Monitoring Rule UK United Kingdom UMRA Unfunded Mandates Reform Act E:\FR\FM\06SEP1.SGM 06SEP1 54416 Federal Register / Vol. 87, No. 171 / Tuesday, September 6, 2022 / Proposed Rules UNEP United Nations Environment Programme U.S. United States U.S.C. United States Code WQCC Water Quality Control Commission WWTP Wastewater treatment plant Table of Contents jspears on DSK121TN23PROD with PROPOSALS I. Public Participation A. Written Comments II. Does this action apply to me? III. General Information A. Executive Summary B. What are PFOA and PFOS and how have they been used? C. What action is the Agency taking? IV. Legal Authority A. Background B. Explanation of Criteria for Designation Decisions 1. Factors To Be Considered Under Section 102 2. CERCLA Section 102(a) Precludes Consideration of Cost a. Consistency With Case Law b. Consistency With Statutory Structure c. Indirect Costs d. Request for Comment V. Designation of PFOA, PFOS, and Their Salts and Structural Isomers as Hazardous Substances A. Introduction B. What is the evidence for designation of PFOA and PFOS as hazardous substances? 1. Chemical/Physical Characteristics 2. Toxicity and Toxicokinetics 3. Environmental Prevalence VI. Effect of Designation A. Default Reportable Quantity B. Direct Effects of a Hazardous Substance Designation 1. Reporting and Notification Requirements for CERCLA Hazardous Substances 2. Requirements Upon Transfer of Government Property VII. Regulatory and Advisory Status at EPA, Other Federal, State and International Agencies A. EPA Actions B. Actions by Other Federal Agencies C. State Actions D. Enforcement E. International Actions VIII. Statutory and Executive Order Reviews A. Executive Order 12866: Regulatory Planning and Review, and Executive Order 13563: Improving Regulation and Regulatory Review B. Paperwork Reduction Act C. Regulatory Flexibility Act D. Unfunded Mandates Reform Act E. Executive Order 13132: Federalism F. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments G. Executive Order 13045: Protection of Children From Environmental Health Risks and Safety Risks H. Executive Order 13211: Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution or Use I. National Technology Transfer and Advancement Act J. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations I. Public Participation A. Written Comments Submit your comments, identified by Docket ID No. EPA–HQ–OLEM–2019– 0341, at https://www.regulations.gov (our preferred method), or the other methods identified in the ADDRESSES section. Once submitted, comments cannot be edited or removed from the docket. The EPA may publish any comment received to its public docket. Do not submit to EPA’s docket at https://www.regulations.gov any information you consider to be Propriety Business Information (PBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. The EPA will generally not consider comments or comment contents located outside of the primary submission (i.e., on the web, cloud or other file sharing system). For additional submission methods, the full EPA public comment policy, information about PBI or multimedia submissions, and general guidance on making effective comments, please visit https://www.epa.gov/dockets/ commenting-epa-dockets. For further information and updates on EPA Docket Center services, please visit us online at https://www.epa.gov/ dockets. The EPA continues to monitor information carefully and continuously from the Centers for Disease Control and Prevention (CDC), local area health departments, and our Federal partners so that we can respond rapidly as conditions change regarding COVID–19. II. Does this action apply to me? The purpose of this proposed rulemaking is to designate PFOA and PFOS, including their salts and structural isomers, as hazardous substances under CERCLA section 102(a). Upon designation, any person in charge of a vessel or an offshore or onshore facility, as soon as they have knowledge of any release of such substances at or above the reportable quantity (RQ) must immediately report such releases to the Federal, state, tribal and local authorities (CERCLA section 103(a), Emergency Planning and Community Right-to-Know Act (EPCRA) section 304). The RQ for these designations is 1 pound or more in a 24hour period. Once EPA has collected more data on the size of releases and the resulting risks to human health and the environment, the Agency may consider issuing a regulation adjusting the reportable quantities for these substances. The five broad categories of entities potentially affected by this action include: (1) PFOA and/or PFOS manufacturers (including importers and importers of articles); (2) PFOA and/or PFOS processors; (3) manufacturers of products containing PFOA and/or PFOS; (4) downstream product manufacturers and users of PFOA and/ or PFOS products; and (5) waste management and wastewater treatment facilities. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this action applies to them. Potentially affected entities may include: NAICS code List of potentially affected U.S. industrial entities 488119 ............................................ 314110 ............................................ 811192 ............................................ 325 .................................................. 332813 ............................................ 325510 ............................................ 325998 ............................................ 562212 ............................................ 339112 ............................................ 922160 ............................................ Aviation operations. Carpet manufacturers. Car washes. Chemical manufacturing. Chrome electroplating, anodizing, and etching services. Coatings, paints, and varnish manufacturers. Firefighting foam manufacturers. Landfills. Medical Devices. Municipal fire departments and firefighting training centers, including Federal agencies that use, trained with, and tested firefighting foams. Paper mills. Pesticides and Insecticides. 322121 and 322130 ........................ 325320 ............................................ VerDate Sep<11>2014 18:21 Sep 02, 2022 Jkt 256001 PO 00000 Frm 00004 Fmt 4702 Sfmt 4702 E:\FR\FM\06SEP1.SGM 06SEP1 Federal Register / Vol. 87, No. 171 / Tuesday, September 6, 2022 / Proposed Rules NAICS code List of potentially affected U.S. industrial entities 324 .................................................. 324110 and 424710 ........................ 352992 ............................................ 325612 ............................................ 325211 ............................................ 323111 and 325910 ........................ 313210, 313220, 313230, 313240, and 313320. 562 .................................................. 221320 ............................................ Petroleum and coal product manufacturing. Petroleum refineries and terminals. Photographic film manufacturers. Polish, wax, and cleaning product manufacturers. Polymer manufacturers. Printing facilities where inks are used in photolithography. Textile mills (textiles and upholstery). Waste management and remediation services. Wastewater treatment plants. jspears on DSK121TN23PROD with PROPOSALS III. General Information A. Executive Summary EPA is proposing to designate two per- and polyfluoroalkyl substances (PFAS)—specifically PFOA and PFOS including their salts and structural isomers 1 as hazardous substances because evidence indicates that these chemicals may present substantial danger to public health or welfare or the environment when released into the environment. All references to PFOA and PFOS in this notice are meant to include their salts and linear and branched structural isomers. Linear and branched structural isomers of PFOA and PFOS maintain the carboxylic acid and sulfonic acid functional groups, respectively, but have different arrangements of the carbon atoms in the fluorinated carbon chain. PFOA and PFOS have historically been found in or used in making a wide range of consumer products including carpets, clothing, fabrics for furniture, and packaging for food and cookware that are resistant to water, grease or stains. They are also used for firefighting at airfields and in a number of industrial processes. PFOA and PFOS are persistent and mobile in the environment, and exposure can lead to adverse human health effects, including high cholesterol, changes in liver enzymes, decreased immune response to vaccination, thyroid disorders, pregnancy-induced hypertension and preeclampsia, and cancer (testicular and kidney for PFOA, liver and thyroid cancer for PFOS). In June 2022, EPA released interim updated health advisories for PFOA and PFOS based on human epidemiology studies in populations exposed to these chemicals. Based on the new data and EPA’s draft analyses, the levels at which negative health effects could occur are much lower than previously understood when 1 All references to PFOA and PFOS in this notice are meant to include their salts and linear and branched structural isomers. Linear and branched structural isomers of PFOA and PFOS maintain the carboxylic acid and sulfonic acid functional groups, respectively, but have different arrangements of the carbon atoms in the fluorinated carbon chain. VerDate Sep<11>2014 18:21 Sep 02, 2022 54417 Jkt 256001 EPA issued the 2016 health advisories for PFOA and PFOS (70 parts per trillion or ppt). EPA believes the totality of evidence about PFOA and PFOS described here demonstrates that they can pose substantial danger to public health or welfare or the environment. This level of evidence is more than sufficient to satisfy the CERCLA section 102(a) standard. EPA believes that this amount and type of evidence exceeds the minimum required under CERCLA section 102(a). PFOA and PFOS are common contaminants in the environment because of their release into the environment and their resistance to degradation. PFAS generally, and PFOA and PFOS specifically, are sometimes referred to as ‘‘forever’’ chemicals because their strong carbon-fluorine bonds cause PFOA and PFOS to be extremely resistant to degradation in the environment. PFAS are found in outdoor air at locations in the United States, Europe, Japan, and over the Atlantic Ocean. PFAS are also found in the artic snow and air.2 PFOA and PFOS are found worldwide in many environmental media and in wildlife. For example: • PFOA and PFOS are widely detected in surface water samples collected from various rivers, lakes, and streams in the United States. • PFOA and PFOS have been detected in surface and subsurface soils. • PFOA and PFOS have been detected in groundwater in monitoring wells, private drinking water wells, and public drinking water systems across the country. PFOA and PFOS have been found in wild and domestic animals such as fish, shellfish, alligators, deer and avian eggs. Environmental sources can include industrial, and inadvertent municipal and agricultural discharges of PFOA and PFOS directly. PFOA and PFOS precursors can be converted to PFOA and PFOS, respectively, by microbes in 2 Scientific Reports (2016) Natural Poly-/ perfluoroalkyl Substances in Air and Snow from the Artic https://www.nature.com/articles/srep08912. PO 00000 Frm 00005 Fmt 4702 Sfmt 4702 soil, sludge, and wastewater and through abiotic chemical reactions. PFOA and PFOS that are deposited or created by the degradation of their precursors in industrial and consumer waste, in a landfill without environmental controls, can discharge via leachates, groundwater pollution/ migration and atmospheric releases. The principal worldwide manufacturers of PFOA and PFOS and related chemicals phased out their production in the early 2000’s although PFOA and PFOS may still be produced domestically for certain uses and by international companies that export treated products to the United States. Environmental contamination and resulting human exposure to PFOA and PFOS are anticipated to continue for the foreseeable future due to its environmental persistence, formation from precursor compounds, continued production by international manufacturers and possible domestic production, and as a result of the large legacy production in the United States. Although PFOA and PFOS levels have been decreasing in human serum samples since the phase out, they are still detected in a high percentage of the U.S. population.3 The adverse human health effects, mobility, persistence, prevalence, and other factors related to these PFAS combine to support EPA’s proposed finding that PFOA and PFOS, when released into the environment may present substantial danger to the public health or welfare or the environment and, as a result, warrant designation as CERCLA hazardous substances. The potential dangers posed by PFOA and PFOS specifically, and more generally by PFAS, have been recognized by numerous Federal, state, and international governmental entities that have taken a wide variety of actions to address these dangers to public health and welfare and the 3 CDC. (2021). National Health and Nutrition Examination Survey: NHANES questionnaires, datasets, and related documentation. Centers for Disease Control and Prevention. https:// wwwn.cdc.gov/nchs/nhanes/Default.aspx. E:\FR\FM\06SEP1.SGM 06SEP1 jspears on DSK121TN23PROD with PROPOSALS 54418 Federal Register / Vol. 87, No. 171 / Tuesday, September 6, 2022 / Proposed Rules environment. For example, the Department of Defense has been providing alternative drinking water to local residents near military bases with elevated PFOA and PFOS levels from DoD activities. Many states, including California, Michigan, and Vermont have drinking water standards for PFOA and PFOS. And numerous international bodies, such as the European Union, and individual countries, such as Australia, China, and Canada, have taken measures to address PFOA and PFOS. Designating PFOA and PFOS as hazardous substances will add to the set of tools already available under CERCLA to protect the public health and welfare and the environment. If finalized, the direct effects of this proposed CERCLA designation would include requiring that any person in charge of a vessel or facility report releases of PFOA and PFOS of one pound or more within a 24-hour period. This would give the Agency, state, Tribal, and local governments, and the public a better understanding of where releases occur and the quantities involved. In addition, when selling or transferring Federally-owned real property, Federal agencies would be required to meet all of the property transfer requirements in CERCLA section 120(h), including providing notice when any hazardous substance ‘‘was stored for one year or more, known to have been released, or disposed of’’ and providing a covenant warranting that ‘‘all remedial action necessary to protect human health and the environment with respect to any [hazardous substances] remaining on the property has been taken before the date of such transfer, and any additional remedial action found to be necessary after the date of such transfer shall be conducted by the United States.’’ This would ensure that any entity receiving Federal land is informed of the presence of PFOA or PFOS, and that these substances will be addressed as required under CERCLA. There would also be an obligation for DOT to list and regulate PFOA and PFOS as hazardous materials under the Hazardous Materials Transportation Act (HMTA) (see CERCLA Section 306(a)). In addition to those direct effects, if finalized, these designations would provide some additional tools that the government and others could use to address PFOA/PFOS contamination and, thus, could facilitate an increase in the pace of cleanups of PFOA/PFOS contaminated sites. Furthermore, there will likely be additional response actions beyond those that are simply undertaken before designating PFOA/ VerDate Sep<11>2014 18:21 Sep 02, 2022 Jkt 256001 PFOS a hazardous substance, although the quantity of such an increase is indeterminable. The Federal government is already authorized to cleanup PFOA/PFOS contamination under some circumstances, including when it finds that a release may present an imminent and substantial danger to public health or welfare. A faster pace of cleanups would provide public health protection for affected communities sooner and could reduce the cost of individual cleanups (generally, the sooner contamination is addressed, the less it spreads and the smaller the area that needs to be cleaned). The indirect, downstream effects of these designations could include the following: • EPA and other agencies exercising delegated CERCLA authority could respond to PFOA and PFOS releases and threatened releases without making the imminent and substantial danger finding that is required for responses now. • EPA and delegated agencies could require potentially responsible parties to address PFOA or PFOS releases that pose an imminent and substantial endangerment to public health or welfare or the environment. • EPA and delegated agencies could recover PFOA and PFOS cleanup costs from potentially responsible parties, to facilitate having polluters and other potentially responsible parties, rather than taxpayers, pay for these cleanups. • Private parties that conduct cleanups that are consistent with the National Oil and Hazardous Substances Contingency Plan (NCP) could also recover PFOA and PFOS cleanup costs from potentially responsible parties. These impacts from the proposed rule will result in meaningful public health benefits, including by increasing transparency around PFOA/PFOS releases and offering additional tools that EPA and other government agencies could use to conduct faster cleanups at contaminated sites.4 In addition to this action, in 2022, the EPA will be developing an advance notice of proposed rulemaking seeking comments and data to assist in the development of potential future regulations pertaining to other PFAS designation as hazardous substances under CERCLA. 4 See the Economic Assessment of the Potential Costs and Other Impacts of the Proposed Rulemaking to Designate Perfluorooctanoic Acid and Perfluorooctanesulfonic Acid as Hazardous Substances in the rulemaking docket for a discussion of indirect benefits and costs. PO 00000 Frm 00006 Fmt 4702 Sfmt 4702 B. What are PFOA and PFOS, and how have they been used? PFAS, including PFOA and PFOS, are human-made chemicals that have been used in industry and consumer products since the 1940s because of their useful properties, including their resistance to water, grease, and stains. In terms of their chemistry, they exist as linear and branched isomers, depending on the methods by which they are produced. Both PFOA and PFOS have been manufactured in numerous salt forms.5 In considering toxicity and fate and transport processes, the salts are deemed the same as the commonly referenced acid versions because, once added to water, the salts dissociate to the component ions (there are two ions, the cation and the anion). Hence, if any of the salt or acid forms of PFOA or PFOS are released into the environment, the anionic form will generally be found in environmental media; all references to PFOA and PFOS in this preamble are meant to include all salts and structural isomers.6 PFOA and PFOS have been produced within the United States (U.S.) 7 as well as imported. Although PFOA and PFOS production may be ending in the United States, their continued use in certain applications and persistence in the environment means that their historical production and use will continue to be a concern in the future. PFOA and PFOS can also be formed by chemical or biological degradation from a large group of related PFAS (i.e., precursor compounds).8 9 The nature of PFOA and PFOS (i.e., reactivity as both a base and acid) has led to their use in a variety of manufactured goods, industrial applications, or the environment, including the following: • Food packaging and preparation, including PFAS-containing materials 5 ATSDR. (2021). Toxicological profile for perfluoroalkyls: final. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, Agency for Toxic Substances and Disease Registry. https:// wwwn.cdc.gov/TSP/ToxProfiles/ ToxProfiles.aspx?id=1117&tid=237. 6 Ibid. 7 ATSDR. (2021). Toxicological profile for perfluoroalkyls: final. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, Agency for Toxic Substances and Disease Registry. https:// wwwn.cdc.gov/TSP/ToxProfiles/ ToxProfiles.aspx?id=1117&tid=237. 8 Ibid. 9 UNEP. (2006). Report of the Persistent Organic Pollutants Review Committee on the work of its second meeting. Addendum: Risk profile on perfluorooctane sulfonate. Stockholm Convention on Persistent Organic Pollutants. (UNEP/POPS/ POPRC.2/17/Add.5). United Nations Environment Programme. https://chm.pops.int/TheConvention/ POPsReviewCommittee/Meetings/POPRC2/POPRC2 ReportandDecisions/tabid/349/Default.aspx. E:\FR\FM\06SEP1.SGM 06SEP1 Federal Register / Vol. 87, No. 171 / Tuesday, September 6, 2022 / Proposed Rules jspears on DSK121TN23PROD with PROPOSALS (e.g., sandwich wrappers, and other paper and paperboard food packaging) and processing equipment that uses PFAS. This can lead to migration of PFAS into food that contacts such surfaces. • Commercial household products, including stain- and water-repellent fabrics, nonstick products, polishes, waxes, paints, and cleaning products. • Certain firefighting foams. PFAS can be found in groundwater and surface water at airports, military bases and other facilities where PFAScontaining firefighting foam was used for training, incident response, or where foam was stored. • Manufacturing and production, including chrome plating, electronics manufacturing, textile manufacturing or oil recovery. • Drinking water, typically because of localized contamination associated with a specific facility (e.g., manufacturer, landfill, wastewater treatment plant, firefighter training facility). • Living organisms, including plants, animals and humans due to the abovementioned sources. • Plating processes, such as a wetting agent/fume suppressant. • Non-stick cookware and food processing equipment. • Processing aids in fluoropolymer production. • Processing aids in textile coating applications. • Insecticides. • Certain types of adhesives. • Cleaning products, such as carpet cleaners, auto washes and electronics. • Coating products, paints, varnishes and inks. • Surfactants for oil extraction and mining. • Photo lithography, photographic coatings • Hydraulic fluids for aviation.10 11 • Certain explosives and pyrotechnics as binders and oxidizers. The most common processes for making fluorinated chemicals, including PFOA and PFOS, are electrochemical fluorination (ECF) and telomerization. Production sites that produced PFAS by means of ECF were located in the U.S., including Decatur, Alabama. International production sites include 10 U.S. EPA. (2014). Certain perfluoroalkyl sulfonates. U.S. Environmental Protection Agency. Code of Federal Regulations. 40 CFR 721.9582. https://www.govinfo.gov/content/pkg/CFR-2014title40-vol31/pdf/CFR-2014-title40-vol31-sec7219582.pdf. 11 Glu ¨ ge, J; Scheringer, M; Cousins, IT; DeWitt, JC; Goldenman, G; Herzke, D; Lohmann, R; Ng, CA; Trier, X; Wang, Z. (2020). An overview of the uses of per-and polyfluoroalkyl substances (PFAS). Environ Sci Process Impacts 22: 2345–2373. https:// www.ncbi.nlm.nih.gov/pubmed/33125022. VerDate Sep<11>2014 18:21 Sep 02, 2022 Jkt 256001 Belgium (Zwijndrecht near Antwerp) and Italy (Miteni in Vicenza)). Although PFOA and PFOS production may be ending in the United States, their continued use in certain applications and persistence in the environment means that their historical production and use will continue to be a concern in the future. Domestic production and import of PFOA has been phased out in the United States by the companies participating in the 2010/2015 PFOA Stewardship Program. Small quantities of PFOA may be produced, imported, and used by companies not participating in the PFOA Stewardship Program and some uses of PFOS are ongoing (see 40 Code of Federal Regulations (CFR) 721.9582).12 The EPA Chemical Data Reporting (CDR) rule under the Toxic Substance Control Act (TSCA) requires manufacturers (including importers) to report certain data about chemicals in commerce in the United States, including information on PFOA and PFOS (subject to a 2,500 pound reporting threshold at a single site). The last time PFOA and PFOS manufacturing information was reported to EPA pursuant to CDR was in 2013 and 2002, respectively. However, Toxics Release Inventory (TRI) data for 2020 shows that small amounts of PFOA and PFOS continue to be released into the environment. Pursuant to TRI reporting requirements, facilities in regulated industry sectors must report annually on releases and other waste management of certain listed toxic chemicals that they manufacture, process, or otherwise use above certain threshold quantities (100 pounds for PFOA and PFOS). C. What action is the Agency taking? The EPA is proposing to designate PFOA and PFOS, including their salts and structural isomers, as hazardous substances under section 102(a) of CERCLA. The designation of PFOA and PFOS, including their salts and structural isomers, as hazardous substances, if finalized, would result in a default RQ of one pound pursuant to CERCLA section 102. CERCLA section 103(a) requires any person in charge of a vessel or facility, as soon as they have knowledge of any release 13 (other than 12 ATSDR. (2021). Toxicological profile for perfluoroalkyls: final. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, Agency for Toxic Substances and Disease Registry. https:// wwwn.cdc.gov/TSP/ToxProfiles/ ToxProfiles.aspx?id=1117&tid=237. 13 See Office of Regulatory Enforcement, EPA, Enforcement Response Policy for Sections 304, 311 PO 00000 Frm 00007 Fmt 4702 Sfmt 4702 54419 a federally permitted release) of a hazardous substance from such vessel or facility in quantities equal to or greater than the RQ (one pound) or more in a 24-hour period, to immediately notify the National Response Center (NRC) of such a release. The reporting requirements are further codified in 40 CFR 302.6(a). Section 304 of EPCRA (42 (United States Code) U.S.C. 11004) also requires facility owners or operators to immediately notify their community emergency coordinator for local emergency planning committee (LEPC) (or Tribal emergency planning committee (TEPC)), if established, for any area likely to be affected by the release and to notify the State Emergency Response Commission (SERC) (or Tribal Emergency Response Commission (TERC)) of any state or Tribal region likely to be affected by the release. EPCRA section 304 also requires facilities to submit a follow-up written report to their SERC (or TERC) and the LEPC (or TEPC) as soon as practicable after the release. EPA published a guidance on July 13, 2010 (75 Federal Register (FR) 39852) defining the phrase, ‘‘as soon as practicable’’ to be 30 days after a release. (Note: Some states or Tribal Nations provide less than 30 days for submitting a follow-up report.) EPCRA section 304 requirements are codified in 40 CFR 355.30 to 355.43.14 In addition, when Federal agencies sell or transfer real property they must provide notice of the presence of hazardous substances in certain circumstances as required by CERCLA section 120(h). Furthermore, in certain circumstances, CERCLA 120(h) requires Federal agencies to provide a covenant warranting that ‘‘all remedial action necessary to protect human health and the environment with respect to any [hazardous substances] remaining on the property has been taken before the date of such transfer, and any additional remedial action found to be necessary after the date of such transfer shall be conducted by the United States.’’ While these are the only direct and automatic consequences of designating PFOA and PFOS hazardous substances for purposes of CERCLA, there are other, indirect impacts described above that should facilitate cleanups and reduce and 312 of EPCRA and Section 103 of CERCLA at 12 (Sept. 30, 1999), available at https:// www.epa.gov/enforcement/enforcement-responsepolicy-epcra-sections-304-311-312-and-cerclasection-103. See also https://www.epa.gov/epcra/ definition-immediate-epcra-and-cercla-releasenotification. 14 For additional information on release reporting requirements, see https://www.epa.gov/faqs/search/ topics/emergency-planning-and-community-rightknow-304487/topics/release-notification-epcra304cercla-103-30450. E:\FR\FM\06SEP1.SGM 06SEP1 54420 Federal Register / Vol. 87, No. 171 / Tuesday, September 6, 2022 / Proposed Rules human and environmental exposure to these hazardous chemicals. jspears on DSK121TN23PROD with PROPOSALS IV. Legal Authority A. Background CERCLA was enacted to promote the timely cleanup of contaminated sites and to ensure that parties responsible for the contamination bear the costs of such cleanups. CERCLA provides the Federal government with the authority to respond to releases or threatened releases of hazardous substances, and pollutants and contaminants in order to protect public health, welfare, and the environment. The statute confers considerable discretion upon the EPA in its exercise of these authorities. Other than the reporting requirements in the statute, CERCLA is not a traditional regulatory statute that prospectively regulates behavior; rather it is remedial in nature, generally designed to address contamination on a site-specific basis. CERCLA required a significant update to the NCP, which provides the ‘‘procedures and standards for responding to releases of hazardous substances, pollutants, and contaminants . . . .’’ CERCLA section 105(a). The NCP is the blueprint for all aspects of the cleanup process, from the discovery of releases of contaminants, to responding to releases or threatened releases that require prompt response, and to prioritizing and developing longer-term remedial actions. Once a Federal agency learns of a release or potential threat of a release of a hazardous substance, pollutant and/or contaminant, CERCLA authorizes response in one of three ways: by determining no action at the Federal level is warranted; by undertaking a removal action (if the situation presents a more immediate threat); or by assessing the relative risk of the release to other releases via the NPL listing process that is the first step towards a longer-term remedial action. Superfund cleanups typically begin with a preliminary assessment/site inspection, which includes reviews of historical information and site visits to evaluate the potential for a release of hazardous substances. EPA determines whether the site poses a threat to people and the environment and whether hazards need to be addressed immediately or additional site information will be collected. Federal entities other than EPA that respond to releases or threatened releases of hazardous substances, pollutants, or contaminants at Federal sites must similarly act consistent with CERCLA and the NCP. Finally, private parties responding to a release or threatened release at their VerDate Sep<11>2014 18:21 Sep 02, 2022 Jkt 256001 facility must act consistent with CERCLA and the NCP in order to maintain CERCLA claims for recovery of response costs. The nature of the subsequent response action depends upon the site-specific circumstances. Short-term ‘‘removals’’ are response actions that EPA and other Federal agencies may take to address releases or threatened releases requiring prompt action and are limited in cost and duration unless specific criteria are met. Long-term ‘‘remedial’’ actions permanently and significantly reduce the risks associated with releases or threats of releases that are serious and are typically associated with chronic exposures, but not immediately lifethreatening. EPA can only conduct remedial actions at sites listed on EPA’s National Priorities List (NPL). Additions to the NPL undergo notice-andcomment rulemaking. The NPL sites are among the worst hazardous substance sites identified by EPA. Only about 3% of the 53,400 assessed sites have been placed on the NPL. If a site is placed on the NPL, a Remedial Investigation/ Feasibility Study is conducted to assess risks posed by releases of a hazardous substance, pollutant, or contaminant at the site by evaluating soil, surface water, ground water, and other media, and waste samples, and to analyze potential treatment methods or cleanup alternatives. EPA then summarizes those alternatives and offers its recommendation in a Proposed Plan, which undergoes a public comment process. The final decision on the cleanup is memorialized in a Record of Decision, which is accompanied by a responsiveness summary addressing the public comments. The specific details of the cleanup are then planned in the Remedial Design and finally carried out in the Remedial Action. Ultimately, the remedy must be one ‘‘that is protective of human health and the environment, that is cost effective, and that utilizes permanent solutions and alternative treatment technologies or resource recovery technologies to the maximum extent practicable.’’ CERCLA section 121(b)(1). CERCLA provides authority for response actions to address releases of hazardous substances as well as releases of pollutants and contaminants. The authority conferred by CERCLA with regard to hazardous substances differs in a few respects from the authority with regard to pollutants and contaminants. With respect to hazardous substances, the Agency can conduct response actions if there is a release or threatened release without having to establish an imminent and substantial danger. In addition, the EPA PO 00000 Frm 00008 Fmt 4702 Sfmt 4702 can also recover costs from potentially responsible parties and require potentially responsible parties to conduct the cleanup themselves. CERCLA also authorizes persons (including private parties) that conduct cleanup activities that are consistent with the NCP to seek to recover cleanup costs from potentially responsible parties. With respect to releases or substantial threat of releases of pollutants and contaminants, EPA can respond if the Agency finds that the release or threat of release may present an imminent and substantial danger to the public health or welfare, and, generally, cannot require a private party to pay for or conduct the removal action. Accordingly, CERCLA already provides significant authority to Federal agencies to address PFOA and PFOS releases because these two chemicals are pollutants and contaminants. Nonetheless, designating PFOA and PFOS as hazardous substances will likely increase the pace at which cleanups occur because it will allow the Federal government to require responsible private parties to address releases of PFOS and PFOA at sites without other ongoing cleanup activities, and allow the government and private parties to seek to recover cleanup costs from potentially responsible parties assuming relevant statutory criteria are met. As a result, risks from releases of PFOA and PFOS may be mitigated. B. Explanation of Criteria for Designation Decisions CERCLA section 101(14) sets out the definition of ‘‘hazardous substance.’’ There are two ways that a substance may be defined as a ‘‘hazardous’’ substance under CERCLA. The first is automatic where the substance is identified as hazardous or toxic pursuant to other specified environmental statutes (e.g., chemicals listed as air toxics by Congress or EPA under section 112 of the Clean Air Act). The second is where the substance is designated as hazardous pursuant to CERCLA section 102. In this action, the Administrator is exercising his authority to designate under section 102. 1. Statutory Factors To Be Considered Under Section 102 The EPA Administrator is authorized under CERCLA section 102(a) to promulgate regulations designating as a hazardous substance: (1) ‘‘such elements, compounds, mixtures, solutions, and substances’’ (2) ‘‘which, when released into the environment’’ E:\FR\FM\06SEP1.SGM 06SEP1 jspears on DSK121TN23PROD with PROPOSALS Federal Register / Vol. 87, No. 171 / Tuesday, September 6, 2022 / Proposed Rules (3) ‘‘may present substantial danger’’ (4) ‘‘to the public health or welfare or the environment.’’ The term ‘‘hazardous substance’’ is defined in section 101(14) of CERCLA primarily by reference to other environmental statutes and includes substances designated pursuant to CERCLA section 102. Pursuant to CERCLA section 101(14) the term hazardous substance means (A) any substances designated pursuant to section 311(b)(2)(A) of the Federal Water Pollution Control Act [33 U.S.C. 1321(b)(2)(A)], (B) any element, compound, mixture, solution, or substances designated pursuant to section 9602 of this title, (C) any hazardous waste having the characteristics identified under or listed pursuant to section 3001 of the Solid Waste Disposal Act [42 U.S.C. 6921], (but not including any waste the regulation of which under the Solid Waste Disposal Act {42 U.S.C. 6901 et seq.] has been suspended by Act of Congress). (D) any toxic pollutant listed under section 307(a) of the Federal Water Pollution Control Act {33 U.S.C. 1317(a)], (E) any hazardous air pollutant listed under section 112 of the Clean Air Act [42 U.S.C. 7412], and (F) any imminently hazardous chemical substance or mixture with respect to which the Administrator has taken action pursuant to section 7 of the Toxic Substances Control Act [15 U.S.C. 2606]. The term does not include petroleum, including crude oil or any fraction thereof which is not otherwise specifically listed or designated as a hazardous substance under paragraphs (A) through (F) of this paragraph, and the term does not include natural gas, natural gas liquids, liquified natural gas, or synthetic gas usable for fuel (or mixtures of natural gas and such synthetic gas). Because EPA has not exercised its authority under CERCLA section 102(a), it has not previously issued an interpretation of the standard for designating hazardous substances. EPA proposes to interpret ‘‘may present’’ in the statutory language as indicating that Congress did not require certainty that the substance presents a substantial danger or require proof of actual harm. In assessing whether a substance, when released, may present ‘‘substantial danger,’’ 15 the EPA 15 The EPA notes that the ‘‘substantial danger’’ language in CERCLA section 102(a) is similar to language in other parts of CERCLA but is interpreted in a different manner due to the contexts in which the language appears. Those other provisions (see, e.g., CERCLA sections 104, 105, 106, and 128) concern enforcement and response actions and apply to and require analyses VerDate Sep<11>2014 18:21 Sep 02, 2022 Jkt 256001 proposes to consider information such as the following: the potential harm to humans or the environment from exposure to the substance (i.e., hazard), and how the substance moves and degrades when in the environment (i.e., environmental fate and transport). To further inform its decision about whether the statutory factors have been met, the Agency proposes to also consider other information that may be relevant when evaluating releases of the substance, such as the frequency, nature and geographic scope of releases of the substances. The Agency proposes to weigh this information to determine whether the substance, when released, may present a ‘‘substantial danger.’’ 2. CERCLA Section 102(a) Precludes Consideration of Cost Given the specific standard Congress established for determining whether a substance is hazardous (i.e., whether it ‘‘may present substantial danger to the public health or welfare or the environment’’), EPA proposes to interpret the language of CERCLA section 102(a) as precluding the Agency from taking cost into account in designating hazardous substances. Congress did not list cost as a required or permissible factor, and none of the Congressionally-listed statutory factors encompass a consideration of cleanup costs. Moreover, as a matter of common sense and straightforward reading, determining whether something is ‘‘hazardous’’ does not naturally lend itself to considerations of cost. A substance is or is not hazardous based on scientific and technical considerations. Subsequent determinations of whether and how to address something hazardous may involve considerations of cost, as CERCLA does in the context of response actions, as discussed below. a. Consistency With Case Law Reading CERCLA as precluding consideration of costs in hazardous substance designations is consistent with relevant Supreme Court precedent on cost consideration in rulemaking of site-specific circumstances relevant to a particular facility or person, and to an event. By contrast, the statutory objectives associated with designating hazardous substances under CERCLA section 102(a) warrant a different implementation strategy because of its broader applicability and analytical requirements. The standard for CERCLA section 102(a) in this notice is based on the specific language and purpose of section 102(a) and does not affect EPA’s interpretations of other CERCLA provisions. See Utility Air Regulatory Group v. EPA, 573 U.S. 302, 320 (2014) (finding that statutory terms, even those that are defined in the statute, ‘‘may take on distinct characters from association with distinct statutory objects calling for different implementation strategies.’’). PO 00000 Frm 00009 Fmt 4702 Sfmt 4702 54421 decisions. CERCLA section 102(a) is similar to Clean Air Act section 109(b)(1),16 which governs EPA’s setting of national ambient air quality standards (NAAQS) and which the Supreme Court said precludes consideration of costs. Whitman v. American Trucking, 531 U.S. 457 (2001). In his majority opinion, Justice Scalia explained, The EPA, ‘‘based on’’ the information about health effects contained in the technical ‘‘criteria’’ documents compiled under section 108(a)(2), 42 U.S.C. 7408(a)(2), is to identify the maximum airborne concentration of a pollutant that the public health can tolerate, decrease the concentration to provide an ‘‘adequate’’ margin of safety, and set the standard at that level. Nowhere are the costs of achieving such a standard made part of that initial calculation. American Trucking, 531 U.S. at 465. Similarly, CERCLA section 102(a) establishes a standard for designation that is tied exclusively to whether the release of a substance ‘‘may present substantial danger to the public health or welfare or the environment.’’ 42 U.S.C. 9602(a). Congress did not mention cost in this language that sets the standard for designation of hazardous substances. Section 102(a)’s specific designation standard and its statutory context differentiate it from the broader statutory standard in Clean Air Act section 112(n)(1)(A), which the Supreme Court held requires EPA to consider costs in determining whether to regulate air toxic emissions from power plants in Michigan v. EPA, 576 U.S. 743 (2015). Clean Air Act section 112(n)(1)(A) states, in part, The Administrator shall regulate electric utility steam generating units under this section, if the Administrator finds such regulation is appropriate and necessary after considering the results of the study required by this paragraph. 42 U.S.C. 7412(n)(1)(A). The Supreme Court explained that ‘‘appropriate’’ is a broad term that ‘‘includes consideration of all the relevant factors’’ and when read in the context of Clean Air Act section 112(n)(1)(A) requires ‘‘at least some attention to cost.’’ Michigan, 576 U.S., at 752. In particular, the Court pointed to a study that was required by 16 ‘‘National primary ambient air quality standards, prescribed under paragraph (a) shall be ambient air quality standards the attainment and maintenance of which in the judgment of the Administrator, based on such criteria and allowing an adequate margin of safety, are requisite to protect the public health. Such primary standards may be revised in the same manner as promulgated.’’ 42 U.S.C. 7409(b)(1). E:\FR\FM\06SEP1.SGM 06SEP1 jspears on DSK121TN23PROD with PROPOSALS 54422 Federal Register / Vol. 87, No. 171 / Tuesday, September 6, 2022 / Proposed Rules the same paragraph (i.e., Clean Air Act section 112(n)(1)), and noted both that Congress required that this study address cost (among other factors), and that EPA said that study helped provide a ‘‘framework’’ for EPA’s decision under Clean Air Act section 112(n)(1). Given this context, in interpreting the Clean Air Act section 112(n)(1)’s ‘‘appropriate and necessary’’ standard for triggering regulation of air toxics from power plants, the Court held that EPA must consider cost in deciding whether to regulate power plants. The standard for designation in CERCLA section 102(a) is significantly more circumscribed than the standard at issue in Michigan. As noted above, in CERCLA section 102(a), Congress specified a public health and welfare and environment standard governing EPA’s designation decisions that did not include cost. In these circumstances, Michigan acknowledged that: American Trucking thus establishes the modest principle that where the Clean Air Act expressly directs EPA to regulate on the basis of a factor that on its face does not include cost, the Act normally should not be read as implicitly allowing the Agency to consider cost anyway. Id. at 755–56. Because CERCLA section 102(a) specifies the standard that EPA is to use, and it wholly relates to danger to public health, welfare, or the environment, cost should not be read in as an additional consideration. Furthermore, CERCLA section 102(a) is lacking provisions that indicate Congressional intent to take cost into account—unlike CAA section 112(n)(1), which had cost elements in provisions that the Court and EPA said were relevant to interpreting the ‘‘appropriate and necessary’’ standard. CERCLA section 102(a) does use the word ‘‘appropriate’’ (the Administrator shall ‘‘promulgate and revise as may be appropriate’’ regulations designating hazardous substances), but significantly, the word ‘‘appropriate’’ is not used in the context of what EPA should consider when assessing whether a substance is hazardous. And as the Michigan Court noted, ‘‘appropriate and necessary’’ does not always encompass cost, context matters. See Michigan, 576 U.S. at 752. Under CAA section 112(n)(1), the substantive standard is nothing more than whether regulation is ‘‘appropriate and necessary’’ and, to the extent Congress provided a contextual indication about the meaning of that capacious phrase, it indicated that cost was relevant. In contrast, under CERCLA section 102(a), the Administrator is to promulgate and VerDate Sep<11>2014 18:21 Sep 02, 2022 Jkt 256001 revise as may be appropriate regulations that accomplish the statutory goal of designating hazardous substances—and the guidance Congress provided was that the Administrator should look to specific criteria that do not include cost. Thus, EPA’s authority to designate a substance as hazardous is tied solely to a finding that, when released, the substance may present a substantial danger to public health or welfare or the environment. In addition, the Court in both American Trucking and Michigan, looked to the overall statutory scheme to determine whether cost should be considered as part of the Agency’s determination. The role of a hazardous substance designation in the overall structure of CERCLA is much closer to the role of a national ambient air quality standard in the overall structure of the NAAQS program than it is to the role of the appropriate and necessary finding in regulating air toxic emissions from power plants. Under CERCLA, the only automatic, private party obligation that flows from designation as a CERCLA hazardous substance under section 102(a) is the obligation to report releases (a relatively small cost). As discussed above, designation does not lead automatically to any response action obligations. CERCLA response actions, which include investigations of hazardous substance releases and determining if removal or remedial action is necessary, are contingent, discretionary, and sitespecific actions.17 EPA prioritizes the highest-risk sites under CERCLA (and that listing process is open to public comment); the process for selecting remedies includes public notice and comment (such as on the remedial action objectives and the consideration of remedial alternatives); and cost considerations, among other important factors such as protectiveness, are part of CERCLA’s site-specific cleanup approach. For both the hazardous substance designation in CERCLA and the setting of a NAAQS, there are later steps in the program where cost can be taken into account before specific requirements are imposed on entities subject to the programs. In contrast, in Michigan, the 17 As noted below in section IV.B.2.c. and the Economic Assessment, the multiple, contingent, discretionary and site-specific steps between designation of a hazardous substance and the incurrence of cleanup costs contribute to the inability to quantify costs at the designation stage. The uncertainty at this stage, when contrasted with the greater certainty and explicit consideration of costs during the later cleanup selection process, further supports EPA’s proposed interpretation that CERCLA precludes consideration of costs when designating a hazardous substance. PO 00000 Frm 00010 Fmt 4702 Sfmt 4702 Court seemed to weigh heavily the fact that, if regulations are ‘‘appropriate and necessary’’ under section 112(n)(1)(A), then, without regard to cost, ‘‘the Agency must promulgate certain minimum emission regulations, known as floor standards.’’ Michigan, 576 U.S., at 748. Furthermore, the designation of a hazardous substance under CERCLA section 102(a) in some cases does not create new costs, but rather allows costs to be shifted from the taxpayer to parties responsible for pollution under CERCLA. Even in those circumstances, where the government is able to transfer costs, a private party’s ability to pay response costs is taken into account under the statute and in EPA’s implementation of the statute.18 The interpretation that section 102(a) precludes the consideration of cost in designation decisions is also supported by the Court of Appeals for the D.C. Circuit. In Utility Solid Waste Activities Group v. EPA, 901 F.3d 414 (D.C. Cir. 2018), the D.C. Circuit, relying on Michigan and American Trucking, upheld EPA’s decision that it should not have considered cost in establishing requirements under the Resource Conservation and Recovery Act (RCRA) for disposing of coal combustion residuals because the statutory standard only addresses ‘‘adverse effects on health or the environment’’ without mentioning costs or including other language that could encompass cost. Based in part on Supreme Court decisions addressing statutory interpretation and the D.C. Circuit’s application of those decisions, EPA proposes to interpret CERCLA section 102(a) as precluding consideration of costs in hazardous substance designations. b. Consistency With Statutory Structure The way CERCLA initially established the list of hazardous substances shows that Congress did not intend for costs to be considered in designation decisions. As noted above, CERCLA offers two ways for a substance to be designated as hazardous. One is a finding pursuant to CERCLA section 102. Another is the list of other statutory provisions in CERCLA section 101(14) that identify hazardous and toxic substances. In that section, Congress directed that the definition of 18 See Memorandum from Susan Shinkman, Director, Office of Civil Enforcement, and Cynthia Mackey, Director, Office of Site Remediation Enforcement, US EPA (June 29, 2015) (Guidance on Evaluating a Violator’s Ability to Pay a Civil Penalty in an Administrative Enforcement Action); Memorandum from Barry Breen, Director, Office of Site Remediation Enforcement, US EPA (Sep. 30, 1997) (General Policy on Superfund Ability to Pay Determinations). E:\FR\FM\06SEP1.SGM 06SEP1 Federal Register / Vol. 87, No. 171 / Tuesday, September 6, 2022 / Proposed Rules ‘‘hazardous substance’’ includes all substances identified as hazardous or toxic by Congress or EPA under other specified environmental statutes: • Clean Water Act section 311(b)(2)(A) hazardous substances; • Resource Conservation and Recovery Act section 3001 hazardous wastes; • Clean Water Act section 307(a) toxic pollutants; • Clean Air Act section 112 hazardous air pollutants; and • Toxic Substances Control Act section 7 imminently hazardous chemical. When EPA adds a substance or chemical for regulation under any of those other statutory provisions, it also becomes a CERCLA hazardous substance—without considering the resulting costs under CERCLA. In addition to the other statutory provisions listed above, CERCLA section 101(14) also includes CERCLA section 102(a), which suggests it should be interpreted in a manner similar to the other authorities on the list. Under the other statutory provisions, that program’s compliance costs are not considered a factor or criteria in making listing decisions,19 and the Agency proposes to interpret CERCLA section 102(a) as similarly excluding consideration of cost. jspears on DSK121TN23PROD with PROPOSALS c. Costs While EPA proposes to interpret CERCLA section 102(a) as excluding consideration of cost in a designation decision, the Agency is soliciting comment on that interpretation and, if costs should be considered, how they should be considered. See section IV.B.2.d. below. EPA has estimated parties’ potential direct costs associated with this designation decision (from reporting releases); they are relatively small and would not impede a designation decision even if the Agency were required to consider costs. It is impractical, however, to quantitatively assess the indirect costs (for response actions) associated with a designation decision because of the uncertainty about such costs at this early stage in in the process. However, a qualitative discussion of indirect costs and benefits, as well as details explaining the impracticality of quantitative estimates are contained in the Economic Assessment of the Potential Costs and Other Impacts of the Proposed Rulemaking to Designate 19 See, e.g., 42 U.S.C. 6921(a) (RCRA section 3001(a)); 42 U.S.C. 7412(b)(2) (Clean Air Act section 112(b)(2). VerDate Sep<11>2014 18:21 Sep 02, 2022 Jkt 256001 Perfluorooctanoic Acid and Perfluorooctanesulfonic Acid as Hazardous Substances.20 Possible indirect costs could arise from an increased number of sites identified, assessed and/or remediated, and from associated research and development. In addition, economic costs could be offset by savings from faster and more efficient response actions. Possible indirect benefits could include reduced health effects such as cancer, immunological problems, high cholesterol, and thyroid disorders resulting from earlier and greater numbers of response actions due to release reporting, and application of enhanced response authority. A designation alone does not require the EPA to take response actions, does not require any response action by a private party, and does not determine liability for hazardous substance release response costs. Response actions are contingent, discretionary, and site-specific decisions made after a hazardous substance release or threatened release. They are contingent upon a series of separate discretionary actions and meeting certain statutory and regulatory requirements, as explained above. In addition, future discretionary decisions about cleanup and response are difficult to quantify due to numerous, significant uncertainties such as: (1) How many sites have PFOA or PFOS contamination at a level that warrants a cleanup action; (2) the extent and type of PFOA and PFOS contamination at/near sites; (3) the extent and type of other contamination at/near sites; (4) the incremental cost of assessing and remediating the PFOA and/or PFOS contamination at/near these sites; and (5) the cleanup level required for these substances. d. Request for Comment EPA proposes to interpret CERCLA section 102(a) as prohibiting the Agency from considering cost as part of its decision to designate hazardous substances, EPA is taking comment on its approach to the consideration of costs, including: (1) Whether CERCLA section 102(a) precludes, allows, or requires consideration of cost in designation decisions, and, if so, (2) which costs and benefits of those discussed in the EA should be considered, (3) whether additional benefits and costs not identified in the EA should be considered, (4) if indirect benefits and costs are considered, how 20 U.S. EPA (2022) Economic Assessment of the Potential Costs and Other Impacts of the Proposed Rulemaking to Designate Perfluorooctanoic Acid and Perfluorooctanesulfonic Acid as Hazardous Substances. PO 00000 Frm 00011 Fmt 4702 Sfmt 4702 54423 they should be assessed in light of the discretion and uncertainties described above, (5) how benefits and costs could be incorporated into the designation decision, and (6) whether designation would be justified if costs were to be considered in the Agency’s designation decision. In addition, the Economic Assessment of the Potential Costs and Other Impacts of the Proposed Rulemaking to Designate Perfluorooctanoic Acid and Perfluorooctanesulfonic Acid as Hazardous Substances includes requests for comments on several topics related to indirect costs that EPA does not currently have robust information about. Please see Section ES–5 of the Economic Assessment for specific details. V. Designation of PFOA, PFOS, and Their Salts and Structural Isomers as Hazardous Substances A. Introduction The EPA is proposing to designate PFOA and PFOS as hazardous substances because significant evidence indicates that they satisfy the statutory criteria set forth in CERCLA section 102(a): (1) They are ‘‘substances’’ as described in section IV.B.; (2) They may be ‘‘released into the environment’’ as described in section IV.B.; (3) They may present substantial danger as described in section V; and (4) That danger is ‘‘to the public health or welfare or the environment’’ as described in section V. While EPA acknowledges that the science regarding PFOA and PFOS human health and environmental effects is still evolving, a significant body of scientific evidence shows that PFOA and PFOS are persistent and mobile in the environment, and that exposure to PFOA and PFOS may lead to adverse human health effects. Assessments conducted by EPA, other Federal, state, Tribal and international agencies, academia, non-profit organizations and the private sector support the conclusion that PFOA and PFOS warrant a hazardous substance designation. This conclusion is based on the factors considered by EPA in this proposal, which, as noted above, included the potential human health or environmental hazards associated with exposure to PFOA and PFOS and the environmental fate and transport of PFOA and PFOS. The evidence for concern about PFOA and PFOS includes: • Chemical/Physical Characteristics • Toxicity and Toxicokinetics E:\FR\FM\06SEP1.SGM 06SEP1 54424 Federal Register / Vol. 87, No. 171 / Tuesday, September 6, 2022 / Proposed Rules • Environmental Prevalence Each of the above evidence categories are discussed in more detail below. PFOA and PFOS hazardous substance designation would be consistent with and supportive of many other actions taken by EPA, other Federal agencies, states, Tribal Nations and international bodies. These entities have set PFOA and PFOS benchmarks and standards and have undertaken PFOA- and PFOSbased regulatory activities and enforcement actions. Details are provided below. B. What is the evidence for designation of PFOA and PFOS as hazardous substances? A significant collection of evidence and actions support designating PFOA and PFOS as hazardous substances under CERCLA section 102(a). EPA is proposing that, when released into the environment, PFOA and PFOS may present substantial danger to the public health or welfare or the environment. What follows are brief summaries and not a comprehensive review of the available literature. 1. Chemical/Physical Characteristics jspears on DSK121TN23PROD with PROPOSALS PFOA and PFOS are persistent chemicals that bioaccumulate, and exposure to PFOA and PFOS may cause adverse human health effects. PFOA and PFOS are distinctive from many other bioaccumulative chemicals because their water-solubility allows them to migrate readily from soil to groundwater. If PFOA and PFOS are released into the environment, they can contaminate surface water and groundwater used as drinking water sources and persist for long periods of time, thereby posing a direct threat to human health and the environment. PFOA is comprised of eight carbons, seven of which are fully fluorinated, and the eighth carbon is part of a carboxylic acid group. PFOA is considered a surfactant (i.e., a substance that tends to reduce the surface tension of a liquid in which it is dissolved) due to its chemical structure consisting of a hydrophobic perfluorinated alkyl ‘‘tail group’’ and a hydrophilic carboxylate ‘‘head group’’.21 22 As a result of the head group, PFOA is water soluble, 21 ChEBI. (2017). ChEBI:35549— perfluorooctanoic acid. Chemical Entities of Biological Interest. European Molecular Biology Laboratory, European Bioinformatics Institute. https://www.ebi.ac.uk/chebi/searchId.do? chebiId=CHEBI:35549. 22 Lindstrom, AB; Strynar, MJ; Libelo, EL. (2011). Polyfluorinated compounds: past, present, and future. Environ Sci Technol 45: 7954–7961. https:// www.ncbi.nlm.nih.gov/pubmed/21866930. VerDate Sep<11>2014 18:21 Sep 02, 2022 Jkt 256001 which contributes to its tendency to be found in groundwater. PFOA is produced and used mainly as ammonium perfluorooctanoate (APFO), a salt of PFOA, that may include both linear and branched isomers. APFO’s isomeric composition depends on the manufacturing processes used. The APFO that is produced through the perfluorooctyl iodide oxidation process, commonly called telomerization, is >99 percent linear, and the APFO that is produced by the ECF process is >70 percent linear with the remaining <30 percent a mixture of branched isomers.23 24 As a result, there are different PFOA structural isomers that may be released and found in the environment. Analytical chemistry methods used to detect and measure PFOA may measure the different isomers separately. PFOS has a fully fluorinated eightcarbon linear or branched tail, with a hydrophilic sulfonate functional head group attached to the carbon tail. PFOS is manufactured from perfluorooctanesulfonyl fluoride (POSF), which is produced through ECF. This process results in linear and branched isomers of PFOS.25 PFOS is often produced as its potassium salt. Like PFOA, PFOS is water soluble, which is why it can be found in groundwater. As noted above, PFOA and PFOS contain carbon atoms bonded to fluorine atoms. These carbon-fluorine bonds are strong, causing PFOA and PFOS to be extremely resistant to degradation in the environment (including biodegradation, photolysis and hydrolysis) and, thus, 23 European Commission. (2015). Analysis of the risks arising from the industrial use of perfluorooctanoic acid (PFOA) and ammonium perfluorooctonate (APFO) and from their use in consumer articles. Evaluation and risk reduction measures for potential restrictions on the manufacture, placing on the market and use of PFOA and APFO. (TOX08.7049). European Commission, Enterprise and Industry Directorate— General. https://ec.europa.eu/docsroom/ documents/13037/attachments/1/translations/en/ renditions/pdf. 24 Buck, RC; Franklin, J; Berger, U; Conder, JM; Cousins, IT; de Voogt, P; Jensen, AA; Kannan, K; Mabury, SA; van Leeuwen, SP. (2011). Perfluoroalkyl and polyfluoroalkyl substances in the environment: terminology, classification, and origins. Integr Environ Assess Manag 7: 513–541. https://www.ncbi.nlm.nih.gov/pubmed/21793199. 25 OECD. (2002). Hazard assessment of perfluorooctane sulfonate (PFOS) and its salts. Environment Directorate, Joint Meeting of the Chemicals Committee and the Working Party on Chemicals, Pesticides and Biotechnology, Cooperation on Existing Chemicals. (ENV/JM/ RD(2002)17/FINAL. JT00135607). Organisation for Economic Co-operation and Development. https:// www.oecd.org/env/ehs/risk-assessment/ 2382880.pdf. PO 00000 Frm 00012 Fmt 4702 Sfmt 4702 likely to persist for long periods of time.26 27 These chemical and physical characteristics of PFOA and PFOS, when viewed in combination with the information that follows, supports this proposed designation of these chemicals as CERCLA hazardous substances. 2. Toxicity and Toxicokinetics Exposure to PFOA and PFOS is associated with a variety of adverse human health effects. Human studies have found associations between PFOA and/or PFOS exposure and effects on the immune system, the cardiovascular system, human development (e.g., decreased birth weight), and cancer. EPA continues to conduct extensive evaluations of human epidemiological and experimental animal study data to support the development of a PFAS National Primary Drinking Water Regulation. In November 2021, EPA released draft updated health effects analyses for PFOA and PFOS; these analyses are undergoing Science Advisory Board (SAB) review. EPA evaluated over 400 peer-reviewed studies published since 2016 and used new approaches, tools, and models to identify and evaluate the information. Based on the new data and draft analyses, the levels at which negative health effects could occur are much lower than previously understood when EPA issued the 2016 Health Advisories for PFOA and PFOS (70 ppt). The following discussion is based on information and conclusions from the EPA 2016 Health Effects Support Documents for PFOA 28 and PFOS 29 and other published peer reviewed science. The weight of scientific evidence presented in the Health Effects Support Documents for PFOA 30 and 26 U.S. EPA. (2016). Drinking water health advisory for perfluorooctanoic acid (PFOA). (EPA822R16005). U.S. Environmental Protection Agency, Office of Water. https://www.epa.gov/sites/ default/files/2016-05/documents/pfoa_health_ advisory_final_508.pdf. 27 U.S. EPA. (2016). Drinking water health advisory for perfluorooctane sulfonate (PFOS). (EPA822R16004). U.S. Environmental Protection Agency. https://www.epa.gov/sites/default/files/ 2016-05/documents/pfos_health_advisory_final_ 508.pdf. 28 U.S. EPA. (2016). Health effects support document for perfluorooctanoic acid (PFOA). U.S. Environmental Protection Agency, Office of Water. https://www.epa.gov/sites/default/files/2016-05/ documents/pfoa_hesd_final-plain.pdf. 29 U.S. EPA. (2016). Health effects support document for perfluorooctane sulfonate (PFOS). U.S. Environmental Protection Agency, Office of Water. https://www.epa.gov/sites/default/files/ 2016-05/documents/pfos_hesd_final_508.pdf. 30 U.S. EPA. (2016). Health effects support document for perfluorooctanoic acid (PFOA). U.S. Environmental Protection Agency, Office of Water. https://www.epa.gov/sites/default/files/2016-05/ documents/pfoa_hesd_final-plain.pdf. E:\FR\FM\06SEP1.SGM 06SEP1 Federal Register / Vol. 87, No. 171 / Tuesday, September 6, 2022 / Proposed Rules jspears on DSK121TN23PROD with PROPOSALS PFOS 31 and supporting documents for the Regulatory Determination 4 process 32 supports the conclusion that exposure to PFOA and PFOS can lead to adverse human health effects. As part of the final Regulatory Determination 4 process, the Agency concluded that exposure to PFOA and PFOS may have adverse health effects.33 Data from human and animal studies indicate that PFOA and PFOS are well absorbed via the oral route and are distributed throughout the body by noncovalent binding to serum albumin and other plasma proteins. PFOA and PFOS are slowly eliminated from the human body as evidenced by the halflife of 2.1–10.1 years for PFOA and 3.3– 27 years for PFOS.34 Because of their resistance to metabolic degradation, PFOA and PFOS are eliminated from mammals primarily unchanged. Human epidemiology studies observed associations between PFOA exposure and high cholesterol, changes in liver enzymes, decreased immune response to vaccination, thyroid effects, pregnancy-induced hypertension and preeclampsia, low birth weight, and cancer (testicular and kidney).35 Epidemiology studies have generally found a positive association between increasing serum PFOA and total cholesterol levels in PFOA-exposed workers and residents of high-exposure communities. In addition, associations between increasing serum PFOA concentrations and elevations in serum levels of alanine aminotransferase and gamma-glutamyl transpeptidase were consistently observed in occupational cohorts, high-exposure communities and the U.S. general population. This could indicate the potential for PFOA to affect liver function. A decreased response to vaccines was found to be associated with PFOA exposure in studies in adults in a highly exposed community and in studies of children in the general population. A study of a community with high exposure to PFOA observed an association between serum PFOA and risk of pregnancy-related 31 U.S. EPA. (2016). Health effects support document for perfluorooctane sulfonate (PFOS). U.S. Environmental Protection Agency, Office of Water. https://www.epa.gov/sites/default/files/ 2016-05/documents/pfos_hesd_final_508.pdf. 32 U.S. EPA. (2021). Final regulatory determination 4 support document. (EPA815R21001). U.S. Environmental Protection Agency. 