Designation of Perfluorooctanoic Acid (PFOA) and Perfluorooctanesulfonic Acid (PFOS) as CERCLA Hazardous Substances, 39124-39192 [2024-08547]

Download as PDF 39124 Federal Register / Vol. 89, No. 90 / Wednesday, May 8, 2024 / Rules and Regulations ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 302 [EPA–HQ–OLEM–2019–0341; FRL–7204– 03–OLEM] RIN 2050–AH09 Designation of Perfluorooctanoic Acid (PFOA) and Perfluorooctanesulfonic Acid (PFOS) as CERCLA Hazardous Substances Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: Pursuant to the Comprehensive Environmental Response, Compensation, and Liability Act (‘‘CERCLA’’ or ‘‘Superfund’’), the Environmental Protection Agency (EPA) is designating two per- and polyfluoroalkyl substances (PFAS)— perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS), including their salts and structural isomers—as hazardous substances. The Agency reached this decision after evaluating the available scientific and technical information about PFOA and PFOS and determining that they may present a substantial danger to the public health or welfare or the environment when released. The Agency also determined that designation is warranted based on a totality of the circumstances analysis, including an analysis of the advantages and disadvantages of designation. DATES: Effective July 8, 2024. ADDRESSES: EPA has established a docket for this rulemaking under Docket ID No. EPA–HQ–OLEM–2019–0341. All documents in the docket are listed in https://www.regulations.gov/. Although listed, some information is not publicly available, e.g., Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the internet and will be publicly available only in hard copy. With the exception of such material, publicly available docket materials are available electronically in https:// www.regulations.gov. FOR FURTHER INFORMATION CONTACT: Sicy Jacob, Office of Emergency Management (5104A), Environmental Protection Agency, 1200 Pennsylvania Avenue NW, Washington, DC 20460; telephone number 202–564–8019; email address: jacob.sicy@epa.gov or Linda Strauss, Office of Superfund Remediation and Technology Innovation, Environmental Protection Agency, 1200 Pennsylvania lotter on DSK11XQN23PROD with RULES3 SUMMARY: VerDate Sep<11>2014 18:22 May 07, 2024 Jkt 262001 Avenue NW, Washington, DC 20460; telephone number 202–564–0797; email address: strauss.linda@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, EPA defines the following terms and acronyms here: AFFF Aqueous film-forming foam ARARs Applicable or Relevant and Appropriate Requirements ATSDR Agency for Toxic Substances and Disease Registry CDC Centers for Disease Control and Prevention CASRN Chemical Abstracts Service Registry Number COC Contaminant of Concern CDR Chemical Data Reporting CERCLA Comprehensive Environmental Response, Compensation, and Liability Act CFR Code of Federal Regulations DoD Department of Defense DOE Department of Energy EA Economic Analysis 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 ICR Information Collection Request LEPC Local Emergency Planning Committee MCL Maximum contaminant level MCLG Maximum Contaminant Level Goals (MCLGs) NAICS North American Industrial Classification System NCP National Oil and Hazardous Substances Pollution Contingency Plan NECI National Enforcement Compliance Initiative NHANES National Health and Nutrition Examination Survey NPDWR National Primary Drinking Water Regulation NPL National Priorities List NRC National Response Center OMB Office of Management and Budget PCBs Polychlorinated biphenyls PFAS Per- and polyfluoroalkyl substances PFOA Perfluorooctanoic acid PFOS Perfluorooctanesulfonic acid PFOSA Perfluorooctanesulfonamide PHGs Public health goals ppt parts per trillion PRG Preliminary remediation goal PRP Potentially responsible party PRSC Post-Removal Site Control PWS Public water system RCRA Resource Conservation and Recovery Act RFA Regulatory Flexibility Act RfD Reference dose RQ Reportable quantity SAB Science Advisory Board SDWA Safe Drinking Water Act SERC State Emergency Response Commission PO 00000 Frm 00002 Fmt 4701 Sfmt 4700 SNURs Significant New Use Rules TEPC Tribal Emergency Planning Committee TERC Tribal Emergency Response Commission TRI Toxic Release Inventory TSCA Toxic Substances Control Act UCMR Unregulated Contaminant Monitoring Rule UMRA Unfunded Mandates Reform Act U.S. United States WWTP Wastewater treatment plant Table of Contents I. Executive Summary II. General Information A. What action is the Agency taking? B. What are the Direct Effects of this Action? C. Does this action apply to me? D. What is the Agency’s Authority for taking this Action? E. What are CERCLA’s primary objectives, and how does it operate to protect human health and the environment? 1. How does CERCLA authority and causes of action differ in key respects between ‘‘hazardous substances’’ and ‘‘pollutants or contaminants’’? 2. What response actions does CERCLA authorize? 3. What discretionary authority does CERCLA provide and how does CERCLA prioritize cleanup actions? 4. What is the CERCLA cleanup process and what role does the National Priorities List (NPL) play in it? 5. What is the process for identifying and selecting remedial actions under CERCLA? 6. How does CERCLA’s framework ensure that those responsible for contamination pay for cleanup? 7. What enforcement discretion is available when exercising CERCLA authority? 8. Why is understanding CERCLA’s overarching provisions critical to understanding the importance of this rulemaking to EPA’s ability to protect human health and the environment? III. Background of this Rulemaking A. Summary of Proposed Designation. B. PFOA and PFOS Production and Use C. EPA’s PFAS Strategic Map IV. Legal Authority A. CERCLA section 102(a) Designation Considerations B. Consistency with other methodologies for identifying CERCLA hazardous substances. C. CERCLA Section 102(a) and Cost Considerations. V. PFOA and PFOS may present a substantial danger to the public health or welfare or the environment when released into the environment. A. PFOA and PFOS Pose a Hazard. B. Information about the fate and transport of PFOA and PFOS demonstrate that they are Persistent and Mobile in the Environment. C. Other Information Considered. VI. The totality of the circumstances confirms that designation of PFOA and PFOS as hazardous substances is warranted. A. Advantages of designation E:\FR\FM\08MYR3.SGM 08MYR3 lotter on DSK11XQN23PROD with RULES3 Federal Register / Vol. 89, No. 90 / Wednesday, May 8, 2024 / Rules and Regulations 1. Designation enables earlier, broader, and more effective cleanups of contaminated sites. a. Designation opens up CERCLA’s notification, response, enforcement, and cost recovery authorities, which allows EPA to more timely address contaminated sites. b. The availability of CERCLA enforcement and cost recovery authority ensures that polluters are financially responsible, which is consistent with CERCLA. c. EPA expects designation will increase Emergency Response and Removal Actions for PFOA/PFOS. d. EPA expects that shifting costs to PRPs to address PFOA/PFOS contamination at NPL sites will make Fund money available for other response work. 2. Designation Brings Broad Health Benefits a. Qualitative potential benefits from decreased exposure after addressing PFOA/PFOS contamination b. Quantifiable health benefits of PFOA and PFOS exposure reduction. i. Quantified Developmental Effects ii. Quantified Cardiovascular Effects iii. Quantified Kidney Cancer Effects iv. Estimated health benefits of PFOA and PFOS exposure reduction. c. Cost Estimates of Burden of PFASRelated Disease d. Environmental Justice (EJ) Analysis e. Summary of health benefits resulting from the designation. 3. Property Reuse and Social, Economic, and Ecological Benefits that may Result from Designation 4. Some facilities may adopt or improve best practices to prevent future releases of PFOA and PFOS B. Potential Disadvantages of Designation 1. Direct costs 2. Potential hardship for parties that did not contribute significantly to contamination. 3. Potential litigation, liability, and uncertainty, C. Results of Totality of the Circumstances Analysis VII. Summary of Public Comments and Responses A. Legal Authority B. Operation of CERCLA C. Toxicity, Human Health Effects/ Mobility, Persistence, Prevalence/ Release into the environment D. Effects of Designation E. National Priorities List (NPL) Sites— Existing and Future Contamination F. Regulate PFAS as a class. G. Managing PFOA and PFOS Contaminated Waste H. Comments on Economic Assessment/ Regulatory Impact Analysis I. Enforcement VIII. Summary of this Final Rule A. Default Reportable Quantity B. Direct Effects of Designating PFOA, PFOS, and their Salts and Structural Isomers as Hazardous Substances IX. Statutory and Executive Order Reviews A. Executive Order 12866: Regulatory Planning and Review, as amended by Executive Order 14094: Modernizing Regulatory Review VerDate Sep<11>2014 18:22 May 07, 2024 Jkt 262001 B. Paperwork Reduction Act C. Regulatory Flexibility Act D. Unfunded Mandates Reform Act (UMRA) 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 and Executive Order 14096: Revitalizing our Nation’s Commitment to Environmental Justice for All References I. Executive Summary A. Overview Pursuant to section 102(a) of the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA), EPA is designating perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS), including their salts and structural isomers, as hazardous substances.1 Each of the actions adding PFOA, PFOS, and their salts and structural isomers, to CERCLA’s hazardous substances list is independent, and severable from the others. The Agency evaluated the available scientific and technical information about those substances and concluded that designation of each substance is warranted under the criteria in section 102(a) because both PFOA and PFOS, and their salts and isomers, may present substantial danger to public health or welfare or the environment. Exercising its discretion with respect to when to make a finding under section 102(a), EPA as part of its decision-making process went beyond considering whether PFOA and PFOS ‘‘may present a substantial danger to public health welfare or the environment’’ within the meaning of section 102(a), and also performed an additional analysis that weighed the advantages and disadvantages of designation, including quantitative and qualitative benefits and costs. As part of that additional discretionary analysis, EPA determined that the advantages of designation outweigh the disadvantages. Among other advantages, designation 1 PFOA and PFOS are part of a group of humanmade chemicals known as per- and polyfluoroalkyl substances (PFAS). All references to PFOA and PFOS in this notice include their salts and structural isomers. PO 00000 Frm 00003 Fmt 4701 Sfmt 4700 39125 best serves CERCLA’s two primary objectives—the timely cleanup of contaminated sites and holding polluters accountable for contamination they caused (i.e., the ‘‘Polluter Pays’’ principle). Designation provides necessary tools to address the challenge of PFOA and PFOS contamination in the environment. Designation will allow EPA to utilize all CERCLA’s authorities, which will enable EPA to address more sites, take earlier action, and to expedite eventual cleanup. Designating PFOA and PFOS as CERCLA hazardous substances is thus critical to addressing PFOA and PFOS releases in the environment and to protecting public health. B. ‘‘May Present Substantial Danger to Public Health or Welfare or the Environment’’ EPA is taking final action on the proposed finding that both PFOA and PFOS ‘‘may present substantial danger to public health or welfare or the environment’’ when released into the environment after considering the available scientific and technical information and after considering comments on the proposed determination. Available information indicates that human exposure to PFOA and/or PFOS is linked to a broad range of adverse health effects, including developmental effects to fetuses during pregnancy or to infants (e.g., low birth weight, accelerated puberty, skeletal variations), liver effects (e.g., tissue damage), immune effects (e.g., antibody production and immunity), and other effects (e.g., cholesterol changes). Both PFOA and PFOS are known to be transmitted to the fetus via the placenta and to the newborn, infant, and child via breast milk. In addition, toxicity assessments in support of EPA’s 2024 National Primary Drinking Water Regulation for PFAS (2024a) indicate that PFOA and PFOS may cause carcinogenic effects in humans and animals (Barry et al., 2013; Bartell & Vieira, 2021; Goodrich et al., 2022; Shearer et al., 2021; Vieira et al., 2013). In the final toxicity assessments, EPA assessed the weight of the evidence for the available cancer data and determined that PFOA and PFOS are Likely to Be Carcinogenic to Humans consistent with the Guidelines for Carcinogen Risk Assessment (U.S. EPA, 2005, 2024b, 2024c, 2024d). Additionally, in November 2023, the International Agency for Research on Cancer (IARC) evaluated the carcinogenicity of PFOA and PFOS and classified PFOA as carcinogenic to humans (Group 1) and PFOS as possibly E:\FR\FM\08MYR3.SGM 08MYR3 39126 Federal Register / Vol. 89, No. 90 / Wednesday, May 8, 2024 / Rules and Regulations lotter on DSK11XQN23PROD with RULES3 carcinogenic to humans (Group 2b) (Zahm, et al., 2023). The potential for adverse health effects is exacerbated by the fact that PFOA and PFOS are persistent in the environment, which can cause longterm exposure. PFAS, including PFOA and PFOS, are sometimes referred to as ‘‘forever’’ chemicals because of their strong carbon-fluorine bonds in the ‘‘tail group’’ that cause them to be extremely resistant to degradation and to remain in the environment for long periods of time. This means that the potential for human exposure continues long after an immediate release has ended. PFOA and PFOS are also highly mobile in the environment and can migrate away from the point of initial release. Studies also show that PFOA and PFOS persist in humans and animals (i.e., bioaccumulate) with estimated elimination half-lives 2 in humans ranging from about two to three years for PFOA to four or five years for PFOS 3 (ATSDR, 2021). Because PFOA and PFOS can remain in the human body for these long durations, individuals who have consistent ongoing exposures to elevated concentrations of PFOA and PFOS (e.g., individuals exposed by drinking contaminated well water) can have elevated concentrations of these compounds in their bodies which may contribute to adverse health effects (Hall et al., 2023; Hoffman et al., 2011; Kotlarz et al., 2020; Steenland et al., 2009). PFOA and PFOS are prevalent in the environment and can be found in surface water, groundwater, soil, and air. PFOA and PFOS are prevalent because they have been produced and used since the 1940s, were among the most widely used of the PFAS constituents and persist in the environment for a long time. PFOA and PFOS have historically been used in a wide range of consumer products including carpets, clothing, fabrics for furniture, packaging for food and cookware, and firefighting foam, in addition to being used in a wide range of industrial processes. See Designation of Perfluorooctanoic Acid (PFOA) and Perfluorooctanesulfonic Acid (PFOS) as CERCLA Hazardous Substances, 87 FR 54415, 54417 (proposed Sept. 6, 2022) (hereinafter ‘‘Proposed Rule’’ or 2 Elimination half-life is the length of time required for the concentration of a particular substance to decrease to half of its starting dose in the body. 3 Data from two studies in Table 3–5 of ATSDR 2021 (Seals et al., 2011 and Zang et al., 2013) were not included in EPA’s estimate of elimination halflife because their findings were significantly different for the other studies, and may not be the most representative. VerDate Sep<11>2014 18:22 May 07, 2024 Jkt 262001 ‘‘Proposal’’) (providing a brief history of PFOA and PFOS production and use). Domestic production and import of PFOA has been phased out by the companies participating in the 2010/ 2015 PFOA Stewardship Program (U.S. EPA, 2023c). Some uses of PFOS are ongoing. The sustained and broad use of PFOA and PFOS by industries means that many sites may be contaminated with high levels of PFOA and PFOS. Furthermore, these substances may still be released into the environment through use and disposal of legacy products and through limited ongoing uses. PFOA and PFOS have been detected in the drinking water of millions of Americans and are widely detected in surface water samples collected from various rivers, lakes, and streams in the United States (ATSDR, 2021; Cadwallader et al., 2022; U.S. EPA, 2017, 2024a). This exposure potential is exacerbated by their persistence and mobility in the environment (Langenbach & Wilson, 2021). The prevalence of PFOA and PFOS is further demonstrated by the fact that these chemicals were detected in the blood of nearly all of the participants in the latest U.S. Centers for Disease Control and Prevention’s (CDC) National Health and Nutrition Examination Survey (NHANES) for which data is available from 2017–2018. (CDC, 2022). This information indicates widespread though generally declining exposure to PFOA and PFOS in the U.S. population. From 1999–2000 to 2017–2018, blood PFOS levels declined by more than 85%. From 1999–2000 to 2017–2018, blood PFOA levels declined by more than 70%. While serum concentrations of PFOA and PFOS in the general population are declining, there is evidence that PFOA and PFOS releases continue to result in elevated environmental concentrations and the potential for human exposure. For example, under the 2018–2019 National Rivers and Streams Assessment (NRSA) PFOS was detected in 91% of the 290 fish fillet composite samples analyzed, corresponding to PFOS being detected in 92% of the sampled population of 41,099 river miles (a statistically significant decrease of 6.7% from NRSA 2013–14) (U.S. EPA, 2023i). In consideration of the evidence of adverse effects to human health and the environment from PFOA and PFOS exposure, their persistence and mobility in the environment, and the significant potential for human exposure due to their prevalence in the environment, EPA concludes that PFOA and PFOS may present a substantial danger to public health or welfare or the PO 00000 Frm 00004 Fmt 4701 Sfmt 4700 environment when released into the environment. EPA further finds that populations located near highly contaminated sites are of particular concern because they are at risk of a disproportionately high potential of repeat exposure to PFOA and PFOS as compared to the general population and across demographic characteristics and repeated exposures increase the likelihood of adverse health effects, as discussed further in the Preamble, Section VI.A,2. d. For these reasons, designation of PFOA and PFOS as hazardous substances is warranted. C. ‘‘Totality of the Circumstances’’ Analysis Along with concluding that PFOA and PFOS each, when released, ‘‘may present a substantial danger’’ to public health or welfare or the environment and therefore meet the statutory designation criteria, EPA also exercised discretion to conduct an additional totality of the circumstances analysis. The analysis looks to CERCLA section 102(a), and its broader context, to help identify the information to weigh and how to balance multiple considerations. In conducting the analysis as to PFOA and PFOS, EPA identified and weighed the advantages and disadvantages of designation relative to CERCLA’s purpose alongside the formal benefitcost analysis, including quantitative and qualitative benefits and costs, provided in the Regulatory Impact Analysis 4 accompanying this final rule. That ‘‘totality of the circumstances’’ analysis confirmed EPA’s conclusion that designation is warranted because the advantages of designation outweigh the disadvantages. EPA considered how designation supports CERCLA’s primary objectives to clean up contaminated sites and ensure the ‘‘Polluter Pays.’’ EPA concluded that designation best serves those objectives and that CERCLA is the best tool to address the legacy of sites contaminated with these substances and to address additional releases of these chemicals in the future. EPA considered that designation would allow EPA to deploy the full suite of CERCLA tools to identify, characterize, and clean up the most contaminated sites expeditiously. It allows EPA to ensure that those parties responsible for significant 4 The RIA was conducted in a consistent manner with economic principles and governmental guidance documents for economic analysis (e.g., OMB Circular A–4 and EPA’s Guidelines for Preparing Economic Analyses) and summarized monetized costs and benefits. The RIA is a neutral analysis tool that allows the federal government to consider potential benefits and costs that may result from designation. It does not consider whether designation is warranted. E:\FR\FM\08MYR3.SGM 08MYR3 Federal Register / Vol. 89, No. 90 / Wednesday, May 8, 2024 / Rules and Regulations lotter on DSK11XQN23PROD with RULES3 contamination bear the costs of cleaning it up. The use of these authorities will allow EPA to address more sites and to do so earlier in time than it otherwise could in the absence of designation. The ability to address more contaminated sites will provide meaningful health benefits to the communities near these sites by reducing the risk of exposure and the potential adverse health and environmental effects associated with such exposure. EPA expects these cleanups will have meaningful health benefits similar to health benefits typically associated with CERCLA actions. EPA also considered the potential quantifiable and qualitative costs and benefits of designation and the comments expressing concerns about widespread liability and litigation after designation. As explained below, EPA finds that the advantages of designation outweigh the disadvantages and that designation is warranted. EPA’s totality of the circumstances analysis considered the adverse health impacts and environmental challenges posed by PFOA and PFOS contamination. PFAS, including PFOA and PFOS, are a nationwide concern because exposure to these chemicals is linked to significant adverse human health impacts, they were in wide use, and they persist and are mobile once released into the environment. CERCLA provides the tools for addressing such contamination and provides a framework to allow EPA, and other delegated Federal agencies,5 to make site-specific determinations and response decisions to address instances of PFOA and PFOS releases that pose unacceptable risk. Specifically, CERCLA provides authority to respond to releases of hazardous substances (including legacy releases). CERCLA’s cleanup process is comprehensive in that it can address contamination to air, water, groundwater, and soil. EPA’s CERCLA response authority also extends from initial investigations to cleanup. No other statute that EPA administers provides the breadth of authority to fully address highly contaminated sites. Thus, CERCLA is the best authority to address existing contamination to mitigate the disproportionate risk borne by communities impacted by those sites. Furthermore, CERCLA is a liability statute. The CERCLA cost recovery and 5 Executive Order 12580 (Jan. 23, 1987, as amended) delegates CERCLA response authority to EPA, as well as the Secretaries of Defense, Interior, Agriculture, Commerce, and Energy with respect to releases from a facility or vessel under their jurisdiction, custody or control and to the U.S. Coast Guard with respect to releases involving the coastal zone, Great Lakes waters, ports, and harbors. VerDate Sep<11>2014 18:22 May 07, 2024 Jkt 262001 enforcement provisions ensure that those parties responsible for significant contamination can be held accountable to pay for or conduct clean up. Designation is the best way for EPA to effectuate CERCLA’s objectives with respect to releases of PFOA and PFOS. EPA also considered whether designation is warranted considering EPA’s existing CERCLA authority, which allows the Agency to address PFOA and PFOS as ‘‘pollutants or contaminants.’’ CERCLA’s authority to address pollutants or contaminants is much more circumscribed than the authority to address hazardous substances. Specifically, CERCLA’s notification requirements for releases do not attach to pollutants or contaminants; EPA cannot address a release of pollutants or contaminants unless the Agency demonstrates that the release may present an ‘‘imminent and substantial danger’’; CERCLA does not provide cost recovery authority for actions taken solely in response to releases or threats of releases of pollutants or contaminants; and CERCLA authority to compel potentially responsible parties (PRPs) to conduct or pay for response work does not extend to pollutants or contaminants. Designating PFOA and PFOS as CERCLA hazardous substances eliminates those limitations. Elimination of those limitations provides meaningful advantages. EPA also considered the advantages of designation. The most significant direct costs associated with designation stem from the requirement for facilities to report releases of PFOA and PFOS that occur after designation. EPA determined these costs were fairly minimal and reasonable in light of the benefits of release notifications. Notification ensures transparency about new releases of PFOA and PFOS, and it allows EPA and affected States and communities to immediately evaluate a release and quickly respond, as necessary, to address risks to human health or the environment. Without notice, EPA is less able to obtain key information to help protect affected communities. Thus, the notification requirement is an advantage that is necessary to adequately protect the public from future releases. Designation also allows EPA to streamline the Federal government’s response authority to address releases of PFOA and PFOS, which will allow EPA to take action sooner. EPA can also begin the lengthy process of identifying, characterizing, and cleaning up the most contaminated sites without delay, either through enforcement or EPA-funded action. PO 00000 Frm 00005 Fmt 4701 Sfmt 4700 39127 Another key advantage to designation is that it best effectuates the Polluter Pays principle underpinning CERCLA. Designation improves equities by transferring costs of cleaning up PFOA and PFOS from the Superfund (‘‘the Fund’’),6 which has been historically funded by taxpayer dollars, to those responsible for contamination. Absent designation, costs incurred for addressing PFOA and PFOS as pollutants or contaminants are paid for by the Fund, rather than responsible parties. Preservation of the Superfund is critical because the monies in it are insufficient to clean up all the existing contamination across the country from the more than 800 CERCLA hazardous substances as well as additional/ emerging pollutants and contaminants. The ability to require PRPs to pay for PFOA and PFOS response costs means that more money will be available in the Fund to address a multitude of priorities, particularly at those sites where there is no viable PRP. It also allows EPA to address more releases earlier than it otherwise could absent designation. Further, cleanup to address PFOA/PFOS supported by designation may allow for incidental cleanup of cocontaminants, including other types of PFAS, which would also benefit human and environmental health. Because contaminated sites often have multiple contaminants of concern (‘‘COCs’’), the benefits from addressing cocontaminants may be substantial for some sites to the extent this occurs. It is critical to initiate more CERCLA actions to address PFOA and PFOS contamination now because the process from investigations to cleanups can take many years, if not decades. And, because PFOA and PFOS are persistent in the environment and highly mobile, further delay increases the extent of contamination, potentially increasing the number of individuals exposed to these substances, and also potentially increasing costs associated with cleanup. EPA’s ability to address PFOA and PFOS contamination through enforcement and EPA-funded action means more communities will be protected from disproportionate and unacceptable health risks, including communities with environmental justice 6 Congress established the Hazardous Substances Trust Fund, otherwise known as the Superfund, to provide funding to address contamination. CERCLA also established liability for parties that contributed to releases of hazardous substances, CERCLA section 107(a), which allows EPA to shift costs from the Fund to PRPs. E:\FR\FM\08MYR3.SGM 08MYR3 39128 Federal Register / Vol. 89, No. 90 / Wednesday, May 8, 2024 / Rules and Regulations lotter on DSK11XQN23PROD with RULES3 (EJ) concerns. Published literature 7 supports the conclusion that certain communities with EJ concerns have a higher likelihood of exposure to PFAS, including PFOA/PFOS. For more information, see RIA Section 6.3 Impacts on Communities with EJ concerns: Analysis. Cleaning up more sites with PFOA and PFOS contamination will help to decrease their exposure to PFOA and PFOS, thus reducing their risk of detrimental health effects, such as decreased immune response to vaccination, decreased birthweight, increased total cholesterol, and cancer. Cleaning up sites also promotes economic benefits, such as improved property values and making land available for reuse. Improving environmental quality can improve local economies by supporting local business, such as recreation companies or industries that rely on natural products like agriculture. Improved quality of natural resources can also contribute to ecosystem services.8 EPA also considered the quantitative and qualitative direct and indirect costs and benefits evaluated in the RIA as part of its totality of the circumstances analysis.9 EPA recognizes that 7 Northeastern University—The PFAS Project Lab, ‘‘PFAS Contamination Is an Equity Issue, and President Trump’s EPA Is Failing to Fix It’’ October 31, 2019. Available at: https://pfasproject.com/ 2019/10/31/pfas-contamination-is-an-equity-issueand-president-trumps-epa-is-failing-to-fix-it/. Lee, Susan, Avinash Kar, and Dr. Anna Reade, Dirty Water: Toxic ‘‘Forever’’ PFAS Chemicals are Prevalent in the Drinking Water of Environmental Justice Communities. Natural Resources Defense Council, New York. 2021. https://www.nrdc.org/ sites/default/files/dirty-water-pfas-ej-communitiesreport.pdf Stoiber, T., Evans, S., & Naidenko, O.V. (2020). Disposal of products and materials containing perand polyfluoroalkyl substances (PFAS): A cyclical problem. Chemosphere 260, Accessed at: https:// doi.org/10.1016/j.chemosphere.2020.127659. 8 Ecosystem services produce the life-sustaining benefits we receive from nature—clean air and water, fertile soil for crop production, pollination, and flood control. 9 The terms ‘‘direct’’ and ‘‘indirect’’ as used to describe potential impacts of this rule are based on established definitions used for analyses under the Regulatory Flexibility Act (RFA). EPA is aware that ‘‘direct’’ and ‘‘indirect’’ costs have distinct definitions for CERCLA purposes; those CERCLAspecific definitions were not used for estimating costs for the purpose of designation. Both EPA and SBA have applicable RFA guidance documents that were considered in developing this rule. For this rule, reporting requirements are direct effects because upon designation of PFOA and PFOS as hazardous substances, entities that release a reportable quantity within a 24-hour period are required to use established procedures to report the release immediately by telephone and provide a follow-up written report. Potential liability for response costs for addressing PFOA and PFOS releases or threatened releases is an indirect effect of designation. This is because CERCLA response actions are not required by this rule, and are discretionary and contingent upon a series of many site-specific determinations. See RIA Section 1.4 VerDate Sep<11>2014 18:22 May 07, 2024 Jkt 262001 designation will lead to both direct and indirect costs. The only quantifiable direct cost associated with designation is the notification requirement, for releases of PFOA and PFOS at or above 1 pound within a 24-hour period. EPA estimates that the notification requirement will cost $2,658 per release and that the total cost of the notification requirement is not anticipated to exceed $1,630,000 per year.10 Notification is critical to ensuring that new releases are identified, evaluated, and addressed to the extent necessary to protect human health and the environment. EPA considers both the individual and total notification costs to be generally reasonable because of the value notification provides to impacted communities and regulatory agencies. Notification can avoid delays in evaluation of a new release. This is particularly important for persistent and mobile substances like PFOA and PFOS because early evaluation can determine whether the release poses an unacceptable risk that requires a response before PFOA and PFOA migrate away from the release. Such migration without intervention can lead to an increase in both the scope of the contamination and the costs necessary to address any identifiable risks. With respect to indirect costs, EPA considered the costs associated with responding to releases of PFOA and PFOS at contaminated sites and with responding to future releases, either through direct EPA action with cost recovery or through enforcement. As stated above, EPA considers the ability to use the full suite of CERCLA authorities—including cost recovery and enforcement—to be an advantage of the rule. Designation eliminates current barriers to timely cleanup of contaminated sites and enables EPA to pursue parties responsible for significant contamination, these are the parties that should bear the costs of cleaning it up. When parties responsible for contamination are required to bear the cost of cleanup, more resources are made available to address additional cleanups. For example, EPA can compel a PRP to take action to address PFOA and PFOS pursuant to CERCLA section 106(a), which will then allow EPA to use Superfund monies and human resources to address other releases at other sites. Further, every contaminated site that is addressed can reduce the disproportionate burden borne by some of the communities at risk of exposure to PFOA and PFOS from the contamination. EPA’s totality of the circumstances analysis included an evaluation of the benefit-cost analysis in the RIA (including indirect costs) as well as additional qualitative considerations related to designation, such as how CERCLA functions. EPA is required to take a measured approach in responding to contamination. For instance, CERCLA ensures that costs are considered when determining the remedy. In addition, EPA, as well as other Federal agencies, have resource constraints that require CERCLA response actions to be prioritized to address the most urgent and highest risks as specified by the National Priorities List (NPL). The NPL is the list of sites of national priority among the known releases or threatened releases of hazardous substances, pollutants, or contaminants throughout the United States and its territories. It is intended primarily to guide EPA in determining which sites warrant further investigation. Eligibility for the NPL includes identifying priority sites based upon relative risk or danger that may be posed to public health or welfare or the environment, considering the population, the hazard potential of the hazardous substances at issue, the potential for contamination of drinking water supplies, the potential for direct human contact, the potential for destruction of sensitive ecosystems, and the damages to natural resources that may affect the human food chain when determining priority. Thus, CERCLA provides EPA with the ability to identify the sites with the highest human health and environmental risks and address those sites first, and the costs of addressing contamination are considered relative to the risks the contamination poses before a remedy is selected. before a remedy is selected. Between FY 2003 and FY 2022, only about four percent of all contaminated sites added to EPA’s Active Site Inventory were placed on the NPL. Since 2013, EPA has, on average, added 11 sites 11 per year to the NPL, and EPA Scope of Analysis and RIA Section 6.2 Small Entity Analysis for more detail. 10 The designation may also result in minimal costs to federal agencies associated with CERCLA section 120(h) notice requirements when selling or transferring federally owned real property where PFOA/PFOS may be present. Future federal property sales and transfers involving property where PFOA and/or PFOS may be present is unknowable and therefore such costs are unquantifiable. 11 This estimate is based on data from EPA’s SEMS database with respect to non-federal NPL sites. EPA determined that it was appropriate to assess the designation’s impact with respect to nonfederal NPL sites only, because federal sites are generally expected to address PFOA and PFOS in the absence of designation consistent with CERCLA section 104. As discussed in Chapter 2 of the RIA, federal sites are addressing PFAS in the baseline as authorized by CERCLA section 104 and corresponding Executive Orders, as required by the PO 00000 Frm 00006 Fmt 4701 Sfmt 4700 E:\FR\FM\08MYR3.SGM 08MYR3 Federal Register / Vol. 89, No. 90 / Wednesday, May 8, 2024 / Rules and Regulations lotter on DSK11XQN23PROD with RULES3 does not expect the rate at which annual additions to the NPL occur to increase as a result of this rule. Moreover, NPL listing does not trigger any immediate actions, liability, or requirements for the site.12 CERCLA ensures that the most significant releases that pose the most risks to human health and the environment are prioritized, and designation will allow EPA to ensure more sites are evaluated sooner, thereby protecting more communities from PFOA and PFOS contamination. In Chapter 5 of the Regulatory Impact Analysis (RIA) for this rulemaking, EPA presents quantified potential response costs 13 that may occur after designation despite the uncertainty of future response actions. Every site is unique and the extent of action necessary to mitigate risks depends on many factors, which leads to uncertainties regarding response activities and associated costs. Notwithstanding these uncertainties, EPA used existing data to estimate response costs for PFOA and PFOS. Specifically, EPA used response costs data for EPA-lead response actions, potential costs associated with cleanup methods and technologies available to address PFOA and PFOS, and information about conditions at contaminated sites. EPA then used that data to assess the incremental costs of cleanup associated with addressing PFOA/PFOS contamination. Data available to EPA demonstrates that PFOA and PFOS generally are not found in isolation; rather, those substances are typically co-located or commingled with other ‘‘contaminants of concern’’ that on their own support a remedy. The NDAA, and consistent with federal facilities agreements under CERCLA section 102(a). Therefore, EPA expects that federal sites will address PFOA and PFOS contamination in the absence of the final rule. With federal sites taking action to address PFAS in the baseline, indirect impacts of the final rule will likely be related to actions taken at non-federal sites. For additional context, since FY 2000 EPA has added 8 federal sites to the NPL. 12 EPA considered the portion of non-federal NPL sites that may be impacted by designation depending on site-specific circumstances. Of final, proposed, or deleted non-federal NPL sites that have been tested for PFOA and/or PFOS, an estimated 33.1% of NPL sites have detectable levels of PFOA and/or PFOS. See Section 3.3 of the RIA for more details about this estimate. In evaluating the designation’s impact non-federal NPL sites, this estimate is instructive and serves as a benchmark for assessing designation’s potential impact to those sites. There are currently 5 sites where either PFOA or PFOS contributed to NPL listing. 13 The term ‘‘response’’ may include actions including but not limited to: site assessment, investigation, remedial action, and removal action. See CERCLA section 101(25). For a description of details on the differences between remedial and removal actions and other response activities under CERCLA, please see Section 2.1 of the RIA. VerDate Sep<11>2014 18:22 May 07, 2024 Jkt 262001 estimated incremental costs to address PFOS and/or PFOS releases at NPL sites are those that the Agency believes it would incur absent the designation, which can be transferred to viable, liable parties as a result of designation. As EPA’s funds would then be used for additional fund-led efforts to address contamination not addressed under the baseline, there will be a net increase in spending on response activities. This ability to transfer costs enables EPA to investigate and clean up additional NPL sites to address potential risks posed by any of the more than 800 hazardous substances, including PFOA and PFOS. EPA estimated the potential transfer of response costs associated with NPL sites range from $10.3M to $51.7M per year (at a 2% discount rate), depending on the cost premium associated with the response work to address PFOA and/or PFOS in addition to other Contaminants of Concerns (COCs) 14 at a given NPL site. Because EPA would use these funds for additional fund-led efforts to address contamination not addressed under the baseline, the transfer of $10.3M to $51.7M would result in additional costs of this same amount. Additionally, indirect costs associated with potential enforcement actions that may result in additional response activities for PFOA and PFOS at nonNPL sites are estimated to range from $327,000 to $18,100,000 per year (at the 2% discount rate), depending on the type of response actions taken at a given site. See RIA Section. 5.1 Indirect Costs and Transfers EPA expects response costs to address PFOA and PFOS to represent an incremental increase above the cost of addressing other substances at NPL sites because, more often than not, PFOA and PFOS are likely to be co-located with or commingled with other substances. EPA also expects that costs to address PFOA and PFOS will fall within typical response cost ranges for actions to address other hazardous substances. This is because many of the same response and cleanup methods available, as noted in the Interim Guidance on the Destruction and Disposal of Perfluoroalkyl and Polyfluoroalkyl Substances and Materials Containing Perfluoroalkyl and Polyfluoroalkyl Substances—Version 2 (2024),15 to address other hazardous 14 Contaminants of Concerns (COCs) are chemicals identified during in-depth site studies (Remedial Investigation/Feasibility Study) that need to be addressed by a cleanup action because they pose a potential threat to human health or the environment. 