33 Ibid. 34 ATSDR. (2021). Toxicological profile for perfluoroalkyls: final. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, Agency for Toxic Substances and Disease Registry. https:// wwwn.cdc.gov/TSP/ToxProfiles/ ToxProfiles.aspx?id=1117&tid=237. 35 Ibid. VerDate Sep<11>2014 18:21 Sep 02, 2022 Jkt 256001 hypertension or preeclampsia, conditions that are related to renal function during pregnancy. An association between increasing maternal PFOA or cord blood PFOA concentrations and decreasing birth weight was seen in several studies.36 Numerous epidemiology studies have examined occupational populations at large-scale PFOS production plants in the United States and the residential populations living near the PFOS production facilities to evaluate the association between increasing PFOS concentrations and various health outcomes. Data also suggest associations between higher PFOS levels and increases in total cholesterol and highdensity lipoproteins, decreases in female fecundity and fertility, in addition to decreased offspring body weights and negative effects on other measures of postnatal growth. Evidence of an association between PFOS exposure and cancer is less conclusive.37 Perfluoroalkyl acids are transferred to the fetus during pregnancy and to breast milk through distribution due to their slow elimination from the human body through excretion.38 Toxicity studies conducted in laboratory animal models demonstrate that the developing fetus is particularly sensitive to PFOA- and PFOS-induced toxicity. Some studies in laboratory animal models indicate that gestation and/or lactation periods are critical exposure windows that may lead to developmental health effects including decreased offspring survival, low birth weight, accelerated puberty and skeletal variations.39 40 41 Numerous animal toxicity studies for PFOA and PFOS are available and provide information about the potential 36 U.S. EPA. (2016). Health effects support document for perfluorooctanoic acid (PFOA). U.S. Environmental Protection Agency, Office of Water. https://www.epa.gov/sites/default/files/2016-05/ documents/pfoa_hesd_final-plain.pdf. 37 U.S. EPA. (2016). Health effects support document for perfluorooctane sulfonate (PFOS). U.S. Environmental Protection Agency, Office of Water. https://www.epa.gov/sites/default/files/ 2016-05/documents/pfos_hesd_final_508.pdf. 38 ATSDR. (2021). Toxicological profile for perfluoroalkyls: final. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, Agency for Toxic Substances and Disease Registry. https:// wwwn.cdc.gov/TSP/ToxProfiles/ ToxProfiles.aspx?id=1117&tid=237. 39 Ibid. 40 U.S. EPA. (2016). Health effects support document for perfluorooctanoic acid (PFOA). U.S. Environmental Protection Agency, Office of Water. https://www.epa.gov/sites/default/files/2016-05/ documents/pfoa_hesd_final-plain.pdf. 41 U.S. EPA. (2016). Health effects support document for perfluorooctane sulfonate (PFOS). U.S. Environmental Protection Agency, Office of Water. https://www.epa.gov/sites/default/files/ 2016-05/documents/pfos_hesd_final_508.pdf. PO 00000 Frm 00013 Fmt 4702 Sfmt 4702 54425 for similar effects in humans. Animal studies and epidemiology studies indicate that PFOA and PFOS are well absorbed orally; absorption may also occur via the inhalation and dermal routes. Absorbed PFOA and/or PFOS are widely distributed in the body, with the highest concentrations typically found in the blood, liver and/or kidney. Across species, the highest extravascular concentrations of PFOA and PFOS are found in the liver, however, PFOA and/or PFOS have also been detected in many other tissues (e.g., lung, kidney, spleen and bone). Though not readily, PFOS can cross the blood-brain barrier and has been detected at low levels in the brains of humans and rodents.42 43 44 PFOA and PFOS in blood bind to plasma albumin and other plasma proteins. Absorbed PFOA and PFOS are not metabolized and are eliminated by excretion primarily in urine. Active transport mechanisms mediate renal tubular reabsorption and secretion of PFOA and PFOS. Some excretion occurs through cord blood in pregnant women, and through lactation and menstrual blood loss. Although PFOA and PFOS are found in the bile of humans, they are reabsorbed from the bile and thus, fecal excretion is substantially lower than urinary excretion; levels in fecal matter represent both unabsorbed material and that discharged with bile.45 46 47 48 49 42 ATSDR. (2021). Toxicological profile for perfluoroalkyls: final. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, Agency for Toxic Substances and Disease Registry. https:// wwwn.cdc.gov/TSP/ToxProfiles/ ToxProfiles.aspx?id=1117&tid=237. 43 U.S. EPA. (2016). Health effects support document for perfluorooctanoic acid (PFOA). U.S. Environmental Protection Agency, Office of Water. https://www.epa.gov/sites/default/files/2016-05/ documents/pfoa_hesd_final-plain.pdf. 44 U.S. EPA. (2016). Health effects support document for perfluorooctane sulfonate (PFOS). U.S. Environmental Protection Agency, Office of Water. https://www.epa.gov/sites/default/files/ 2016-05/documents/pfos_hesd_final_508.pdf. 45 ATSDR. (2021). Toxicological profile for perfluoroalkyls: final. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, Agency for Toxic Substances and Disease Registry. https:// wwwn.cdc.gov/TSP/ToxProfiles/ ToxProfiles.aspx?id=1117&tid=237. 46 U.S. EPA. (2016). Health effects support document for perfluorooctanoic acid (PFOA). U.S. Environmental Protection Agency, Office of Water. https://www.epa.gov/sites/default/files/2016-05/ documents/pfoa_hesd_final-plain.pdf. 47 U.S. EPA. (2016). Health effects support document for perfluorooctane sulfonate (PFOS). U.S. Environmental Protection Agency, Office of Water. https://www.epa.gov/sites/default/files/ 2016-05/documents/pfos_hesd_final_508.pdf. 48 NJDWQI. (2017). Appendix A: Health-based maximum contaminant level support document perfluorooctanoic acid (PFOA). New Jersey Drinking Water Quality Institute, Health Effects E:\FR\FM\06SEP1.SGM Continued 06SEP1 54426 Federal Register / Vol. 87, No. 171 / Tuesday, September 6, 2022 / Proposed Rules jspears on DSK121TN23PROD with PROPOSALS For PFOA, oral studies of short-term (subchronic) and chronic duration are available in multiple species including monkeys, rats and mice. The animal studies report developmental effects, liver and kidney toxicity, immune effects and cancer (liver, testicular and pancreatic). The developmental effects observed in rodents include decreased survival, delayed eye opening, reduced ossification, skeletal defects, altered puberty (delayed vaginal opening in females and accelerated puberty in males) and altered mammary gland development. For PFOS, numerous animal studies are available in multiple species including monkeys, rats and mice. Short-term and chronic exposure studies in animals demonstrate increases in liver weight, changes in cholesterol, hepatic steatosis, lower body weight and liver histopathological changes. One- and two- generation rodent toxicity studies also show decreased pup survival and body weights. Additionally, developmental neurotoxicity studies in rodents show increased motor activity, decreased habituation and increased escape latency in the water maze test (tests spatial learning and memory) following in utero and lactational exposure to PFOS. Gestational and lactational exposures were also associated with higher serum glucose levels and evidence of insulin resistance in adult offspring. Evidence suggests immunological effects in animal models.50 51 The International Agency for Research on Cancer (IARC) concluded that PFOA is possibly carcinogenic to humans.52 Study findings are mixed. While a mutagenic mode of action has not been established for PFOA or PFOS, studies Subcommittee. https://www.state.nj.us/dep/ watersupply/pdf/pfoa-appendixa.pdf. 49 NJDWQI. (2018). Appendix A: Health-based maximum contaminant level support document perfluorooctane sulfonate (PFOS). New Jersey Drinking Water Quality Institute, Health Effects Subcommittee. https://www.state.nj.us/dep/ watersupply/pdf/pfos-recommendation-appendixa.pdf. 50 ATSDR. (2021). Toxicological profile for perfluoroalkyls: final. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, Agency for Toxic Substances and Disease Registry. https:// wwwn.cdc.gov/TSP/ToxProfiles/ ToxProfiles.aspx?id=1117&tid=237. 51 U.S. EPA. (2016). Health effects support document for perfluorooctane sulfonate (PFOS). U.S. Environmental Protection Agency, Office of Water. https://www.epa.gov/sites/default/files/ 2016-05/documents/pfos_hesd_final_508.pdf. 52 IARC. (2021). Agents classified by the IARC monographs, volumes 1–129. List of classifications. International Agency for Research on Cancer. https://monographs.iarc.who.int/list-ofclassifications. VerDate Sep<11>2014 18:21 Sep 02, 2022 Jkt 256001 indicate that PFOA (the more extensively studied of the two compounds) can induce deoxyribonucleic acid (DNA) damage.53 In 2016, the EPA determined there is suggestive evidence that PFOA and PFOS may contribute to tumor development in humans.54 55 Epidemiology studies show an association between exposure to high levels of serum PFOA and testicular and kidney cancer in humans; two chronic bioassays in rats 56 57 also support the finding that PFOA is tumorigenic (i.e., capable of producing tumors).58 Epidemiology studies establishing a correlation between PFOS exposure and the incidence of cancer are limited; however, a chronic toxicity and carcinogenicity study in rats provides some evidence of tumorigenicity.59 This information does not reflect recent scientific data that has been collected to support EPA’s ongoing PFAS National Primary Drinking Water Regulation. The Agency’s draft new analyses, released in November 2021 for independent scientific review by the EPA Science Advisory Board (SAB), indicate that negative health effects may occur at much lower levels of exposure to PFOA and PFOS than previously understood and that PFOA is likely 53 ATSDR. (2021). Toxicological profile for perfluoroalkyls: final. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, Agency for Toxic Substances and Disease Registry. https:// wwwn.cdc.gov/TSP/ToxProfiles/ ToxProfiles.aspx?id=1117&tid=237. 54 U.S. EPA. (2016). Health effects support document for perfluorooctanoic acid (PFOA). U.S. Environmental Protection Agency, Office of Water. https://www.epa.gov/sites/default/files/2016-05/ documents/pfoa_hesd_final-plain.pdf. 55 U.S. EPA. (2016). Health effects support document for perfluorooctane sulfonate (PFOS). U.S. Environmental Protection Agency, Office of Water. https://www.epa.gov/sites/default/files/ 2016-05/documents/pfos_hesd_final_508.pdf. 56 NTP. (2020). NTP Technical report on the toxicology and carcinogenesis studies of perfluorooctanoic acid (CASRN 335–67–1) administered in feed to Sprague Dawley (Hsd:Sprague Dawley® SD®) rats. (NTP TR 598). Research Triangle Park, NC: National Toxicology Program. https://ntp.niehs.nih.gov/ntp/htdocs/lt_ rpts/tr598_508.pdf?utm_source=direct&utm_ medium=prod&utm_campaign=ntpgolinks&utm_ term=tr598. 57 Butenhoff, J.L.; Kennedy, G.L.; Chang, S.; Olsen, G.W. (2012). Chronic dietary toxicity and carcinogenicity study with ammonium perfluorooctanoate in Sprague Dawley rats. Toxicology 298: 1–13. 58 U.S. EPA. (2016). Health effects support document for perfluorooctanoic acid (PFOA). U.S. Environmental Protection Agency, Office of Water. https://www.epa.gov/sites/default/files/2016-05/ documents/pfoa_hesd_final-plain.pdf. 59 U.S. EPA. (2016). Health effects support document for perfluorooctane sulfonate (PFOS). U.S. Environmental Protection Agency, Office of Water. https://www.epa.gov/sites/default/files/ 2016-05/documents/pfos_hesd_final_508.pdf. PO 00000 Frm 00014 Fmt 4702 Sfmt 4702 carcinogenic to humans. The draft documents present EPA’s initial analysis and findings with respect to this newly available updated information.60 61 Following SAB peer review, the final documents will be used to inform the development of Maximum Contaminant Level Goals and ultimately a National Primary Drinking Water Regulation for PFOA and PFOS. While this preliminary data was not used for this proposal, it appears to support designating PFOA and PFOS as hazardous substances. In sum, studies have shown that exposure to PFOA and PFOS is associated with numerous and varied adverse effects to human health. This evidence plays a major role in the EPA’s proposal to designate PFOA and PFOS as hazardous substances. 3. Environmental Prevalence PFOA and PFOS are common contaminants in the environment because of their release into the environment since the 1940s and their resistance to degradation. PFOA and PFOS are found in many environmental media and in wildlife worldwide, including in remote polar regions. As an example, the polar bear, the top predator of arctic marine ecosystems, bioaccumulates high concentrations of PFAS (especially PFOS), which may be harmful to their health.62 Environmental sources can include direct industrial discharges of PFOA and PFOS to soil, air, and water. Precursors can also degrade to PFOA and/or PFOS (e.g., perfluorooctanesulfonamide (PFOSA) can be transformed to PFOS in the environment). PFOA and PFOS precursors can be converted to PFOA and PFOS, respectively, by microbes in soil, sludge, and wastewater and through abiotic chemical reactions. PFOA and PFOS that are deposited, created by the degradation of their precursors in industrial and consumer 60 U.S. EPA. (2021). Proposed approaches for deriving maximum contaminant level goals for PFOA in drinking water. (EPA822D21001). U.S. Environmental Protection Agency. 61 U.S. EPA. (2021). Proposed approaches for deriving maximum contaminant level goals for PFOS in drinking water. (EPA822D21002). U.S. Environmental Protection Agency. 62 Tartu, S.; Bourgeon, S.; Aars, J.; Andersen, M.; Lone, K.; Jenssen, B.M.; Polder, A.; Thiemann, G.W.; Torget, V.; Welker, J.M.; Routti, H. (2017). Diet and metabolic state are the main factors determining concentrations of perfluoroalkyl substances in female polar bears from Svalbard. Environ Pollut 229: 146–158. https:// www.ncbi.nlm.nih.gov/pubmed/28587979. Tartu et al. (2017) found that the concentration of PFAS increased with the trophic level of female polar bears, which is consistent with other studies showing biomagnification of PFAS in Arctic marine ecosystems. E:\FR\FM\06SEP1.SGM 06SEP1 Federal Register / Vol. 87, No. 171 / Tuesday, September 6, 2022 / Proposed Rules jspears on DSK121TN23PROD with PROPOSALS waste, in a landfill without environmental controls can discharge via leachates, groundwater pollution/ migration and atmospheric releases.63 64 65 The discharge of aqueous film-forming foam (AFFF) starting in the 1970s is also an important source for some locations. AFFF is a foam containing many PFAS, including PFOA and PFOS, which is effective at extinguishing petroleum fueled fires. PFAS, including PFOA and PFOS, were found in the soil and groundwater where AFFF was used to fight fires or for training and storage. Concrete where AFFF has been repeatedly discharged, such as for training activities, can absorb PFAS, including PFOA and PFOS, and then release PFAS to groundwater and soils during precipitation events.66 Industrial uses that have led to PFOA and PFOS in the soil and groundwater include, but are not limited to, chrome plating facilities where PFAS were used as a wetting agent/fume suppressant and industries where textiles and other materials are coated with PFAS. PFAS manufactured for use as a stain or water repellant may be released from these facilities into the air and wastewater.67 The principal worldwide manufacturers of PFOA and PFOS and related chemicals phased out their production in the early 2000’s. PFOA and PFOS may still be produced domestically for certain uses and by international companies that import treated products to the United States.68 Some uses of PFOS are ongoing, such as use as a component of a photoresist substance, including a photo acid 63 Lindstrom, A.B.; Strynar, M.J.; Libelo, E.L. (2011). Polyfluorinated compounds: past, present, and future. Environ Sci Technol 45: 7954–7961. https://www.ncbi.nlm.nih.gov/pubmed/21866930. 64 Buck, R.C.; Franklin, J.; Berger, U.; Conder, J.M.; Cousins, I.T.; de Voogt, P.; Jensen, A.A.; Kannan, K.; Mabury, S.A.; van Leeuwen, S.P. (2011). Perfluoroalkyl and polyfluoroalkyl substances in the environment: terminology, classification, and origins. Integr Environ Assess Manag 7: 513–541. https://www.ncbi.nlm.nih.gov/ pubmed/21793199. 65 Oliaei, F.; Kriens, D.; Weber, R.; Watson, A. (2013). PFOS and PFC releases and associated pollution from a PFC production plant in Minnesota (USA). Environ Sci Pollut Res Int 20: 1977–1992. https://www.ncbi.nlm.nih.gov/pubmed/ 23128989. 66 Baduel, C.; Paxman, C.J.; Mueller, J.F. (2015). Perfluoroalkyl substances in a firefighting training ground (FTG), distribution and potential future release. J. Hazard Mater 296: 46–53. https:// www.ncbi.nlm.nih.gov/pubmed/25966923. 67 ATSDR. (2021). Toxicological profile for perfluoroalkyls: final. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, Agency for Toxic Substances and Disease Registry. https:// wwwn.cdc.gov/TSP/ToxProfiles/ ToxProfiles.aspx?id=1117&tid=237. 68 Ibid. VerDate Sep<11>2014 18:21 Sep 02, 2022 Jkt 256001 generator or surfactant, or as a component of an anti-reflective coating, used in a photomicrolithography process to produce semiconductors or similar components of electronic or other miniaturized devices. Environmental contamination and resulting human exposure to PFOA and PFOS are declining, but are anticipated to continue for the foreseeable future due to their environmental persistence, formation from precursor compounds, continued production primarily by international manufacturers and their long history of production in the United States.69 Wastewater treatment plants (WWTPs) may receive wastewater that contains PFOA, PFOS or their precursors, from a variety of sources, including industries that manufacture or use these PFAS and their precursors. Some companies may operate onsite wastewater treatment facilities, but typically they are not designed to remove PFAS. PFOA and PFOS are the most widely detected PFAS in wastewater, and generally treatment units at conventional WWTPs do not remove PFAS efficiently.70 Certain PFAS can be volatilized into the atmosphere from wastewater treatment plant operations, such as aeration chambers.71 72 Although effluent discharged to receiving water bodies may contain PFOA or PFOS, much of these substances may concentrate in the WWTP biosolids. Biosolids are also commonly applied to land as fertilizers or soil amendments but can also be sent to a landfill. The use of biosolids on farmland and home gardens can lead to the uptake of PFOA and PFOS in the food chain, as acknowledged by the U.S. Food and Drug Administration (FDA).73 69 (ATSDR) Per- and Polyfluoroalkyl Substances (PFAS) and Your Health U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, Agency for Toxic Substances and Disease Registry. https://www.atsdr.cdc.gov/pfas/ health-effects/us-population.html. 70 Rainey, M.; Beecher, N. (2018). PFAS in wastewater residuals. National Pretreatment & Pollution Prevention Workshop & Training. North East Biosolids & Residuals Association. https:// www.nacwa.org/docs/default-source/conferencesevents/2018-pretreatment/18pret-mrainey.pdf?sfvrsn=2. 71 Ma, R.; Shih, K. (2010). Perfluorochemicals in wastewater treatment plants and sediments in Hong Kong. Environ Pollut 158: 1354–1362. https:// www.ncbi.nlm.nih.gov/pubmed/20153098. 72 Ahrens, L.; Shoeib, M.; Harner, T.; Lee, S.C.; Guo, R.; Reiner, E.J. (2011). Wastewater treatment plant and landfills as sources of polyfluoroalkyl compounds to the atmosphere. Environ Sci Technol 45: 8098–8105. https://www.ncbi.nlm.nih.gov/ pubmed/21466185. 73 Genualdi, S.; deJager, L.; South, P.; Sheehan, J.; Begley, T. (2019). Investigation of PFAS concentrations in US food products. Center for Food Safety and Applied Nutrition, Food and Drug Administration. In SETAC Europe 29th annual PO 00000 Frm 00015 Fmt 4702 Sfmt 4702 54427 Biosolids from wastewater treatment plants and some industrial wastewater that is land applied are also potential sources of contamination.74 75 PFAS have been found in outdoor air at locations in the United States, Europe, Japan, and over the Atlantic Ocean.76 Concentrations are not generally correlated with rural or urban environments, but rather, around PFAS production industries and industries that use PFAS. Mean PFOA levels ranged from 1.54 to 15.2 picograms per cubic meter (pg/m3) in air samples collected in the urban locations in Albany, New York, Fukuchiyama, Japan, and Morioka, Japan and in the rural locations in Kjeller, Norway, and Mace Head, Ireland. However, higher mean concentrations (101–552 pg/m3) were measured at the urban locations in Oyamazaki, Japan, and Manchester, United Kingdom (UK), and semirural locations in Hazelrigg, UK. Maximum reported concentrations at Oyamazaki and Hazelrigg were 919 and 828 pg/m3, respectively. Thus, there is no correlation between higher concentrations and urban versus rural locations; rather, high concentrations in certain locations may be attributable to a specific industrial plant.77 PFOA and PFOS are widely detected in surface water samples collected from various rivers, lakes, and streams in the United States.78 Therefore, municipalities and other entities that use surface water sources for drinking water may face challenges treating and removing PFOA and PFAS from their finished drinking water. The most vulnerable drinking water systems are those in close proximity to sites contaminated with PFOA and PFOS.79 Levels of these substances in surface water are declining since the major U.S. meeting 26–30 May 2019 (pp. 357). Helsinki, Finland: Society of Environmental Toxicology and Chemistry. 74 NJDWQI. (2018). Appendix A: Health-based maximum contaminant level support document perfluorooctane sulfonate (PFOS). New Jersey Drinking Water Quality Institute, Health Effects Subcommittee. https://www.state.nj.us/dep/ watersupply/pdf/pfos-recommendation-appendixa.pdf. 75 NJDWQI. (2017). Appendix A: Health-based maximum contaminant level support document perfluorooctanoic acid (PFOA). New Jersey Drinking Water Quality Institute, Health Effects Subcommittee. https://www.state.nj.us/dep/ watersupply/pdf/pfoa-appendixa.pdf. 76 ATSDR. (2021). Toxicological profile for perfluoroalkyls: final. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, Agency for Toxic Substances and Disease Registry. https:// www.cdc.gov/TSP/ToxProfiles/ ToxProfiles.aspx?id=1117&tid=237. 77 Ibid. 78 Ibid. 79 Ibid. E:\FR\FM\06SEP1.SGM 06SEP1 54428 Federal Register / Vol. 87, No. 171 / Tuesday, September 6, 2022 / Proposed Rules producers phased out these two substances.80 PFOA and PFOS have been detected in surface and subsurface soils. Levels of PFOA and PFOS generally increased with increasing depth at sampled locations, suggesting a downward movement of the contaminants and the potential to contaminate groundwater.81 PFAS can be inadvertently released to soils when biosolids are applied as fertilizer to help maintain productive agricultural soils and stimulate plant growth.82 PFOA and PFOS have been detected in both biosolids and biosolidamended soils. PFAS can also reach soil due to atmospheric transport and wet/ dry deposition.83 PFOA and PFOS have been detected in groundwater in monitoring wells, private drinking water wells, and public drinking water systems across the country. The EPA worked with the states and local communities to monitor for six PFAS, including PFOA and PFOS, under the third Unregulated Contaminant Monitoring Rule to understand the nationwide occurrence of these chemicals in the U.S. drinking water provided by public water systems (PWSs). Of the 4,920 PWSs with results for PFOA and PFOS, PFOA were detected above the minimum reporting level (minimum reporting level = 20 nanogram/liter (ng/L)) in 117 PWSs. Detections exceeded above the MRL for PFOS (MRL = 40 ng/L) at 95 PWSs.84 As previously stated, PFOA and PFOS are common contaminants in the environment because they and their precursors have been produced and released into the environment since the 1940s, and they are resistant to degradation. In addition to being found in groundwater, surface water, soil, sediment, and air, they have been found in wild and domestic animals such as fish, shellfish, alligators, deer and avian eggs; and in humans.85 For example, PFOA has been found in snack foods, vegetables, meat, dairy products and fish, and PFOS has been found in eggs, milk, meat, fish and root 80 Ibid. 81 Ibid. 82 Ibid. jspears on DSK121TN23PROD with PROPOSALS 83 Ibid. 84 U.S. EPA. (2017). The third Unregulated Contaminant Monitoring Rule (UCMR 3): Data summary, January 2017. (EPA815S17001). U.S. Environmental Protection Agency, Office of Water. https://www.epa.gov/sites/default/files/2017-02/ documents/ucmr3-data-summary-january-2017.pdf. 85 ATSDR. (2021). Toxicological profile for perfluoroalkyls: final. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, Agency for Toxic Substances and Disease Registry. https:// www.atsdr.cdc.gov/pfas/health-effects/uspopulation.html. VerDate Sep<11>2014 18:21 Sep 02, 2022 Jkt 256001 vegetables.86 87 88 89 90 91 92 93 94 95 In one study investigating the global distribution of PFAS, wildlife samples were collected on four continents including North America and Antarctica. Wildlife sampled included marine mammals, birds, and polar bears. Only a few samples contained PFOA in concentrations greater than the limit of quantification. However, over 30 different species had measurable levels of PFOS. The study reported PFOS concentrations in mink liver in the midwestern U.S. ranging from 970– 3, 680 nanograms per gram (ng/g), river otter liver in northwestern U.S. from 34–990 ng/g, brown pelican liver in 86 U.S. EPA. (2016). Drinking water health advisory for perfluorooctanoic acid (PFOA). (EPA822R16005). U.S. Environmental Protection Agency, Office of Water. https://www.epa.gov/sites/ default/files/2016-05/documents/pfoa_health_ advisory_final_508.pdf. 87 U.S. EPA. (2016). Drinking water health advisory for perfluorooctane sulfonate (PFOS). (EPA822R16004). U.S. Environmental Protection Agency. https://www.epa.gov/sites/default/files/ 2016-05/documents/pfos_health_advisory_final_ 508.pdf. 88 Holmstrom, K.E.; Jarnberg, U.; Bignert, A. (2005). Temporal trends of PFOS and PFOA in guillemot eggs from the Baltic Sea, 1968–2003. Environ Sci Technol 39: 80–84. https:// www.ncbi.nlm.nih.gov/pubmed/15667078. 89 Wang, Y.; Yeung, L.W.Y.; Yamashita, N.; Taniyasu, S.; So, M.K.; Murphy, M.B.; Lam, P.K.S. (2008). Perfluorooctane sulfonate (PFOS) and related fluorochemicals in chicken egg in China. Chinese Science Bulletin 53: 501–507. 90 Gewurtz, S.B.; Martin, P.A.; Letcher, R.J.; Burgess, N.M.; Champoux, L.; Elliott, J.E.; Weseloh, D.V.C. (2016). Spatio-temporal trends and monitoring design of perfluoroalkyl acids in the eggs of gull (Larid) species from across Canada and parts of the United States. Sci Total Environ 565: 440–450. https://www.ncbi.nlm.nih.gov/pubmed/ 27183458. 91 Morganti, M.; Polesello, S.; Pascariello, S.; Ferrario, C.; Rubolini, D.; Valsecchi, S.; Parolini, M. (2021). Exposure assessment of PFAS-contaminated sites using avian eggs as a biomonitoring tool: A frame of reference and a case study in the Po River valley (Northern Italy). Integr Environ Assess Manag 17: 733–745. https://www.ncbi.nlm.nih.gov/ pubmed/33764673. 92 Michigan.gov. (2021). Michigan PFAS Action Response Team: Fish and wildlife. PFAS in deer. Michigan Department of Environment, Great Lakes, and Energy. https://www.michigan.gov/ pfasresponse/0,9038,7-365-86512_88981_88982— ,00.html. 93 Wisconsin DNR. (2020). DNR And DHS issue do not eat advisory for deer liver in five-mile area surrounding JCI/TYCO site in Marinette. Wisconsin Department of Natural Resources. https:// dnr.wisconsin.gov/newsroom/release/37921. 94 Falk, S.; Brunn, H.; Schroter-Kermani, C.; Failing, K.; Georgii, S.; Tarricone, K.; Stahl, T. (2012). Temporal and spatial trends of perfluoroalkyl substances in liver of roe deer (Capreolus capreolus). Environ Pollut 171: 1–8. https://www.ncbi.nlm.nih.gov/pubmed/22868342. 95 Bangma, J.T.; Reiner, J.L.; Jones, M.; Lowers, R.H.; Nilsen, F.; Rainwater, T.R.; Somerville, S.; Guillette, L.J.; Bowden, J.A. (2017). Variation in perfluoroalkyl acids in the American alligator (Alligator mississippiensis) at Merritt Island National Wildlife Refuge. Chemosphere 166: 72–79. https://www.ncbi.nlm.nih.gov/pubmed/27689886. PO 00000 Frm 00016 Fmt 4702 Sfmt 4702 Mississippi from 290–620 ng/g, and lake whitefish eggs in Michigan waters from 150–380 ng/g.96 97 PFOS bioaccumulates in animals. A fish kinetic bioconcentration factor for PFOS has been estimated to range from 1,000 to 4,000.98 The time to reach 50% clearance of PFOS in fish has been estimated to be around 100 days.99 Bioaccumulation has been demonstrated for fish, birds, crustaceans, worms, plankton, and alligators, among others.100 101 102 PFOA bioaccumulates as well, but not to the same degree as PFOS.103 The prevalence of PFOA and PFOS in environmental media, wild animals, livestock, and plants not only affects the environment but can also lead to human exposure. PFOA and PFOS can also enter the drinking water supply from contamination in groundwater and surface water sources for drinking water. Contaminated drinking water or groundwater can also be used to irrigate or wash home-grown foods or farmgrown foods, thereby providing another means for human exposure. Wild animals are contaminated through environmental exposure, and some wild animals are caught or hunted and eaten by humans, thus, increasing human exposure. Contaminated water also results in the contamination of beef, pork, poultry, etc. Susceptible populations, such as women of reproductive age, pregnant and breastfeeding women, and young children who eat fish may have increased exposure to PFOA and PFOS due to bioaccumulation in fish.104 105 106 96 Giesy, J.P.; Kannan, K. (2001). Global distribution of perfluorooctane sulfonate in wildlife. Environ Sci Technol 35: 1339–1342. https://www.ncbi.nlm.nih.gov/pubmed/11348064. 97 EFSA. (2008). Perfluorooctane sulfonate (PFOS), perfluorooctanoic acid (PFOA) and their salts Scientific Opinion of the Panel on Contaminants in the Food chain. EFSA Journal 6. 98 Ibid. 99 Ibid. 100 Bangma, J.T.; Reiner, J.L.; Jones, M.; Lowers, R.H.; Nilsen, F.; Rainwater, T.R.; Somerville, S.; Guillette, L.J.; Bowden, J.A. (2017). Variation in perfluoroalkyl acids in the American alligator (Alligator mississippiensis) at Merritt Island National Wildlife Refuge. Chemosphere 166: 72–79. https://www.ncbi.nlm.nih.gov/pubmed/27689886. 101 Ng, C.A.; Hungerbuhler, K. (2014). Bioaccumulation of perfluorinated alkyl acids: observations and models. Environ Sci Technol 48: 4637–4648. https://www.ncbi.nlm.nih.gov/pubmed/ 24762048. 102 Burkhard, L.P. (2021). Evaluation of published bioconcentration factor (BCF) and bioaccumulation factor (BAF) data for per- and polyfluoroalkyl substances across aquatic species. Environ Toxicol Chem 40: 1530–1543. https:// www.ncbi.nlm.nih.gov/pubmed/33605484. 103 https://setac.onlinelibrary.wiley.com/doi/ epdf/10.1002/etc.5010. 104 U.S. EPA. (2019). Fish and shellfish program newsletter. (EPA823N19002). U.S. Environmental E:\FR\FM\06SEP1.SGM 06SEP1 Federal Register / Vol. 87, No. 171 / Tuesday, September 6, 2022 / Proposed Rules Human exposure is confirmed by measurements of PFOA and PFOS that were detected in human serum as part of the continuous National Health and Nutrition Examination Survey (NHANES), a program of the CDC. PFOA and PFOS were measured in the serum of a representative sample of the U.S. population ages 12 years and older in each two-year cycle of NHANES since 1999–2000, with the exception of 2001–2002. PFOA and PFOS have been detected in 99% of those surveyed in each NHANES cycle. However, the mean concentrations of PFOA and PFOS in the serum have been steadily decreasing since 1999–2000.107 108 Taken together, this information illustrates the prevalence of PFOA and PFOS in water, soil, air, plants, and animals worldwide due to its transportability and persistence. This widespread distribution of these PFAS significantly contributes to the EPA’s proposed finding that PFOA and PFOS, when released into the environment may present substantial danger to the public health or welfare or the environment. EPA’s proposal to designate PFOA and PFOS, and their salts and structural isomers, as hazardous substances under CERCLA section 102(a) is based on significant evidence, summarized above, that indicates, when released into the environment, these substances may present substantial danger to the public health, welfare or the environment. Collectively, this information demonstrates that PFOA and PFOS should be designated as hazardous substances under CERCLA. jspears on DSK121TN23PROD with PROPOSALS VI. Effect of Designation The designation of PFOA and PFOS would have three direct effects— triggering reporting obligations when there is a release of PFOA or PFOS above the reportable quantity, Protection Agency. https://www.epa.gov/sites/ production/files/2019-04/documents/fish-newsmar2019.pdf. 105 FDA. (2021). Testing food for PFAS and assessing dietary exposure. U.S. Food and Drug Administration. https://www.fda.gov/food/ chemical-contaminants-food/testing-food-pfas-andassessing-dietary-exposure. 106 Christensen, K.Y.; Raymond, M.; Blackowicz, M.; Liu, Y.; Thompson, B.A.; Anderson, H.A.; Turyk, M. (2017). Perfluoroalkyl substances and fish consumption. Environ Res 154: 145–151. https://www.ncbi.nlm.nih.gov/pubmed/28073048. 107 CDC. (2021). National Health and Nutrition Examination Survey: NHANES questionnaires, datasets, and related documentation. Centers for Disease Control and Prevention. https:// wwwn.cdc.gov/nchs/nhanes/Default.aspx. 108 U.S. EPA. (2019). EPA’s per- and polyfluoroalkyl substances (PFAS) action plan. (EPA823R18004). U.S. Environmental Protection Agency. https://nepis.epa.gov/Exe/ ZyPURL.cgi?Dockey=P100W32I.txt. VerDate Sep<11>2014 18:21 Sep 02, 2022 Jkt 256001 obligations on the U.S. Government when it transfers certain properties, and an obligation on DOT to list and regulate CERCLA designated hazardous substances as hazardous materials. A. Default Reportable Quantity Section 102(b) of CERCLA provides that, until superseded by regulation, the reportable quantity for any hazardous substance is one pound. This proposed rule does not include an RQ adjustment for PFOA or PFOS. EPA is setting the RQ by operation of law at the statutory default of one pound pursuant to Section 102(b) of CERCLA. If the Agency chooses to propose adjusting the RQ in the future, it would do so through notice-and-comment rulemaking. B. Direct Effects of a Hazardous Substance Designation 1. Reporting and Notification Requirements for CERCLA Hazardous Substances Section 103 of CERCLA requires any person in charge of a vessel or facility to immediately notify the NRC when there is a release of a hazardous substance, as defined under CERCLA section 101(14), in an amount equal to or greater than the RQ for that substance. The reporting requirements are further codified in 40 CFR 302.6. If this action is finalized, any person in charge of a vessel or facility as soon as he or she has knowledge of a release from such vessel or facility of one pound or more of PFOA or PFOS in a 24-hour period is required to immediately notify the NRC in accordance with 40 CFR part 302. EPA solicits comment on the number of small entities affected by and the estimated cost impacts on small entities from these reporting requirements. In addition to these CERCLA reporting requirements, EPCRA section 304 also requires owners or operators of facilities to immediately notify their SERC (or TERC) and LEPC (or TEPC) when there is a release of a CERCLA hazardous substance in an amount equal to or greater than the RQ for that substance within a 24-hour period. EPCRA section 304 requires these facilities to submit a follow-up written report to the SERC (or TERC) and LEPC (or TEPC) within 30 days of the release. (Note: Some states provide less than 30 days to submit the follow-up written report. Facilities are encouraged to contact the appropriate state or tribal agency for additional reporting requirements.) See 40 CFR part 355, subpart C, for information on the contents for the initial telephone PO 00000 Frm 00017 Fmt 4702 Sfmt 4702 54429 notification and the follow-up written report. EPCRA and CERCLA are separate, but interrelated, environmental laws that work together to provide emergency release notifications to Federal, state, Tribal, and local officials. Notice given to the NRC under CERCLA serves to inform the Federal government of a release so that Federal personnel can evaluate the need for a response in accordance with the National Oil and Hazardous Substances Contingency Plan, the Federal government’s framework for responding to both oil and hazardous substance releases. The NRC maintains all reports of hazardous substance and oil releases made to the Federal government. Relatedly, release notifications under EPCRA given to the SERC (or TERC) and to the LEPC (or TEPC) are crucial so that these state, Tribal, and local authorities have information to help protect the community. 2. Requirements Upon Transfer of Government Property Under CERCLA section 120(h), when Federal agencies sell or transfer federally-owned, real property, they must provide notice of when any hazardous substances ‘‘was stored for one year or more, known to have been released, or disposed of’’ and covenants concerning the remediation of such hazardous substances in certain circumstances. 3. Requirement of DOT To List and Regulate CERCLA Hazardous Substances Section 306(a) of CERCLA requires substances designated as hazardous under CERCLA be listed and regulated as hazardous materials by DOT under the Hazardous Materials Transportation Act (HMTA). DOT typically does not undertake a public notice and comment period when adding a CERCLAdesignated hazardous substance to the list of regulated hazardous materials under HMTA. VII. Regulatory and Advisory Status at EPA, Other Federal, State and International Agencies Designating PFOA and PFOS as hazardous substances would be one additional piece of an extensive, widespread response to address the dangers these chemicals pose. Regulatory requirements, enforcement actions, and other activities of many Federal, state, and international entities together indicate the widespread and serious concern with PFOA and PFOS. E:\FR\FM\06SEP1.SGM 06SEP1 jspears on DSK121TN23PROD with PROPOSALS 54430 Federal Register / Vol. 87, No. 171 / Tuesday, September 6, 2022 / Proposed Rules A. EPA Actions The EPA has taken several actions in the past to address risks from PFOA and PFOS. In 2006, the EPA launched the 2010/2015 PFOA Stewardship Program, under which eight major chemical manufacturers and processors agreed to phase out the use of PFOA and PFOArelated chemicals in their products and emissions from their facilities. All companies met the PFOA Stewardship Program goals by 2015. The TSCA program has taken a range of regulatory actions to address PFAS in manufacturing and consumer products. Since 2002, EPA has finalized a number of TSCA Section 5(a) Significant New Use Rules (SNURs) covering hundreds of existing PFAS no longer in use. These regulatory actions require notice to EPA, as well as Agency review and regulation, as necessary, before manufacture (including import) or processing for significant new uses of these chemicals can begin or resume. The SNURs also apply to imported articles containing certain PFAS, including consumer products such as carpets, furniture, electronics, and household appliances. EPA also has issued SNURs for dozens of PFAS that have undergone EPA’s new chemicals review prior to commercialization; these actions ensure that any new uses which may present risk concerns but were not part of the EPA new chemicals review, do not commence unless EPA is notified, conducts a risk review, and regulates as appropriate under TSCA section 5. In 2009, EPA published provisional drinking water health advisories of 400 ppt for PFOA and 200 ppt for PFOS based on health effects information available at that time. The provisional health advisories were developed for application to short-term (weeks to months) risk assessment exposure scenarios. The provisional health advisories were intended as guidelines for public water systems while allowing time for EPA to develop final lifetime health advisories for PFOA and PFOS. EPA published final lifetime drinking water health advisories for PFOA and PFOS (70 ppt individually, and in combination) in 2016. New health information has become available since 2016, and in June 2022, EPA replaced the 2016 advisories with interim updated lifetime health advisories for PFOA and PFOS based on human epidemiology studies in populations exposed to these chemicals. Based on the new data and EPA’s draft analyses, the levels at which negative health effects could occur are much lower than previously understood when VerDate Sep<11>2014 18:21 Sep 02, 2022 Jkt 256001 EPA issued the 2016 health advisories for PFOA and PFOS. The interim updated health advisory levels are 0.004 ppt for PFOA and 0.02 ppt for PFOS, which are below the levels at which analytical methods can measure these PFAS in drinking water. The EPA Science Advisory Board is reviewing EPA’s analyses, and therefore, the interim health advisories are subject to change. However, EPA does not anticipate changes that will result in health advisory levels that are greater than the minimum reporting levels. The interim health advisories are intended to provide information to states and public water systems until the PFAS National Primary Drinking Water Regulation takes effect. Health advisories provide drinking water system operators, and state, Tribal, and local officials who have the primary responsibility for overseeing these systems, with information on the health risks of these chemicals, so they can take the appropriate actions to protect their residents. In 2019, EPA issued the Interim Recommendations to Address Groundwater Contaminated with PFOA and PFOS to facilitate cleaning up contaminated groundwater that is a current or potential source of drinking water. The recommendations provide a starting point for making site-specific cleanup decisions. The guidance recommends: 109 • Use the following tapwater screening levels for PFOA and PFOS to determine if PFOA and/or PFOS is present at a site and may warrant further attention. Æ If both are detected in tapwater— PFOS regional screening level (RSL) = 6 parts per trillion (ppt) and PFOS regional removal management levels (RMLs) = 4 ppt. Æ If they are the only contaminant detected in tapwater—PFOA RSL = 60 ppt and PFOS RSL = 40 ppt. Æ Screening levels are risk-based values that are used to determine if levels of contamination may warrant further investigation at a site. • Using EPA’s 2016 PFOA and PFOS LHA level of 70 ppt as the preliminary remediation goal (PRG) for contaminated groundwater that is a current or potential source of drinking water, where no state or tribal maximum contaminant level (MCL) or other applicable or relevant and appropriate 109 U.S. EPA. (2019). USEPA draft interim recommendations to address groundwater contaminated with perfluorooctanoic acid and perfluorooctane sulfonate. (EPA–HQ–OLEM–2019– 0229–0002). U.S. Environmental Protection Agency. https://downloads.regulations.gov/EPA-HQ-OLEM2019-0229-0002/content.pdf. PO 00000 Frm 00018 Fmt 4702 Sfmt 4702 requirements are available or sufficiently protective. Æ PRGs are generally initial targets for cleanup that may be adjusted on a sitespecific basis as more information becomes available. In 2020, the EPA issued a final rule strengthening the regulation of PFAS (i.e., PFOA and its salts, long-chain perfluoroalkyl carboxylate chemical substances) by requiring notice and EPA review before the use of long-chain PFAS that have been phased out in the United States could begin again. Additionally, products containing certain long-chain PFAS as a surface coating and carpet containing perfluoroalkyl sulfonate chemical substances can no longer be imported into the United States without EPA review. This action means that articles like textiles, carpet, furniture, electronics, and household appliances that could contain certain PFAS cannot be imported into the United States unless EPA reviews and approves the use or puts in place the necessary restrictions to address any unreasonable risks. In 2020, the EPA also added 172 PFAS (including PFOA and PFOS) to the TRI, and 3 additional compounds were added in 2021. Additional PFAS will continue to be added to TRI, consistent with the National Defense Authorization Act for Fiscal Year 2020. In October 2021, the EPA released the PFAS Strategic Roadmap that presents EPA’s whole-of-agency approach to addressing PFAS and sets timelines by which the Agency plans to take concrete actions.110 Several actions described in the roadmap, including this proposed rule, address PFOA and PFOS. Other ongoing EPA actions on PFOA and PFOS include: • Finalizing a proposed rule that would impose certain reporting and recordkeeping requirements under TSCA for PFAS, including PFOA and PFOS, manufactured at any time since January 1, 2011 (86 FR 33926). • Finalizing the proposed Unregulated Contaminant Monitoring Rule 5 (UCMR5). As proposed, UCMR5 would collect data on 29 PFAS, including PFOA and PFOS, in public water systems (86 FR 13846). • Establishing a national primary drinking water regulation for PFOA and PFOS under the Safe Drinking Water Act. • Publishing recommended aquatic life water quality criteria for PFOA and 110 U.S. EPA. (2021). PFAS strategic roadmap: EPA’s commitments to action 2021–2024. U.S. Environmental Protection Agency. https:// www.epa.gov/system/files/documents/2021-10/ pfas-roadmap_final-508.pdf. E:\FR\FM\06SEP1.SGM 06SEP1 Federal Register / Vol. 87, No. 171 / Tuesday, September 6, 2022 / Proposed Rules jspears on DSK121TN23PROD with PROPOSALS PFOS (draft criteria were released for public comment in May 2022) and developing human health water quality criteria for PFOA and PFOS. • Finalizing a risk assessment for PFOA and PFOS in biosolids, which will serve as the basis for determining whether regulation of PFOA and PFOS in biosolids is appropriate. Further, based on public health and environmental protection concerns, and in response to a petition from the Governor of New Mexico, which requested EPA to take regulatory action on PFAS under RCRA, EPA announced on October 26, 2021, the initiation of two rulemakings. First, EPA will initiate the rulemaking process to propose adding four PFAS as RCRA hazardous constituents under 40 CFR part 261 Appendix VIII, by evaluating the existing data for these chemicals and establishing a record to support such a proposed rule. The four PFAS EPA will evaluate are: PFOA, PFOS, perfluorobutane sulfonic acid (PFBS) and GenX chemicals (hexafluoropropylene oxide (HFPO) dimer acid and its ammonium salt). Second, EPA will initiate a rulemaking to clarify in the Agency’s regulations that the RCRA Corrective Action Program has the authority to require investigation and cleanup for wastes that meet the statutory definition of hazardous waste, as defined under RCRA section 1004(5). This modification would clarify that emerging contaminants such as PFAS can be addressed through RCRA corrective action. Recent scientific data and the Agency’s new analyses indicate that negative health effects may occur at much lower levels of exposure to PFOA and PFOS than previously understood and that PFOA is likely carcinogenic to humans. The Agency’s new analyses were released in November 2021 111 112 for independent scientific review by the EPA Science Advisory Board. The draft documents present EPA’s initial analysis and findings with respect to 111 U.S. EPA (U.S. Environmental Protection Agency). 2021a. External Peer Review Draft: Proposed Approaches to the Derivation of a Draft Maximum Contaminant Level Goal for Perfluorooctanoic Acid (PFOA) (CASRN 335–67–1) in Drinking Water. EPA–822–D–21–001. EPA, Office of Water, Washington, DC. Accessed April 2022. https://sab.epa.gov/ords/sab/ f?p=100:18:16490947993:::RP,18:P18_ID:2601. 112 U.S. EPA (U.S. Environmental Protection Agency). 2021b. External Peer Review Draft: Proposed Approaches to the Derivation of a Draft Maximum Contaminant Level Goal for Perfluorooctane Sulfonic Acid (PFOS) CASRN 1763–23–1 in Drinking Water. EPA–822–D–21–002. EPA, Office of Water, Washington, DC. Accessed April 2022. https://sab.epa.gov/ords/sab/ f?p=100:18:16490947993:::RP,18:P18_ID:2601. VerDate Sep<11>2014 18:21 Sep 02, 2022 Jkt 256001 this new information. EPA’s 2021 draft non-cancer reference doses based on human epidemiology studies for various effects (e.g., developmental/growth, cardiovascular health outcomes, immune health) range from ∼10¥7 to 10¥9 milligram per kilogram per day (mg/kg/day). These draft reference doses are two to four orders of magnitude lower than EPA’s 2016 reference doses for PFOA and PFOS of 2 × 10¥5 mg/kg/ day. Following peer review, this information will be used to inform updated EPA drinking water health advisories and the development of Maximum Contaminant Level Goals and a National Primary Drinking Water Regulation for PFOA and PFOS. The EPA routinely updates RSLs and RMLs two times per year. EPA’s next regularly scheduled update to the RSL and RML tables will be in November 2022. Since the science of PFAS toxicity is evolving we expect to update the numbers as appropriate during future updates. B. Actions by Other Federal Agencies • ATSDR: The Agency for Toxic Substances and Disease Registry (ATSDR), in response to a congressional mandate under CERCLA, develops comparison values to help identify chemicals that may be of concern to the public’s health at hazardous waste sites. The ATSDR’s guideline values are minimal risk levels (MRLs). An MRL is an estimate of the amount of a chemical a person can eat, drink, or breathe each day over a specified duration without a detectable risk to health. MRLs are developed for health effects other than cancer. If someone is exposed to an amount above the MRLs, it does not mean that health problems will happen. MRLs are a screening tool that help identify exposures that could be potentially hazardous to human health. Exposure above the MRLs does not mean that health problems will occur. Instead, it may act as a signal to health assessors to look more closely at a particular site where exposures may be identified. The ATSDR works closely with EPA at both a national and regional level to determine areas and populations potentially at risk for health effects from exposure to PFAS.113 The ATSDR has final intermediate duration (15–364 days) MRLs (2021) for PFOA and PFOS which are 3 × 10¥6 mg/kg/day and 2 × 10¥6 mg/kg/day, respectively.114 113 ATSDR. (2018). Minimal risk levels (MRLs). Atlanta, GA: Agency for Toxic Substances and Disease Registry. https://www.atsdr.cdc.gov/ minimalrisklevels/. 114 ATSDR. (2021). Toxicological profile for perfluoroalkyls: final. Atlanta, GA: U.S. Department PO 00000 Frm 00019 Fmt 4702 Sfmt 4702 54431 ATSDR also has a PFAS strategy, exposure assessments, and a multi-site study—PFAS Cooperative Agreement. • DoD: The Department of Defense (DoD) included PFOA and PFOS on its list of emerging chemicals of concern.115 The DoD defines emerging chemicals as chemicals or materials that the department currently uses or plans to use that present a potentially unacceptable human health or environmental risk; have a reasonably possible pathway to enter the environment; and either do not have regulatory standards based on peerreviewed science, or their regulatory standards are evolving due to new science, detection capabilities or exposure pathways.116 In 2017, the DoD updated their military specification for AFFF to include no more than 800 parts per billion, the quantitation limit by DoD Quality Systems Manual 5.1, of PFOA and PFOS in the concentrate.117 The DoD is working to remove AFFF containing PFOA and PFOS from the supply chain.118 ‘‘In January 2016, the Office of the Assistant Secretary of Defense for Energy, Installations and Environment issued a policy requiring the DoD components to: (1) issue Military Service-specific risk management procedures to prevent uncontrolled land-based releases of AFFF during maintenance, testing and training activities, and (2) remove and properly dispose of AFFF containing PFOS from the local stored supplies for non-shipboard use to prevent future environmental response action costs, where practical’’.119 Under this policy, of Health and Human Services, Centers for Disease Control and Prevention, Agency for Toxic Substances and Disease Registry. https:// wwwn.cdc.gov/TSP/ToxProfiles/ ToxProfiles.aspx?id=1117&tid=237. 115 DoD. (2019). DoD instruction 4715.18: Emerging chemicals (ECs) of environmental concern. U.S. Department of Defense. https:// www.esd.whs.mil/Portals/54/Documents/DD/ issuances/dodi/471518p.pdf?ver=2017-12-13110558-727. 116 Ibid. 117 U.S. Navy. (2017). Performance specification fire extinguishing agent, aqueous film-forming foam (AFFF) liquid concentrate, for fresh and sea water. (MIL–PRF–24385F(SH) w/Amendment 2). U.S. Navy, Naval Sea Systems Command (Ship Systems). https://quicksearch.dla.mil/Transient/ E3EA5BB276A741A292E87C18DE644702.pdf https://quicksearch.dla.mil/Transient/ C26F946AAE39463BBFCB321B047611E4.pdf. 118 WH.gov. (2021). Fact sheet: President Biden signs executive order catalyzing America’s clean energy economy through federal sustainability. Washington, DC: The White House. https:// www.whitehouse.gov/briefing-room/statementsreleases/2021/12/08/fact-sheet-president-bidensigns-executive-order-catalyzing-americas-cleanenergy-economy-through-federal-sustainability/. 119 DoD. (2017). Aqueous film forming foam: Report to Congress. U.S. Department of Defense, E:\FR\FM\06SEP1.SGM Continued 06SEP1 54432 Federal Register / Vol. 87, No. 171 / Tuesday, September 6, 2022 / Proposed Rules jspears on DSK121TN23PROD with PROPOSALS for example, the Air Force funded the removal of AFFF from all fire trucks and crash response vehicles and replaced it with PFOS-free AFFF, which contains only trace quantities of PFOA. All Air Force bases except Thule Air Force Base, Greenland, have received replacement AFFF, and 97 percent of the bases have completed the transition. In addition, the Navy is updating the military specification requirements for AFFF and DoD continues its research efforts to find a PFAS-free alternative to AFFF.120 DoD has also set up a taskforce to address PFAS on and near military bases from DoD activities. DoD is investing over $49 million through fiscal year 2025 in research, development, testing, and evaluation in collaboration with academia and industry to identify alternative firefighting material and practices. In the meantime, DoD only uses AFFF to respond to emergency events and no longer uses it for uncontained landbased testing and training.121 In addition, DoD has initiated other actions to test for, investigate, and mitigate elevated levels of PFOA and PFOS at or near installations across the military departments. Following the release of EPA’s LHAs for PFOA and PFOS in May 2016, each of the military departments issued guidance directing installations to test for PFOA and PFOS in their drinking water and take steps to address drinking water that contained amounts of PFOA and PFOS above EPA’s health advisory level. The military departments also directed their installations to identify locations with a known or suspected prior release of PFOA and PFOS and to address any releases that pose a risk to human health.122 As of December 31, 2021, the DoD was performing the PA/SI for PFAS at 700 DoD installations and National Guard Facilities. • DOE: On September 16, 2021, the Department of Energy (DOE) issued a memo that focused on four main points; discontinue use of AFFF except in emergencies, suspend disposal of AFFF pending further guidance, establish reporting requirements for any release or spill of PFAS and establish a DOE Office of the Under Secretary of Defense for Acquisition, Technology and Logistics. https:// www.denix.osd.mil/derp/home/documents/ aqueous-film-forming-foam-report-to-congress/ Aqueous%20Film%20Forming %20Foam%20(AFFF)%20Report%20to %20Congress_DENIX.PDF. 120 DoD. (2020). Per- and polyfluoroalkyl substances (PFAS) Task Force progress report. U.S. Department of Defense. https://media.defense.gov/ 2020/Mar/13/2002264440/-1/-1/1/PFAS_Task_ Force_Progress_Report_March_2020.pdf. 121 Ibid. 122 Ibid. VerDate Sep<11>2014 18:21 Sep 02, 2022 Jkt 256001 PFAS Coordinating Committee. DOE has completed an assessment of its PFAS usage and inventory across the department and is in the process of developing a department wide report of the results of that assessment. At the request of Council on Environmental Quality, DOE, as well as other agencies and departments, is developing a PFAS Roadmap similar to EPA’s that will guide future PFAS related actions for 2022–2025.FAA: On January 17, 2019, the Federal Aviation Administration (FAA) released guidance in the form of a CertAlert to all certificated Part 139 Aircraft Rescue and Firefighting departments regarding safer methods for the required bi-annual testing of AFFF for firefighting. In the guidance, the FAA suggests alternative AFFF testing systems that minimize environmental impact while still satisfying the regulatory requirement for safety testing. The recommendations include addressing environmental concerns such as establishing safe and environmentally effective handling and disposal procedures.123 On October 4, 2021, the FAA published a CertAlert which informs Part 139 airport operators about changes to the military specification (MIL–PRF– 24385F(SH)) for firefighting foam referenced in Chapter 6 of AC No.: 150/ 5210–6D. While the performance standard remains the same, the military specification no longer requires the use of fluorinated chemicals. One acceptable means of satisfying 14 CFR part 139 requirements is to continue to use the existing approved foam which does contain fluorinated chemicals. However, FAA encourages certificate holders that have identified a different foam that meets the performance standard to seek approval for such foam from the FAA.124 • FDA: In 2011, FDA reached voluntary agreements with manufacturers and suppliers of long chain PFAS subject to Food Contact Notification to no longer sell those substances for use in food contact applications. In 2016, the FDA revoked the regulations authorizing the remaining uses of these long-chain PFAS in food packaging (see 81 FR 5, January 4, 2016, and 81 FR 83672, 123 FAA. (2019). National part 139 CertAlert: Aqueous film forming foam (AFFF) testing at certificated part 139 airports. (No. 19–01). Federal Aviation Administration. https://www.faa.gov/ airports/airport_safety/certalerts/media/part-139cert-alert-19-01-AFFF.pdf. 124 FAA. (2021). National part 139 CertAlert: Part 139 extinguishing agent requirements. (No. 21–05). Federal Aviation Administration. https:// www.faa.gov/airports/airport_safety/certalerts/ media/part-139-cert-alert-21-05-ExtinguishingAgent-Requirements.pdf. PO 00000 Frm 00020 Fmt 4702 Sfmt 4702 November 22, 2016). As of November 2016, long-chain PFAS are no longer used in food contact applications sold in the United States.125 In addition to EPA, a number of agencies including ATSDR, DoD, DOI, DOT, FDA, and USDA Have or are developing PFAS plans outlining how their agencies will address PFAS contamination. C. State Actions As concerns have arisen regarding PFOA and PFOS many states have taken regulatory action. In addition to some of the states discussed in more detail below, Alabama, Arizona, Idaho, Kentucky, Nebraska, and West Virginia have opted to use EPA’s 2016 LHAs of 70 ppt for PFOA and PFOS.126 127 128 129 • Alaska: The Alaska Department of Environmental Conservation (ADEC) promulgated groundwater cleanup levels of 400 ppt and soil cleanup levels of 1.3 to 2.2 milligram per kilogram (mg/ kg) (range depending on precipitation zone) for PFOA and PFOS, respectively, in Oil and Other Hazardous Substances Pollution Control Regulations as amended through June 2021.130 Healthbased action levels for drinking water of 70 ppt for PFOA and PFOS, individually or combined, were established by ADEC in 2018 (updated in 2019) based on EPA’s 2016 LHAs.131 • California: In August 2019, the California Office of Environmental Health Hazard Assessment developed PFOA and PFOS toxicity values 125 https://www.fda.gov/food/chemicalcontaminants-food/authorized-uses-pfas-foodcontact-applications. 126 Pontius, F. (2019). Regulation of perfluorooctanoic acid (PFOA) and perfluorooctane sulfonic acid (PFOS) in drinking water: A comprehensive review. Water 11: 2003. 127 Idaho DEQ. (2021). PFAS and Idaho drinking water. Idaho Department of Environmental Quality. https://www.deq.idaho.gov/water-quality/drinkingwater/pfas-and-idaho-drinking-water/. 128 Kentucky EEC. (2019). Evaluation of Kentucky community drinking water for per- & polyfluoroalkyl substances. Kentucky Energy and Environment Cabinet, Department for Environmental Protection. https://eec.ky.gov/ Documents%20for%20URLs/PFAS%20Drinking %20Water%20Report%20Final.pdf. 129 AWWA. (2020). Per- and polyfluoroalkyl substances (PFAS): summary of state policies to protect drinking water. American Water Works Association. https://www.awwa.org/LinkClick.aspx? fileticket=nCRhtmGcA3k%3D&portalid=0. 130 Alaska DEC. (2021). Oil and other hazardous substances pollution control. (Alaska Admin Code 18 AAC 75). Alaska Department of Environmental Conservation. https://dec.alaska.gov/commish/ regulations/. 131 Alaska DEC. (2019). Technical memorandum: Action levels for PFAS in water and guidance on sampling groundwater and drinking water. Alaska Department of Environmental Conservation. https:// dec.alaska.gov/media/15773/pfas-drinking-wateraction-levels-technical-memorandum-10-2-19.pdf. E:\FR\FM\06SEP1.SGM 06SEP1 Federal Register / Vol. 87, No. 171 / Tuesday, September 6, 2022 / Proposed Rules jspears on DSK121TN23PROD with PROPOSALS (acceptable daily doses) of 4.5 × 10¥7 mg/kg-day and 1.8 × 10¥6 mg/kg-day, respectively, and reference levels based on cancer effects of 0.1 ppt and 0.4 ppt, respectively. They noted that the levels are lower than the levels of PFOA and PFOS that can be reliably detected in drinking water using currently available technologies. Thus, they recommended that the State Water Resources Control Board set notification limits at the lowest levels at which PFOA and PFOS can be reliably detected in drinking water using available and appropriate technologies.132 The California State Water Resources Control Board issued new drinking water notification limits for local water agencies to follow for finding and reporting PFOA and PFOS of 5.1 ppt for PFOA and 6.5 ppt for PFOS. As part of these guidelines, California also established a response level of 10 ppt for PFOA and 40 ppt for PFOS.133 134 If this level is exceeded in drinking water provided to consumers, California recommends that the water agency remove the water source from service.135 In July 2021, the California Office of Environmental Health Hazard Assessment released draft Public Health Goals (PHGs) for PFOA of 0.007 ppt based on human kidney cancer data and PFOS of 1 ppt based on liver and pancreatic tumor animal data. PHGs are not regulatory requirements and are based solely on protection of public health without regard to cost impacts or other factors.136 132 OEHHA. (2019). Notification level recommendations: Perfluorooctanoic acid and perfluorooctane sulfonate in drinking water. California Office of Environmental Health Hazard Assessment. https://oehha.ca.gov/media/ downloads/water/chemicals/nl/final-pfoapfosnl082119.pdf. 133 California Water Boards. (2020). Notification level issuance: Contaminant(s): perfluorooctanoic acid (PFOA). State Water Resources Control Board. California Water Boards. https:// www.waterboards.ca.gov/drinking_water/certlic/ drinkingwater/documents/pfos_and_pfoa/pfoa_nl_ issuance_jan2020.pdf. 134 California Water Boards. (2020). Notification level issuance: Contaminant(s): perfluorooctanesulfonic acid (PFOS). State Water Resources Control Board. California Water Boards. https://www.waterboards.ca.gov/drinking_water/ certlic/drinkingwater/documents/pfos_and_pfoa/ pfos_nl_issuance_jan2020.pdf. 135 California Water Boards. (2020). Perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS). State Water Resources Control Board. California Water Boards. https://www.waterboards.ca.gov/drinking_water/ certlic/drinkingwater/PFOA_PFOS.html. 136 OEHHA. (2021). Public health goals: First public review draft: Perfluorooctanoic acid and perfluorooctane sulfonic acid in drinking water Office of Environmental Health Hazard Assessment. California Environmental Protection Agency. https://oehha.ca.gov/sites/default/files/media/ downloads/crnr/pfoapfosphgdraft061021.pdf. VerDate Sep<11>2014 18:21 Sep 02, 2022 Jkt 256001 California is also conducting sampling efforts targeting airports, chrome plating facilities, landfills, WWTPs and nearby water supply wells.137 • Colorado: To address known contamination in El Paso County, the Colorado Water Quality Control Commission (WQCC) adopted a sitespecific groundwater quality standard of 70 ppt for PFOA and PFOS combined in 2018 based on the EPA 2016 LHAs.138 139 By 2019, the Colorado Department of Public Health and Environment adopted a PFAS Action Plan outlining methods by which the state planned to protect residents from PFAS. As part of this initiative, a survey was conducted regarding the use of firefighting foams that resulted in rules with respect to the registration and use of PFAS-containing foams.140 The Colorado WQCC approved a policy interpreting the existing narrative standards for PFAS in 2020. This policy outlines the use of translation levels of 70 ppt for PFOA, PFOS, PFOA and PFOS parent constituents, and perfluorononanoic acid (PFNA), individually or combined, based on the EPA’s 2016 LHAs.141 • Connecticut has issued a drinking water action level of 70 ppt for PFOA, PFOS, PFNA, perfluorohexanesulfonic acid (PFHxS) and perfluoroheptanoic acid (PFHpA) individually or combined. The action level is based on risk and similar health effects of the five PFAS. An interagency task force was formed that has recommended actions including take-back and safe disposal of AFFF containing PFAS from state and municipal fire departments.142 137 California Water Boards. (2021). GeoTracker PFAS map. State Water Resources Control Board. California Water Boards. https:// geotracker.waterboards.ca.gov/map/pfas_map. 138 CDPHE. (2017). Site-specific groundwater standard: PFOA/PFOS. Colorado Department of Public Health & Environment. https:// www.colorado.gov/pacific/sites/default/files/WQ_ GWStandard_PFOA_100417%20FINAL.pdf. 139 CDPHE. (2020). Policy 20–1. Policy for interpreting the narrative water quality: Standards for per- and polyfluoroalkyl substances (PFAS). Colorado Department of Public Health & Environment, Water Quality Control Commission. https://drive.google.com/file/d/ 119FjO4GZVaJtw7YFvFqs9pmlwDhDO_eG/view. 140 Coleman, C. (2020). Colorado enacts arsenal of laws to stop ‘‘forever chemicals’’. Water Education Colorado. https://www.watereducationcolorado.org/ fresh-water-news/colorado-enacts-arsenal-of-lawsto-stop-forever-chemicals/. 141 CDPHE. (2020). Policy 20–1. Policy for interpreting the narrative water quality: Standards for per- and polyfluoroalkyl substances (PFAS). Colorado Department of Public Health & Environment, Water Quality Control Commission. https://drive.google.com/file/d/ 119FjO4GZVaJtw7YFvFqs9pmlwDhDO_eG/view. 142 CT Interagency PFAS Task Force. (2019). PFAS action plan. Connecticut Interagency PFAS Task Force. Department of Public Health & PO 00000 Frm 00021 Fmt 4702 Sfmt 4702 54433 • Delaware: Based on Delaware’s Department of Natural Resources and Environmental Control Hazardous Substance Cleaning Act Screening Level Table Guidance (last updated in November 2021), a screening/reporting level for PFOA and PFOS, individually or combined, of 70 ppt in groundwater is based on EPA’s 2016 LHAs; and a reporting/screening level for PFOA and PFOS in the soil (of 0.13 mg/kg based on screening document and 1.3 mg/kg based on the reporting level table) is based on EPA’s Regional Screening Level Calculator.143 144 • Florida issued guidance identifying provisional groundwater target cleanup levels of 70 ppt for PFOA and PFOS combined, provisional soil cleanup target levels of 1.3 mg/kg for PFOA and PFOS, and surface water screening levels of 500 ppt for PFOA and 10 ppt for PFOS; these values were last updated in 2020.145 • Hawaii: In 2020, Hawaii published a memorandum identifying interim soil and water and soil environmental action levels (EALs) for PFAS. For groundwater that is a current potential source of drinking water, groundwater EALs are 40 ppt for PFOA and PFOS. Soil EALs are 0.0012 mg/kg for PFOA and 0.0075 mg/kg for PFOS.146 • Illinois: By July 2021, Illinois EPA issued statewide health advisories for six PFAS: PFOA, PFOS, PFNA, perfluorohexanoic acid (PFHxA), PFHxS and PFBS. A health advisory is a regulatory action that provides guidance to local officials and community water supply operators in protecting the health of their customers. Illinois EPA is authorized to issue a health advisory when there is a confirmed detection in a community water supply well of a chemical substance for which no Department of Energy and Environmental Protection. https://portal.ct.gov/-/media/Office-ofthe-Governor/News/20191101-CT-InteragencyPFAS-Task-Force-Action-Plan.pdf. 143 DNREC. (2021). Hazardous Substance Cleanup Act: Screening level table guidance. Delaware Department of Natural Resources and Environmental Control. https:// documents.dnrec.delaware.gov/dwhs/remediation/ HSCA-Screening-Level-Table-Guidance.pdf. 144 DNREC. (2021). Sortable HSCA reporting level table (Excel). Delaware Department of Natural Resources and Environmental Control. https:// dnrec.alpha.delaware.gov/waste-hazardous/ remediation/laws-regs-guidance/. 145 Florida DEP. (2020). Provisional PFOA and PFOS cleanup target levels & screening levels. Florida Department of Environmental Protection. https://floridadep.gov/waste/district-businesssupport/documents/provisional-pfoa-and-pfoscleanup-target-levels-screening. 146 Hawai’i DOH. (2020). Interim soil and water environmental action levels (EALs) for perfluoroalkyl and polyfluoroalkyl substances (PFASs). Hawaii State Department of Health. https://health.hawaii.gov/heer/files/2020/12/ PFASs-Techncal-Memo-HDOH-Dec-2020.pdf. E:\FR\FM\06SEP1.SGM 06SEP1 54434 Federal Register / Vol. 87, No. 171 / Tuesday, September 6, 2022 / Proposed Rules jspears on DSK121TN23PROD with PROPOSALS numeric groundwater standard exists. The health-based guidance level for PFOA is 2 ppt and PFOS is 14 ppt.147 Illinois EPA is conducting a statewide investigation into the prevalence and occurrence of PFAS in finished water at entry points to the distribution system representing 1,749 community water supplies across Illinois.148 • Iowa: The Iowa Department of Natural Resources issued Statewide Standards for PFOA and PFOS in 2016. The standards were set at 70 ppt for PFOA and PFOS for a protected groundwater source, and 50,000 ppt for PFOA and 1,000 ppt for PFOS for a nonprotected groundwater source. Statewide standards for soil are 35 mg/ kg for PFOA and 1.8 mg/kg for PFOS.149 • Kansas: The Kansas Department of Health and Environment, the Bureau of Environmental Remediation, and the Bureau of Water are working together to address PFAS in drinking water. The process involves the development of a statewide inventory and prioritization of potential PFAS sources. This information will be used to develop a public water supply monitoring program.150 • Maine’s Department of Environmental Protection requires the testing of all sludge material licensed for land application in the state for PFAS (including PFOA and PFOS). The governor created a task force to mobilize state agencies and other stakeholders to review the prevalence of PFAS in Maine.151 Maine Remedial Action Guidelines (RAGs) for Sites Contaminated with Hazardous Substances (2018) identified a water RAG of 400 ppt for PFOA and PFOS and a soils (residential) RAG of 1.7 mg/kg for PFOA and PFOS.152 In June 2021, the 147 Illinois EPA. (2021). PFAS statewide health advisory. Illinois Environmental Protection Agency, Office of Toxicity Assessment. https:// www2.illinois.gov/epa/topics/water-quality/pfas/ Pages/pfas-healthadvisory.aspx. 148 Illinois EPA. (2021). PFAS statewide investigation network: Community water supply sampling. Illinois Environmental Protection Agency, Office of Toxicity Assessment. https:// www2.illinois.gov/epa/topics/water-quality/pfas/ Pages/pfas-statewide-investigation-network.aspx. 149 Iowa DNR. (2021). Cumulative risk calculator: Statewide standards. Iowa Department of Natural Resources. https://programs.iowadnr.gov/riskcalc/ Home/statewidestandards. 150 KDHE. (2021). Per- and polyfluoroalkyl substances (PFAS). Kansas Department of Health and Environment. https://www.kdheks.gov/pws/ PFAS.htm. 151 Maine EPA. (2021). Per- and polyfluoroalkyl substances (PFAS). Maine Department of Environmental Protection Agency. https:// www.maine.gov/dep/spills/topics/pfas/. 152 Maine DEP. (2018). Maine remedial action guidelines (RAGs) for sites contaminated with hazardous substances. Maine Department of Environmental Protection. https://www.maine.gov/ VerDate Sep<11>2014 18:21 Sep 02, 2022 Jkt 256001 Governor also signed an emergency resolution establishing an interim drinking water standard of 20 ppt for 6 PFAS. The resolution also requires that the Maine Department of Health and Human Services promulgate an MCL for PFAS by June 1, 2024. • Massachusetts: In December 2019, the Massachusetts Department of Environmental Protection Office of Research and Standards reassessed the toxicity information for a subgroup of longer chain PFAS. They applied a revised reference dose (RfD) of 5 × 10¥6 mg/kg-day to PFOA, PFOS, PFNA, PFHxS, PFHpA and perfluorodecanoic acid (PFDA). This reassessment resulted in an MCL of 20 ppt, promulgated in October 2020.153 154 Also, PFAS are considered to be hazardous material subject to the notification, assessment and cleanup requirements of the Massachusetts Waste Site Cleanup Program.155 • Michigan derived a toxicity value of 3.9 × 10¥6 mg/kg-day for PFOA and 2.89 × 10¥6 mg/kg-day for PFOS.156 Michigan’s public health drinking water MCLs are 8 ppt for PFOA and 16 ppt for PFOS, effective in August 2020. The Michigan PFAS Action Response Team has coordinated many actions across the state. Michigan Department of Health and Human Services has recommended people avoid contaminant-induced foam occurring on certain PFAScontaminated surface water bodies and has initiated a PFAS Exposure and Health Study. The Michigan Department of Environment, Great Lakes, and Energy began a statewide initiative to test drinking water from all community water supplies for PFAS and has been dep/spills/publications/guidance/rags/MERemedial-Action-Guidelines-10-19-18cc.pdf. 153 MassDEP. (2019). Technical support document: Per- and polyfluoroalkyl substances (PFAS): An updated subgroup approach to groundwater and drinking water values. Massachusetts Department of Environmental Protection. https://www.mass.gov/files/documents/ 2019/12/27/PFAS%20TSD%202019-1226%20FINAL.pdf. 154 MassDEP. (2020). 310 CMR 22: The Massachusetts drinking water regulations. Massachusetts Department of Environmental Protection, Drinking Water Program. https:// www.mass.gov/doc/310-cmr-2200-themassachusetts-drinking-water-regulations/ download. 155 MassDEP. (2019). Final PFAS-related revisions to the MCP. Massachusetts Department of Environmental Protection, Drinking Water Program. https://www.mass.gov/lists/final-pfas-relatedrevisions-to-the-mcp-2019. 156 Michigan.gov. (2022). Health-based drinking water value recommendations for PFAS in Michigan. Michigan Department of Environment, Great Lakes, and Energy. Science Advisory Workgroup. https://www.michigan.gov/documents/ pfasresponse/Health-Based_Drinking_Water_ Value_Recommendations_for_PFAS_in_Michigan_ Report_659258_7.pdf. PO 00000 Frm 00022 Fmt 4702 Sfmt 4702 testing watersheds. Do not eat advisories have also been issued for deer, fish, and other wildlife in certain parts of the state.157 158 159 160 161 162 • Minnesota’s Department of Health (MDH) identified RfDs of 1.8 × 10¥5 milligram/kilogram-day (mg/kg-day) for PFOA, adopted as Rule in August 2018 163 and 3.1 × 10¥6 mg/kg-day for PFOS, adopted as Rule in August 2020.164 MDH developed guidance values in drinking water of 35 ppt for PFOA and 15 ppt for PFOS. The MDH is helping with drinking water well testing in certain areas of the state. Due to PFAS contamination in surface water bodies and levels of PFOS found in fish, the MDH has issued fish advisories for certain surface water bodies. Minnesota’s Pollution Control Agency Toxics Reduction and Pollution Prevention program is working to reduce PFAS in firefighting foam, chrome plating, and food packaging, with related efforts in state and local government purchasing.165 157 Michigan.gov. (2021). Michigan PFAS Action Response Team: Investigations. Michigan Department of Environment, Great Lakes, and Energy. https://www.michigan.gov/pfasresponse/ 0,9038,7-365-86511---,00.html. 158 Michigan.gov. (2021). Michigan PFAS Action Response Team: Investigations: Watershed investigations. Michigan Department of Environment, Great Lakes, and Energy. https:// www.michigan.gov/pfasresponse/0,9038,7-36586511_95792---,00.html. 159 Michigan.gov. (2018). Michigan PFAS Action Response Team: Drinking water: Public drinking water: Statewide sampling initiative: Statewide testing initiative. Michigan Department of Environment, Great Lakes, and Energy. https:// www.michigan.gov/pfasresponse/0,9038,7-36595571_95577_95587---,00.html. 160 Michigan.gov. (2021). Michigan PFAS Action Response Team: Fish and wildlife. Michigan Department of Environment, Great Lakes, and Energy. https://www.michigan.gov/pfasresponse/ 0,9038,7-365-86512---,00.html. 161 Michigan.gov. (2021). Michigan PFAS Action Response Team: MPART: Press releases: MDHHS recommends Michiganders avoid foam on lakes and rivers. Michigan Department of Environment, Great Lakes, and Energy. https://www.michigan.gov/ pfasresponse/0,9038,7-365-86513_96296-563821-y_2018,00.html. 162 Michigan.gov. (2020). Michigan PFAS Action Response Team: MPART: Press releases: MDHHS announces launch of new PFAS health study in impacted West Michigan communities. Michigan Department of Environment, Great Lakes, and Energy. https://www.michigan.gov/pfasresponse/ 0,9038,7-365-86513_96296-544808--y_2018,00.html. 163 MDH. (2020). Toxicological summary for: Perfluorooctanoate. Minnesota Department of Health. https://www.health.state.mn.us/ communities/environment/risk/docs/guidance/gw/ pfoa.pdf. 164 MDH. (2020). Toxicological summary for: Perfluorooctane sulfonate. Minnesota Department of Health. https://www.health.state.mn.us/ communities/environment/risk/docs/guidance/gw/ pfos.pdf. 165 Minnesota PCA. (2022U.S.Navy). What is Minnesota doing about PFAS? Minnesota Pollution Control Agency. https://www.pca.state.mn.us/ waste/what-minnesota-doing-about-pfas. E:\FR\FM\06SEP1.SGM 06SEP1 Federal Register / Vol. 87, No. 171 / Tuesday, September 6, 2022 / Proposed Rules jspears on DSK121TN23PROD with PROPOSALS • Montana Department of Environmental Quality set a Groundwater Quality Standard for PFOA and PFOS, individually or combined, of 70 ppt in 2019.166 • Nevada Division of Environmental Protection identified basic comparison level values of 667 ppt for PFOA and PFOS in residential water and 1.56 mg/ kg in residential soil.167 Exceedance of a basic comparison level does not automatically trigger a response action but warrants further evaluation of health risks.168 • New Hampshire’s Department of Environmental Services recommended RfDs of 6.1 × 10¥6 mg/kg/day and 3.0 × 10¥6 mg/kg/day for PFOA and PFOS, respectively, in June 2019.169 New Hampshire has undertaken sampling for PFAS at water supplies (including drinking water sources), wastewater treatment plants, fire stations, landfills and contaminated waste sites to better understand the scope of contamination in the state. The New Hampshire Department of Environmental Services filed and finalized its rulemaking to establish MCLs for PFOA of 12 ppt and PFOS of 15 ppt, as well as 11 ppt for PFNA and 18 ppt for PFHxS.170 The MCLs initially became effective on September 30, 2019. However, on December 31, 2019, the Merrimack County Superior Court issued a preliminary injunction barring enforcement of the MCLs. The New Hampshire legislature subsequently 166 Montana DEQ. (2019). Circular DEQ–7. Montana numeric water quality standards. Montana Department of Environmental Quality. https:// deq.mt.gov/files/Water/WQPB/Standards/PDF/ DEQ7/DEQ-7.pdf. 167 NDEP. (2017). Nevada Division of Environmental Protection basic comparison levels. Nevada Division of Environmental Protection. https://ndep.nv.gov/uploads/documents/july-2017ndep-bcls.pdf. 168 Pontius, F. (2019). Regulation of perfluorooctanoic acid (PFOA) and perfluorooctane sulfonic acid (PFOS) in drinking water: A comprehensive review. Water 11: 2003. 169 NHDES. (2019). Technical background report for the June 2019 proposed maximum contaminant levels (MCLs) and ambient groundwater quality standards (AGQSs) for perfluorooctane sulfonic acid (PFOS), perfluorooctanoic acid (PFOA), perfluorononanoic acid (PFNA), and perfluorohexane sulfonic acid (PFHxS) and letter from Dr. Stephen M. Roberts, Ph.D. dated 6/25/ 2019—findings of peer review conducted on technical background report. New Hampshire Department of Environmental Services. https:// www4.des.state.nh.us/nh-pfas-investigation/wpcontent/uploads/June-PFAS-MCL-TechnicalSupport-Document-FINAL.pdf. 170 NHDES. (2019). New Hampshire Code of Administrative Rules: Section Env-Dw 701.03— Units of measure for maximum contaminant levels (MCLs) and maximum contaminant level goals (MCLGs). New Hampshire Department of Environmental Services. https:// services.statescape.com/ssu/Regs/ss_ 8586370873779209008.pdf. VerDate Sep<11>2014 18:21 Sep 02, 2022 Jkt 256001 amended the New Hampshire Safe Drinking Water Act in July 2020 establishing the 4 PFAS MCLs. • New Jersey Department of Environmental Protection (NJDEP) identified RfDs of 2 × 10¥6 mg/kg-day for PFOA and 1.8 × 10¥6 mg/kg-day for PFOS.171 172 On June 1, 2020, the NJDEP published a health based MCL for PFOA of 14 ppt and an MCL for PFOS of 13 ppt in the New Jersey Register. New Jersey previously adopted an MCL for PFNA of 13 ppt on September 4, 2018. New Jersey uses a risk assessment approach to protect for chronic drinking water exposure when setting MCLs. The NJDEP also adopted these same levels as formal groundwater quality standards for the purposes of site remediation activities and discharges to groundwater.173 New Jersey has added PFNA, PFOA and PFOS to its hazardous substances list. • New Mexico Environment Department issued Risk Assessment Guidance for Site Investigations and Remediation that identified preliminary screening levels of 70 ppt for PFOA, PFOS, and PFHxS, individually or combined, in drinking water and 1.56 mg/kg for PFOA, PFOS, and PFHxS in residential soil in 2019.174 • New York regulates PFOA and PFOS as hazardous substances. New York finalized regulations in 2017 that specify storage and registration requirements for Class B firefighting foams containing at least one percent by volume of one or more of four PFAS (including PFOA and PFOS) and prohibits the release of one pound or more of each into the environment during use. If a release meets or exceeds the one-pound threshold, it is considered a hazardous waste spill and must be reported, and cleanup may be 171 NJDWQI. (2017). Maximum contaminant level recommendation for perfluorooctanoic acid in drinking water basis and background. New Jersey Drinking Water Quality Institute. https:// www.nj.gov/dep/watersupply/pdf/pfoarecommend.pdf. 172 NJDWQI. (2017). Appendix A. Health-based maximum contaminant level support document: perfluorooctanoic acid (PFOA). New Jersey Drinking Water Quality Institute. https:// www.nj.gov/dep/watersupply/pdf/pfoaappendixa.pdf. 173 NJDEP. (2020). Ground water quality standards and maximum contaminant levels (MCLs) for perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS). New Jersey Department of Environmental Protection. https:// www.nj.gov/dep/rules/adoptions/adopt_ 20200601a.pdf. 174 NMED. (2019). Risk assessment guidance for site investigations and remediation. Volume I. Soil screening guidance for human health risk assessments. New Mexico Environment Department. https://www.env.nm.gov/wp-content/ uploads/sites/12/2016/11/Final-NMED-SSG-VOL-I_ -Rev.2-6_19_19.pdf. PO 00000 Frm 00023 Fmt 4702 Sfmt 4702 54435 required under the state’s Superfund or Brownfields programs. In August 2020, New York adopted MCLs of 10 ppt for both PFOA and PFOS.175 176 • North Carolina’s Department of Environmental Quality determined an Interim Maximum Allowable Concentration for groundwater of 2,000 ppt for PFOA (table last updated in June 2021).177 • Ohio Environmental Protection Agency and Ohio Department of Health released a Polyfluoroalkyl Substances Action Plan for Drinking Water in 2019. Objectives included gathering sampling data, providing private water system owners with guidelines and resources to identify and respond to PFAS contamination, identifying resources to assist public water systems in the implementation of preventative and long-term measures to reduce PFASrelated risks, increasing awareness of PFAS and associated risks, ongoing engagement, and establishing Action Levels for drinking water systems in Ohio that are protective for human health. As part of this initiative, Ohio indicated that Action Levels of 70 ppt for PFOA and PFOS, singly or combined, would be established.178 • Oregon Department of Environmental Quality set initiation levels (ILs) for PFOA and PFOS of 24,000 ppt and 300,000 ppt, respectively (last amended in 2019). The rule indicated that ILs referred to concentrations in effluent, that, if exceeded, requires preparation of a pollutant reduction plan.179 180 175 NYSDOH. (2020). Amendment of subpart 5–1 of title 10 NYCRR (maximum contaminant levels (MCLs)) notice of revised rulemaking. New York State Department of Health. https:// regs.health.ny.gov/sites/default/files/proposedregulations/Maximum%20Contaminant%20Levels %20%28MCLs%29_0.pdf. 176 DEC. (2017). Fact sheet: Storage and use of Class B firefighting foams under new hazardous substance regulations. New York State Department of Environmental Conservation. https:// www.dec.ny.gov/docs/remediation_hudson_pdf/ affffactsheet.pdf. 177 NCDEQ. (2021). Appendix #1: Interim maximum allowable concentrations (IMACs). North Carolina Department of Environmental Quality. https://files.nc.gov/ncdeq/Water%20Quality/ Planning/CSU/Ground%20Water/APPENDIX_I_ IMAC_2-01-21.pdf. 178 Ohio.gov. (2019). Ohio per- and polyfluoroalkyl substances (PFAS) action plan for drinking water. Ohio Environmental Protection Agency. Ohio Department of Health. https:// content.govdelivery.com/attachments/OHOOD/ 2019/12/02/file_attachments/1335154/ PFAS%20Action%20Plan%2012.02.19.pdf. 179 OAR. (2019). Division 45. Regulations pertaining to NPDES and WPCF permits 340–045– 0100 Effect of a permit: Initiation level rule. Oregon Administrative Rule. https://secure.sos.state.or.us/ oard/viewSingleRule.action?ruleVrsnRsn=256058. 180 OAR. ([2010]). OAR 340–045–0100: Table A— Persistent pollutants. Oregon Administrative Rule. E:\FR\FM\06SEP1.SGM Continued 06SEP1 54436 Federal Register / Vol. 87, No. 171 / Tuesday, September 6, 2022 / Proposed Rules jspears on DSK121TN23PROD with PROPOSALS • Pennsylvania Department of Environmental Protection (PADEP) adopted a medium-specific concentration of 70 ppt in groundwater for PFOA and PFOS, individually or combined, based on EPA’s 2016 LHAs. MSCs are 4.4 mg/kg for PFOA and PFOS in residential soil. PADEP has proposed rulemaking to incorporate groundwater and soil cleanup standards for PFOA, PFOS, and PFBS, and has initiated the process to set drinking water MCLs for PFOA and PFOS.181 • Rhode Island Department of Environmental Management (RIDEM) set Groundwater Quality Standards for PFOA and PFOS, individually or combined, of 70 ppt. RIDEM indicated that EPA’s 2016 LHAs are used to determine the response to protect human health when these substances are detected in groundwater known or presumed to be suitable for drinking water use without treatment.182 • Texas has developed toxicity factors for PFOA and PFOS (using appropriate adjustments and uncertainty factors) for use at remediation sites. When combined with reasonable maximum long-term exposure assumptions for standard receptors (e.g., residents, commercial/industrial workers) and multiple simultaneous routes of exposure (e.g., incidental soil ingestion, dermal exposure), the Texas Commission on Environmental Quality believes these toxicity factors (e.g., RfDs) will result in sufficiently protective environmental media (e.g., soil) cleanup concentrations based on available data. Texas’s RfDs for PFOA and PFOS are 1.2 × 10¥05 and 2.3 × 10¥05 mg/kg/day, respectively.183 Tier 1 Protective Concentration Level (PCL) tables, released in January 2021, identified PCLs of 290 ppt for PFOA and 560 ppt for PFOS. PCLs are the default https://secure.sos.state.or.us/oard/ viewAttachment.action;JSESSIONID_ OARD=kx0KPdcNidFhJyQctRxEOn3fLasJ_ U1SHXoqfYc80w8WtuLnSAlk!888754201?ruleVrsnRsn=256058. 181 Schena, R. (2021). New Pennsylvania PFOS and PFOA cleanup standards reach final major regulatory hurdle. JD Supra. https:// www.jdsupra.com/legalnews/new-pennsylvaniapfos-and-pfoa-cleanup-3985880/. 182 RIDEM. (2017). Rhode Island Department of Environmental Management determination of a groundwater quality standard for: Perfluorooctanoic acid (PFOA) and perfluorooctane sulfonate (PFOS). Rhode Island Department of Environmental Management. https://www.dem.ri.gov/programs/ benviron/water/quality/pdf/pfoa.pdf. 183 TCEQ. (2016). Perfluoro compounds (PFCs): Various CASRN numbers. Texas Commission on Environmental Quality. https://www.tceq.texas.gov/ assets/public/implementation/tox/evaluations/ pfcs.pdf. VerDate Sep<11>2014 18:21 Sep 02, 2022 Jkt 256001 cleanup standards in the Texas Reduction Program.184 • Vermont’s drinking water health advisory is 20 ppt for a combination of five (PFOA, PFOS, PFHxS, PFHpA and PFNA) compounds based on a combined risk assessment. Vermont has issued final rules amending a number of regulations pertaining to groundwater to set cleanup levels of 20 ppt for PFOA, PFOS, PFHxS, PFHpA and PFNA. These rules became effective on July 6, 2019. Vermont passed a law in 2019 requiring public water systems to monitor for PFAS.185 186 It also directed the Agency of Natural Resources to potentially regulate PFAS and report on various monitoring activities.187 • Washington is developing rule language to establish proposed state action levels (SALs) of 10 ppt for PFOA and 15 ppt for PFOS (also levels for 3 other PFAS). SALs are levels set for long-term daily drinking water to protect human health; systems that exceed SALs would be required to notify their customers.188 • Wisconsin identified a toxicity value (acceptable daily intake) of 2 × 10¥6 mg/kg-day for PFOA and recommended the ATSDR value of 2 × 10¥6 mg/kg-day for PFOS.189 The Wisconsin Department of Health Services has sent to Wisconsin Department of Natural Resources recommended groundwater standards of 20 ppt for PFOA and PFOS individually and combined.190 The Wisconsin PFAS 184 TCEQ. (2021). TRRP Protective concentration levels. Texas Commission on Environmental Quality. https://www.tceq.texas.gov/remediation/ trrp/trrppcls.html. 185 HealthVermont. (2018). Memorandum: Drinking water health advisory for five PFAS (perand polyfluorinated alkyl substances). Vermont Department of Health. https:// www.healthvermont.gov/sites/default/files/ documents/pdf/ENV_DW_PFAS_ HealthAdvisory.pdf. 186 Vermont ANR. (2019). Chapter 12 of the environmental protection rules: Groundwater protection rule and strategy. Vermont Agency of Natural Resources. https://dec.vermont.gov/sites/ dec/files/dwgwp/DW/2019.07.06%20%20GWPRS.pdf. 187 Vermont ANR. (2019). ACT 21 (S. 49): Vermont 2019 PFAS law factsheet. Vermont Agency of Natural Resources. https://dec.vermont.gov/sites/ dec/files/PFAS/Docs/Act21-2019-VT-PFAS-LawFactsheet.pdf. 188 WA DOH. (2021). PFAS and drinking water: What is a state action level? Washington State Department of Health. https://www.doh.wa.gov/ CommunityandEnvironment/Contaminants/ PFAS#StateActionLevels. 189 Wisconsin DHS. (2019). Recommended public health groundwater quality standards: Scientific support documents for cycle 10 substances. Wisconsin Department of Health Services. https:// www.dhs.wisconsin.gov/publications/p02434v.pdf. 190 Wisconsin DHS. (2021). Per- and polyfluoroalkyl substances (PFAS). Wisconsin Department of Health Services. https:// www.dhs.wisconsin.gov/chemical/pfas.htm. PO 00000 Frm 00024 Fmt 4702 Sfmt 4702 Action Council has developed statewide initiatives to address PFAS in Wisconsin. The council led the development of a comprehensive Wisconsin PFAS Action Plan that will serve as a roadmap for how state agencies will address these emerging chemicals.191 D. Enforcement Enforcement actions, both by states and EPA, have been taken to mitigate risks from PFOA and PFOS. To date, EPA has addressed PFAS in 16 cases using a variety of enforcement tools under the Safe Drinking Water Act (SDWA), TSCA, RCRA, and CERCLA,192 as well as overseeing PFAS response actions by Federal agencies at National Priorities List sites. For example, in 2002 the EPA entered into an emergency administrative order on consent under SDWA with E. I. du Pont de Nemours and Company. DuPont agreed to provide alternative drinking water or treatment for public or private water users living near the Washington Works facility in Washington, West Virginia, if the level of PFOA detected in their drinking water was greater than the PFOA screening level established by a C–8 Assessment of Toxicity team. The C–8 Assessment team was formed pursuant to a state order and established the screening level for PFOA at 150,000 ppt. In 2006, after the science on health effects of PFOA evolved, the EPA entered into a second emergency administrative order under SDWA with DuPont that replaced the 2002 order and established a site-specific action level equal to or greater than 500 ppt.193 In 2009, after EPA scientists established a provisional health advisory for PFOA of 400 ppt to address short-term exposure to PFOA, EPA entered into a third emergency administrative order under the SDWA with DuPont that replaced the 2006 order and lowered the allowable concentration of PFOA in drinking water from 500 ppt to 400 ppt in communities near the facility. The provisional health advisory for PFOA 191 WisPAC. (2020). Wisconsin PFAS Action Plan. Wisconsin PFAS Action Council. Department of Natural Resources. https://dnr.wisconsin.gov/topic/ Contaminants/ActionPlan.html. 192 Where PFAS are commingled with CERCLA hazardous substances, EPA can require PRPs to address the PFAS. Additionally, CERCLA Section 120 federal facility agreements for federal facilities listed on the NPL require federal agencies to investigate and clean up hazardous substances, pollutants and contaminants which includes PFAS. 193 U.S. EPA. (2021). E.I. DuPont de Nemours and Company PFOA settlements. U.S. Environmental Protection Agency. https://www.epa.gov/ enforcement/ei-dupont-de-nemours-and-companypfoa-settlements. E:\FR\FM\06SEP1.SGM 06SEP1 Federal Register / Vol. 87, No. 171 / Tuesday, September 6, 2022 / Proposed Rules was based on available science at that time.194 In 2017, EPA issued an amendment to the 2009 emergency administrative order with DuPont by adding The Chemours Company as a respondent and lowering the allowable concentration of PFOA in drinking water from 400 ppt to 70 ppt in communities near the facility. The amendment, issued on May 19, 2016, was based upon current science, changed circumstances, site-specific information, and EPA’s health advisories for PFOA and PFOS.195 Designating PFOA and PFOS as CERCLA hazardous substances will allow EPA to use its CERCLA enforcement authorities, in appropriate circumstances and where relevant statutory elements are met, which could allow a transfer of the cost-burden of response activities at privately owned sites from the taxpayers/fund to potentially responsible parties. E. International Actions PFAS, including PFOA and PFOS, are subject to international treaties and individual country regulations on their production, use, and release to the environment. PFOA is identified by the United Nations Environment Programme (UNEP) as ‘‘a substance of very high concern with a persistent, bioaccumulative and toxic structure for the environment and living organisms’’ and is listed under Annex A of the Stockholm convention.196 (Parties must take measures to eliminate production and use of the chemicals listed in Annex A.) In November 2017, the Persistent Organic Pollutants Review Committee adopted a risk management evaluation for PFOA, its salts and PFOA-related compounds, defined as ‘‘any substances that degrade to PFOA, including any substances (including salts and polymers) having a linear or branched perfluoroheptyl group with the moiety (C7F15)C as one of the structural elements, for example: (i) Polymers with ≥C8 based perfluoroalkyl side chains; 8:2 fluorotelomer compounds; and (iii) jspears on DSK121TN23PROD with PROPOSALS 194 Ibid. 195 U.S. EPA. (2017). News releases from Region 03 EPA amends drinking water order to DuPont. U.S. Environmental Protection Agency. https:// archive.epa.gov/epa/newsreleases/epa-amendsdrinking-water-order-dupont.html. 196 UNEP. (2019). POPs chemicals Mandeeps. Stockholm Convention on Persistent Organic Pollutants. United Nations Environment Programme. https://chm.pops.int/DNNADMIN/ DataEntry/MandeepsHiddenModules/ POPsChemicalsMandeeps/tabid/754/Default.aspx. VerDate Sep<11>2014 18:21 Sep 02, 2022 Jkt 256001 10:2 fluorotelomer compounds’’.197 198 In 2019, at the 9th Conference of Parties (COP–9) meeting, the Stockholm Convention agreed to a global ban on PFOA and some related compounds for criteria including health effects such as kidney cancer, testicular cancer, thyroid disease, ulcerative colitis and pregnancy-induced hypertension. This action also included five-year exemptions for use in semiconductor manufacturing, firefighting foams, worker-safety textiles, photographic coatings for films and medical devices. While a signatory to the Stockholm Convention, the U.S. has not ratified and is therefore not a Party to the convention however; additional exemptions were requested by China, Iran and the European Union.199 PFOS, along with its salts and precursor POSF have been classified as a persistent, highly bioaccumulative organic pollutant and listed under Annex B of the Stockholm Convention.200 At the 2009 Stockholm Convention COP–4 meeting, parties to the convention restricted PFOS production and use, but also included exemptions. The 2019 COP–9 meeting tightened PFOA and PFOS restrictions, but left an exemption for the pesticide sulfluramid, which is known to degrade into PFOS and PFOA.201 202 This 197 UNEP. (2017). Report of the Persistent Organic Pollutants Review Committee on the work of its thirteenth meeting: Addendum: Risk management evaluation on pentadecafluorooctanoic acid (CAS No: 335–67–1, PFOA, perfluorooctanoic acid), its salts and PFOA-related compounds. Stockholm Convention on Persistent Organic Pollutants. (UNEP/POPS/POPRC.13/7/Add.2). United Nations Environment Programme. https://chm.pops.int/ TheConvention/POPsReviewCommittee/Meetings/ POPRC13/MeetingDocuments/tabid/6024/ Default.aspx/. 198 UNEP. (2018). Report of the Persistent Organic Pollutants Review Committee on the work of its fourteenth meeting—Addendum to the risk management evaluation on perfluorooctanoic acid (PFOA), its salts and PFOA-related compounds. Stockholm Convention on Persistent Organic Pollutants. (UNEP/POPS/POPRC.14/6/Add.2). United Nations Environment Programme. https:// chm.pops.int/theconvention/popsreviewcommittee/ meetings/poprc14/overview/tabid/7398/ default.aspx. 199 UNEP. (2019). Recommendation by the Persistent Organic Pollutants Review Committee to list perfluorooctanoic acid (PFOA), its salts and PFOA-related compounds in Annex A to the Convention and draft text of the proposed amendment. Stockholm Convention on Persistent Organic Pollutants. (UNEP/POPS/COP.9/14). United Nations Environment Programme. https:// chm.pops.int/TheConvention/ ConferenceoftheParties/Meetings/COP9/tabid/7521/ Default.aspx. 200 UNEP. (2019). POPs chemicals Mandeeps. Stockholm Convention on Persistent Organic Pollutants. United Nations Environment Programme. https://chm.pops.int/DNNADMIN/ DataEntry/MandeepsHiddenModules/ POPsChemicalsMandeeps/tabid/754/Default.aspx. 201 UNEP. (2009). Listing of perfluorooctane sulfonic acid, its salts and perfluorooctane sulfonyl PO 00000 Frm 00025 Fmt 4702 Sfmt 4702 54437 pesticide is no longer registered for use in the United States. The European Union (EU) has taken steps to regulate PFOA, its salts and related substances in a wide range of products.203 PFOA and APFO are also required to be classified, labelled, and packaged under regulation EC No 1272/ 2008 204 and there is a ban on placing these chemicals on the market as substances, constituents of other substances, or in mixtures for supply to the general public. PFNA and PFDA have been proposed for similar classification and labelling by Sweden. In July 2020, the European Food Safety Authority 205 modified its 2018 decision to set safety levels for PFOA and PFOS to include PFNA and PFHxS, based on their observed human bioaccumulation and toxicity. A combined safety threshold or group tolerable weekly limit in food and water of 4.4 nanograms/kilogram of body weight was set for these four PFAS. Because there are thousands of PFAS widespread in the environment and substance-by-substance risk assessments, environmental monitoring and regulation would be extremely lengthy and resource-intensive, an alternative approach has been proposed to regulate PFAS as a class, or as subgroups, based on toxicity or chemical similarities. The agreement by the European Parliament and the fluoride. Stockholm Convention on Persistent Organic Pollutants. (UNEP–POPS–COP.4–SC–4– 17). United Nations Environment Programme. https://chm.pops.int/TheConvention/ ConferenceoftheParties/Meetings/COP4/ COP4Documents/tabid/531/Agg3187_SelectTab/4/ Default.aspx. 202 UNEP. (2019). Evaluation of perfluorooctane sulfonic acid, its salts and perfluorooctane sulfonyl fluoride pursuant to paragraphs 5 and 6 of part III of Annex B to the Convention. Stockholm Convention on Persistent Organic Pollutants. (UNEP/POPS/COP.9/7). United Nations Environment Programme. https://chm.pops.int/ TheConvention/ConferenceoftheParties/Meetings/ COP9/tabid/7521/Default.aspx. 203 EU. (2017). Commission regulation (EU) 2017/ 1000 of 13 June 2017 amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the registration, evaluation, authorisation and restriction of chemicals (REACH) as regards perfluorooctanoic acid (PFOA), its salts and PFOArelated substances. (Official J Eur Union L150/14). European Union. https://eur-lex.europa.eu/legalcontent/EN/TXT/?uri=celex:32017R1000. 204 EU. (2008). Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/ EC, and amending Regulation (EC) No 1907/2006. (Official J Eur Union L353/1). European Union. https://eur-lex.europa.eu/legal-content/EN/TXT/ ?uri=celex%3A32008R1272. 205 EFSA. (2020). Risk to human health related to the presence of perfluoroalkyl substances in food. EFSA Journal 18: e06223. https:// www.ncbi.nlm.nih.gov/pubmed/32994824. E:\FR\FM\06SEP1.SGM 06SEP1 54438 Federal Register / Vol. 87, No. 171 / Tuesday, September 6, 2022 / Proposed Rules Council in December 2019 on the recast of the Drinking Water Directive includes a limit of 0.5 micrograms per liter for all PFAS.206 In December 2020, the European Parliament formally adopted the revised Drinking Water Directive.207 Based on the widespread occurrence of PFAS in the environment and their risk properties, in June 2019 the European Council of Ministers called for an action plan to eliminate all non-essential uses of PFAS.208 A number of countries have issued standards and guidance values for PFOA, PFOS, and other PFAS individually or cumulatively. These are summarized below. Australia and New Zealand 209—The Food Standards Australia New Zealand (FSANZ), a statutory authority in the Australian Government health portfolio, and the National Medical Research Council have developed health-based guidance values for PFOA, PFOS, and PFHxS for exposure from food, drinking water and surface water used for recreation. The guidance values give tolerable daily intake (TDI) for lifetime exposure levels from food or drinking water that will not result in significant risk to human health. Based on the TDI, FSANZ recommended tolerable daily intake and issued drinking water and recreational water guideline values for use in site investigations in Australia. TDI were derived from animal studies and pharmacokinetic modeling used to extrapolate to humans. For PFHxS, FSANZ concluded that the available data were insufficient to develop a TDI and that the PFOS TDI should be applied to PFHxS and a combined concentration of PFOS plus PFHxS should be used to evaluate exposure. Total PFOS+PFHxS Health based guidance value jspears on DSK121TN23PROD with PROPOSALS Tolerable daily intake (nanograms/kilogram of body weight per day) .................................................................... Drinking water quality guideline value (nanograms per liter) .................................................................................. Recreational water quality guideline value (nanograms per liter) ........................................................................... 20 70 2,000 PFOA 160 560 10,000 Canada—PFOA, its salts and precursors, as well as long-chain perfluorocarboxylic acids, their salts and precursors were assessed in 2012. These substances are prohibited for import and use with a limited number of exemptions under the Prohibition of Certain Toxic Substances Regulations, 2012. In 2018 additional proposed amendments to the Canadian Environmental Protection Act, 1999, to regulate additional PFAS were postponed to late 2021. The proposed amendments include PFOS, its salts and precursors that contain one of the following groups: C8F17SO2, C8F17SO3 or C8F17SO2N (PFOS), PFOA and its salts and precursors. It also includes all longer chain perfluorocarboxylic acids having the molecular formula CnF2n∂1CO2H in which 8 ≤ n ≤ 20, their salts and precursors.210 211 Guidelines for Canadian Drinking Water Quality set the maximum acceptable concentration (MAC) for PFOA in drinking water at 200 ppt 212 and PFOS in drinking water at 600 ppt.213 These MACs are based on exposure to individual chemicals. Because the toxicological effects of PFOA and PFOS are additive they should be evaluated together, and the ratio of the observed concentration for PFOS to its MAC plus the ratio of the observed concentration for PFOA to its MAC should be below 1 for drinking water to considered safe.214 215 For other PFAS with a more limited database, drinking water screening values were developed. Peoples Republic of China—The ‘‘Industrial Recon-structuring Guide Directory’’ 216 restricted the production of PFOS and PFOA. In 2014, the Ministry of Environmental Protection announcement No. [2014]21, banned ‘‘production, transportation, application, imports and exports of PFOS, its salts, and POSF, except for specific exemptions and acceptable use.’’ Denmark—Based on toxicity the Danish Environmental Protection Agency 217 has identified health-based criteria or limit values for drinking water, groundwater used for drinking water and soil. Criteria or limit values for drinking water and groundwater used for drinking water are 100 nanograms per liter for PFOS and/or PFOSA (a PFOS precursor) and 300 206 EEA. (2019). Emerging chemical risks in Europe—‘PFAS’. European Environment Agency. European Union. https://www.eea.europa.eu/ds_ resolveuid/a8da291194084d2eaa5bb0a9147e793a. 207 EC. (2020). Review of the drinking water directive. European Commission. https:// ec.europa.eu/environment/water/water-drink/ review_en.html. 208 EU. (2019). Outcome of proceedings: Subject: Towards a sustainable chemicals policy strategy of the Union—Council conclusions. Council of the European Union. https://www.consilium.europa.eu/ media/40042/st10713-en19.pdf. 209 Australian Government. (2019). Health based guidance values for PFAS. Australian Government, Department of Health. https://www1.health.gov.au/ internet/main/publishing.nsf/Content/ 2200FE086D480353CA2580C900817CDC/$File/ HBGV-Factsheet-20190911.pdf. 210 Environment and Climate Change Canada. (2021). Toxic substances list: long-chain perfluorocarboxylic acids. Environment and Climate Change Canada, Government of Canada. https://www.canada.ca/en/environment-climatechange/services/management-toxic-substances/listcanadian-environmental-protection-act/long-chainperfluorocarboxylic-acids.html. 211 Environment and Climate Change Canada. (2021). Toxic substances list: PFOS. Environment and Climate Change Canada, Government of Canada. https://www.canada.ca/en/environmentclimate-change/services/management-toxicsubstances/list-canadian-environmental-protectionact/perfluorooctane-sulfonate.html. 212 Health Canada. (2018). Guidelines for Canadian drinking water quality: Guideline technical document—perfluorooctanoic acid (PFOA). Health Canada. Minister of Health. https:// www.canada.ca/en/health-canada/services/ publications/healthy-living/guidelines-canadiandrinking-water-quality-technical-documentperfluorooctanoic-acid/document.html. 213 Health Canada. (2018). Guidelines for Canadian drinking water quality: Guideline technical document—perfluorooctane sulfonate (PFOS). Health Canada. Minister of Health. https:// www.canada.ca/en/health-canada/services/ publications/healthy-living/guidelines-canadiandrinking-water-quality-guideline-technicaldocument-perfluorooctane-sulfonate/ document.html. 214 Health Canada. (2018). Guidelines for Canadian drinking water quality: Guideline technical document—perfluorooctanoic acid (PFOA). Health Canada. Minister of Health. https:// www.canada.ca/en/health-canada/services/ publications/healthy-living/guidelines-canadiandrinking-water-quality-technical-documentperfluorooctanoic-acid/document.html. 215 Health Canada. (2018). Guidelines for Canadian drinking water quality: Guideline technical document—perfluorooctane sulfonate (PFOS). Health Canada. Minister of Health. https:// www.canada.ca/en/health-canada/services/ publications/healthy-living/guidelines-canadiandrinking-water-quality-guideline-technicaldocument-perfluorooctane-sulfonate/ document.html. 216 OECD. (2021). Portal on per and poly fluorinated chemicals: Country information: People’s Republic of China. Organisation for Economic Co-operation and Development. https:// www.oecd.org/chemicalsafety/portalperfluorinated-chemicals/countryinformation/ china.htm. 217 Danish Ministry of the Environment. (2015). Perfluoroalkylated substances: PFOA, PFOS and PFOSA: Evaluation of health hazards and proposal of a health based quality criterion for drinking water, soil and ground water. (Environmental project No. 1665). Copenhagen, Denmark: The Danish Environmental Protection Agency. https:// www2.mst.dk/Udgiv/publications/2015/04/978-8793283-01-5.pdf. VerDate Sep<11>2014 18:21 Sep 02, 2022 Jkt 256001 PO 00000 Frm 00026 Fmt 4702 Sfmt 4702 E:\FR\FM\06SEP1.SGM 06SEP1 Federal Register / Vol. 87, No. 171 / Tuesday, September 6, 2022 / Proposed Rules nanograms per liter for PFOA. For cumulative exposure the ratio of the sum of concentration/limit value ratios for PFOA, PFOS and PFOSA should be below 1. The health-based criteria or limit value for soil is 390 micrograms per kilogram for PFOS and PFOSA and 1,300 micrograms per kilogram for PFOA and its salts. Cumulatively the sum of concentration/limit value ratios for PFOA, PFOS and PFOSA should be below 1.218 The Danish Ministry of the Environment and Food 219 banned food contact paper and cardboard in which per and polyfluoro chemicals, including PFOA and PFOS and their salts and precursors, have been used unless they incorporate a barrier to prevent migration into food. Japan—In 2010, Japan designated PFOS, its salts, and POSF as Class I Specified Chemical Substances following their addition to the Stockholm Convention on Persistent to Organic Pollutants Annex B regulating manufacture, use, export, and import of PFOA and its salts.220 Norway—Norway listed PFOA and PFOS on its national list of priority substances 221 based on monitoring data that showed high levels of these substances in the environment as well as their toxicological profiles. In 2014, Norway banned manufacturing, production, import and retail of consumer products containing PFOA.222 VIII. Statutory and Executive Order Reviews Additional information about these statutes and Executive Orders can be found at https://www.epa.gov/lawsregulations/laws-and-executive-orders. jspears on DSK121TN23PROD with PROPOSALS 218 Ibid. 219 PackingLaw.com. (2020). Denmark’s PFAS ban in paper and cardboard effective in July 2020. Keller and Heckman LLP. https:// www.packaginglaw.com/news/denmarks-pfas-banpaper-and-cardboard-effective-july-2020. 220 Ministry of the Environment of Japan. (2013). Summary of the guideline on the treatment of wastes containing perfluorooctane sulfonic acid (PFOS), and its salts in Japan. Ministry of the Environment of Japan. https://www.env.go.jp/en/ focus/docs/files/201304-89.pdf. 221 OECD. (2021). Portal on per and poly fluorinated chemicals: Country information: Norway. Organisation for Economic Co-operation and Development. https://www.oecd.org/ chemicalsafety/portal-perfluorinated-chemicals/ countryinformation/norway.htm. 222 UL. (2013). Norway introduces restrictions on PFOA. UL, LLC. https://www.ul.com/news/norwayintroduces-restrictions-pfoa. VerDate Sep<11>2014 18:21 Sep 02, 2022 Jkt 256001 A. Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: Improving Regulation and Regulatory Review This action is a significant regulatory action that was submitted to the OMB for review. While EPA is not considering costs in its hazardous substance designation decisions in this proposed rule, and despite that there is still significant uncertainty and lack of data as discussed in the economic analysis (EA), OMB designated this proposed rulemaking as an economically significant action. Any changes made in response to the OMB recommendations have been documented in the docket. Although CERCLA section 102(a) precludes EPA from taking cost into account in the designation of a hazardous substance, to inform the public, EPA prepared an EA of the potential costs, benefits, and impacts associated with this action. This analysis, Economic Assessment of the Potential Costs and Other Impacts of the Proposed Rulemaking to Designate Perfluorooctanoic Acid and Perfluorooctanesulfonic Acid as Hazardous Substances is available in the docket for this action. The EA includes request for comments on several topics that EPA does not currently have robust information about. Please see Section ES–5 of the EA for specific details. If finalized, this proposed CERCLA designation is estimated to have a quantifiable direct annual social cost of approximately $370,000 from reporting releases at or above the RQ. Additional, unquantifiable future costs may occur when Federal agencies sell or transfer real property where PFOA or PFOS was stored, released or disposed of as specified by CERCLA section 120(h). There is also the direct effect resulting in an obligation of DOT to list and regulate CERCLA-designated hazardous substances as hazardous materials under the Hazardous Materials Transportation Act (see CERCLA Section 306(a)). EPA estimates these incremental costs associated with the DOT rulemaking as zero or negligible. This action’s direct benefits from release reporting include improved quality of information providing a more comprehensive understanding of the number and location of PFOA and PFOS releases meeting or exceeding the RQ. An important benefit of this information is that it may lead to more efficient property and capital markets. Another potential direct benefit from the proposed reporting requirement is better waste management and/or treatment by facilities handling PFOA or PFOS. PO 00000 Frm 00027 Fmt 4702 Sfmt 4702 54439 Greater transparency provided by release reporting can lead to fewer releases to the environment and thus to health benefits associated with avoided exposure. Designating PFOA and PFOS as hazardous substances may also have indirect, indeterminate impacts associated with potential increases in the speed of response activity and in the total number of response actions taken to address PFOA and PFOS releases. Both potential increases may lead to health benefits associated with avoided risks. Other indirect effects may be experienced as a result of the movement forward in time of assessment and cleanup costs. The proposed designation would also improve the Agency’s ability to transfer response costs from the public to polluters contingent upon specific statutory requirements being met and discretionary actions by EPA. These indirect costs, benefits, and transfers cannot be quantified due to significant uncertainties about each. The full discussion of these impacts can be found in the EA. B. Paperwork Reduction Act The information collection activities in this proposed rule have been submitted for approval to the OMB under the Paperwork Reduction Act. The Information Collection Request (ICR) document that the EPA prepared has been assigned EPA ICR number 2708.01. You can find a copy of the ICR in the docket for this rule, and it is briefly summarized here. If finalized, the designation of PFOA and PFOS, and their salts and structural isomers, as hazardous substances would require any person in charge of a vessel or facility that identifies a release of one pound or more within a 24-hour period of these substances to report the release to the NRC under section 103 of CERCLA and to the SERC (or TERC) and LEPC (or TEPC) under section 304 of EPCRA. The implementing regulations of CERCLA section 103 and EPCRA section 304 are codified at 40 CFR parts 302 and 355, respectively. Respondents/affected entities: Any person in charge of a vessel or facility from which there is a release of PFOA or PFOS and their salts and structural isomers, equal to or greater than the RQ of one pound within 24 hours. Respondent’s obligation to respond: Mandatory under section 103 of CERCLA and section 304 of EPCRA. Estimated number of respondents: From 0 to 660 releases per year. Frequency of response: Varies. E:\FR\FM\06SEP1.SGM 06SEP1 54440 Federal Register / Vol. 87, No. 171 / Tuesday, September 6, 2022 / Proposed Rules Total estimated burden: 6,415 hours (per year) maximum. Burden is defined at 5 CFR 1320.3(b). Total estimated cost: $370,000 (per year) maximum, includes $3,503 annualized operation and maintenance costs (and no capital costs). An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for the EPA’s regulations in 40 CFR are listed in 40 CFR 9. Submit your comments on the Agency’s need for this information, the accuracy of the provided burden estimates and any suggested methods for minimizing respondent burden to the EPA using the docket identified at the beginning of this rule. You may also send your ICR-related comments to OMB’s Office of Information and Regulatory Affairs using the interface at www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting ‘‘Currently under Review—Open for Public Comments’’ or by using the search function. Since OMB is required to make a decision concerning the ICR between 30 and 60 days after receipt, OMB must receive comments no later than October 6, 2022. The EPA will respond to any ICRrelated comments in the final rule. jspears on DSK121TN23PROD with PROPOSALS C. Regulatory Flexibility Act (RFA) I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. The small entities subject to the requirements of this action are: (1) producers and importers of PFOA and PFOS, (2) producers and users of PFOA or PFOS-containing articles, and (3) waste management and wastewater facilities. The Agency has estimated that there may be up to 660 reported releases of PFOA or PFOS in any one year and that an indeterminate number, but small percentage, of the annual reports will be submitted by small entities. The estimated cost of $561 to report a release of PFOA or PFOS is not greater than 1% of the annual revenues per small entity in any impacted industry. Details of this analysis are presented in the Economic Assessment of the Potential Costs and Other Impacts of the Proposed Rulemaking to Designate Perfluorooctanoic Acid and Perfluorooctanesulfonic Acid as Hazardous Substances. We have therefore concluded that this action will VerDate Sep<11>2014 18:21 Sep 02, 2022 Jkt 256001 not have a significant regulatory burden for all directly regulated small entities. D. Unfunded Mandates Reform Act (UMRA) This action does not contain an unfunded mandate of $100 million or more as described in UMRA, 2 U.S.C. 1531–1538, and does not significantly or uniquely affect small governments. This action is expected to result in reporting costs of $561 per release that meets or exceeds the RQ, and the estimated annual cost of the proposed rule is not expected to exceed $370,000 per year. E. Executive Order 13132: Federalism This action does not have federalism implications. It will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government. F. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments This action does not have Tribal implications as specified in Executive Order 13175 because it does not have substantial direct effects on one or more Tribal Nations, on the relationship between the Federal Government and Tribal Nations, or on the distribution of power and responsibilities between the Federal Government and Tribal Nations. EPA does not expect that it would result in any adverse impacts on tribal entities. Thus, Executive Order 13175 does not apply to this action. Consistent with the EPA Policy on Consultation with Tribal Nations, the EPA intends to consult with and request comments from tribal officials. G. Executive Order 13045: Protection of Children From Environmental Health Risks and Safety Risks This action, which proposes to designate PFOA and PFOS as hazardous substances, does not itself address environmental health or safety risks. Beyond the requirements of E.O. 13045, EPA’s 2021 Policy on Children’s Health (October 5, 2021) 223 requires EPA to consider early life exposures and lifelong health consistently and explicitly in all human health decisions. The EPA believes that the 223 U.S. EPA. (2021). The administrator: 2021 policy on children’s health. Washington, DC: U.S. Environmental Protection Agency. https:// www.epa.gov/system/files/documents/2021-10/ 2021-policy-on-childrens-health.pdf. PO 00000 Frm 00028 Fmt 4702 Sfmt 4702 environmental health or safety risk posed by exposure to PFOA and/or PFOS may have a disproportionate effect on children. A discussion of health and risk assessments related to PFOA and PFOS, including developmental and reproductive health effects, are contained in EPA’s Health Effects Support Documents for PFOA and PFOS (2016). H. Executive Order 13211: Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution or Use This action is not a ‘‘significant energy action’’ because it is not likely to have a significant adverse effect on the supply, distribution or use of energy. This action proposes to designate PFOA and PFOS as hazardous substances, and thus, does not involve the supply, distribution or use of energy. I. National Technology Transfer and Advancement Act This action does not involve technical standards. J. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations The EPA is unable to determine if this action does or does not have disproportionately high and adverse human health or environmental effects on minority populations, low-income populations and/or indigenous peoples, as specified in Executive Order 12898 (59 FR 7629, February 16, 1994). Several key demographic categories were analyzed relative to facilities with known historical use and/or releases of PFOA and PFOS.224 Because the location of future releases of PFAS is uncertain, this analysis considers populations around facilities in sectors associated with widespread historical uses and releases of PFAS as proxies for facilities that may have future releases of the PFAS considered in the proposed rule. This analysis examines the following site types as proxies for facilities that are known to have commonly used PFAS: • Operating Department of Defense (DOD) facilities • Operating U.S. airports and airfields 224 U.S. EPA. ([2021]). Assessment of the potential costs and other impacts of the proposed rulemaking to designate perfluorooctanoic acid and perfluorooctanesulfonic acid as hazardous substances. U.S. Environmental Protection Agency. E:\FR\FM\06SEP1.SGM 06SEP1 Federal Register / Vol. 87, No. 171 / Tuesday, September 6, 2022 / Proposed Rules jspears on DSK121TN23PROD with PROPOSALS • Plastics material and resin manufacturing firms identified as having produced PFOS and/or PFOA, • 2020 PFOS and PFOA releases reported to EPA’s Toxic Release Inventory (TRI) On average, airports across the U.S. are surrounded by populations that reflect national averages in relevant demographic categories. Large airports, however, are more likely to be surrounded by minority and lowincome populations than medium or small airports. Some DOD sites are surrounded by populations with higher concentrations of minority and lowincome residents, but the majority of these sites are below the national averages for these metrics. In contrast, areas around plastics material and resin manufacturer sites and/or sites reporting releases to TRI, on average, are in areas with higher concentrations of minority residents and households experiencing poverty than the U.S. averages for these demographics, suggesting that releases related to manufacturing facilities could have environmental justice implications. A complete discussion of the analysis behind these findings is available in Section 4.3 of the EA accompanying this rulemaking. These findings, combined with the uncertainty surrounding the location of future releases, are indicative of potential impacts but do not provide a clear indication of the type of disparities related to potential exposure to PFAS. Consistent with the priorities outlined in Executive Orders 12898 225 and 14008,226 it is unclear whether this proposed regulation will have a significant impact on disadvantaged populations or communities with environmental justice (EJ) concerns relative to other communities. While the locations that may report releases are unknown, to the extent that these proxy locations are representative of likely reporting locations, this screening analysis suggests that the reporting required under the rule may provide 225 The White House. (1994). Presidential documents: Executive order 12898 of February 11, 1994: Federal actions to address environmental justice in minority populations and low-income populations. Federal Register 59: 7629. https:// www.archives.gov/files/federal-register/executiveorders/pdf/12898.pdf. 226 WH.gov. (2021). Executive order on tackling the climate crisis at home and abroad. Washington, DC: The White House. https://www.whitehouse.gov/ briefing-room/presidential-actions/2021/01/27/ executive-order-on-tackling-the-climate-crisis-athome-and-abroad/. VerDate Sep<11>2014 18:21 Sep 02, 2022 Jkt 256001 better information to nearby populations potentially at risk of exposure, including communities with EJ concerns. To the extent that PFAS releases are consistent with the broader releases reported to TRI and typically involve disposal or manufacturing sites, demographic data around plastics material and resin manufacturer sites and historical releases may be a more reliable predictor of the type of community potentially affected by this proposed rulemaking. Specific site conditions and demographic patterns may become clear as reporting occurs following completion of a final rule. Once available, this information would improve EPA’s ability to examine disparate impacts on EJ communities. This improved information would not increase risk for communities with EJ concerns and may improve the speed and design of remediation. EPA is committed to minimizing and/or eliminating existing barriers and burdens that communities with EJ concerns may encounter related to accessing data and information collected as a result of this rulemaking, if finalized. EPA seeks comment on strategies to improve access to the reporting data expected to be collected, if designation of PFOA and PFOS as hazardous substances is finalized, for communities with environmental justice concerns. Further, the documentation for this decision is contained in the following sections in the preamble to this action: II.C., VI.A. and B. These sections explain that the designation of PFOA and PFOS as hazardous substances, if finalized, and the required reporting and notification requirements, will result in more information about the location and extent of releases. This improved information does not increase risk or result in any adverse environmental justice impacts. List of Subjects in 40 CFR Part 302 Environmental protection, Air pollution control, Chemicals, Hazardous substances, Hazardous waste, Intergovernmental relations, Natural resources, Reporting and recordkeeping requirements, Superfund, Water pollution control, Water supply. Michael S. Regan, Administrator. PART 302—DESIGNATION, REPORTABLE QUANTITIES, AND NOTIFICATION 1. The authority citation for part 302 continues to read as follows: ■ Authority: 33 U.S.C. 1251 et. seq., 42 U.S.C. 9601, et seq., 42 U.S.C. 9602, 42 U.S.C. 9603. 2. Amend § 302.4 by: ■ a. Revising in paragraph (b) the Note II to Table; ■ b. Adding in the Table—List of Hazardous Substances and Reportable Quantities in alphabetical order the following new entries for ’’Perfluorooctanesulfonic acid, salts, & structural isomers’’ and ‘‘Perfluorooctanoic acid, & salts, & structural isomers’’; ■ c. Adding in Appendix A—Sequential CAS Registry Number List of CERCLA Hazardous Substances in numerical order the new entries for ‘‘335–67–1’’ and ‘‘1763–23–1’’. The revisions read as follows: ■ § 302.4 * [Amended] * * (b) * * * Frm 00029 Fmt 4702 Sfmt 4702 * * Note II to Table 302.4 Hazardous substances are given a Statutory Code based on their statutory source. The ‘‘Statutory Code’’ column indicates the statutory source for designating each substance as a CERCLA hazardous substance. Statutory Code ‘‘1’’ indicates a Clean Water Act (CWA) Hazardous Substance. Statutory Code ‘‘2’’ indicates a CWA Toxic Pollutant. Statutory Code ‘‘3’’ indicates a CAA HAP. Statutory Code ‘‘4’’ indicates Resource Conservation and Recovery Act (RCRA) Hazardous Wastes. Statutory Code ‘‘5’’ indicates a hazardous substance designated under section 102(a) of CERCLA. The ‘‘RCRA waste No.’’ column provides the waste identification numbers assigned by RCRA regulations. The ‘‘Final RQ [pounds (kg)]’’ column provides the reportable quantity for each hazardous substance in pounds and kilograms. * * * * * For the reasons set forth in the preamble, EPA proposes to amend 40 CFR part 302 as follows: PO 00000 54441 E:\FR\FM\06SEP1.SGM 06SEP1 54442 Federal Register / Vol. 87, No. 171 / Tuesday, September 6, 2022 / Proposed Rules TABLE 302.4—LIST OF HAZARDOUS SUBSTANCES AND REPORTABLE QUANTITIES [All comments/notes are located at the end of this table] Hazardous substance CASRN * * * * Perfluorooctanesulfonic acid, & salts, & structural isomers ................................................................... Perfluorooctanoic acid, & salts, & structural isomers ............................................................................. * * * * * * * * * * 5 5 * * .................... .................... ## (0.454) ## (0.454) * Perfluorooctanoic acid, & salts, & structural isomers. Perfluorooctanesulfonic acid, & salts, & structural isomers. [FR Doc. 2022–18657 Filed 9–2–22; 8:45 am] BILLING CODE 6560–50–P DEPARTMENT OF THE INTERIOR Office of the Secretary 43 CFR Part 2 [DOI–2022–0007; 223D0102DM, DLSN00000.000000, DS65100000, DX.65101] RIN 1090–AB16 Privacy Act Regulations; Exemption for the Personnel Security Program Files System Office of the Secretary, Interior. Notice of proposed rulemaking. AGENCY: The Department of the Interior (DOI) is proposing to amend its regulations to exempt certain records in the INTERIOR/DOI–45, Personnel Security Program Files, system of records from one or more provisions of the Privacy Act of 1974 because of criminal, civil, and administrative law enforcement requirements. DATES: Submit comments on or before November 7, 2022. ADDRESSES: You may submit comments, identified by docket number [DOI– 2022–0007] or [Regulatory Information Number (RIN) 1090–AB16], by any of the following methods: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the instructions for sending comments. • Email: DOI_Privacy@ios.doi.gov. Include docket number [DOI–2022– 0007] or RIN 1090–AB16 in the subject line of the message. • U.S. Mail or Hand-Delivery: Teri Barnett, Departmental Privacy Officer, U.S. Department of the Interior, 1849 C SUMMARY: jspears on DSK121TN23PROD with PROPOSALS * 1763–23–1 335–67–1 Final RQ [pounds (kg)] Hazardous substance 335–67–1 .............. 1763–23–1 ............ VerDate Sep<11>2014 RCRA waste No. Appendix A to § 302.4—Sequential CAS Registry Number List of CERCLA Hazardous Substances CASRN ACTION: * Statutory code † 18:21 Sep 02, 2022 Jkt 256001 Street NW, Room 7112, Washington, DC 20240. Instructions: All submissions received must include the agency name and docket number [DOI–2022–0007] or RIN 1090–AB16 for this rulemaking. All comments received will be posted without change to https:// www.regulations.gov, including any personal information provided. Docket: For access to the docket to read background documents or comments received, go to https:// www.regulations.gov. FOR FURTHER INFORMATION CONTACT: Teri Barnett, Departmental Privacy Officer, U.S. Department of the Interior, 1849 C Street NW, Room 7112, Washington, DC 20240, DOI_Privacy@ios.doi.gov or (202) 208–1605. SUPPLEMENTARY INFORMATION: Background The Privacy Act of 1974, as amended, 5 U.S.C. 552a, governs the means by which the U.S. Government collects, maintains, uses and disseminates personally identifiable information. The Privacy Act applies to information about individuals that is maintained in a ‘‘system of records.’’ A system of records is a group of any records under the control of an agency from which information about an individual is retrieved by the name of the individual or by some identifying number, symbol, or other identifying particular assigned to the individual. See 5 U.S.C. 552a(a)(4) and (5). Individuals may request access to records containing information about themselves under the Privacy Act, 5 U.S.C. 552a(b), (c) and (d). However, the Privacy Act authorizes Federal agencies to exempt systems of records from access by individuals under certain circumstances, such as where the access PO 00000 Frm 00030 Fmt 4702 Sfmt 4702 or disclosure of such information would impede national security or law enforcement efforts. Exemptions from Privacy Act provisions must be established by regulation, 5 U.S.C. 552a(j) and (k). The DOI Office of Law Enforcement and Security (OLES) maintains the INTERIOR/DOI–45, Personnel Security Program Files, system of records. This system supports the DOI bureau and office Personnel Security Program functions to determine suitability, eligibility, and fitness for service of applicants for Federal employment and contract positions who require access to Departmental facilities and information systems and networks. The system also helps OLES manage a National Security Program to document and support decisions regarding clearance access to classified information and implement provisions that apply to Federal employees and contractors who access classified information or materials and participate in classified activities that impact national security, and ensure the safety, storage of classified information and security of Departmental facilities, information systems and networks, occupants, and users. The Personnel Security Program Files system will contain records created and managed by DOI bureaus and offices to support personnel security activities and document evaluations and decisions regarding suitability, eligibility, and fitness for service of applicants for Federal employment and contract positions to the extent necessary to manage secure access to Departmental facilities, information systems and networks, and to manage access to classified information and reciprocity. These records may include information about individuals related to possible violations of Federal laws and E:\FR\FM\06SEP1.SGM 06SEP1