15 Interim PFAS Destruction and Disposal Guidance; Notice of Availability for Public PO 00000 Frm 00007 Fmt 4701 Sfmt 4700 39129 substances can be used to address PFOA and PFOS (e.g., dig and haul for soil and granulated activated carbon for water). Moreover, EPA expects that response and cleanup costs may decrease over time as associated methods improve. Finally, by addressing PFOA and PFOS releases earlier, EPA can mitigate the spread of contamination, which likely mitigates the costs of an otherwise more wide-spread cleanup. EPA also considered liability and litigation that may arise after designation. CERCLA is designed to ensure that those responsible for contamination pay to clean it up. For PRPs that have significantly contributed to contamination, imposing CERCLA liability is wholly consistent with CERCLA and necessary to address the public health threat posed by PFOA and PFOS. However, EPA also gave serious consideration to potential liability for parties that have not played a significant role in contamination. Those parties include entities that did not generate PFOA- or PFOS-contaminated materials. EPA evaluated CERCLA liability limitations, EPA’s enforcement policies, settlement protections for settling and non-settling parties, and parameters for CERCLA lawsuits to resolve who should pay and how much. Those mechanisms, combined with decades of historical practice, show that CERCLA liability is not unlimited; enforcement is targeted; and parties’ ability to recover costs from other PRPs is constrained. Although CERCLA’s liability structure is broad, both the statute and EPA enforcement discretion policies may constrain a party’s ability to secure reimbursement of response costs.16 CERCLA includes liability exemptions as well as affirmative defenses against liability. See, e.g., CERCLA section 101(10), 107(b), (d), (k). Parties must incur response costs before they can recover those costs from other viable, liable parties. And parties must prove that response costs incurred are consistent with the National Contingency Plan, CERCLA’s implementing regulations. Id. section 107(a)(4)(B). EPA’s enforcement authorities and policies can serve as a deterrent for responsible parties to pursue entities that did not contribute Comment was published in the Federal Register on April 16, 2024 (89 FR 26879) https:// www.govinfo.gov/content/pkg/FR-2024-04-16/pdf/ 2024-08064.pdf. 16 Other Federal agencies including DOD, DOE, USDA, and DOI have delegated CERCLA authority. EPA’s policies apply only to EPA and its exercise of enforcement discretion. Please note that EPA’s policies are not regulations and do not create new legal obligations or limit or expand obligations under any Federal, State, Tribal or local law. E:\FR\FM\08MYR3.SGM 08MYR3 39130 Federal Register / Vol. 89, No. 90 / Wednesday, May 8, 2024 / Rules and Regulations lotter on DSK11XQN23PROD with RULES3 significantly to contamination.17 EPA has a well-proven track record of developing enforcement discretion policies that have been effective and well-received.18 EPA’s enforcement policies, such as its policy regarding de minimis or de micromis parties and innocent landowner policies, have proven to be useful tools in convincing responsible parties not to pursue entities covered by these enforcement discretion policies. Finally, the statute provides that a party that resolves its potential liability with the United States or a State in a judicially approved settlement is entitled to contribution protection—the ability to block thirdparty claims for matters addressed in the settlement. These liability limitations and mitigation tools are 17 CERCLA is designed to achieve the cleanup of contaminated sites by ensuring that those responsible for the contamination pay to clean it up, which EPA supports through its longstanding ‘‘enforcement first’’ policy. (‘‘Guidelines for Using the Imminent Hazard, Enforcement and Emergency Response Authorities of Superfund and Other Statutes,’’ 1982.) Furthermore, CERCLA’s settlement provisions are designed to support and achieve those outcomes by making it efficient for EPA to secure clean up from those that have significantly contributed to contamination. See, e.g. Section 122(a) (‘‘Whenever practical and in the public interest, . . . [EPA] shall act to facilitate agreements . . . that are in the public interest and minimize litigation.’’); Section 122(g)(1) (allowing for ‘‘expedited’’ de minimis settlements for ‘‘minor portions of the response costs’’). In practice, CERCLA’s settlement parameters incentivize PRPs that likely bare a large share of responsibility to settle with EPA, which in turn can deter those same parties from pursuing other PRPs. Ultimately, settlement is generally less expensive than litigation and can serve as an effective mechanism for achieving the true goal of CERCLA—that the parties most responsible for contamination pay to clean it up. 18 While EPA’s enforcement discretion policies themselves are not regulations and do not create new legal obligations or limit or expand obligations under any federal, state, tribal or local law, such policies have influenced Congress to create new laws that have been upheld by courts. The Small Business Liability Relief and Brownfields Revitalization Act of 2002 (‘‘Brownfields Amendments’’) illustrate how EPA’s policies have influenced Congressional action. The Brownfields Amendments amended CERCLA and promoted the cleanup, reuse, and redevelopment of sites by addressing potential liability concerns associated with contaminated, potentially contaminated, and formerly contaminated properties. The Brownfields Amendments provided important selfimplementing liability limitations for certain categories of landowners, enabling private parties to save time and costs, in part, by reducing EPA involvement in most private party transactions. EPA launched the Brownfields Initiative in the 1990s and developed guidance and tools to help further the Initiative’s goals to empower states, communities, and other stakeholders to assess, safely clean up, sustainably reuse, and prevent future brownfield sites. EPA’s Brownfields Initiative established a number of practices, policies, and guidances to support cleanup and reuse at contaminated property. In 2002, many elements of EPA’s Brownfields Initiative were codified into CERCLA by the Brownfields Amendments. VerDate Sep<11>2014 18:22 May 07, 2024 Jkt 262001 more fully discussion in Section VI.B.2. EPA concludes that designation is not expected to result in excessive litigation and that CERCLA will continue to operate as it has for decades. Indeed, CERCLA’s liability framework, coupled with EPA enforcement policies, has operated in a rational way for the more than 800 CERCLA hazardous substances already within its purview, some of which are similar to PFOA and PFOS in terms of ubiquity, mobility, and persistence. Heavy metals, such as arsenic and chromium, are persistent, and in at least some places, prevalent in the environment. Although EPA understands that designation will result in new litigation regarding PFOA and PFOS releases for responsible parties, forty years of CERCLA experience indicates that designation should not result in unusual CERCLA liability or litigation outcomes for parties who did not significantly contribute to the contamination as a result of this designation, and, therefore, the potential for litigation should not be a barrier to designation. EPA aims to further support reasonable liability and litigation outcomes through the implementation of its CERCLA enforcement program. EPA will continue to implement its ‘‘Enforcement First’’ policy (‘‘Guidelines for Using the Imminent Hazard, Enforcement and Emergency Response Authorities of Superfund and Other Statutes,’’ 1982)—in which EPA aims to compel viable PRPs to conduct and pay for investigation and cleanup before resorting to the Fund—which supports the Polluter Pays principle. EPA has a proven track record of developing and applying enforcement discretion policies that are effective and wellreceived by the public and interested parties, and courts have sanctioned this approach. Enforcement discretion policies historically have given EPA the needed flexibility to offer liability comfort or protections when circumstances warrant. For example, for more than 30 years, EPA has maintained its ‘‘Policy Towards Owners of Residential Property at Superfund Sites,’’ which generally provides that EPA will not take action against residential property owners provided their own actions do not cause a release that requires a response action. Although EPA believes existing limitations in CERCLA coupled with existing CERCLA enforcement policies mitigate concerns about liability that may arise after designation, EPA recognizes that some parties that do not bear primary responsibility for litigation may be sued and face uncertain litigation costs as a consequence. EPA PO 00000 Frm 00008 Fmt 4701 Sfmt 4700 believes that the statutory safeguards described above will likely limit this type of litigation, or at a minimum, limit adverse outcomes. Even if litigation costs are incurred by parties that do not bear primary responsibility, EPA does not believe that these potential costs will outweigh the substantial advantages from the rule. While some commenters shared concerns that these mechanisms may not mitigate concerns, these commenters did not support their concerns with any specific data or evidence. Generally, in enforcement matters, the facts, circumstances, and equities of a case help dictate which parties the Agency will pursue. EPA, intends to develop a policy, consistent with those limitations and policies, that explains EPA’s priorities for enforcement in the context of PFOA and PFOS releases.19 As EPA states in the FY 2024–2027 National Enforcement and Compliance Initiatives (NECI), the Agency expects to ‘‘focus on implementing EPA’s PFAS Strategic Roadmap and holding responsible those who significantly contribute to the release of PFAS into the environment . . . much as [EPA] exercises CERCLA enforcement discretion in other areas.’’.20 Available at https:// www.epa.gov/system/files/documents/ 2023-08/fy2024-27necis.pdf. In sum, EPA’s additional ‘‘totality of the circumstances’’ analysis affirms that designation is warranted. The totality of the circumstances analysis gave particular weight to the scientific basis for designation—that PFOA and PFOS may present substantial danger when released into the environment. EPA also concluded that designation best addresses the problem posed by PFOA and PFOS in the environment, particularly for those communities living in and around highly contaminated sites, and that designation meaningfully furthers CERCLA’s purposes. Designation ensures that EPA has the full suite of CERCLA tools necessary to address contamination and that EPA is able to take more timely response actions, including those necessary to address immediate risks. EPA’s analysis shows that designation results in quantitative and qualitative benefits, including significant health 19 EPA received valuable public input that EPA is considering in drafting a CERCLA PFAS enforcement discretion policy. EPA held two public listening sessions in March 2023 and several stakeholder meetings in 2023 with the agriculture sector, water sector, pulp and paper sector, solid waste management sector, and NGOs to hear stakeholder concerns regarding potential CERCLA PFAS enforcement concerns. 20 https://www.epa.gov/enforcement/nationalenforcement-and-compliance-initiatives. E:\FR\FM\08MYR3.SGM 08MYR3 Federal Register / Vol. 89, No. 90 / Wednesday, May 8, 2024 / Rules and Regulations lotter on DSK11XQN23PROD with RULES3 benefits. EPA’s analysis accounts for potential direct and indirect costs that may result from designation. Direct costs, particularly for release notifications, are minimal and reasonable in light of the substantial benefits notification provides. EPA assessed the potential for litigation and liability costs, particularly for parties that have not significantly contributed to contamination. EPA was unable to quantify those costs with reasonable certainty but conducted a qualitative assessment of CERCLA’s liability provisions and enforcement policies to assess the potential magnitude of such costs. EPA’s analysis shows that designation should not result in excessive or unreasonable liability and litigation outcomes. Rather, CERCLA will continue to operate as it has for decades. EPA concludes that the substantial advantages of designation outweigh potential disadvantages, and that designation is warranted based on its additional totality of the circumstances analysis. D. Conclusion EPA concludes that designation is warranted based solely on its finding that PFOA and PFOS may present a substantial danger to the public health or welfare or the environment when released into the environment. Additionally, EPA believes designation is warranted based on its totality of the circumstances analysis. The latest science is clear: human exposure to PFOA and PFOS is linked to significant health risks. CERCLA provides the tools necessary to address those risks posed by significant contamination of PFOA and PFOS in the environment. CERCLA is designed to target and prioritize sites that present unreasonable risk to human health and the environment and serves those communities that are most vulnerable to potential adverse health risks from exposure. Designation eliminates barriers to cleanup and enables EPA to secure more timely actions. It streamlines response authority, provides a mechanism for parties to recover response costs from PRPs, and makes available CERCLA enforcement authority to compel PRPs to conduct or pay for cleanup. Designation also requires facilities to notify Federal, State, local, and Tribal authorities, as well as potentially injured parties, of significant releases. EPA considered the potential costs that may arise after designation, including both quantified and unquantified costs, and finds that they are outweighed by the substantial advantages of designation. Further delay in accessing CERCLA’s complete suite of tools to VerDate Sep<11>2014 18:22 May 07, 2024 Jkt 262001 address contamination will allow PFOA and PFOS more time to migrate within the environment and exacerbate existing contamination. Thus, designation best achieves CERCLA’s primary objectives—the timely cleanup of contaminated sites and ensuring that those responsible for contamination pay to clean it up. Designation will help protect communities near contaminated sites from potential health risks. For all these reasons, discussed in detail below, EPA concludes that designation of both PFOA and PFOS as CERCLA hazardous substances is warranted under the statute. II. General Information A. What action is the Agency taking? As proposed on September 6, 2022, EPA is designating PFOA and PFOS, including their salts and structural isomers, as hazardous substances under section 102(a) of CERCLA. See Designation of Perfluorooctanoic Acid (PFOA) and Perfluorooctanesulfonic Acid (PFOS) as CERCLA Hazardous Substances, 87 FR 54415 (Sept. 6, 2022). The list of hazardous substances in Table 302.4 of 40 CFR part 302 is amended to include PFOA, PFOS and their salts and structural isomers. (Note: EPA’s CompTox Chemicals Dashboard (https://comptox.epa.gov/dashboard/) is a resource that can be used to identify salts and structural isomers of PFOA and PFOS. EPA periodically updates the CompTox Chemicals Dashboard to include new information on PFAS, including PFOA and PFOS.) B. What are the direct effects of this Action? The designation of PFOA and PFOS, including their salts and structural isomers, as hazardous substances, can trigger the applicability of release reporting requirements under CERCLA sections 103 and 111(g), and accompanying regulations, and section 304 of the Emergency Planning and Community Right-to-Know Act (EPCRA). Facilities must report releases of hazardous substances at or above the reportable quantity (RQ) within a 24hour period. For PFOA and PFOS, a default 21 reportable quantity (RQ) of one pound is assigned to these substances pursuant to CERCLA section 102(b). Therefore, consistent with CERCLA section 103(a), any person in charge of a vessel or facility is required, as soon as they have knowledge of any release (other than a federally permitted release) of any PFOA, PFOS, their salts 21 42 U.S.C. 9602(b). https://www.govinfo.gov/ content/pkg/USCODE-2021-title42/pdf/USCODE2021-title42-chap103-subchapI-sec9601.pdf. PO 00000 Frm 00009 Fmt 4701 Sfmt 4700 39131 or structural isomers from such vessel or facility in quantities equal to or greater than the RQ of one pound or more within 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). https://www.ecfr.gov/ current/title-40/chapter-I/subchapter-J/ part-302/section-302.6. In addition to CERCLA 103(a), EPCRA section 304 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 of these substances. These entities may have specific release reporting requirements under the State, Tribal, and local EPCRA program. https://www.epa.gov/epcra/statecontact-information-epcra-section-304emergency-release-notification. 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. EPCRA section 304 requirements are codified in 40 CFR 355.30 to 355.43. https://www.ecfr.gov/ current/title-40/chapter-I/subchapter-J/ part-355/subpart-C. CERCLA section 111(g) requires that owners or operators of any vessel or facility ‘‘provide reasonable notice to potential injured parties by publication in local newspapers serving the affected area’’ of any release of these substances. CERCLA section 120(h) requires Federal agencies that sell or transfer real property to provide notice of the presence of hazardous substances in certain circumstances. CERCLA section 120(h) also 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.’’ As provided by CERCLA section 306, the Department of Transportation (DOT) is required to regulate any substance added to the CERCLA list as hazardous materials in accordance with the Hazardous Materials Transportation Act (HMTA). E:\FR\FM\08MYR3.SGM 08MYR3 39132 Federal Register / Vol. 89, No. 90 / Wednesday, May 8, 2024 / Rules and Regulations While these are the only direct, automatic requirements of designating PFOA and PFOS as CERCLA hazardous substances, EPA has also considered other, indirect impacts in the Regulatory Impact Analysis (RIA) of the Final Rulemaking to Designate Perfluorooctanoic Acid (PFOA) and Perfluorooctanesulfonic Acid (PFOS) as CERCLA Hazardous Substances, available in the docket, including those that are expected to facilitate cleanups and reduce human and environmental exposure to these hazardous substances. lotter on DSK11XQN23PROD with RULES3 C. Does this Action apply to me? The seven broad categories of entities that may potentially be affected by this VerDate Sep<11>2014 18:22 May 07, 2024 Jkt 262001 action include, but are not limited to: (1) PFOA and/or PFOS manufacturers (including importers and importers of articles that contain these substances); (2) PFOA and/or PFOS processors; (3) manufacturers of products containing PFOA and/or PFOS; (4) downstream users of PFOA and PFOS; (5) downstream users of PFOA and/or PFOS products; (6) waste management facilities; and (7) wastewater treatment facilities.22 (Note: PFOA and PFOS proposed rule listed 5 broad categories of entities potentially affected by this designation. This action separated two of these categories to be clearer. Entities listed as downstream product manufacturers and users of PFOA and/or PFOS products in the proposed rule are split into two noted here include their salts and structural isomers.) The following list of North American Industrial Classification System (NAICS) codes identifies entities that may be directly or indirectly affected by this action. It is not intended to be exhaustive, but rather a guide to help readers determine whether this action applies to them. Potentially affected entities may include: BILLING CODE 6560–50–P 22 The PO 00000 Frm 00010 Fmt 4701 Sfmt 4700 separate categories in the final rule (see (4) and (5)). Entities listed as waste management and wastewater treatment facilities in the proposed rule are split into two categories in the final rule (see (6) and (7)). E:\FR\FM\08MYR3.SGM 08MYR3 Federal Register / Vol. 89, No. 90 / Wednesday, May 8, 2024 / Rules and Regulations 6-Digit NAICS 211120 211130 212221 Industry Group Oil and Gas Extraction Oil and Gas Extraction Mining (except Oil Metal Ore Mining and Gas) 212230 212291 Water, Sewage and Other Systems Fiber, Yarn, and Thread Mills Utilities Textile Mills Textile and Fabric Finishing and Fabric Coating Mills Textile Furnishings Mills Textile Product Mills Other Textile Product Mills Leather and Allied Product Manufacturing lotter on DSK11XQN23PROD with RULES3 Paper Manufacturing Printing and Related Support Activities Petroleum and Coal Products Manufacturing VerDate Sep<11>2014 18:22 May 07, 2024 Sewage Treatment Facilities 313110 Fiber, Yarn, and Thread Mills 313210 313230 313240 313310 Broad Woven Fabric Mills Narrow Fabric Mills and Schiffli Machine Embroidery Nonwoven Fabric Mills Knit Fabric Mills Textile and Fabric Finishing Mills 313320 Fabric Coating Mills 314110 Carpet and Rug Mills 314910 Textile Bag and Canvas Mills All Other Miscellaneous Textile Product Mills 314999 Leather and Hide Tanning and Finishing Other Leather and Allied Product Manufacturing Pulp, Paper, and Paperboard Mills 316110 Leather and Hide Tanning and Finishing 316998 All Other Leather Good and Allied Product Manufacturing 322121 322130 Converted Paper Product Manufacturing 322219 Printing and Related Support Activities 323111 322220 Petroleum and Coal Products Manufacturing Jkt 262001 PO 00000 Frm 00011 Crude Petroleum Extraction Natural Gas Extraction Gold Ore Mining Copper, Nickel, Lead, and Zinc Mining Uranium-Radium-Vanadium Ore Mining 221320 313220 Fabric Mills 6-Digit NAICS Description 323120 324110 324191 Fmt 4701 Sfmt 4725 Paper (except Newsprint) Mills Paperboard Mills Other Paperboard Container Manufacturing Paper Bag and Coated and Treated Paper Manufacturing Commercial Printing (except Screen and Books) Support Activities for Printing Petroleum Refineries Petroleum Lubricating Oil and Grease Manufacturing E:\FR\FM\08MYR3.SGM 08MYR3 ER08MY24.000</GPH> Sector 39133 Federal Register / Vol. 89, No. 90 / Wednesday, May 8, 2024 / Rules and Regulations Sector 6-Digit NAICS Industry Group 325110 325120 325130 Basic Chemical Manufacturing 325180 325193 325199 Resin, Synthetic Rubber, and Artificial and Synthetic Fibers and Filaments Manufacturing Pesticide, Fertilizer, and Other Agricultural Chemical Manufacturing Pharmaceutical and Medicine Manufacturing Paint, Coating, and Adhesive Manufacturing Chemical Manufacturing Soap, Cleaning Compound, and Toilet Preparation Manufacturing Other Chemical Product and Preparation Manufacturing 325211 325212 lotter on DSK11XQN23PROD with RULES3 Plastics Product Manufacturing Artificial and Synthetic Fibers and Filaments Manufacturing 325320 Pesticide and Other Agricultural Chemical Manufacturing 325411 Medicinal and Botanical Manufacturing 325510 Paint and Coating Manufacturing 325611 325612 325613 325910 325992 325998 326113 326121 326130 VerDate Sep<11>2014 18:22 May 07, 2024 Jkt 262001 PO 00000 Frm 00012 Petrochemical Manufacturing Industrial Gas Manufacturing Synthetic Dye and Pigment Manufacturing Other Basic Inorganic Chemical Manufacturing Ethyl Alcohol Manufacturing All Other Basic Organic Chemical Manufacturing Plastics Material and Resin Manufacturing Synthetic Rubber Manufacturing 325220 326112 Plastics and Rubber Products Manufacturing 6-Digit NAICS Description Fmt 4701 Sfmt 4725 Soap and Other Detergent Manufacturing Polish and Other Sanitation Good Manufacturing Surface Active Agent Manufacturing Printing Ink Manufacturing Photographic Film, Paper, Plate, and Chemical Manufacturing All Other Miscellaneous Chemical Product and Preparation Manufacturing Plastics Packaging Film and Sheet (including Laminated) Manufacturing Unlaminated Plastics Film and Sheet (except Packaging) Manufacturing Unlaminated Plastics Profile Shape Manufacturing Laminated Plastics Plate, Sheet (except Packaging), and Shape Manufacturing E:\FR\FM\08MYR3.SGM 08MYR3 ER08MY24.001</GPH> 39134 Federal Register / Vol. 89, No. 90 / Wednesday, May 8, 2024 / Rules and Regulations 6-Digit NAICS Industry Group Nonmetallic Mineral Product Manufacturing Primary Metal Manufacturing Fabricated Metal Product Manufacturing Machinery Manufacturing Computer and Electronic Product Manufacturing Rubber Product Manufacturing Glass and Glass Product Manufacturing Cement and Concrete Product Manufacturing Other Nonmetallic Mineral Product Manufacturing Steel Product Manufacturing from Purchased Steel Alumina and Aluminum Production and Processing Coating, Engraving, Heat Treating, and Allied Activities Other Fabricated Metal Product Manufacturing Industrial Machinery Manufacturing Commercial and Service Industry Machinery Manufacturing Communications Equipment Manufacturing Audio and Video Equipment Manufacturing 326211 Tire Manufacturing (except Retreadirnz) 327215 Glass Product Manufacturing Made of Purchased Glass 327310 Cement Manufacturing 327999 All Other Miscellaneous Nonmetallic Mineral Product Manufacturing 331221 Rolled Steel Shape Manufacturing 331313 Alumina Refining and Primary Aluminum Production 332812 332813 332999 333249 333316 333318 334220 334310 334412 Semiconductor and Other Electronic Component Manufacturing 334413 334418 lotter on DSK11XQN23PROD with RULES3 334419 Electrical Equipment, VerDate Sep<11>2014 18:22 May 07, 2024 Other Electrical Equipment and Jkt 262001 PO 00000 Frm 00013 6-Digit NAICS Description 335931 Fmt 4701 Sfmt 4725 Metal Coating, Engraving (except Jewelry and Silverware), and Allied Services to Manufacturers Electroplating, Plating, Polishing, Anodizing, and Coloring All Other Miscellaneous Fabricated Metal Product Manufacturing Other Industrial Machinery Manufacturing Photographic and Photocopying Equipment Manufacturing Other Commercial and Service Industrv Machinery Manufacturing Radio and Television Broadcasting and Wireless Communications Equipment Manufacturing Audio and Video Equipment Manufacturing Bare Printed Circuit Board Manufacturing Semiconductor and Related Device Manufacturing Printed Circuit Assembly (Electronic Assembly) Manufacturing Other Electronic Component Manufacturing Current-Carrying Wiring Device Manufacturing E:\FR\FM\08MYR3.SGM 08MYR3 ER08MY24.002</GPH> Sector 39135 Federal Register / Vol. 89, No. 90 / Wednesday, May 8, 2024 / Rules and Regulations Sector 6-Digit NAICS Industry Group Appliance, and Component Manufacturing Transportation Equipment Manufacturing Miscellaneous Manufacturing Merchant Wholesalers, Nondurable Goods Furniture and Home Furnishings Stores Rail Transportation Truck Transportation Component Manufacturing 335999 All Other Miscellaneous Electrical Equipment and Component Manufacturing 336399 All Other Motor Vehicle Parts Manufacturing 339112 Surgical and Medical Instrument Manufacturing 424690 Other Chemical and Allied Products Merchant Wholesalers 424710 Petroleum Bulk Stations and Terminals Home Furnishings Stores 442291 Window Treatment Stores Rail Transportation 482111 Freight Rail 484110 Truck Freight 488119 Other Airport Operations 488310 Port and Harbor Operators 561740 Carpet and Upholstery Cleaning Services Motor Vehicle Parts Manufacturing Medical Equipment and Supplies Manufacturing Chemical and Allied Products Merchant Wholesalers Petroleum and Petroleum Products Merchant Wholesalers General Freight Trucking Support Activities for Air Support Activities Transportation for Transportation Support Activities for Water Transportation Services to Administrative and Buildings and Support Services Dwellings Waste Collection Waste Management and Remediation Services 562112 562211 Waste Treatment and Disposal 562212 562213 562219 lotter on DSK11XQN23PROD with RULES3 Repair and Maintenance Personal and Laundrv Services VerDate Sep<11>2014 18:22 May 07, 2024 6-Digit NAICS Description Automotive Repair and Maintenance Personal and Household Goods Repair and Maintenance Drycleaning and Laundrv Services Jkt 262001 PO 00000 Frm 00014 Hazardous Waste Collection Hazardous Waste Treatment and Disposal Solid Waste Landfill Solid Waste Combustors and Incinerators Other Nonhazardous Waste Treatment and Disposal 811192 Car Washes 811420 Reupholstery and Furniture Repair 812300 Dry Cleaner and Laundry Operators Fmt 4701 Sfmt 4725 E:\FR\FM\08MYR3.SGM 08MYR3 ER08MY24.003</GPH> 39136 Federal Register / Vol. 89, No. 90 / Wednesday, May 8, 2024 / Rules and Regulations Justice, Public Order, and Safety Activities National Security and International Affairs Industry Group Justice, Public Order, and Safety Activities National Security and International Affairs BILLING CODE 6560–50–C D. What is the Agency’s authority for taking this action? CERCLA section 102(a) authorizes the EPA Administrator to ‘‘promulgate and revise as may be appropriate, 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[.]’’ CERCLA section 102(b) establishes a default RQ of one pound for releases of designated hazardous substances. See Section IV of this document for additional details on EPA’s authority, including statutory criteria. lotter on DSK11XQN23PROD with RULES3 E. What are CERCLA’s primary objectives, and how does it operate to protect human health and the environment? CERCLA establishes broad Federal authority to address past, current, and future releases or threat of releases of hazardous substances and pollutants or contaminants. The statute’s primary objectives are to promote the timely cleanup of contaminated sites and to ensure parties responsible for contamination bear site cleanup costs. CERCLA is unlike traditional environmental statutes that prospectively regulate, among other things, how facilities operate and provide limitations on discharges, emissions, releases, or disposal of certain chemicals into water, air, or land. Instead, CERCLA is designed to address contamination already in the environment on a site-specific basis, which includes evaluating the nature, extent, and risk to human health and/or the environment from the release. CERCLA affords EPA broad discretion as to whether or how to respond to a release. It includes cost-shifting mechanisms and liability provisions that support PRP cleanups rather than relying on the Fund. VerDate Sep<11>2014 18:22 May 07, 2024 Jkt 262001 6-Digit NAICS 6-Digit NAICS Description 922160 Fire Protection 928110 National Security 1. How does CERCLA authority and causes of action differ in key respects between ‘‘hazardous substances’’ and ‘‘pollutants or contaminants’’? For hazardous substances,23 CERCLA section 103(a) requires reporting of releases. 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 in an amount equal to or greater than the RQ for that substance. 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 pursuant to CERCLA and its accompanying regulations, the National Oil and Hazardous Substances Pollution Contingency Plan (NCP). (40 CFR part 300). CERCLA response authorities apply to releases or the threat of releases into the environment of ‘‘hazardous substances’’ and/or ‘‘pollutants or contaminants’’ 24; however, the CERCLA authorities available to address each type of release differs. With respect to hazardous substances, the Agency can conduct response actions if there is a release or threatened release; however, for pollutants or contaminants, EPA can only respond if it establishes that the release may present an imminent and substantial danger. (CERCLA section 104(a)). In addition, CERCLA’s cost recovery and some specific enforcement authorities extend to hazardous substances but not pollutants or 23 CERCLA defines ‘‘hazardous substance’’ primarily by reference to other environmental statutes (i.e., the Clean Water Act, Solid Waste Disposal Act, Clean Air Act and the Toxic Substances Control Act) and includes substances designated as hazardous under CERCLA section 102. (CERCLA section 101(14)). 24 CERCLA defines the term ‘‘pollutant or contaminant’’ to include, ‘‘but not be limited to, any element, substance, compound, or mixture . . . which after release into the environment and upon exposure, ingestion, inhalation, or assimilation into any organism . . . will or may reasonably be anticipated to cause death, disease, behavioral abnormalities, cancer, genetic mutation, physiological malfunctions . . . or physical deformations.’’ (CERCLA 104). PO 00000 Frm 00015 Fmt 4701 Sfmt 4700 contaminants. (CERCLA section 107(a), 106(a)). For hazardous substances, EPA can recover all response costs (e.g., investigation and cleanup costs) from PRPs the Agency incurs that are not inconsistent with the NCP and require PRPs to conduct the response. CERCLA also authorizes non-governmental entities (including private parties) who conduct cleanup activities related to hazardous substance releases to recover response costs from liable parties provided the costs incurred are consistent with the NCP. 2. What response actions does CERCLA authorize? CERCLA authorizes two types of response actions—removal and remedial. (CERCLA section 101(25)). Removals include ‘‘such actions as may be necessary taken in the event of the threat of release,’’ including those ‘‘necessary to prevent, minimize, or mitigate damage to the public health or welfare or the environment.’’ (CERCLA section 101(23)). Removals are typically short-term response actions that may be taken to address releases or threatened releases requiring prompt action; they are limited in cost and duration unless specific criteria are met. (CERCLA section 104(c)(1)). Remedial includes those actions consistent with ‘‘permanent remedy taken instead of or in addition to removal actions in the event of a release or threatened release of a hazardous substance into the environment, to prevent or minimize the release of hazardous substances so that they do not migrate to cause substantial danger to present or future public health or welfare or the environment’’ (CERCLA section 101(24)). Remedial actions (RAs) entail longer-term and more complex cleanup actions designed to provide permanent solutions to mitigate risks typically associated with chronic exposures often not immediately life-threatening. E:\FR\FM\08MYR3.SGM 08MYR3 ER08MY24.004</GPH> Sector 39137 39138 Federal Register / Vol. 89, No. 90 / Wednesday, May 8, 2024 / Rules and Regulations lotter on DSK11XQN23PROD with RULES3 3. What discretionary authority does CERCLA provide and how does CERCLA prioritize cleanup actions? EPA has broad discretionary authority to decide on a site-specific basis whether to respond to a release or threat of release and to prioritize the order in which it undertakes response actions determined to be necessary. (CERCLA section 105(a)(8)(A)). Site-specific decisions take into consideration factors such as relative risk, hazard potential, population at risk and the potential for drinking water contamination. Those considerations are embodied in the NCP. (See, e.g., 40 CFR 300.410, 300.415, 300.430). 4. What is the CERCLA cleanup process and what role does the National Priorities List (NPL) play in it? Before identifying an appropriate response action—removal or remedial— EPA or another lead agency, may first identify a release, investigate its scope and extent, and evaluate its potential risk to human health and the environment. 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 (CERCLA section 104(b); 40 CFR 300.410, 300.430(b)). After an initial investigation, EPA has several options, including determining a release does not pose sufficient risk to warrant further action and deciding that the release warrants a CERCLA response action. EPA may also defer the site to the State where it is located. The NCP provides guidance on the process to determine whether to undertake a removal or a remedial action. For removal actions, the NCP provides that the lead agency may take such an action when it has determined ‘‘that there is a threat to public health or welfare’’ based on a set of factors such as actual or potential exposure to drinking water supplies, the potential for hazardous substances to migrate, and the availability of other appropriate Federal or State response mechanisms to address the release. (40 CFR 300.415(b)). For remedial actions, EPA first evaluates a site for consideration as an NPL site, (40 CFR part 300 App. A); only sites added to the NPL are eligible for Superfund monies to conduct remedial actions. A site’s addition to the NPL does not trigger any immediate action but represents an initial step towards a site’s VerDate Sep<11>2014 18:22 May 07, 2024 Jkt 262001 potential long-term remedy; NPL sites are among the Nation’s worst contaminated sites. EPA has placed on the NPL only about 3 percent of the 53,400 sites assessed since the program’s beginning in 1980. 5. What is the process for identifying and selecting remedial actions under CERCLA? EPA can only begin the process to identify potential remedial actions after completing the careful and deliberate process to add a site to the NPL. CERCLA and the NCP together prescribe a comprehensive and detailed process for evaluating, selecting, and implementing remedies, which includes State and community roles. (40 CFR 300.430). The process’ first step is conducting a remedial investigation and feasibility study (RI/FS) to assess site conditions and to evaluate the remedial alternatives identified. (40 CFR 300.430(a)(2)). Next, the NCP mandates consideration of several factors by which to evaluate remedial alternatives. (40 CFR 300.430(e)(9)). At a minimum, all eligible remedies must be protective of human health and the environment and comply with all applicable or relevant and appropriate requirements (ARARs).25 (CERCLA section 121(a), (d); 40 CFR 300.430(f)(1)(i)(A)). The alternatives satisfying these two threshold criteria are then further evaluated against one another using balancing criteria, including factors such as long-term effectiveness and permanence; toxicity, mobility or volume reduction; implementability; cost; and finally modifying criteria of State acceptance; and community acceptance. (40 CFR 300.430(e)(9), (f)). A remedial action’s selection must include public review and comment on the lead agency’s preferred alternative as presented in a proposed plan. (CERCLA section 117; 40 CFR 300.430(f)(2)). EPA documents its selection of a remedy in a record of decision. (40 CFR 300.430(f)(1)(ii)). A site’s selected remedy then enters the remedial design (RD)/remedial action (RA) stage in which the remedy is designed and constructed, followed in some instances by an Operation & Maintenance (O&M) period.26 (40 CFR 25 ARARs may be waived under certain circumstances. (CERCLA section 121(d)(4)). 26 O&M is an important component of a Superfund response, ensuring that the remedy continues to perform as intended and remains protective of human health and the environment. O&M activities may include remedy operation, PO 00000 Frm 00016 Fmt 4701 Sfmt 4700 300.435(a), (f)). Five-year reviews (FYR) 27 are required at sites where completed remedial actions result in any hazardous substances, pollutants, or contaminants remaining onsite. (CERCLA section 121(c)). They also must be conducted where remedial actions result in any hazardous substances, pollutants, or contaminants remaining at the site above levels that allow for unlimited use and unrestricted exposure after the initiation of the selected remedial action. (40 CFR 300.430(f)(4)(ii)). 6. How does CERCLA’s framework ensure that those responsible for contamination pay for cleanup? A critical CERCLA component is holding those responsible for the contamination accountable to perform or pay for its cleanup. EPA’s preference, and one of CERCLA’s main goals, is to have PRPs be responsible for the cleanup of releases of hazardous substances. EPA can compel a PRP to take action pursuant to a CERCLA enforcement instrument. (CERCLA section 106). EPA can also perform the response action using Fund money and then seek reimbursement of costs incurred from liable parties in litigation, (CERCLA section 107(a)), or subsequent cost recovery settlement (CERCLA section 122(a)). Under CERCLA, potentially liable parties include: (1) current owners and operators of facilities, (2) past owners and facility operators in place at the time of hazardous substance disposal, (3) any person who ‘‘arranged for disposal’’ of that facility’s hazardous substances, and (4) any person that accepts hazardous substances for ‘‘transport to disposal or treatment facilities.’’ (CERCLA section 107(a)(1)–(4)). If found liable under the statute, a PRP is financially responsible for the government’s response costs incurred not inconsistent with the NCP in addition to other categories of costs. (CERCLA section 107(4)(A)–(D). maintenance and monitoring, as well as monitoring of impacted media and monitoring and maintenance of implemented Institutional Controls (IC)s. ICs are non-engineered instruments, such as administrative and/or legal controls, that help minimize the potential for human exposure to contamination and/or protect the integrity of a remedy by limiting land or resource use. Examples include fishing restrictions, deed restrictions, and the posting of warning signs outside of a contaminated site. 27 Five-year reviews evaluate the implementation and performance of a remedy to determine whether it remains protective. E:\FR\FM\08MYR3.SGM 08MYR3 Federal Register / Vol. 89, No. 90 / Wednesday, May 8, 2024 / Rules and Regulations 7. What enforcement discretion is available when exercising CERCLA authority? lotter on DSK11XQN23PROD with RULES3 EPA has a proven track record of developing and applying enforcement discretion policies that are effective and well-received, and courts have sanctioned this approach. CERCLA’s limitations and EPA’s enforcement discretion policies historically have given EPA the needed flexibility to provide assurances when circumstances warrant. Although CERCLA’s liability scheme is broad, the statutory affirmative defenses and EPA’s enforcement discretion policies provide mechanisms to narrow the scope of liability and focus on the significant contributors to contamination. Both the statute and EPA enforcement discretion policies may constrain a party’s ability to secure reimbursement of response costs. CERCLA itself includes liability exemptions as well as affirmative defenses against liability. See, e.g., CERCLA section 101(10), 107(b), (d), (k). Additionally, parties must prove that response costs incurred are consistent with the National Contingency Plan, CERCLA’s implementing regulations. Id. section 107(a)(4)(B). Parties must also incur response costs before they can recover those costs from other viable, liable parties. EPA’s enforcement authorities and policies can serve as a deterrent for responsible parties to pursue parties that did not contribute significantly to contamination. EPA has a well-proven track record of developing enforcement discretion policies that have been effective and well-received by stakeholders. EPA’s enforcement policies, such as its policy regarding de minimis or de micromis parties and innocent landowner policies, have proven to be useful tools in convincing responsible parties not to pursue parties covered by these enforcement discretion policies. Finally, the statute provides that a party that resolves its potential liability with the United States or a State in a judicially approved settlement is entitled to contribution protection— the ability to block third-party claims for matters addressed in the settlement. These liability limitations and mitigation tools are more fully discussion in Section VI.B.2. 8. Why is understanding CERCLA’s overarching provisions critical to understanding the importance of this rulemaking to EPA’s ability to protect human health and the environment? Understanding CERCLA’s basic concepts, particularly its liability scheme and CERCLA’s authority to VerDate Sep<11>2014 18:22 May 07, 2024 Jkt 262001 address hazardous substances (versus its authorities to respond to pollutants or contaminants) are essential to understanding this regulatory action’s importance in protecting human health and the environment. Designating PFOA and PFOS as hazardous substances is an important step for EPA to take because it makes available the full suite of CERCLA tools to address releases of these substances. Designation provides a more streamlined path to respond to PFOA and PFOS releases. It also makes available CERCLA enforcement authority that EPA can use to compel PRPs to pay for or conduct CERCLA response actions, rather than EPA using the Fund to clean up. Designation is expected to expediate PFOA and PFOS cleanups, and in turn, mitigate risks to public health and the environment from these substances. III. Background for This Rulemaking A. Summary of Proposed Designation On September 6, 2022 (87 FR 54415), EPA proposed to find that PFOA and PFOS and their salts and structural isomers warrant designation as hazardous substances pursuant to CERCLA section 102(a). EPA concluded that significant evidence indicates that PFOA and PFOS may present a substantial danger to public health or welfare or the environment when released. (87 FR 54417, 54423). In reaching the proposed conclusion, the Agency relied on a significant body of evidence showing that PFOA and PFOS are persistent and mobile in the environment and that exposure to such substances may lead to adverse health effects. The Agency primarily relied on evidence concerning the hazard and fate and transport, as well as other information that may be relevant to whether the statutory criteria are met. EPA looked at scientific and technical data regarding toxicity and toxicokinetics, chemical and physical characteristics, and environmental prevalence of PFOA and PFOS to support the proposed finding that these chemicals may present substantial danger when released into the environment. See Proposed Rule, 87 FR at 54423–29. In short, the evidence related to the chemical and physical characteristics indicated that PFOA and PFOS are persistent in the environment and that they bioaccumulate in both humans and wildlife. The evidence also showed that PFOA and PFOS are distinct from many other bioaccumulative chemicals because their water solubility allows PFOA and PFOS to more readily migrate from soil PO 00000 Frm 00017 Fmt 4701 Sfmt 4700 39139 to groundwater; thus, their release into the environment has the potential to contaminate both surface water and groundwater used as drinking water sources. Concerning the toxicity and toxicokinetics, both human and animal studies supported a conclusion that exposure to PFOA and PFOS may cause adverse health effects, including effects on the immune system, the cardiovascular system, fetus development, and cancer. The evidence also showed that PFOA and PFOS are prevalent in the environment because they have been produced and used since the 1940s and are resistant to degradation. The evidence showed that PFOA and PFOS are not only prevalent in humans, but also prevalent in environmental media, wild animals, livestock, and plants. EPA concluded that the prevalence of these substances impacts the environment directly and increases the likelihood of exposures that may lead to additional human exposure. The adverse human health effects, mobility, persistence, prevalence, and other information about PFOA and PFOS combined to support EPA’s proposed finding that these chemicals may present a substantial danger to public health or welfare or the environment when released such that designation of PFOA and PFOS as CERCLA hazardous substances is warranted. B. PFOA and PFOS Production and Use PFOA and PFOS are part of a large family of human-made chemicals known as PFAS that have been in use in the U.S. since the 1940s. PFAS, including PFOA and PFOS, are used in industry and consumer products because of their useful properties, including their resistance to water, grease, and stains. These substances have 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 have also been used for firefighting and various industrial processes. 