Agencies

ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 87, Number 171 (Tuesday, September 6, 2022)]
[Proposed Rules]
[Pages 54415-54442]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-18657]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 302

[EPA-HQ-OLEM-2019-0341; FRL-7204-02-OLEM]
RIN 2050-AH09


Designation of Perfluorooctanoic Acid (PFOA) and 
Perfluorooctanesulfonic Acid (PFOS) as CERCLA Hazardous Substances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: Under the Comprehensive Environmental Response, Compensation, 
and Liability Act of 1980, as amended (``CERCLA'' or ``Superfund''), 
the Environmental Protection Agency (EPA or the Agency) is proposing to 
designate perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic 
acid (PFOS), including their salts and structural isomers, as hazardous 
substances. CERCLA authorizes the Administrator to promulgate 
regulations designating as hazardous substances such elements, 
compounds, mixtures, solutions, and substances which, when released 
into the environment, may present substantial danger to the public 
health or welfare or the environment. Such a designation would 
ultimately facilitate cleanup of contaminated sites and reduce human 
exposure to these ``forever'' chemicals.

DATES: Comments must be received on or before November 7, 2022. Under 
the Paperwork Reduction Act, comments on the information collection 
provisions are best assured of consideration if the Office of 
Management and Budget (OMB) receives a copy of your comments on or 
before October 6, 2022.

ADDRESSES: You may send comments, identified by Docket ID No. EPA-HQ-
OLEM-2019-0341, by any of the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov 
(our preferred method). Follow the online instructions for submitting 
comments.
     Mail: U.S. Environmental Protection Agency, EPA Docket 
Center, OLEM Docket, Mail Code 28221T, 1200 Pennsylvania Avenue NW, 
Washington, DC 20460.
     Hand Delivery or Courier: EPA Docket Center, WJC West 
Building, Room 3334, 1301 Constitution Avenue NW, Washington, DC 20004. 
The Docket Center's hours of operations are 8:30 a.m.-4:30 p.m., 
Monday-Friday (except Federal Holidays).
    Instructions: All submissions received must include the Docket ID 
No. for this rulemaking. Comments received may be posted without change 
to https://www.regulations.gov/, including any personal information 
provided. For detailed instructions on sending comments and additional 
information on the rulemaking process, see the ``Public Participation'' 
heading of the SUPPLEMENTARY INFORMATION section of this document. For 
further information on EPA Docket Center services and the current 
status, please visit us online at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michelle Schutz, Office of Superfund 
Remediation and Technology Innovation (5202T), Environmental Protection 
Agency, 1200 Pennsylvania Avenue NW, Washington, DC 20460; telephone 
number 703-346-9536; email address: [email protected].