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. Once dissolved in water, the salt and the acid forms will dissociate into the respective ions. See Proposed Rule, 87 FR at 54417 (providing a brief history of PFOA and PFOS production and use). Production and use of these chemicals have resulted in releases into the E:\FR\FM\08MYR3.SGM 08MYR3 lotter on DSK11XQN23PROD with RULES3 39140 Federal Register / Vol. 89, No. 90 / Wednesday, May 8, 2024 / Rules and Regulations environment for many decades. Historic releases of PFOA and PFOS are significant sources of environmental contamination and present ongoing hazards to human health and the environment. Precursors of PFOA and PFOS can be converted to PFOA and PFOS 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 or in a landfill without environmental controls can discharge via leachates, groundwater pollution/migration, and atmospheric releases. PFAS have been detected in the ambient environment, in wildlife, and in humans around the globe, and PFOA and PFOS were among the most used PFAS from the beginning of their development in the 1940s (Blake & Fenton, 2020; Calafat et al., 2007; Domingo & Nadal, 2019; Hanssen et al., 2013; Olsen et al., 2017). The potential health risks associated with PFAS were first recognized in occupationally exposed workers in the 1980s and community level exposure concerns were first raised in 1998. Since that time, the U.S. government, including EPA, and many other environmental and human health organizations both within the U.S. and internationally have researched PFAS to determine the risks posed by exposure to such chemicals. The additional evaluation since the late 1990s has added support for early concerns that exposure to PFAS may present a risk and that exposure to long chain PFAS, such as PFOA and PFOS, are of particular concern because of, among other things, their prevalence in the environment, mobility, and resistance to degradation. In response to the growing body of evidence concerning the potential risks, Federal, State, and international agencies have taken steps to mitigate exposure to PFOA and PFOS. For example, in 2016, the FDA revoked a regulation that allowed the use of long chain PFAS in food contact applications in the U.S.; the DoD added PFOA and PFOS to its list of emerging chemicals of concern and is in the process of requiring any of its new firefighting foam it purchases to be made without PFAS per a January 2023 military specification; several States have established groundwater cleanup standards for PFOA and/or PFOS; and PFAS, including PFOA and PFOS, are addressed in several international treaties.28 28 See Proposed Rule, 87 FR at 54429–39 (providing a list of regulatory and other PFAS VerDate Sep<11>2014 18:22 May 07, 2024 Jkt 262001 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 (U.S. EPA, 2023c, 2023d). 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 (U.S. EPA, 2023a). The EPA Chemical Data Reporting (CDR) rule (see 40 CFR 721.9582) under 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. The reports showed that these chemicals were still being produced or used in those reporting years, however manufacturers did not report PFOA and PFOS in excess of the reporting limit in subsequent reporting cycles. However, 2020–2022 Toxic Release Inventory (TRI) data show that PFOA and PFOS continue to be released into the environment, which means that there are on-going uses of these substances. Pursuant to TRI reporting requirements, regulated facilities must report annually on releases and other waste management of toxic chemicals that they manufacture, process, or otherwise use above certain threshold quantities. The TRI reporting threshold for PFOA and PFOS is 100 pounds. Between 2020 and 2022, TRI data on releases 29 of PFOA, PFOS, and their salts 30 reported by 21 facilities amount to 71,411 lbs. In 2020, TRI data on releases of PFOA, PFOS, and their salts reported by nine facilities totaled 1,706 lbs. In 2021 and 2022, reported releases increased to 24,351 lbs. and 45,384 lbs., respectively.31 PFOA is not produced domestically or imported by the companies participating in the 2010/ related actions at EPA, other Federal Agencies, states, and international agencies). 29 Facilities are required to report total releases per year of listed toxic chemicals into the environment (e.g., releases to land on-site, discharges to receiving streams or water bodies, etc.). https://www.ecfr.gov/current/title-40/part372/subpart-E#p-372.85(b)(14) (40 CFR 372.85(b)(14). 30 As of November 2023, the list of toxic chemicals under the TRI program include 8 salts, as well as PFOA and PFOS, that are also listed as CERCLA HSs in this final action. 31 In addition to these releases, the TRI also includes data on PFOA and PFOS productionrelated waste. See U.S. Environmental Protection Agency. Toxic Release Inventory (TRI) Search. Available at: https://www.epa.gov/enviro/tri-search. PO 00000 Frm 00018 Fmt 4701 Sfmt 4700 2015 PFOA Stewardship Program. However, based on the TRI report, it is possible that PFOA may still be produced domestically or imported by companies that did not participate in the PFOA Stewardship Program and that PFOS may be as well. Environmental contamination and resulting human exposure to PFOA and PFOS are anticipated to continue for the foreseeable future due to their past wide-scale manufacture and use, environmental persistence, formation from precursor compounds, and continued limited domestic production and use. 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 (NHANES). This indicates humans are still being exposed to PFOA and PFOS. C. EPA’s PFAS Strategic Roadmap EPA issued the PFAS Strategic Roadmap (Roadmap) in October 2021, wherein the Agency recognized the potential dangers posed by exposure to PFAS and committed to a comprehensive whole-of-Agency plan to address PFAS (U.S. EPA, 2021a). EPA’s integrated approach to PFAS is focused on three central directives: (1) Research. Invest in research, development, and innovation to increase understanding of PFAS exposures and toxicities, human health and ecological effects, and effective interventions that incorporate the best available science; (2) Restrict. Pursue a comprehensive approach to proactively prevent PFAS from entering air, land, and water at levels that can adversely impact human health and the environment; and (3) Remediate. Broaden and accelerate the cleanup of PFAS contamination to protect human health and ecological systems. The Roadmap committed to an Agency-wide approach, in which EPA would utilize the tools at its disposal to urgently address PFAS and bring tangible health benefits to communities impacted by PFAS. EPA identified a variety of authorities to address PFAS, including the TSCA, the Safe Drinking Water Act (SDWA), CWA, and RCRA, in addition to CERCLA. The Agency recognized that each authority has a unique set of tools to address discrete and specific environmental challenges posed by PFAS. Since 2021, EPA has taken several actions to address PFAS contamination under the Agency’s various regulatory programs. Visit Agency’s website at https:// www.epa.gov/pfas/key-epa-actionsaddress-pfas. E:\FR\FM\08MYR3.SGM 08MYR3 Federal Register / Vol. 89, No. 90 / Wednesday, May 8, 2024 / Rules and Regulations IV. Legal Authority A. CERCLA Section 102(a) Designation Considerations lotter on DSK11XQN23PROD with RULES3 In this action, the Administrator is exercising his authority to designate PFOA and PFOS as hazardous substances pursuant to CERCLA section 102(a). CERCLA’s definition of ‘‘hazardous substances’’ includes any substance designated pursuant to specified provisions in select environmental statutes (CWA, RCRA, CAA, and TSCA) and ‘‘any element, compound, mixture, solution, or substance designation pursuant to [CERCLA section 102]. CERCLA section 101(14).32 Section 102(a), in turn, provides clear authority to designate hazardous substances in addition to substances designated automatically through the operation of CERCLA section 101(14). In relevant part, section 102(a) provides that, ‘‘[t]he Administrator shall promulgate and revise as may be appropriate, regulations designating as hazardous substances, in addition to those referred to in section 101(14), 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. . . .’’ The statutory language delegates to EPA the authority to identify and weigh the scientific, technical, and other factual information relevant to determining whether a substance ‘‘may present a substantial danger,’’ and then determine whether to promulgate regulations designating such substances. Reading Section 102(a) in context, including the broader context of 32 The complete definition of ‘‘hazardous substances’’ is: ‘‘(A) any substance 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 substance 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 subparagraphs (A) through (F) of this paragraph, and the term does not include natural gas, natural gas liquids, liquefied natural gas, or synthetic gas usable for fuel (or mixtures of natural gas and such synthetic gas).’’ VerDate Sep<11>2014 18:22 May 07, 2024 Jkt 262001 CERCLA as a whole, EPA affirms the factors it proposed to evaluate for determining what constitutes ‘‘substantial danger’’ and designating hazardous substances under CERCLA section 102(a). 87 FR at 54421. To inform its decision whether a substance, when released, may present ‘‘substantial danger’’ pursuant to CERCLA section 102(a), EPA considers two primary factors: the potential harm to humans or the environment from exposure to the substance (i.e., hazard), and how the substance potentially moves, persists and/or changes when in the environment (i.e., environmental fate and transport). EPA will then weigh this information in deciding whether the substance, when released, may present a substantial danger. In deciding whether a substance presents potential harm to humans or the environment from exposure to the substance (hazard), EPA may consider such information as human health toxicity, including carcinogenicity, neurotoxicity, developmental toxicity, reproductive toxicity, and other adverse health effects. EPA may also consider toxicity or adverse impacts to nonhuman organisms or ecosystems, such as adverse effects to wildlife, aquatic life, or other natural resources, including adverse impacts on populations of endangered or threatened species or significant degradation of environmental quality over broad areas. Additionally, EPA may consider chemical properties such as combustibility, flammability, reactivity, or corrosiveness. Regarding the environmental fate and transport of a substance, EPA may consider whether a substance moves readily through the environment, and whether it persists and/or changes in the environment. In weighing this information, EPA will consider the degree or magnitude of the danger posed based on the substance’s hazard and environmental fate and transport characteristics. The hazard that a substance presents can be shown in a variety of ways. For example, it could be toxic to humans or other organisms in the environment, or it could exhibit a more physical hazard, such as corrosivity or explosivity. In assessing a substance’s hazard if based on toxicity, EPA could consider whether the substance may be acutely toxic (and thus lead to an immediate health problem or even death) or may have chronic toxicity (and thus lead to detrimental health effects after longterm exposure). For example, there could be a substance that is acutely toxic but does not move far from the point of release. This substance might pose substantial danger due to its ability PO 00000 Frm 00019 Fmt 4701 Sfmt 4700 39141 to immediately harm people and other organisms at the point of release. As another example, there may be a substance that exhibits chronic toxicity and is very persistent. In this case, the substance might also pose substantial danger when released because people and other organisms near the point of release could be exposed to the substance over a long period of time, potentially leading to adverse health effects. Designation may be appropriate if the hazard and fate and transport, when taken together, demonstrate there may be danger and the danger is substantial. Hazard and environmental fate and transport are the primary factors EPA will assess in evaluating whether to designate a substance under section 102(a). However, EPA may also consider additional information that could inform the degree of danger a substance may pose when released. This includes, but is not limited to, information such as frequency, nature, and geographic scope of releases (e.g., prevalence) and likelihood of human exposure. For example, the Agency may review accident history or other release data (e.g., TRI, UCMR) to determine how frequently a substance is released or found in the environment, and how or if the substance has caused any adverse health effects to the public or the environment. Together with hazard and environmental fate and transport, this additional information will inform EPA’s conclusion on whether a substance, when released, may present a substantial danger to public health or welfare or the environment. EPA interprets section 102(a) as requiring that, at a minimum, there is a possibility the substance, when released into the environment, presents substantial danger. EPA need not have certainty that the substance poses a substantial danger or require proof of actual harm when released into the environment. This reading of CERCLA section 102(a) is consistent with the ordinary meaning of ‘‘may’’ which is defined as a term ‘‘used to indicate possibility or probability.’’ MerriamWebster (https://www.merriamwebster.com/dictionary/may). It is also consistent with the caselaw interpreting the term ‘‘may’’ in the phrase ‘‘may present an imminent and substantial endangerment’’ under RCRA, which has been construed as not requiring certainty. See ME. People’s Alliance v. Mallinckrodt, Inc., 471 F.3d 277, 288 (1st Cir. 2006) (noting that ‘‘at least four of our sister circuits have construed [section 7002(a)(1)(B)] expansively’’ and that ‘‘all four courts have emphasized the preeminence of the word ‘may’ in E:\FR\FM\08MYR3.SGM 08MYR3 lotter on DSK11XQN23PROD with RULES3 39142 Federal Register / Vol. 89, No. 90 / Wednesday, May 8, 2024 / Rules and Regulations defining the degree of risk needed to support [section 7002(a)(1)(B)’s] liability standard’’ and that certainty of harm is not required); Price v. United States Navy, 39 F.3d 1011, 1019 (9th Cir. 1994) (reasoning that the term ‘‘may’’ ‘‘implies that there must be a threat which is present now, although the impact of the threat may not be felt until later’’). The information that EPA may consider in determining whether the release of a substance may present a substantial danger is consistent with the criteria that the Agency uses in implementing CERCLA through the Hazard Ranking System (HRS) (U.S. EPA, 2023b). CERCLA section 105(a)(8)(A) requires EPA to set criteria for determining priorities among releases or threatened releases throughout the United States for the purpose of taking remedial and removal action, to the extent practicable taking into account the potential urgency of such action. The statute directs EPA to develop criteria based upon relative risk or danger to public health or welfare or the environment, taking into account to the extent possible the population at risk, the hazard potential of the hazardous substances at such facilities, the potential for contamination of drinking water supplies, the potential for direct human contact, the potential for destruction of sensitive ecosystems, the damage to natural resources which may affect the human food chain and which is associated with any release or threatened release, and the contamination or potential contamination of the ambient air which is associated with the release or threatened release. EPA’s regulations establishing criteria for placing sites on the National Priorities List are codified in EPA’s Hazard Ranking System (HRS), 40 CFR part 300 App. A. Ultimately, the HRS factors are consistent with the information EPA considered in designating PFOA and PFOS under CERCLA section 102(a). The standard that EPA has adopted for CERCLA section 102(a) is also consistent with EPA’s interpretation of similar statutory language. See, e.g., CERCLA section 104(a) (allowing for response to pollutants or contaminants that ‘‘may present an imminent and substantial danger’’) and CERCLA section 106(a) (granting enforcement authority ‘‘when there may be an imminent and substantial endangerment’’).33 For example, 33 These provisions concern enforcement and response actions and apply to and require analysis of narrow, site-specific circumstances relevant to a particular facility or person, and to a specific event. As a result, the Agency conducts an assessment of the particular situation at each site when it invokes VerDate Sep<11>2014 18:22 May 07, 2024 Jkt 262001 CERCLA section 106(a) provides EPA with enforcement authority when ‘‘there may be an imminent and substantial endangerment.’’ EPA guidance provides that EPA should rely on ‘‘scientific evidence and documentation’’ to determine if conditions may present an imminent and substantial endangerment (Breen et al., 2001). This may include an evaluation of site-specific conditions that provide a ‘‘reasonable cause for concern that someone or something may be exposed to a risk of harm by a release or a threatened release of a hazardous substance.’’ B.F. Goodrich Co. v. Murtha, 697 F. Supp. 89, 96 (D. Conn. 1988). ‘‘Hazard’’ and ‘‘fate and transport’’ are inherently a part of that analysis, and courts have long examined such considerations under CERCLA section 106(a). See, e.g., United States v. Northeastern Pharmaceutical and Chemical Co., Inc., 579 F. Supp. 823, 832 (W.D. Mo. 1984), aff’d in part, rev’d in part, 810 F.2d 726 (8th Cir. 1986) (examining toxicological properties, hazard, fate and transport, as well as likelihood of exposure in determining whether substances posed an ‘‘imminent and substantial endangerment’’); United States v. E.I. du Pont de Nemours & Co., Inc., 341 F.Supp.2d 215, 247 (W.D.N.Y. 2004) (collecting cases and concluding endangerment exists where, examining all impacts, ‘‘there is reasonable cause for concern that someone or something may be exposed to a risk of harm by a release or a threatened release’’); see also Cox v. City of Dallas, Tex., 256 F.3d 281, 300 (5th Cir. 2001) (examining hazard and fate and transport posed from dangerous gases in concluding that old landfill ‘‘may present an imminent and substantial endangerment’’ under RCRA).34 B. Consistency With Other Methodologies for Identifying CERCLA Hazardous Substances The two central factors that EPA considers in the context of CERCLA section 102(a)—hazard, as well as fate and transport—are consistent with other those other authorities. That purpose is distinct from the purpose of CERCLA section 102(a), which requires a more generalized, non-site-specific evaluation. 34 CERCLA section 106 sets forth a site-specific standard, which differs from the general applicability of CERCLA section 102(a). The language between each section also slightly differs. The phrase ‘‘imminent and substantial endangerment’’ in section 106 is different from the phrase ‘‘may present a substantial danger’’ in section 102. However, given the similar language, the factors that courts have considered in analyzing whether a substance poses a threat under section 106 are instructive to determining whether a substance ‘‘may pose a substantial danger’’ under section 102. PO 00000 Frm 00020 Fmt 4701 Sfmt 4700 methodologies used for identifying CERCLA hazardous substances. CERCLA’s list of ‘‘hazardous substances’’ includes more than 800 substances identified as hazardous or toxic by Congress or EPA under the following 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 chemicals. See 40 CFR Table 302.4 (list of hazardous substances). EPA has applied these authorities in a manner similar to how EPA is interpreting and applying its authority under CERCLA section 102(a) in this action. For this designation, under section 102(a), EPA evaluated toxicity data to assess ‘‘hazard’’ from exposure to PFOA and PFOS. Similarly, the statutes cited in CERCLA’s definition of hazardous substance consider toxicity in some fashion in their listing or identification decisions. See RCRA section 3001 (providing that EPA’s criteria for listing RCRA regulated hazardous wastes take into account ‘‘toxicity,’’ along with other factors); CWA section 311(b)(2)(A) and 42 FR 10474, 10475 (March 13, 1978) (describing ‘‘toxicological selection criteria’’ for hazardous substances designated under the CWA section 311); CWA section 307(a) (providing CWA authority to list ‘‘toxic pollutants’’ taking into account ‘‘toxicity of the pollutant’’); CAA section 112(b)(2) (providing CAA authority to identify air toxics which ‘‘present, or may present . . . a threat of adverse human health effects (including . . . substances which are known to be, or may reasonably be anticipated to be . . . acutely or chronically toxic)); TSCA section 7 (providing TSCA authority to identify a chemical substance or mixture as imminently hazardous when it ‘‘presents an imminent and unreasonable risk of serious or widespread injury to health or the environment, without consideration of costs or other non-risk factors.’’). EPA also evaluated data regarding the fate and transport of PFOA and PFOS in the environment. This analysis focused primarily on the chemical and physical characteristics of PFOA and PFOS, including mobility, resistance to degradation, and persistence in the E:\FR\FM\08MYR3.SGM 08MYR3 Federal Register / Vol. 89, No. 90 / Wednesday, May 8, 2024 / Rules and Regulations environment. Similarly, the CWA, RCRA, and CAA provisions referenced in CERCLA, also consider persistence and resistance to degradation in their listing and identification decisions. See CWA section 307(a) (providing that EPA may list toxic pollutants under the CWA that take into account ‘‘persistence and degradability,’’ alongside toxicity); RCRA section 3001 (providing that EPA’s criteria for listing RCRA regulated hazardous wastes take into account ‘‘persistence and degradability in nature,’’ along with other factors); CAA section 112(b)(2) (identifying ‘‘bioaccumulation’’ as a consideration for evaluating whether a pollutant may be identified as a hazardous air pollutant under CAA). lotter on DSK11XQN23PROD with RULES3 C. CERCLA Section 102(a) and Cost Considerations EPA proposed interpreting CERCLA section 102(a) as precluding the consideration of cost in designating CERCLA hazardous substances. EPA recognizes that, as a general matter, a statutory assessment of health- and environmental-based criteria like the criteria in section 102 does not typically allow for consideration of costs. See, e.g., Whitman v. American Trucking, 531 U.S. 457, 471 (2001) (finding that public health criteria provided in the Clean Air Act, interpreted in its statutory and historical context and with appreciation for its importance to the CAA as a whole, unambiguously bars cost considerations.’’). EPA is not resolving in this final action whether section 102 is best construed as precluding or requiring consideration of costs in designating a hazardous substance. It need not resolve this question here because designation is appropriate under either construction. Specifically, as discussed in Section V, examining only whether PFOA and PFOS may present a substantial danger to public health or welfare or the environment, without considering costs and benefits, EPA has concluded that designation is warranted. In addition to the analysis of the health- and environmental-based criteria, EPA also conducted a totality-of-thecircumstances analysis, including an evaluation of quantitative and qualitative benefits and costs of designation. This additional analysis confirmed that designation is appropriate. In sum, designation is warranted either by examining the health- and environmental-based criteria alone or by examining these criteria along with the broader totality of the circumstances. VerDate Sep<11>2014 18:22 May 07, 2024 Jkt 262001 V. PFOA and PFOS May Present a Substantial Danger to the Public Health or Welfare or the Environment When Released Into the Environment In evaluating hazard with respect to PFOA and PFOS, EPA considered the substantial evidence, based on epidemiological and toxicological studies, indicating that human exposure to PFOA or PFOS is linked to adverse human health effects. Regarding environmental fate and transport, EPA considered evidence that PFOA and PFOS migrate through the environment from the point of release, that they persist in the environment for long durations, and that they bioaccumulate in humans and other organisms. For PFOA and PFOS, EPA considered other relevant information about the frequency, nature, and geographic scope of releases of the substances (i.e., prevalence) demonstrating that these substances have been widely detected in drinking water, surface water, wild animals, and humans in the United States. This other information about the prevalence of PFOA and PFOS is relevant to EPA’s designation decision because widespread detections of these substances in the environment and people demonstrates a greater potential for communities to be exposed to the substances at concentrations that could result in adverse health effects. EPA weighed all of this information—hazard, environmental fate and transport, prevalence—in evaluating the degree or magnitude of danger posed. EPA concluded that PFOA and PFOS may present a substantial danger when released because of the potential for harm to human health, evidence of persistence and bioaccumulation, and high likelihood of exposure. A. PFOA and PFOS Pose a Hazard EPA is confirming the proposed finding that exposure to PFOA and PFOS may pose a hazard, after evaluating the available scientific and technical information as well as public comments. There is evidence from both epidemiological and animal toxicological studies that oral exposure to either PFOA or PFOS has been associated with various adverse health effects across many health outcomes. Numerous health studies support a finding that PFOA and PFOS exposure can lead to adverse human health effects, including cancer (testicular and kidney for PFOA, liver cancer for PFOS), pregnancy-induced hypertension and preeclampsia, and decreased immune response to vaccination (ATSDR, 2021). Toxicology studies suggest that PFOA and PFOS PO 00000 Frm 00021 Fmt 4701 Sfmt 4700 39143 exposure is associated with decreases in serum thyroid hormone levels 35 and adverse effects to the endocrine system (ATSDR, 2021; USEPA, 2024b; 2024c). Based on studies of PFOA and PFOS, in 2021, EPA found that PFOA and PFOS may have adverse effects on public health (’’Announcement of the Final Regulatory Determinations for Contaminants on the Fourth Drinking Water Contaminant Candidate List,’’ 2021). EPA determined that studies indicate human exposure to PFOA and/ or PFOS is linked to a broad range of adverse health effects, including developmental effects to fetuses during pregnancy or to infants (e.g., low birth weight, accelerated puberty, skeletal variations), liver effects (e.g., tissue damage), immune effects (e.g., antibody production and immunity), and other effects (e.g., cholesterol changes). Both PFOA and PFOS are known to be transmitted to the fetus via the placenta and to the newborn, infant, and child via breast milk or formula made with contaminated water. Both compounds were also associated with carcinogenic effects in human epidemiological and long-term animal studies (NTP, 2020; U.S. EPA, 2016a, 2016b). In November 2023, the International Agency for Research on Cancer (IARC) evaluated the carcinogenicity of PFOA and PFOS and classified PFOA as carcinogenic to humans (Group 1) and PFOS as possibly carcinogenic to humans (Group 2b) (Zahm, et al., 2023). These adverse health effects of PFOA and PFOS were further described in the final toxicity assessments and Final Maximum Contaminant Level Goals (MCLGs 36) for Perfluorooctanoic Acid (PFOA) and Perfluorooctane Sulfonic Acid (PFOS) in Drinking Water (U.S. EPA, 2024b, 2024c, 2024d). These toxicity assessments indicate that PFOA and PFOS are associated with adverse health effects at lower levels than previously recognized. In the final toxicity assessments, EPA assessed the weight of the evidence for the available cancer data and determined that PFOA and PFOS are Likely to Be Carcinogenic to Humans consistent with the Guidelines for Carcinogen Risk Assessment (U.S. EPA, 2005). For PFOA, this determination is based on 35 Decreased thyroid hormone levels are associated with effects such as changes in thyroid and adrenal gland weight, hormone fluctuations, and organ histopathology (ATSDR, 2021; USEPA, 2024b; USEPA, 2024c). 36 Maximum Contaminant Level Goal (MCLG)— the maximum level of a contaminant in drinking water at which no known or anticipated adverse effect on the health of persons would occur, allowing an adequate margin of safety. (https:// www.epa.gov/sdwa/how-epa-regulates-drinkingwater-contaminants.) E:\FR\FM\08MYR3.SGM 08MYR3 lotter on DSK11XQN23PROD with RULES3 39144 Federal Register / Vol. 89, No. 90 / Wednesday, May 8, 2024 / Rules and Regulations the evidence of kidney and testicular cancer in humans and Leydig cell tumors, pancreatic acinar cell tumors, and hepatocellular adenomas in rats. (U.S. EPA, 2024c, 2024d). For PFOS, this determination is based on the evidence of hepatocellular tumors in humans and rats, pancreatic islet cell carcinomas in male rats, and mixed but plausible evidence of bladder, prostate, kidney, and breast cancers in humans as described by U.S. EPA (2024b, 2024d). The EPA’s 2024 PFOA and PFOS toxicity assessments prioritized the following five health endpoint categories with the strongest weight of evidence and indicating that oral PFOA and PFOS exposure is associated with adverse health effects: immunological, hepatic, developmental, cardiovascular, and cancer effects. This prioritization was based on findings from conducting systematic review (including the study quality evaluation, evidence synthesis and evidence integration) on the available and relevant human epidemiological and animal toxicity studies (U.S. EPA, 2024b, U.S. EPA, 2024c). EPA evaluated sixteen noncancer health outcomes as part of the 2024 toxicity assessments and, in accordance with recommendations from the SAB {U.S. EPA, 2022, 10476098} and the IRIS Handbook {U.S. EPA, 2022, 10367891}, EPA’s toxicity assessments prioritized the five categories of health outcomes above with either evidence demonstrating or evidence indicating associations between PFOA and PFOS exposure and adverse health effects. Accordingly, to support EPA’s finding in this final rule that both PFOA and PFOS each individually pose a human health hazard, EPA gave weight to immunological, hepatic, developmental, cardiovascular, and cancer effects. For this final rule, EPA considered a wide range of potential health effects associated with exposure to PFOA and PFOS using five comprehensive peerreviewed Federal government documents that summarize the recent literature on PFAS (mainly PFOA and PFOS) exposure and its health impacts: (1) EPA’s 2016 Health Effects Support Documents for PFOA (U.S. EPA, 2016c); (2) EPA’s 2016 Health Effects Support Documents for PFOS (U.S. EPA, 2016d); (3) U.S. Department of Health and Human Services Agency for Toxic Substances and Disease Registry’s (ATSDR) 2021 Toxicological Profile for Perfluoroalkyls (ATSDR, 2021); (4) EPA’s 2024 Final Human Health Toxicity Assessment for Perfluorooctanoic Acid (PFOA) (U.S. EPA, 2024b); and (5) EPA’s 2024 Final Human Health Toxicity Assessment for VerDate Sep<11>2014 18:22 May 07, 2024 Jkt 262001 Perfluorooctane Sulfonic Acid (PFOS), (U.S. EPA, 2024c). Each source presents comprehensive, systematic reviews of relevant, peer-reviewed literature on adverse health effects associated with PFOA and PFOS. The EPA assessments were prepared by the Office of Water. Data from human and animal studies indicate that PFOA and PFOS are well absorbed in the human body after being ingested and are distributed throughout the body by binding to proteins. PFOA and PFOS bioaccumulate in the human body as evidenced by the elimination half-lives from about two to three years for PFOA and four to five years for PFOS (ATSDR, 2021). There is no evidence that humans or animals are able to break down these substances, and they can be distributed to tissues throughout the human body and are not readily eliminated, resulting in long elimination half-lives in the human body and bioaccumulation. Available evidence supports urine as the primary route of excretion in most species, though fecal elimination is prominent in rats. In rats, hair is another route of elimination in both males and females. In females, elimination pathways include menstruation, pregnancy (cord blood, placenta, amniotic fluid, and fetal tissues) and lactation (breast milk) (PFOA Toxicity Assessment 2024, PFOS Toxicity Assessment 2024). Thus, PFOA and PFOS remain in the body after exposure has ended and can potentially cause detrimental health effects even after an initial exposure has ceased. Continued exposures to PFOA and PFOS can lead to significantly elevated concentrations in the human body and result in adverse health effects due to this bioaccumulation (Ballesteros et al., 2017; Barry et al., 2014; Dhingra et al., 2016; Frisbee et al., 2010; Gallo V et al., 2012; Hall et al., 2023; Hoffman et al., 2011; Kotlarz et al., 2020; Savitz et al., 2012; Steenland et al., 2009; Steenland et al., 2018a; Steenland et al., 2018b). EPA’s 2024 Final Human Health Toxicity Assessments for PFOA and PFOS integrated the available data on absorption, distribution, metabolism and elimination into the derivation of reference values for PFOA and PFOS. Collectively the adverse health effects evidence demonstrates that each PFOA and PFOS individually pose a human health hazard, and the substantial body of evidence for several individual adverse health effects also supports EPA’s human health hazard finding for each of these substances. A discussion of some of the detrimental health effects follows. Developmental Effects: Adverse developmental effects can increase the likelihood of difficulties during labor PO 00000 Frm 00022 Fmt 4701 Sfmt 4700 through post-delivery. Evidence indicates that exposure to PFOA and PFOS is likely associated with developmental effects such as lower infant birth weight, lower birth length, smaller head circumference at birth, and other effects (Verner et al., 2015; U.S. EPA, 2016e; U.S. EPA, 2016f; Negri et al., 2017; ATSDR, 2018; Waterfield et al., 2020; U.S. EPA, 2023b; U.S. EPA, 2024c). Research suggests that exposure to PFOA and PFOS is associated with developmental effects, including decreased infant birth weight (ATSDR, 2021; Negri et al., 2017; U.S. EPA, 2016c, 2016d, 2024b, 2024c; Verner et al., 2015; Waterfield et al., 2020). Low birth weight is linked to a number of health effects that may be a source of economic burden to society in the form of medical costs, infant mortality, parental and caregiver costs, labor market productivity loss, and education costs (Behrman & Rosenzweig, 2004; Chaikind & Corman, 1991; Colaizy et al., 2016; Institute of Medicine, 2007; Joyce et al., 2012; Klein & Lynch, 2018; Kowlessar et al., 2013; Nicoletti et al., 2018). 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 animals 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 (ATSDR, 2021; U.S. EPA, 2016c, 2016d). The embryo and fetus are exposed prenatally to PFOA and PFOS through maternal blood via the placenta (ATSDR, 2021). Several epidemiological studies of the association between maternal serum PFOA/PFOS and birth weight have found evidence for decreased body weight of infants exposed in utero (Chu et al., 2020; Darrow et al., 2013; Dzierlenga et al., 2020; Govarts et al., 2016; Negri et al., 2017; Sagiv et al., 2018; Starling et al., 2017; Verner et al., 2015; Wikstrom et al., 2020; Yao et al., 2021). Other developmental associations with PFOA and PFOS include small for gestational age (SGA), decreased birth length, decreased head circumference at birth, and other effects (ATSDR, 2021; Negri et al., 2017; U.S. EPA, 2016c, 2016d, 2024b, 2024c; Verner et al., 2015; Waterfield et al., 2020). Epidemiology evidence for SGA related to PFOA/ PFOS exposure was mixed; some studies reported increased risk of SGA with PFOA/PFOS exposure, while other studies observed null results (USEPA, E:\FR\FM\08MYR3.SGM 08MYR3 lotter on DSK11XQN23PROD with RULES3 Federal Register / Vol. 89, No. 90 / Wednesday, May 8, 2024 / Rules and Regulations 2024b; USEPA, 2024c). SGA is a developmental health outcome of interest when studying potential effects of PFOA/PFOS exposure because SGA infants have increased health risks during pregnancy and delivery as well as post-delivery (Osuchukwu & Reed, 2022). Cardiovascular Effects: Cardiovascular Disease (CVD) is one of the leading causes of premature mortality in the United States (D’Agostino et al., 2008; Goff et al., 2014; Lloyd-Jones et al., 2017). Changes in total cholesterol and blood pressure are associated with changes in incidence of CVD events such as myocardial infarction (i.e., heart attack), ischemic stroke, and cardiovascular mortality occurring in populations without prior CVD event experience (D’Agostino et al., 2008; Goff et al., 2014; Lloyd-Jones et al., 2017). Evidence indicates that exposure to PFOA and PFOS is likely associated with increased low-density lipoprotein cholesterol (LDLC), total cholesterol, and highdensity lipoprotein cholesterol (ATSDR, 2021; U.S. EPA, 2024b, 2024c). High levels of LDLC lead to the buildup of cholesterol in the arteries, which can raise the risk of heart disease and stroke. Epidemiology studies showed a positive association between PFOA or PFOS exposure and LDLC or total cholesterol levels in children (U.S. EPA, 2024b, 2024c). In particular, the evidence suggested positive associations between serum PFOA and PFOS levels and LDLC levels in adolescents ages 12–18, while positive associations between serum levels and LDLC levels in younger children were observed only for PFOA (ATSDR, 2021). Other epidemiology studies have generally found a positive association between increasing serum PFOA and total cholesterol levels (ATSDR, 2021). Cancer Effects: PFOA and PFOS are Consistent with the Guidelines for Carcinogen Risk Assessment (U.S. EPA, 2005), EPA determined that both PFOA and PFOS are Likely to Be Carcinogenic to Humans based on sufficient evidence of carcinogenicity in humans and animals (U.S. EPA, 2024b, USEPA 2024c). Additionally, in November 2023, the International Agency for Research on Cancer (IARC) evaluated the carcinogenicity of PFOA and PFOS and classified PFOA as carcinogenic to humans (Group 1) and PFOS as possibly carcinogenic to humans (Group 2b) (Zahm, et al., 2023). For PFOA, cancer evidence in epidemiological studies is primarily based on the incidence of kidney and testicular cancer, as well as some evidence of breast cancer, which is most consistent in genetically VerDate Sep<11>2014 18:22 May 07, 2024 Jkt 262001 susceptible subpopulations or for particular breast cancer types (U.S. EPA, 2024c). Epidemiology studies indicated that exposure to PFOA was associated with an increased risk of renal cell carcinoma (RCC) (ATSDR, 2021; California EPA, 2021; U.S. EPA, 2016d, 2024d). For PFOS, the available epidemiology studies report elevated risk of liver cancer, consistent with increased incidence of liver tumors reported in long-term rat exposure studies. There is also mixed but plausible evidence of bladder, prostate, kidney, and breast cancers in humans after chronic exposure and evidence of pancreatic islet cell tumors in rats (U.S. EPA, 2024b). Liver Effects: High levels of the enzyme alanine transaminase (ALT) in the bloodstream may indicate liver damage. Evidence indicates that exposure to PFOS and PFOA is associated with increased liver enzymes (U.S. EPA, 2024b; 2024c). Epidemiology data provides evidence of a positive association between PFOS/PFOA exposure and ALT levels in adults (ATSDR, 2021; U.S. EPA, 2024b, 2024c). Studies of adults showed consistent evidence of a positive association between PFOA exposure and elevated ALT levels at both high exposure levels and exposure levels typical of the general population (U.S. EPA, 2024c). Associations between increasing serum PFOA concentrations and elevations in different serum enzyme levels were consistently observed in occupational cohorts, high-exposure communities and the U.S. general population that could indicate the potential for PFOA to affect liver function (ATSDR, 2021). There is also consistent epidemiology evidence of associations between PFOS and elevated ALT levels. A limited number of studies reported inconsistent evidence on whether PFOA/PFOS exposure is associated with increased risk of liver disease (U.S. EPA, 2024b). Results reported in animal toxicological studies are consistent with the observed elevated ALT indicative of hepatic damage in epidemiological studies. Specifically, studies in rodents found that oral PFOA or PFOS treatment resulted in biologically significant alterations in levels of at least one serum biomarker of liver injury (e.g., ALT) and evidence of histopathological alterations including hepatocyte degenerative or necrotic changes. Immune Effects: Proper antibody response helps maintain the immune system by recognizing and responding to antigens. Evidence indicates that exposure to PFOS and PFOA is associated with immunosuppression; (U.S. EPA, 2024b; U.S. EPA, 2024c); PO 00000 Frm 00023 Fmt 4701 Sfmt 4700 39145 epidemiology studies showed suppression of at least one measure of the antibody response for tetanus and diphtheria among people with higher prenatal, childhood, and adult serum concentrations of PFOA (U.S. EPA, 2024c). Data reporting associations between PFOA exposure and antibody response to vaccinations other than tetanus and diphtheria are limited (ATSDR, 2021; USEPA, 2024c). Several epidemiological studies have shown a relationship between increased PFOA and PFOS serum concentrations and decreased response to vaccinations in children (Budtz-Jorgensen & Grandjean, 2018; Grandjean et al., 2012; Grandjean, Heilmann, Weihe, Nielsen, Mogensen, & Budtz-Jorgensen, 2017; Grandjean, Heilmann, Weihe, Nielsen, Mogensen, Timmermann, et al., 2017; Timmermann et al., 2022; Zhang et al., 2023). Epidemiology evidence suggests that children with preexisting immunological conditions are particularly susceptible to immunosuppression associated with PFOA exposure (U.S. EPA, 2024c). Available studies supported an association between PFOS exposure and immunosuppression in children, where increased PFOS serum levels were associated with decreased antibody production (U.S. EPA, 2024b). Studies reporting associations between PFOA or PFOS and immunosuppression in adults are less consistent; there is a lack of high confidence data. (U.S. EPA, 2024b). In addition to the adverse health effects listed above, there was suggestive evidence that exposure to PFOS and PFOA is associated with the additional health effects summarized below. Endocrine Effects: Elevated thyroid hormone levels can accelerate metabolism and cause irregular heartbeat; low levels of thyroid hormone can cause neurodevelopmental effects, tiredness, weight gain, and increased susceptibility to the common cold. There is suggestive evidence of a positive association between PFOA/ PFOS exposure and thyroid hormone disruption (ATSDR, 2021; U.S. EPA, 2024b, 2024c). Toxicology studies in animals indicated that PFOA and PFOS exposure can affect thyroid function 37 (ATSDR, 2021; U.S. EPA, 2024b, 2024c). Changes to serum thyroid hormone levels in animals lead to adverse effects to the endocrine system (U.S. EPA, 2024b, 2024c). Despite uncertainty around the applicability of animal studies in this area, changes in serum 37 Decreased thyroid hormone levels are associated with effects such as changes in thyroid and adrenal gland weight, hormone fluctuations, and organ histopathology (ATSDR, 2021; U.S. EPA, 2024b, 2024c). E:\FR\FM\08MYR3.SGM 08MYR3 lotter on DSK11XQN23PROD with RULES3 39146 Federal Register / Vol. 89, No. 90 / Wednesday, May 8, 2024 / Rules and Regulations thyroid hormone levels in animals did indicate adverse effects after PFOS and PFOA exposure that is relevant to humans (U.S. EPA, 2024b; 2024c). Metabolic Effects: Leptin is a hormone that controls hunger, and high leptin levels are associated with obesity, overeating, and inflammation (e.g., of adipose tissue, the hypothalamus, blood vessels, and other areas). Animal studies showed increases in serum leptin levels in mice that were exposed to low levels of PFOA (ATSDR, 2021). Based on a review of 69 human epidemiology studies, evidence of associations between PFOS and metabolic outcomes appears inconsistent, but in some studies, suggestive evidence was observed between PFOS exposure and leptin levels (U.S. EPA, 2024b). Reproductive Effects: Studies of the reproductive effects from PFOA/PFOS exposure have focused on associations between exposure to these pollutants and increased risk of gestational hypertension and preeclampsia in pregnant women (ATSDR, 2021; U.S. EPA, 2024b, 2024c). Gestational hypertension (high blood pressure during pregnancy) can lead to fetal health outcomes such as poor growth and stillbirth. Preeclampsia—instances of gestational hypertension where the mother also has increased levels of protein in her urine—can similarly lead to fetal problems and maternal complications. The epidemiology evidence yields mixed (positive and non-significant) associations, with some suggestive evidence supporting positive associations between PFOA/PFOS exposure and both preeclampsia and gestational hypertension (ATSDR, 2021; U.S. EPA, 2024b, 2024c). 