SUPPLEMENTARY INFORMATION: 
    Acronyms and Abbreviations: We use multiple acronyms and terms in 
this preamble. While this list may not be exhaustive, to ease the 
reading of the preamble and for reference purposes, the EPA defines the 
following terms and acronyms here:

ADEC Alaska Department of Environmental Conservation
AFFF Aqueous film-forming foam
APFO Ammonium perfluorooctanoate
ATSDR Agency for Toxic Substances and Disease Registry
CDC Center for Disease Control and Prevention
CDR Chemical Data Reporting
CERCLA Comprehensive Environmental Response, Compensation, and 
Liability Act
CFR Code of Federal Regulations
COP-9 9th Conference of Parties
DoD Department of Defense
DOE Department of Energy
DNA Deoxyribonucleic acid
EA Economic Analysis
EALs Environmental action levels
ECF Electrochemical fluorination
EJ Environmental justice
EPA Environmental Protection Agency
EPCRA Emergency Planning and Community Right-to-Know Act
EU European Union
FAA Federal Aviation Administration
FDA Food and Drug Administration
FR Federal Register
FSANZ Food Standards Australia New Zealand
IARC International Agency for Research of Cancer
ICR Information Collection Request
ILs Initiation levels
LEPC Local Emergency Planning Committee
LHA Lifetime health advisories
MAC Maximum acceptable concentration
MCL Maximum contaminant level
MDH Minnesota Department of Health
mg/kg milligram per kilogram
mg/kg/day milligram per kilogram per day
MRL Minimal risk level
MSC Medium-specific concentration
NAICS North American Industrial Classification System
NCP National Oil and Hazardous Substances Pollution Contingency Plan
ng/g nanograms per gram
ng/L nanograms per liter
NHANES National Health and Nutrition Examination Survey
NJDEP New Jersey Department of Environmental Protection
NPL National Priorities List
NRC National Response Center
OMB Office of Management and Budget
PADEP Pennsylvania Department of Environmental Protection
PBI Proprietary business information
PCBs Polychlorinated biphenyls
PCL Protective concentration level
PER Perimeter Well Study
PFAS Per- and polyfluoroalkyl substances
PFBS Perfluorobutanesulfonic acid
PFDA Perfluorodecanoic acid
PFHpA Perfluoroheptanoic acid
PFHxA Perfluorohexanoic acid
PFHxS Perfluorohexanesulfonic acid
PFNA Perfluorononanoic acid
PFOA Perfluorooctanoic acid
PFOS Perfluorooctanesulfonic acid
PFOSA Perfluorooctanesulfonamide
pg/m\3\ picogram per cubic meter
PHGs Public health goals
POSF Perfluorooctanesulfonyl fluoride
ppt parts per trillion
PRG Preliminary remediation goal
PWS Public water system
RAGs Remedial action guidelines
RCRA Resource Conservation and Recovery Act
REACH Registration Evaluation, Authorisation and Restriction of 
Chemicals
RFA Regulatory Flexibility Act
RfD Reference dose
RIDEM Rhode Island Department of Environmental Management
RML Regional removal management level
RQ Reportable quantity
RSL Regional screening level
SAB Science Advisory Board
SALs State action levels
SDWA Safe Drinking Water Act SERC State Emergency Response 
Commission
SNURs Significant New Use Rules
TDI Tolerable daily intake
TEPC Tribal Emergency Planning Committee
TERC Tribal Emergency Response Commission
TRI Toxic Release Inventory
TSCA Toxic Substances Control Act
UCMR Unregulated Contaminant Monitoring Rule
UK United Kingdom
UMRA Unfunded Mandates Reform Act

[[Page 54416]]

UNEP United Nations Environment Programme
U.S. United States
U.S.C. United States Code
WQCC Water Quality Control Commission
WWTP Wastewater treatment plant

Table of Contents

I. Public Participation
    A. Written Comments
II. Does this action apply to me?
III. General Information
    A. Executive Summary
    B. What are PFOA and PFOS and how have they been used?
    C. What action is the Agency taking?
IV. Legal Authority
    A. Background
    B. Explanation of Criteria for Designation Decisions
    1. Factors To Be Considered Under Section 102
    2. CERCLA Section 102(a) Precludes Consideration of Cost
    a. Consistency With Case Law
    b. Consistency With Statutory Structure
    c. Indirect Costs
    d. Request for Comment
V. Designation of PFOA, PFOS, and Their Salts and Structural Isomers 
as Hazardous Substances
    A. Introduction
    B. What is the evidence for designation of PFOA and PFOS as 
hazardous substances?
    1. Chemical/Physical Characteristics
    2. Toxicity and Toxicokinetics
    3. Environmental Prevalence
VI. Effect of Designation
    A. Default Reportable Quantity
    B. Direct Effects of a Hazardous Substance Designation
    1. Reporting and Notification Requirements for CERCLA Hazardous 
Substances
    2. Requirements Upon Transfer of Government Property
VII. Regulatory and Advisory Status at EPA, Other Federal, State and 
International Agencies
    A. EPA Actions
    B. Actions by Other Federal Agencies
    C. State Actions
    D. Enforcement
    E. International Actions
VIII. Statutory and Executive Order Reviews
    A. Executive Order 12866: Regulatory Planning and Review, and 
Executive Order 13563: Improving Regulation and Regulatory Review
    B. Paperwork Reduction Act
    C. Regulatory Flexibility Act
    D. Unfunded Mandates Reform Act
    E. Executive Order 13132: Federalism
    F. Executive Order 13175: Consultation and Coordination With 
Indian Tribal Governments
    G. Executive Order 13045: Protection of Children From 
Environmental Health Risks and Safety Risks
    H. Executive Order 13211: Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution or Use
    I. National Technology Transfer and Advancement Act
    J. Executive Order 12898: Federal Actions To Address 
Environmental Justice in Minority Populations and Low-Income 
Populations

I. Public Participation

A. Written Comments

    Submit your comments, identified by Docket ID No. EPA-HQ-OLEM-2019-
0341, at https://www.regulations.gov (our preferred method), or the 
other methods identified in the ADDRESSES section. Once submitted, 
comments cannot be edited or removed from the docket. The EPA may 
publish any comment received to its public docket. Do not submit to 
EPA's docket at https://www.regulations.gov any information you 
consider to be Propriety Business Information (PBI) or other 
information whose disclosure is restricted by statute. Multimedia 
submissions (audio, video, etc.) must be accompanied by a written 
comment. The written comment is considered the official comment and 
should include discussion of all points you wish to make. The EPA will 
generally not consider comments or comment contents located outside of 
the primary submission (i.e., on the web, cloud or other file sharing 
system). For additional submission methods, the full EPA public comment 
policy, information about PBI or multimedia submissions, and general 
guidance on making effective comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets.
    For further information and updates on EPA Docket Center services, 
please visit us online at https://www.epa.gov/dockets.
    The EPA continues to monitor information carefully and continuously 
from the Centers for Disease Control and Prevention (CDC), local area 
health departments, and our Federal partners so that we can respond 
rapidly as conditions change regarding COVID-19.

II. Does this action apply to me?

    The purpose of this proposed rulemaking is to designate PFOA and 
PFOS, including their salts and structural isomers, as hazardous 
substances under CERCLA section 102(a). Upon designation, any person in 
charge of a vessel or an offshore or onshore facility, as soon as they 
have knowledge of any release of such substances at or above the 
reportable quantity (RQ) must immediately report such releases to the 
Federal, state, tribal and local authorities (CERCLA section 103(a), 
Emergency Planning and Community Right-to-Know Act (EPCRA) section 
304). The RQ for these designations is 1 pound or more in a 24-hour 
period. Once EPA has collected more data on the size of releases and 
the resulting risks to human health and the environment, the Agency may 
consider issuing a regulation adjusting the reportable quantities for 
these substances.
    The five broad categories of entities potentially affected by this 
action include: (1) PFOA and/or PFOS manufacturers (including importers 
and importers of articles); (2) PFOA and/or PFOS processors; (3) 
manufacturers of products containing PFOA and/or PFOS; (4) downstream 
product manufacturers and users of PFOA and/or PFOS products; and (5) 
waste management and wastewater treatment facilities. The following 
list of North American Industrial Classification System (NAICS) codes 
is not intended to be exhaustive, but rather provides a guide to help 
readers determine whether this action applies to them. Potentially 
affected entities may include:

------------------------------------------------------------------------
                                      List of potentially affected U.S.
            NAICS code                       industrial entities
------------------------------------------------------------------------
488119............................  Aviation operations.
314110............................  Carpet manufacturers.
811192............................  Car washes.
325...............................  Chemical manufacturing.
332813............................  Chrome electroplating, anodizing,
                                     and etching services.
325510............................  Coatings, paints, and varnish
                                     manufacturers.
325998............................  Firefighting foam manufacturers.
562212............................  Landfills.
339112............................  Medical Devices.
922160............................  Municipal fire departments and
                                     firefighting training centers,
                                     including Federal agencies that
                                     use, trained with, and tested
                                     firefighting foams.
322121 and 322130.................  Paper mills.
325320............................  Pesticides and Insecticides.

[[Page 54417]]

 
324...............................  Petroleum and coal product
                                     manufacturing.
324110 and 424710.................  Petroleum refineries and terminals.
352992............................  Photographic film manufacturers.
325612............................  Polish, wax, and cleaning product
                                     manufacturers.
325211............................  Polymer manufacturers.
323111 and 325910.................  Printing facilities where inks are
                                     used in photolithography.
313210, 313220, 313230, 313240,     Textile mills (textiles and
 and 313320.                         upholstery).
562...............................  Waste management and remediation
                                     services.
221320............................  Wastewater treatment plants.
------------------------------------------------------------------------

III. General Information

A. Executive Summary

    EPA is proposing to designate two per- and polyfluoroalkyl 
substances (PFAS)--specifically PFOA and PFOS including their salts and 
structural isomers \1\ as hazardous substances because evidence 
indicates that these chemicals may present substantial danger to public 
health or welfare or the environment when released into the 
environment. All references to PFOA and PFOS in this notice are meant 
to include their salts and linear and branched structural isomers. 
Linear and branched structural isomers of PFOA and PFOS maintain the 
carboxylic acid and sulfonic acid functional groups, respectively, but 
have different arrangements of the carbon atoms in the fluorinated 
carbon chain.
---------------------------------------------------------------------------

    \1\ All references to PFOA and PFOS in this notice are meant to 
include their salts and linear and branched structural isomers. 
Linear and branched structural isomers of PFOA and PFOS maintain the 
carboxylic acid and sulfonic acid functional groups, respectively, 
but have different arrangements of the carbon atoms in the 
fluorinated carbon chain.
---------------------------------------------------------------------------

    PFOA and PFOS have historically been found in or used in making a 
wide range of consumer products including carpets, clothing, fabrics 
for furniture, and packaging for food and cookware that are resistant 
to water, grease or stains. They are also used for firefighting at 
airfields and in a number of industrial processes. PFOA and PFOS are 
persistent and mobile in the environment, and exposure can lead to 
adverse human health effects, including high cholesterol, changes in 
liver enzymes, decreased immune response to vaccination, thyroid 
disorders, pregnancy-induced hypertension and preeclampsia, and cancer 
(testicular and kidney for PFOA, liver and thyroid cancer for PFOS). In 
June 2022, EPA released interim updated health advisories for PFOA and 
PFOS based on human epidemiology studies in populations exposed to 
these chemicals. Based on the new data and EPA's draft analyses, the 
levels at which negative health effects could occur are much lower than 
previously understood when EPA issued the 2016 health advisories for 
PFOA and PFOS (70 parts per trillion or ppt).
    EPA believes the totality of evidence about PFOA and PFOS described 
here demonstrates that they can pose substantial danger to public 
health or welfare or the environment. This level of evidence is more 
than sufficient to satisfy the CERCLA section 102(a) standard. EPA 
believes that this amount and type of evidence exceeds the minimum 
required under CERCLA section 102(a).
    PFOA and PFOS are common contaminants in the environment because of 
their release into the environment and their resistance to degradation. 
PFAS generally, and PFOA and PFOS specifically, are sometimes referred 
to as ``forever'' chemicals because their strong carbon-fluorine bonds 
cause PFOA and PFOS to be extremely resistant to degradation in the 
environment. PFAS are found in outdoor air at locations in the United 
States, Europe, Japan, and over the Atlantic Ocean. PFAS are also found 
in the artic snow and air.\2\
---------------------------------------------------------------------------

    \2\ Scientific Reports (2016) Natural Poly-/perfluoroalkyl 
Substances in Air and Snow from the Artic https://www.nature.com/articles/srep08912.
---------------------------------------------------------------------------

    PFOA and PFOS are found worldwide in many environmental media and 
in wildlife. For example:
     PFOA and PFOS are widely detected in surface water samples 
collected from various rivers, lakes, and streams in the United States.
     PFOA and PFOS have been detected in surface and subsurface 
soils.
     PFOA and PFOS have been detected in groundwater in 
monitoring wells, private drinking water wells, and public drinking 
water systems across the country. PFOA and PFOS have been found in wild 
and domestic animals such as fish, shellfish, alligators, deer and 
avian eggs.
    Environmental sources can include industrial, and inadvertent 
municipal and agricultural discharges of PFOA and PFOS directly. PFOA 
and PFOS precursors can be converted to PFOA and PFOS, respectively, by 
microbes in soil, sludge, and wastewater and through abiotic chemical 
reactions. PFOA and PFOS that are deposited or created by the 
degradation of their precursors in industrial and consumer waste, in a 
landfill without environmental controls, can discharge via leachates, 
groundwater pollution/migration and atmospheric releases.
    The principal worldwide manufacturers of PFOA and PFOS and related 
chemicals phased out their production in the early 2000's although PFOA 
and PFOS may still be produced domestically for certain uses and by 
international companies that export treated products to the United 
States. Environmental contamination and resulting human exposure to 
PFOA and PFOS are anticipated to continue for the foreseeable future 
due to its environmental persistence, formation from precursor 
compounds, continued production by international manufacturers and 
possible domestic production, and as a result of the large legacy 
production in the United States. Although PFOA and PFOS levels have 
been decreasing in human serum samples since the phase out, they are 
still detected in a high percentage of the U.S. population.\3\
---------------------------------------------------------------------------

    \3\ CDC. (2021). National Health and Nutrition Examination 
Survey: NHANES questionnaires, datasets, and related documentation. 
Centers for Disease Control and Prevention. https://wwwn.cdc.gov/nchs/nhanes/Default.aspx.
---------------------------------------------------------------------------

    The adverse human health effects, mobility, persistence, 
prevalence, and other factors related to these PFAS combine to support 
EPA's proposed finding that PFOA and PFOS, when released into the 
environment may present substantial danger to the public health or 
welfare or the environment and, as a result, warrant designation as 
CERCLA hazardous substances.
    The potential dangers posed by PFOA and PFOS specifically, and more 
generally by PFAS, have been recognized by numerous Federal, state, and 
international governmental entities that have taken a wide variety of 
actions to address these dangers to public health and welfare and the

[[Page 54418]]

environment. For example, the Department of Defense has been providing 
alternative drinking water to local residents near military bases with 
elevated PFOA and PFOS levels from DoD activities. Many states, 
including California, Michigan, and Vermont have drinking water 
standards for PFOA and PFOS. And numerous international bodies, such as 
the European Union, and individual countries, such as Australia, China, 
and Canada, have taken measures to address PFOA and PFOS. Designating 
PFOA and PFOS as hazardous substances will add to the set of tools 
already available under CERCLA to protect the public health and welfare 
and the environment.
    If finalized, the direct effects of this proposed CERCLA 
designation would include requiring that any person in charge of a 
vessel or facility report releases of PFOA and PFOS of one pound or 
more within a 24-hour period. This would give the Agency, state, 
Tribal, and local governments, and the public a better understanding of 
where releases occur and the quantities involved.
    In addition, when selling or transferring Federally-owned real 
property, Federal agencies would be required to meet all of the 
property transfer requirements in CERCLA section 120(h), including 
providing notice when any hazardous substance ``was stored for one year 
or more, known to have been released, or disposed of'' and providing a 
covenant warranting that ``all remedial action necessary to protect 
human health and the environment with respect to any [hazardous 
substances] remaining on the property has been taken before the date of 
such transfer, and any additional remedial action found to be necessary 
after the date of such transfer shall be conducted by the United 
States.'' This would ensure that any entity receiving Federal land is 
informed of the presence of PFOA or PFOS, and that these substances 
will be addressed as required under CERCLA. There would also be an 
obligation for DOT to list and regulate PFOA and PFOS as hazardous 
materials under the Hazardous Materials Transportation Act (HMTA) (see 
CERCLA Section 306(a)).
    In addition to those direct effects, if finalized, these 
designations would provide some additional tools that the government 
and others could use to address PFOA/PFOS contamination and, thus, 
could facilitate an increase in the pace of cleanups of PFOA/PFOS 
contaminated sites. Furthermore, there will likely be additional 
response actions beyond those that are simply undertaken before 
designating PFOA/PFOS a hazardous substance, although the quantity of 
such an increase is indeterminable. The Federal government is already 
authorized to cleanup PFOA/PFOS contamination under some circumstances, 
including when it finds that a release may present an imminent and 
substantial danger to public health or welfare. A faster pace of 
cleanups would provide public health protection for affected 
communities sooner and could reduce the cost of individual cleanups 
(generally, the sooner contamination is addressed, the less it spreads 
and the smaller the area that needs to be cleaned). The indirect, 
downstream effects of these designations could include the following:
     EPA and other agencies exercising delegated CERCLA 
authority could respond to PFOA and PFOS releases and threatened 
releases without making the imminent and substantial danger finding 
that is required for responses now.
     EPA and delegated agencies could require potentially 
responsible parties to address PFOA or PFOS releases that pose an 
imminent and substantial endangerment to public health or welfare or 
the environment.
     EPA and delegated agencies could recover PFOA and PFOS 
cleanup costs from potentially responsible parties, to facilitate 
having polluters and other potentially responsible parties, rather than 
taxpayers, pay for these cleanups.
     Private parties that conduct cleanups that are consistent 
with the National Oil and Hazardous Substances Contingency Plan (NCP) 
could also recover PFOA and PFOS cleanup costs from potentially 
responsible parties.
    These impacts from the proposed rule will result in meaningful 
public health benefits, including by increasing transparency around 
PFOA/PFOS releases and offering additional tools that EPA and other 
government agencies could use to conduct faster cleanups at 
contaminated sites.\4\
---------------------------------------------------------------------------

    \4\ See the Economic Assessment of the Potential Costs and Other 
Impacts of the Proposed Rulemaking to Designate Perfluorooctanoic 
Acid and Perfluorooctanesulfonic Acid as Hazardous Substances in the 
rulemaking docket for a discussion of indirect benefits and costs.
---------------------------------------------------------------------------

    In addition to this action, in 2022, the EPA will be developing an 
advance notice of proposed rulemaking seeking comments and data to 
assist in the development of potential future regulations pertaining to 
other PFAS designation as hazardous substances under CERCLA.

B. What are PFOA and PFOS, and how have they been used?

    PFAS, including PFOA and PFOS, are human-made chemicals that have 
been used in industry and consumer products since the 1940s because of 
their useful properties, including their resistance to water, grease, 
and stains. In terms of their chemistry, they exist as linear and 
branched isomers, depending on the methods by which they are produced. 
Both PFOA and PFOS have been manufactured in numerous salt forms.\5\ In 
considering toxicity and fate and transport processes, the salts are 
deemed the same as the commonly referenced acid versions because, once 
added to water, the salts dissociate to the component ions (there are 
two ions, the cation and the anion). Hence, if any of the salt or acid 
forms of PFOA or PFOS are released into the environment, the anionic 
form will generally be found in environmental media; all references to 
PFOA and PFOS in this preamble are meant to include all salts and 
structural isomers.\6\
---------------------------------------------------------------------------

    \5\ ATSDR. (2021). Toxicological profile for perfluoroalkyls: 
final. Atlanta, GA: U.S. Department of Health and Human Services, 
Centers for Disease Control and Prevention, Agency for Toxic 
Substances and Disease Registry. https://wwwn.cdc.gov/TSP/ToxProfiles/ToxProfiles.aspx?id=1117&tid=237.
    \6\ Ibid.
---------------------------------------------------------------------------

    PFOA and PFOS have been produced within the United States (U.S.) 
\7\ as well as imported. Although PFOA and PFOS production may be 
ending in the United States, their continued use in certain 
applications and persistence in the environment means that their 
historical production and use will continue to be a concern in the 
future.
---------------------------------------------------------------------------

    \7\ ATSDR. (2021). Toxicological profile for perfluoroalkyls: 
final. Atlanta, GA: U.S. Department of Health and Human Services, 
Centers for Disease Control and Prevention, Agency for Toxic 
Substances and Disease Registry. https://wwwn.cdc.gov/TSP/ToxProfiles/ToxProfiles.aspx?id=1117&tid=237.
---------------------------------------------------------------------------

    PFOA and PFOS can also be formed by chemical or biological 
degradation from a large group of related PFAS (i.e., precursor 
compounds).\8\ \9\ The nature of PFOA and PFOS (i.e., reactivity as 
both a base and acid) has led to their use in a variety of manufactured 
goods, industrial applications, or the environment, including the 
following:
---------------------------------------------------------------------------

    \8\ Ibid.
    \9\ UNEP. (2006). Report of the Persistent Organic Pollutants 
Review Committee on the work of its second meeting. Addendum: Risk 
profile on perfluorooctane sulfonate. Stockholm Convention on 
Persistent Organic Pollutants. (UNEP/POPS/POPRC.2/17/Add.5). United 
Nations Environment Programme. https://chm.pops.int/TheConvention/POPsReviewCommittee/Meetings/POPRC2/POPRC2ReportandDecisions/tabid/349/Default.aspx.
---------------------------------------------------------------------------

     Food packaging and preparation, including PFAS-containing 
materials

[[Page 54419]]

(e.g., sandwich wrappers, and other paper and paperboard food 
packaging) and processing equipment that uses PFAS. This can lead to 
migration of PFAS into food that contacts such surfaces.
     Commercial household products, including stain- and water-
repellent fabrics, nonstick products, polishes, waxes, paints, and 
cleaning products.
     Certain firefighting foams. PFAS can be found in 
groundwater and surface water at airports, military bases and other 
facilities where PFAS-containing firefighting foam was used for 
training, incident response, or where foam was stored.
     Manufacturing and production, including chrome plating, 
electronics manufacturing, textile manufacturing or oil recovery.
     Drinking water, typically because of localized 
contamination associated with a specific facility (e.g., manufacturer, 
landfill, wastewater treatment plant, firefighter training facility).
     Living organisms, including plants, animals and humans due 
to the above-mentioned sources.
     Plating processes, such as a wetting agent/fume 
suppressant.
     Non-stick cookware and food processing equipment.
     Processing aids in fluoropolymer production.
     Processing aids in textile coating applications.
     Insecticides.
     Certain types of adhesives.
     Cleaning products, such as carpet cleaners, auto washes 
and electronics.
     Coating products, paints, varnishes and inks.
     Surfactants for oil extraction and mining.
     Photo lithography, photographic coatings
     Hydraulic fluids for aviation.\10\ \11\
---------------------------------------------------------------------------

    \10\ U.S. EPA. (2014). Certain perfluoroalkyl sulfonates. U.S. 
Environmental Protection Agency. Code of Federal Regulations. 40 CFR 
721.9582. https://www.govinfo.gov/content/pkg/CFR-2014-title40-vol31/pdf/CFR-2014-title40-vol31-sec721-9582.pdf.
    \11\ Gl[uuml]ge, J; Scheringer, M; Cousins, IT; DeWitt, JC; 
Goldenman, G; Herzke, D; Lohmann, R; Ng, CA; Trier, X; Wang, Z. 
(2020). An overview of the uses of per-and polyfluoroalkyl 
substances (PFAS). Environ Sci Process Impacts 22: 2345-2373. 
https://www.ncbi.nlm.nih.gov/pubmed/33125022.
---------------------------------------------------------------------------

     Certain explosives and pyrotechnics as binders and 
oxidizers.
    The most common processes for making fluorinated chemicals, 
including PFOA and PFOS, are electrochemical fluorination (ECF) and 
telomerization. Production sites that produced PFAS by means of ECF 
were located in the U.S., including Decatur, Alabama. International 
production sites include Belgium (Zwijndrecht near Antwerp) and Italy 
(Miteni in Vicenza)).
    Although PFOA and PFOS production may be ending in the United 
States, their continued use in certain applications and persistence in 
the environment means that their historical production and use will 
continue to be a concern in the future.
    Domestic production and import of PFOA has been phased out in the 
United States by the companies participating in the 2010/2015 PFOA 
Stewardship Program. Small quantities of PFOA may be produced, 
imported, and used by companies not participating in the PFOA 
Stewardship Program and some uses of PFOS are ongoing (see 40 Code of 
Federal Regulations (CFR) 721.9582).\12\ The EPA Chemical Data 
Reporting (CDR) rule under the Toxic Substance Control Act (TSCA) 
requires manufacturers (including importers) to report certain data 
about chemicals in commerce in the United States, including information 
on PFOA and PFOS (subject to a 2,500 pound reporting threshold at a 
single site). The last time PFOA and PFOS manufacturing information was 
reported to EPA pursuant to CDR was in 2013 and 2002, respectively. 
However, Toxics Release Inventory (TRI) data for 2020 shows that small 
amounts of PFOA and PFOS continue to be released into the environment. 
Pursuant to TRI reporting requirements, facilities in regulated 
industry sectors must report annually on releases and other waste 
management of certain listed toxic chemicals that they manufacture, 
process, or otherwise use above certain threshold quantities (100 
pounds for PFOA and PFOS).
---------------------------------------------------------------------------

    \12\ ATSDR. (2021). Toxicological profile for perfluoroalkyls: 
final. Atlanta, GA: U.S. Department of Health and Human Services, 
Centers for Disease Control and Prevention, Agency for Toxic 
Substances and Disease Registry. https://wwwn.cdc.gov/TSP/ToxProfiles/ToxProfiles.aspx?id=1117&tid=237.
---------------------------------------------------------------------------

C. What action is the Agency taking?

    The EPA is proposing to designate PFOA and PFOS, including their 
salts and structural isomers, as hazardous substances under section 
102(a) of CERCLA.
    The designation of PFOA and PFOS, including their salts and 
structural isomers, as hazardous substances, if finalized, would result 
in a default RQ of one pound pursuant to CERCLA section 102. CERCLA 
section 103(a) requires any person in charge of a vessel or facility, 
as soon as they have knowledge of any release \13\ (other than a 
federally permitted release) of a hazardous substance from such vessel 
or facility in quantities equal to or greater than the RQ (one pound) 
or more in a 24-hour period, to immediately notify the National 
Response Center (NRC) of such a release. The reporting requirements are 
further codified in 40 CFR 302.6(a). Section 304 of EPCRA (42 (United 
States Code) U.S.C. 11004) also requires facility owners or operators 
to immediately notify their community emergency coordinator for local 
emergency planning committee (LEPC) (or Tribal emergency planning 
committee (TEPC)), if established, for any area likely to be affected 
by the release and to notify the State Emergency Response Commission 
(SERC) (or Tribal Emergency Response Commission (TERC)) of any state or 
Tribal region likely to be affected by the release. EPCRA section 304 
also requires facilities to submit a follow-up written report to their 
SERC (or TERC) and the LEPC (or TEPC) as soon as practicable after the 
release. EPA published a guidance on July 13, 2010 (75 Federal Register 
(FR) 39852) defining the phrase, ``as soon as practicable'' to be 30 
days after a release. (Note: Some states or Tribal Nations provide less 
than 30 days for submitting a follow-up report.) EPCRA section 304 
requirements are codified in 40 CFR 355.30 to 355.43.\14\
---------------------------------------------------------------------------

    \13\ See Office of Regulatory Enforcement, EPA, Enforcement 
Response Policy for Sections 304, 311 and 312 of EPCRA and Section 
103 of CERCLA at 12 (Sept. 30, 1999), available at https://www.epa.gov/enforcement/enforcement-response-policy-epcra-sections-304-311-312-and-cercla-section-103. See also https://www.epa.gov/epcra/definition-immediate-epcra-and-cercla-release-notification.
    \14\ For additional information on release reporting 
requirements, see https://www.epa.gov/faqs/search/topics/emergency-planning-and-community-right-know-304487/topics/release-notification-epcra-304cercla-103-30450.
---------------------------------------------------------------------------

    In addition, when Federal agencies sell or transfer real property 
they must provide notice of the presence of hazardous substances in 
certain circumstances as required by CERCLA section 120(h). 
Furthermore, in certain circumstances, CERCLA 120(h) requires Federal 
agencies to provide a covenant warranting that ``all remedial action 
necessary to protect human health and the environment with respect to 
any [hazardous substances] remaining on the property has been taken 
before the date of such transfer, and any additional remedial action 
found to be necessary after the date of such transfer shall be 
conducted by the United States.''
    While these are the only direct and automatic consequences of 
designating PFOA and PFOS hazardous substances for purposes of CERCLA, 
there are other, indirect impacts described above that should 
facilitate cleanups and reduce

[[Page 54420]]

human and environmental exposure to these hazardous chemicals.

IV. Legal Authority

A. Background

    CERCLA was enacted to promote the timely cleanup of contaminated 
sites and to ensure that parties responsible for the contamination bear 
the costs of such cleanups. CERCLA provides the Federal government with 
the authority to respond to releases or threatened releases of 
hazardous substances, and pollutants and contaminants in order to 
protect public health, welfare, and the environment. The statute 
confers considerable discretion upon the EPA in its exercise of these 
authorities. Other than the reporting requirements in the statute, 
CERCLA is not a traditional regulatory statute that prospectively 
regulates behavior; rather it is remedial in nature, generally designed 
to address contamination on a site-specific basis.
    CERCLA required a significant update to the NCP, which provides the 
``procedures and standards for responding to releases of hazardous 
substances, pollutants, and contaminants . . . .'' CERCLA section 
105(a). The NCP is the blueprint for all aspects of the cleanup 
process, from the discovery of releases of contaminants, to responding 
to releases or threatened releases that require prompt response, and to 
prioritizing and developing longer-term remedial actions.
    Once a Federal agency learns of a release or potential threat of a 
release of a hazardous substance, pollutant and/or contaminant, CERCLA 
authorizes response in one of three ways: by determining no action at 
the Federal level is warranted; by undertaking a removal action (if the 
situation presents a more immediate threat); or by assessing the 
relative risk of the release to other releases via the NPL listing 
process that is the first step towards a longer-term remedial action. 
Superfund cleanups typically begin with a preliminary assessment/site 
inspection, which includes reviews of historical information and site 
visits to evaluate the potential for a release of hazardous substances. 
EPA determines whether the site poses a threat to people and the 
environment and whether hazards need to be addressed immediately or 
additional site information will be collected. Federal entities other 
than EPA that respond to releases or threatened releases of hazardous 
substances, pollutants, or contaminants at Federal sites must similarly 
act consistent with CERCLA and the NCP. Finally, private parties 
responding to a release or threatened release at their facility must 
act consistent with CERCLA and the NCP in order to maintain CERCLA 
claims for recovery of response costs.
    The nature of the subsequent response action depends upon the site-
specific circumstances. Short-term ``removals'' are response actions 
that EPA and other Federal agencies may take to address releases or 
threatened releases requiring prompt action and are limited in cost and 
duration unless specific criteria are met. Long-term ``remedial'' 
actions permanently and significantly reduce the risks associated with 
releases or threats of releases that are serious and are typically 
associated with chronic exposures, but not immediately life-
threatening. EPA can only conduct remedial actions at sites listed on 
EPA's National Priorities List (NPL). Additions to the NPL undergo 
notice-and-comment rulemaking. The NPL sites are among the worst 
hazardous substance sites identified by EPA. Only about 3% of the 
53,400 assessed sites have been placed on the NPL. If a site is placed 
on the NPL, a Remedial Investigation/Feasibility Study is conducted to 
assess risks posed by releases of a hazardous substance, pollutant, or 
contaminant at the site by evaluating soil, surface water, ground 
water, and other media, and waste samples, and to analyze potential 
treatment methods or cleanup alternatives. EPA then summarizes those 
alternatives and offers its recommendation in a Proposed Plan, which 
undergoes a public comment process. The final decision on the cleanup 
is memorialized in a Record of Decision, which is accompanied by a 
responsiveness summary addressing the public comments. The specific 
details of the cleanup are then planned in the Remedial Design and 
finally carried out in the Remedial Action. Ultimately, the remedy must 
be one ``that is protective of human health and the environment, that 
is cost effective, and that utilizes permanent solutions and 
alternative treatment technologies or resource recovery technologies to 
the maximum extent practicable.'' CERCLA section 121(b)(1).
    CERCLA provides authority for response actions to address releases 
of hazardous substances as well as releases of pollutants and 
contaminants. The authority conferred by CERCLA with regard to 
hazardous substances differs in a few respects from the authority with 
regard to pollutants and contaminants. With respect to hazardous 
substances, the Agency can conduct response actions if there is a 
release or threatened release without having to establish an imminent 
and substantial danger. In addition, the EPA can also recover costs 
from potentially responsible parties and require potentially 
responsible parties to conduct the cleanup themselves. CERCLA also 
authorizes persons (including private parties) that conduct cleanup 
activities that are consistent with the NCP to seek to recover cleanup 
costs from potentially responsible parties. With respect to releases or 
substantial threat of releases of pollutants and contaminants, EPA can 
respond if the Agency finds that the release or threat of release may 
present an imminent and substantial danger to the public health or 
welfare, and, generally, cannot require a private party to pay for or 
conduct the removal action.
    Accordingly, CERCLA already provides significant authority to 
Federal agencies to address PFOA and PFOS releases because these two 
chemicals are pollutants and contaminants. Nonetheless, designating 
PFOA and PFOS as hazardous substances will likely increase the pace at 
which cleanups occur because it will allow the Federal government to 
require responsible private parties to address releases of PFOS and 
PFOA at sites without other ongoing cleanup activities, and allow the 
government and private parties to seek to recover cleanup costs from 
potentially responsible parties assuming relevant statutory criteria 
are met. As a result, risks from releases of PFOA and PFOS may be 
mitigated.

B. Explanation of Criteria for Designation Decisions

    CERCLA section 101(14) sets out the definition of ``hazardous 
substance.'' There are two ways that a substance may be defined as a 
``hazardous'' substance under CERCLA. The first is automatic where the 
substance is identified as hazardous or toxic pursuant to other 
specified environmental statutes (e.g., chemicals listed as air toxics 
by Congress or EPA under section 112 of the Clean Air Act). The second 
is where the substance is designated as hazardous pursuant to CERCLA 
section 102. In this action, the Administrator is exercising his 
authority to designate under section 102.
1. Statutory Factors To Be Considered Under Section 102
    The EPA Administrator is authorized under CERCLA section 102(a) to 
promulgate regulations designating as a hazardous substance:
    (1) ``such elements, compounds, mixtures, solutions, and 
substances''
    (2) ``which, when released into the environment''

[[Page 54421]]

    (3) ``may present substantial danger''
    (4) ``to the public health or welfare or the environment.''
    The term ``hazardous substance'' is defined in section 101(14) of 
CERCLA primarily by reference to other environmental statutes and 
includes substances designated pursuant to CERCLA section 102. Pursuant 
to CERCLA section 101(14) the term hazardous substance means (A) any 
substances designated pursuant to section 311(b)(2)(A) of the Federal 
Water Pollution Control Act [33 U.S.C. 1321(b)(2)(A)], (B) any element, 
compound, mixture, solution, or substances designated pursuant to 
section 9602 of this title, (C) any hazardous waste having the 
characteristics identified under or listed pursuant to section 3001 of 
the Solid Waste Disposal Act [42 U.S.C. 6921], (but not including any 
waste the regulation of which under the Solid Waste Disposal Act {42 
U.S.C. 6901 et seq.] has been suspended by Act of Congress). (D) any 
toxic pollutant listed under section 307(a) of the Federal Water 
Pollution Control Act {33 U.S.C. 1317(a)], (E) any hazardous air 
pollutant listed under section 112 of the Clean Air Act [42 U.S.C. 
7412], and (F) any imminently hazardous chemical substance or mixture 
with respect to which the Administrator has taken action pursuant to 
section 7 of the Toxic Substances Control Act [15 U.S.C. 2606]. The 
term does not include petroleum, including crude oil or any fraction 
thereof which is not otherwise specifically listed or designated as a 
hazardous substance under paragraphs (A) through (F) of this paragraph, 
and the term does not include natural gas, natural gas liquids, 
liquified natural gas, or synthetic gas usable for fuel (or mixtures of 
natural gas and such synthetic gas).
    Because EPA has not exercised its authority under CERCLA section 
102(a), it has not previously issued an interpretation of the standard 
for designating hazardous substances.
    EPA proposes to interpret ``may present'' in the statutory language 
as indicating that Congress did not require certainty that the 
substance presents a substantial danger or require proof of actual 
harm. In assessing whether a substance, when released, may present 
``substantial danger,'' \15\ the EPA proposes to consider information 
such as the following: the potential harm to humans or the environment 
from exposure to the substance (i.e., hazard), and how the substance 
moves and degrades when in the environment (i.e., environmental fate 
and transport). To further inform its decision about whether the 
statutory factors have been met, the Agency proposes to also consider 
other information that may be relevant when evaluating releases of the 
substance, such as the frequency, nature and geographic scope of 
releases of the substances. The Agency proposes to weigh this 
information to determine whether the substance, when released, may 
present a ``substantial danger.''
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    \15\ The EPA notes that the ``substantial danger'' language in 
CERCLA section 102(a) is similar to language in other parts of 
CERCLA but is interpreted in a different manner due to the contexts 
in which the language appears. Those other provisions (see, e.g., 
CERCLA sections 104, 105, 106, and 128) concern enforcement and 
response actions and apply to and require analyses of site-specific 
circumstances relevant to a particular facility or person, and to an 
event. By contrast, the statutory objectives associated with 
designating hazardous substances under CERCLA section 102(a) warrant 
a different implementation strategy because of its broader 
applicability and analytical requirements. The standard for CERCLA 
section 102(a) in this notice is based on the specific language and 
purpose of section 102(a) and does not affect EPA's interpretations 
of other CERCLA provisions. See Utility Air Regulatory Group v. EPA, 
573 U.S. 302, 320 (2014) (finding that statutory terms, even those 
that are defined in the statute, ``may take on distinct characters 
from association with distinct statutory objects calling for 
different implementation strategies.'').
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2. CERCLA Section 102(a) Precludes Consideration of Cost
    Given the specific standard Congress established for determining 
whether a substance is hazardous (i.e., whether it ``may present 
substantial danger to the public health or welfare or the 
environment''), EPA proposes to interpret the language of CERCLA 
section 102(a) as precluding the Agency from taking cost into account 
in designating hazardous substances. Congress did not list cost as a 
required or permissible factor, and none of the Congressionally-listed 
statutory factors encompass a consideration of cleanup costs. Moreover, 
as a matter of common sense and straightforward reading, determining 
whether something is ``hazardous'' does not naturally lend itself to 
considerations of cost. A substance is or is not hazardous based on 
scientific and technical considerations. Subsequent determinations of 
whether and how to address something hazardous may involve 
considerations of cost, as CERCLA does in the context of response 
actions, as discussed below.
a. Consistency With Case Law
    Reading CERCLA as precluding consideration of costs in hazardous 
substance designations is consistent with relevant Supreme Court 
precedent on cost consideration in rulemaking decisions. CERCLA section 
102(a) is similar to Clean Air Act section 109(b)(1),\16\ which governs 
EPA's setting of national ambient air quality standards (NAAQS) and 
which the Supreme Court said precludes consideration of costs. Whitman 
v. American Trucking, 531 U.S. 457 (2001). In his majority opinion, 
Justice Scalia explained,
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    \16\ ``National primary ambient air quality standards, 
prescribed under paragraph (a) shall be ambient air quality 
standards the attainment and maintenance of which in the judgment of 
the Administrator, based on such criteria and allowing an adequate 
margin of safety, are requisite to protect the public health. Such 
primary standards may be revised in the same manner as 
promulgated.'' 42 U.S.C. 7409(b)(1).

The EPA, ``based on'' the information about health effects contained in 
the technical ``criteria'' documents compiled under section 108(a)(2), 
42 U.S.C. 7408(a)(2), is to identify the maximum airborne concentration 
of a pollutant that the public health can tolerate, decrease the 
concentration to provide an ``adequate'' margin of safety, and set the 
standard at that level. Nowhere are the costs of achieving such a 
---------------------------------------------------------------------------
standard made part of that initial calculation.

American Trucking, 531 U.S. at 465.

    Similarly, CERCLA section 102(a) establishes a standard for 
designation that is tied exclusively to whether the release of a 
substance ``may present substantial danger to the public health or 
welfare or the environment.'' 42 U.S.C. 9602(a). Congress did not 
mention cost in this language that sets the standard for designation of 
hazardous substances.
    Section 102(a)'s specific designation standard and its statutory 
context differentiate it from the broader statutory standard in Clean 
Air Act section 112(n)(1)(A), which the Supreme Court held requires EPA 
to consider costs in determining whether to regulate air toxic 
emissions from power plants in Michigan v. EPA, 576 U.S. 743 (2015). 
Clean Air Act section 112(n)(1)(A) states, in part,

The Administrator shall regulate electric utility steam generating 
units under this section, if the Administrator finds such regulation is 
appropriate and necessary after considering the results of the study 
required by this paragraph.

42 U.S.C. 7412(n)(1)(A). The Supreme Court explained that 
``appropriate'' is a broad term that ``includes consideration of all 
the relevant factors'' and when read in the context of Clean Air Act 
section 112(n)(1)(A) requires ``at least some attention to cost.'' 
Michigan, 576 U.S., at 752. In particular, the Court pointed to a study 
that was required by

[[Page 54422]]

the same paragraph (i.e., Clean Air Act section 112(n)(1)), and noted 
both that Congress required that this study address cost (among other 
factors), and that EPA said that study helped provide a ``framework'' 
for EPA's decision under Clean Air Act section 112(n)(1). Given this 
context, in interpreting the Clean Air Act section 112(n)(1)'s 
``appropriate and necessary'' standard for triggering regulation of air 
toxics from power plants, the Court held that EPA must consider cost in 
deciding whether to regulate power plants.
    The standard for designation in CERCLA section 102(a) is 
significantly more circumscribed than the standard at issue in 
Michigan. As noted above, in CERCLA section 102(a), Congress specified 
a public health and welfare and environment standard governing EPA's 
designation decisions that did not include cost. In these 
circumstances, Michigan acknowledged that:

American Trucking thus establishes the modest principle that where the 
Clean Air Act expressly directs EPA to regulate on the basis of a 
factor that on its face does not include cost, the Act normally should 
not be read as implicitly allowing the Agency to consider cost anyway.

Id. at 755-56. Because CERCLA section 102(a) specifies the standard 
that EPA is to use, and it wholly relates to danger to public health, 
welfare, or the environment, cost should not be read in as an 
additional consideration. Furthermore, CERCLA section 102(a) is lacking 
provisions that indicate Congressional intent to take cost into 
account--unlike CAA section 112(n)(1), which had cost elements in 
provisions that the Court and EPA said were relevant to interpreting 
the ``appropriate and necessary'' standard.
    CERCLA section 102(a) does use the word ``appropriate'' (the 
Administrator shall ``promulgate and revise as may be appropriate'' 
regulations designating hazardous substances), but significantly, the 
word ``appropriate'' is not used in the context of what EPA should 
consider when assessing whether a substance is hazardous. And as the 
Michigan Court noted, ``appropriate and necessary'' does not always 
encompass cost, context matters. See Michigan, 576 U.S. at 752. Under 
CAA section 112(n)(1), the substantive standard is nothing more than 
whether regulation is ``appropriate and necessary'' and, to the extent 
Congress provided a contextual indication about the meaning of that 
capacious phrase, it indicated that cost was relevant. In contrast, 
under CERCLA section 102(a), the Administrator is to promulgate and 
revise as may be appropriate regulations that accomplish the statutory 
goal of designating hazardous substances--and the guidance Congress 
provided was that the Administrator should look to specific criteria 
that do not include cost. Thus, EPA's authority to designate a 
substance as hazardous is tied solely to a finding that, when released, 
the substance may present a substantial danger to public health or 
welfare or the environment.
    In addition, the Court in both American Trucking and Michigan, 
looked to the overall statutory scheme to determine whether cost should 
be considered as part of the Agency's determination. The role of a 
hazardous substance designation in the overall structure of CERCLA is 
much closer to the role of a national ambient air quality standard in 
the overall structure of the NAAQS program than it is to the role of 
the appropriate and necessary finding in regulating air toxic emissions 
from power plants.
    Under CERCLA, the only automatic, private party obligation that 
flows from designation as a CERCLA hazardous substance under section 
102(a) is the obligation to report releases (a relatively small cost). 
As discussed above, designation does not lead automatically to any 
response action obligations. CERCLA response actions, which include 
investigations of hazardous substance releases and determining if 
removal or remedial action is necessary, are contingent, discretionary, 
and site-specific actions.\17\ EPA prioritizes the highest-risk sites 
under CERCLA (and that listing process is open to public comment); the 
process for selecting remedies includes public notice and comment (such 
as on the remedial action objectives and the consideration of remedial 
alternatives); and cost considerations, among other important factors 
such as protectiveness, are part of CERCLA's site-specific cleanup 
approach.
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    \17\ As noted below in section IV.B.2.c. and the Economic 
Assessment, the multiple, contingent, discretionary and site-
specific steps between designation of a hazardous substance and the 
incurrence of cleanup costs contribute to the inability to quantify 
costs at the designation stage. The uncertainty at this stage, when 
contrasted with the greater certainty and explicit consideration of 
costs during the later cleanup selection process, further supports 
EPA's proposed interpretation that CERCLA precludes consideration of 
costs when designating a hazardous substance.
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    For both the hazardous substance designation in CERCLA and the 
setting of a NAAQS, there are later steps in the program where cost can 
be taken into account before specific requirements are imposed on 
entities subject to the programs. In contrast, in Michigan, the Court 
seemed to weigh heavily the fact that, if regulations are ``appropriate 
and necessary'' under section 112(n)(1)(A), then, without regard to 
cost, ``the Agency must promulgate certain minimum emission 
regulations, known as floor standards.'' Michigan, 576 U.S., at 748.
    Furthermore, the designation of a hazardous substance under CERCLA 
section 102(a) in some cases does not create new costs, but rather 
allows costs to be shifted from the taxpayer to parties responsible for 
pollution under CERCLA. Even in those circumstances, where the 
government is able to transfer costs, a private party's ability to pay 
response costs is taken into account under the statute and in EPA's 
implementation of the statute.\18\
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    \18\ See Memorandum from Susan Shinkman, Director, Office of 
Civil Enforcement, and Cynthia Mackey, Director, Office of Site 
Remediation Enforcement, US EPA (June 29, 2015) (Guidance on 
Evaluating a Violator's Ability to Pay a Civil Penalty in an 
Administrative Enforcement Action); Memorandum from Barry Breen, 
Director, Office of Site Remediation Enforcement, US EPA (Sep. 30, 
1997) (General Policy on Superfund Ability to Pay Determinations).
---------------------------------------------------------------------------

    The interpretation that section 102(a) precludes the consideration 
of cost in designation decisions is also supported by the Court of 
Appeals for the D.C. Circuit. In Utility Solid Waste Activities Group 
v. EPA, 901 F.3d 414 (D.C. Cir. 2018), the D.C. Circuit, relying on 
Michigan and American Trucking, upheld EPA's decision that it should 
not have considered cost in establishing requirements under the 
Resource Conservation and Recovery Act (RCRA) for disposing of coal 
combustion residuals because the statutory standard only addresses 
``adverse effects on health or the environment'' without mentioning 
costs or including other language that could encompass cost.
    Based in part on Supreme Court decisions addressing statutory 
interpretation and the D.C. Circuit's application of those decisions, 
EPA proposes to interpret CERCLA section 102(a) as precluding 
consideration of costs in hazardous substance designations.
b. Consistency With Statutory Structure
    The way CERCLA initially established the list of hazardous 
substances shows that Congress did not intend for costs to be 
considered in designation decisions. As noted above, CERCLA offers two 
ways for a substance to be designated as hazardous. One is a finding 
pursuant to CERCLA section 102. Another is the list of other statutory 
provisions in CERCLA section 101(14) that identify hazardous and toxic 
substances. In that section, Congress directed that the definition of

[[Page 54423]]

``hazardous substance'' includes all substances identified as hazardous 
or toxic by Congress or EPA under other specified environmental 
statutes:
     Clean Water Act section 311(b)(2)(A) hazardous substances;
     Resource Conservation and Recovery Act section 3001 
hazardous wastes;
     Clean Water Act section 307(a) toxic pollutants;
     Clean Air Act section 112 hazardous air pollutants; and
     Toxic Substances Control Act section 7 imminently 
hazardous chemical.

When EPA adds a substance or chemical for regulation under any of those 
other statutory provisions, it also becomes a CERCLA hazardous 
substance--without considering the resulting costs under CERCLA.
    In addition to the other statutory provisions listed above, CERCLA 
section 101(14) also includes CERCLA section 102(a), which suggests it 
should be interpreted in a manner similar to the other authorities on 
the list. Under the other statutory provisions, that program's 
compliance costs are not considered a factor or criteria in making 
listing decisions,\19\ and the Agency proposes to interpret CERCLA 
section 102(a) as similarly excluding consideration of cost.
---------------------------------------------------------------------------

    \19\ See, e.g., 42 U.S.C. 6921(a) (RCRA section 3001(a)); 42 
U.S.C. 7412(b)(2) (Clean Air Act section 112(b)(2).
---------------------------------------------------------------------------

c. Costs
    While EPA proposes to interpret CERCLA section 102(a) as excluding 
consideration of cost in a designation decision, the Agency is 
soliciting comment on that interpretation and, if costs should be 
considered, how they should be considered. See section IV.B.2.d. below.
    EPA has estimated parties' potential direct costs associated with 
this designation decision (from reporting releases); they are 
relatively small and would not impede a designation decision even if 
the Agency were required to consider costs.
    It is impractical, however, to quantitatively assess the indirect 
costs (for response actions) associated with a designation decision 
because of the uncertainty about such costs at this early stage in in 
the process. However, a qualitative discussion of indirect costs and 
benefits, as well as details explaining the impracticality of 
quantitative estimates are contained in the Economic Assessment of the 
Potential Costs and Other Impacts of the Proposed Rulemaking to 
Designate Perfluorooctanoic Acid and Perfluorooctanesulfonic Acid as 
Hazardous Substances.\20\ Possible indirect costs could arise from an 
increased number of sites identified, assessed and/or remediated, and 
from associated research and development. In addition, economic costs 
could be offset by savings from faster and more efficient response 
actions. Possible indirect benefits could include reduced health 
effects such as cancer, immunological problems, high cholesterol, and 
thyroid disorders resulting from earlier and greater numbers of 
response actions due to release reporting, and application of enhanced 
response authority.
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    \20\ U.S. EPA (2022) Economic Assessment of the Potential Costs 
and Other Impacts of the Proposed Rulemaking to Designate 
Perfluorooctanoic Acid and Perfluorooctanesulfonic Acid as Hazardous 
Substances.
---------------------------------------------------------------------------

    A designation alone does not require the EPA to take response 
actions, does not require any response action by a private party, and 
does not determine liability for hazardous substance release response 
costs.
    Response actions are contingent, discretionary, and site-specific 
decisions made after a hazardous substance release or threatened 
release. They are contingent upon a series of separate discretionary 
actions and meeting certain statutory and regulatory requirements, as 
explained above. In addition, future discretionary decisions about 
cleanup and response are difficult to quantify due to numerous, 
significant uncertainties such as: (1) How many sites have PFOA or PFOS 
contamination at a level that warrants a cleanup action; (2) the extent 
and type of PFOA and PFOS contamination at/near sites; (3) the extent 
and type of other contamination at/near sites; (4) the incremental cost 
of assessing and remediating the PFOA and/or PFOS contamination at/near 
these sites; and (5) the cleanup level required for these substances.
d. Request for Comment
    EPA proposes to interpret CERCLA section 102(a) as prohibiting the 
Agency from considering cost as part of its decision to designate 
hazardous substances, EPA is taking comment on its approach to the 
consideration of costs, including: (1) Whether CERCLA section 102(a) 
precludes, allows, or requires consideration of cost in designation 
decisions, and, if so, (2) which costs and benefits of those discussed 
in the EA should be considered, (3) whether additional benefits and 
costs not identified in the EA should be considered, (4) if indirect 
benefits and costs are considered, how they should be assessed in light 
of the discretion and uncertainties described above, (5) how benefits 
and costs could be incorporated into the designation decision, and (6) 
whether designation would be justified if costs were to be considered 
in the Agency's designation decision. In addition, the Economic 
Assessment of the Potential Costs and Other Impacts of the Proposed 
Rulemaking to Designate Perfluorooctanoic Acid and 
Perfluorooctanesulfonic Acid as Hazardous Substances includes requests 
for comments on several topics related to indirect costs that EPA does 
not currently have robust information about. Please see Section ES-5 of 
the Economic Assessment for specific details.

V. Designation of PFOA, PFOS, and Their Salts and Structural Isomers as 
Hazardous Substances

A. Introduction

    The EPA is proposing to designate PFOA and PFOS as hazardous 
substances because significant evidence indicates that they satisfy the 
statutory criteria set forth in CERCLA section 102(a):
    (1) They are ``substances'' as described in section IV.B.;
    (2) They may be ``released into the environment'' as described in 
section IV.B.;
    (3) They may present substantial danger as described in section V; 
and
    (4) That danger is ``to the public health or welfare or the 
environment'' as described in section V.
    While EPA acknowledges that the science regarding PFOA and PFOS 
human health and environmental effects is still evolving, a significant 
body of scientific evidence shows that PFOA and PFOS are persistent and 
mobile in the environment, and that exposure to PFOA and PFOS may lead 
to adverse human health effects. Assessments conducted by EPA, other 
Federal, state, Tribal and international agencies, academia, non-profit 
organizations and the private sector support the conclusion that PFOA 
and PFOS warrant a hazardous substance designation. This conclusion is 
based on the factors considered by EPA in this proposal, which, as 
noted above, included the potential human health or environmental 
hazards associated with exposure to PFOA and PFOS and the environmental 
fate and transport of PFOA and PFOS. The evidence for concern about 
PFOA and PFOS includes:

 Chemical/Physical Characteristics
 Toxicity and Toxicokinetics

[[Page 54424]]

 Environmental Prevalence

    Each of the above evidence categories are discussed in more detail 
below. PFOA and PFOS hazardous substance designation would be 
consistent with and supportive of many other actions taken by EPA, 
other Federal agencies, states, Tribal Nations and international 
bodies. These entities have set PFOA and PFOS benchmarks and standards 
and have undertaken PFOA- and PFOS-based regulatory activities and 
enforcement actions. Details are provided below.

B. What is the evidence for designation of PFOA and PFOS as hazardous 
substances?

    A significant collection of evidence and actions support 
designating PFOA and PFOS as hazardous substances under CERCLA section 
102(a). EPA is proposing that, when released into the environment, PFOA 
and PFOS may present substantial danger to the public health or welfare 
or the environment. What follows are brief summaries and not a 
comprehensive review of the available literature.
1. Chemical/Physical Characteristics
    PFOA and PFOS are persistent chemicals that bioaccumulate, and 
exposure to PFOA and PFOS may cause adverse human health effects. PFOA 
and PFOS are distinctive from many other bioaccumulative chemicals 
because their water-solubility allows them to migrate readily from soil 
to groundwater. If PFOA and PFOS are released into the environment, 
they can contaminate surface water and groundwater used as drinking 
water sources and persist for long periods of time, thereby posing a 
direct threat to human health and the environment.
    PFOA is comprised of eight carbons, seven of which are fully 
fluorinated, and the eighth carbon is part of a carboxylic acid group. 
PFOA is considered a surfactant (i.e., a substance that tends to reduce 
the surface tension of a liquid in which it is dissolved) due to its 
chemical structure consisting of a hydrophobic perfluorinated alkyl 
``tail group'' and a hydrophilic carboxylate ``head 
group''.^{21 22} As a result of the head group, PFOA is water 
soluble, which contributes to its tendency to be found in groundwater.
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    \21\ ChEBI. (2017). ChEBI:35549--perfluorooctanoic acid. 
Chemical Entities of Biological Interest. European Molecular Biology 
Laboratory, European Bioinformatics Institute. https://www.ebi.ac.uk/chebi/searchId.do?chebiId=CHEBI:35549.
    \22\ Lindstrom, AB; Strynar, MJ; Libelo, EL. (2011). 
Polyfluorinated compounds: past, present, and future. Environ Sci 
Technol 45: 7954-7961. https://www.ncbi.nlm.nih.gov/pubmed/21866930.
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    PFOA is produced and used mainly as ammonium perfluorooctanoate 
(APFO), a salt of PFOA, that may include both linear and branched 
isomers. APFO's isomeric composition depends on the manufacturing 
processes used. The APFO that is produced through the perfluorooctyl 
iodide oxidation process, commonly called telomerization, is >99 
percent linear, and the APFO that is produced by the ECF process is >70 
percent linear with the remaining <30 percent a mixture of branched 
isomers.^{23 24} As a result, there are different PFOA 
structural isomers that may be released and found in the environment. 
Analytical chemistry methods used to detect and measure PFOA may 
measure the different isomers separately.
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    \23\ European Commission. (2015). Analysis of the risks arising 
from the industrial use of perfluorooctanoic acid (PFOA) and 
ammonium perfluorooctonate (APFO) and from their use in consumer 
articles. Evaluation and risk reduction measures for potential 
restrictions on the manufacture, placing on the market and use of 
PFOA and APFO. (TOX08.7049). European Commission, Enterprise and 
Industry Directorate--General. https://ec.europa.eu/docsroom/documents/13037/attachments/1/translations/en/renditions/pdf.
    \24\ Buck, RC; Franklin, J; Berger, U; Conder, JM; Cousins, IT; 
de Voogt, P; Jensen, AA; Kannan, K; Mabury, SA; van Leeuwen, SP. 
(2011). Perfluoroalkyl and polyfluoroalkyl substances in the 
environment: terminology, classification, and origins. Integr 
Environ Assess Manag 7: 513-541. https://www.ncbi.nlm.nih.gov/pubmed/21793199.
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    PFOS has a fully fluorinated eight-carbon linear or branched tail, 
with a hydrophilic sulfonate functional head group attached to the 
carbon tail. PFOS is manufactured from perfluorooctanesulfonyl fluoride 
(POSF), which is produced through ECF. This process results in linear 
and branched isomers of PFOS.\25\ PFOS is often produced as its 
potassium salt. Like PFOA, PFOS is water soluble, which is why it can 
be found in groundwater.
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    \25\ OECD. (2002). Hazard assessment of perfluorooctane 
sulfonate (PFOS) and its salts. Environment Directorate, Joint 
Meeting of the Chemicals Committee and the Working Party on 
Chemicals, Pesticides and Biotechnology, Co-operation on Existing 
Chemicals. (ENV/JM/RD(2002)17/FINAL. JT00135607). Organisation for 
Economic Co-operation and Development. https://www.oecd.org/env/ehs/risk-assessment/2382880.pdf.
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    As noted above, PFOA and PFOS contain carbon atoms bonded to 
fluorine atoms. These carbon-fluorine bonds are strong, causing PFOA 
and PFOS to be extremely resistant to degradation in the environment 
(including biodegradation, photolysis and hydrolysis) and, thus, likely 
to persist for long periods of time.^{26 27}
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    \26\ U.S. EPA. (2016). Drinking water health advisory for 
perfluorooctanoic acid (PFOA). (EPA822R16005). U.S. Environmental 
Protection Agency, Office of Water. https://www.epa.gov/sites/default/files/2016-05/documents/pfoa_health_advisory_final_508.pdf.
    \27\ U.S. EPA. (2016). Drinking water health advisory for 
perfluorooctane sulfonate (PFOS). (EPA822R16004). U.S. Environmental 
Protection Agency. https://www.epa.gov/sites/default/files/2016-05/documents/pfos_health_advisory_final_508.pdf.
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    These chemical and physical characteristics of PFOA and PFOS, when 
viewed in combination with the information that follows, supports this 
proposed designation of these chemicals as CERCLA hazardous substances.
2. Toxicity and Toxicokinetics
    Exposure to PFOA and PFOS is associated with a variety of adverse 
human health effects. Human studies have found associations between 
PFOA and/or PFOS exposure and effects on the immune system, the 
cardiovascular system, human development (e.g., decreased birth 
weight), and cancer. EPA continues to conduct extensive evaluations of 
human epidemiological and experimental animal study data to support the 
development of a PFAS National Primary Drinking Water Regulation. In 
November 2021, EPA released draft updated health effects analyses for 
PFOA and PFOS; these analyses are undergoing Science Advisory Board 
(SAB) review. EPA evaluated over 400 peer-reviewed studies published 
since 2016 and used new approaches, tools, and models to identify and 
evaluate the information. Based on the new data and draft analyses, the 
levels at which negative health effects could occur are much lower than 
previously understood when EPA issued the 2016 Health Advisories for 
PFOA and PFOS (70 ppt).
    The following discussion is based on information and conclusions 
from the EPA 2016 Health Effects Support Documents for PFOA \28\ and 
PFOS \29\ and other published peer reviewed science. The weight of 
scientific evidence presented in the Health Effects Support Documents 
for PFOA \30\ and

[[Page 54425]]

PFOS \31\ and supporting documents for the Regulatory Determination 4 
process \32\ supports the conclusion that exposure to PFOA and PFOS can 
lead to adverse human health effects. As part of the final Regulatory 
Determination 4 process, the Agency concluded that exposure to PFOA and 
PFOS may have adverse health effects.\33\
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    \28\ U.S. EPA. (2016). Health effects support document for 
perfluorooctanoic acid (PFOA). U.S. Environmental Protection Agency, 
Office of Water. https://www.epa.gov/sites/default/files/2016-05/documents/pfoa_hesd_final-plain.pdf.
    \29\ U.S. EPA. (2016). Health effects support document for 
perfluorooctane sulfonate (PFOS). U.S. Environmental Protection 
Agency, Office of Water. https://www.epa.gov/sites/default/files/2016-05/documents/pfos_hesd_final_508.pdf.
    \30\ U.S. EPA. (2016). Health effects support document for 
perfluorooctanoic acid (PFOA). U.S. Environmental Protection Agency, 
Office of Water. https://www.epa.gov/sites/default/files/2016-05/documents/pfoa_hesd_final-plain.pdf.
    \31\ U.S. EPA. (2016). Health effects support document for 
perfluorooctane sulfonate (PFOS). U.S. Environmental Protection 
Agency, Office of Water. https://www.epa.gov/sites/default/files/2016-05/documents/pfos_hesd_final_508.pdf.
    \32\ U.S. EPA. (2021). Final regulatory determination 4 support 
document. (EPA815R21001). U.S. Environmental Protection Agency.
    \33\ Ibid.
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    Data from human and animal studies indicate that PFOA and PFOS are 
well absorbed via the oral route and are distributed throughout the 
body by noncovalent binding to serum albumin and other plasma proteins. 
PFOA and PFOS are slowly eliminated from the human body as evidenced by 
the half-life of 2.1-10.1 years for PFOA and 3.3-27 years for PFOS.\34\ 
Because of their resistance to metabolic degradation, PFOA and PFOS are 
eliminated from mammals primarily unchanged.
---------------------------------------------------------------------------

    \34\ ATSDR. (2021). Toxicological profile for perfluoroalkyls: 
final. Atlanta, GA: U.S. Department of Health and Human Services, 
Centers for Disease Control and Prevention, Agency for Toxic 
Substances and Disease Registry. https://wwwn.cdc.gov/TSP/ToxProfiles/ToxProfiles.aspx?id=1117&tid=237.
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    Human epidemiology studies observed associations between PFOA 
exposure and high cholesterol, changes in liver enzymes, decreased 
immune response to vaccination, thyroid effects, pregnancy-induced 
hypertension and preeclampsia, low birth weight, and cancer (testicular 
and kidney).\35\ Epidemiology studies have generally found a positive 
association between increasing serum PFOA and total cholesterol levels 
in PFOA-exposed workers and residents of high-exposure communities. In 
addition, associations between increasing serum PFOA concentrations and 
elevations in serum levels of alanine aminotransferase and gamma-
glutamyl transpeptidase were consistently observed in occupational 
cohorts, high-exposure communities and the U.S. general population. 
This could indicate the potential for PFOA to affect liver function. A 
decreased response to vaccines was found to be associated with PFOA 
exposure in studies in adults in a highly exposed community and in 
studies of children in the general population. A study of a community 
with high exposure to PFOA observed an association between serum PFOA 
and risk of pregnancy-related hypertension or preeclampsia, conditions 
that are related to renal function during pregnancy. An association 
between increasing maternal PFOA or cord blood PFOA concentrations and 
decreasing birth weight was seen in several studies.\36\
---------------------------------------------------------------------------

    \35\ Ibid.
    \36\ U.S. EPA. (2016). Health effects support document for 
perfluorooctanoic acid (PFOA). U.S. Environmental Protection Agency, 
Office of Water. https://www.epa.gov/sites/default/files/2016-05/documents/pfoa_hesd_final-plain.pdf.
---------------------------------------------------------------------------

    Numerous epidemiology studies have examined occupational 
populations at large-scale PFOS production plants in the United States 
and the residential populations living near the PFOS production 
facilities to evaluate the association between increasing PFOS 
concentrations and various health outcomes. Data also suggest 
associations between higher PFOS levels and increases in total 
cholesterol and high-density lipoproteins, decreases in female 
fecundity and fertility, in addition to decreased offspring body 
weights and negative effects on other measures of postnatal growth. 
Evidence of an association between PFOS exposure and cancer is less 
conclusive.\37\
---------------------------------------------------------------------------

    \37\ U.S. EPA. (2016). Health effects support document for 
perfluorooctane sulfonate (PFOS). U.S. Environmental Protection 
Agency, Office of Water. https://www.epa.gov/sites/default/files/2016-05/documents/pfos_hesd_final_508.pdf.
---------------------------------------------------------------------------

    Perfluoroalkyl acids are transferred to the fetus during pregnancy 
and to breast milk through distribution due to their slow elimination 
from the human body through excretion.\38\ Toxicity studies conducted 
in laboratory animal models demonstrate that the developing fetus is 
particularly sensitive to PFOA- and PFOS-induced toxicity. Some studies 
in laboratory animal models indicate that gestation and/or lactation 
periods are critical exposure windows that may lead to developmental 
health effects including decreased offspring survival, low birth 
weight, accelerated puberty and skeletal variations.^{39 40 41}
---------------------------------------------------------------------------

    \38\ ATSDR. (2021). Toxicological profile for perfluoroalkyls: 
final. Atlanta, GA: U.S. Department of Health and Human Services, 
Centers for Disease Control and Prevention, Agency for Toxic 
Substances and Disease Registry. https://wwwn.cdc.gov/TSP/ToxProfiles/ToxProfiles.aspx?id=1117&tid=237.
    \39\ Ibid.
    \40\ U.S. EPA. (2016). Health effects support document for 
perfluorooctanoic acid (PFOA). U.S. Environmental Protection Agency, 
Office of Water. https://www.epa.gov/sites/default/files/2016-05/documents/pfoa_hesd_final-plain.pdf.
    \41\ U.S. EPA. (2016). Health effects support document for 
perfluorooctane sulfonate (PFOS). U.S. Environmental Protection 
Agency, Office of Water. https://www.epa.gov/sites/default/files/2016-05/documents/pfos_hesd_final_508.pdf.
---------------------------------------------------------------------------

    Numerous animal toxicity studies for PFOA and PFOS are available 
and provide information about the potential for similar effects in 
humans. Animal studies and epidemiology studies indicate that PFOA and 
PFOS are well absorbed orally; absorption may also occur via the 
inhalation and dermal routes. Absorbed PFOA and/or PFOS are widely 
distributed in the body, with the highest concentrations typically 
found in the blood, liver and/or kidney. Across species, the highest 
extravascular concentrations of PFOA and PFOS are found in the liver, 
however, PFOA and/or PFOS have also been detected in many other tissues 
(e.g., lung, kidney, spleen and bone). Though not readily, PFOS can 
cross the blood-brain barrier and has been detected at low levels in 
the brains of humans and rodents.^{42 43 44}
---------------------------------------------------------------------------

    \42\ ATSDR. (2021). Toxicological profile for perfluoroalkyls: 
final. Atlanta, GA: U.S. Department of Health and Human Services, 
Centers for Disease Control and Prevention, Agency for Toxic 
Substances and Disease Registry. https://wwwn.cdc.gov/TSP/ToxProfiles/ToxProfiles.aspx?id=1117&tid=237.
    \43\ U.S. EPA. (2016). Health effects support document for 
perfluorooctanoic acid (PFOA). U.S. Environmental Protection Agency, 
Office of Water. https://www.epa.gov/sites/default/files/2016-05/documents/pfoa_hesd_final-plain.pdf.
    \44\ U.S. EPA. (2016). Health effects support document for 
perfluorooctane sulfonate (PFOS). U.S. Environmental Protection 
Agency, Office of Water. https://www.epa.gov/sites/default/files/2016-05/documents/pfos_hesd_final_508.pdf.
---------------------------------------------------------------------------

    PFOA and PFOS in blood bind to plasma albumin and other plasma 
proteins. Absorbed PFOA and PFOS are not metabolized and are eliminated 
by excretion primarily in urine. Active transport mechanisms mediate 
renal tubular reabsorption and secretion of PFOA and PFOS. Some 
excretion occurs through cord blood in pregnant women, and through 
lactation and menstrual blood loss. Although PFOA and PFOS are found in 
the bile of humans, they are reabsorbed from the bile and thus, fecal 
excretion is substantially lower than urinary excretion; levels in 
fecal matter represent both unabsorbed material and that discharged 
with bile.^{45 46 47 48 49}
---------------------------------------------------------------------------

    \45\ ATSDR. (2021). Toxicological profile for perfluoroalkyls: 
final. Atlanta, GA: U.S. Department of Health and Human Services, 
Centers for Disease Control and Prevention, Agency for Toxic 
Substances and Disease Registry. https://wwwn.cdc.gov/TSP/ToxProfiles/ToxProfiles.aspx?id=1117&tid=237.
    \46\ U.S. EPA. (2016). Health effects support document for 
perfluorooctanoic acid (PFOA). U.S. Environmental Protection Agency, 
Office of Water. https://www.epa.gov/sites/default/files/2016-05/documents/pfoa_hesd_final-plain.pdf.
    \47\ U.S. EPA. (2016). Health effects support document for 
perfluorooctane sulfonate (PFOS). U.S. Environmental Protection 
Agency, Office of Water. https://www.epa.gov/sites/default/files/2016-05/documents/pfos_hesd_final_508.pdf.
    \48\ NJDWQI. (2017). Appendix A: Health-based maximum 
contaminant level support document perfluorooctanoic acid (PFOA). 
New Jersey Drinking Water Quality Institute, Health Effects 
Subcommittee. https://www.state.nj.us/dep/watersupply/pdf/pfoa-appendixa.pdf.
    \49\ NJDWQI. (2018). Appendix A: Health-based maximum 
contaminant level support document perfluorooctane sulfonate (PFOS). 
New Jersey Drinking Water Quality Institute, Health Effects 
Subcommittee. https://www.state.nj.us/dep/watersupply/pdf/pfos-recommendation-appendix-a.pdf.

---------------------------------------------------------------------------

[[Page 54426]]

    For PFOA, oral studies of short-term (subchronic) and chronic 
duration are available in multiple species including monkeys, rats and 
mice. The animal studies report developmental effects, liver and kidney 
toxicity, immune effects and cancer (liver, testicular and pancreatic). 
The developmental effects observed in rodents include decreased 
survival, delayed eye opening, reduced ossification, skeletal defects, 
altered puberty (delayed vaginal opening in females and accelerated 
puberty in males) and altered mammary gland development.
    For PFOS, numerous animal studies are available in multiple species 
including monkeys, rats and mice. Short-term and chronic exposure 
studies in animals demonstrate increases in liver weight, changes in 
cholesterol, hepatic steatosis, lower body weight and liver 
histopathological changes. One- and two- generation rodent toxicity 
studies also show decreased pup survival and body weights. 
Additionally, developmental neurotoxicity studies in rodents show 
increased motor activity, decreased habituation and increased escape 
latency in the water maze test (tests spatial learning and memory) 
following in utero and lactational exposure to PFOS. Gestational and 
lactational exposures were also associated with higher serum glucose 
levels and evidence of insulin resistance in adult offspring. Evidence 
suggests immunological effects in animal models.^{50 51}
---------------------------------------------------------------------------

    \50\ ATSDR. (2021). Toxicological profile for perfluoroalkyls: 
final. Atlanta, GA: U.S. Department of Health and Human Services, 
Centers for Disease Control and Prevention, Agency for Toxic 
Substances and Disease Registry. https://wwwn.cdc.gov/TSP/ToxProfiles/ToxProfiles.aspx?id=1117&tid=237.
    \51\ U.S. EPA. (2016). Health effects support document for 
perfluorooctane sulfonate (PFOS). U.S. Environmental Protection 
Agency, Office of Water. https://www.epa.gov/sites/default/files/2016-05/documents/pfos_hesd_final_508.pdf.
---------------------------------------------------------------------------

    The International Agency for Research on Cancer (IARC) concluded 
that PFOA is possibly carcinogenic to humans.\52\ Study findings are 
mixed. While a mutagenic mode of action has not been established for 
PFOA or PFOS, studies indicate that PFOA (the more extensively studied 
of the two compounds) can induce deoxyribonucleic acid (DNA) 
damage.\53\ In 2016, the EPA determined there is suggestive evidence 
that PFOA and PFOS may contribute to tumor development in 
humans.^{54 55} Epidemiology studies show an association 
between exposure to high levels of serum PFOA and testicular and kidney 
cancer in humans; two chronic bioassays in rats ^{56 57} also 
support the finding that PFOA is tumorigenic (i.e., capable of 
producing tumors).\58\ Epidemiology studies establishing a correlation 
between PFOS exposure and the incidence of cancer are limited; however, 
a chronic toxicity and carcinogenicity study in rats provides some 
evidence of tumorigenicity.\59\
---------------------------------------------------------------------------

    \52\ IARC. (2021). Agents classified by the IARC monographs, 
volumes 1-129. List of classifications. International Agency for 
Research on Cancer. https://monographs.iarc.who.int/list-of-classifications.
    \53\ ATSDR. (2021). Toxicological profile for perfluoroalkyls: 
final. Atlanta, GA: U.S. Department of Health and Human Services, 
Centers for Disease Control and Prevention, Agency for Toxic 
Substances and Disease Registry. https://wwwn.cdc.gov/TSP/ToxProfiles/ToxProfiles.aspx?id=1117&tid=237.
    \54\ U.S. EPA. (2016). Health effects support document for 
perfluorooctanoic acid (PFOA). U.S. Environmental Protection Agency, 
Office of Water. https://www.epa.gov/sites/default/files/2016-05/documents/pfoa_hesd_final-plain.pdf.
    \55\ U.S. EPA. (2016). Health effects support document for 
perfluorooctane sulfonate (PFOS). U.S. Environmental Protection 
Agency, Office of Water. https://www.epa.gov/sites/default/files/2016-05/documents/pfos_hesd_final_508.pdf.
    \56\ NTP. (2020). NTP Technical report on the toxicology and 
carcinogenesis studies of perfluorooctanoic acid (CASRN 335-67-1) 
administered in feed to Sprague Dawley (Hsd:Sprague Dawley[supreg] 
SD[supreg]) rats. (NTP TR 598). Research Triangle Park, NC: National 
Toxicology Program. https://ntp.niehs.nih.gov/ntp/htdocs/lt_rpts/tr598_508.pdf?utm_source=direct&utm_medium=prod&utm_campaign=ntpgolinks&utm_term=tr598.
    \57\ Butenhoff, J.L.; Kennedy, G.L.; Chang, S.; Olsen, G.W. 
(2012). Chronic dietary toxicity and carcinogenicity study with 
ammonium perfluorooctanoate in Sprague Dawley rats. Toxicology 298: 
1-13.
    \58\ U.S. EPA. (2016). Health effects support document for 
perfluorooctanoic acid (PFOA). U.S. Environmental Protection Agency, 
Office of Water. https://www.epa.gov/sites/default/files/2016-05/documents/pfoa_hesd_final-plain.pdf.
    \59\ U.S. EPA. (2016). Health effects support document for 
perfluorooctane sulfonate (PFOS). U.S. Environmental Protection 
Agency, Office of Water. https://www.epa.gov/sites/default/files/2016-05/documents/pfos_hesd_final_508.pdf.
---------------------------------------------------------------------------

    This information does not reflect recent scientific data that has 
been collected to support EPA's ongoing PFAS National Primary Drinking 
Water Regulation. The Agency's draft new analyses, released in November 
2021 for independent scientific review by the EPA Science Advisory 
Board (SAB), indicate that negative health effects may occur at much 
lower levels of exposure to PFOA and PFOS than previously understood 
and that PFOA is likely carcinogenic to humans. The draft documents 
present EPA's initial analysis and findings with respect to this newly 
available updated information.^{60 61} Following SAB peer 
review, the final documents will be used to inform the development of 
Maximum Contaminant Level Goals and ultimately a National Primary 
Drinking Water Regulation for PFOA and PFOS. While this preliminary 
data was not used for this proposal, it appears to support designating 
PFOA and PFOS as hazardous substances.
---------------------------------------------------------------------------

    \60\ U.S. EPA. (2021). Proposed approaches for deriving maximum 
contaminant level goals for PFOA in drinking water. (EPA822D21001). 
U.S. Environmental Protection Agency.
    \61\ U.S. EPA. (2021). Proposed approaches for deriving maximum 
contaminant level goals for PFOS in drinking water. (EPA822D21002). 
U.S. Environmental Protection Agency.
---------------------------------------------------------------------------

    In sum, studies have shown that exposure to PFOA and PFOS is 
associated with numerous and varied adverse effects to human health. 
This evidence plays a major role in the EPA's proposal to designate 
PFOA and PFOS as hazardous substances.
3. Environmental Prevalence
    PFOA and PFOS are common contaminants in the environment because of 
their release into the environment since the 1940s and their resistance 
to degradation. PFOA and PFOS are found in many environmental media and 
in wildlife worldwide, including in remote polar regions. As an 
example, the polar bear, the top predator of arctic marine ecosystems, 
bioaccumulates high concentrations of PFAS (especially PFOS), which may 
be harmful to their health.\62\
---------------------------------------------------------------------------

    \62\ Tartu, S.; Bourgeon, S.; Aars, J.; Andersen, M.; Lone, K.; 
Jenssen, B.M.; Polder, A.; Thiemann, G.W.; Torget, V.; Welker, J.M.; 
Routti, H. (2017). Diet and metabolic state are the main factors 
determining concentrations of perfluoroalkyl substances in female 
polar bears from Svalbard. Environ Pollut 229: 146-158. https://www.ncbi.nlm.nih.gov/pubmed/28587979. Tartu et al. (2017) found that 
the concentration of PFAS increased with the trophic level of female 
polar bears, which is consistent with other studies showing 
biomagnification of PFAS in Arctic marine ecosystems.
---------------------------------------------------------------------------

    Environmental sources can include direct industrial discharges of 
PFOA and PFOS to soil, air, and water. Precursors can also degrade to 
PFOA and/or PFOS (e.g., perfluorooctanesulfonamide (PFOSA) can be 
transformed to PFOS in the environment). PFOA and PFOS precursors can 
be converted to PFOA and PFOS, respectively, by microbes in soil, 
sludge, and wastewater and through abiotic chemical reactions. PFOA and 
PFOS that are deposited, created by the degradation of their precursors 
in industrial and consumer

[[Page 54427]]

waste, in a landfill without environmental controls can discharge via 
leachates, groundwater pollution/migration and atmospheric 
releases.^{63 64 65} The discharge of aqueous film-forming foam 
(AFFF) starting in the 1970s is also an important source for some 
locations. AFFF is a foam containing many PFAS, including PFOA and 
PFOS, which is effective at extinguishing petroleum fueled fires. PFAS, 
including PFOA and PFOS, were found in the soil and groundwater where 
AFFF was used to fight fires or for training and storage. Concrete 
where AFFF has been repeatedly discharged, such as for training 
activities, can absorb PFAS, including PFOA and PFOS, and then release 
PFAS to groundwater and soils during precipitation events.\66\
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    \63\ Lindstrom, A.B.; Strynar, M.J.; Libelo, E.L. (2011). 
Polyfluorinated compounds: past, present, and future. Environ Sci 
Technol 45: 7954-7961. https://www.ncbi.nlm.nih.gov/pubmed/21866930.
    \64\ Buck, R.C.; Franklin, J.; Berger, U.; Conder, J.M.; 
Cousins, I.T.; de Voogt, P.; Jensen, A.A.; Kannan, K.; Mabury, S.A.; 
van Leeuwen, S.P. (2011). Perfluoroalkyl and polyfluoroalkyl 
substances in the environment: terminology, classification, and 
origins. Integr Environ Assess Manag 7: 513-541. https://www.ncbi.nlm.nih.gov/pubmed/21793199.
    \65\ Oliaei, F.; Kriens, D.; Weber, R.; Watson, A. (2013). PFOS 
and PFC releases and associated pollution from a PFC production 
plant in Minnesota (USA). Environ Sci Pollut Res Int 20: 1977-1992. 
https://www.ncbi.nlm.nih.gov/pubmed/23128989.
    \66\ Baduel, C.; Paxman, C.J.; Mueller, J.F. (2015). 
Perfluoroalkyl substances in a firefighting training ground (FTG), 
distribution and potential future release. J. Hazard Mater 296: 46-
53. https://www.ncbi.nlm.nih.gov/pubmed/25966923.
---------------------------------------------------------------------------

    Industrial uses that have led to PFOA and PFOS in the soil and 
groundwater include, but are not limited to, chrome plating facilities 
where PFAS were used as a wetting agent/fume suppressant and industries 
where textiles and other materials are coated with PFAS. PFAS 
manufactured for use as a stain or water repellant may be released from 
these facilities into the air and wastewater.\67\
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    \67\ ATSDR. (2021). Toxicological profile for perfluoroalkyls: 
final. Atlanta, GA: U.S. Department of Health and Human Services, 
Centers for Disease Control and Prevention, Agency for Toxic 
Substances and Disease Registry. https://wwwn.cdc.gov/TSP/ToxProfiles/ToxProfiles.aspx?id=1117&tid=237.
---------------------------------------------------------------------------

    The principal worldwide manufacturers of PFOA and PFOS and related 
chemicals phased out their production in the early 2000's. PFOA and 
PFOS may still be produced domestically for certain uses and by 
international companies that import treated products to the United 
States.\68\ Some uses of PFOS are ongoing, such as use as a component 
of a photoresist substance, including a photo acid generator or 
surfactant, or as a component of an anti-reflective coating, used in a 
photomicrolithography process to produce semiconductors or similar 
components of electronic or other miniaturized devices. Environmental 
contamination and resulting human exposure to PFOA and PFOS are 
declining, but are anticipated to continue for the foreseeable future 
due to their environmental persistence, formation from precursor 
compounds, continued production primarily by international 
manufacturers and their long history of production in the United 
States.\69\
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    \68\ Ibid.
    \69\ (ATSDR) Per- and Polyfluoroalkyl Substances (PFAS) and Your 
Health U.S. Department of Health and Human Services, Centers for 
Disease Control and Prevention, Agency for Toxic Substances and 
Disease Registry. https://www.atsdr.cdc.gov/pfas/health-effects/us-population.html.
---------------------------------------------------------------------------

    Wastewater treatment plants (WWTPs) may receive wastewater that 
contains PFOA, PFOS or their precursors, from a variety of sources, 
including industries that manufacture or use these PFAS and their 
precursors. Some companies may operate onsite wastewater treatment 
facilities, but typically they are not designed to remove PFAS. PFOA 
and PFOS are the most widely detected PFAS in wastewater, and generally 
treatment units at conventional WWTPs do not remove PFAS 
efficiently.\70\ Certain PFAS can be volatilized into the atmosphere 
from wastewater treatment plant operations, such as aeration 
chambers.^{71 72} Although effluent discharged to receiving 
water bodies may contain PFOA or PFOS, much of these substances may 
concentrate in the WWTP biosolids. Biosolids are also commonly applied 
to land as fertilizers or soil amendments but can also be sent to a 
landfill. The use of biosolids on farmland and home gardens can lead to 
the uptake of PFOA and PFOS in the food chain, as acknowledged by the 
U.S. Food and Drug Administration (FDA).\73\ Biosolids from wastewater 
treatment plants and some industrial wastewater that is land applied 
are also potential sources of contamination.^{74 75}
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    \70\ Rainey, M.; Beecher, N. (2018). PFAS in wastewater 
residuals. National Pretreatment & Pollution Prevention Workshop & 
Training. North East Biosolids & Residuals Association. https://www.nacwa.org/docs/default-source/conferences-events/2018-pretreatment/18pret-m-rainey.pdf?sfvrsn=2.
    \71\ Ma, R.; Shih, K. (2010). Perfluorochemicals in wastewater 
treatment plants and sediments in Hong Kong. Environ Pollut 158: 
1354-1362. https://www.ncbi.nlm.nih.gov/pubmed/20153098.
    \72\ Ahrens, L.; Shoeib, M.; Harner, T.; Lee, S.C.; Guo, R.; 
Reiner, E.J. (2011). Wastewater treatment plant and landfills as 
sources of polyfluoroalkyl compounds to the atmosphere. Environ Sci 
Technol 45: 8098-8105. https://www.ncbi.nlm.nih.gov/pubmed/21466185.
    \73\ Genualdi, S.; deJager, L.; South, P.; Sheehan, J.; Begley, 
T. (2019). Investigation of PFAS concentrations in US food products. 
Center for Food Safety and Applied Nutrition, Food and Drug 
Administration. In SETAC Europe 29th annual meeting 26-30 May 2019 
(pp. 357). Helsinki, Finland: Society of Environmental Toxicology 
and Chemistry.
    \74\ NJDWQI. (2018). Appendix A: Health-based maximum 
contaminant level support document perfluorooctane sulfonate (PFOS). 
New Jersey Drinking Water Quality Institute, Health Effects 
Subcommittee. https://www.state.nj.us/dep/watersupply/pdf/pfos-recommendation-appendix-a.pdf.
    \75\ NJDWQI. (2017). Appendix A: Health-based maximum 
contaminant level support document perfluorooctanoic acid (PFOA). 
New Jersey Drinking Water Quality Institute, Health Effects 
Subcommittee. https://www.state.nj.us/dep/watersupply/pdf/pfoa-appendixa.pdf.
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    PFAS have been found in outdoor air at locations in the United 
States, Europe, Japan, and over the Atlantic Ocean.\76\ Concentrations 
are not generally correlated with rural or urban environments, but 
rather, around PFAS production industries and industries that use PFAS. 
Mean PFOA levels ranged from 1.54 to 15.2 picograms per cubic meter 
(pg/m\3\) in air samples collected in the urban locations in Albany, 
New York, Fukuchiyama, Japan, and Morioka, Japan and in the rural 
locations in Kjeller, Norway, and Mace Head, Ireland. However, higher 
mean concentrations (101-552 pg/m\3\) were measured at the urban 
locations in Oyamazaki, Japan, and Manchester, United Kingdom (UK), and 
semirural locations in Hazelrigg, UK. Maximum reported concentrations 
at Oyamazaki and Hazelrigg were 919 and 828 pg/m\3\, respectively. 
Thus, there is no correlation between higher concentrations and urban 
versus rural locations; rather, high concentrations in certain 
locations may be attributable to a specific industrial plant.\77\
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    \76\ ATSDR. (2021). Toxicological profile for perfluoroalkyls: 
final. Atlanta, GA: U.S. Department of Health and Human Services, 
Centers for Disease Control and Prevention, Agency for Toxic 
Substances and Disease Registry. https://www.cdc.gov/TSP/ToxProfiles/ToxProfiles.aspx?id=1117&tid=237.
    \77\ Ibid.
---------------------------------------------------------------------------

    PFOA and PFOS are widely detected in surface water samples 
collected from various rivers, lakes, and streams in the United 
States.\78\ Therefore, municipalities and other entities that use 
surface water sources for drinking water may face challenges treating 
and removing PFOA and PFAS from their finished drinking water. The most 
vulnerable drinking water systems are those in close proximity to sites 
contaminated with PFOA and PFOS.\79\ Levels of these substances in 
surface water are declining since the major U.S.

[[Page 54428]]

producers phased out these two substances.\80\
---------------------------------------------------------------------------

    \78\ Ibid.
    \79\ Ibid.
    \80\ Ibid.
---------------------------------------------------------------------------

    PFOA and PFOS have been detected in surface and subsurface soils. 
Levels of PFOA and PFOS generally increased with increasing depth at 
sampled locations, suggesting a downward movement of the contaminants 
and the potential to contaminate groundwater.\81\ PFAS can be 
inadvertently released to soils when biosolids are applied as 
fertilizer to help maintain productive agricultural soils and stimulate 
plant growth.\82\ PFOA and PFOS have been detected in both biosolids 
and biosolid-amended soils. PFAS can also reach soil due to atmospheric 
transport and wet/dry deposition.\83\
---------------------------------------------------------------------------

    \81\ Ibid.
    \82\ Ibid.
    \83\ Ibid.
---------------------------------------------------------------------------

    PFOA and PFOS have been detected in groundwater in monitoring 
wells, private drinking water wells, and public drinking water systems 
across the country. The EPA worked with the states and local 
communities to monitor for six PFAS, including PFOA and PFOS, under the 
third Unregulated Contaminant Monitoring Rule to understand the 
nationwide occurrence of these chemicals in the U.S. drinking water 
provided by public water systems (PWSs). Of the 4,920 PWSs with results 
for PFOA and PFOS, PFOA were detected above the minimum reporting level 
(minimum reporting level = 20 nanogram/liter (ng/L)) in 117 PWSs. 
Detections exceeded above the MRL for PFOS (MRL = 40 ng/L) at 95 
PWSs.\84\
---------------------------------------------------------------------------

    \84\ U.S. EPA. (2017). The third Unregulated Contaminant 
Monitoring Rule (UCMR 3): Data summary, January 2017. 
(EPA815S17001). U.S. Environmental Protection Agency, Office of 
Water. https://www.epa.gov/sites/default/files/2017-02/documents/ucmr3-data-summary-january-2017.pdf.
---------------------------------------------------------------------------

    As previously stated, PFOA and PFOS are common contaminants in the 
environment because they and their precursors have been produced and 
released into the environment since the 1940s, and they are resistant 
to degradation. In addition to being found in groundwater, surface 
water, soil, sediment, and air, they have been found in wild and 
domestic animals such as fish, shellfish, alligators, deer and avian 
eggs; and in humans.\85\ For example, PFOA has been found in snack 
foods, vegetables, meat, dairy products and fish, and PFOS has been 
found in eggs, milk, meat, fish and root 
vegetables.^{86 87 88 89 90 91 92 93 94 95} In one study 
investigating the global distribution of PFAS, wildlife samples were 
collected on four continents including North America and Antarctica. 
Wildlife sampled included marine mammals, birds, and polar bears. Only 
a few samples contained PFOA in concentrations greater than the limit 
of quantification. However, over 30 different species had measurable 
levels of PFOS. The study reported PFOS concentrations in mink liver in 
the midwestern U.S. ranging from 970-3, 680 nanograms per gram (ng/g), 
river otter liver in northwestern U.S. from 34-990 ng/g, brown pelican 
liver in Mississippi from 290-620 ng/g, and lake whitefish eggs in 
Michigan waters from 150-380 ng/g.^{96 97}
---------------------------------------------------------------------------

    \85\ ATSDR. (2021). Toxicological profile for perfluoroalkyls: 
final. Atlanta, GA: U.S. Department of Health and Human Services, 
Centers for Disease Control and Prevention, Agency for Toxic 
Substances and Disease Registry. https://www.atsdr.cdc.gov/pfas/health-effects/us-population.html.
    \86\ U.S. EPA. (2016). Drinking water health advisory for 
perfluorooctanoic acid (PFOA). (EPA822R16005). U.S. Environmental 
Protection Agency, Office of Water. https://www.epa.gov/sites/default/files/2016-05/documents/pfoa_health_advisory_final_508.pdf.
    \87\ U.S. EPA. (2016). Drinking water health advisory for 
perfluorooctane sulfonate (PFOS). (EPA822R16004). U.S. Environmental 
Protection Agency. https://www.epa.gov/sites/default/files/2016-05/documents/pfos_health_advisory_final_508.pdf.
    \88\ Holmstrom, K.E.; Jarnberg, U.; Bignert, A. (2005). Temporal 
trends of PFOS and PFOA in guillemot eggs from the Baltic Sea, 1968-
2003. Environ Sci Technol 39: 80-84. https://www.ncbi.nlm.nih.gov/pubmed/15667078.
    \89\ Wang, Y.; Yeung, L.W.Y.; Yamashita, N.; Taniyasu, S.; So, 
M.K.; Murphy, M.B.; Lam, P.K.S. (2008). Perfluorooctane sulfonate 
(PFOS) and related fluorochemicals in chicken egg in China. Chinese 
Science Bulletin 53: 501-507.
    \90\ Gewurtz, S.B.; Martin, P.A.; Letcher, R.J.; Burgess, N.M.; 
Champoux, L.; Elliott, J.E.; Weseloh, D.V.C. (2016). Spatio-temporal 
trends and monitoring design of perfluoroalkyl acids in the eggs of 
gull (Larid) species from across Canada and parts of the United 
States. Sci Total Environ 565: 440-450. https://www.ncbi.nlm.nih.gov/pubmed/27183458.
    \91\ Morganti, M.; Polesello, S.; Pascariello, S.; Ferrario, C.; 
Rubolini, D.; Valsecchi, S.; Parolini, M. (2021). Exposure 
assessment of PFAS-contaminated sites using avian eggs as a 
biomonitoring tool: A frame of reference and a case study in the Po 
River valley (Northern Italy). Integr Environ Assess Manag 17: 733-
745. https://www.ncbi.nlm.nih.gov/pubmed/33764673.
    \92\ Michigan.gov. (2021). Michigan PFAS Action Response Team: 
Fish and wildlife. PFAS in deer. Michigan Department of Environment, 
Great Lakes, and Energy. https://www.michigan.gov/pfasresponse/
0,9038,7-365-86512_88981_88982_,00.html.
    \93\ Wisconsin DNR. (2020). DNR And DHS issue do not eat 
advisory for deer liver in five-mile area surrounding JCI/TYCO site 
in Marinette. Wisconsin Department of Natural Resources. https://dnr.wisconsin.gov/newsroom/release/37921.
    \94\ Falk, S.; Brunn, H.; Schroter-Kermani, C.; Failing, K.; 
Georgii, S.; Tarricone, K.; Stahl, T. (2012). Temporal and spatial 
trends of perfluoroalkyl substances in liver of roe deer (Capreolus 
capreolus). Environ Pollut 171: 1-8. https://www.ncbi.nlm.nih.gov/pubmed/22868342.
    \95\ Bangma, J.T.; Reiner, J.L.; Jones, M.; Lowers, R.H.; 
Nilsen, F.; Rainwater, T.R.; Somerville, S.; Guillette, L.J.; 
Bowden, J.A. (2017). Variation in perfluoroalkyl acids in the 
American alligator (Alligator mississippiensis) at Merritt Island 
National Wildlife Refuge. Chemosphere 166: 72-79. https://www.ncbi.nlm.nih.gov/pubmed/27689886.
    \96\ Giesy, J.P.; Kannan, K. (2001). Global distribution of 
perfluorooctane sulfonate in wildlife. Environ Sci Technol 35: 1339-
1342. https://www.ncbi.nlm.nih.gov/pubmed/11348064.
    \97\ EFSA. (2008). Perfluorooctane sulfonate (PFOS), 
perfluorooctanoic acid (PFOA) and their salts Scientific Opinion of 
the Panel on Contaminants in the Food chain. EFSA Journal 6.
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    PFOS bioaccumulates in animals. A fish kinetic bioconcentration 
factor for PFOS has been estimated to range from 1,000 to 4,000.\98\ 
The time to reach 50% clearance of PFOS in fish has been estimated to 
be around 100 days.\99\ Bioaccumulation has been demonstrated for fish, 
birds, crustaceans, worms, plankton, and alligators, among 
others.^{100 101 102}
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    \98\ Ibid.
    \99\ Ibid.
    \100\ Bangma, J.T.; Reiner, J.L.; Jones, M.; Lowers, R.H.; 
Nilsen, F.; Rainwater, T.R.; Somerville, S.; Guillette, L.J.; 
Bowden, J.A. (2017). Variation in perfluoroalkyl acids in the 
American alligator (Alligator mississippiensis) at Merritt Island 
National Wildlife Refuge. Chemosphere 166: 72-79. https://www.ncbi.nlm.nih.gov/pubmed/27689886.
    \101\ Ng, C.A.; Hungerbuhler, K. (2014). Bioaccumulation of 
perfluorinated alkyl acids: observations and models. Environ Sci 
Technol 48: 4637-4648. https://www.ncbi.nlm.nih.gov/pubmed/24762048.
    \102\ Burkhard, L.P. (2021). Evaluation of published 
bioconcentration factor (BCF) and bioaccumulation factor (BAF) data 
for per- and polyfluoroalkyl substances across aquatic species. 
Environ Toxicol Chem 40: 1530-1543. https://www.ncbi.nlm.nih.gov/pubmed/33605484.
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    PFOA bioaccumulates as well, but not to the same degree as 
PFOS.\103\
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    \103\ https://setac.onlinelibrary.wiley.com/doi/epdf/10.1002/etc.5010.
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    The prevalence of PFOA and PFOS in environmental media, wild 
animals, livestock, and plants not only affects the environment but can 
also lead to human exposure. PFOA and PFOS can also enter the drinking 
water supply from contamination in groundwater and surface water 
sources for drinking water. Contaminated drinking water or groundwater 
can also be used to irrigate or wash home-grown foods or farm-grown 
foods, thereby providing another means for human exposure. Wild animals 
are contaminated through environmental exposure, and some wild animals 
are caught or hunted and eaten by humans, thus, increasing human 
exposure. Contaminated water also results in the contamination of beef, 
pork, poultry, etc. Susceptible populations, such as women of 
reproductive age, pregnant and breastfeeding women, and young children 
who eat fish may have increased exposure to PFOA and PFOS due to 
bioaccumulation in fish.^{104 105 106}
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    \104\ U.S. EPA. (2019). Fish and shellfish program newsletter. 
(EPA823N19002). U.S. Environmental Protection Agency. https://www.epa.gov/sites/production/files/2019-04/documents/fish-news-mar2019.pdf.
    \105\ FDA. (2021). Testing food for PFAS and assessing dietary 
exposure. U.S. Food and Drug Administration. https://www.fda.gov/food/chemical-contaminants-food/testing-food-pfas-and-assessing-dietary-exposure.
    \106\ Christensen, K.Y.; Raymond, M.; Blackowicz, M.; Liu, Y.; 
Thompson, B.A.; Anderson, H.A.; Turyk, M. (2017). Perfluoroalkyl 
substances and fish consumption. Environ Res 154: 145-151. https://www.ncbi.nlm.nih.gov/pubmed/28073048.

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[[Page 54429]]

    Human exposure is confirmed by measurements of PFOA and PFOS that 
were detected in human serum as part of the continuous National Health 
and Nutrition Examination Survey (NHANES), a program of the CDC. PFOA 
and PFOS were measured in the serum of a representative sample of the 
U.S. population ages 12 years and older in each two-year cycle of 
NHANES since 1999-2000, with the exception of 2001-2002. PFOA and PFOS 
have been detected in 99% of those surveyed in each NHANES cycle. 
However, the mean concentrations of PFOA and PFOS in the serum have 
been steadily decreasing since 1999-2000.^{107 108}
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    \107\ CDC. (2021). National Health and Nutrition Examination 
Survey: NHANES questionnaires, datasets, and related documentation. 
Centers for Disease Control and Prevention. https://wwwn.cdc.gov/nchs/nhanes/Default.aspx.
    \108\ U.S. EPA. (2019). EPA's per- and polyfluoroalkyl 
substances (PFAS) action plan. (EPA823R18004). U.S. Environmental 
Protection Agency. https://nepis.epa.gov/Exe/ZyPURL.cgi?Dockey=P100W32I.txt.
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    Taken together, this information illustrates the prevalence of PFOA 
and PFOS in water, soil, air, plants, and animals worldwide due to its 
transportability and persistence. This widespread distribution of these 
PFAS significantly contributes to the EPA's proposed finding that PFOA 
and PFOS, when released into the environment may present substantial 
danger to the public health or welfare or the environment.
    EPA's proposal to designate PFOA and PFOS, and their salts and 
structural isomers, as hazardous substances under CERCLA section 102(a) 
is based on significant evidence, summarized above, that indicates, 
when released into the environment, these substances may present 
substantial danger to the public health, welfare or the environment. 
Collectively, this information demonstrates that PFOA and PFOS should 
be designated as hazardous substances under CERCLA.