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 (U.S. EPA, 2016d). Musculoskeletal effects: Adverse musculoskeletal effects such as osteoarthritis and decreased bone mineral density impact bone integrity and cause bones to become brittle and more prone to fracture. There is limited evidence from studies pointing to effects of PFOS on skeletal size (height), lean body mass, and osteoarthritis (U.S. EPA, 2024b). Epidemiology evidence suggested that PFOA exposure may be linked to decreased bone mineral density, bone mineral density relative to bone area, height in adolescence, osteoporosis, and osteoarthritis (ATSDR, 2021; U.S. EPA, 2024c). Evidence from four PFOS studies suggests that PFOS exposure has a harmful effect on bone VerDate Sep<11>2014 18:22 May 07, 2024 Jkt 262001 health, particularly measures of bone mineral density, with greater statistically significance of effects occurring among females (U.S. EPA, 2024b). Taken together, the technical/ scientific information above demonstrate that both PFOA and PFOS individually are each associated with considerable and varied adverse health effects. EPA also considered potential effects on children’s health. EPA’s Policy on Children’s Health requires the Agency to consider early life exposures (from conception, infancy, early childhood and through adolescence until 21 years of age) and lifelong health consistently and explicitly in all human health decisions through identifying and integrating children’s health data and information. As described throughout this section, information on PFOA and PFOS shows exposure to PFOA and/or PFOS is linked to adverse health effects relevant to children. These adverse health effects include developmental effects to fetuses during pregnancy or to infants, cardiovascular effects and immune effects in children and endocrine and reproductive effects that impact development. Suggestive evidence of associations found in human epidemiological studies between PFOA and PFOS and adverse development effects of include decreased infant birth weight (ATSDR, 2021; Negri et al., 2017; U.S. EPA, 2016c, 2016d, 2024b, 2024c; Verner et al., 2015; Waterfield et al., 2020). Animal studies have shown developmental health effects including associations with decreased offspring survival, low birth weight, accelerated puberty and skeletal variations (ATSDR, 2021; U.S. EPA, 2016c, 2016d). Cardiovascular effects include positive associations between serum PFOA and PFOS levels and LDLC levels in adolescents ages 12–18 (ATSDR, 2021). Several epidemiological studies have shown a relationship between increased PFOA and PFOS serum concentrations and decreased response to vaccinations in children (Budtz-Jorgensen & Grandjean, 2018; Grandjean et al., 2012; Grandjean, Heilmann, Weihe, Nielsen, Mogensen, & Budtz-Jorgensen, 2017; Grandjean, Heilmann, Weihe, Nielsen, Mogensen, Timmermann, et al., 2017; Timmermann et al., 2022). There is suggestive evidence of a positive association between PFOA and/or PFOS exposure and thyroid hormone disruption (ATSDR, 2021; U.S. EPA, 2024b, 2024c). The epidemiology evidence yields mixed (positive and non-significant) associations, with some evidence suggesting positive PO 00000 Frm 00024 Fmt 4701 Sfmt 4700 associations between PFOA and/or PFOS exposure and both preeclampsia and gestational hypertension which can lead to fetal health outcomes such as poor growth, stillbirth and maternal complications (ATSDR, 2021; U.S. EPA, 2024b, 2024c). EPA also considered the hazards associated with salts and structural isomers of PFOA and PFOS. The hazards associated with PFOA and PFOS can be associated with their respective salts and both their linear and branched isomers. Salts are deemed to have the same toxicity as the commonly referenced acid versions because, once put in water (and likewise when in the human body), the acid and salt forms will dissociate to the ionic form. Further, many toxicity studies on PFAS were often performed using the salt form. For example, while Emmett et al. (2006) toxicity studies were performed on the acid version of PFOA, Butenhoff et al. (2012) used the ammonium salt of PFOA. The potassium salt of PFOS was generally used in animal toxicity studies such as Ankley et al. (2004). Additionally, PFOA and PFOS exist as linear and branched isomers, and the linear and branched isomers have been found in environmental media and in human sera. For example, in the last NHANES for which results are available (2017–2018), branched PFOS was detected in 99% of those sampled, while branched PFOA was found in 10%. Most animal toxicity studies using isomeric mixtures do not state the ratio of linear and branched isomers in the test material, and, therefore, it is not feasible to distinguish the toxicity of the individual isomers. However, in a few studies, including Butenhoff et al. (2012), Lau et al. (2006), and Lou et al. (2009) for PFOA, and Ankley et al. (2004) for PFOS, the authors stated that the PFAS test substance was not 100% linear, and thus, any effects indicated in these studies can only be associated with the isomeric mixture of linear and branched and not specifically with linear isomers or branched isomers. Further, Loveless et al. (2006) compared the toxicity of linear ammonium PFOA, branched ammonium PFOA, and a mixture of linear and branched ammonium PFOA in rodents and demonstrated that both linear and branched isomers exhibit similar types of toxicity. B. Information About the Fate and Transport of PFOA and PFOS Demonstrate That They Are Persistent and Mobile in the Environment Available information about the fate and transport of PFOA and PFOS E:\FR\FM\08MYR3.SGM 08MYR3 lotter on DSK11XQN23PROD with RULES3 Federal Register / Vol. 89, No. 90 / Wednesday, May 8, 2024 / Rules and Regulations support EPA’s conclusions that these substances remain in the environment for many years (i.e., persistency) and that they can move through air, land, and water (i.e., mobility) after release. Both PFOA and PFOS are considered surfactants due to their chemical structures that consists of a hydrophobic perfluorinated alkyl ‘‘tail group’’ and a hydrophilic carboxylate (for PFOA) or sulfonate (for PFOS) ‘‘head group.’’ Surfactants decrease the surface tension between two liquids (i.e., oil and water), a gas and a liquid, or a solid and a liquid. This attribute means they increase mixing and transport between soil and groundwater or air and water, and thus PFOA and PFOS move between environmental media more easily. These chemicals are sometimes referred to as ‘‘forever’’ chemicals because of their strong carbon-fluorine bonds in the ‘‘tail group’’ that cause PFOA and PFOS to be extremely resistant to degradation through biological degradation and also through chemical degradation (i.e., photooxidation and hydrolysis). Photooxidation describes the process of oxidation through light exposure and hydrolysis describes the chemical breakdown of compound due to reaction with water. Degradation data from 3M for PFOA states ‘‘Hydrolysis half-life >92 years @ pH 7 & 25 °C (ammonium salt tested); Photolysis in water: half-life > = 342 days; neither direct nor indirect photolysis in water observed based on loss of PFOA; Biodegradation-OECD 301C, 28 days, 5% BOD/ThOD; Biodegradation-Aerobic sludge, 18 days, no degradation observed (ammonium salt tested); Biodegradation-Anaerobic sludge, 94 days, no degradation observed.’’ Degradation date from 3M for PFOS states ‘‘BiodegradationAnaerobic sludge, 105 days, no degradation observed; BiodegradationOECD 301C (MITI–I), 28 days, 0% BOD/ ThOD (3M 2021).’’ The resistance to degradation causes PFOA and PFOS to remain in the environment for long periods of time. This means that the potential for human exposure continues long after a release has ended. PFAS are mobile in the environment and have been found in remote locations, indicating they are widespread in the environment (Giesy & Kannan, 2001). PFAS have been found in outdoor air at locations in the United States, Europe, Japan, and over the Atlantic Ocean (ATSDR, 2021). PFOA and PFOS are water soluble and thus may be found in groundwater and surface water (U.S. EPA 2024a). Further, PFOA and PFOS have water-soil/ sediment partition coefficients of 15– VerDate Sep<11>2014 18:22 May 07, 2024 Jkt 262001 708 L/kg and 7–120 L/kg, respectively (3M, 2021). These values are on the order of many metals, indicating that PFOA and PFOS are fairly mobile and will move from soil and sediment to water. Experimental data indicates in the marine environment, where suspended solid concentrations are generally low, PFOA and PFOS are mainly transported in the dissolved phase rather than being adsorbed to suspended solids (Ahrens et al., 2011). Their presence in the water column means that they will be transported further and are available for long range transport and bioaccumulation (Ahrens et al., 2011). In a 2001 study investigating the global distribution of PFAS, wildlife samples were collected on four continents including North America and Antarctica and PFAS was found to be widely distributed on a global scale.38 39 Over 30 different species had measurable levels of PFOS (European Food Safety Authority, 2008; Giesy & Kannan, 2001). PFOA and PFOS have been shown to persist in humans and animals, with estimated half-lives in humans ranging from about two to three years for PFOA to four or five years for PFOS (ATSDR, 2021). Organisms that are exposed to PFOA and PFOS cannot break them down inside the body and excrete very little. Because PFOA and PFOS can remain in human and animal bodies for long durations, individuals with consistent ongoing exposures to PFOA and PFOS (e.g., individuals consistently exposed by drinking contaminated water or eating contaminated food) can have elevated concentrations of these substances in their bodies (Bangma et al., 2017; Burkhard, 2021; Ng & Hungerbuhler, 2014). C. Other Information Considered Other information that EPA considered includes, the frequency, nature, and geographic scope of releases of these substances. This information demonstrates that PFOA and PFOS are prevalent, including in the U.S., and there is likelihood of exposure to humans and the environment. PFOA and PFOS are prevalent throughout the environment because of their widespread use since the 1940s in a wide range of commercial and consumer products and because of their 38 Global Distribution of Perfluorooctane Sulfonate in Wildlife; John P. Giesy and Kurunthachalam Kannan; Department of Zoology, National Food Safety and Toxicology Center, Institute for Environmental Toxicology; Michigan State University. 39 https://www.efsa.europa.eu/en/efsajournal/ pub/653. PO 00000 Frm 00025 Fmt 4701 Sfmt 4700 39147 persistence. Currently, the public can be exposed to PFOA and PFOS through a variety of sources, including water, food, and environmental media. See Proposed Rule, 87 FR at 54418–19 (Discussion on the uses of PFOA and PFOS). Major causes of PFOA and PFOS environmental contamination include historical uses, limited ongoing uses, and ongoing uses of precursors. These activities include past direct industrial discharges of PFOA and PFOS to soil, air, and water and disposal of these substances or products that contain these substances. Precursor chemicals 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. See Proposed Rule, 87 FR at 54426 (providing a brief history of sources of PFOA and PFOS to the environment). PFOA and PFOS have been detected in groundwater in monitoring wells, private drinking water wells, and public drinking water systems across the country. The most vulnerable drinking water systems are those in close proximity to sites contaminated with PFOA and PFOS (ATSDR, 2021). Under the third Unregulated Contaminant Monitoring Rule (UCMR), EPA worked with the States and local communities to monitor for six PFAS, including PFOA and PFOS, 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 was detected above the minimum reporting level (minimum reporting level = 20 nanogram/liter (ng/L)) in 379 samples in 117 PWSs serving a population of approximately 7.6 million people located in 28 States, Tribes, or U.S. territories. PFOS was found in 292 samples at 95 systems above the UCMR 3 MRL (40 ppt). These systems serve a population of approximately 10.4 million people located in 28 States, Tribes, or U.S. territories (U.S. EPA, 2017). More recent available data collected by States show continued occurrence of PFOA and PFOS in drinking water supplies in multiple geographic locations throughout the country, as well as occurrences at lower concentrations and significantly greater frequencies than were measured under the UCMR3 (‘‘PFAS National,’’ 2023). PFOA and PFOS are also widely detected in surface water samples E:\FR\FM\08MYR3.SGM 08MYR3 lotter on DSK11XQN23PROD with RULES3 39148 Federal Register / Vol. 89, No. 90 / Wednesday, May 8, 2024 / Rules and Regulations collected from various rivers, lakes, and streams in the United States. Municipalities and other entities may use surface water sources for drinking water and that creates an additional potential exposure pathway to PFOA and PFOS. PFOA and PFOS can reach soil due to atmospheric transport and wet/dry deposition (ATSDR, 2021). These substances have been found in outdoor air at locations across the globe around PFAS production facilities and facilities that use PFAS. PFOA and PFOS have been detected in surface and subsurface soils. Levels of PFOA and PFOS generally increased with increasing depth at sampled locations (PFAS manufacturing facilities), suggesting a downward movement of the contaminants and the potential to contaminate groundwater (ATSDR, 2021). PFOA and PFOS can be taken up by plants, as evidenced by their presence in produce analyzed by the U.S. Food and Drug Administration (2021). PFOA and PFOS have also been found in wild and domestic animals such as fish, shellfish, alligators, deer, and avian eggs and in humans (ATSDR, 2021). 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 (Bangma et al., 2017; Falk et al., 2012; Gewurtz et al., 2016; Holmstrom et al., 2005; Michigan PFAS Action Response Team, 2021; Morganti et al., 2021; U.S. EPA, 2016a, 2016b; Wang et al., 2008; Wisconsin DNR, 2020). There is a significant potential for human exposure to PFOA or PFOS because of their persistence, mobility, and prevalence in the environment (Langenbach & Wilson, 2021). PFOA and PFOS contamination in the environment can lead to human exposure through ingestion of contaminated water, plants, wild animals, and livestock. PFOA and PFOS 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. Human exposure can occur through the consumption of wild animals that have been contaminated by environmental exposure. Several States have issued advisories recommending that hunters and fishers avoid eating deer, turkey, or fish due to high levels of PFOS detected in the animals (MDIFW, 2023; Michigan PFAS Action Response Team, 2023; VerDate Sep<11>2014 18:22 May 07, 2024 Jkt 262001 NCDHHS, 2023). Contaminated water also results in the contamination of livestock such as 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 (Christensen et al., 2017; FDA, 2021; U.S. EPA, 2019b). Food can also be contaminated through food packaging made with these chemicals. However, in 2016, the Food and Drug Administration revoked the regulations authorizing the remaining uses of long-chain PFAS in food packaging (see 81 FR 5, January 4, 2016, and 81 FR 83672, November 22, 2016). Therefore, PFOA and PFOS should not be in food packaging now. Humans can also be exposed through incidental ingestion of contaminated soil and dust. Numerous studies have shown that PFOA and PFOS can be found in residences, offices, and other workplaces, and in consumer goods (Gaines, 2023; Hall et al., 2020; Strynar & Lindstrom, 2008). PFOA and PFOS have been detected in nearly all of the blood of the participants in the NHANES. This indicates widespread exposure to these PFAS in the U.S. population (CDC, 2022). As part of the continuous NHANES, 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. As of the 2017– 2018 data, PFOA and PFOS were still detectable in 99% of the population, although the mean concentrations of PFOA and PFOS in the serum have been steadily decreasing since 1999–2000 (CDC, 2021; U.S. EPA, 2019a). Communities drinking water or eating food contaminated with PFAS can have significantly elevated blood levels of PFAS compared to national average concentrations (Graber et al., 2019; Kotlarz et al., 2020). Because PFOA and PFOS can remain in the human body and for long durations, individuals who have consistent ongoing exposures to PFOA and PFOS (e.g., those exposed by drinking contaminated water or eating contaminated food) can have high concentrations of these compounds in their bodies. Epidemiological studies measuring PFAS levels in humans have noted that people living near contaminated sites have higher concentrations of these chemicals than the general population and that drinking PO 00000 Frm 00026 Fmt 4701 Sfmt 4700 water is an important contributor to exposure (Emmett et al., 2006). Conclusion In light of the evidence regarding hazard and the fate and transport of these chemicals, and consideration of the degree or magnitude of danger posed, EPA concludes for several reasons described above that PFOA and PFOS each may present a substantial danger when released into the environment.40 Furthermore, the other information EPA considered, such as environmental prevalence and the likelihood of exposure, reinforce its conclusion. individuals living in communities located near sites with high levels of PFOA and PFOS (e.g., sites where PFOA and PFOS were manufactured or used in the manufacture of products) are the populations (i.e., non-occupationally exposed populations) most likely to be exposed to PFOA or PFOS and are thus more likely to experience associated adverse health effects. At the same time, the mobility of PFOA and PFOS means that these substances have the potential to migrate away from a highly contaminated site into sources of drinking water, both groundwater and surface water. And the mobility and persistence combine to create an ever-expanding area of contamination if it is not contained and/ or cleaned up. The persistence, mobility, and prevalence of PFOA and PFOS create more opportunities for exposure to humans and the environment, thereby increasing the likelihood of adverse health effects and adverse ecological burdens stemming from the toxicity of these compounds. See Proposed Rule, 87 FR 54415. In sum, communities located near sites with the highest concentrations of PFOA and PFOS are subject to a disproportionately higher risk of exposure to those substances as compared to the general population. For all these reasons, EPA finds that both PFOA and PFOS, and their salts and isomers, each may present a substantial danger to the public health, or welfare, or the environment when released. 40 EPA need only determine that PFOA and PFOS ‘‘may present’’ a substantial danger to designate as hazardous substances pursuant to CERCLA. CERCLA section 102(a). Other actions taken by EPA, pursuant to other statutory authorities, may require a different or more stringent finding. The scientific and technical data that EPA is relying on in this action may be relevant to those determinations and may support a finding under a more stringent standard. E:\FR\FM\08MYR3.SGM 08MYR3 Federal Register / Vol. 89, No. 90 / Wednesday, May 8, 2024 / Rules and Regulations lotter on DSK11XQN23PROD with RULES3 VI. The Totality of the Circumstances Confirms That Designation of PFOA and PFOS as Hazardous Substances Is Warranted Along with concluding that both PFOA and PFOS ‘‘may present a substantial danger,’’ EPA also independently exercised its discretion and conducted an additional ‘‘totality of the circumstances’’ analysis to evaluate whether designation was warranted. The analysis looks to the evidence showing that PFOA and PFOS ‘‘may present a substantial danger’’ along with CERCLA section 102(a) and its broader context. CERCLA section 102(a) and its broader context help identify the information to weigh and how to balance multiple considerations. In conducting the analysis as to PFOA and PFOS, EPA identified and weighed the advantages and disadvantages of designation. This analysis included consideration of the formal benefit-cost analysis, including quantitative and qualitative benefits and costs provided in the Regulatory Impact Analysis accompanying this final rule. The totality of the circumstances analysis first considered the evidence that both PFOA and PFOS may present a substantial danger to public health or welfare or the environment when released, see CERCLA section 102(a). Specifically, EPA examined the scientific basis for designation. EPA gave the scientific evidence considerable weight. As discussed in Section V above, PFOA and PFOS exposure has been connected to a wide range of adverse human health and environmental effects. PFOA and PFOS bioaccumulate in humans and animals, including the fish and other wild animals we eat. And PFOA and PFOS are persistent and mobile in the environment. If not addressed, PFOA and PFOS will continue to migrate, further exacerbating exposure risk and potential cleanup costs. EPA then evaluated CERCLA section 102(a) in the broader context of CERCLA. Section 102(a) provides EPA with health- and environmental-based criteria to evaluate whether a substance can be designated as hazardous. A hazardous substance designation, in turn, makes available the full suite of CERCLA authorities. EPA examined the ways in which designation serves CERCLA’s express purposes and functions: ensuring that the ‘‘Polluter Pays’’ for cleanup (CERCLA sections 107(a), 106(a)); allowing for timely cleanup of contaminated sites (CERCLA sections 104, 106, 121); and authorizing response that protects human health VerDate Sep<11>2014 18:22 May 07, 2024 Jkt 262001 and the environment (CERCLA sections 104, 106, 121). With these statutory purposes in mind, EPA considered the core problem posed by PFOA and PFOS in the environment and whether designating PFOA and PFOS as hazardous substances would meaningfully improve EPA’s ability to address the problem. EPA believes that the likelihood of the public being exposed to PFOA and PFOS is high. The science demonstrates that human exposure to these chemicals is linked to a broad range of adverse health effects. These concerns apply particularly to those communities living near former manufacturing sites, where PFOA and PFOS were produced (and then widely used) since the 1940s. As a result, communities may be exposed to existing contamination at and near sites where those substances were manufactured and used for decades. These contaminated sites have the potential to disproportionately harm nearby communities and ecosystems. Because of this potential risk, such sites need to be investigated, evaluated for risk to human health and the environment, and cleaned up as appropriate. EPA concluded that CERCLA is best suited to address the problem posed by legacy PFOA and PFOS contamination. EPA next considered whether the hazardous substances designation is warranted considering EPA’s existing authority that allows the Agency to address PFOA and PFOS as CERCLA ‘‘pollutants and contaminants.’’ EPA weighed how designation may promote cleanups that might otherwise be delayed or not occur. EPA’s current authority to is limited in meaningful ways.41 This rule, however, will allow EPA to utilize the full suite of CERCLA authorities and enable EPA to address more sites, allow for earlier action, and expedite eventual cleanup. This is, in large part, because EPA will be able to employ CERCLA’s liability and enforcement provisions to require parties responsible for significant pollution to address existing contamination. As a consequence, designation greatly expands societal 41 As described in Section II.E., CERCLA authority differs with respect to ‘‘hazardous substances’’ and ‘‘pollutants or contaminants.’’ Designation of PFOA and PFOS as ‘‘hazardous substances’’ streamlines response authority, makes available cost recovery authorities allowing parties to recover response costs from PRPs, and makes available CERCLA enforcement authority to compel PRPs to conduct or pay for cleanup. See CERCLA sections 104(a), 106(a), 107(a). Designation also requires facilities to notify federal, state, local, and tribal authorities, as well as potentially injured parties, of significant releases. See CERCLA sections 103(a), 111(g); EPCRA section 304. PO 00000 Frm 00027 Fmt 4701 Sfmt 4700 39149 resources available (both financial and human capital) for investigation and cleanup that would not be available absent designation. EPA also weighed the quantitative and qualitative costs and benefits evaluated in the RIA.42 EPA considered the estimated direct and indirect monetized costs. These costs include direct costs to comply with release notification requirements and indirect costs for response actions, including potential costs for existing and future NPL sites as well as potential costs that may arise from enforcement actions taken at non-NPL sites. EPA also considered qualitative costs, which are those that EPA could not quantify with reasonable certainty. Qualitative costs encompass the potential costs of litigation and liability. Although EPA was unable to quantify these potential costs, EPA evaluated how designation may affect CERCLA liability and litigation. EPA analyzed whether CERCLA’s statutory provisions (e.g., liability limitations, cost recovery provisions and settlement authorities) and existing enforcement discretion policies could mitigate those potential costs. Next, in evaluating benefits, EPA considered the quantified baseline benefits associated with transferring response costs from EPA to PRPs as well as quantified health benefits that may result from the designation. These health effects include those associated with birth weight, cardiovascular disease (CVD) and renal cell carcinoma (RCC)-avoided morbidity and mortality associated with reductions in PFOA and/or PFOS. Unquantified health benefits include health effects such as immune, liver, endocrine, metabolic, reproductive, musculoskeletal, as well as certain cancers such as combined hepatocellular adenomas and carcinomas. EPA also considered the ways in which the accompanying RIA does not fully capture the quantitative costs or benefits of the rule due to data limitations. As discussed throughout this preamble, CERCLA response actions are discretionary, contingent, and site-specific determinations. Whether it is appropriate to take any action—such as through CERCLA 42 EPA conducted a Regulatory Impact Analysis (RIA) consistent with E.O. 12866. The E.O. requires, among other things, that the Agency quantify costs and benefits to the extent possible and that it qualitatively address the costs and benefits that cannot be quantified. The analyses required under the E.O. do not determine the appropriate consideration of advantages and disadvantages for EPA final actions. Instead, the EPA statute, in this case CERCLA, must be evaluated to determine the intended benefits of the statute as determined by it terms. E:\FR\FM\08MYR3.SGM 08MYR3 lotter on DSK11XQN23PROD with RULES3 39150 Federal Register / Vol. 89, No. 90 / Wednesday, May 8, 2024 / Rules and Regulations response authority under section 104 or CERCLA enforcement authority under section 106—is based on a myriad of factors and most importantly whether the releases at the site pose unacceptable risk. Because EPA cannot fully assess and characterize the magnitude and number of instances where the rule would reduce impacts associated with PFOA or PFOS exposure, the benefits are difficult to fully ascertain and estimate with certainty. In addition, there is considerable uncertainty regarding the cost of health burdens that may result from exposure to PFOA or PFOS, and associated cost savings from reducing the incidence of these burdens because of designation. Relatedly, future response costs are also difficult to quantify due to the sitespecific nature of CERCLA. Unlike with benefits, though, EPA concluded that it has sufficient information to reasonably estimate anticipated future costs for NPL and non-NPL sites. EPA was able to utilize existing data to estimate a high and low range for response costs at these sites. As explained in Section VI.A, the investigative and remedial technologies available to address PFOA and PFOS are, in large part, the same remedial technologies used to address other hazardous substances (e.g., the costs to pump and treat groundwater; to dig and haul contaminated soil; or to provide alternative drinking water). Therefore, EPA can use historic response cost information to reasonably assess PFOA and PFOS response costs. EPA acknowledges, however, that there remains uncertainty concerning the location and number of sites that will be identified as needing remediation and the extent of contamination at those sites. There is also uncertainty regarding the potential incremental increase in cost (if any) of addressing PFOA or PFOS at a site along with other COCs present.43 EPA concluded that a ‘‘totality of the circumstances’’ analysis is a useful benchmark for assessing whether action is warranted under a unique statute like CERCLA. Unlike other environmental statutes which are premised on ‘‘command and control’’ regulation, CERCLA is a remedial statute. It does not set prospective limits on the amount of permissible contamination. Instead, CERCLA imposes financial liability on those responsible for existing contamination that presents 43 Designation does not require any specific response actions or confer liability. Whether response costs will be incurred is wholly dependent on site-specific discretionary decisions. Before taking any action, EPA evaluates the level of risk posed by any given release. VerDate Sep<11>2014 18:22 May 07, 2024 Jkt 262001 unacceptable risk to public health and the environment. In many instances (e.g., at NPL sites) cost considerations are evaluated on a site-specific basis. A totality of the circumstances analysis best reflects the advantages and disadvantages of designation and allows for a more holistic assessment of designation. The totality of the circumstances analysis is provided below. Section VI.A discusses the numerous advantages of designation. Designation allows EPA to deploy the full suite of CERCLA tools to identify, characterize, and cleanup the most contaminated sites expeditiously. It also allows EPA to hold responsible those parties that have contributed to significant contamination so that they bear the costs of cleaning it up. This, in turn, makes more resources available, allowing for additional and/or earlier cleanups relative to what could occur absent designation. These additional, earlier cleanups will protect vulnerable populations and communities living near contaminated sites. Further, these cleanups will have meaningful health benefits similar to other CERCLA actions by reducing a broad range of potential adverse human health effects. Thus, cleaning up PFOA and PFOS contamination that is posing unacceptable risk to human health, or the environment will improve quality of life and reduce health care expenditures for the communities living in and around PFOA and PFOS contaminated sites. Section VI.B evaluates the disadvantages of designation such as direct costs of the rule, the potential for the rule to create hardship for parties that did not significantly contribute to contamination, and the potential for uncertainty for PRPs. EPA estimates that direct costs, particularly release notification costs, are fairly minimal. EPA recognizes that some parties that do not bear primary responsibility for contamination may be sued and face uncertain litigation costs. EPA believes that CERCLA’s liability limitations, coupled with EPA enforcement discretion policies, should operate to minimize hardship for parties that did not significantly contribute to contamination. EPA expects that designation should not change CERCLA’s liability framework and that CERCLA will continue to operate as it has for decades (with respect to the more than 800 existing hazardous substances) to resolve who should pay for the cleanup and how much. In Section VI.C, EPA explains the results of the totality of the circumstances analysis to demonstrate that potential costs and disadvantages PO 00000 Frm 00028 Fmt 4701 Sfmt 4700 are not unreasonable when weighed against the numerous advantages of designation. A. Advantages of Designation EPA examined the advantages of designation, including its positive impacts on public health, the Superfund program, local economies and ecosystems, and the importance of shifting response costs to parties responsible for significant contamination. Unlike other environmental statutes which are premised on ‘‘command and control’’ regulation, CERCLA is a remedial statute. It does not set prospective limits on the amount of permissible contamination. Instead, CERCLA imposes financial liability on those responsible for existing contamination that presents unacceptable risk to public health and the environment. As a consequence, benefits of the designation flow from CERCLA’s liability framework—which leads to more cleanups of existing contaminated sites—rather than the prospective regulation of releases at regulated sources. Designating PFOA and PFOS as CERCLA hazardous substances eliminates barriers to timely cleanup of contaminated sites, enables EPA to shift responsibility for cleaning up certain sites from the Fund to PRPs, and allows EPA to compel PRPs to address additional contaminated sites. Ensuring the timely cleanup of sites, and that the parties responsible for significant contamination bear the costs of cleaning it up, are the primary objectives of CERCLA. EPA gave significant weight to these considerations because, absent designation, the cleanup of PFOA and PFOS contamination would be significantly hampered. PFOA and PFOS contamination is widespread, and EPA’s current authority is limited. Earlier and more timely responses at contaminated sites will better address the urgent public health issue of PFOA and PFOS contamination. As discussed above in Section V, the latest science is clear: human exposure to PFOA and PFOS is linked to a broad range of adverse health effects. EPA gave significant weight to its finding that both PFOA and PFOS may present substantial danger. The potential for harm to public health is unabated if PFOA and PFOS remain in the environment, and designation is necessary to facilitate swift action. EPA also gave significant weight to the substantial health benefits—realized by communities nationwide—that are expected to result from designation. Earlier, expeditious response to PFOA E:\FR\FM\08MYR3.SGM 08MYR3 Federal Register / Vol. 89, No. 90 / Wednesday, May 8, 2024 / Rules and Regulations and PFOS releases will reduce exposure to PFOA and PFOS across the country and will minimize the likelihood of adverse health effects, particularly for sensitive groups such as pregnant woman and children. As discussed supra in Section V, PFOA and PFOS exposure is linked to serious health conditions, including cancer and cardiovascular disease. Reducing PFOA and PFOS exposures can improve community health while potentially saving Americans billions of dollars in health care and other expenses. PFOA exposure alone has been estimated to have caused billions of dollars of health care and other economic costs (Malits et al., 2018). EPA also quantified certain potential health benefits associated with reducing PFOA and PFOS exposure in private drinking water wells. Designation allows for earlier, and additional, CERCLA response activities to address areas with high levels of PFOA and PFOS contamination, which translates to lower risk of adverse health effects for the most exposed communities. Ensuring that EPA can utilize CERCLA to the fullest extent is critical to address this serious public health issue. lotter on DSK11XQN23PROD with RULES3 1. Designation Enables Earlier, Broader, and More Effective Cleanups of Contaminated Sites Designation of PFOA and PFOS as hazardous substances is critical to EPA’s ability to address the public health threats posed by PFOA and PFOS in the environment. CERCLA imposes notification requirements and potential liability on those that release hazardous substances and makes available authorities that promote timely cleanup of hazardous substances. This includes release notification under CERCLA section 103, response authority under CERCLA section 104, enforcement authority under CERCLA section 106, and cost recovery under CERCLA section 107. Thus, designation allows EPA to employ a broader suite of CERCLA authorities to address contamination, which in turn allows EPA to address more sites, enables earlier and more expeditious responses to PFOA and PFOS releases, and makes available additional resources allowing for cleanup of other COCs at NPL sites. It also provides EPA with authority to pursue those responsible for the most significant contamination so that they bear the financial responsibility for cleaning it up. VerDate Sep<11>2014 18:22 May 07, 2024 Jkt 262001 a. Designation Opens Up CERCLA’s Notification, Response, Enforcement and Cost Recovery Authorities, Which Allows EPA to More Timely Address Contaminated Sites This action will make PFOA and PFOS subject to CERCLA’s notification, response, enforcement, and cost recovery authorities. This is because those authorities either do not apply, or are limited, with respect to pollutants or contaminants (which PFOA and PFOS are currently). A direct consequence of designating PFOA and PFOS as hazardous substances is that, once designated, entities that release PFOA and PFOS at or above the reportable quantity must provide notification of the release. The requirements include notification to the National Response Center for releases that meet or exceed the reportable quantity, CERCLA section 103; newspaper notice to parties potentially injured by a release, CERCLA section 111(g); and State, local, and Tribal notice, as appropriate, for reportable releases, EPCRA section 304. These notifications allow EPA to assess whether CERCLA response actions are necessary to mitigate risks to public health and the environment and to respond promptly where response actions are necessary. Swift action to address harmful releases can prevent further migration of PFOA and PFOS from the source of the release and reduce the need for more expensive, more expansive cleanup in the future. Designation also allows EPA to streamline the Federal government’s response authority under CERCLA section 104 to address releases or threatened releases using removal or remedial authority. Absent designation, EPA (and other Federal agencies) can only address PFOA and PFOS as pollutants or contaminants. This means that, for each individual response, EPA (or another agency) needs to find that a release, or threat of release, ‘‘may present an imminent and substantial danger to the public health or welfare.’’ 42 U.S.C. 9604(a)(1). After designation, agencies will be able to respond to a release or threatened release without first making this determination, allowing for action sooner. Designation also makes CERCLA’s enforcement and cost recovery authorities available for PFOA and PFOS. In the absence of designation, CERCLA authority to compel PRPs to conduct or pay for response work does not extend to ‘‘pollutants or contaminants’’ and CERCLA does not provide cost recovery for actions taken solely in response to releases or threats PO 00000 Frm 00029 Fmt 4701 Sfmt 4700 39151 of releases of ‘‘pollutants or contaminants.’’ Having access to these authorities will allow EPA to hold PRPs responsible for addressing PFOA/PFOS contamination, which can lead to the timely cleanup of more contaminated sites. Designation will allow EPA to take enforcement actions against PRPs under CERCLA section 106(a) when there may be an imminent and substantial endangerment from an actual or threatened release of PFOA or PFOS. EPA will be able to use CERCLA section 106(a) to compel PRPs to take immediate action to start the timeconsuming process of investigating, scoping, and cleaning up PFOA and PFOS releases. This authority also helps to ensure that PRPs are financially accountable for releases of PFOA and PFOS by enabling EPA to compel PRPs to undertake response action. This, in turn, enables earlier and more EPA response work by diversifying EPA’s options. Enforcement actions are also complementary to Fund-financed response activities (‘‘Guidelines for Using the Imminent Hazard, Enforcement and Emergency Response Authorities of Superfund and Other Statutes,’’ 1982). EPA aims, whenever possible, to seek cleanup by responsible parties prior to recourse to either the Fund or litigation. This allows EPA to preserve the valuable resources of the Fund to address as many priorities as possible. Enforcement authority contributes to timely response actions at the most contaminated sites. Because PRPs, rather than EPA, are best positioned to know the location and extent of potential contamination at and from their facilities, PRP-led cleanups can be more efficient. PRP-led cleanups can also be faster because EPA need not secure access orders with PRPs if the PRP is conducting the response actions. Also, EPA generally takes enforcement actions to address sites that pose the highest relative risks; therefore, making enforcement authority available supports EPA’s ability to target and prioritize existing sites where PFOA and PFOS releases pose substantial risk to public health and the environment. Additionally, designation will allow EPA to use CERCLA section 107 to recover costs expended by EPA to clean up PFOA and PFOS contamination. CERCLA section 107 provides that liable parties are responsible for the costs associated with responding to hazardous substances. Liable parties under CERCLA include: (1) Current owners and operators of facilities, (2) past owners and facility operators in place at the time of hazardous substance E:\FR\FM\08MYR3.SGM 08MYR3 39152 Federal Register / Vol. 89, No. 90 / Wednesday, May 8, 2024 / Rules and Regulations lotter on DSK11XQN23PROD with RULES3 disposal, (3) any person who ‘‘arranged for disposal’’ of that facility’s hazardous substances, and (4) any person that accepts hazardous substances for ‘‘transport to disposal or treatment facilities.’’ (CERCLA section 107(a)). If a person is liable for a release of hazardous substances, that person may be responsible to pay for response costs, natural resource damages, and assessment costs, and costs pertaining to certain health assessment or health effects studies. CERCLA section 107(a)(4)(A)–(D). b. The Availability of CERCLA Enforcement and Cost Recovery Authority Ensures That Polluters Are Financially Responsible, Which Is Consistent With CERCLA This action will allow EPA to hold polluters responsible for addressing significant contamination. After designation, EPA will have authority under CERCLA section 106 to compel PRPs to take response actions at their facilities. This may allow EPA to reach more sites more quickly. After designation, EPA can also rely on authority under CERCLA section 107 to recover costs expended by EPA to clean up PFOA and PFOS contamination. The availability of CERCLA enforcement authority to address PFOA and PFOS releases aligns with the Polluter Pays principle, a central objective of CERCLA, and is an important advantage of the rule. CERCLA is specifically designed to hold responsible those parties that contributed to dangers to human health and the environment by releasing hazardous chemicals into the environment. See H.R. Rep. No. 99–253, pt. 3, at 15 (1985), as reprinted in 1978 U.S.C.C.A.N. 3038, 3038 (stating that a goal of CERCLA is ‘‘to hold responsible parties liable’’ for cleanup costs); H.R. Rep. No. 96–1016, pt 1, at 1 (1980) (acknowledging that CERCLA establishes ‘‘strict liability to enable the Administrator to pursue rapid recovery of costs . . . and to induce [liable parties] voluntarily to pursue appropriate environmental response actions . . . .’’). The ability to require liable parties to pay for cleanup is the cornerstone of ensuring that sites are cleaned up to protect public health from ‘‘one of the most pressing environmental problems.’’ See H.R. Rep. No. 99–253, pt 1, at 54 (1986), as reprinted in 1986 U.S.C.C.A.N. 2835, 2836. In reauthorizing CERCLA, Congress acknowledged that, ‘‘[I]t is clear from the accumulating data on waste sites that EPA will never have adequate monies or manpower to address the problem itself. As a result, VerDate Sep<11>2014 18:22 May 07, 2024 Jkt 262001 an underlying principle . . . is that Congress must facilitate cleanups of hazardous substances by the responsible parties . . . .’’ H.R. Rep. No. 99–253 at 55. Consistent with these legislative goals, this rule enables EPA to hold PRPs, particularly those that have contributed significantly to PFOA and PFOS contamination, financially responsible for addressing such contamination. Designation also signals to the market that there is value in the prevention of releases and mitigation of existing releases. EPA considered the additional costs that PRPs may face and concluded that these potential costs do not outweigh the advantages of designating PFOA and PFOS. Potential costs associated with CERCLA enforcement actions that may occur after designation are difficult to assess. Nonetheless, EPA used historical cost data to assess the potential for additional costs to PRPs associated with response work at non-NPL sites that may result from enforcement actions, see Chapter 5 of the RIA for more detail. EPA cannot ascertain with certainty the number of sites that may be subject to a CERCLA enforcement action over the next several years. Depending on the circumstances, EPA may determine that authority provided under a different statute, such as RCRA, SDWA, CWA, or TSCA, may be best suited to address the environmental harm. In addition, the site could be referred to the State for further action rather than EPA; or site activity could be Fund-lead, which may occur when there is no viable PRP or when immediate action is required. Should EPA proceed using CERCLA enforcement, the scope of the enforcement action—including the response activities required and the amount of time it may take to implement them—is also difficult to estimate absent a preliminary assessment of the scope of contamination at a specific site. Ensuring that the PRPs responsible for significant contamination bear the costs of cleanup is one of the express purposes of CERCLA and can only be realized through designation. This is an important advantage of designation. Bringing PFOA and PFOS into CERCLA’s liability framework is a critical and essential advantage of designation, considering that PFOA and PFOS are prevalent in the environment, threaten communities across the country, and PRPs are best situated to address releases from their facilities. And while it cannot be determined with specificity where or when enforcement and response actions will occur, EPA attempted to estimate anticipated expenditures to the best of its ability. PO 00000 Frm 00030 Fmt 4701 Sfmt 4700 Considering all of this together, EPA concluded that designation achieves a principal objective of CERCLA—the polluter pays. The payment of these costs by those responsible for significant contamination represents an improvement in social welfare as a result of the rule. c. EPA Expects Designation Will Increase Emergency Response and Removal Actions for PFOA/PFOS EPA expects that designation will result in more removal actions, including emergency actions, to address PFOA and PFOS releases, which in turn may increase health benefits. These removal actions can be taken by EPA (i.e., Fund-lead actions) or a PRP (i.e., PRP-lead actions).44 Additional removal actions are expected to occur because EPA prioritizes responses to hazardous substances and in particular those with the greatest threat to human health, and EPA expects an increase in State referrals, each of which are explained in turn. After designation, EPA expects to take more Fund-lead removal actions for PFOA and PFOS contamination because existing limitations on response authority and cost recovery will no longer apply. EPA’s removal program, although not limited to responses to hazardous substance releases, prioritizes responses to hazardous substance releases. This is in part because the removal budget is limited, and the administrative burden for addressing hazardous substances is reduced relative to addressing PFOA/PFOS as pollutants or contaminants. Absent designation, to respond to PFOA or PFOS contamination utilizing CERCLA section 104(a), the statute requires EPA to determine the release or threat of release may pose an imminent and substantial endangerment. The statute also does not allow EPA to cost recover for actions exclusive to pollutants or contaminants. A hazardous substance designation removes those statutory limitations, as EPA need not demonstrate on a case-by-case basis that releases of hazardous substances may pose an ‘‘imminent and substantial endangerment.’’ Designation thus enables additional Fund-lead removal actions to address immediate risks.45 44 This section only discusses designation impacts on Fund-lead removals. Designation impacts pertaining to PRP-lead actions, including removal orders, are discussed in section VI.1.b. 45 When a removal action is appropriate, EPA should take action ‘‘as soon as possible,’’ (40 CFR 300.415(b)(3)), and may often choose to take a Fund-lead removal rather than pursing a PRP-lead action through use of CERCLA enforcement authority. Negotiating an enforcement order can be a time-consuming effort, which can in turn delay E:\FR\FM\08MYR3.SGM 08MYR3 Federal Register / Vol. 89, No. 90 / Wednesday, May 8, 2024 / Rules and Regulations lotter on DSK11XQN23PROD with RULES3 EPA can then later recover costs for cleanup of these substances. Recovered costs for each removal action that EPA takes to address sites contaminated with PFOA and/or PFOS are costs that would be shifted from taxpayers to PRPs. Removal actions to address PFOA and PFOS releases may also increase as a result of State referrals, which often trigger a Fund-lead removal action. States refer sites to EPA when they do not have the capacity, technical expertise, or funding to take action under their own authorities. EPA expects an increase in State referrals to EPA for PFOA and PFOS removal actions because State budgets are limited. And because State budgets are limited, Federal involvement may be the only financially viable path toward responding to PFOA and PFOS releases. EPA is not required to initiate a removal in response to referrals; however, EPA must evaluate the need for removal actions as promptly as possible after receiving the notification and determine the appropriate response. (40 CFR 300.405(f)(1), 300.410(b)). EPA may determine that a Fund-lead removal is the appropriate response or, if not, EPA may continue monitoring the situation should EPA involvement be appropriate at a later point in time. EPA expects that removal costs for addressing PFOA and PFOS releases will likely be roughly similar to removal costs for other substances. The same response methods that exist for addressing other hazardous substances are available for PFOA and PFOS. As one example, in cases where PFOA and PFOS are contaminating drinking water, removal actions would primarily focus on risk reduction for exposure to contaminated drinking water. Methods of addressing exposure may include granulated activated carbon, ion exchange, connecting customers to the nearest public water system, and/or temporarily providing bottled water. Any contamination left in place would be managed using post-removal site controls 46 or referred to a cleanup program (e.g., State, local, or the Superfund remedial program),47 a response. When immediate action is required, EPA will use Fund dollars to initiate a removal and later cost recover. 46 Post-removal site control (PRSC) means ‘‘those activities that are necessary to sustain the integrity of a Fund-financed removal action following its conclusion.’’ (40 CFR 300.5). This may include, for example, replacing water treatment system filters or collecting leachate. Once field actions end, and all EPA resources are demobilized, any additional actions required are PRSCs. PRSCs continue until they are no longer necessary or until such time as a PRP, state or local government, or EPA’s remedial program implements a remedy. (40 CFR 300.415(l)). 47 After EPA takes a removal action, it may be appropriate to refer the site back to the state to VerDate Sep<11>2014 18:22 May 07, 2024 Jkt 262001 dependent on relative risk. EPA expects that Fund-led removal actions to address PFOA and PFOS releases may range from $160,000 to $503,000 per site. See RIA Chapter 5. Where PFOA and/or PFOS are the sole driver for initiating a removal action, the cost estimate above represents the estimated cost of the action. Where EPA may be responding to multiple COCs, the cost of addressing PFOA/PFOS would represent an incremental increase to the overall cost of response in addition to those other COCs. An increase in removal actions for PFOA and PFOS releases is expected to produce meaningful health benefits. Fund-lead removal actions are the fastest way for EPA to respond to the most urgent situations. Removal actions are typically quick responses to immediate threats to eliminate or mitigate a threat to the public. Thus, EPA is able to initiate a removal action more quickly than it can remedial action—actions which often take decades to develop and implement. Through removal actions, EPA can more quickly eliminate or mitigate exposure pathways. For example, if it becomes known to EPA that a resident’s drinking water is contaminated with PFOA and PFOS above risk-based levels, EPA can take action to eliminate that exposure pathway by providing alternative drinking water or connecting the resident to an alternative water source. Such actions mitigate the risk of adverse health outcomes associated with chronic and cumulative exposures to PFOA and PFOS. See Section VI.A.2 of this document, discussion of health benefits. d. EPA Expects That Shifting Costs to PRPs To Address PFOA/PFOS Contamination at NPL Sites Will Make Fund Money Available for Other Response Work Through this action, EPA may compel viable PRPs to clean up PFOA/PFOS contamination. EPA may thus conserve use of the Fund for addressing other COCs or sites where there are no viable PRPs, expanding EPA’s ability to provide meaningful benefits for public health and the environment across the country. Absent designation, EPA would continue to spend Fund resources to clean up PFOA and PFOS releases at non-Federal facility NPL sites maintain PRSCs. The NCP provides that EPA should provide for PRSC, to the extent practicable, before the removal action begins. (40 CFR 300.415(l)). EPA often coordinates with states to obtain a commitment that the state will maintain PRSCs after the removal ends. States may not have funding to undertake the initial removal action, but often are able to budget PRSC costs. PO 00000 Frm 00031 Fmt 4701 Sfmt 4700 39153 under EPA’s authority to address PFOA and PFOS as ‘‘pollutants or contaminants.’’ Prior to this rule, EPA evaluated PFOA and PFOS releases as pollutants and contaminants as part of its process to identify potential NPL sites, in its selection of a remedy, and in evaluation of the remedy. See supra—Section II.E.4, 5. After designation, EPA will continue to evaluate PFOA and PFOS releases as part of the Superfund process, but now EPA can transfer these costs to PRPs— the entities responsible for the contamination and associated hazards to human health and the environment.48 Designation or not, EPA has been and will continue to evaluate hazardous substances, pollutants or contaminants, at NPL sites and, if necessary, address releases that present unacceptable risk to human health or the environment. A major difference this designation makes for NPL sites is who bears responsibility. After designation, parties responsible for significant contamination may bear liability. As discussed in Section VI.A.1.b., the transfer of costs from EPA to PRPs directly advances CERCLA’s objective that those that contributed to contamination bear the cost of cleaning it up. While these cost transfers at NPL sites are an important outcome of the designation, the designation itself does not lead to greater response costs at particular NPL sites. Absent designation, EPA would incur these costs, which would be paid by the Superfund. After designation, EPA can transfer these costs to viable PRPs by compelling PRPs to implement response actions at NPL sites or through cost recovery. The transfer of costs to viable PRPs leads to more total resources available for cleanups. Superfund resources that otherwise would have been used for PFOA and PFOS response actions can now be available for other priorities. Such monies could be made available for additional Superfund response activities at NPL sites to be spent addressing any of the more than 800 hazardous substances, including PFOA and PFOS, as well as other pollutants and contaminants. EPA estimates that this will result in $10.3M to $51.7M (at a 2% discount rate) of Fund resources available each year for NPL response work because of designation. While EPA cannot fully quantify the benefits attributable to funds being available for more response work at NPL sites, EPA 48 As detailed in the RIA accompanying this rule, these ‘‘cost transfers’’ from EPA to the PRP do not result in a net increase in economic costs—rather, they just change ‘‘who pays’’ for these cleanup costs. E:\FR\FM\08MYR3.SGM 08MYR3 lotter on DSK11XQN23PROD with RULES3 39154 Federal Register / Vol. 89, No. 90 / Wednesday, May 8, 2024 / Rules and Regulations believes these benefits will be meaningful. More money for NPL response work means that EPA will be able to better address threats to public health and our natural environment from contamination. Addressing PFOA and PFOS contamination may lead to an incremental increase in the costs associated with addressing NPL sites depending on what other COCs are located at a given site. It is unusual for a remedy to address a sole ‘‘contaminant of concern,’’ many of which are hazardous substances. Typically, remedial actions address a number of COCs at once. In some cases, the remedy for other COCs will also address PFOA and PFOS contamination; in other cases, there will need to be additional work to address PFOA and PFOS contamination. For instance, if PFOA and PFOS are not already part of a remedy for the site, adding them to the remedy would then have the potential to incrementally increase the overall cost of the remedy (e.g., by increasing the frequency of GAC replacement). Any costs of cleaning up PFOA and PFOS contamination could then be transferred to PRPs, instead of borne by the Fund. EPA estimates that the incremental cost for addressing PFOA and PFOS releases at NPL sites may range from $10.3 million annually to $51.7 million annually (at a 2% discount rate). See RIA Chapter 5. These represent estimated response costs that the Fund would incur absent designation; designation is not expected to result in an overall increase in cost to EPA to address NPL sites. However, the recovery of $10.3M to $51.7M (at a 2% discount rate) of Fund resources each year because of designation will result in EPA continuing to spend that same amount on other Superfund response activities. This represents an increase in resources expended on Superfund response as EPA continues to spend as before and parties responsible for PFOA and PFOS contamination also must spend to address contamination at NPL sites. This represents an indirect incremental cost of the rule. In sum, EPA concludes that significant advantages of designation are that it will enable earlier, broader, and more effective cleanups of contaminated sites. Designation will provide additional or enhanced notification, response, liability, and enforcement authority under CERCLA. This enhanced authority may allow EPA to address more contaminated sites more quickly. Designation will also ensure that polluters pay for cleaning up contamination that poses unacceptable risks to human health and the VerDate Sep<11>2014 18:22 May 07, 2024 Jkt 262001 environment, which is consistent with CERCLA’s objectives. EPA expects to conduct more removal and emergency response actions and that more resources will be available for NPL site response actions. These are significant advantages of the rule because it effectuates the two primary objectives of CERCLA’s statutory framework—timely cleanup of contaminated sites and polluter pays—by bringing widespread, persistent chemicals—PFOA and PFOS—under the umbrella of CERCLA’s liability framework, which in turn makes more resources available to address this widespread public health threat. 2. Designation Brings Broad Health Benefits EPA also weighed the health benefits that may indirectly result from designation. EPA considered quantified and unquantified health benefits associated with reducing exposure to PFOA and PFOS, as well as from additional response work at NPL sites. While it is hard to determine with certainty the nature and scope of future response actions, EPA expects that reducing PFOA and PFOS exposure will reduce the risk of adverse health effects, as detailed below. a. Qualitative Potential Benefits From Decreased Exposure After Addressing PFOA/PFOS Contamination EPA weighed the indirect potential health benefits associated with removing PFOA and PFOS from the environment. When exposure pathways are mitigated or eliminated, communities living around contaminated sites would be expected to have lower rates of adverse health effects because they are exposed to less PFOA and PFOS. Historical data, such as NPL sites with soil lead contamination and cleanups, demonstrates improved health outcomes after Superfund cleanups.49 So here, one advantage from designation is that EPA expects overall reductions of adverse health outcomes for exposed communities to occur sooner, in addition to wholly avoided exposure in some instances. EPA expects that additional response actions to address PFOA/PFOS at non-NPL sites resulting from more removals and enforcement actions will reduce or in some cases eliminate exposure to PFOA and PFOS from contaminated sites, resulting in 49 Heather Klemick, Henry Mason, and Karen Sullivan. 2020. ‘‘Superfund Cleanups and Children’s Lead Exposure,’’ Journal of Environmental Management, 100. doi: 10.1016/ j.jeem.2019.102289. For more information: https:// www.epa.gov/superfund/lead-superfund-sites#sites. PO 00000 Frm 00032 Fmt 4701 Sfmt 4700 several categories of non-quantified health benefits realized as avoided adverse health effects. As described in section V.A. of this document, PFOA and PFOS exposure can be associated with the following adverse health outcomes: • Developmental birth effects such as low infant birth weight, birth length, and head circumference • cardiovascular effects such as changes in cholesterol and blood pressure • cancer, including renal cell carcinoma • changes in liver enzymes • decreased immune response to vaccination • endocrine effects, including thyroid disorders • reproductive effects (for PFOA) • nervous system effects (for PFOS). Designation provides a robust mechanism to minimize the potential for these adverse health effects from PFOA and PFOS exposure. To the extent that adverse health effects are reduced or avoided, healthcare expenditures to address these outcomes could be reduced, and worker productivity and overall quality of life would be enhanced due to reduced illness and chronic health conditions. Given that PFOA and PFOS are often expected to be co-located and/or commingled with other chemicals, cleanup at non-NPL sites because of enforcement actions may simultaneously clean up cocontaminants other than PFOA and PFOS that would otherwise go unaddressed, potentially including other types of PFAS. This may include cleanup of co-contaminants from private drinking water wells as well as the source water used for public water supply (to the extent contamination entered source waters and will be cleaned up as a result of this rule). As a result, addressing these cocontaminants has the potential to result in additional health and ecological benefits. Despite the array of adverse health and environmental risks associated with exposure to PFOA and PFOS, it is technically challenging to quantitatively estimate adverse effects from exposure that will occur absent the designation of PFOA and PFOS as hazardous substances. Furthermore, it is challenging to quantitatively estimate the benefits that may result from designation. In fact, many important benefits (including those associated with possible immune, hepatic, endocrine, metabolic, reproductive, musculoskeletal outcomes) of cleaning up PFOA and PFOS can only be E:\FR\FM\08MYR3.SGM 08MYR3 Federal Register / Vol. 89, No. 90 / Wednesday, May 8, 2024 / Rules and Regulations lotter on DSK11XQN23PROD with RULES3 described in qualitative terms due to the lack of robust data. They cannot be quantified or monetized due to data gaps, and due to uncertainty regarding where and when cleanups will occur. But that does not mean that these benefits are small, insignificant, or nonexistent, particularly to the communities CERCLA exists to protect. Quantifying benefits from cleanup of PFOA and PFOS requires data to characterize the risk and quantify the magnitude of expected (cancer and noncancer) health outcomes. Generally, robust data needed to quantify the magnitude of expected adverse noncancer impacts are unavailable, and full quantification of these benefits is made even more challenging by the overlap of effects from PFOA and PFOS exposure. For these reasons, EPA was able to estimate only a few of the many potential benefits from reduced exposure to PFOA and PFOS. The quantified illustrative benefits of addressing PFOA/PFOS contamination discussed below are in addition to the potential qualitative benefits discussed above. EPA believes that the advantages of this action outweigh the disadvantages even without consideration of quantified benefits. The quantified benefits account for only a portion of the overall benefits from the designation of PFOA and PFOS as hazardous substances. That is, addressing PFOA and PFOS contamination in private drinking water wells also results in additional health benefits for additional health endpoints that cannot be quantified, and addressing PFOA/PFOS contamination more broadly brings health and ecological benefits well beyond private drinking water wells. The quantitative benefits described below, however, make clear the meaningful health benefits achieved from reduced exposure to PFOA and PFOS. b. Quantifiable Health Benefits of PFOA and PFOS Exposure Reduction In the RIA supporting this final regulation, EPA performed an illustrative estimate of benefits calculated using monetized health benefits estimates per unit reduction of PFOA and PFOS derived for 2024 National Primary Drinking Water Regulation (U.S. EPA, 2024a). The estimated benefits attributable to this rule due to reduced PFOA and PFOS levels in private wells (which are not subject to the PFAS NPDWR) are distinct from those attributable to the PFAS NPDWR from reduced PFOA and PFOS in public and community water systems. A portion of benefits from this rule derive from reduced PFOA and VerDate Sep<11>2014 18:22 May 07, 2024 Jkt 262001 PFOS in private wells used for drinking water that may result from addressing contaminated sites, both in the baseline (at NPL sites) and under this final rule (at non-NPL sites). The benefits estimation methodology and results are discussed here. Quantified benefits in the PFAS NPDWR were assessed as avoided cases of illness and deaths (or morbidity and mortality, respectively) associated with exposure to PFOA and PFOS. The PFAS NPDWR provided a quantitative estimate of birth weight and cardiovascular disease (CVD)—avoided morbidity and mortality associated with reductions in PFOA and PFOS. A quantitative estimate of renal cell carcinoma (RCC)—avoided morbidity and mortality for reductions in PFOA was also developed. EPA was not able to quantify or monetize other health benefits, including those related to other reported health effects including immune, liver, endocrine, metabolic, reproductive, musculoskeletal, as well as certain cancers such as combined hepatocellular adenomas and carcinomas. EPA assesses potential benefits quantitatively if evidence of exposure and health effects is likely, it is possible to link the outcome to risk of a health effect, and there is no overlap in effect with another quantified endpoint in the same outcome group. Particularly, the most consistent epidemiological associations with PFOA and PFOS include decreased immune system response, decreased birthweight, increased serum lipids, and increased liver enzymes (particularly Alanine Transaminase (ALT)). The available evidence indicates effects across immune, developmental, cardiovascular, and hepatic organ systems at the same or approximately the same level of exposure. i. Quantified Developmental Effects Research indicates that exposure to PFOA and PFOS is associated with developmental effects, including infant birth weight (ATSDR, 2021; Negri et al., 2017; U.S. EPA, 2016c, 2016d, 202bg, 2024c; Verner et al., 2015; Waterfield et al., 2020). The route through which the embryo and fetus are exposed prenatally to PFOA and PFOS is maternal blood serum via the placenta. Most studies of the association between maternal serum PFOA/PFOS and birth weight report negative relationships (Dzierlenga et al., 2020; Negri et al., 2017; Verner et al., 2015). EPA quantified and valued changes in birth weight-related risks associated with reductions in exposure to PFOA and PFOS in drinking water. Low birth weight is linked to a number of health effects that may be a source of economic burden to society in PO 00000 Frm 00033 Fmt 4701 Sfmt 4700 39155 the form of medical costs, infant mortality, parental and caregiver costs, labor market productivity loss, and education costs (Behrman & Rosenzweig, 2004; Chaikind & Corman, 1991; Colaizy et al., 2016; Institute of Medicine, 2007; Joyce et al., 2012; Klein & Lynch, 2018; Kowlessar et al., 2013; Nicoletti et al., 2018). Recent literature also linked low birth weight to educational attainment and required remediation to improve students’ outcomes, childhood disability, and future earnings (Chatterji et al., 2014; Dobson et al., 2018; Elder et al., 2020; Hines et al., 2020; Jelenkovic et al., 2018; Temple et al., 2010). EPA’s analysis focuses on two categories of birth weight impacts that are amenable to monetization associated with incremental changes in birth weight: (1) medical costs associated with changes in infant birth weight and (2) the value of avoiding infant mortality at various birth weights. ii. Quantified Cardiovascular Effects Cardiovascular Disease (CVD) is one of the leading causes of premature mortality in the United States (D’Agostino et al., 2008; Goff et al., 2014; Lloyd-Jones et al., 2017). As discussed in Section V.A above, exposure to PFOA and PFOS is associated with increased serum PFOA and PFOS concentrations and potentially elevated levels of total cholesterol and elevated levels of systolic blood pressure (U.S. EPA, 2024b; U.S. EPA, 2024c). Changes in total cholesterol and blood pressure are associated with changes in incidence of CVD events such as myocardial infarction (i.e., heart attack), ischemic stroke, and cardiovascular mortality occurring in populations without prior CVD event experience (D’Agostino et al., 2008; Goff et al., 2014; Lloyd-Jones et al., 2017). iii. Quantified Kidney Cancer Effects The strongest evidence of an association between PFOA exposure and cancer in human populations is from studies of kidney cancer (e.g., renal cell carcinoma (RCC)). Epidemiology studies indicated that exposure to PFOA was associated with an increased risk of kidney cancer (ATSDR, 2021; California EPA, 2021; U.S. EPA, 2016d, 2024c, U.S. EPA 2024d). The C8 Science Panel (2012) characterized the evidence for PFOA effects on kidney cancer as ‘‘probable’’ based on two occupational population studies (Raleigh et al., 2014; Steenland & Woskie, 2012) and two high-exposure community studies (Barry et al., 2013; Vieira et al., 2013). A recent study of the relationship E:\FR\FM\08MYR3.SGM 08MYR3 39156 Federal Register / Vol. 89, No. 90 / Wednesday, May 8, 2024 / Rules and Regulations between PFOA and RCC in U.S. general populations found a statistically significant positive exposure-response association between prediagnostic serum PFOA concentrations and subsequent risk of RCC within a population-based US prospective cohort (Shearer et al., 2021). This study also observed associations with RCC for PFOS and PFHxS in models unadjusted for other PFAS. However, after mutual adjustment for these 3 chemicals, only the association with PFOA remained statistically significant. As such, EPA selected RCC as a key outcome when assessing the health impacts of reduced PFOA exposures. In the PFAS NPDWR, EPA quantified and valued the changes in RCC risk associated with reductions in serum PFOA levels that are in turn associated with reductions in drinking water PFOA concentrations. For more details regarding the quantification of benefits from potential reduced developmental, CVD, and RCC impacts, as well as key limitations and uncertainties in that analysis, See Chapter 6 of the EA for the 2024 NPDWR Final Rule. (U.S. EPA, 2024a). 2. Estimated Health Benefits of PFOA and PFOS Exposure Reduction For this final CERCLA rule, the quantitative benefit estimates from reducing the adverse health effects described throughout this rule are characterized as illustrative because, in addition to several uncertainties regarding potential cleanups at these sites, it is not possible to estimate the precise magnitude of potential healthrelated benefits from reducing PFOA/ PFOS at these sites. Chapter 3 of the RIA supporting this final rule describes other limitations of the benefits-estimate transfer approach adopted from the PFAS NPDWR, including the simplifying assumption of combining PFOA and PFOS concentrations into one metric and the assumption that benefits per person are linear per PFOA and PFOS part per trillion (ppt) removed.50 For context of baseline benefits associated with addressing PFOA/PFOS at NPL sites, the low-end annualized baseline benefits under the assumption 10% of wells within one mile of NPL sites are impacted with 10 ppt reduction in PFOA/PFOS exposure are $430,000 (2% discount rate). The high-end annualized baseline benefits under the assumption 30% of wells near NPL sites are impacted with 200 ppt reduction in PFOA/PFOS exposure are $25,800,000 (2% discount rate). Exhibit 1 shows the results of the illustrative baseline benefits estimates under the scenarios analyzed. Note that these estimates are associated with potential cost transfers as described in Section VI.A.1.d. above and are expected to occur in the baseline (absence of the designation), therefore they are not a result of designation. However, these and other health benefits are expected to be conferred earlier than without designation because designation as hazardous substances reduce the administrative burden on the Agency and makes available enforcement authorities that allow EPA to address PFOA/PFOS contamination sooner. Exhibit 1. Estimated Illustrative Range of Baseline Annualized Human Health Benefits as a Result of Addressing PFOA/PFOS Contamination at NPL sites (2022$) % of wells with PFOA/PFOS detections 2% Discount Rate Estimates 10 ppt reduction 50 ppt reduction 200 ppt reduction 10% of wells $430,000 $2,150,000 $8,5900,000 20% of wells $859,000 $4,300,000 $17,200,000 30% of wells $1,290,000 $6,440,000 $25,800,000 As noted previously, the final rule is likely to result in enforcement actions brought by EPA to address PFOA and PFOS releases at non-NPL sites, which are expected to reduce exposure thereby mitigating or eliminating adverse health effects for nearby communities. Due to uncertainties regarding the level of contamination at affected sites, the level of exposure avoided, populations near these sites of concern, and response actions taken, it is not possible to estimate the precise magnitude of potential health-related benefits from reducing PFOA/PFOS at these sites. Given this uncertainty, EPA presents a range of illustrative potential health benefits associated with this 50 The extent to which PFOA or PFOS or both will be reduced at any given site where EPA may implement CERCLA response action is unknown at this time. While PFOA and PFOS are typically found together, to the extent that any CERCLA response action only reduces PFOS concentrations and not PFOA concentrations, the potential health benefits associated with reducing renal cell carcinoma presented here would be overestimated because RCC is associated with PFOA exposure and not PFOS. Further limitations and potential bias are described in more detail in Section 3.5 of the accompanying RIA. VerDate Sep<11>2014 18:22 May 07, 2024 Jkt 262001 PO 00000 Frm 00034 Fmt 4701 Sfmt 4700 E:\FR\FM\08MYR3.SGM 08MYR3 ER08MY24.005</GPH> lotter on DSK11XQN23PROD with RULES3 Notes: 1. Values rounded to three significant digits. 2. Results reflect PFOA/PFOS addressed at final, proposed, deleted, and future NPL sites. 3. Benefits estimated are associated with reduced incidence of developmental effects, cardiovascular effects, and renal cell carcinoma for populations served by private drinking water wells. Federal Register / Vol. 89, No. 90 / Wednesday, May 8, 2024 / Rules and Regulations designation. Consistent with the assessment of baseline benefits at NPL sites presented above, the analysis presented here is limited to benefits related to reductions in PFOA/PFOS concentrations in private wells that lead to a reduced incidence of developmental effects, cardiovascular effects, and renal cell carcinoma. This analysis focuses on sites where EPA may address PFOA/PFOS contamination at non-NPL sites using enforcement authorities made available by designation. These sites may include those that are owned/operated by plastics material and resin manufacturing firms identified as having produced PFOS/PFOA,51 and sites owned/operated by companies reporting PFOS/PFOA releases (including PFOA/PFOS salts) to EPA’s TRI.52 53 Under the low-end assumptions, estimated annualized benefits range from as low as $8,990 to as high as $539,000. These low-end values reflect an assumption that clean up actions are 39157 completed in year 19 for each group of sites analyzed. The corresponding range based on the high-end assumptions is $13,000 to $779,000. These high-end values reflect the assumption that response actions are completed in year 1 for each group of sites. Exhibit 2 below shows the results of the illustrative range of benefits estimates under the low-end and high-end scenarios analyzed. For more information about this analysis, see Section 5.2.2 of the RIA. Exhibit 2. Estimated Illustrative Range of Annualized Human Health Benefits as a Result of Addressin PFOA/PFOS Contamination at non-NPL Sites 2022$ 10% of wells $8,990 $44,900 $180,000 $13,000 $64,900 $260,000 20% of wells $18,000 $89,900 $360,000 $26,000 $130,000 $519,000 30% of wells $27,000 $135,000 $539,000 $39,000 $195,000 $779,000 4. Values rounded to three significant digits and reflect a 2% discount rate. Results reflect PFOA/PFOS addressed at certain sites where EPA may use enforcement authorities. Benefits estimated are associated with reduced incidence of developmental effects, cardiovascular effects, and renal cell carcinoma for populations served by private drinking water wells. Benefits realized over a period of77 years. EPA also considered the potential for designation to contribute to reduction in the burden of PFAS-related disease by looking at published studies related to PFAS disease burden. Expanding upon the exposure-response literature for PFAS, a recent study published by Obsekov et al. (2023) estimated a total United States disease burden of $5.52 billion related to PFOA and PFOS in the U.S. in 2018. Based on PFAS exposure data from the NHANES, the study stratified the population into percentile groups according to PFAS concentrations. The incidence of five adverse health effects was then estimated for each group based on exposure-response relationships from the literature. These health effects include: (1) Low birth weight, (2) Childhood obesity, (3) Kidney cancer, (4) Testicular cancer, and (5) Hypothyroidism in women. These health effects were chosen based on the existence of statistically significant associations for each effect derived from published meta-analyses of epidemiological studies. To value the economic costs associated with these health effects, the study relies on a combination of cost-of-illness data (e.g., the costs of hospitalization), human capital-based metrics (e.g., reduction in lifetime income associated with lost IQ points related to low birth weight), and the value of disability-adjusted life years (related to kidney cancer). The study also includes a sensitivity analysis that expands the scope of health effects examined to include health conditions for which relationships with PFAS had been identified in the literature but had not been meta-analyzed. These additional health effects include adult obesity, type 2 diabetes in females, gestational diabetes due to exposure during pregnancy, endometriosis, polycystic ovarian syndrome, couple infertility, female breast cancer, and pneumonia. With these health effects added, the sensitivity analysis in Obsekov et al. (2023) estimates a PFOS- 51 Data acquired from: Environmental Protection Agency, ‘‘Enforcement and Compliance History Online (ECHO).’’ Because not all plastic material and resin manufacturers use PFAS, only a fraction of the facilities reported in ECHO as plastics material and resin manufacturers were used in this analysis. To filter facilities involved in the use or manufacture of PFAS, this RIA uses proxy sites identified using sites owned/operated by companies that participated in EPA’s PFOA Stewardship Program, under the assumption that the likelihood of PFOA/PFOS contamination is potentially high at these sites. 52 Environmental Protection Agency, ‘‘Toxics Release Inventory (TRI) Program, 2022 TRI Preliminary Dataset: Basic Data Files,’’ July 2023. Accessed at: https://www.epa.gov/toxics-releaseinventory-tri-program/2022-tri-preliminary-datasetbasic-data-files. 53 TRI reporting is not currently required for isomers of PFOA and PFOS. lotter on DSK11XQN23PROD with RULES3 c. Cost Estimates of Burden of PFASRelated Disease VerDate Sep<11>2014 18:22 May 07, 2024 Jkt 262001 PO 00000 Frm 00035 Fmt 4701 Sfmt 4700 E:\FR\FM\08MYR3.SGM 08MYR3 ER08MY24.006</GPH> Notes: 1. 2. 3. 39158 Federal Register / Vol. 89, No. 90 / Wednesday, May 8, 2024 / Rules and Regulations lotter on DSK11XQN23PROD with RULES3 and PFOA-related disease burden of $62.6 billion in 2018. However, the authors recognize ‘‘that some studies for each of the included outcomes might have reported null findings, [and that] the lower bound of economic cost added for this group of outcomes is zero.’’ (Id.) e. Environmental Justice (EJ) Analysis EPA believes that the human health and environmental conditions that exist prior to this action result in or have the potential to result in disproportionate and adverse human health or environmental effects on communities with EJ concerns. The demographic analysis of plastics manufacturers, facilities reporting to the Toxic Release Inventory (TRI), and U.S. airports found that people of color and low-income populations are disproportionately represented (except near small/medium airports). In particular, these sites have higher rates of Black, Asian, and Hispanic people surrounding them relative to the national average. This finding holds whether focusing on all such populations within one or three miles of these sites or only such populations served by private wells. Consequently, EPA believes that this action is likely to reduce existing disproportionate and adverse effects on communities with EJ concerns. To the extent that the final rule leads to additional response actions to mitigate or eliminate exposure to PFOA/PFOS, or to actions that mitigate exposure earlier, health risks for populations living near sites where releases occur may decline. Based on the detailed analysis found in Section 6.3 of the RIA, the proportion of the population near these sites identified potential communities with EJ concerns, or (in some cases) people living in structures with a higher probability of containing lead paint (built before 1960) exceeds the national average. Thus, EPA expects that the final rule will at least partially mitigate the existing burden of PFOS/ PFOA exposure that falls disproportionately on communities with EJ concerns. As further context for EJ effects potentially associated with the final rule, published literature concludes that communities with potential EJ concerns, and other socio-economic burdens, have a higher likelihood of exposure to PFAS, including PFOA/PFOS. For instance, reported data from Northeastern University’s Social Science Environmental Health Institute published in 2019 show that people of color and low-income populations are disproportionately exposed to PFAS as nearly 39,000 more low-income households (15% more than the VerDate Sep<11>2014 18:22 May 07, 2024 Jkt 262001 expected based on U.S. census data) and approximately 295,000 more people of color (22% more than expected) live within five miles of a site contaminated with PFAS (PFAS Project Lab, 2019). In addition, information on the broader links between PFAS exposure and communities with EJ concerns continues to emerge. An August 2021 Natural Resources Defense Council (NRDC) report examined exposure to PFAS in drinking water in California and found that at least 69 percent of State-identified disadvantaged communities have PFAS contamination in their public water systems, and a number of these communities have levels of PFAS contamination that are higher than the State average PFAS concentrations. In their report, NRDC examined the relationship between the PFAS results and California’s CalEnviroScreen 3.0 (CES) scores, which measure the environmental burden at the census-tract level. CES identifies communities that are disproportionately burdened by and vulnerable to multiple sources of pollution. The top 25 percent most impacted communities are identified as ‘‘disadvantaged communities’’ for the purpose of allocating funds from the State’s cap-and-trade climate program (Senate Bill 535). By examining the overlap of CES scores and PFAS results at the census level, NRDC identified census tracts that may be the most vulnerable to PFAS contaminated drinking water. (Lee, Susan, Avinash Kar, and Dr. Anna Reade, Dirty Water: Toxic ‘‘Forever’’ PFAS Chemicals are Prevalent in the Drinking Water of Environmental Justice Communities. Natural Resources Defense Council, New York. 2021). Therefore, this final rulemaking may improve conditions for exposed populations and communities, including communities with EJ concerns that may have greater PFAS exposure than the general population. Designation of PFOA and PFOS as hazardous substances would allow EPA to address more sites and to implement response actions earlier in time at sites contaminated with PFOA/PFOS, including those near exposed populations and communities, than the Agency could otherwise address in the absence of designation. f. Summary of Potential Health Benefits Resulting From the Designation EPA estimates that a portion of potential health benefits associated with reduced exposure resulting from addressing PFOA and PFOS contamination in private drinking water around non-NPL sites that may result from EPA exercising enforcement PO 00000 Frm 00036 Fmt 4701 Sfmt 4700 authorities range from $8,900 to $779,000 (2% discount rate) per year, depending on the percentage of private wells impacted, the reduced level of PFOA/PFOS exposure at each well, and when the cleanup is expected to occur. Note that additional health benefits could also arise through other routes of exposure and for other health effects and non-health effects related to PFOA and PFOS that did not have adequate information for monetization in the PFAS NPDWR, which was used to develop estimates of potential indirect benefits of this designation. Remediation of PFOA and PFOS contaminated sites under CERCLA, including sites with contaminated sediment in water bodies, may reduce the transport of these substances to waters that can be sources of water to public water systems (PWS). There are potential health benefits to customers of public PWSs if source waters are cleaned up to levels below the PFAS NPDWR MCLs 54 or are cleaned up before the PWSs take action to comply with the PFAS NPDWR; EPA cannot quantify these potential benefits. EPA expects that health benefits that would accrue absent this designation through addressing PFOA and PFOS as pollutants or contaminants under CERCLA, and the additional health benefits due to a potential increase in enforcement actions and removal actions, will be realized sooner rather than later because of this designation. Low-end annualized estimated baseline benefits associated with addressing PFOA/PFOS as pollutants or contaminants at NPL sites under the assumption 10% of wells near NPL sites are impacted with 10 ppt reduction in PFOA/PFOS exposure are $430,000 (2% discount rate). The high-end annualized baseline benefits under the assumption that 30% of wells near NPL sites are impacted with 200 ppt reduction in PFOA/PFOS exposure are $25,800,000 (2% discount rate). Designation is expected to result in earlier response actions because the rule will make EPA aware of PFOA/PFOS contamination earlier than in the baseline (at both NPL and non-NPL sites). As described previously, designation allows EPA access to enforcement authorities to investigate potential releases and compel PRPs to address releases and requires notification of releases above the RQ. These factors may allow for 54 MCL—Once the MCLG is determined, EPA sets an enforceable standard. In most cases, the standard is a maximum contaminant level (MCL). The MCL is the maximum level allowed of a contaminant in water which is delivered to any user of a public water system. (https://www.epa.gov/sdwa/how-eparegulates-drinking-water-contaminants.) E:\FR\FM\08MYR3.SGM 08MYR3 Federal Register / Vol. 89, No. 90 / Wednesday, May 8, 2024 / Rules and Regulations lotter on DSK11XQN23PROD with RULES3 timelier cleanup relative to a world without the rule. EPA also expects that industry may improve best practices and handling procedures to prevent or mitigate releases of PFOA and PFOS that, in turn, could result in less expensive cleanups over the long run. 3. Property Reuse and Social, Economic, and Ecological Benefits That May Result From Designation Superfund cleanups have a proven track record of contributing to social, economic, and ecological benefits. EPA expects similar benefits to accrue as a result of more PFOA and PFOS cleanups that will occur after designation. As a first step, EPA considered studies that evaluated property value trends for communities living around contaminated sites that were cleaned up. Some studies evaluated communities surrounding Superfund sites and other RCRA facilities. RCRA studies examining the effects of remediating hazardous waste sites are also illustrative of how cleanups can improve property values for nearby communities. Thus, EPA considered both sets of studies in evaluating how designation may contribute to increased property values. Many studies demonstrate that cleaning up contaminated sites can positively improve property values. Residential property values within 3 miles (4.8 kilometers) of Superfund sites may increase as much as 18.7 to 24.4 percent when sites are cleaned up and deleted from the NPL. Research specific to RCRA cleanups also suggest that property values may improve from cleanup, perhaps as much as five percent (Taylor et al., 2016). Improved property values also have social equity and environmental justice benefits. Communities near Superfund sites tend to be more disadvantaged than those living farther from the sites, and so increased housing values may provide the most benefit to the poorest segments of the population as opposed to other population groups. Cleanup may help correct sociodemographic disparities in access to a clean and safe environment. EPA also considered the potential for designation to support returning property to beneficial use. Superfund cleanups also make property usable for various purposes. Many Superfund sites—often vacant and underused areas—can become valuable local assets after cleanup. Many once-blighted properties across the country are now in use for a wide range of purposes, including shopping centers, offices, public parks, recreational fields, wildlife habitat, neighborhoods, and renewable energy facilities. Cleanups VerDate Sep<11>2014 18:22 May 07, 2024 Jkt 262001 can also deter blight, vandalism and trespassing. https://www.epa.gov/ superfund/superfund-programprotecting-healthy-communitiesadvancing-environmentalprotection#community_anchor. Sites in reuse and continued use can revitalize a local economy with economic benefits such as jobs, new businesses, tax revenues, and local spending. As of FY 2022, more than 1,040 Federal and non-federal 55 NPL sites support new and ongoing uses. EPA has collected data on more than 10,250 businesses at 671 non-Federal NPL sites. In FY 2022, these businesses generated $74.1 billion in sales and employed more than 236,802 people who earned a combined income of more than $18.6 billion. Over the last 12 years (2011–2022), these businesses’ ongoing operations have generated over $589 billion (inflation adjusted) in sales. https://www.epa.gov/superfund/ superfund-remedial-annualaccomplishmentsmetrics#redevelopment. EPA considered the potential for designation to contribute to ecological benefits, such as ecological reuse and ecosystem services. Superfund cleanups can reduce or reverse damage to ecosystems and generate ecological or recreational reuse activities. These improvements can contribute to a thriving local community and spark local investment, which can improve local well-being, quality of life, employment rates, property values, and tax revenue generation. While the exact monetary value of ecosystem services and ecological reuse can be challenging to measure, historical evidence shows they provide meaningful benefits to communities. Ecosystem services support all facets of human systems, providing trillions of dollars in amenities and important natural capital. New or restored ecosystems as a result of Superfund actions can generate important economic benefits. See EPA document on the Agency’s website, Ecosystems at Superfund Sites, Reuse and the Benefit to Community. https:// semspub.epa.gov/work/HQ/100003256. pdf. Cleanups can produce a range of ecosystem services—timber, purification of surface water and recreation opportunities, habitat to use for new hives to support pollinators, and enhance flora and fauna, among others. It can lead to ecological and recreational reuse activities, which include waterbodies, wildlife sanctuaries, nature 55 While all NPL sites are overseen by the federal government, the term non-federal NPL sites is used in this context to refer to sites that are not federally owned. PO 00000 Frm 00037 Fmt 4701 Sfmt 4700 39159 preserves, wetlands, pollinator habitats, forests, grasslands, beaches, and forests. Recreational reuse can also include the installation of athletic fields, parks, playgrounds, and trails. Now there are nearly 2,000 ecological and recreational reuse activities at about 460 Superfund sites. EPA expects that PFOA and PFOS cleanups can contribute to similar benefits. In summary, past experience shows that cleaning up Superfund sites can restore ecosystems, allow for beneficial reuses of the sites (e.g., shopping centers, parks, ecological or wildlife sanctuaries) spurring and revitalizing local community economies, increase property values and tax revenues, create jobs, and improve the quality of life and well-being those living on or near sites. EPA expects similar benefits to accrue from designation. EPA expects, as a result of designation, that these economic, social, and ecological benefits will also be realized sooner rather than later. Designation will bring PFOA/PFOS entirely into the Superfund program, including investigation, cleanup, enforcement, and liability. 