VI. Effect of Designation

    The designation of PFOA and PFOS would have three direct effects--
triggering reporting obligations when there is a release of PFOA or 
PFOS above the reportable quantity, obligations on the U.S. Government 
when it transfers certain properties, and an obligation on DOT to list 
and regulate CERCLA designated hazardous substances as hazardous 
materials.

A. Default Reportable Quantity

    Section 102(b) of CERCLA provides that, until superseded by 
regulation, the reportable quantity for any hazardous substance is one 
pound. This proposed rule does not include an RQ adjustment for PFOA or 
PFOS. EPA is setting the RQ by operation of law at the statutory 
default of one pound pursuant to Section 102(b) of CERCLA. If the 
Agency chooses to propose adjusting the RQ in the future, it would do 
so through notice-and-comment rulemaking.

B. Direct Effects of a Hazardous Substance Designation

1. Reporting and Notification Requirements for CERCLA Hazardous 
Substances
    Section 103 of CERCLA requires any person in charge of a vessel or 
facility to immediately notify the NRC when there is a release of a 
hazardous substance, as defined under CERCLA section 101(14), in an 
amount equal to or greater than the RQ for that substance. The 
reporting requirements are further codified in 40 CFR 302.6. If this 
action is finalized, any person in charge of a vessel or facility as 
soon as he or she has knowledge of a release from such vessel or 
facility of one pound or more of PFOA or PFOS in a 24-hour period is 
required to immediately notify the NRC in accordance with 40 CFR part 
302. EPA solicits comment on the number of small entities affected by 
and the estimated cost impacts on small entities from these reporting 
requirements.
    In addition to these CERCLA reporting requirements, EPCRA section 
304 also requires owners or operators of facilities to immediately 
notify their SERC (or TERC) and LEPC (or TEPC) when there is a release 
of a CERCLA hazardous substance in an amount equal to or greater than 
the RQ for that substance within a 24-hour period. EPCRA section 304 
requires these facilities to submit a follow-up written report to the 
SERC (or TERC) and LEPC (or TEPC) within 30 days of the release. (Note: 
Some states provide less than 30 days to submit the follow-up written 
report. Facilities are encouraged to contact the appropriate state or 
tribal agency for additional reporting requirements.) See 40 CFR part 
355, subpart C, for information on the contents for the initial 
telephone notification and the follow-up written report.
    EPCRA and CERCLA are separate, but interrelated, environmental laws 
that work together to provide emergency release notifications to 
Federal, state, Tribal, and local officials. Notice given to the NRC 
under CERCLA serves to inform the Federal government of a release so 
that Federal personnel can evaluate the need for a response in 
accordance with the National Oil and Hazardous Substances Contingency 
Plan, the Federal government's framework for responding to both oil and 
hazardous substance releases. The NRC maintains all reports of 
hazardous substance and oil releases made to the Federal government.
    Relatedly, release notifications under EPCRA given to the SERC (or 
TERC) and to the LEPC (or TEPC) are crucial so that these state, 
Tribal, and local authorities have information to help protect the 
community.
2. Requirements Upon Transfer of Government Property
    Under CERCLA section 120(h), when Federal agencies sell or transfer 
federally-owned, real property, they must provide notice of when any 
hazardous substances ``was stored for one year or more, known to have 
been released, or disposed of'' and covenants concerning the 
remediation of such hazardous substances in certain circumstances.
3. Requirement of DOT To List and Regulate CERCLA Hazardous Substances
    Section 306(a) of CERCLA requires substances designated as 
hazardous under CERCLA be listed and regulated as hazardous materials 
by DOT under the Hazardous Materials Transportation Act (HMTA). DOT 
typically does not undertake a public notice and comment period when 
adding a CERCLA-designated hazardous substance to the list of regulated 
hazardous materials under HMTA.

VII. Regulatory and Advisory Status at EPA, Other Federal, State and 
International Agencies

    Designating PFOA and PFOS as hazardous substances would be one 
additional piece of an extensive, widespread response to address the 
dangers these chemicals pose. Regulatory requirements, enforcement 
actions, and other activities of many Federal, state, and international 
entities together indicate the widespread and serious concern with PFOA 
and PFOS.

[[Page 54430]]

A. EPA Actions

    The EPA has taken several actions in the past to address risks from 
PFOA and PFOS. In 2006, the EPA launched the 2010/2015 PFOA Stewardship 
Program, under which eight major chemical manufacturers and processors 
agreed to phase out the use of PFOA and PFOA-related chemicals in their 
products and emissions from their facilities. All companies met the 
PFOA Stewardship Program goals by 2015.
    The TSCA program has taken a range of regulatory actions to address 
PFAS in manufacturing and consumer products. Since 2002, EPA has 
finalized a number of TSCA Section 5(a) Significant New Use Rules 
(SNURs) covering hundreds of existing PFAS no longer in use. These 
regulatory actions require notice to EPA, as well as Agency review and 
regulation, as necessary, before manufacture (including import) or 
processing for significant new uses of these chemicals can begin or 
resume. The SNURs also apply to imported articles containing certain 
PFAS, including consumer products such as carpets, furniture, 
electronics, and household appliances. EPA also has issued SNURs for 
dozens of PFAS that have undergone EPA's new chemicals review prior to 
commercialization; these actions ensure that any new uses which may 
present risk concerns but were not part of the EPA new chemicals 
review, do not commence unless EPA is notified, conducts a risk review, 
and regulates as appropriate under TSCA section 5.
    In 2009, EPA published provisional drinking water health advisories 
of 400 ppt for PFOA and 200 ppt for PFOS based on health effects 
information available at that time. The provisional health advisories 
were developed for application to short-term (weeks to months) risk 
assessment exposure scenarios. The provisional health advisories were 
intended as guidelines for public water systems while allowing time for 
EPA to develop final lifetime health advisories for PFOA and PFOS. EPA 
published final lifetime drinking water health advisories for PFOA and 
PFOS (70 ppt individually, and in combination) in 2016.
    New health information has become available since 2016, and in June 
2022, EPA replaced the 2016 advisories with interim updated lifetime 
health advisories for PFOA and PFOS based on human epidemiology studies 
in populations exposed to these chemicals. Based on the new data and 
EPA's draft analyses, the levels at which negative health effects could 
occur are much lower than previously understood when EPA issued the 
2016 health advisories for PFOA and PFOS. The interim updated health 
advisory levels are 0.004 ppt for PFOA and 0.02 ppt for PFOS, which are 
below the levels at which analytical methods can measure these PFAS in 
drinking water. The EPA Science Advisory Board is reviewing EPA's 
analyses, and therefore, the interim health advisories are subject to 
change. However, EPA does not anticipate changes that will result in 
health advisory levels that are greater than the minimum reporting 
levels. The interim health advisories are intended to provide 
information to states and public water systems until the PFAS National 
Primary Drinking Water Regulation takes effect. Health advisories 
provide drinking water system operators, and state, Tribal, and local 
officials who have the primary responsibility for overseeing these 
systems, with information on the health risks of these chemicals, so 
they can take the appropriate actions to protect their residents.
    In 2019, EPA issued the Interim Recommendations to Address 
Groundwater Contaminated with PFOA and PFOS to facilitate cleaning up 
contaminated groundwater that is a current or potential source of 
drinking water. The recommendations provide a starting point for making 
site-specific cleanup decisions. The guidance recommends: \109\
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    \109\ U.S. EPA. (2019). USEPA draft interim recommendations to 
address groundwater contaminated with perfluorooctanoic acid and 
perfluorooctane sulfonate. (EPA-HQ-OLEM-2019-0229-0002). U.S. 
Environmental Protection Agency. https://downloads.regulations.gov/EPA-HQ-OLEM-2019-0229-0002/content.pdf.
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     Use the following tapwater screening levels for PFOA and 
PFOS to determine if PFOA and/or PFOS is present at a site and may 
warrant further attention.
    [cir] If both are detected in tapwater--PFOS regional screening 
level (RSL) = 6 parts per trillion (ppt) and PFOS regional removal 
management levels (RMLs) = 4 ppt.
    [cir] If they are the only contaminant detected in tapwater--PFOA 
RSL = 60 ppt and PFOS RSL = 40 ppt.
    [cir] Screening levels are risk-based values that are used to 
determine if levels of contamination may warrant further investigation 
at a site.
     Using EPA's 2016 PFOA and PFOS LHA level of 70 ppt as the 
preliminary remediation goal (PRG) for contaminated groundwater that is 
a current or potential source of drinking water, where no state or 
tribal maximum contaminant level (MCL) or other applicable or relevant 
and appropriate requirements are available or sufficiently protective.
    [cir] PRGs are generally initial targets for cleanup that may be 
adjusted on a site-specific basis as more information becomes 
available.
    In 2020, the EPA issued a final rule strengthening the regulation 
of PFAS (i.e., PFOA and its salts, long-chain perfluoroalkyl 
carboxylate chemical substances) by requiring notice and EPA review 
before the use of long-chain PFAS that have been phased out in the 
United States could begin again. Additionally, products containing 
certain long-chain PFAS as a surface coating and carpet containing 
perfluoroalkyl sulfonate chemical substances can no longer be imported 
into the United States without EPA review. This action means that 
articles like textiles, carpet, furniture, electronics, and household 
appliances that could contain certain PFAS cannot be imported into the 
United States unless EPA reviews and approves the use or puts in place 
the necessary restrictions to address any unreasonable risks.
    In 2020, the EPA also added 172 PFAS (including PFOA and PFOS) to 
the TRI, and 3 additional compounds were added in 2021. Additional PFAS 
will continue to be added to TRI, consistent with the National Defense 
Authorization Act for Fiscal Year 2020.
    In October 2021, the EPA released the PFAS Strategic Roadmap that 
presents EPA's whole-of-agency approach to addressing PFAS and sets 
timelines by which the Agency plans to take concrete actions.\110\ 
Several actions described in the roadmap, including this proposed rule, 
address PFOA and PFOS. Other ongoing EPA actions on PFOA and PFOS 
include:
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    \110\ U.S. EPA. (2021). PFAS strategic roadmap: EPA's 
commitments to action 2021-2024. U.S. Environmental Protection 
Agency. https://www.epa.gov/system/files/documents/2021-10/pfas-roadmap_final-508.pdf.
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     Finalizing a proposed rule that would impose certain 
reporting and recordkeeping requirements under TSCA for PFAS, including 
PFOA and PFOS, manufactured at any time since January 1, 2011 (86 FR 
33926).
     Finalizing the proposed Unregulated Contaminant Monitoring 
Rule 5 (UCMR5). As proposed, UCMR5 would collect data on 29 PFAS, 
including PFOA and PFOS, in public water systems (86 FR 13846).
     Establishing a national primary drinking water regulation 
for PFOA and PFOS under the Safe Drinking Water Act.
     Publishing recommended aquatic life water quality criteria 
for PFOA and

[[Page 54431]]

PFOS (draft criteria were released for public comment in May 2022) and 
developing human health water quality criteria for PFOA and PFOS.
     Finalizing a risk assessment for PFOA and PFOS in 
biosolids, which will serve as the basis for determining whether 
regulation of PFOA and PFOS in biosolids is appropriate.
    Further, based on public health and environmental protection 
concerns, and in response to a petition from the Governor of New 
Mexico, which requested EPA to take regulatory action on PFAS under 
RCRA, EPA announced on October 26, 2021, the initiation of two 
rulemakings. First, EPA will initiate the rulemaking process to propose 
adding four PFAS as RCRA hazardous constituents under 40 CFR part 261 
Appendix VIII, by evaluating the existing data for these chemicals and 
establishing a record to support such a proposed rule. The four PFAS 
EPA will evaluate are: PFOA, PFOS, perfluorobutane sulfonic acid (PFBS) 
and GenX chemicals (hexafluoropropylene oxide (HFPO) dimer acid and its 
ammonium salt). Second, EPA will initiate a rulemaking to clarify in 
the Agency's regulations that the RCRA Corrective Action Program has 
the authority to require investigation and cleanup for wastes that meet 
the statutory definition of hazardous waste, as defined under RCRA 
section 1004(5). This modification would clarify that emerging 
contaminants such as PFAS can be addressed through RCRA corrective 
action.
    Recent scientific data and the Agency's new analyses indicate that 
negative health effects may occur at much lower levels of exposure to 
PFOA and PFOS than previously understood and that PFOA is likely 
carcinogenic to humans. The Agency's new analyses were released in 
November 2021 ^{111 112} for independent scientific review by 
the EPA Science Advisory Board. The draft documents present EPA's 
initial analysis and findings with respect to this new information. 
EPA's 2021 draft non-cancer reference doses based on human epidemiology 
studies for various effects (e.g., developmental/growth, cardiovascular 
health outcomes, immune health) range from ~10^-7 to 
10^-9 milligram per kilogram per day (mg/kg/day). These draft 
reference doses are two to four orders of magnitude lower than EPA's 
2016 reference doses for PFOA and PFOS of 2 x ^10-5 mg/kg/
day. Following peer review, this information will be used to inform 
updated EPA drinking water health advisories and the development of 
Maximum Contaminant Level Goals and a National Primary Drinking Water 
Regulation for PFOA and PFOS.
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    \111\ U.S. EPA (U.S. Environmental Protection Agency). 2021a. 
External Peer Review Draft: Proposed Approaches to the Derivation of 
a Draft Maximum Contaminant Level Goal for Perfluorooctanoic Acid 
(PFOA) (CASRN 335-67-1) in Drinking Water. EPA-822-D-21-001. EPA, 
Office of Water, Washington, DC. Accessed April 2022. https://sab.epa.gov/ords/sab/f?p=100:18:16490947993:::RP,18:P18_ID:2601.
    \112\ U.S. EPA (U.S. Environmental Protection Agency). 2021b. 
External Peer Review Draft: Proposed Approaches to the Derivation of 
a Draft Maximum Contaminant Level Goal for Perfluorooctane Sulfonic 
Acid (PFOS) CASRN 1763-23-1 in Drinking Water. EPA-822-D-21-002. 
EPA, Office of Water, Washington, DC. Accessed April 2022. https://sab.epa.gov/ords/sab/f?p=100:18:16490947993:::RP,18:P18_ID:2601.
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    The EPA routinely updates RSLs and RMLs two times per year. EPA's 
next regularly scheduled update to the RSL and RML tables will be in 
November 2022. Since the science of PFAS toxicity is evolving we expect 
to update the numbers as appropriate during future updates.

B. Actions by Other Federal Agencies

     ATSDR: The Agency for Toxic Substances and Disease 
Registry (ATSDR), in response to a congressional mandate under CERCLA, 
develops comparison values to help identify chemicals that may be of 
concern to the public's health at hazardous waste sites. The ATSDR's 
guideline values are minimal risk levels (MRLs). An MRL is an estimate 
of the amount of a chemical a person can eat, drink, or breathe each 
day over a specified duration without a detectable risk to health. MRLs 
are developed for health effects other than cancer. If someone is 
exposed to an amount above the MRLs, it does not mean that health 
problems will happen. MRLs are a screening tool that help identify 
exposures that could be potentially hazardous to human health. Exposure 
above the MRLs does not mean that health problems will occur. Instead, 
it may act as a signal to health assessors to look more closely at a 
particular site where exposures may be identified.
    The ATSDR works closely with EPA at both a national and regional 
level to determine areas and populations potentially at risk for health 
effects from exposure to PFAS.\113\ The ATSDR has final intermediate 
duration (15-364 days) MRLs (2021) for PFOA and PFOS which are 3 x 
10^-6 mg/kg/day and 2 x 10^-6 mg/kg/day, 
respectively.\114\ ATSDR also has a PFAS strategy, exposure 
assessments, and a multi-site study--PFAS Cooperative Agreement.
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    \113\ ATSDR. (2018). Minimal risk levels (MRLs). Atlanta, GA: 
Agency for Toxic Substances and Disease Registry. https://www.atsdr.cdc.gov/minimalrisklevels/.
    \114\ ATSDR. (2021). Toxicological profile for perfluoroalkyls: 
final. Atlanta, GA: U.S. Department of Health and Human Services, 
Centers for Disease Control and Prevention, Agency for Toxic 
Substances and Disease Registry. https://wwwn.cdc.gov/TSP/ToxProfiles/ToxProfiles.aspx?id=1117&tid=237.
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     DoD: The Department of Defense (DoD) included PFOA and 
PFOS on its list of emerging chemicals of concern.\115\ The DoD defines 
emerging chemicals as chemicals or materials that the department 
currently uses or plans to use that present a potentially unacceptable 
human health or environmental risk; have a reasonably possible pathway 
to enter the environment; and either do not have regulatory standards 
based on peer-reviewed science, or their regulatory standards are 
evolving due to new science, detection capabilities or exposure 
pathways.\116\
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    \115\ DoD. (2019). DoD instruction 4715.18: Emerging chemicals 
(ECs) of environmental concern. U.S. Department of Defense. https://www.esd.whs.mil/Portals/54/Documents/DD/issuances/dodi/471518p.pdf?ver=2017-12-13-110558-727.
    \116\ Ibid.
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    In 2017, the DoD updated their military specification for AFFF to 
include no more than 800 parts per billion, the quantitation limit by 
DoD Quality Systems Manual 5.1, of PFOA and PFOS in the 
concentrate.\117\ The DoD is working to remove AFFF containing PFOA and 
PFOS from the supply chain.\118\ ``In January 2016, the Office of the 
Assistant Secretary of Defense for Energy, Installations and 
Environment issued a policy requiring the DoD components to: (1) issue 
Military Service-specific risk management procedures to prevent 
uncontrolled land-based releases of AFFF during maintenance, testing 
and training activities, and (2) remove and properly dispose of AFFF 
containing PFOS from the local stored supplies for non-shipboard use to 
prevent future environmental response action costs, where 
practical''.\119\ Under this policy,

[[Page 54432]]

for example, the Air Force funded the removal of AFFF from all fire 
trucks and crash response vehicles and replaced it with PFOS-free AFFF, 
which contains only trace quantities of PFOA. All Air Force bases 
except Thule Air Force Base, Greenland, have received replacement AFFF, 
and 97 percent of the bases have completed the transition. In addition, 
the Navy is updating the military specification requirements for AFFF 
and DoD continues its research efforts to find a PFAS-free alternative 
to AFFF.\120\ DoD has also set up a taskforce to address PFAS on and 
near military bases from DoD activities.
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    \117\ U.S. Navy. (2017). Performance specification fire 
extinguishing agent, aqueous film-forming foam (AFFF) liquid 
concentrate, for fresh and sea water. (MIL-PRF-24385F(SH) w/
Amendment 2). U.S. Navy, Naval Sea Systems Command (Ship Systems). 
https://quicksearch.dla.mil/Transient/E3EA5BB276A741A292E87C18DE644702.pdf https://quicksearch.dla.mil/Transient/C26F946AAE39463BBFCB321B047611E4.pdf.
    \118\ WH.gov. (2021). Fact sheet: President Biden signs 
executive order catalyzing America's clean energy economy through 
federal sustainability. Washington, DC: The White House. https://www.whitehouse.gov/briefing-room/statements-releases/2021/12/08/fact-sheet-president-biden-signs-executive-order-catalyzing-americas-clean-energy-economy-through-federal-sustainability/.
    \119\ DoD. (2017). Aqueous film forming foam: Report to 
Congress. U.S. Department of Defense, Office of the Under Secretary 
of Defense for Acquisition, Technology and Logistics. https://www.denix.osd.mil/derp/home/documents/aqueous-film-forming-foam-report-to-congress/Aqueous%20Film%20Forming%20Foam%20(AFFF)%20Report%20to%20Congress_DEN
IX.PDF.
    \120\ DoD. (2020). Per- and polyfluoroalkyl substances (PFAS) 
Task Force progress report. U.S. Department of Defense. https://media.defense.gov/2020/Mar/13/2002264440/-1/-1/1/PFAS_Task_Force_Progress_Report_March_2020.pdf.
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    DoD is investing over $49 million through fiscal year 2025 in 
research, development, testing, and evaluation in collaboration with 
academia and industry to identify alternative firefighting material and 
practices. In the meantime, DoD only uses AFFF to respond to emergency 
events and no longer uses it for uncontained land-based testing and 
training.\121\
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    \121\ Ibid.
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    In addition, DoD has initiated other actions to test for, 
investigate, and mitigate elevated levels of PFOA and PFOS at or near 
installations across the military departments. Following the release of 
EPA's LHAs for PFOA and PFOS in May 2016, each of the military 
departments issued guidance directing installations to test for PFOA 
and PFOS in their drinking water and take steps to address drinking 
water that contained amounts of PFOA and PFOS above EPA's health 
advisory level. The military departments also directed their 
installations to identify locations with a known or suspected prior 
release of PFOA and PFOS and to address any releases that pose a risk 
to human health.\122\ As of December 31, 2021, the DoD was performing 
the PA/SI for PFAS at 700 DoD installations and National Guard 
Facilities.
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    \122\ Ibid.
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     DOE: On September 16, 2021, the Department of Energy (DOE) 
issued a memo that focused on four main points; discontinue use of AFFF 
except in emergencies, suspend disposal of AFFF pending further 
guidance, establish reporting requirements for any release or spill of 
PFAS and establish a DOE PFAS Coordinating Committee. DOE has completed 
an assessment of its PFAS usage and inventory across the department and 
is in the process of developing a department wide report of the results 
of that assessment. At the request of Council on Environmental Quality, 
DOE, as well as other agencies and departments, is developing a PFAS 
Roadmap similar to EPA's that will guide future PFAS related actions 
for 2022-2025.FAA: On January 17, 2019, the Federal Aviation 
Administration (FAA) released guidance in the form of a CertAlert to 
all certificated Part 139 Aircraft Rescue and Firefighting departments 
regarding safer methods for the required bi-annual testing of AFFF for 
firefighting. In the guidance, the FAA suggests alternative AFFF 
testing systems that minimize environmental impact while still 
satisfying the regulatory requirement for safety testing. The 
recommendations include addressing environmental concerns such as 
establishing safe and environmentally effective handling and disposal 
procedures.\123\
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    \123\ FAA. (2019). National part 139 CertAlert: Aqueous film 
forming foam (AFFF) testing at certificated part 139 airports. (No. 
19-01). Federal Aviation Administration. https://www.faa.gov/airports/airport_safety/certalerts/media/part-139-cert-alert-19-01-AFFF.pdf.
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    On October 4, 2021, the FAA published a CertAlert which informs 
Part 139 airport operators about changes to the military specification 
(MIL-PRF-24385F(SH)) for firefighting foam referenced in Chapter 6 of 
AC No.: 150/5210-6D. While the performance standard remains the same, 
the military specification no longer requires the use of fluorinated 
chemicals. One acceptable means of satisfying 14 CFR part 139 
requirements is to continue to use the existing approved foam which 
does contain fluorinated chemicals. However, FAA encourages certificate 
holders that have identified a different foam that meets the 
performance standard to seek approval for such foam from the FAA.\124\
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    \124\ FAA. (2021). National part 139 CertAlert: Part 139 
extinguishing agent requirements. (No. 21-05). Federal Aviation 
Administration. https://www.faa.gov/airports/airport_safety/certalerts/media/part-139-cert-alert-21-05-Extinguishing-Agent-Requirements.pdf.
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     FDA: In 2011, FDA reached voluntary agreements with 
manufacturers and suppliers of long chain PFAS subject to Food Contact 
Notification to no longer sell those substances for use in food contact 
applications. In 2016, the FDA revoked the regulations authorizing the 
remaining uses of these long-chain PFAS in food packaging (see 81 FR 5, 
January 4, 2016, and 81 FR 83672, November 22, 2016). As of November 
2016, long-chain PFAS are no longer used in food contact applications 
sold in the United States.\125\
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    \125\ https://www.fda.gov/food/chemical-contaminants-food/authorized-uses-pfas-food-contact-applications.
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    In addition to EPA, a number of agencies including ATSDR, DoD, DOI, 
DOT, FDA, and USDA Have or are developing PFAS plans outlining how 
their agencies will address PFAS contamination.

C. State Actions

    As concerns have arisen regarding PFOA and PFOS many states have 
taken regulatory action.
    In addition to some of the states discussed in more detail below, 
Alabama, Arizona, Idaho, Kentucky, Nebraska, and West Virginia have 
opted to use EPA's 2016 LHAs of 70 ppt for PFOA and 
PFOS.^{126 127 128 129}
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    \126\ Pontius, F. (2019). Regulation of perfluorooctanoic acid 
(PFOA) and perfluorooctane sulfonic acid (PFOS) in drinking water: A 
comprehensive review. Water 11: 2003.
    \127\ Idaho DEQ. (2021). PFAS and Idaho drinking water. Idaho 
Department of Environmental Quality. https://www.deq.idaho.gov/water-quality/drinking-water/pfas-and-idaho-drinking-water/.
    \128\ Kentucky EEC. (2019). Evaluation of Kentucky community 
drinking water for per- & poly-fluoroalkyl substances. Kentucky 
Energy and Environment Cabinet, Department for Environmental 
Protection. https://eec.ky.gov/Documents%20for%20URLs/PFAS%20Drinking%20Water%20Report%20Final.pdf.
    \129\ AWWA. (2020). Per- and polyfluoroalkyl substances (PFAS): 
summary of state policies to protect drinking water. American Water 
Works Association. https://www.awwa.org/LinkClick.aspx?fileticket=nCRhtmGcA3k%3D&portalid=0.
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     Alaska: The Alaska Department of Environmental 
Conservation (ADEC) promulgated groundwater cleanup levels of 400 ppt 
and soil cleanup levels of 1.3 to 2.2 milligram per kilogram (mg/kg) 
(range depending on precipitation zone) for PFOA and PFOS, 
respectively, in Oil and Other Hazardous Substances Pollution Control 
Regulations as amended through June 2021.\130\ Health-based action 
levels for drinking water of 70 ppt for PFOA and PFOS, individually or 
combined, were established by ADEC in 2018 (updated in 2019) based on 
EPA's 2016 LHAs.\131\
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    \130\ Alaska DEC. (2021). Oil and other hazardous substances 
pollution control. (Alaska Admin Code 18 AAC 75). Alaska Department 
of Environmental Conservation. https://dec.alaska.gov/commish/regulations/.
    \131\ Alaska DEC. (2019). Technical memorandum: Action levels 
for PFAS in water and guidance on sampling groundwater and drinking 
water. Alaska Department of Environmental Conservation. https://dec.alaska.gov/media/15773/pfas-drinking-water-action-levels-technical-memorandum-10-2-19.pdf.
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     California: In August 2019, the California Office of 
Environmental Health Hazard Assessment developed PFOA and PFOS toxicity 
values

[[Page 54433]]

(acceptable daily doses) of 4.5 x 10^-7 mg/kg-day and 1.8 x 
10^-6 mg/kg-day, respectively, and reference levels based on 
cancer effects of 0.1 ppt and 0.4 ppt, respectively. They noted that 
the levels are lower than the levels of PFOA and PFOS that can be 
reliably detected in drinking water using currently available 
technologies. Thus, they recommended that the State Water Resources 
Control Board set notification limits at the lowest levels at which 
PFOA and PFOS can be reliably detected in drinking water using 
available and appropriate technologies.\132\ The California State Water 
Resources Control Board issued new drinking water notification limits 
for local water agencies to follow for finding and reporting PFOA and 
PFOS of 5.1 ppt for PFOA and 6.5 ppt for PFOS. As part of these 
guidelines, California also established a response level of 10 ppt for 
PFOA and 40 ppt for PFOS.^{133 134} If this level is exceeded 
in drinking water provided to consumers, California recommends that the 
water agency remove the water source from service.\135\
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    \132\ OEHHA. (2019). Notification level recommendations: 
Perfluorooctanoic acid and perfluorooctane sulfonate in drinking 
water. California Office of Environmental Health Hazard Assessment. 
https://oehha.ca.gov/media/downloads/water/chemicals/nl/final-pfoa-pfosnl082119.pdf.
    \133\ California Water Boards. (2020). Notification level 
issuance: Contaminant(s): perfluorooctanoic acid (PFOA). State Water 
Resources Control Board. California Water Boards. https://www.waterboards.ca.gov/drinking_water/certlic/drinkingwater/documents/pfos_and_pfoa/pfoa_nl_issuance_jan2020.pdf.
    \134\ California Water Boards. (2020). Notification level 
issuance: Contaminant(s): perfluorooctanesulfonic acid (PFOS). State 
Water Resources Control Board. California Water Boards. https://www.waterboards.ca.gov/drinking_water/certlic/drinkingwater/documents/pfos_and_pfoa/pfos_nl_issuance_jan2020.pdf.
    \135\ California Water Boards. (2020). Perfluorooctanoic acid 
(PFOA) and perfluorooctanesulfonic acid (PFOS). State Water 
Resources Control Board. California Water Boards. https://www.waterboards.ca.gov/drinking_water/certlic/drinkingwater/PFOA_PFOS.html.
---------------------------------------------------------------------------

    In July 2021, the California Office of Environmental Health Hazard 
Assessment released draft Public Health Goals (PHGs) for PFOA of 0.007 
ppt based on human kidney cancer data and PFOS of 1 ppt based on liver 
and pancreatic tumor animal data. PHGs are not regulatory requirements 
and are based solely on protection of public health without regard to 
cost impacts or other factors.\136\
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    \136\ OEHHA. (2021). Public health goals: First public review 
draft: Perfluorooctanoic acid and perfluorooctane sulfonic acid in 
drinking water Office of Environmental Health Hazard Assessment. 
California Environmental Protection Agency. https://oehha.ca.gov/sites/default/files/media/downloads/crnr/pfoapfosphgdraft061021.pdf.
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    California is also conducting sampling efforts targeting airports, 
chrome plating facilities, landfills, WWTPs and nearby water supply 
wells.\137\
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    \137\ California Water Boards. (2021). GeoTracker PFAS map. 
State Water Resources Control Board. California Water Boards. 
https://geotracker.waterboards.ca.gov/map/pfas_map.
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     Colorado: To address known contamination in El Paso 
County, the Colorado Water Quality Control Commission (WQCC) adopted a 
site-specific groundwater quality standard of 70 ppt for PFOA and PFOS 
combined in 2018 based on the EPA 2016 LHAs.^{138 139} By 2019, 
the Colorado Department of Public Health and Environment adopted a PFAS 
Action Plan outlining methods by which the state planned to protect 
residents from PFAS. As part of this initiative, a survey was conducted 
regarding the use of firefighting foams that resulted in rules with 
respect to the registration and use of PFAS-containing foams.\140\ The 
Colorado WQCC approved a policy interpreting the existing narrative 
standards for PFAS in 2020. This policy outlines the use of translation 
levels of 70 ppt for PFOA, PFOS, PFOA and PFOS parent constituents, and 
perfluorononanoic acid (PFNA), individually or combined, based on the 
EPA's 2016 LHAs.\141\
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    \138\ CDPHE. (2017). Site-specific groundwater standard: PFOA/
PFOS. Colorado Department of Public Health & Environment. https://www.colorado.gov/pacific/sites/default/files/WQ_GWStandard_PFOA_100417%20FINAL.pdf.
    \139\ CDPHE. (2020). Policy 20-1. Policy for interpreting the 
narrative water quality: Standards for per- and polyfluoroalkyl 
substances (PFAS). Colorado Department of Public Health & 
Environment, Water Quality Control Commission. https://drive.google.com/file/d/119FjO4GZVaJtw7YFvFqs9pmlwDhDO_eG/view.
    \140\ Coleman, C. (2020). Colorado enacts arsenal of laws to 
stop ``forever chemicals''. Water Education Colorado. https://www.watereducationcolorado.org/fresh-water-news/colorado-enacts-arsenal-of-laws-to-stop-forever-chemicals/.
    \141\ CDPHE. (2020). Policy 20-1. Policy for interpreting the 
narrative water quality: Standards for per- and polyfluoroalkyl 
substances (PFAS). Colorado Department of Public Health & 
Environment, Water Quality Control Commission. https://drive.google.com/file/d/119FjO4GZVaJtw7YFvFqs9pmlwDhDO_eG/view.
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     Connecticut has issued a drinking water action level of 70 
ppt for PFOA, PFOS, PFNA, perfluorohexanesulfonic acid (PFHxS) and 
perfluoroheptanoic acid (PFHpA) individually or combined. The action 
level is based on risk and similar health effects of the five PFAS. An 
interagency task force was formed that has recommended actions 
including take-back and safe disposal of AFFF containing PFAS from 
state and municipal fire departments.\142\
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    \142\ CT Interagency PFAS Task Force. (2019). PFAS action plan. 
Connecticut Interagency PFAS Task Force. Department of Public Health 
& Department of Energy and Environmental Protection. https://portal.ct.gov/-/media/Office-of-the-Governor/News/20191101-CT-Interagency-PFAS-Task-Force-Action-Plan.pdf.
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     Delaware: Based on Delaware's Department of Natural 
Resources and Environmental Control Hazardous Substance Cleaning Act 
Screening Level Table Guidance (last updated in November 2021), a 
screening/reporting level for PFOA and PFOS, individually or combined, 
of 70 ppt in groundwater is based on EPA's 2016 LHAs; and a reporting/
screening level for PFOA and PFOS in the soil (of 0.13 mg/kg based on 
screening document and 1.3 mg/kg based on the reporting level table) is 
based on EPA's Regional Screening Level Calculator.^{143 144}
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    \143\ DNREC. (2021). Hazardous Substance Cleanup Act: Screening 
level table guidance. Delaware Department of Natural Resources and 
Environmental Control. https://documents.dnrec.delaware.gov/dwhs/remediation/HSCA-Screening-Level-Table-Guidance.pdf.
    \144\ DNREC. (2021). Sortable HSCA reporting level table 
(Excel). Delaware Department of Natural Resources and Environmental 
Control. https://dnrec.alpha.delaware.gov/waste-hazardous/remediation/laws-regs-guidance/.
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     Florida issued guidance identifying provisional 
groundwater target cleanup levels of 70 ppt for PFOA and PFOS combined, 
provisional soil cleanup target levels of 1.3 mg/kg for PFOA and PFOS, 
and surface water screening levels of 500 ppt for PFOA and 10 ppt for 
PFOS; these values were last updated in 2020.\145\
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    \145\ Florida DEP. (2020). Provisional PFOA and PFOS cleanup 
target levels & screening levels. Florida Department of 
Environmental Protection. https://floridadep.gov/waste/district-business-support/documents/provisional-pfoa-and-pfos-cleanup-target-levels-screening.
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     Hawaii: In 2020, Hawaii published a memorandum identifying 
interim soil and water and soil environmental action levels (EALs) for 
PFAS. For groundwater that is a current potential source of drinking 
water, groundwater EALs are 40 ppt for PFOA and PFOS. Soil EALs are 
0.0012 mg/kg for PFOA and 0.0075 mg/kg for PFOS.\146\
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    \146\ Hawai'i DOH. (2020). Interim soil and water environmental 
action levels (EALs) for perfluoroalkyl and polyfluoroalkyl 
substances (PFASs). Hawaii State Department of Health. https://health.hawaii.gov/heer/files/2020/12/PFASs-Techncal-Memo-HDOH-Dec-2020.pdf.
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     Illinois: By July 2021, Illinois EPA issued statewide 
health advisories for six PFAS: PFOA, PFOS, PFNA, perfluorohexanoic 
acid (PFHxA), PFHxS and PFBS. A health advisory is a regulatory action 
that provides guidance to local officials and community water supply 
operators in protecting the health of their customers. Illinois EPA is 
authorized to issue a health advisory when there is a confirmed 
detection in a community water supply well of a chemical substance for 
which no

[[Page 54434]]

numeric groundwater standard exists. The health-based guidance level 
for PFOA is 2 ppt and PFOS is 14 ppt.\147\ Illinois EPA is conducting a 
statewide investigation into the prevalence and occurrence of PFAS in 
finished water at entry points to the distribution system representing 
1,749 community water supplies across Illinois.\148\
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    \147\ Illinois EPA. (2021). PFAS statewide health advisory. 
Illinois Environmental Protection Agency, Office of Toxicity 
Assessment. https://www2.illinois.gov/epa/topics/water-quality/pfas/Pages/pfas-healthadvisory.aspx.
    \148\ Illinois EPA. (2021). PFAS statewide investigation 
network: Community water supply sampling. Illinois Environmental 
Protection Agency, Office of Toxicity Assessment. https://www2.illinois.gov/epa/topics/water-quality/pfas/Pages/pfas-statewide-investigation-network.aspx.
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     Iowa: The Iowa Department of Natural Resources issued 
Statewide Standards for PFOA and PFOS in 2016. The standards were set 
at 70 ppt for PFOA and PFOS for a protected groundwater source, and 
50,000 ppt for PFOA and 1,000 ppt for PFOS for a non-protected 
groundwater source. Statewide standards for soil are 35 mg/kg for PFOA 
and 1.8 mg/kg for PFOS.\149\
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    \149\ Iowa DNR. (2021). Cumulative risk calculator: Statewide 
standards. Iowa Department of Natural Resources. https://programs.iowadnr.gov/riskcalc/Home/statewidestandards.
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     Kansas: The Kansas Department of Health and Environment, 
the Bureau of Environmental Remediation, and the Bureau of Water are 
working together to address PFAS in drinking water. The process 
involves the development of a statewide inventory and prioritization of 
potential PFAS sources. This information will be used to develop a 
public water supply monitoring program.\150\
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    \150\ KDHE. (2021). Per- and polyfluoroalkyl substances (PFAS). 
Kansas Department of Health and Environment. https://www.kdheks.gov/pws/PFAS.htm.
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     Maine's Department of Environmental Protection requires 
the testing of all sludge material licensed for land application in the 
state for PFAS (including PFOA and PFOS). The governor created a task 
force to mobilize state agencies and other stakeholders to review the 
prevalence of PFAS in Maine.\151\ Maine Remedial Action Guidelines 
(RAGs) for Sites Contaminated with Hazardous Substances (2018) 
identified a water RAG of 400 ppt for PFOA and PFOS and a soils 
(residential) RAG of 1.7 mg/kg for PFOA and PFOS.\152\ In June 2021, 
the Governor also signed an emergency resolution establishing an 
interim drinking water standard of 20 ppt for 6 PFAS. The resolution 
also requires that the Maine Department of Health and Human Services 
promulgate an MCL for PFAS by June 1, 2024.
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    \151\ Maine EPA. (2021). Per- and polyfluoroalkyl substances 
(PFAS). Maine Department of Environmental Protection Agency. https://www.maine.gov/dep/spills/topics/pfas/.
    \152\ Maine DEP. (2018). Maine remedial action guidelines (RAGs) 
for sites contaminated with hazardous substances. Maine Department 
of Environmental Protection. https://www.maine.gov/dep/spills/publications/guidance/rags/ME-Remedial-Action-Guidelines-10-19-18cc.pdf.
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     Massachusetts: In December 2019, the Massachusetts 
Department of Environmental Protection Office of Research and Standards 
reassessed the toxicity information for a subgroup of longer chain 
PFAS. They applied a revised reference dose (RfD) of 5 x 
10^-6 mg/kg-day to PFOA, PFOS, PFNA, PFHxS, PFHpA and 
perfluorodecanoic acid (PFDA). This reassessment resulted in an MCL of 
20 ppt, promulgated in October 2020.\153\ \154\ Also, PFAS are 
considered to be hazardous material subject to the notification, 
assessment and cleanup requirements of the Massachusetts Waste Site 
Cleanup Program.\155\
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    \153\ MassDEP. (2019). Technical support document: Per- and 
polyfluoroalkyl substances (PFAS): An updated subgroup approach to 
groundwater and drinking water values. Massachusetts Department of 
Environmental Protection. https://www.mass.gov/files/documents/2019/12/27/PFAS%20TSD%202019-12-26%20FINAL.pdf.
    \154\ MassDEP. (2020). 310 CMR 22: The Massachusetts drinking 
water regulations. Massachusetts Department of Environmental 
Protection, Drinking Water Program. https://www.mass.gov/doc/310-cmr-2200-the-massachusetts-drinking-water-regulations/download.
    \155\ MassDEP. (2019). Final PFAS-related revisions to the MCP. 
Massachusetts Department of Environmental Protection, Drinking Water 
Program. https://www.mass.gov/lists/final-pfas-related-revisions-to-the-mcp-2019.
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     Michigan derived a toxicity value of 3.9 x 10^-6 
mg/kg-day for PFOA and 2.89 x 10^-6 mg/kg-day for PFOS.\156\ 
Michigan's public health drinking water MCLs are 8 ppt for PFOA and 16 
ppt for PFOS, effective in August 2020. The Michigan PFAS Action 
Response Team has coordinated many actions across the state. Michigan 
Department of Health and Human Services has recommended people avoid 
contaminant-induced foam occurring on certain PFAS-contaminated surface 
water bodies and has initiated a PFAS Exposure and Health Study. The 
Michigan Department of Environment, Great Lakes, and Energy began a 
statewide initiative to test drinking water from all community water 
supplies for PFAS and has been testing watersheds. Do not eat 
advisories have also been issued for deer, fish, and other wildlife in 
certain parts of the state.\157\ \158\ \159\ \160\ \161\ \162\
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    \156\ Michigan.gov. (2022). Health-based drinking water value 
recommendations for PFAS in Michigan. Michigan Department of 
Environment, Great Lakes, and Energy. Science Advisory Workgroup. 
https://www.michigan.gov/documents/pfasresponse/Health-Based_Drinking_Water_Value_Recommendations_for_PFAS_in_Michigan_Report_659258_7.pdf.
    \157\ Michigan.gov. (2021). Michigan PFAS Action Response Team: 
Investigations. Michigan Department of Environment, Great Lakes, and 
Energy. https://www.michigan.gov/pfasresponse/0,9038,7-365-86511_-
,00.html.
    \158\ Michigan.gov. (2021). Michigan PFAS Action Response Team: 
Investigations: Watershed investigations. Michigan Department of 
Environment, Great Lakes, and Energy. https://www.michigan.gov/
pfasresponse/0,9038,7-365-86511_95792_-,00.html.
    \159\ Michigan.gov. (2018). Michigan PFAS Action Response Team: 
Drinking water: Public drinking water: Statewide sampling 
initiative: Statewide testing initiative. Michigan Department of 
Environment, Great Lakes, and Energy. https://www.michigan.gov/
pfasresponse/0,9038,7-365-95571_95577_95587_-,00.html.
    \160\ Michigan.gov. (2021). Michigan PFAS Action Response Team: 
Fish and wildlife. Michigan Department of Environment, Great Lakes, 
and Energy. https://www.michigan.gov/pfasresponse/0,9038,7-365-
86512_-,00.html.
    \161\ Michigan.gov. (2021). Michigan PFAS Action Response Team: 
MPART: Press releases: MDHHS recommends Michiganders avoid foam on 
lakes and rivers. Michigan Department of Environment, Great Lakes, 
and Energy. https://www.michigan.gov/pfasresponse/0,9038,7-365-
86513_96296-563821_y_2018,00.html.
    \162\ Michigan.gov. (2020). Michigan PFAS Action Response Team: 
MPART: Press releases: MDHHS announces launch of new PFAS health 
study in impacted West Michigan communities. Michigan Department of 
Environment, Great Lakes, and Energy. https://www.michigan.gov/
pfasresponse/0,9038,7-365-86513_96296-544808_y_2018,00.html.
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     Minnesota's Department of Health (MDH) identified RfDs of 
1.8 x 10^-5 milligram/kilogram-day (mg/kg-day) for PFOA, 
adopted as Rule in August 2018 \163\ and 3.1 x 10^-6 mg/kg-
day for PFOS, adopted as Rule in August 2020.\164\ MDH developed 
guidance values in drinking water of 35 ppt for PFOA and 15 ppt for 
PFOS. The MDH is helping with drinking water well testing in certain 
areas of the state. Due to PFAS contamination in surface water bodies 
and levels of PFOS found in fish, the MDH has issued fish advisories 
for certain surface water bodies. Minnesota's Pollution Control Agency 
Toxics Reduction and Pollution Prevention program is working to reduce 
PFAS in firefighting foam, chrome plating, and food packaging, with 
related efforts in state and local government purchasing.\165\
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    \163\ MDH. (2020). Toxicological summary for: 
Perfluorooctanoate. Minnesota Department of Health. https://www.health.state.mn.us/communities/environment/risk/docs/guidance/gw/pfoa.pdf.
    \164\ MDH. (2020). Toxicological summary for: Perfluorooctane 
sulfonate. Minnesota Department of Health. https://www.health.state.mn.us/communities/environment/risk/docs/guidance/gw/pfos.pdf.
    \165\ Minnesota PCA. (2022U.S.Navy). What is Minnesota doing 
about PFAS? Minnesota Pollution Control Agency. https://www.pca.state.mn.us/waste/what-minnesota-doing-about-pfas.

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[[Page 54435]]

     Montana Department of Environmental Quality set a 
Groundwater Quality Standard for PFOA and PFOS, individually or 
combined, of 70 ppt in 2019.\166\
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    \166\ Montana DEQ. (2019). Circular DEQ-7. Montana numeric water 
quality standards. Montana Department of Environmental Quality. 
https://deq.mt.gov/files/Water/WQPB/Standards/PDF/DEQ7/DEQ-7.pdf.
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     Nevada Division of Environmental Protection identified 
basic comparison level values of 667 ppt for PFOA and PFOS in 
residential water and 1.56 mg/kg in residential soil.\167\ Exceedance 
of a basic comparison level does not automatically trigger a response 
action but warrants further evaluation of health risks.\168\
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    \167\ NDEP. (2017). Nevada Division of Environmental Protection 
basic comparison levels. Nevada Division of Environmental 
Protection. https://ndep.nv.gov/uploads/documents/july-2017-ndep-bcls.pdf.
    \168\ Pontius, F. (2019). Regulation of perfluorooctanoic acid 
(PFOA) and perfluorooctane sulfonic acid (PFOS) in drinking water: A 
comprehensive review. Water 11: 2003.
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     New Hampshire's Department of Environmental Services 
recommended RfDs of 6.1 x 10^-6 mg/kg/day and 3.0 x 
10^-6 mg/kg/day for PFOA and PFOS, respectively, in June 
2019.\169\ New Hampshire has undertaken sampling for PFAS at water 
supplies (including drinking water sources), wastewater treatment 
plants, fire stations, landfills and contaminated waste sites to better 
understand the scope of contamination in the state. The New Hampshire 
Department of Environmental Services filed and finalized its rulemaking 
to establish MCLs for PFOA of 12 ppt and PFOS of 15 ppt, as well as 11 
ppt for PFNA and 18 ppt for PFHxS.\170\ The MCLs initially became 
effective on September 30, 2019. However, on December 31, 2019, the 
Merrimack County Superior Court issued a preliminary injunction barring 
enforcement of the MCLs. The New Hampshire legislature subsequently 
amended the New Hampshire Safe Drinking Water Act in July 2020 
establishing the 4 PFAS MCLs.
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    \169\ NHDES. (2019). Technical background report for the June 
2019 proposed maximum contaminant levels (MCLs) and ambient 
groundwater quality standards (AGQSs) for perfluorooctane sulfonic 
acid (PFOS), perfluorooctanoic acid (PFOA), perfluorononanoic acid 
(PFNA), and perfluorohexane sulfonic acid (PFHxS) and letter from 
Dr. Stephen M. Roberts, Ph.D. dated 6/25/2019--findings of peer 
review conducted on technical background report. New Hampshire 
Department of Environmental Services. https://www4.des.state.nh.us/nh-pfas-investigation/wp-content/uploads/June-PFAS-MCL-Technical-Support-Document-FINAL.pdf.
    \170\ NHDES. (2019). New Hampshire Code of Administrative Rules: 
Section Env-Dw 701.03--Units of measure for maximum contaminant 
levels (MCLs) and maximum contaminant level goals (MCLGs). New 
Hampshire Department of Environmental Services. https://services.statescape.com/ssu/Regs/ss_8586370873779209008.pdf.
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     New Jersey Department of Environmental Protection (NJDEP) 
identified RfDs of 2 x 10^-6 mg/kg-day for PFOA and 1.8 x 
10^-6 mg/kg-day for PFOS.¹⁷¹ ¹⁷² On 
June 1, 2020, the NJDEP published a health based MCL for PFOA of 14 ppt 
and an MCL for PFOS of 13 ppt in the New Jersey Register. New Jersey 
previously adopted an MCL for PFNA of 13 ppt on September 4, 2018. New 
Jersey uses a risk assessment approach to protect for chronic drinking 
water exposure when setting MCLs. The NJDEP also adopted these same 
levels as formal groundwater quality standards for the purposes of site 
remediation activities and discharges to groundwater.\173\ New Jersey 
has added PFNA, PFOA and PFOS to its hazardous substances list.
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    \171\ NJDWQI. (2017). Maximum contaminant level recommendation 
for perfluorooctanoic acid in drinking water basis and background. 
New Jersey Drinking Water Quality Institute. https://www.nj.gov/dep/watersupply/pdf/pfoa-recommend.pdf.
    \172\ NJDWQI. (2017). Appendix A. Health-based maximum 
contaminant level support document: perfluorooctanoic acid (PFOA). 
New Jersey Drinking Water Quality Institute. https://www.nj.gov/dep/watersupply/pdf/pfoa-appendixa.pdf.
    \173\ NJDEP. (2020). Ground water quality standards and maximum 
contaminant levels (MCLs) for perfluorooctanoic acid (PFOA) and 
perfluorooctanesulfonic acid (PFOS). New Jersey Department of 
Environmental Protection. https://www.nj.gov/dep/rules/adoptions/adopt_20200601a.pdf.
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     New Mexico Environment Department issued Risk Assessment 
Guidance for Site Investigations and Remediation that identified 
preliminary screening levels of 70 ppt for PFOA, PFOS, and PFHxS, 
individually or combined, in drinking water and 1.56 mg/kg for PFOA, 
PFOS, and PFHxS in residential soil in 2019.\174\
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    \174\ NMED. (2019). Risk assessment guidance for site 
investigations and remediation. Volume I. Soil screening guidance 
for human health risk assessments. New Mexico Environment 
Department. https://www.env.nm.gov/wp-content/uploads/sites/12/2016/11/Final-NMED-SSG-VOL-I_-Rev.2-6_19_19.pdf.
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     New York regulates PFOA and PFOS as hazardous substances. 
New York finalized regulations in 2017 that specify storage and 
registration requirements for Class B firefighting foams containing at 
least one percent by volume of one or more of four PFAS (including PFOA 
and PFOS) and prohibits the release of one pound or more of each into 
the environment during use. If a release meets or exceeds the one-pound 
threshold, it is considered a hazardous waste spill and must be 
reported, and cleanup may be required under the state's Superfund or 
Brownfields programs. In August 2020, New York adopted MCLs of 10 ppt 
for both PFOA and PFOS.¹⁷⁵ ¹⁷⁶
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    \175\ NYSDOH. (2020). Amendment of subpart 5-1 of title 10 NYCRR 
(maximum contaminant levels (MCLs)) notice of revised rulemaking. 
New York State Department of Health. https://regs.health.ny.gov/sites/default/files/proposed-regulations/Maximum%20Contaminant%20Levels%20%28MCLs%29_0.pdf.
    \176\ DEC. (2017). Fact sheet: Storage and use of Class B 
firefighting foams under new hazardous substance regulations. New 
York State Department of Environmental Conservation. https://www.dec.ny.gov/docs/remediation_hudson_pdf/affffactsheet.pdf.
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     North Carolina's Department of Environmental Quality 
determined an Interim Maximum Allowable Concentration for groundwater 
of 2,000 ppt for PFOA (table last updated in June 2021).\177\
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    \177\ NCDEQ. (2021). Appendix #1: Interim maximum allowable 
concentrations (IMACs). North Carolina Department of Environmental 
Quality. https://files.nc.gov/ncdeq/Water%20Quality/Planning/CSU/Ground%20Water/APPENDIX_I_IMAC_2-01-21.pdf.
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     Ohio Environmental Protection Agency and Ohio Department 
of Health released a Polyfluoroalkyl Substances Action Plan for 
Drinking Water in 2019. Objectives included gathering sampling data, 
providing private water system owners with guidelines and resources to 
identify and respond to PFAS contamination, identifying resources to 
assist public water systems in the implementation of preventative and 
long-term measures to reduce PFAS-related risks, increasing awareness 
of PFAS and associated risks, ongoing engagement, and establishing 
Action Levels for drinking water systems in Ohio that are protective 
for human health. As part of this initiative, Ohio indicated that 
Action Levels of 70 ppt for PFOA and PFOS, singly or combined, would be 
established.\178\
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    \178\ Ohio.gov. (2019). Ohio per- and polyfluoroalkyl substances 
(PFAS) action plan for drinking water. Ohio Environmental Protection 
Agency. Ohio Department of Health. https://content.govdelivery.com/attachments/OHOOD/2019/12/02/file_attachments/1335154/PFAS%20Action%20Plan%2012.02.19.pdf.
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     Oregon Department of Environmental Quality set initiation 
levels (ILs) for PFOA and PFOS of 24,000 ppt and 300,000 ppt, 
respectively (last amended in 2019). The rule indicated that ILs 
referred to concentrations in effluent, that, if exceeded, requires 
preparation of a pollutant reduction plan.^{179 180}
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    \179\ OAR. (2019). Division 45. Regulations pertaining to NPDES 
and WPCF permits 340-045-0100 Effect of a permit: Initiation level 
rule. Oregon Administrative Rule. https://secure.sos.state.or.us/oard/viewSingleRule.action?ruleVrsnRsn=256058.
    \180\ OAR. ([2010]). OAR 340-045-0100: Table A--Persistent 
pollutants. Oregon Administrative Rule. https://secure.sos.state.or.us/oard/viewAttachment.action;JSESSIONID_OARD=kx0KPdcNidFhJyQctRxEOn3fLasJ_U1
SHXoqfYc80w8WtuLnSAlk!-888754201?ruleVrsnRsn=256058.

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[[Page 54436]]

     Pennsylvania Department of Environmental Protection 
(PADEP) adopted a medium-specific concentration of 70 ppt in 
groundwater for PFOA and PFOS, individually or combined, based on EPA's 
2016 LHAs. MSCs are 4.4 mg/kg for PFOA and PFOS in residential soil. 
PADEP has proposed rulemaking to incorporate groundwater and soil 
cleanup standards for PFOA, PFOS, and PFBS, and has initiated the 
process to set drinking water MCLs for PFOA and PFOS.\181\
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    \181\ Schena, R. (2021). New Pennsylvania PFOS and PFOA cleanup 
standards reach final major regulatory hurdle. JD Supra. https://www.jdsupra.com/legalnews/new-pennsylvania-pfos-and-pfoa-cleanup-3985880/.
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     Rhode Island Department of Environmental Management 
(RIDEM) set Groundwater Quality Standards for PFOA and PFOS, 
individually or combined, of 70 ppt. RIDEM indicated that EPA's 2016 
LHAs are used to determine the response to protect human health when 
these substances are detected in groundwater known or presumed to be 
suitable for drinking water use without treatment.\182\
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    \182\ RIDEM. (2017). Rhode Island Department of Environmental 
Management determination of a groundwater quality standard for: 
Perfluorooctanoic acid (PFOA) and perfluorooctane sulfonate (PFOS). 
Rhode Island Department of Environmental Management. https://www.dem.ri.gov/programs/benviron/water/quality/pdf/pfoa.pdf.
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     Texas has developed toxicity factors for PFOA and PFOS 
(using appropriate adjustments and uncertainty factors) for use at 
remediation sites. When combined with reasonable maximum long-term 
exposure assumptions for standard receptors (e.g., residents, 
commercial/industrial workers) and multiple simultaneous routes of 
exposure (e.g., incidental soil ingestion, dermal exposure), the Texas 
Commission on Environmental Quality believes these toxicity factors 
(e.g., RfDs) will result in sufficiently protective environmental media 
(e.g., soil) cleanup concentrations based on available data. Texas's 
RfDs for PFOA and PFOS are 1.2 x 10^-05 and 2.3 x 
10^-05 mg/kg/day, respectively.\183\ Tier 1 Protective 
Concentration Level (PCL) tables, released in January 2021, identified 
PCLs of 290 ppt for PFOA and 560 ppt for PFOS. PCLs are the default 
cleanup standards in the Texas Reduction Program.\184\
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    \183\ TCEQ. (2016). Perfluoro compounds (PFCs): Various CASRN 
numbers. Texas Commission on Environmental Quality. https://www.tceq.texas.gov/assets/public/implementation/tox/evaluations/pfcs.pdf.
    \184\ TCEQ. (2021). TRRP Protective concentration levels. Texas 
Commission on Environmental Quality. https://www.tceq.texas.gov/remediation/trrp/trrppcls.html.
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     Vermont's drinking water health advisory is 20 ppt for a 
combination of five (PFOA, PFOS, PFHxS, PFHpA and PFNA) compounds based 
on a combined risk assessment. Vermont has issued final rules amending 
a number of regulations pertaining to groundwater to set cleanup levels 
of 20 ppt for PFOA, PFOS, PFHxS, PFHpA and PFNA. These rules became 
effective on July 6, 2019. Vermont passed a law in 2019 requiring 
public water systems to monitor for PFAS.^{185 186} It also 
directed the Agency of Natural Resources to potentially regulate PFAS 
and report on various monitoring activities.\187\
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    \185\ HealthVermont. (2018). Memorandum: Drinking water health 
advisory for five PFAS (per- and polyfluorinated alkyl substances). 
Vermont Department of Health. https://www.healthvermont.gov/sites/default/files/documents/pdf/ENV_DW_PFAS_HealthAdvisory.pdf.
    \186\ Vermont ANR. (2019). Chapter 12 of the environmental 
protection rules: Groundwater protection rule and strategy. Vermont 
Agency of Natural Resources. https://dec.vermont.gov/sites/dec/files/dwgwp/DW/2019.07.06%20-%20GWPRS.pdf.
    \187\ Vermont ANR. (2019). ACT 21 (S. 49): Vermont 2019 PFAS law 
factsheet. Vermont Agency of Natural Resources. https://dec.vermont.gov/sites/dec/files/PFAS/Docs/Act21-2019-VT-PFAS-Law-Factsheet.pdf.
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     Washington is developing rule language to establish 
proposed state action levels (SALs) of 10 ppt for PFOA and 15 ppt for 
PFOS (also levels for 3 other PFAS). SALs are levels set for long-term 
daily drinking water to protect human health; systems that exceed SALs 
would be required to notify their customers.\188\
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    \188\ WA DOH. (2021). PFAS and drinking water: What is a state 
action level? Washington State Department of Health. https://www.doh.wa.gov/CommunityandEnvironment/Contaminants/PFAS#StateActionLevels.
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     Wisconsin identified a toxicity value (acceptable daily 
intake) of 2 x 10^-6 mg/kg-day for PFOA and recommended the 
ATSDR value of 2 x 10^-6 mg/kg-day for PFOS.\189\ The 
Wisconsin Department of Health Services has sent to Wisconsin 
Department of Natural Resources recommended groundwater standards of 20 
ppt for PFOA and PFOS individually and combined.\190\ The Wisconsin 
PFAS Action Council has developed statewide initiatives to address PFAS 
in Wisconsin. The council led the development of a comprehensive 
Wisconsin PFAS Action Plan that will serve as a roadmap for how state 
agencies will address these emerging chemicals.\191\
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    \189\ Wisconsin DHS. (2019). Recommended public health 
groundwater quality standards: Scientific support documents for 
cycle 10 substances. Wisconsin Department of Health Services. 
https://www.dhs.wisconsin.gov/publications/p02434v.pdf.
    \190\ Wisconsin DHS. (2021). Per- and polyfluoroalkyl substances 
(PFAS). Wisconsin Department of Health Services. https://www.dhs.wisconsin.gov/chemical/pfas.htm.
    \191\ WisPAC. (2020). Wisconsin PFAS Action Plan. Wisconsin PFAS 
Action Council. Department of Natural Resources. https://dnr.wisconsin.gov/topic/Contaminants/ActionPlan.html.
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D. Enforcement

    Enforcement actions, both by states and EPA, have been taken to 
mitigate risks from PFOA and PFOS. To date, EPA has addressed PFAS in 
16 cases using a variety of enforcement tools under the Safe Drinking 
Water Act (SDWA), TSCA, RCRA, and CERCLA,\192\ as well as overseeing 
PFAS response actions by Federal agencies at National Priorities List 
sites.
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    \192\ Where PFAS are commingled with CERCLA hazardous 
substances, EPA can require PRPs to address the PFAS. Additionally, 
CERCLA Section 120 federal facility agreements for federal 
facilities listed on the NPL require federal agencies to investigate 
and clean up hazardous substances, pollutants and contaminants which 
includes PFAS.
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    For example, in 2002 the EPA entered into an emergency 
administrative order on consent under SDWA with E. I. du Pont de 
Nemours and Company. DuPont agreed to provide alternative drinking 
water or treatment for public or private water users living near the 
Washington Works facility in Washington, West Virginia, if the level of 
PFOA detected in their drinking water was greater than the PFOA 
screening level established by a C-8 Assessment of Toxicity team. The 
C-8 Assessment team was formed pursuant to a state order and 
established the screening level for PFOA at 150,000 ppt. In 2006, after 
the science on health effects of PFOA evolved, the EPA entered into a 
second emergency administrative order under SDWA with DuPont that 
replaced the 2002 order and established a site-specific action level 
equal to or greater than 500 ppt.\193\
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    \193\ U.S. EPA. (2021). E.I. DuPont de Nemours and Company PFOA 
settlements. U.S. Environmental Protection Agency. https://www.epa.gov/enforcement/ei-dupont-de-nemours-and-company-pfoa-settlements.
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    In 2009, after EPA scientists established a provisional health 
advisory for PFOA of 400 ppt to address short-term exposure to PFOA, 
EPA entered into a third emergency administrative order under the SDWA 
with DuPont that replaced the 2006 order and lowered the allowable 
concentration of PFOA in drinking water from 500 ppt to 400 ppt in 
communities near the facility. The provisional health advisory for PFOA

[[Page 54437]]

was based on available science at that time.\194\
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    \194\ Ibid.
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    In 2017, EPA issued an amendment to the 2009 emergency 
administrative order with DuPont by adding The Chemours Company as a 
respondent and lowering the allowable concentration of PFOA in drinking 
water from 400 ppt to 70 ppt in communities near the facility. The 
amendment, issued on May 19, 2016, was based upon current science, 
changed circumstances, site-specific information, and EPA's health 
advisories for PFOA and PFOS.\195\
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    \195\ U.S. EPA. (2017). News releases from Region 03 EPA amends 
drinking water order to DuPont. U.S. Environmental Protection 
Agency. https://archive.epa.gov/epa/newsreleases/epa-amends-drinking-water-order-dupont.html.
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    Designating PFOA and PFOS as CERCLA hazardous substances will allow 
EPA to use its CERCLA enforcement authorities, in appropriate 
circumstances and where relevant statutory elements are met, which 
could allow a transfer of the cost-burden of response activities at 
privately owned sites from the taxpayers/fund to potentially 
responsible parties.

E. International Actions

    PFAS, including PFOA and PFOS, are subject to international 
treaties and individual country regulations on their production, use, 
and release to the environment.
    PFOA is identified by the United Nations Environment Programme 
(UNEP) as ``a substance of very high concern with a persistent, 
bioaccumulative and toxic structure for the environment and living 
organisms'' and is listed under Annex A of the Stockholm 
convention.\196\ (Parties must take measures to eliminate production 
and use of the chemicals listed in Annex A.)
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    \196\ UNEP. (2019). POPs chemicals Mandeeps. Stockholm 
Convention on Persistent Organic Pollutants. United Nations 
Environment Programme. https://chm.pops.int/DNNADMIN/DataEntry/MandeepsHiddenModules/POPsChemicalsMandeeps/tabid/754/Default.aspx.
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    In November 2017, the Persistent Organic Pollutants Review 
Committee adopted a risk management evaluation for PFOA, its salts and 
PFOA-related compounds, defined as ``any substances that degrade to 
PFOA, including any substances (including salts and polymers) having a 
linear or branched perfluoroheptyl group with the moiety 
(C7F15)C as one of the structural elements, for 
example: (i) Polymers with >=C8 based perfluoroalkyl side chains; 8:2 
fluorotelomer compounds; and (iii) 10:2 fluorotelomer compounds''.\197\ 
\198\ In 2019, at the 9th Conference of Parties (COP-9) meeting, the 
Stockholm Convention agreed to a global ban on PFOA and some related 
compounds for criteria including health effects such as kidney cancer, 
testicular cancer, thyroid disease, ulcerative colitis and pregnancy-
induced hypertension. This action also included five-year exemptions 
for use in semiconductor manufacturing, firefighting foams, worker-
safety textiles, photographic coatings for films and medical devices. 
While a signatory to the Stockholm Convention, the U.S. has not 
ratified and is therefore not a Party to the convention however; 
additional exemptions were requested by China, Iran and the European 
Union.\199\
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    \197\ UNEP. (2017). Report of the Persistent Organic Pollutants 
Review Committee on the work of its thirteenth meeting: Addendum: 
Risk management evaluation on pentadecafluorooctanoic acid (CAS No: 
335-67-1, PFOA, perfluorooctanoic acid), its salts and PFOA-related 
compounds. Stockholm Convention on Persistent Organic Pollutants. 
(UNEP/POPS/POPRC.13/7/Add.2). United Nations Environment Programme. 
https://chm.pops.int/TheConvention/POPsReviewCommittee/Meetings/POPRC13/MeetingDocuments/tabid/6024/Default.aspx/.
    \198\ UNEP. (2018). Report of the Persistent Organic Pollutants 
Review Committee on the work of its fourteenth meeting--Addendum to 
the risk management evaluation on perfluorooctanoic acid (PFOA), its 
salts and PFOA-related compounds. Stockholm Convention on Persistent 
Organic Pollutants. (UNEP/POPS/POPRC.14/6/Add.2). United Nations 
Environment Programme. https://chm.pops.int/theconvention/popsreviewcommittee/meetings/poprc14/overview/tabid/7398/default.aspx.
    \199\ UNEP. (2019). Recommendation by the Persistent Organic 
Pollutants Review Committee to list perfluorooctanoic acid (PFOA), 
its salts and PFOA-related compounds in Annex A to the Convention 
and draft text of the proposed amendment. Stockholm Convention on 
Persistent Organic Pollutants. (UNEP/POPS/COP.9/14). United Nations 
Environment Programme. https://chm.pops.int/TheConvention/ConferenceoftheParties/Meetings/COP9/tabid/7521/Default.aspx.
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    PFOS, along with its salts and precursor POSF have been classified 
as a persistent, highly bioaccumulative organic pollutant and listed 
under Annex B of the Stockholm Convention.\200\ At the 2009 Stockholm 
Convention COP-4 meeting, parties to the convention restricted PFOS 
production and use, but also included exemptions. The 2019 COP-9 
meeting tightened PFOA and PFOS restrictions, but left an exemption for 
the pesticide sulfluramid, which is known to degrade into PFOS and 
PFOA.\201\ \202\ This pesticide is no longer registered for use in the 
United States.
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    \200\ UNEP. (2019). POPs chemicals Mandeeps. Stockholm 
Convention on Persistent Organic Pollutants. United Nations 
Environment Programme. https://chm.pops.int/DNNADMIN/DataEntry/MandeepsHiddenModules/POPsChemicalsMandeeps/tabid/754/Default.aspx.
    \201\ UNEP. (2009). Listing of perfluorooctane sulfonic acid, 
its salts and perfluorooctane sulfonyl fluoride. Stockholm 
Convention on Persistent Organic Pollutants. (UNEP-POPS-COP.4-SC-4-
17). United Nations Environment Programme. https://chm.pops.int/TheConvention/ConferenceoftheParties/Meetings/COP4/COP4Documents/tabid/531/Agg3187_SelectTab/4/Default.aspx.
    \202\ UNEP. (2019). Evaluation of perfluorooctane sulfonic acid, 
its salts and perfluorooctane sulfonyl fluoride pursuant to 
paragraphs 5 and 6 of part III of Annex B to the Convention. 
Stockholm Convention on Persistent Organic Pollutants. (UNEP/POPS/
COP.9/7). United Nations Environment Programme. https://chm.pops.int/TheConvention/ConferenceoftheParties/Meetings/COP9/tabid/7521/Default.aspx.
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    The European Union (EU) has taken steps to regulate PFOA, its salts 
and related substances in a wide range of products.\203\ PFOA and APFO 
are also required to be classified, labelled, and packaged under 
regulation EC No 1272/2008 \204\ and there is a ban on placing these 
chemicals on the market as substances, constituents of other 
substances, or in mixtures for supply to the general public. PFNA and 
PFDA have been proposed for similar classification and labelling by 
Sweden.
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    \203\ EU. (2017). Commission regulation (EU) 2017/1000 of 13 
June 2017 amending Annex XVII to Regulation (EC) No 1907/2006 of the 
European Parliament and of the Council concerning the registration, 
evaluation, authorisation and restriction of chemicals (REACH) as 
regards perfluorooctanoic acid (PFOA), its salts and PFOA-related 
substances. (Official J Eur Union L150/14). European Union. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:32017R1000.
    \204\ EU. (2008). Regulation (EC) No 1272/2008 of the European 
Parliament and of the Council of 16 December 2008 on classification, 
labelling and packaging of substances and mixtures, amending and 
repealing Directives 67/548/EEC and 1999/45/EC, and amending 
Regulation (EC) No 1907/2006. (Official J Eur Union L353/1). 
European Union. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A32008R1272.
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    In July 2020, the European Food Safety Authority \205\ modified its 
2018 decision to set safety levels for PFOA and PFOS to include PFNA 
and PFHxS, based on their observed human bioaccumulation and toxicity. 
A combined safety threshold or group tolerable weekly limit in food and 
water of 4.4 nanograms/kilogram of body weight was set for these four 
PFAS.
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    \205\ EFSA. (2020). Risk to human health related to the presence 
of perfluoroalkyl substances in food. EFSA Journal 18: e06223. 
https://www.ncbi.nlm.nih.gov/pubmed/32994824.
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    Because there are thousands of PFAS widespread in the environment 
and substance-by-substance risk assessments, environmental monitoring 
and regulation would be extremely lengthy and resource-intensive, an 
alternative approach has been proposed to regulate PFAS as a class, or 
as subgroups, based on toxicity or chemical similarities. The agreement 
by the European Parliament and the

[[Page 54438]]

Council in December 2019 on the recast of the Drinking Water Directive 
includes a limit of 0.5 micrograms per liter for all PFAS.\206\ In 
December 2020, the European Parliament formally adopted the revised 
Drinking Water Directive.\207\ Based on the widespread occurrence of 
PFAS in the environment and their risk properties, in June 2019 the 
European Council of Ministers called for an action plan to eliminate 
all non-essential uses of PFAS.\208\
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    \206\ EEA. (2019). Emerging chemical risks in Europe--`PFAS'. 
European Environment Agency. European Union. https://www.eea.europa.eu/ds_resolveuid/a8da291194084d2eaa5bb0a9147e793a.
    \207\ EC. (2020). Review of the drinking water directive. 
European Commission. https://ec.europa.eu/environment/water/water-drink/review_en.html.
    \208\ EU. (2019). Outcome of proceedings: Subject: Towards a 
sustainable chemicals policy strategy of the Union--Council 
conclusions. Council of the European Union. https://www.consilium.europa.eu/media/40042/st10713-en19.pdf.
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    A number of countries have issued standards and guidance values for 
PFOA, PFOS, and other PFAS individually or cumulatively. These are 
summarized below.
    Australia and New Zealand \209\--The Food Standards Australia New 
Zealand (FSANZ), a statutory authority in the Australian Government 
health portfolio, and the National Medical Research Council have 
developed health-based guidance values for PFOA, PFOS, and PFHxS for 
exposure from food, drinking water and surface water used for 
recreation. The guidance values give tolerable daily intake (TDI) for 
lifetime exposure levels from food or drinking water that will not 
result in significant risk to human health. Based on the TDI, FSANZ 
recommended tolerable daily intake and issued drinking water and 
recreational water guideline values for use in site investigations in 
Australia. TDI were derived from animal studies and pharmacokinetic 
modeling used to extrapolate to humans. For PFHxS, FSANZ concluded that 
the available data were insufficient to develop a TDI and that the PFOS 
TDI should be applied to PFHxS and a combined concentration of PFOS 
plus PFHxS should be used to evaluate exposure.
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    \209\ Australian Government. (2019). Health based guidance 
values for PFAS. Australian Government, Department of Health. 
https://www1.health.gov.au/internet/main/publishing.nsf/Content/
2200FE086D480353CA2580C900817CDC/$File/HBGV-Factsheet-20190911.pdf.

------------------------------------------------------------------------
                                               Total
       Health based guidance value          PFOS+PFHxS         PFOA
------------------------------------------------------------------------
Tolerable daily intake (nanograms/                    20             160
 kilogram of body weight per day).......
Drinking water quality guideline value                70             560
 (nanograms per liter)..................
Recreational water quality guideline               2,000          10,000
 value (nanograms per liter)............
------------------------------------------------------------------------

    Canada--PFOA, its salts and precursors, as well as long-chain 
perfluorocarboxylic acids, their salts and precursors were assessed in 
2012. These substances are prohibited for import and use with a limited 
number of exemptions under the Prohibition of Certain Toxic Substances 
Regulations, 2012. In 2018 additional proposed amendments to the 
Canadian Environmental Protection Act, 1999, to regulate additional 
PFAS were postponed to late 2021. The proposed amendments include PFOS, 
its salts and precursors that contain one of the following groups: 
C8F17SO2, 
C8F17SO3 or 
C8F17SO2N (PFOS), PFOA and its salts 
and precursors. It also includes all longer chain perfluorocarboxylic 
acids having the molecular formula 
CnF2n+1CO2H in which 8 <= n <= 20, 
their salts and precursors.\210\ \211\
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    \210\ Environment and Climate Change Canada. (2021). Toxic 
substances list: long-chain perfluorocarboxylic acids. Environment 
and Climate Change Canada, Government of Canada. https://www.canada.ca/en/environment-climate-change/services/management-toxic-substances/list-canadian-environmental-protection-act/long-chain-perfluorocarboxylic-acids.html.
    \211\ Environment and Climate Change Canada. (2021). Toxic 
substances list: PFOS. Environment and Climate Change Canada, 
Government of Canada. https://www.canada.ca/en/environment-climate-change/services/management-toxic-substances/list-canadian-environmental-protection-act/perfluorooctane-sulfonate.html.
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    Guidelines for Canadian Drinking Water Quality set the maximum 
acceptable concentration (MAC) for PFOA in drinking water at 200 ppt 
\212\ and PFOS in drinking water at 600 ppt.\213\ These MACs are based 
on exposure to individual chemicals. Because the toxicological effects 
of PFOA and PFOS are additive they should be evaluated together, and 
the ratio of the observed concentration for PFOS to its MAC plus the 
ratio of the observed concentration for PFOA to its MAC should be below 
1 for drinking water to considered safe.^{214 215} For other 
PFAS with a more limited database, drinking water screening values were 
developed.
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    \212\ Health Canada. (2018). Guidelines for Canadian drinking 
water quality: Guideline technical document--perfluorooctanoic acid 
(PFOA). Health Canada. Minister of Health. https://www.canada.ca/en/health-canada/services/publications/healthy-living/guidelines-canadian-drinking-water-quality-technical-document-perfluorooctanoic-acid/document.html.
    \213\ Health Canada. (2018). Guidelines for Canadian drinking 
water quality: Guideline technical document--perfluorooctane 
sulfonate (PFOS). Health Canada. Minister of Health. https://www.canada.ca/en/health-canada/services/publications/healthy-living/guidelines-canadian-drinking-water-quality-guideline-technical-document-perfluorooctane-sulfonate/document.html.
    \214\ Health Canada. (2018). Guidelines for Canadian drinking 
water quality: Guideline technical document--perfluorooctanoic acid 
(PFOA). Health Canada. Minister of Health. https://www.canada.ca/en/health-canada/services/publications/healthy-living/guidelines-canadian-drinking-water-quality-technical-document-perfluorooctanoic-acid/document.html.
    \215\ Health Canada. (2018). Guidelines for Canadian drinking 
water quality: Guideline technical document--perfluorooctane 
sulfonate (PFOS). Health Canada. Minister of Health. https://www.canada.ca/en/health-canada/services/publications/healthy-living/guidelines-canadian-drinking-water-quality-guideline-technical-document-perfluorooctane-sulfonate/document.html.
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    Peoples Republic of China--The ``Industrial Recon-structuring Guide 
Directory'' \216\ restricted the production of PFOS and PFOA. In 2014, 
the Ministry of Environmental Protection announcement No. [2014]21, 
banned ``production, transportation, application, imports and exports 
of PFOS, its salts, and POSF, except for specific exemptions and 
acceptable use.''
---------------------------------------------------------------------------

    \216\ OECD. (2021). Portal on per and poly fluorinated 
chemicals: Country information: People's Republic of China. 
Organisation for Economic Co-operation and Development. https://www.oecd.org/chemicalsafety/portal-perfluorinated-chemicals/countryinformation/china.htm.
---------------------------------------------------------------------------

    Denmark--Based on toxicity the Danish Environmental Protection 
Agency \217\ has identified health-based criteria or limit values for 
drinking water, groundwater used for drinking water and soil. Criteria 
or limit values for drinking water and groundwater used for drinking 
water are 100 nanograms per liter for PFOS and/or PFOSA (a PFOS 
precursor) and 300

[[Page 54439]]

nanograms per liter for PFOA. For cumulative exposure the ratio of the 
sum of concentration/limit value ratios for PFOA, PFOS and PFOSA should 
be below 1.
---------------------------------------------------------------------------

    \217\ Danish Ministry of the Environment. (2015). 
Perfluoroalkylated substances: PFOA, PFOS and PFOSA: Evaluation of 
health hazards and proposal of a health based quality criterion for 
drinking water, soil and ground water. (Environmental project No. 
1665). Copenhagen, Denmark: The Danish Environmental Protection 
Agency. https://www2.mst.dk/Udgiv/publications/2015/04/978-87-93283-01-5.pdf.
---------------------------------------------------------------------------

    The health-based criteria or limit value for soil is 390 micrograms 
per kilogram for PFOS and PFOSA and 1,300 micrograms per kilogram for 
PFOA and its salts. Cumulatively the sum of concentration/limit value 
ratios for PFOA, PFOS and PFOSA should be below 1.\218\
---------------------------------------------------------------------------

    \218\ Ibid.
---------------------------------------------------------------------------

    The Danish Ministry of the Environment and Food \219\ banned food 
contact paper and cardboard in which per and polyfluoro chemicals, 
including PFOA and PFOS and their salts and precursors, have been used 
unless they incorporate a barrier to prevent migration into food.
---------------------------------------------------------------------------

    \219\ PackingLaw.com. (2020). Denmark's PFAS ban in paper and 
cardboard effective in July 2020. Keller and Heckman LLP. https://www.packaginglaw.com/news/denmarks-pfas-ban-paper-and-cardboard-effective-july-2020.
---------------------------------------------------------------------------

    Japan--In 2010, Japan designated PFOS, its salts, and POSF as Class 
I Specified Chemical Substances following their addition to the 
Stockholm Convention on Persistent to Organic Pollutants Annex B 
regulating manufacture, use, export, and import of PFOA and its 
salts.\220\
---------------------------------------------------------------------------

    \220\ Ministry of the Environment of Japan. (2013). Summary of 
the guideline on the treatment of wastes containing perfluorooctane 
sulfonic acid (PFOS), and its salts in Japan. Ministry of the 
Environment of Japan. https://www.env.go.jp/en/focus/docs/files/201304-89.pdf.
---------------------------------------------------------------------------

    Norway--Norway listed PFOA and PFOS on its national list of 
priority substances \221\ based on monitoring data that showed high 
levels of these substances in the environment as well as their 
toxicological profiles. In 2014, Norway banned manufacturing, 
production, import and retail of consumer products containing 
PFOA.\222\
---------------------------------------------------------------------------

    \221\ OECD. (2021). Portal on per and poly fluorinated 
chemicals: Country information: Norway. Organisation for Economic 
Co-operation and Development. https://www.oecd.org/chemicalsafety/portal-perfluorinated-chemicals/countryinformation/norway.htm.
    \222\ UL. (2013). Norway introduces restrictions on PFOA. UL, 
LLC. https://www.ul.com/news/norway-introduces-restrictions-pfoa.
---------------------------------------------------------------------------

VIII. Statutory and Executive Order Reviews

    Additional information about these statutes and Executive Orders 
can be found at https://www.epa.gov/laws-regulations/laws-and-executive-orders.

A. Executive Order 12866: Regulatory Planning and Review and Executive 
Order 13563: Improving Regulation and Regulatory Review

    This action is a significant regulatory action that was submitted 
to the OMB for review. While EPA is not considering costs in its 
hazardous substance designation decisions in this proposed rule, and 
despite that there is still significant uncertainty and lack of data as 
discussed in the economic analysis (EA), OMB designated this proposed 
rulemaking as an economically significant action. Any changes made in 
response to the OMB recommendations have been documented in the docket. 
Although CERCLA section 102(a) precludes EPA from taking cost into 
account in the designation of a hazardous substance, to inform the 
public, EPA prepared an EA of the potential costs, benefits, and 
impacts associated with this action. This analysis, Economic Assessment 
of the Potential Costs and Other Impacts of the Proposed Rulemaking to 
Designate Perfluorooctanoic Acid and Perfluorooctanesulfonic Acid as 
Hazardous Substances is available in the docket for this action. The EA 
includes request for comments on several topics that EPA does not 
currently have robust information about. Please see Section ES-5 of the 
EA for specific details.
    If finalized, this proposed CERCLA designation is estimated to have 
a quantifiable direct annual social cost of approximately $370,000 from 
reporting releases at or above the RQ. Additional, unquantifiable 
future costs may occur when Federal agencies sell or transfer real 
property where PFOA or PFOS was stored, released or disposed of as 
specified by CERCLA section 120(h). There is also the direct effect 
resulting in an obligation of DOT to list and regulate CERCLA-
designated hazardous substances as hazardous materials under the 
Hazardous Materials Transportation Act (see CERCLA Section 306(a)). EPA 
estimates these incremental costs associated with the DOT rulemaking as 
zero or negligible. This action's direct benefits from release 
reporting include improved quality of information providing a more 
comprehensive understanding of the number and location of PFOA and PFOS 
releases meeting or exceeding the RQ. An important benefit of this 
information is that it may lead to more efficient property and capital 
markets. Another potential direct benefit from the proposed reporting 
requirement is better waste management and/or treatment by facilities 
handling PFOA or PFOS. Greater transparency provided by release 
reporting can lead to fewer releases to the environment and thus to 
health benefits associated with avoided exposure.
    Designating PFOA and PFOS as hazardous substances may also have 
indirect, indeterminate impacts associated with potential increases in 
the speed of response activity and in the total number of response 
actions taken to address PFOA and PFOS releases. Both potential 
increases may lead to health benefits associated with avoided risks. 
Other indirect effects may be experienced as a result of the movement 
forward in time of assessment and cleanup costs. The proposed 
designation would also improve the Agency's ability to transfer 
response costs from the public to polluters contingent upon specific 
statutory requirements being met and discretionary actions by EPA. 
These indirect costs, benefits, and transfers cannot be quantified due 
to significant uncertainties about each. The full discussion of these 
impacts can be found in the EA.

B. Paperwork Reduction Act

    The information collection activities in this proposed rule have 
been submitted for approval to the OMB under the Paperwork Reduction 
Act. The Information Collection Request (ICR) document that the EPA 
prepared has been assigned EPA ICR number 2708.01. You can find a copy 
of the ICR in the docket for this rule, and it is briefly summarized 
here.
    If finalized, the designation of PFOA and PFOS, and their salts and 
structural isomers, as hazardous substances would require any person in 
charge of a vessel or facility that identifies a release of one pound 
or more within a 24-hour period of these substances to report the 
release to the NRC under section 103 of CERCLA and to the SERC (or 
TERC) and LEPC (or TEPC) under section 304 of EPCRA. The implementing 
regulations of CERCLA section 103 and EPCRA section 304 are codified at 
40 CFR parts 302 and 355, respectively.
    Respondents/affected entities: Any person in charge of a vessel or 
facility from which there is a release of PFOA or PFOS and their salts 
and structural isomers, equal to or greater than the RQ of one pound 
within 24 hours.
    Respondent's obligation to respond: Mandatory under section 103 of 
CERCLA and section 304 of EPCRA.
    Estimated number of respondents: From 0 to 660 releases per year.
    Frequency of response: Varies.

[[Page 54440]]

    Total estimated burden: 6,415 hours (per year) maximum. Burden is 
defined at 5 CFR 1320.3(b).
    Total estimated cost: $370,000 (per year) maximum, includes $3,503 
annualized operation and maintenance costs (and no capital costs).
    An agency may not conduct or sponsor, and a person is not required 
to respond to, a collection of information unless it displays a 
currently valid OMB control number. The OMB control numbers for the 
EPA's regulations in 40 CFR are listed in 40 CFR 9.
    Submit your comments on the Agency's need for this information, the 
accuracy of the provided burden estimates and any suggested methods for 
minimizing respondent burden to the EPA using the docket identified at 
the beginning of this rule. You may also send your ICR-related comments 
to OMB's Office of Information and Regulatory Affairs using the 
interface at www.reginfo.gov/public/do/PRAMain. Find this particular 
information collection by selecting ``Currently under Review--Open for 
Public Comments'' or by using the search function. Since OMB is 
required to make a decision concerning the ICR between 30 and 60 days 
after receipt, OMB must receive comments no later than October 6, 2022. 
The EPA will respond to any ICR-related comments in the final rule.

C. Regulatory Flexibility Act (RFA)

    I certify that this action will not have a significant economic 
impact on a substantial number of small entities under the RFA. The 
small entities subject to the requirements of this action are: (1) 
producers and importers of PFOA and PFOS, (2) producers and users of 
PFOA or PFOS-containing articles, and (3) waste management and 
wastewater facilities. The Agency has estimated that there may be up to 
660 reported releases of PFOA or PFOS in any one year and that an 
indeterminate number, but small percentage, of the annual reports will 
be submitted by small entities. The estimated cost of $561 to report a 
release of PFOA or PFOS is not greater than 1% of the annual revenues 
per small entity in any impacted industry. Details of this analysis are 
presented in the Economic Assessment of the Potential Costs and Other 
Impacts of the Proposed Rulemaking to Designate Perfluorooctanoic Acid 
and Perfluorooctanesulfonic Acid as Hazardous Substances. We have 
therefore concluded that this action will not have a significant 
regulatory burden for all directly regulated small entities.

D. Unfunded Mandates Reform Act (UMRA)

    This action does not contain an unfunded mandate of $100 million or 
more as described in UMRA, 2 U.S.C. 1531-1538, and does not 
significantly or uniquely affect small governments. This action is 
expected to result in reporting costs of $561 per release that meets or 
exceeds the RQ, and the estimated annual cost of the proposed rule is 
not expected to exceed $370,000 per year.

E. Executive Order 13132: Federalism

    This action does not have federalism implications. It will not have 
substantial direct effects on the states, on the relationship between 
the national government and the states, or on the distribution of power 
and responsibilities among the various levels of government.

F. Executive Order 13175: Consultation and Coordination With Indian 
Tribal Governments

    This action does not have Tribal implications as specified in 
Executive Order 13175 because it does not have substantial direct 
effects on one or more Tribal Nations, on the relationship between the 
Federal Government and Tribal Nations, or on the distribution of power 
and responsibilities between the Federal Government and Tribal Nations. 
EPA does not expect that it would result in any adverse impacts on 
tribal entities. Thus, Executive Order 13175 does not apply to this 
action.
    Consistent with the EPA Policy on Consultation with Tribal Nations, 
the EPA intends to consult with and request comments from tribal 
officials.

G. Executive Order 13045: Protection of Children From Environmental 
Health Risks and Safety Risks

    This action, which proposes to designate PFOA and PFOS as hazardous 
substances, does not itself address environmental health or safety 
risks. Beyond the requirements of E.O. 13045, EPA's 2021 Policy on 
Children's Health (October 5, 2021) \223\ requires EPA to consider 
early life exposures and lifelong health consistently and explicitly in 
all human health decisions. The EPA believes that the environmental 
health or safety risk posed by exposure to PFOA and/or PFOS may have a 
disproportionate effect on children. A discussion of health and risk 
assessments related to PFOA and PFOS, including developmental and 
reproductive health effects, are contained in EPA's Health Effects 
Support Documents for PFOA and PFOS (2016).
---------------------------------------------------------------------------

    \223\ U.S. EPA. (2021). The administrator: 2021 policy on 
children's health. Washington, DC: U.S. Environmental Protection 
Agency. https://www.epa.gov/system/files/documents/2021-10/2021-policy-on-childrens-health.pdf.
---------------------------------------------------------------------------

H. Executive Order 13211: Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution or Use

    This action is not a ``significant energy action'' because it is 
not likely to have a significant adverse effect on the supply, 
distribution or use of energy. This action proposes to designate PFOA 
and PFOS as hazardous substances, and thus, does not involve the 
supply, distribution or use of energy.

I. National Technology Transfer and Advancement Act

    This action does not involve technical standards.

J. Executive Order 12898: Federal Actions To Address Environmental 
Justice in Minority Populations and Low-Income Populations

    The EPA is unable to determine if this action does or does not have 
disproportionately high and adverse human health or environmental 
effects on minority populations, low-income populations and/or 
indigenous peoples, as specified in Executive Order 12898 (59 FR 7629, 
February 16, 1994).
    Several key demographic categories were analyzed relative to 
facilities with known historical use and/or releases of PFOA and 
PFOS.\224\ Because the location of future releases of PFAS is 
uncertain, this analysis considers populations around facilities in 
sectors associated with widespread historical uses and releases of PFAS 
as proxies for facilities that may have future releases of the PFAS 
considered in the proposed rule. This analysis examines the following 
site types as proxies for facilities that are known to have commonly 
used PFAS:
---------------------------------------------------------------------------

    \224\ U.S. EPA. ([2021]). Assessment of the potential costs and 
other impacts of the proposed rulemaking to designate 
perfluorooctanoic acid and perfluorooctanesulfonic acid as hazardous 
substances. U.S. Environmental Protection Agency.

 Operating Department of Defense (DOD) facilities
 Operating U.S. airports and airfields

[[Page 54441]]

 Plastics material and resin manufacturing firms identified as 
having produced PFOS and/or PFOA,
 2020 PFOS and PFOA releases reported to EPA's Toxic Release 
Inventory (TRI)

    On average, airports across the U.S. are surrounded by populations 
that reflect national averages in relevant demographic categories. 
Large airports, however, are more likely to be surrounded by minority 
and low-income populations than medium or small airports. Some DOD 
sites are surrounded by populations with higher
concentrations of minority and low-income residents, but the majority 
of these sites are below the national averages for these metrics. In 
contrast, areas around plastics material and resin manufacturer sites 
and/or sites reporting releases to TRI, on average, are in areas with 
higher concentrations of minority residents and households experiencing 
poverty than the U.S. averages for these demographics, suggesting that 
releases related to manufacturing facilities could have environmental 
justice implications. A complete discussion of the analysis behind 
these findings is available in Section 4.3 of the EA accompanying this 
rulemaking. These findings, combined with the uncertainty surrounding 
the location of future releases, are indicative of potential impacts 
but do not provide a clear indication of the type of disparities 
related to potential exposure to PFAS. Consistent with the priorities 
outlined in Executive Orders 12898 \225\ and 14008,\226\ it is unclear 
whether this proposed regulation will have a significant impact on 
disadvantaged populations or communities with environmental justice 
(EJ) concerns relative to other communities. While the locations that 
may report releases are unknown, to the extent that these proxy 
locations are representative of likely reporting locations, this 
screening analysis suggests that the reporting required under the rule 
may provide better information to nearby populations potentially at 
risk of exposure, including communities with EJ concerns. To the extent 
that PFAS releases are consistent with the broader releases reported to 
TRI and typically involve disposal or manufacturing sites, demographic 
data around plastics material and resin manufacturer sites and 
historical releases may be a more reliable predictor of the type of 
community potentially affected by this proposed rulemaking. Specific 
site conditions and demographic patterns may become clear as reporting 
occurs following completion of a final rule. Once available, this 
information would improve EPA's ability to examine disparate impacts on 
EJ communities. This improved information would not increase risk for 
communities with EJ concerns and may improve the speed and design of 
remediation. EPA is committed to minimizing and/or eliminating existing 
barriers and burdens that communities with EJ concerns may encounter 
related to accessing data and information collected as a result of this 
rulemaking, if finalized. EPA seeks comment on strategies to improve 
access to the reporting data expected to be collected, if designation 
of PFOA and PFOS as hazardous substances is finalized, for communities 
with environmental justice concerns.
---------------------------------------------------------------------------

    \225\ The White House. (1994). Presidential documents: Executive 
order 12898 of February 11, 1994: Federal actions to address 
environmental justice in minority populations and low-income 
populations. Federal Register 59: 7629. https://www.archives.gov/files/federal-register/executive-orders/pdf/12898.pdf.
    \226\ WH.gov. (2021). Executive order on tackling the climate 
crisis at home and abroad. Washington, DC: The White House. https://www.whitehouse.gov/briefing-room/presidential-actions/2021/01/27/executive-order-on-tackling-the-climate-crisis-at-home-and-abroad/.
---------------------------------------------------------------------------

    Further, the documentation for this decision is contained in the 
following sections in the preamble to this action: II.C., VI.A. and B. 
These sections explain that the designation of PFOA and PFOS as 
hazardous substances, if finalized, and the required reporting and 
notification requirements, will result in more information about the 
location and extent of releases. This improved information does not 
increase risk or result in any adverse environmental justice impacts.

List of Subjects in 40 CFR Part 302

    Environmental protection, Air pollution control, Chemicals, 
Hazardous substances, Hazardous waste, Intergovernmental relations, 
Natural resources, Reporting and recordkeeping requirements, Superfund, 
Water pollution control, Water supply.

Michael S. Regan,
Administrator.

    For the reasons set forth in the preamble, EPA proposes to amend 40 
CFR part 302 as follows:

PART 302--DESIGNATION, REPORTABLE QUANTITIES, AND NOTIFICATION

0
1. The authority citation for part 302 continues to read as follows:

    Authority:  33 U.S.C. 1251 et. seq., 42 U.S.C. 9601, et seq., 42 
U.S.C. 9602, 42 U.S.C. 9603.

0
2. Amend Sec.  302.4 by:
0
a. Revising in paragraph (b) the Note II to Table;
0
b. Adding in the Table--List of Hazardous Substances and Reportable 
Quantities in alphabetical order the following new entries for 
''Perfluorooctanesulfonic acid, salts, & structural isomers'' and 
``Perfluorooctanoic acid, & salts, & structural isomers'';
0
c. Adding in Appendix A--Sequential CAS Registry Number List of CERCLA 
Hazardous Substances in numerical order the new entries for ``335-67-
1'' and ``1763-23-1''.
    The revisions read as follows:


Sec.  302.4  [Amended]

* * * * *
    (b) * * *

Note II to Table 302.4

    Hazardous substances are given a Statutory Code based on their 
statutory source. The ``Statutory Code'' column indicates the statutory 
source for designating each substance as a CERCLA hazardous substance. 
Statutory Code ``1'' indicates a Clean Water Act (CWA) Hazardous 
Substance. Statutory Code ``2'' indicates a CWA Toxic Pollutant. 
Statutory Code ``3'' indicates a CAA HAP. Statutory Code ``4'' 
indicates Resource Conservation and Recovery Act (RCRA) Hazardous 
Wastes. Statutory Code ``5'' indicates a hazardous substance designated 
under section 102(a) of CERCLA. The ``RCRA waste No.'' column provides 
the waste identification numbers assigned by RCRA regulations. The 
``Final RQ [pounds (kg)]'' column provides the reportable quantity for 
each hazardous substance in pounds and kilograms.
* * * * *

[[Page 54442]]



                       Table 302.4--List of Hazardous Substances and Reportable Quantities
                            [All comments/notes are located at the end of this table]
----------------------------------------------------------------------------------------------------------------
                                                           Statutory
           Hazardous substance                 CASRN          code          RCRA waste No.           Final RQ
                                                            [dagger]                              [pounds (kg)]
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
Perfluorooctanesulfonic acid, & salts, &       1763-23-1            5  ........................       ## (0.454)
 structural isomers.
Perfluorooctanoic acid, & salts, &              335-67-1            5  ........................       ## (0.454)
 structural isomers.
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *

Appendix A to Sec.  302.4--Sequential CAS Registry Number List of 
CERCLA Hazardous Substances

------------------------------------------------------------------------
          CASRN                         Hazardous substance
------------------------------------------------------------------------
335-67-1.................  Perfluorooctanoic acid, & salts, & structural
                            isomers.
1763-23-1................  Perfluorooctanesulfonic acid, & salts, &
                            structural isomers.
------------------------------------------------------------------------


[FR Doc. 2022-18657 Filed 9-2-22; 8:45 am]
BILLING CODE 6560-50-P

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