4. Some Facilities May Adopt or Improve Best Practices To Prevent Future Releases of PFOA and PFOS To the extent they have not done so already, some facilities that use or have legacy stocks of PFOA and PFOS and products that contain these substances may adopt best practices to prevent any future releases and adopt best practices to manage waste that contains these substances and products. Other facilities, such as landfills, firefighting training facilities, metal plating facilities and textile coating operations—may improve their best practices as a result of designation. Congress considered this benefit when enacting CERCLA: ‘‘Expenditures to prevent a threatened release, discharge, or disposal may be necessary if damages are to be avoided while also providing considerable savings when compared to the costs of removal after a release, discharge or disposal has occurred.’’ S. Rep. No. 96–848, at 51 (1980). Better waste management practices could result in fewer releases and in cost-savings. B. Potential Disadvantages of Designation EPA assessed potential disadvantages of designation and weighed those against the advantages. The disadvantages include direct costs, indirect costs associated with potential response activities, and the potential for uncertainty. For indirect costs, at the outset, EPA acknowledges that there is E:\FR\FM\08MYR3.SGM 08MYR3 lotter on DSK11XQN23PROD with RULES3 39160 Federal Register / Vol. 89, No. 90 / Wednesday, May 8, 2024 / Rules and Regulations uncertainty associated with both quantified and unquantified potential costs; including response costs, costs that may arise from a judgment of liability, and litigation costs. The magnitude of costs arising from liability and litigation are linked to response costs, and future response costs that may arise after designation are uncertain. Additionally, CERCLA is a discretionary statute and decisions are made on a site-by-site basis. 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 described below. In addition, future discretionary decisions about cleanup and response are difficult to quantify due to numerous 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 at each individual site. Designation alone does not require EPA to take response actions, does not require any response action by a private party, and does not determine liability. As such, none of the indirect costs associated with response, liability, or litigation that EPA estimates are costs that are certain to be incurred after designation. EPA also considered potential liability, including the risk of a judgment of liability and associated litigation costs, that may arise after designation. EPA was unable to quantify these costs. Liability and litigation are directly tied to response actions taken for any given release, and as explained, future response costs are uncertain. EPA assessed data that may inform potential liability and litigation costs, but ultimately determined that such data was insufficient to quantify these costs given the number of variables that inform potential liability and litigation. Nonetheless, EPA gave careful consideration to CERCLA’s liability scheme, and the impact designation may have on CERCLA liability. EPA concludes that designation will not change CERCLA’s liability framework. Designation does not automatically confer liability, nor does it alter CERCLA’s statutory or regulatory framework for liability. This conclusion VerDate Sep<11>2014 18:22 May 07, 2024 Jkt 262001 is supported by an analysis of CERCLA’s statutory limitations, EPA’s existing enforcement discretion policies, CERCLA settlement authorities, and CERCLA’s parameters for cost recovery and contribution actions. The disadvantages from designation are discussed in turn. 1. Direct Costs EPA evaluated direct costs that may result from designation and determined that there are three categories of direct effects that result from designation: notification and reporting requirements pursuant to CERCLA section 103(a) and section 111(g), as well as EPCRA section 304(a); Federal property sale and transfer requirements pursuant to CERCLA section 120(h); and designation of these substances as hazardous materials under the HMTA, see CERCLA section 306(a). EPA analyzed direct costs that may arise from those requirements, as explained below. Direct costs that may result from designation are limited to costs associated with notification requirements and are expected to not exceed $1,630,000 in annualized costs. EPA estimated potential notification costs for facilities that must comply with CERCLA section 103(a), CERCLA section 111(g), and EPCRA section 304. Reporting and notification requirements are only triggered in the event of a PFOA or PFOS release that meet or exceed the reportable quantity. Per release, the estimated cost for a facility is expected to be no more than $2,658. This is a minimal financial burden compared to the benefit of having more immediate information about significant releases of PFOA and PFOS. Reporting will result in increased transparency about releases of PFOA and PFOS, which will inform our understanding of these substances in the environment and allow EPA to respond as necessary. In addition, State, Tribal and local officials will receive immediate notification of these releases so these entities can take actions to protect the community where release occurs. EPA also considered direct costs that may be associated with DOT regulations under CERCLA section 306 and Federal property sales and transfers under CERCLA section 120(h). EPA has not estimated the cost to DOT to implement this requirement but expects it to be minimal; additionally, EPA estimates the subsequent indirect incremental costs to shippers as zero or negligible. The number and magnitude of future Federal property sales and transfers involving property contaminated with PFOA and/or PFOS is highly uncertain and cannot be known at this time. Due PO 00000 Frm 00038 Fmt 4701 Sfmt 4700 to this uncertainty, EPA does not attempt to quantify these costs. 2. Potential Hardship for Parties That Did Not Contribute Significantly to Contamination EPA also considered how designation may impact CERCLA liability for PRPs. As discussed in Section VI.A, as an advantage of designation, it ensures that parties that contributed to releases of PFOA and PFOS are responsible for response costs necessary to cleanup those releases. For PRPs that have significantly contributed to PFOA and PFOS contamination, imposing liability is appropriate and necessary to address this public health threat. However, EPA also gave serious consideration to potential liability for parties that have not played a significant role in contamination, such as parties that did not generate PFOA- or PFOScontaminated waste. For those parties that have not played a significant role in contamination, EPA examined the role of CERCLA’s liability limitations and protections in safeguarding against liability. EPA also considered how EPA’s existing CERCLA enforcement discretion and settlement policies may offer protection from litigation in some situations that may arise after designation. EPA also considered the role that CERCLA settlements may play in resolving potential liability and limiting litigation risk. Taken together, EPA expects that designation should not change CERCLA’s liability framework and that CERCLA will continue to operate as it has for decades to resolve who should pay for the cleanup and how much. EPA expects that those parties that are primarily responsible for contamination will bear the brunt of costs to address PFOA and PFOS releases while parties that are not primarily responsible can rely on statutory protections to limit liability, settlement with EPA to secure contribution protection, and EPA enforcement discretion to provide additional comfort. Indeed, this is how CERCLA has operated for decades with respect to the more than 800 hazardous substances already covered by CERCLA. Below, EPA examines CERCL’s liability framework, including CERCLA’s limiting provisions, EPA’s enforcement discretion policies, and relief available under CERCLA’s primary causes of action. CERCLA includes a number of provisions that may limit liability or the financial impact of liability. These include: • De minimis or de micromis parties: CERCLA provides EPA the ability to settle with parties whose contribution is E:\FR\FM\08MYR3.SGM 08MYR3 lotter on DSK11XQN23PROD with RULES3 Federal Register / Vol. 89, No. 90 / Wednesday, May 8, 2024 / Rules and Regulations minimal in comparison to other parties and provides a statutory exemption to de micromis parties. CERCLA section 107(o). • Third-Party Defense: Parties may have a defense to liability if they can show that the contamination was solely caused by acts or omissions of a third party. CERCLA section 107(b)(3). • Residential, small business and non-profit generators of municipal solid waste (MSW) Exemption: This exemption provides an equitable methodology for resolving CERCLA liability of certain MSW generators and transporters. CERCLA section 107(p). • Bona Fide Prospective Purchasers (BFPP): Parties that meet the threshold criteria and continuing obligations for a BFPP are provided with CERCLA liability protection. CERCLA section 101(40). • Innocent Landowners (ILO): Certain entities that acquire contaminated property with no knowledge of the contamination at the time of purchase may be protected from CERCLA liability. CERCLA section 101(35). • Contiguous Property Owners (CPO): This provision protects parties that are victims of contamination caused by a neighbor’s action. CERCLA section 101(q). • Permit Shield Defense: CERCLA liability is limited for certain releases that fall within the federally permitted release provision of CERCLA. CERCLA section 101(10). • Normal Application of Fertilizer: CERCLA provides that the ‘‘normal application of fertilizer’’ does not constitute a release and, therefore, does not trigger liability under the statute. CERCLA section 101(22).22). EPA also considered the Agency’s existing CERCLA enforcement policies that may mitigate liability concerns and litigation risks. EPA will continue to follow its ‘‘Enforcement First’’ policy, which provides that EPA will aim to compel viable PRPs to conduct and pay for cleanup before resorting to the Fund. EPA’s existing enforcement discretion policies generally reflect EPA’s interest in pursuing major PRPs over minor PRPs. For example, EPA’s ‘‘Policy Towards Owners of Residential Properties at Superfund Sites’’ (U.S. EPA, 1991) is designed to relieve residential owners of the fear that they might be subject to an enforcement action involving contaminated property, even though they had not caused the contamination of the property. EPA’s ‘‘Final Policy Toward Owners of Property Containing Contaminated Aquifers’’ (U.S. EPA, 1995) similarly provides assurance to certain property owners that EPA will not take VerDate Sep<11>2014 18:22 May 07, 2024 Jkt 262001 enforcement actions against them when the landowner did not cause, contribute or exacerbate release of the hazardous substances. CERCLA’s limiting provisions and EPA’s enforcement policies work together to support equitable outcomes. Residential landowner PRPs provide a helpful example of how these provisions may work together. Residential landowners may avail themselves of statutory protections such as those available to Bona Fide Prospective Purchasers, Contiguous Property Owners, or ‘‘innocent landowners.’’ These protections are selfimplementing, which means the protections provided under the statute are automatic, and all a landowner must do to be protected is comply with the requirements of the statute. EPA also has policies in place that provide further comfort to residential landowners, such as the residential landowner policy mentioned above. Existing limitations in CERCLA coupled with existing CERCLA enforcement policies are sufficient to mitigate concerns about liability that may arise after designation. No additional action is necessary to ensure that those limitations and policies continue to operate as they have for decades. Nonetheless, although unnecessary to justify designating PFOA and PFOS as hazardous substances, EPA intends to develop a policy, consistent with those limitations and policies, that explains EPA’s priorities for CERCLA enforcement in the context of PFOA and PFOS releases.56 As EPA states in the FY 2024–2027 National Enforcement and Compliance Initiatives (NECI) (August 17, 2023) (Uhlmann, 2023), the Agency expects to ‘‘focus on implementing EPA’s PFAS Strategic Roadmap and holding responsible those who significantly contribute to the release of PFAS into the environment . . . .’’ The NECI also clarifies that EPA ‘‘does not intend to pursue entities where equitable factors do not support CERCLA responsibility, such as farmers, water utilities, airports, or local fire departments, much as [EPA] exercises CERCLA enforcement discretion in other areas.’’ EPA may exercise enforcement discretion on a site-by-site 56 To help EPA develop a CERCLA PFAS enforcement discretion and settlement policy, EPA held two public listening sessions to solicit individual public input on CERCLA PFAS enforcement concerns. The input received will be reviewed and considered by EPA in drafting the policy. EPA’s CERCLA PFAS enforcement discretion and settlement policy is aimed at addressing stakeholder concerns and reducing uncertainties by clarifying when EPA intends to use its CERCLA enforcement authorities or its CERCLA enforcement discretion. PO 00000 Frm 00039 Fmt 4701 Sfmt 4700 39161 basis informed by site-specific circumstances. CERCLA has additional mechanisms that may operate to temper financial responsibility if a party is potentially liable to equitably resolve how much each party should pay for the costs of cleanup. Under CERCLA section 113(f), liable parties that believe they paid more than their fair share of response costs at a site may, in certain circumstances, seek contribution from other liable parties. In resolving contribution claims, courts consider equitable factors. See infra-Section VI.B.3. CERCLA settlements can also operate to balance equities. CERCLA settlements include protection from CERCLA contribution claims by other PRPs related to the matters addressed in the settlement, CERCLA section 122(h)(4), which should help limit litigation and associated costs. In addition, EPA settlements with major PRPs may provide contribution protection for non-settling parties. For example, if EPA settles with a PFAS manufacturer, EPA may secure a waiver of rights providing that the PFAS manufacturer cannot pursue contribution against certain non-settling parties to that settlement. The waiver of rights helps provide some protection to parties that EPA does not intend to pursue from both the costs of litigation and the costs of cleanup. Without such a waiver, settling major PRPs could pursue contribution under CERCLA from those parties for a portion of the CERCLA cleanup. CERCLA has several mechanisms that can operate to mitigate liability concerns and temper CERCLA’s liability scheme. EPA expects these mechanisms to continue to operate as they have for decades to ensure that designation does not result in inequitable outcomes. This conclusion is supported by the fact that PFOA and PFOS are similar to other hazardous substances, and CERCLA’s liability scheme has functioned in a rational way as to these hazardous substances. Specifically, several designated hazardous substances have a similar fate and transport to PFOA and PFOS and are similarly ubiquitous. See 40 CFR 302.4. CERCLA hazardous substances, such as the chlorinated solvents trichloroethene (TCE) and tetrachloroethene (PCE), as well as heavy metals like mercury and arsenic are prevalent in the environment. TCE and PCE, for example have been found at over 800 NPL sites as well other contaminated sites from their use as industrial solvents including TCE’s use for degreasing manufactured metal parts and PCE’s use for dry cleaning. Heavy metals, like mercury and arsenic, are E:\FR\FM\08MYR3.SGM 08MYR3 39162 Federal Register / Vol. 89, No. 90 / Wednesday, May 8, 2024 / Rules and Regulations lotter on DSK11XQN23PROD with RULES3 commonly found in soil and groundwater. Arsenic has been found at over 1100 NPL sites and mercury at over 600 sites. Some municipalities also encounter these substances on a regular basis from industrial wastewater discharges. Property owners may also handle these substances as a result of home renovations or gardening or normal activities. For example, TCE can be found in some cleaners sold for household use, including paint removers, glue, spot and stain removers, carpet spot removers, metal cleaners, and gun cleaners. Mercury is found in fluorescent light bulbs and is also found in some water bodies as a consequence of pollution from industrial and mining wastes, powerplant emissions, and other sources. This mercury contamination in turn affects fish and those that consume these fish (U.S. EPA, 2023f). In addition, americium, a radioactive element that is on the hazardous substances list is found in household smoke detectors. Similarly, PFOA and PFOS were historically manufactured on a broad scale, have past and continued releases to the environment (e.g., through legacy disposal, release of precursors, or manufacture as a byproduct), and are detected widely in multiple environmental media, including groundwater, surface water, wild animals, livestock, and plants. Despite the fact that people come into contact with these hazardous substances on a regular basis, CERCLA has continued to operate in a rational way, generally protecting those that have played little to no role in significant environmental contamination from liability. 3. Potential Litigation, Liability, and Uncertainty EPA considered the potential for litigation costs, such as attorney’s fees and costs associated with negotiating settlements, following the designation. EPA was unable to quantify these costs given the number of variables that inform potential litigation. In addition to threshold issues associated with liability considerations described previously, variables that inform litigation may include, among others: whether EPA takes a response action; whether there are viable PRPs; the number of parties involved in the litigation; whether it is cost effective for a party to pursue litigation; and whether litigation results in settlement or goes to trial. There also remains an open question of how many actions are taken pursuant to CERCLA or taken pursuant to a State Superfund law. Whether an action is taken pursuant to CERCLA or State law creates an additional level of uncertainty that makes it difficult for VerDate Sep<11>2014 18:22 May 07, 2024 Jkt 262001 EPA to fully evaluate and quantify the potential litigation costs associated with designation. CERCLA is, in part, a liability statute and is designed to ensure that those responsible for the contamination pay to clean it up. Some amount of litigation to resolve ‘‘who should pay’’ is an expected, and intended, aspect of CERCLA, and this is true in the context of actions to address PFOA and PFOS releases as well as the more than 800 hazardous substances that are already within CERCLA’s scope. EPA considered how CERCLA may operate to minimize the risks posed by litigation. EPA evaluated how CERCLA’s primary causes of action—cost recovery and contribution—operate to resolve liability. EPA also considered the role that CERCLA settlements may play in minimizing risks posed by litigation. EPA weighed these considerations against CERCLA’s objective of ensuring the polluter pays. EPA determined that CERCLA cost recovery and contribution provide parameters that safeguard against excessive litigation, and furthermore, that CERCLA settlements may further mitigate future litigation. The presence of a hazardous substance does not create liability under CERCLA. Under section 107, there must be a ‘‘release’’ or ‘‘threat of release’’ of a hazardous substance and the entity must fall within one of the categories of liable parties. CERCLA section 107(a)(1)–(4). In addition, an entity can only recover response costs that are ‘‘consistent with the NCP.’’ Section 107(a)(4)(B). Further, a party’s potential liability may be limited as a result of contribution or settlement, CERCLA section 113(f). The statute provides that a party that resolves its potential liability with the United States or a State in a judicially approved settlement is entitled contribution protection—the ability to block thirdparty claims for matters addressed in the settlement. In addition to CERCLA’s limiting provisions, litigation may also be constrained by the relief available. Private party CERCLA cost recovery actions are limited to relief associated with certain costs and damages. Most notably is the relief permitted for response costs, which is limited to costs incurred ‘‘consistent with the NCP.’’ The NCP provides a technical and detailed process for implementing response actions and creates benchmarks that may limit actions that have no discernible human health, welfare, or environmental benefit. Parties also may only receive reimbursement for response costs incurred, and so a party would need to PO 00000 Frm 00040 Fmt 4701 Sfmt 4700 have the financial means to conduct a cleanup before obtaining any recovery. Those parameters may operate to limit frivolous lawsuits or excessive litigation. Courts’ assessment of equitable factors in allocating cleanup costs can also serve as an important limitation on liability. In resolving contribution claims, courts typically allocate a particular party’s share of costs based on equitable factors. As a result, courts aim to resolve claims in an equitable manner, which generally results in those that contributed significantly to contamination bearing the most liability; those that did not will bear only a small percentage of response costs, if any. The equitable factors that courts generally apply include: the volume and toxicity of the hazardous substances and their wastes contributed to the contamination by each party; the degree of involvement in generating the hazardous substances or wastes released/deposited; the degree of care exercised in handling the hazardous substances; and the degree of cooperation by the parties with government officials in preventing further harm to public health or the environment.57 These factors are designed to ensure that those who have contributed significantly to contamination bear financial responsibility for cleanup. Given the information before the Agency, including the comments on the proposal, EPA does not believe that designation is going to result in widespread, significant liability consequences for parties that lack meaningful responsibility for the contamination at issue. Contribution claims are further limited by CERCLA settlements that provide contribution protection, and such settlements may serve to prevent contribution lawsuits against settling parties. A party that resolves its liability through a CERCLA settlement with the United States will not be liable for thirdparty contribution claims related to the matters addressed in the settlement. This means that PRPs will not be able to pursue the settling parties for 57 See, e.g., United States v. A&F Materials Co., 578 F. Supp. 1249, 1256 (S.D. Ill. 1984) (establishing equitable factors for apportioning financial responsibility (i.e., the ‘‘Gore Factors’’)); see also In re Bell Petroleum Services, Inc., 3 F.3d 889, 894 (5th Cir. 1993) (discussing considerations for apportioning liability among contributors); Waste Mgmt. of Alameda County, Inc. v. East Bat Reg’l Park, 135 F. Supp. 2d 1071, 1089–90 (N.D. Cal. 2001) (in exercising its discretion on allocation, court does not need to limit itself to any particular set of factors, courts may consider factors appropriate to balance the equities in the totality of circumstances). E:\FR\FM\08MYR3.SGM 08MYR3 Federal Register / Vol. 89, No. 90 / Wednesday, May 8, 2024 / Rules and Regulations lotter on DSK11XQN23PROD with RULES3 contribution costs under CERCLA related to the settlement, thus minimizing litigation costs and discouraging third-party litigation. In certain situations, parties may qualify for de minimis or de micromis settlements under the terms of the Agency’s 2002 enforcement discretion/ settlement policy. On a case-by-case basis, EPA may enter into limited ‘‘ability to pay’’ settlements with parties to resolve CERCLA response costs, where payment could result in undue financial hardship for the PRP. Further, parties may also be asked to perform actions such as in-kind services, including PFAS monitoring activities and implementing institutional controls. EPA also considered the potential for CERCLA litigation that may arise as the result of ‘‘voluntary’’ private-party cleanup or as the result of cleanup conducted or ordered pursuant to a State program. The safeguards and limitations on CERCLA liability discussed in this section are equally applicable in the context of CERCLA litigation arising from voluntary or stateled cleanups. Such litigation is subject to the same paradigms as litigation that arises out of a Federal-led CERCLA action. EPA acknowledges though that some parties that do not bear primary responsibility for contamination may be sued and face litigation costs as a consequence. These costs cannot be known at this juncture with reasonable certainty. Notwithstanding this, EPA believes that statutory safeguards described above will likely limit this type of litigation or adverse outcomes. Even if litigation costs are incurred by parties that do not bear primary responsibility, EPA does not believe that the potential for such costs will outweigh the substantial advantages of designation discussed above. C. Results of Totality of the Circumstances Analysis Taken together, weighing the advantages and disadvantages of the designation alongside EPA’s determination that both PFOA and PFOS may present a ‘‘substantial danger,’’ EPA concludes that designation of PFOA and PFOS as hazardous substances is warranted. First, the scientific evidence establishes that PFOA and PFOS releases into the environment pose diverse and serious health hazards to exposed populations. The full scope of the hazards from PFOA and PFOS is not yet known, and scientists continue to gain greater understanding of the effects of these human-made chemicals on public health and the environment. Among VerDate Sep<11>2014 18:22 May 07, 2024 Jkt 262001 other things, the current body of scientific and technical literature establishes that PFOA and PFOS exposure are associated with adverse impacts on pregnant women and developing fetuses, such as an increased likelihood of pregnant women getting preeclampsia and hypertension or that babies will be born with a lower birth weight and smaller head circumference. PFOA and PFOS exposure are associated with increased risk for renal cell carcinoma, a type of kidney cancer. Exposure is associated with an increased risk for many other adverse health effects including cardiovascular effects, such as changes to blood pressure and cholesterol, and thyroid disorders, which in turn can impact heart rate, mood, energy level, metabolism, bone health, pregnancy, and many other functions. [See section V.A.] PFOA and PFOS exposure are also associated with decrease immune response to vaccinations, in turn leaving vaccinated individuals more vulnerable to harmful disease. These health risks are documented in an extensive body of scientific and technical literature that is continuing to develop as more is learned about the widespread adverse impacts of PFOA and PFOS exposure. In addition to the serious potential health hazards posed by these substances, available information about the fate and transport of PFOA and PFOS support EPA’s conclusions that these substances remain in the environment for many years (i.e., persistence) and that they can move through air, land, and water (i.e., mobility) after release. These chemicals are sometimes referred to as ‘‘forever’’ chemicals because of their strong carbon-fluorine bonds in the ‘‘tail group’’ that cause PFOA and PFOS to be extremely resistant to degradation through biological degradation and also through chemical degradation (i.e., photooxidation and hydrolysis). Other information that EPA considered demonstrates that PFOA and PFOS are prevalent and there is a likelihood of exposure to humans and the environment. PFOA and PFOS are prevalent throughout the environment because they are persistent and have been widely used since the 1940s in a wide range of commercial and consumer products. Currently, the public can be exposed to PFOA and PFOS through a variety of sources, including drinking water, food, and environmental media. PFOA and PFOS have been detected in the drinking water of millions of Americans and are widely detected in surface water samples collected from various rivers, lakes, and streams in the United States (ATSDR, 2021; PO 00000 Frm 00041 Fmt 4701 Sfmt 4700 39163 Cadwallader et al., 2022; U.S. EPA, 2017, 2024a). The prevalence of PFOA and PFOS is further demonstrated by the fact that these chemicals were detected in the blood of nearly all of the participants in NHANES. This information indicates widespread exposure to PFOA and PFOS in the U.S. population. Addressing PFOA and PFOS contamination, including cleaning up contaminated soils and water supplies, can reduce PFOA and PFOS exposure to affected communities, and bring substantial benefits. In particular, individuals living near heavily contaminated sites—that is, those sites that are most likely to be targeted for EPA enforcement action, removal action, or designation on the NPL list for more complex cleanup—often include communities with EJ concerns. These communities are at particular risk from adverse health impacts from PFOA and PFOS exposure as well and so are vulnerable to further cumulative harm. Designation of PFOA and PFOS as hazardous substances under CERCLA section 102(a) will have concrete, on the ground impact, and reduce serious harm. CERCLA’s scheme gives EPA authority to cleanup both pollutants and contaminants (which PFOA and PFOS have long been considered) and hazardous substances. But only once a chemical is designated as a hazardous substance, can EPA employ the full suite of CERCLA authorities. These include: the requirement that authorities be notified of certain releases; the authority to compel PRPs to investigate and cleanup contamination where there may be an imminent and substantial endangerment; and the authority to recover response costs where EPA takes Fund-lead actions. These authorities are critical to addressing existing and future PFOA and PFOS contamination and reducing risk of ongoing exposure to these harmful chemicals. EPA’s analysis shows that designation of PFOA and PFOS as hazardous substances will allow EPA to address more sites and to implement response actions earlier in time than it otherwise could in the absence of designation. This is because designation allows EPA to complement Fund-lead actions with PRP-lead actions. Shifting costs to PRPs to address PFOA and PFOS contamination at NPL sites will make Fund money available for cleanup work at Superfund sites. More cleanups promote economic benefits, such as improved property values and making land available for reuse, which can revitalize a local economy with economic benefits such as jobs, new businesses, tax revenues and local E:\FR\FM\08MYR3.SGM 08MYR3 lotter on DSK11XQN23PROD with RULES3 39164 Federal Register / Vol. 89, No. 90 / Wednesday, May 8, 2024 / Rules and Regulations spending. Designation also removes barriers to taking removal actions, which is expected to result in more short-term actions to address immediate risks. Collectively, these actions are expected to have meaningful benefits to human health and the environment, limit further exposure to PFOA and PFOS, and reduce the spread of PFOA and PFOS contamination. Expeditious response to mitigate PFOA and PFOS releases is particularly important given the chemical properties of these substances which make them persistent and mobile in the environment. While the full extent of health, social, economic, and ecological benefits of the designation cannot be quantified, such benefits are expected to be substantial, bringing particular benefit to vulnerable populations. Designation also serves CERCLA’s key purpose of ensuring that those entities that are primarily responsible for contamination bear the economic burden of cleaning it up. Without designation, EPA actions to address PFOA and PFOS are more limited, and response costs may only be paid for through the Fund. After designation, EPA will have authority to compel action by and recover costs from PRPs, which effectively places financial responsibility on those entities responsible for contamination. When EPA is able to transfer NPL site costs addressing PFOA and PFOS contamination, as described previously, it improves societal equity by ensuring that the Polluter Pays for cleanup rather relying exclusively on Fund resources. Further upholding the Polluter Pays principle of CERCLA, designation allows EPA to compel PRPs to address PFOA and PFOS contamination at sites outside of the NPL. This means that additional sites can be addressed, and contamination can be addressed earlier. ‘‘Polluter pays’’ is a central objective of CERCLA as a liability statute. Response costs at NPL sites enabled by transfers from EPA to PRPs are estimated to be $10.3 million annually to $51.7 million annually (2% discount rate). Indirect costs associated with response work at non-NPL sites compelled through enforcement actions is estimated to be $327,000 to $18,100,000 annually (2% discount rate). (See RIA Chapter 5). EPA recognizes that designation will result in economic costs borne by PRPs. While CERCLA’s primary aim is to ensure that PRPs bear cleanup costs, EPA acknowledges that the costs parties expend to clean up PFOA and PFOS is a burden for them. Notwithstanding this, EPA views the cleanup monies spent by PRPs as an advantage of the VerDate Sep<11>2014 18:22 May 07, 2024 Jkt 262001 rule for the reasons stated above. In addition, EPA believes that these cleanup costs will substantially reduce the hazards posed by exposure to PFOA and PFOS, providing significant health benefits (particularly to sensitive populations) that justify the costs. EPA recognizes that, under CERCLA, a PRP—including those parties that significantly contributed to contamination and those that did not— may be jointly and severally liable to the government for the entire amount of response costs unless it proves that the harm from the release of hazardous substances is divisible. This is true of all listed hazardous substances. EPA’s experience over the past four decades administering CERCLA shows that the statute, combined with EPA’s existing enforcement discretion policies, ensure that CERCLA will continue to function in a rational manner, with those primarily responsible for pollution bearing the costs of cleanup. The decision to designate PFOA and PFOS as CERCLA hazardous substances is supported by CERCLA’s legislative aims underpinning CERCLA’s enactment. CERCLA was enacted to promote the timely cleanup of contaminated sites and to ensure that those responsible for contamination pay to clean it up. H.R. Rep. No. 99–253, pt. 3, at 15 (1985); Burlington Northern and Santa Fe Railroad Co. v. U.S., 556 U.S. 599, 602 (2009) (‘‘The Act was designed to promote the ‘cleanup of hazardous waste sites’ and to ensure that the costs of such cleanup efforts were borne by those responsible for the contamination.’’). Designation ensures that CERCLA activities to address PFOA and PFOS contamination conforms to those objectives. Moreover, CERCLA was enacted to address the challenge of community exposure to hazardous chemicals, like PFOA and PFOS, released into the environment.58 EPA’s decision to designate aligns with Congress’s vision for CERCLA as an important Federal tool in removing chemicals from the environment that have the potential to pose serious risks to human health and the environment. Indeed, CERCLA designation is necessary to adequately tackle the threat 58 Congress enacted CERCLA to address contaminated sites across the nation, which was considered one of ‘‘the most serious health and environmental challenge[s] of the decade.’’ S. Rep. No. 96–848, at 2 (1980). Congress acknowledged that ‘‘the potential impact of toxic chemicals on the general public and environment through unsound hazardous disposal sites and other releases of chemicals is tremendous.’’ Id. And in fact, expert testimony solicited by Congress stated that the breadth and scope of the effect of exposure to hazardous chemicals nearly ‘‘extend[ed] to the entire population of the United States.’’ Id. PO 00000 Frm 00042 Fmt 4701 Sfmt 4700 posed by PFOA and PFOS contamination to communities across the country. CERCLA authority provides EPA with tools to address immediate and longterm needs for mitigating and eliminating PFOA and PFOS exposures that present unreasonable risk. CERCLA’s approach to identifying, investigating, and cleaning up contamination is also designed to promote response for the subset of releases that present the most urgent risks. This is evidenced through CERCLA’s removal authorities, NPL listing process, the remedial process, and enforcement authority for imminent and substantial endangerments. CERCLA directs Federal agencies to assess risks by considering the population, the hazard potential of hazardous substances, the potential for drinking water contamination, the potential for direct human contact, the potential for destruction of sensitive ecosystems, and the damages to natural resources that may affect the human food chain. Indeed, with those considerations in mind, a small fraction of sites qualifies for the NPL every year.59 CERCLA also includes safeguards against excessive cleanup costs relative to the effectiveness of a remedy, and those safeguards are reinforced by CERCLA’s cost recovery mechanisms. Collectively, these tools ensure that CERCLA prioritizes and targets releases that pose the most risk to human health and the environment; ensures that EPA can respond quickly when necessary and design durable, long-term remedies that ensure protection for public health and the environment; and that site-specific remedies are cost-effective. In conclusion, the totality of the circumstances analysis confirms that designation of PFOA and PFOS as CERCLA hazardous substances is warranted. An analysis of the advantages and disadvantages of designation, including weighing of 59 The hazardous substance designation is not expected to change the approach EPA uses for identifying potential NPL sites. EPA already has the authority to add PFOA and PFOS releases to the NPL. EPA evaluates a number of options before determining the most effective approach for site cleanup. Alternatives to NPL listing may include: Superfund Alternative Approach, state cleanup, cleanup by other federal agencies, EPA removal, deferral to another EPA program and various enforcement mechanisms. Therefore, releases that contain PFOA or PFOS are more likely to be addressed through non-NPL mechanisms than through the NPL. Between FY 2003 and FY 2022, only about four percent of all contaminated sites evaluated by EPA for placement on the NPL were added to it. Since 2013, EPA has, on average, added 11 non-federal sites per year to the NPL and EPA does not expect the rate at which annual additions to the NPL occur to increase as a result of this rule. E:\FR\FM\08MYR3.SGM 08MYR3 Federal Register / Vol. 89, No. 90 / Wednesday, May 8, 2024 / Rules and Regulations quantitative and qualitative benefits and costs, demonstrates that the advantages outweigh the disadvantages. Further, designation best achieves CERCLA’s dual objectives—the timely cleanup of contaminated sites and ensuring that those responsible pay for cleanup. Designation provides additional tools that allow for earlier, broader, more effective cleanups, allowing EPA to protect communities that are exposed to high concentrations of PFOA and PFOS. VII. Summary of Public Comments and Responses In this final action, EPA is designating PFOA and PFOS, including their salts and structural isomers, as hazardous substances pursuant to CERCLA section 102(a). In response to the September 6, 2022, proposed rule (2022 Proposal), EPA received approximately 64,000 comments, including mass mail. EPA received comments from a variety of sources, including the regulated community, trade associations, and State, Tribal and local agencies. The Agency received comments generally supporting and opposing the designation of PFOA and PFOS as CERCLA hazardous substances. EPA also received a number of comments requesting clarity on the various issues that EPA considered in support of the 2022 Proposal. EPA has taken the submitted comments into consideration in preparing this final action. Comments have been summarized and EPA has provided detailed responses to the significant comments either here in this final action or in the Response to Comments on the Designation of Perfluorooctanoic Acid (PFOA) and Perflurooctanesulfonic Acid (PFOS) as CERCLA Hazardous Substances, which is available in the rulemaking docket. This section includes responses to a selection of the significant comments received on various topics addressed in the 2022 Proposal. A. Legal Authority lotter on DSK11XQN23PROD with RULES3 1. Consideration of Cost and Section 102(a) Comment: Several commenters assert that EPA must consider costs when designating a hazardous substance pursuant to CERCLA section 102(a). These commenters disagreed with EPA’s proposed interpretation of CERCLA section 102(a) ‘‘as precluding consideration of costs in hazardous substance designations.’’ Those commenters generally remarked that EPA’s position is inconsistent with U.S. Supreme Court case law on considering costs in regulatory actions. Commenters VerDate Sep<11>2014 18:22 May 07, 2024 Jkt 262001 that disagreed with EPA’s position also generally argued in the alternative that, at a minimum, EPA has discretion to consider cost. Conversely, some commenters agreed with EPA’s proposed position that CERCLA section 102(a) precludes the consideration of cost. Commenters that disagreed with EPA’s position assert that CERCLA section 102(a) requires the consideration of cost. Commenters assert that the phrase ‘‘as may be appropriate’’ in CERCLA section 102(a) means that EPA must consider cost in considering whether to promulgate regulations to designate hazardous substances. Commenters support this interpretation by: (1) Asserting that CERCLA provides no textual basis to preclude cost citing Michigan v. EPA, 576 U.S. 743, 752 (2015), where the court held that the phrase ‘‘appropriate and necessary’’ as used in section 112(n)(1)(A) of the CAA must include some consideration of cost; and (2) distinguishing Whitman v. American Trucking Ass’ns, Inc., 531 U.S. 457 (2001), and Utility Solid Waste Activities Group v. EPA, 901 F.3d 414 (D.C. Cir. 2018), in which the courts upheld EPA determinations that healthbased statutory provisions precluded consideration of costs. A few commenters further supported their position by asserting that CERCLA’s definition of ‘‘hazardous substance,’’ CERCLA section 101(14), incorporates by reference other environmental statutes with listing or identification criteria that include cost considerations. These commenters also argued in the alternative that even if EPA is not required to consider cost, it at least has discretion to do so. Looking to the Court’s decision in Entergy Corp. v. Riverkeeper, Inc., one commenter implied that ‘‘. . . silence [as to cost] is meant to convey nothing more than a refusal to tie the agency’s hands as to whether cost-benefit analysis should be used, and if so to what degree.’’ 556 U.S. 208, 222 (2009). EPA also received comments agreeing with its proposed interpretation that CERCLA section 102(a) precludes the consideration of cost. As one commenter stated, EPA’s proposed interpretation ‘‘accords with CERCLA’s unambiguous text, statutory structure, and judicial interpretations of comparable provisions of other environmental laws.’’ The commenter notes that ‘‘CERCLA’s text contains a single criterion for the designation of a hazardous substance: whether the substance, ‘when released into the environment[,] may present substantial danger to the public health or welfare or the environment.’ ’’ The commenter also PO 00000 Frm 00043 Fmt 4701 Sfmt 4700 39165 states that ‘‘[c]ompliance costs do not constitute ‘substantial danger to the public health or the environment’ and are not attributed to the ‘release[ ]’ of a hazardous substance into the environment. . . .’’ The commenter contrasts CERCLA section 102(a) with other CERCLA provisions that authorize or require cost considerations to conclude that Congress intended a difference in meaning. Finally, the commenter suggests that CERCLA section 102(a) is akin to other ‘‘healthfocused provisions of other environmental laws’’ that courts have interpreted to exclude cost considerations. Response: EPA proposed interpreting CERCLA section 102(a) as precluding the consideration of cost in designating CERCLA hazardous substances. EPA recognizes that, as a general matter, a statutory assessment of health and environmental-based criteria like the criteria in section 102 does not generally allow for consideration of costs. As discussed in Section V of this document, examining only the statutory criteria—whether PFOA or PFOS ‘‘may present a substantial danger to public health or welfare or the environment’’ and without considering costs and benefits—EPA has concluded that designation is warranted. EPA considered comments supporting and disagreeing with the position that CERCLA section 102(a) precludes the consideration of cost. In taking final action, EPA decided it need not determine whether section 102(a) precludes consideration of costs and benefits because designation is warranted either by examining the health- and environmental-based criteria alone or by examining these criteria along with the broader totality of the circumstances. The Agency first evaluated the available scientific and technical information about those substances and concluded that designation of each is warranted based solely on a finding that PFOA and PFOS may present substantial danger to public health or welfare or the environment. The Agency next conducted a separate totality-of-the-circumstances analysis, which did consider costs and benefits. EPA considered the available scientific and technical information, along with the advantages and disadvantages of designation, including quantified and unquantified benefits and costs, and concluded this analysis reinforced that designation was warranted as reflected in section VI of this preamble. Because EPA’s designation is warranted when considering benefits and costs as part of a totality of the circumstances analysis, EPA need not resolve whether CERCLA E:\FR\FM\08MYR3.SGM 08MYR3 39166 Federal Register / Vol. 89, No. 90 / Wednesday, May 8, 2024 / Rules and Regulations lotter on DSK11XQN23PROD with RULES3 section 102(a) precludes EPA from taking into account costs. 2. Interpretation of the Phrase ‘‘May Present Substantial Danger’’ Comment: Commenters posit that the standard for designation proposed by EPA is overbroad, vague, and arbitrary and capricious. Some commenters argue that EPA’s alleged vague articulation of this standard provides little guidance on how or why PFOA and PFOS satisfy that standard. Commenters go on to assert that the lack of clarity regarding EPA’s proposed interpretation of ‘‘may present a substantial danger’’ suggests that the Agency has deprived the public of the ability to meaningfully comment on its proposed rule. Relatedly, these commenters state that EPA must clearly state the level of evidence that is sufficient to demonstrate ‘‘substantial danger’’ before proceeding with the designation. Commenters also asserted that EPA failed to demonstrate how PFOA and PFOS qualify as toxic, persistent, and prevalent. Commenters also argue that EPA must address the likelihood of exposure to PFOA and PFOS in evaluating whether designation of PFOA and PFOS is consistent with section 102(a). Another commenter suggests that EPA propose a standard for designating substances consistent with 102(a) in a separate rulemaking before proceeding with designating any substances. Commenters further claim that the standard EPA articulated makes it unclear how EPA may apply CERCLA section 102(a) in the future to designate additional substances. A commenter asserts that EPA has not identified an ‘‘intelligible principle’’ to apply when making listing decisions, and therefore, any level of risk is sufficient to support a listing of a chemical so long as it is also mobile, persistent, and prevalent. Commenters also argue that there should be a level of predictability for potential future designations; for example, EPA should identify a brightline risk threshold at which a substance poses ‘‘substantial danger’’ for the purposes of section 102(a). One commenter suggests that EPA must explain the characteristics that a substance must exhibit to be designated as a hazardous substance under section 102(a). Another commenter stated that the criteria articulated for CERCLA section 102(a) should have a level of specificity similar to the criteria for listing decisions made under the environmental statutes incorporated by reference through CERCLA’s definition of hazardous substances. Several commenters also suggest that EPA’s interpretation of ‘‘substantial VerDate Sep<11>2014 18:22 May 07, 2024 Jkt 262001 danger’’ for the purposes of CERCLA section 102(a) is inconsistent with a reading of that phrase offered by EPA in an Advanced Notice of Proposed Rulemaking released on January 14, 2021. Finally, one commenter argues that EPA should explain how ‘‘substantial danger’’ aligns with the NCP’s risk thresholds for cancer and noncancer risks. Response: EPA disagrees with the commenters’ position that the information the Agency considered in proposing to designate PFOA and PFOS as hazardous substances under CERCLA section 102(a) was overbroad, vague, and arbitrary and capricious. In the final rule, EPA identified the information it considered in evaluating whether a substance satisfies CERCLA section 102(a) and described the information it considered in reaching its conclusion that PFOA and PFOS satisfy CERCLA section 102(a). Specifically, as detailed in section IV.A., the two primary factors the Agency considered in the context of CERCLA section 102(a)—hazard, and fate and transport—are consistent with other statutory methodologies used for identifying CERCLA hazardous substances. Under section 102(a) of CERCLA, EPA has been delegated the authority to identify and weigh information relevant to determining whether a substance, when released, may present a substantial danger and the approach we have adopted is reasonable and consistent with EPA’s other authorities. In the final rule, EPA also conducted an additional, discretionary analysis of the totality of the circumstances. EPA also disagrees with commenters that EPA should identify a bright-line risk threshold at which a substance poses ‘‘substantial danger’’ for the purposes of section 102(a). The plain language of CERCLA section 102(a) does not require a ‘‘bright-line’’ risk threshold applicable to any and all substances. Further, the Agency does not know how it would establish such a line, including because exposures at different levels are associated with a variety of health effects, carcinogenic and non-carcinogenic risk are calculated separately, risk must consider, acute, sub-chronic, and chronic exposure, and risk is calculated for all site contaminants combined,60 and the commenters do not provide suggestions for how such an approach would work. Instead, EPA is utilizing the discretion provided in CERCLA section 102(a) to 60 USEPA. 1986a. Guidelines for the Health Risk Assessment of Chemical Mixtures. EPA 630–R–98– 002. Available on the internet at: https:// www.epa.gov/risk/guidelines-health-riskassessment-chemical-mixtures. PO 00000 Frm 00044 Fmt 4701 Sfmt 4700 conduct individual analyses of substances that account for all of their characteristics to determine whether, when released, the substances may present substantial danger. Moreover, EPA also finds that a bright-line test is not appropriate because the plain language of CERCLA section 102(a) (‘‘may present a substantial danger’’) does not require certainty that a release of a substance in fact presents a substantial danger in any given location it is found. EPA disputes the commenter’s position that the NCP’s risk thresholds for cancer are relevant to its interpretation of whether PFOA or PFOS may present a substantial danger to public health or the environment under section 102(a) of CERCLA. EPA’s cancer risk thresholds are used on a sitespecific basis—during EPA’s remedy selection process—to take into account an individual’s lifetime cancer risk. By contrast, the analysis of whether a substance ‘‘may present a substantial danger’’ for the purposes of designation as a CERCLA hazardous substance does not require certainty and is not sitespecific. It would be inconsistent with the plain language of section 102(a) for EPA, at this stage and for the purpose of designating hazardous substances, to evaluate the specific releases in which exposure to PFOA and PFOS pose actual risk. Those determinations are left for later stages in the CERCLA process and evaluated on a site-by-site basis. EPA also rejects the commenter’s assertion that CERCLA section 102(a) requires the Agency to promulgate a standard for designating hazardous substances in advance of today’s action. CERCLA section 102(a) includes no such requirement, and neither do the other environmental statutes that authorize EPA to list or designate substances as hazardous. Rather, CERCLA section 102(a) provides that, ‘‘[t]he Administrator shall promulgate and revise as may be appropriate, regulations designating . . . hazardous substances . . .’’ CERCLA section 102(a) (emphasis added). This language is distinct from other places in CERCLA where Congress directed EPA to promulgate regulations or procedures for various CERCLA activities. For example, CERCLA section 112 explicitly provides that EPA shall ‘‘prescribe appropriate forms and procedures’’ for filing CERCLA claims. CERCLA section 112(b)(1). Likewise, CERCLA section 105 directs EPA to ‘‘establish procedures and standards for responding to releases of hazardous substances.’’ CERCLA section 105(a). Section 102(a) does not include similar E:\FR\FM\08MYR3.SGM 08MYR3 Federal Register / Vol. 89, No. 90 / Wednesday, May 8, 2024 / Rules and Regulations lotter on DSK11XQN23PROD with RULES3 language and does not require that EPA promulgate a standard for designating hazardous substances in advance of doing so. Nonetheless, EPA identified two primary factors—hazard, as well as fate and transport—relevant to the designation of hazardous substances. To further inform its decision, EPA concluded that other information may be relevant to evaluating releases of the substance, such as the frequency, nature, and geographic scope of releases of the substances and likelihood of exposure. EPA’s evaluation of the scientific and technical information pertaining to those factors support the Agency’s finding that both PFOA and PFOS may present substantial danger to public health and the environment.61 EPA further disagrees with the commenter’s claim that Congress failed to provide an ‘‘intelligible principle’’ to guide EPA’s authority to designate hazardous substances pursuant to section 102(a) of CERCLA. The nondelegation doctrine provides that ‘‘Congress generally cannot delegate its legislative power to another Branch.’’ Mistretta v. United States, 488 U.S. 361, 371–72 (1989). This test requires that Congress ‘‘lay down by legislative act some intelligible principle’’ to which the recipient must conform. Id. (quoting J.W. Hampton. Jr. & Co. v. United States, 276 U.S. 394, 409 (1928)). Congress’s delegation of authority to EPA in the context of CERCLA section 102(a) amply satisfies the constitutional standard set forth in controlling Supreme Court precedent because Congress has clearly provided an ‘‘intelligible principle’’ in the provision limiting EPA’s discretion in designating substances under the statute. Specifically, section 102(a) provides that the Agency may designate those substances which, ‘‘when released into the environment may present substantial danger to the public health or welfare or the environment.’’ 42 U.S.C. 9602(a). Contrary to the commenter’s claim, the authority conferred by Congress is neither openended nor otherwise so imprecise as to provide no principles for the Agency to apply in designating hazardous substances. Rather, CERCLA section 102(a) requires EPA to base its designation decisions on certain specified principles, including whether the substance in question poses a substantial danger to either public 61 To support EPA’s finding in this final rule that both PFOA and PFOS each individually pose a human health hazard, EPA gave weight to immunological, hepatic, developmental, cardiovascular, and cancer effects. These health outcomes had the strongest evidence of associations between PFOA and PFOS exposure and adverse health effects. VerDate Sep<11>2014 18:22 May 07, 2024 Jkt 262001 health, welfare, or the environment. These considerations intelligibly confine EPA’s discretion to designate substances under the statute and the Agency’s listing decision is not only based upon the criteria prescribed by Congress but is firmly within the bounds of the Court’s nondelegation precedents. See, e.g., American Power & Light Co., 329 U.S. at 104 (upholding the authority of the Securities and Exchange Commission to modify the structure of holding company systems so as to ensure that they are not ‘‘unduly or unnecessarily complicate[d]’’ and do not ‘‘unfairly or inequitably distribute voting power among security holders.’’); Yakus v. United States, 321 U. S. 414, 420, 423–26 (1944) (approving the wartime conferral of agency power to fix the prices of commodities at a level that ‘‘will be generally fair and equitable and will effectuate the [in some respects conflicting] purposes of the] Act.’’ (internal quotations omitted); National Broadcasting Co. v. United States, 319 U.S. 190, 225–26 (1943) (finding an ‘‘intelligible principle’’ in the Federal Communication Commission’s power to regulate airwaves in the ‘‘public interest.’’). In sum, CERCLA section 102(a) provides an intelligible principle that guides the Agency in the exercise of its authority under section 102(a). EPA also disagrees with the assertion that its interpretation of ‘‘substantial danger’’ is inconsistent with its past interpretation of this phrase or EPA’s interpretation of similar phrases. In the context of CERCLA section 102(a), EPA has never authoritatively issued an interpretation of ‘‘substantial danger’’ prior to this designation. In 2021, EPA issued an Advanced Notice of Proposed Rulemaking (ANPRM) seeking comment and data to assist in the consideration of the development of future regulations pertaining to PFOA and PFOS. See Addressing PFOA and PFOS in the Environment: Potential Future Regulation Pursuant to the Comprehensive Environmental Response, Compensation, and Liability Act and the Resource Conservation and Recovery Act (Jan. 14, 2021). The ANPRM represented a preliminary effort by the Agency to obtain public input on certain issues to inform its thinking on any future proposed rulemaking regarding PFAS. EPA never received feedback on the ANPRM’s discussion of ‘‘substantial danger’’ as the document was withdrawn shortly after it was issued and never published in the Federal Register. Since that time, the Agency has proposed an interpretation of section 102(a) and solicited and obtained comments through this PO 00000 Frm 00045 Fmt 4701 Sfmt 4700 39167 rulemaking process that have informed the development of EPA’s final interpretation of ‘‘substantial danger.’’ 62 As EPA explained in section IV.A., the Agency’s interpretation of CERCLA section 102(a) is consistent with the proposed rule and in harmony with its application of similar language in sitespecific provisions. Section 102(a) does not require certainty that the substance poses a substantial danger or require proof of actual harm when released into the environment. EPA also disagrees with the commenters assertions that the Agency failed to substantiate EPA’s conclusion that PFOA and PFOS may present a substantial danger to public health and the environment. The proposed rule established, and this final action confirms that the available scientific and technical information demonstrate that both PFOA and PFOS may present substantial danger to public health and the environment. That conclusion is supported by the scientific and technical evidence of adverse effects to human health and the environment from PFOA and PFOS exposure, their persistence and mobility in the environment, and the significant potential for human exposure due to their prevalence in the environment. 3. Authority To Create Exclusions From the Designation Comment: Several commenters suggest that section 102(a) grants EPA authority to create exclusions from designation for certain uses of or materials containing PFOA and PFOS. According to one commenter the phrase ‘‘as may be appropriate’’ in section 102(a) grants EPA broad authority to include and exclude substances from a designation. Commenters also argue that CERCLA’s definition of ‘‘hazardous substance’’ in section 101(14) supports this interpretation. CERCLA section 101(14) incorporates substances or chemicals regulated under select provisions of the CWA, RCRA, CAA, and TSCA, and at least some of those statutory provisions include exclusions; 62 Both interpretations of 102(a)—the preliminary interpretation offered in the 2021 ANPRM and today’s final rule—allow for consideration of similar information to assess whether a release into the environment may present substantial danger. Hazard can encompass ‘‘the degree of danger posed;’’ fate and transport can encompass temporal considerations as in whether a substance remains in the environment ‘‘more than fleeting in terms of time;’’ and the consideration of additional information may include a consideration of the ‘‘geographic scope’’ of the substance in the environment. The standard that EPA is affirming today more accurately describes the type of scientific information needed to consider whether a substance, when released in the environment, may present substantial danger. E:\FR\FM\08MYR3.SGM 08MYR3 lotter on DSK11XQN23PROD with RULES3 39168 Federal Register / Vol. 89, No. 90 / Wednesday, May 8, 2024 / Rules and Regulations therefore, according to commenters, Congress would have expected EPA to have the authority to create exclusions pursuant to a CERCLA 102(a) designation. Some commenters suggested that EPA can create exclusions that mirror other exclusions or defenses in CERCLA. For example, some commenters suggested that application of biosolids should be excepted from designation consistent with CERCLA’s definition of release in section 101(22), which excludes ‘‘the normal application of fertilizer.’’ Another commenter suggested that EPA create an exclusion that reflects the liability defense in CERCLA section 107(d) for government ‘‘actions taken in response to an emergency created by the release . . . of a hazardous substance generated by or from a facility owned by another person.’’ Commenters requested that EPA create exclusions for: (1) paper mill residuals that are beneficially land applied as a fertilizer or soil conditioner; (2) land application of municipal biosolids; and (3) PFOA and PFOS contained in AFFF used in response to a fire or other emergency. Another commenter suggested that EPA should only designate PFOA and PFOS contained in specific mixtures or compounds generated by specific sources. Some commenters suggest that an exclusion for certain materials or uses of PFOA and PFOS is necessary to avoid unintended consequences from the designation or over-broad impacts. For example, commenters expressed concern that designating PFOA and PFOS would result in liability for entities, such as farms applying biosolids or airports using AFFF for firefighting activities in emergency situations, that should not bear responsibility for generating or creating the contamination. Finally, one commenter claimed that CERCLA should not be used to designate PFOA and PFOS because designation will have the end-result of negatively impacting ‘‘good actors.’’ Response: EPA declines to create exclusions for certain uses of PFOA and/or PFOS in this rulemaking. EPA believes there is a strong argument that section 102(a) does not authorize exclusions for certain uses of a substance where EPA has concluded that the substance (here, PFOA and PFOS) may present substantial danger to the public health or welfare or environment, based on its review and analysis of a significant body of scientific and technical information. In this circumstance, EPA believes that section 102(a) is best read to preclude VerDate Sep<11>2014 18:22 May 07, 2024 Jkt 262001 exclusions for certain uses of PFOA and PFOS—relative to other uses—without a factual or scientific basis showing that a particular use does not meet the standard articulated by Congress. See CERCLA section 102(a) (authorizing EPA to designate substances that, when released into the environment, ‘‘may present substantial danger to the public health or welfare of the environment’’). Even if EPA had authority to create exclusions for certain uses, it lacks the basis to do so here. Commenters did not provide information or data to support a conclusion that certain types of releases of PFOA and PFOS do not present a substantial danger, including an exclusion for AFFF as used for firefighting purposes and an exclusion for PFOA and PFOS contained in biosolids or soil amendments.63 Given EPA’s conclusion that PFOA and PFOS do present a substantial danger, and in the absence of evidence that certain releases of PFOA and PFOS do not present a substantial danger to public health or welfare or the environment, EPA lacks a scientific or factual basis for the exclusions requested. Commenters also did not provide a persuasive justification for EPA to otherwise carve out specific uses of PFOA and/or PFOS from this designation irrespective of scientific or factual evidence relative to potential public health and environmental impacts. Commenters appear to be proposing that EPA create an exclusion to liability via CERCLA section 102(a); the Agency, however, does not believe that section 102 is the appropriate mechanism to establish liability exclusions, and EPA questions whether it has the authority to do so, through this provision. For example, the D.C. Circuit has held that, in enacting CERCLA, Congress reserved resolution of liability issues to the judiciary, not the Agency.64 See Kelley v. EPA, 15 F.3d 63 EPA received requests for exclusions from liability from specific sectors—namely, water utilities, municipal landfills, local governments, landowners or utilities that land apply biosolids or paper mill sludge, and landowners adjacent to offsite sources—for the use of certain materials (i.e., biosolids), and for the disposal of particular types of waste, including landfill leachate, research waste, and medical waste. However, the commenters did not present data supporting their claims that certain releases, either from specific types of entities, uses, or kinds of waste, do not present a substantial danger to public health, welfare, or the environment. 64 Although a court is the final arbiter of whether a party is liable under CERCLA section 107, EPA intends to develop a policy that explains the Agency’s priorities for CERCLA enforcement in the context of PFOA and PFOS releases. Enforcement discretion policies are not exclusions from liability but instead describe circumstances in which the Agency may exercise its discretion to not pursue enforcement actions against certain parties that may PO 00000 Frm 00046 Fmt 4701 Sfmt 4700 1100, 1108 (D.C. Cir. 1994) (‘‘Congress . . . has designated the courts and not EPA as the adjudicator of the scope of CERCLA liability.’’). Congress explicitly identified CERCLA’s liable parties in section 107. In fact, Congress has enumerated many exclusions to CERCLA’s liability scheme over the years—and courts have regularly interpreted and applied those provisions. For example, CERCLA section 107(d) provides a mechanism to account for liability concerns arising out of an emergency response, which appears similar to one commenter’s request for an exclusion for the use of AFFF in response to an emergency. See, e.g., CERCLA section 107(d)(1)–(2) (providing a defense to costs and damages in the event of an incident creating danger to public health or in the event of an emergency).). EPA believes this Congressionallyestablished framework, discussed in further detail below, is more appropriate for the type of exclusions that commenters suggest. EPA also concludes that the commenter’s request for an exclusion for the application of biosolids containing PFOA or PFOS is not appropriate for resolution in this rulemaking under section 102(a). Section 102(a) provides for designation of a substance that, when ‘‘released into the environment,’’ may present substantial danger to the public health or welfare or environment. CERCLA section 102(a). As stated above, EPA considered a significant body of scientific and technical information in concluding that both PFOA and PFOS— irrespective of use—may present a substantial danger to public health or welfare or the environment. Against this backdrop, EPA considered commenters’ request for EPA to exclude from designation PFOA and PFOS when contained in biosolids consistent with the language in CERCLA section 101(22). EPA acknowledges that the CERCLA definition of ‘‘release’’ explicitly excludes the ‘‘normal application of fertilizer.’’ CERCLA section 101(22)(D). EPA believes this language is best read as requiring a sitespecific analysis and that a categorical exclusion for all contaminated biosolid application using section 102(a) risks exceeding the limits of the exclusion as envisioned by Congress. See, e.g., Sierra Club, Inc. v. Tyson Foods, Inc., 299 F. Supp. 2d 693, 714 (W.D. Ky. 2003) (defendant did not qualify for the normal application of fertilizer fall within a category of liable parties under CERCLA section 107. EPA’s enforcement discretion is guided by the unique circumstances of each case. E:\FR\FM\08MYR3.SGM 08MYR3 Federal Register / Vol. 89, No. 90 / Wednesday, May 8, 2024 / Rules and Regulations lotter on DSK11XQN23PROD with RULES3 exemption because it was not applying ammonia to farm fields as fertilizer when it vented the ammonia into the atmosphere); City of Waco v. Schouten, 385 F. Supp. 2d 595, 602 (W.D. Tex. 2005) (defendants’ agricultural practices (namely, the improper storage and maintenance of manure waste storage areas) did not fall within the ‘‘normal application of fertilizer’’ exclusion)). EPA also does not believe an exclusion under section 102(a) is necessary, because it would be duplicative of the exclusion in section 101(22)(D). And because liability under CERCLA section 107 is tied to a ‘‘release’’ or threat of a ‘‘release,’’ any entity facing potential liability for the application of biosolids contaminated with PFOA or PFOS will have the opportunity to make sitespecific arguments as to whether its actions fall within the ‘‘normal application of fertilizer’’ exclusion to the definition of ‘‘release.’’ 65 EPA also rejects the commenters’ assertion that creating an exclusion for this designation is necessary to address concerns regarding over-broad or unintended liability, such as for farmers or water utilities. Designation does not alter CERCLA’s liability framework, which EPA expects to continue to operate as it has for decades to equitably resolve who should pay, or automatically confer liability. First, potential plaintiffs must establish a legal basis for CERCLA liability; to recover costs from the parties responsible for contamination requires a plaintiff to show that a ‘‘release’’ or ‘‘threatened release’’ of a ‘‘hazardous substance’’ from a ‘‘facility’’ has caused it to incur cleanup costs. CERCLA section 107(a). The defendant must also fall within at least one of four classes of covered persons: (1) the owner or operator of the facility, (2) the owner or operator of the facility ‘‘at the time of disposal’’ of hazardous substances, (3) persons who ‘‘arranged for disposal’’ or treatment of hazardous substances, and (4) certain transporters of hazardous substances. Id. Although liability under CERCLA section 107(a) is strict, subject only to a few limited defenses specified in 65 Not all releases warrant response under CERCLA, and not all release lead to litigation and liability for all PRPs. Whether a party may be exposed to any liability in the first instance is ultimately a function of whether a response action is taken to address the release. As an initial matter, EPA has discretion to determine whether to respond to a release and only responds to those releases that pose unacceptable risk to human health and the environment. Even then, EPA may assess relative risk among releases to determine which releases should be prioritized for investigation and, potentially, clean up. Further, whether a PRP may be pursued for costs, found liable by a court, and required to pay some portion of costs remain uncertain for any given release. VerDate Sep<11>2014 18:22 May 07, 2024 Jkt 262001 section 107(b), it is not unlimited, and courts may decide to apportion costs among defendants where the harm is divisible and there is a reasonable basis for doing so. Burlington N., 556 U.S. at 613–15. Further, if a defendant is found jointly and severally liable for response costs under CERCLA section 107(a), the defendant may also seek contribution from other potentially responsible parties pursuant to CERCLA section 113(f). In addition, CERCLA provides defenses to and exemptions from Superfund liability for certain parties that are otherwise liable. For example, under CERCLA section 107(b), liability is limited in situations in which the release or threat of release of a hazardous substance was caused by an act of God, an act of war, or an act or omission of a third party (or some combination thereof). CERCLA section 107(b)(1)–(4). CERCLA also contains several statutory limitations on liability, which are more fully described in section VI.B. These include liability exemptions for contiguous property owners, innocent landowners under certain circumstances, de minimis or de micromis parties, and ‘‘federally permitted’’ releases, among others. And a party may not be subject to CERCLA at all if the release is considered a ‘‘normal application of fertilizer.’’ EPA also notes that—as detailed in section VI.B.—it has well-established enforcement policies that help the Agency prioritize sites that pose the most risk. Finally, the commenters’ concerns regarding liability do not account for the intervening steps between designation and site-specific cleanup or enforcement decisions. A designation alone does not require EPA or others to take response actions, does not require any response action by a private party, and does not determine liability. Response actions are contingent, discretionary, and sitespecific decisions that are made after a hazardous substance release or threatened release. Site-specific decisions are also the more appropriate opportunity to evaluate unacceptable risk posed by specific releases, rather than a blanket exclusion for certain uses or PFAS-containing materials that may not account for site-specific risk. The first steps in the CERCLA process are to identify a release, investigate the scope and extent of such a release, and evaluate its potential risk to human health and the environment. CERCLA is a largely discretionary statute that gives EPA leeway to determine whether, after that investigatory stage, it is appropriate to move forward with a cleanup. CERCLA speaks to this evaluation of PO 00000 Frm 00047 Fmt 4701 Sfmt 4700 39169 releases and risk. For example, Congress provided that EPA shall identify ‘‘criteria for determining priorities among releases or threatened releases throughout the United States for the purpose of taking remedial action and, to the extent practical taking into account the potential urgency of such action, for the purpose of taking removal action.’’ CERCLA section 105(a)(8)(A). CERCLA goes on to provide that ‘‘[c]riteria and priorities . . . shall be based upon relative risk or danger to public health or welfare or the environment . . . taking into account to the extent possible the population at risk, the hazard potential of the hazardous substances at such facilities, the potential for contamination of drinking water supplies, the potential for direct human contact,’’ among other considerations embodied in the NCP. The NCP provides guidance on when it may be appropriate to cleanup releases either through a removal or remedial action. For example, for removal actions, the NCP provides that the lead agency may take action when the agency has determined ‘‘that there is a threat to public health or welfare’’ based on a set of factors such as actual or potential exposure to drinking water supplies, the potential for hazardous substances to migrate, and the availability of other appropriate Federal or State response mechanisms to address the release. 40 CFR 300.415(b). Even if EPA determines that it is appropriate to move forward with a cleanup and a site is listed on the NPL, a listing does not require any immediate action. Rather, an NPL listing is the initial step towards a potential longterm remedy for a site. Listing also allows EPA to prioritize which sites warrant further investigation to better understand potential risks to human health and the environment. This process identifies less than 10% of CERCLA sites as NPL sites. Only after those very careful and deliberative steps to investigate and prioritize sites does EPA begin the process of identifying potential cleanup actions. Because of this significant narrowing of sites that will receive EPA attention, it follows that not every instance of contamination by a hazardous substance—including a PFOA and/or PFOS release—will lead to enforcement and liability. And, as previously noted, EPA has a long history of focusing its enforcement on significant polluters, potentially further narrowing the extent of liability. While there may be independent third-party cleanups, those too are not immediately triggered by designation and just like with EPA-focused cleanups, parties E:\FR\FM\08MYR3.SGM 08MYR3 lotter on DSK11XQN23PROD with RULES3 39170 Federal Register / Vol. 89, No. 90 / Wednesday, May 8, 2024 / Rules and Regulations would typically have the benefit of CERCLA’s liability protections, equitable divisions of responsibility by the courts, and so forth. EPA also notes that concerns about the cost of liability, the cost of cleanup, and the costs that certain facilities will bear managing PFOA and PFOS in waste to mitigate CERCLA liability risk are costs that Congress had front of mind in enacting CERCLA and chose to proceed anyway. The statutory language of CERCLA clearly provides interconnected response, enforcement and liability authorities that impose costs on PRPs enumerated in the statute. First, CERCLA section 104(a) authorizes EPA to respond to a release (or substantial threat of a release) of a hazardous substance into the environment, or of a pollutant or contaminant that may present an ‘‘imminent and substantial danger to the public health or welfare.’’ CERCLA section 104(a). In addition, CERCLA section 106 gives EPA the authority to compel action by liable parties in response to a release or threatened release of a hazardous substance that may pose an ‘‘imminent and substantial endangerment’’ to public health or welfare or the environment. CERCLA section 106(a). Finally, under CERCLA section 107, when the United States, states, or Tribes perform cleanup work and incur costs, section 107(a) authorizes them to recover those costs from potentially responsible parties. See CERCLA section 107(a). Legislative history also shows that one of Congress’ aims was to incentivize better waste management practices: ‘‘In correcting the historic neglect of hazardous substances disposal, it is essential that this incentive for greater care focus on the initial generators of hazardous wastes since they are in the best position to control the risks. Generators create the hazardous wastes, they have more knowledge about the risks inherent in their wastes and how to avoid them, and they determine whether and how to dispose of these wastes.’’ S. Rep. No. 96–848, at 14 (1980). Congress’ expectation was that better waste management practices could ultimately result in cost savings by reducing the need for expensive remedies to clean up hazardous waste in the environment: ‘‘Expenditures to prevent a threatened release, discharge, or disposal may be necessary if damages are to be avoided while also providing considerable savings when compared to the costs of removal after a release, discharge or disposal has occurred.’’ Id. Ultimately, Congress’ calculation was that the benefit to human health and the environment to prevent exposure to VerDate Sep<11>2014 18:22 May 07, 2024 Jkt 262001 hazardous chemicals is worth the costs borne by industry to improve waste management practices, prevent releases, and minimize the costs of retroactive efforts to clean up hazardous waste. EPA concludes that it would be inappropriate to carve out certain uses or materials containing PFOA or PFOS from the designation because any PFOA or PFOS release ‘‘may present substantial danger,’’ and subsequent steps in the CERCLA process are more appropriate for determining whether any specific release poses risk sufficient for further investigation and, potentially, cleanup. 4. Designating PFOA and PFOS as ‘‘Hazardous Substances’’ Under CERCLA Section 102(a) Does Not Present a ‘‘Major Question’’ Comment: Commenters contend that EPA’s use of section 102(a) of CERCLA to designate PFOA and PFOS as hazardous substances—as well as the Agency’s interpretation of the scope of the authority granted by this provision—run afoul of the ‘‘major questions doctrine’’ articulated by the Supreme Court in West Virginia v. EPA, 142 S.Ct. 2587 (2022). To support this assertion, the commenters argue that the designation will have a substantial ‘‘economic, social, and legal impact’’ and point to the fact that EPA is utilizing section 102(a) of CERCLA for the first time to contend that today’s action represents a novel and transformative expansion of the Agency’s regulatory authority. Response: EPA disagrees that this rulemaking raises a major question as defined in West Virginia v. EPA, 142 S. Ct. 2587 (2022). The designation of PFOA and PFOS pursuant to section 102(a) of CERCLA does not represent a radical change to CERCLA’s statutory scheme. Rather, the designation is well within the statutory framework that Congress provided. CERCLA by its express terms authorizes EPA to designate hazardous substances and the designation is consonant with the Agency’s longstanding practice of adding other chemicals to CERCLA’s hazardous substances list through CERCLA’s ‘‘automatic’’ designation process in section 101(14). That provision cross-references listing authorities in the CAA, CWA, RCRA, and TSCA. CERCLA’s automatic designation process has resulted in the addition of more than 800 hazardous substances to the statute’s list of hazardous substances through separate actions. And just like it did when making designations under those other statutes, here EPA examined scientific and technical factors, including hazard PO 00000 Frm 00048 Fmt 4701 Sfmt 4700 and fate and transport, when evaluating whether PFOA and PFOS met the statutory standard and may present substantial danger to the public health or welfare or the environment. See supra-Section IV. Further, as discussed in Section VI.B, PFOA and PFOS are not different in kind from the other substances added to CERCLA’s hazardous substance list. While EPA’s action today utilizes a different mechanism for designation than the procedure outlined in CERCLA section 101(14)—which defines the term ‘‘hazardous substance’’ by reference to provisions in other environmental statutes and to substances designated under CERCLA section 102—Congress specifically provided EPA with multiple pathways to address the varied threats posed by hazardous substances in various media. Although the commenters argue that EPA’s approach to PFOA and PFOS represents an unprecedented expansion of EPA’s authority, EPA has added similarly ubiquitous substances to CERCLA’s hazardous substance list for decades. For example, polychlorinated biphenyls (PCBs) became hazardous substances when EPA initially promulgated its list of hazardous substances on April 4, 1985, Notification Requirements; Reportable Quantity Adjustments, 50 FR 13456, 13475 (1985), and are generally considered ‘‘ubiquitous contaminants in the environment.’’ Rouzbeh Tehrani and Benoit Van Aken, Hydroxylated Polychlorinated Biphenyls in the Environment: Sources, Fate, and Toxicities, 21 Environmental Science and Pollution Research, 6334–6345 (2014); see also U.S. Dept. of Health and Human Services, Toxicological Profile for Polychlorinated Biphenyls (PCBs), at 291 (November 2000) (‘‘PCBs are ubiquitous and continuously circulating in the global environment. . . .’’); U.S. Environmental Protection Agency, Remediation of PCBs at Superfund Sites, at 7 (2001) (noting that as of publication ‘‘[o]f the 1,229 Superfund sites currently on the NPL, PCBs have been detected at 357 sites.’’). PCBs, however, are far from the only highly prevalent contaminant of concern that EPA has routinely grappled with at Superfund sites for decades. In fact, at the 1,548 Superfund sites with a selected remedy, arsenic has been identified at 919 facilities, lead at 897, benzene at 885, and trichloroethene at 816. See U.S. Environmental Protection Agency, Contaminant of Concern Data for Decision Documents by Media, fYs 1982–2021 (Final NPL, Deleted NPL, and Superfund Alternative Approach Sites) (2024), available at https:// E:\FR\FM\08MYR3.SGM 08MYR3 Federal Register / Vol. 89, No. 90 / Wednesday, May 8, 2024 / Rules and Regulations www.epa.gov/superfund/superfunddata-and-reports. Ultimately, EPA’s decision to designate PFOA and PFOS under section 102(a) is not an expansion of the Agency’s authority that would cause a ‘‘radical’’ or ‘‘fundamental’’ shift in CERCLA’s statutory scheme. For these reasons, EPA’s regulatory action to designate PFOA and PFOS as CERCLA hazardous substances does not present a major question. B. Operation of CERCLA lotter on DSK11XQN23PROD with RULES3 1. Comments Suggesting That Other Authorities Are Better Suited To Address PFAS Contamination Comment: Several commenters argued that CERCLA is not the appropriate tool to address PFOA and PFOS in the environment. Commenters also argued that EPA already possesses the authority to protect public health, welfare, and the environment from any potential risks posed by PFOA and PFOS without designating these substances as hazardous under section 102(a). Instead, these commenters contend that EPA should utilize existing tools under SDWA, RCRA, CWA, and other laws to address PFAS-contaminated sites. Multiple commenters also argued that EPA should not use CERCLA to designate PFOA and PFOS as hazardous substances because the Agency has not yet regulated PFOA and PFOS under other statutes (e.g., CWA, RCRA, SDWA), and accordingly—because CERCLA site cleanup standards and responsibilities are informed by other statutes’ regulatory frameworks— potentially responsible parties lack the necessary structure to conduct CERCLA cleanups of PFOA and PFOS. In arguing that CERCLA is not the appropriate tool to address the problem posed by PFOA and PFOS, one commenter also specifically claimed that the statute was designed to address only inactive hazardous waste sites and facilities impacted by groundwater plumes contaminated by specific hazardous substances, rather than ‘‘problematic class[es] of chemicals with widespread contamination across the country.’’ Another commenter stated that it appears ARARs do not yet exist and urges EPA to delay this rulemaking until such standards are developed. Response: EPA disagrees with the commenters’ position that CERCLA is not the appropriate tool to address the challenges posed by PFOA and PFOS contamination. Congress enacted CERCLA to provide EPA with the ability to timely clean up contaminated sites that pose risk to human health and the environment. CERCLA is the right tool for addressing wide-spread, existing VerDate Sep<11>2014 18:22 May 07, 2024 Jkt 262001 PFOA and PFOS contamination, which is a nationwide concern. CERCLA includes authorities to investigate and scope releases to better understand the extent of contamination. CERCLA includes response authority to implement short-term and long-term actions to address contamination and risks to public health and the environment. CERCLA removal authority is available to address emergency situations, such as when immediate action is necessary to mitigate consumption of contaminated drinking water. It also includes authority to take remedial actions that are designed to provide a more permanent remedy to mitigate or reduce unacceptable risk from highly contaminated sites. CERCLA also provides mechanisms to ensure that those responsible for the contamination pay to clean it up rather than using Fund resources. By designating PFOA and PFOS as CERCLA hazardous substances, EPA can utilize the full suite of CERCLA tools to address contamination. CERCLA is the best tool to address the legacy of sites contaminated with these substances and to address additional releases of these chemicals in the future. As EPA noted in its Strategic Roadmap, ‘‘[t]he risks posed by PFAS demand that the Agency attack the problem on multiple fronts at the same time. EPA must leverage the full range of statutory authorities to confront the human health and ecological risks of PFAS.’’ The Roadmap looked at a variety of authorities to address PFAS, including TSCA, SDWA, CWA, RCRA, and CAA, and identified CERCLA as a tool to accomplish one of its three central directives: Research, Restrict, Remediate. CERCLA is applicable to address all environmental media: air, surface water, groundwater, and soils. And CERCLA can apply to any type of industrial, commercial, or noncommercial facility, regardless of whether there are specific regulations that affect that type of facility or how that facility might affect the environment. The Agency also disputes the commenters’ assertion that designation under CERCLA is premature in the absence of pre-existing regulatory standards for PFOA and PFOS. The plain language of CERCLA section 102(a) includes no such explicit limitation. The statute requires only that EPA determine that a substance ‘‘may present substantial danger to public health or welfare or the environment’’ to designate. Considering the significant, and growing, body of evidence that PFOA and PFOS, when released in the PO 00000 Frm 00049 Fmt 4701 Sfmt 4700 39171 environment, may present substantial danger, designation is warranted. Such a limitation also runs counter to the ‘‘automatic’’ designation that occurs through CERCLA section 101(14) when a substance is identified as toxic or hazardous under another statutory authority. When a substance is designated pursuant to the specified CWA, CAA, RCRA, and TSCA authorities, there aren’t necessarily preexisting regulatory standards for that substance. For example, a substance could be listed under RCRA as a regulated hazardous waste, but not be subject to regulatory standards under the Clean Water Act or the Safe Drinking Water Act. The absence of such a regulatory framework is not a bar to listing under RCRA and nor should such a limitation be read into CERCLA section 102(a). EPA also disagrees that, at present, there is no regulatory framework in place that allows EPA to respond effectively to PFOA and PFOS releases. While it is true that PFOA and PFOS regulations, environmental standards, and remediation technologies are evolving, CERCLA and the NCP provide a process to identify cleanup standards on a site-by-site basis that ensure that a remedy is protective of human health and the environment. CERCLA section 121(a) provides that a remedial action must be ‘‘protective of human health and the environment.’’ All remedies selected must satisfy that requirement. Cleanup standards often help define remedy protectiveness. CERCLA cleanup standards are generally those standards that are determined to be ‘‘applicable or relevant and appropriate requirements’’ (ARARs).66 ARARs are Federal, or more stringent State, standards, requirements, criteria, or limitations. CERCLA section 121(d)(2)(A). ARARs apply to hazardous substances or pollutants and contaminants that remain on-site at the completion of a remedy. A final remedy must attain ARARs by the completion of the remedy, unless compliance with the ARAR is waived. CERCLA section 121(d)(2)(A), (d)(4). ARARs frequently are determinant in establishing preliminary remediation goals, which become site cleanup levels. The current regulatory landscape for PFOA and PFOS is sufficient to inform future remedies, and regulatory actions to address PFOA and PFOS are 66 The NCP provides that Fund-financed removal actions (or removals under CERCLA section 106) must comply with ARARs to the extent practicable considering the exigencies of the situation. 40 CFR 300.415. For the sake of discussion, EPA’s response focuses on compliance with ARARs in the remedial context. E:\FR\FM\08MYR3.SGM 08MYR3 lotter on DSK11XQN23PROD with RULES3 39172 Federal Register / Vol. 89, No. 90 / Wednesday, May 8, 2024 / Rules and Regulations increasing. Currently, there are certain Federal standards that may be considered as ARARs. For example, a potential ARAR for drinking water cleanups may be the final PFOA and PFOS MCLs. For PFOA and PFOS, the MCLs are 4.0 parts per trillion (PPT) each. A number of States have also promulgated cleanup numbers for PFOA and PFOS, which may be evaluated as potential ARARs at sites. For example, Pennsylvania 67 promulgated an MCL of 14 ppt for PFOA and 18 ppt for PFOS. In addition, New Jersey 68 has adopted an MCL of 14 ppt for PFOA and 13 ppt for PFOS (NJ DEQ, 2023). There are also non-chemical specific ARARs that may be relevant to a potential remedy. Those include ‘‘location-specific’’ and ‘‘actionspecific’’ ARARs. Location-specific ARARs are restrictions placed on the concentration of hazardous substances or the conduct of activities solely because they are in specific locations. Some examples of specific locations include floodplains, wetlands, historic places, and sensitive ecosystem habitats. An example of a location-specific requirement is the substantive CWA section 404 prohibitions regarding unrestricted discharge of dredged or fill material into wetlands. Action-specific ARARs are usually technology- or activity-based requirements or limitations on actions taken with respect to hazardous wastes. These requirements are triggered by particular remedial activities that are selected to accomplish a remedy. Examples of action-specific ARARs include activities such as ground-water diversion, dredging, and landfill closure with waste in place. EPA has also developed an Interim Guidance on the Destruction and Disposal of Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS) and Materials Containing PFASSubstances—Version 2 (2024), which outlines the current science on techniques and treatments that may be used to destroy or dispose of PFAS and PFAS-containing materials from nonconsumer products, along with screening methods to assess vulnerable populations near destruction and disposal sites. In sum, the evolving regulatory landscape with respect to PFOA and PFOS cleanup standards is not a barrier to designation nor is it a barrier to evaluating, identifying, and selecting protective remedies. The Agency is also striving to ensure 67 https://www.pacodeandbulletin.gov/Display/ pabull?file=/secure/pabulletin/data/vol53/53-2/ 46.html. 68 https://dep.nj.gov/pfas/standards/. VerDate Sep<11>2014 18:22 May 07, 2024 Jkt 262001 regulatory actions do not overlap with one another and duplicate efforts. EPA also disagrees with the commenter’s claim that CERCLA is designed solely to address inactive hazardous waste sites and facilities subject to groundwater contamination from specific contaminants of concern. The commenter’s view of CERCLA runs counter to the plain language of the statute. CERCLA’s language does not include any limitation on response authority to only ‘‘inactive’’ waste sites. Rather, CERCLA makes clear that authority extends to inactive and active ‘‘facilities.’’ CERCLA defines a facility as ‘‘any building, structure, equipment, pipe or pipeline (including any pipe into a sewer or publicly owned treatment works) . . . .’’ CERCLA section 101(9)(A). Moreover, CERCLA provides authority to respond to past, current, and future releases. Response authority extends to releases and the threat of release of ‘‘any hazardous substance’’ and ‘‘any pollutant or contaminant which may present an imminent and substantial danger to public health or welfare.’’ CERCLA section 104(a). CERCLA’s definition of the term ‘‘release’’ also makes clear that it encompasses past and current releases. See CERCLA section 101(22) (defining release to include ‘‘any spilling, leaking, pumping, pouring, emitting, emptying, discharging, injecting, escaping, leaching, dumping, or disposing into the environment (including the abandonment or discarding of barrels, containers, and other closed receptacles . . .)’’). This language is broad enough to encompass inactive and active sites. Although one impetus for CERCLA was a growing concern about the public health threats posed by improperly disposed toxic waste, Congress’s interest in addressing issues associated with environmental contamination was more holistic. Addressing the challenge of widespread community exposure to hazardous chemicals such as PFOA and PFOS—when released into the environment—is the exact kind of environmental threat that Congress sought to ameliorate in enacting CERCLA. Moved to action by the Love Canal incident, Congress crafted CERCLA to address contaminated sites across the nation, which it considered one of ‘‘the most serious health and environmental challenge[s] of the decade.’’ S. Rep. No. 96–848, at 2 (1980). Congress acknowledged at that time that ‘‘more than 43,000 chemical substances are in commercial production and thousands of new ones are introduced each year . . . As a PO 00000 Frm 00050 Fmt 4701 Sfmt 4700 result, the potential impact of toxic chemicals on the general public and environment through unsound hazardous disposal sites and other releases of chemicals is tremendous.’’ Id. Indeed, expert testimony solicited by Congress stated that the breadth and scope of the impact of exposure to hazardous chemicals nearly ‘‘extend[ed] to the entire population of the United States.’’ Id. Designating PFOA and PFOS is wholly consistent with Congress’ vision for CERCLA as an important Federal tool in removing widespread toxic chemicals from the environment that have the potential to pose substantial danger to human health, welfare, and the environment. 2. Addressing PFOA/PFOS as ‘‘Pollutants or Contaminants’’ Comment: Several commenters contend that EPA should use its existing authority to address PFOA and PFOS as pollutants or contaminants rather than designate these substances as hazardous under section 102(a) of CERCLA. One commenter also argued that PFOA and PFOS must be specifically designated as pollutants or contaminants before they are designated as hazardous substances. Finally, a commenter claimed that EPA has failed to demonstrate that PFOA and PFOS qualify as pollutants or contaminants under section 101(33) of CERCLA because the Agency has not indicated why these substances ‘‘cause or are reasonably expected to cause death, disease, physiological malfunctions, or any other conditions in the definition of ‘pollutant or contaminant’ in CERCLA [s]ection 101(33).’’ Response: EPA disagrees with the commenters’ position that the Agency should treat PFOA and PFOS contamination by relying solely on its authority to address these substances as CERCLA pollutants or contaminants. See CERCLA section 101(33) (defining ‘‘pollutants or contaminants’’). As EPA has explained, EPA’s authority to address ‘‘pollutants and contaminants’’ is limited. Designation of hazardous substances provides the Agency with a suite of tools necessary to identify, characterize, and clean up the most contaminated sites without delay, either through PRP- or Fund-lead actions. EPA also disagrees with the commenters that the Agency must designate PFOA and PFOS as a pollutant or contaminant under section 101(33) of CERCLA before utilizing its authority under section 102(a) to designate PFOA and PFOS as hazardous substances. Section 102(a) requires only a determination that the substance ‘‘may present . . . substantial danger to the E:\FR\FM\08MYR3.SGM 08MYR3 Federal Register / Vol. 89, No. 90 / Wednesday, May 8, 2024 / Rules and Regulations lotter on DSK11XQN23PROD with RULES3 public health or welfare or the environment’’ when released into the environment. Moreover, a substance’s status as a pollutant or contaminant is determined on a site-specific basis. And, in fact, EPA has already identified and treated PFOA and PFOS as pollutants and contaminants at multiple Superfund sites, including the SaintGobain Performance Plastics facility in Hoosick Falls, New York, and the Blades Groundwater site in Blades, Delaware. The Agency further disagrees that PFOA and PFOS do not qualify as pollutants or contaminants because EPA has not shown that these substances either ‘‘cause or are reasonably expected to cause’’ human health effects. In fact, the commenter misstates the qualifying criteria for a pollutant or contaminant. The statute requires only that pollutants or contaminants may ‘‘reasonably be anticipated’’ to impact human health. In keeping with this broad standard, multiple courts have consistently reaffirmed the principle that section 101(33) ‘‘. . . refers to, basically, any substance which may reasonably be anticipated to cause harm’’ to human health when released into the environment. Eagle-Picher Industries, Inc. v. EPA, 759 F.2d 922, 931 (D.C. Cir. 1985); see also APWU, et al. v. Potter, 343 F.3d 619 (2d Cir. 2003) (anthrax); Lozar v. Birds Eye, Inc., 678 F.Supp.2d 589 (W.D. Mich. 2009) (iron, manganese, arsenic, chloride, and sodium); Jastram, et al. v. Phillips Petroleum Co., et al., 844 F. Supp. 1139 (E.D. La. 1994) (produced water). PFOA and PFOS readily meet the definition of pollutants or contaminants, particularly given the weight of scientific evidence— as discussed in section V—indicating that exposure to PFOA and PFOS is associated with a host of negative health effects. Accordingly, EPA has determined PFOA and PFOS to be pollutants or contaminants on a sitespecific basis, further demonstrating that PFOA and PFOS satisfy the definition in section 101(33) of CERCLA. 3. Relationship Between SDWA and CERCLA Comment: Commenters stated that the 2022 interim Health Advisory Levels (HALs) of 0.004 ppt for PFOA and 0.02 ppt for PFOS are below the value that laboratory methods can accurately quantify, creating uncertainties with the proposed designation. Another commenter stated that EPA should provide additional clarity as to how the Agency’s SDWA process will impact the setting of cleanup goals. A few commenters stated that while ‘‘[the VerDate Sep<11>2014 18:22 May 07, 2024 Jkt 262001 health advisories] are not regulations and should not be construed as legally enforceable Federal standards,’’ they do shape public perception and almost certainly influence people’s (including organizations’) behavior. Similarly, there were comments concerning whether EPA was coordinating internally on how the SDWA rule to regulate PFOA and PFOS may impact the CERCLA program. Response: As stated in the proposed rule, EPA did not rely on the interim PFOA or PFOS HALs or draft toxicity values as support for the proposed designation decision. EPA’s 2022 interim PFOA and PFOS HALs are beyond the scope of today’s action. EPA HALs are non-enforceable advisory levels that provide information to drinking water systems and officials responsible for protecting public health when emergency spills or other contamination situations occur. Based on the record before the Agency, with today’s action EPA is designating PFOA and PFOS as hazardous substances. EPA’s actions establishing NPDWR for PFOA, PFOS, and other PFAS, pursuant to SDWA are beyond the scope of this action. Nonetheless, EPA has closely coordinated these actions to ensure consistency. For information about EPA’s PFAS NPDWR, please see https:// www.epa.gov/sdwa/andpolyfluoroalkyl-substances-pfas, or visit regulations.gov under docket id EPA– HQ–OW–2022–0114. The 2024 NPDWR pursuant to the Safe Drinking Water Act, EPA established a maximum contaminant level (MCL) of 4.0 ppt for both PFOA and PFOS and a maximum contaminant level goal (MCLG) of 0 ppt for both PFOA and PFOS. Consistent with CERCLA, EPA may evaluate MCLs and non-zero MCLGs as Applicable or Relevant and Appropriate Requirements (ARARs) cleanup levels on a sitespecific basis. 42 U.S.C. 9621(d). For any Superfund site, EPA evaluates the risk and determines the appropriate cleanup level for the site, including for PFOA and PFOS. The risk is evaluated according to guidance, mainly Risk Assessment Guidance for Superfund using final toxicity information, and exposure information, and according to guidance, mainly Risk Assessment Guidance for Superfund (https:// www.epa.gov/risk/risk-assessmentguidance-superfund-rags-part). PFOA and PFOS toxicity information used in CERCLA for any risk calculations are based on toxicity values that support EPA’s 2024 NPDWR. Once a basis for action has been determined, the risk at a site has been assessed, and the need for a response action is determined, then the MCLs for PFOA and PFOS will PO 00000 Frm 00051 Fmt 4701 Sfmt 4700 39173 potentially be considered as ARARs on a site-specific basis and documented in a decision document. While MCLs, MCLGs, and HAs are potentially appropriate to consider at CERCLA sites, other standards may be considered for other media evaluated at a site, such as soil, air, and biota such as fish. C. Toxicity, Human Health Effects/ Mobility, Persistence, Prevalence/ Release Into the Environment 1. Data Supporting Designation Comment: Several commenters argued that EPA has not presented sufficient information regarding the environmental and human health effects of PFOA and PFOS salts and structural isomers to support the designation of such substances as hazardous under CERCLA section 102(a). Multiple commenters contend that additional scientific study is needed prior to designation of PFOA and PFOS as CERCLA hazardous substances to enhance an understanding of the risks posed by these substances to human health and the environment. Response: EPA believes that the available data clearly supports the conclusion that PFOA and PFOS, as well as their salts and structural isomers, present a hazard to human health and the environment. For further discussion of this issue, see Section V of this document, which describes the scientific and technical information supporting the Agency’s conclusion that both PFOA and PFOS may present substantial danger to public health or welfare or the environment when released into the environment. EPA disagrees with the commenters’ position regarding the need for additional data prior to designation. As discussed in detail in Sections I and V, EPA has determined that a robust body of epidemiological and toxicological studies support the Agency’s conclusion that exposure to PFOA or PFOS are associated with serious and wideranging adverse health effects. Comment: Several commenters asserted that EPA could not utilize draft toxicity assessments developed as part of the PFAS NPDWR rulemaking process (draft MCLG documents) to substantiate the designation of PFOA and PFOS as CERCLA hazardous substances (See Response to Comment Document, Section 3B). Specifically, these commenters argued that the draft MCLG documents are flawed because the Science Advisory Board identified certain methodological issues with the initial approaches the Agency used to derive PFOA and PFOS MCLGs. Relatedly, one commenter also E:\FR\FM\08MYR3.SGM 08MYR3 lotter on DSK11XQN23PROD with RULES3 39174 Federal Register / Vol. 89, No. 90 / Wednesday, May 8, 2024 / Rules and Regulations challenged EPA’s purported reliance on interim Health Advisories (HAs) issued by the Agency in 2021, arguing that the underlying toxicity assessments supporting the interim HAs are flawed and have not been finalized by the Agency. Finally, several commenters critiqued the reliability of several studies cited by EPA as part of this rulemaking, including certain epidemiological studies conducted in the Faroe Islands that EPA used to develop non-cancer toxicity values (reference doses) in the draft MCLG documents. Response: As an initial matter, EPA disagrees with the commenters’ characterization of the Agency’s reliance on the draft MCLG documents and Interim HAs. EPA considered the peerreviewed scientific studies underlying the toxicity assessments supporting the draft MCLG documents and the interim HAs as part of the Agency’s comprehensive evaluation of available scientific information regarding the human health and environmental effects of exposure to PFOA and PFOS. To that point, as delineated in Section V, EPA considered hundreds of peer-reviewed publications in determining that exposure to PFOA or PFOS, when released into the environment, may present a substantial danger to the public health or welfare or the environment, including the 2016 EPA Health Effects Support Documents for PFOA and PFOS, the 2021 ATSDR Toxicological Profile for PFAS, and numerous peer-reviewed epidemiological and toxicological studies (ATSDR, 2021; U.S. EPA, 2016c, 2016d). Secondarily, while beyond the scope of today’s action, because these documents were finalized in 2024 as part of a separate, unrelated rulemaking after undergoing a robust peer-review and public comment process EPA rejects the commenter’s assertion that the draft MCLG documents are inherently flawed because of issues identified by the Science Advisory Board (SAB). The Agency’s final toxicity assessments reflect recommendations from both the Science Advisory Board (SAB) and the public comment process and address the SAB PFAS Review Panel’s recommendations to improve the transparency of EPA’s systematic review process. Additionally, EPA updated and expanded the protocols and methods based on SAB recommendations to improve the transparency of the process EPA used to derive the MCLGs for PFOA and PFOS and to improve consistency with the ORD Staff Handbook for Developing IRIS Assessments (U.S. EPA, 2022). EPA VerDate Sep<11>2014 18:22 May 07, 2024 Jkt 262001 followed this transparent systematic review process to evaluate the best available peer-reviewed science to conduct the PFOA and PFOS toxicity assessments (U.S. EPA, 2024b, 2024c, 2024d). For information on EPA’s PFAS NPDWR rule, visit EPA’s website at https://www.epa.gov/sdwa/andpolyfluoroalkyl-substances-pfas, or visit www.regulations.gov, under Docket No. EPA–HQ–OW–2022–0114. EPA also disagrees with the commenter’s claim that the Faroe Islands epidemiological studies fail to provide evidence of the impacts of PFOA and PFOS on vaccine response in children. The Faroe Islands epidemiological studies were peerreviewed by the various scientific journals in which they were published. Additional studies, including one from a Greenland epidemiological study, provide support for associations between decreased vaccine response in children and exposure to PFOA and PFOS (Timmermann et al., 2022; Zhang et al., 2023). Additionally, the Science Advisory Board—in their ‘‘Review of EPA’s Analyses to Support EPA’s National Primary Drinking Water Rulemaking for PFAS’’—agreed with the selection of the critical study, Grandjean et al. (2012), that identified an association between exposure to PFOA and PFOS and suppression of a vaccine response in children exposed during development, as appropriate for the derivation of chronic RfDs 69 for PFOA and PFOS. D. Effects of Designation 1. Reporting and Notification Requirements a. Reportable Quantity (RQ) for PFOA and PFOS Should be Set Either Higher or Lower Than 1 Pound Comment: Some commenters stated that EPA should lower the RQ to 0.1 pound while others expressed that the RQ should be higher than one pound. A few commenters stated that EPA should consider a RQ for cumulative releases, i.e., X pounds per year. One commenter argued that EPA’s proposed RQ would allow companies to release massive 69 Reference Dose (RfD)—An estimate (with uncertainty spanning perhaps an order of magnitude) of a daily oral exposure to the human population (including sensitive subgroups) that is likely to be without an appreciable risk of deleterious effects during a lifetime. It can be derived from a NOAEL, LOAEL, or benchmark dose, with uncertainty factors generally applied to reflect limitations of the data used. Generally used in EPA’s noncancer health assessments. Generally used in EPA’s noncancer health assessments. Durations include acute, short-term, subchronic, and chronic. (https://www.epa.gov/iris/basicinformation-about-integrated-risk-informationsystem). PO 00000 Frm 00052 Fmt 4701 Sfmt 4700 amounts of PFAS-containing waste before triggering any CERCLA requirements. Response: Pursuant to CERCLA section 102, in this final rule the Agency is assigning a default RQ of one pound to PFOA and PFOS and their salts and structural isomers. The Agency believes that the statutory default RQ is appropriate in this instance because it will facilitate reliable reporting of substantial releases of PFOA or PFOS and allow government officials to evaluate and undertake timely response actions, if appropriate to do so. To ensure that it focuses its resources on those releases that threaten public health or welfare or the environment, EPA, may, however, consider adjusting the default RQ in the future if it receives data regarding the scope of releases of PFOA or PFOS indicating that one pound is not a suitable unit on which to base a notification requirement. b. The Reportable Quantity (RQ) of One Pound Is Appropriate Comment: A few commenters expressed support for a RQ of one pound. Response: For the reasons provided in response to the prior comment (see 1.a.), the Agency agrees that it is appropriate to maintain a reportable quantity of one pound over a 24-hour period. c. The Reportable Quantities (RQs) Should Be Chemical-Specific, Not Applied to PFAS as a Class Comment: One commenter argued that EPA’s decision to establish a RQ of one pound is indicative of the fact that the Agency lacks sufficient risk information for PFOA and PFOS to set a chemical-specific RQ, thereby demonstrating that the rulemaking is premature. Another commenter stated that there is precedent for tailoring reportable quantities to the unique characteristics of a given class of hazardous substances; specifically, the commenter pointed to the RQ approach the Agency has adopted with respect to radionuclides as support for their proposed methodology. Response: This action is focused on designating PFOA and PFOS, and their salts and isomers as CERCLA hazardous substances. CERCLA 102(b) establishes a default of one pound and EPA has assigned 1 pound for each of these substances, including their salts and isomers. The Agency may revise the RQ in the future through notice and comment rulemaking after reviewing release information received pursuant to CERCLA 103. On May 25, 1983, the Agency proposed to adjust the statutory default E:\FR\FM\08MYR3.SGM 08MYR3 Federal Register / Vol. 89, No. 90 / Wednesday, May 8, 2024 / Rules and Regulations RQ of one pound for radionuclides. See Notification Requirements; Reportable Quantity Adjustments, 48 FR 23514, 23552 (May 25, 1983). EPA subsequently published a final rule and assigned a specific RQ for each radionuclide based on a methodology specific to those substances. See Reportable Quantity Adjustment Radionuclides, 54 FR 22405, 22524 (May 24, 1989). Similarly, with respect to PFOS and PFOA, the Agency may exercise its discretion at any time after designation to adjust the RQ if it determines that the circumstances warrant doing so. lotter on DSK11XQN23PROD with RULES3 d. Effluent That Violates NPDES Permit Limits Comment: One commenter stated that effluent that violates any present or future NPDES permit covering PFAS needs to be reported under CERCLA to help attain the primary goal of this rulemaking: determining where releases of PFOA and PFOS occur and in what amount. Response: Whether a particular release of PFOA or PFOS is exempt from CERCLA reporting requirements requires a case-by-case evaluation based on specific permit language or applicable control requirements. Generally, any release that violates a standard or limit specified in a facility’s NPDES permit must be reported pursuant to CERCLA section 103 and EPCRA section 304. If the permit limit is below the RQ for these substances, those releases are not required to be reported. d. The Reportable Quantity (RQ) Should Be Applied Over a Different Time Period Than 24 Hours Comment: One commenter argued that EPA should require reporting of releases on a monthly basis rather than over a 24-hour period. To support this proposition, the commenter argued that the conditions of water-borne discharges do not change on a day-to-day basis and reporting can therefore be handled through other statutory reporting structures, specifically, under the terms of NPDES permits issued under the CWA. The commenter also argued that this designation would result in inconsistent reporting requirements as between TSCA and CERCLA. Here, the commenter stated that, under EPA’s Chemical Data Reporting (CDR) rule, PFOA and PFOS are subject to a 2,500pound reporting threshold at a single site. The commenter then noted that, regardless of TSCA stipulations, if the reporting quantity threshold is one pound in 24 hours, a site could spill 0.99 pounds per day for 365 days a year, VerDate Sep<11>2014 18:22 May 07, 2024 Jkt 262001 or nearly 360 pounds, with no reporting required. If, however, EPA imposed a weekly or monthly RQ reporting timeframe, the commenter contended that this issue would be addressed. Finally, the commenter noted that, pursuant to Toxics Release Inventory reporting requirements, facilities in regulated industry sectors must report annually on releases and the waste management of certain listed toxic chemicals that they manufacture, process, or otherwise use above certain threshold quantities (100 pounds for PFOA and PFOS). Response: EPA declines the commenter’s request to amend the timeframe it uses to determine if a reportable release has occurred. The Agency believes that a 24-hour reporting period—which it has utilized successfully for 38 years and with which the regulated community is highly familiar—best serves the primary purpose of CERCLA’s notification requirements, namely, to alert government officials to releases that may require timely and proper response action to prevent or mitigate damage to public health or welfare or the environment. To the extent facilities are aware of ongoing releases of hazardous substances below the reportable quantity, the Agency believes that regulated entities will conduct due diligence by reporting any releases that may cause substantial danger to the public health, or welfare or the environment. Finally, while the commenter identifies what it regards as inconsistencies in reporting thresholds between various regulatory programs, EPA notes that statutory and regulatory programs maintain reporting thresholds that are intended for different purposes. For example, EPCRA section 313 (Toxic Release Inventory (TRI)) requires certain facilities that manufacture, process, or otherwise use listed toxic chemicals in amounts above reporting threshold levels to report their environmental releases and other waste management quantities of such chemicals annually. TRI data can, in conjunction with other information, be used as a starting point in evaluating such exposures and the risks posed by such exposures. The purpose of the Chemical Data Reporting Rule under TSCA is to provide EPA with information on the production and use of chemicals in commerce. However, release reporting requirements under CERCLA section 103 and EPCRA section 304 create a reporting process that inform government officials of releases that require immediate evaluation to determine the need for response action. PO 00000 Frm 00053 Fmt 4701 Sfmt 4700 39175 f. The Proposal Provides Little or No Guidance on How PFAS Quantities Are To Be Specifically Determined or Calculated for the Purposes of the RQ Comment: Several commenters argued that the designation would necessitate costly daily sampling for PFOA and PFOS; relatedly, these commenters also claimed that the designation fails to provide adequate guidance regarding the appropriate methodology for sampling of PFOA and PFOS. Response: This final designation under CERCLA does not require any testing and EPA does not intend to require any further testing beyond that which is already required by other statutes and their implementing regulations. Testing may be required on a site-specific basis, consistent with CERCLA section 104(b). g. Reportable Quantities of PFAS May Be Difficult or Impossible To Identify Due to Being Proprietary, Being Disclosed Incompletely in Safety Data Sheets, or Not Meeting the 1 Percent Labeling Threshold Comment: Several commenters were concerned with the identification of reportable PFAS because in some cases, PFAS chemicals in products are listed as proprietary, not by name or Chemical Abstracts Service (CAS) number. Furthermore, because not all Safety Data Sheets (SDSs) accurately disclose PFAS constituents, these commenters argue that the designation will result in constant uncertainties regarding quantities, reporting and recordkeeping, even though EPA has taken the position that SDSs and Technical Data Sheets should be considered primary sources of information in ascertaining the presence of PFAS-containing compounds. One commenter also noted that compositions of products containing PFOS or PFOA, or other PFAS, are currently not required to be communicated on Safety Data Sheets or otherwise labeled normally below one percent, questioning how EPA proposes to make determinations on volumes if percent composition is not disclosed by manufacturers. One commenter stated that the rule should clarify expectations and requirements for PFOA and/or PFOS producers regarding the communication and/or disclosure of these substances when used as ingredients. By way of example, the commenter suggested that EPA should consider whether PFOA and PFOS producer reporting requirements should be effectuated through OSHA regulations such as the Hazard Communication Standard. E:\FR\FM\08MYR3.SGM 08MYR3 lotter on DSK11XQN23PROD with RULES3 39176 Federal Register / Vol. 89, No. 90 / Wednesday, May 8, 2024 / Rules and Regulations One commenter noted that EPA’s current proposal would designate not just PFOA and PFOS as hazardous substances with RQ requirements, but also ‘‘their salts and structural isomers’’ which often do not even have their own names. The commenter asserted that if a constituent has not even been named yet and/or is not currently detectable with the available sampling methods, then the regulation of that constituent is not practicably enforceable and puts regulated entities in an untenable situation. Response: According to OSHA’s Hazard Communication Standard (HCS), a manufacturer, importer, or employer may claim ingredients in their product as proprietary if they meet the requirements of 29 CFR 1910.1200(i). However, if a chemical ingredient is below the thresholds (i.e., 1% or 0.1%, depending on the specific health endpoint), it is required to be listed on an SDS if the chemical can cause a health hazard below the cut-offs.70 Downstream users of mixtures or products that contain PFOA, PFOS, or their salts and isomers are encouraged to contact their distributors as well as manufacturers to obtain (SDSs), which should include concentrations of each ingredient or constituent in a mixture or product. The specific requirements for developing SDS and its contents are regulated under OSHA HCS. See 29 CFR 1910.1200. (Note: EPA’s CompTox Chemicals Dashboard (https://comptox. epa.gov/dashboard/) is a resource that can be used to identify salts and structural isomers of PFOA and PFOS. EPA periodically updates the CompTox Chemicals Dashboard to include new information on PFAS, including PFOA and PFOS.) EPA has amended Table 302.4 of 40 CFR part 302 to designate PFOA, PFOS and their salts and structural isomers and parties that use such chemicals are responsible for knowing the makeup of their products and ingredients and ensuring compliance with the CERCLA and EPCRA reporting requirements if a release occurs. The regulations at 40 CFR 302.6 (b) provides requirements for release reporting of mixtures with known and unknown constituents or their quantities. https://www.ecfr.gov/ current/title-40/chapter-I/subchapter-J/ part-302/section-302.6. 70 EPA coordinated with OSHA to develop this response. VerDate Sep<11>2014 18:22 May 07, 2024 Jkt 262001 h. EPA Should Clarify That Any NPDES Permit Violation for PFOA and PFOS Would Not Constitute a ‘‘Federally Permitted Release’’ and Must Be Reported Comment: One commenter argued that EPA should clarify that any releases of PFOA or PFOS in violation of the terms of a NPDES permit would not constitute a ‘‘federally permitted release’’ under CERCLA section 101(10)(C) and must therefore be reported in accordance with CERCLA section 103. This commenter also argued that EPA’s ability to require monitoring of PFOA and PFOS through NPDES permits is limited because the Agency’s April 2022 guidance— Addressing PFAS Discharges in National Pollutant Discharge Elimination System Permits and Through the Pretreatment Program and Monitoring Programs (Memorandum)— is directed only at federally issued NPDES permits. Response: CERCLA requires a person in charge of a vessel or a facility to report any release (other than a federally permitted release) of a hazardous substance over a certain quantity to the National Response Center as soon as they are aware of a release. See 42 U.S.C. 9603(a). CERCLA section 101(10) defines the term ‘‘federally permitted release,’’ which includes NPDES permits issued under the Clean Water Act. See CERCLA 101(10)(A), (B), & (C). Whether a particular release is a ‘‘federally permitted release’’ such that it would be exempt from CERCLA section 103 reporting requirements requires a case-by-case determination based on the specific permit language or applicable control requirement. These provisions are sufficient to inform whether a release is a federally permitted release for any hazardous substance, including releases of PFOA and PFOS. EPA also notes that on December 5, 2022, it updated the Memorandum to provide guidance to States for addressing PFAS discharges when they are authorized to administer the NPDES permitting program and/or pretreatment program. https:// www.epa.gov/system/files/documents/ 2022-12/NPDES_PFAS_ State%20Memo_December_2022.pdf. i. Default Reportable Quantity (RQ) of 1 Pound Comment: One commenter noted that EPA arbitrarily set the default reporting requirement at one pound, which is not supported by scientific analysis. Response: Although one commenter argues that EPA acted ‘‘arbitrarily’’ in setting the reportable quantity (RQ) for PO 00000 Frm 00054 Fmt 4701 Sfmt 4700 PFOA and PFOS at one pound, in fact, the Agency is setting the RQ by operation of law at the statutory default of one pound pursuant to CERCLA section 102(b). See 42 U.S.C. 9602(b) (‘‘Unless and until superseded by regulations establishing a reportable quantity under subsection (a) of this section for any hazardous substance as defined in section 9601(14) of this title, (1) a quantity of one pound, or (2) for those hazardous substances for which reportable quantities have been established pursuant to section 1321(b)(4) of title 33, such reportable quantity, shall be deemed that quantity, the release of which requires notification . . .’’). 2. Community Notification Requirement Under CERCLA Section 111(g) Comment: One commenter requested clarification regarding the impact of the rule on the community notification requirement of section 111(g) of CERCLA. Response: Upon finalization of this rulemaking, the owner or operator of a facility or vessel from which PFOA or PFOS have been released will be required to ‘‘provide reasonable notice to potential injured parties by publication in local newspapers serving the affected area.’’ CERCLA section 111(g). Note that the section 111(g) notification mechanism is independent of the reporting requirements of section 103(a). See Notification Requirements; Reportable Quantity Adjustments, 50 FR 13456, 13464 (Apr. 4, 1985) (‘‘One commenter asked whether RQ notification requirements revoke section 111(g). The newspaper notification requirement established by section 111(g) of CERCLA is not affected by any of the notification requirements in today’s rule.’’). E. National Priorities List (NPL) Sites— Existing and Future Contamination Comment: A number of commenters were concerned that the designation of PFOA and PFOS would result in the addition of a significant number of new sites to the NPL, thereby preventing EPA from focusing on significantly contaminated sites. One commenter noted that designation would require EPA to prioritize the cleanup of new Superfund sites, but also claimed that the Agency has not clarified how any prioritization process would occur. Another commenter noted their specific concern that the designation will result in the implication of a significant number of agricultural operations as Superfund sites. Several commenters also argued that designation could both extend the E:\FR\FM\08MYR3.SGM 08MYR3 lotter on DSK11XQN23PROD with RULES3 Federal Register / Vol. 89, No. 90 / Wednesday, May 8, 2024 / Rules and Regulations remediation timeline for existing Superfund sites and slow down the rate at which sites can be deemed ‘‘closed.’’ Ongoing and unmitigated releases could result in a contaminated site having to be cleaned up multiple times. Finally, multiple commenters stated that EPA has not properly accounted for and considered the additional economic burden associated with the addition of multiple new Superfund sites, reopening of sites, and corresponding cleanup obligations. Response: EPA does not expect the number of sites on the NPL to substantially increase after designation. EPA already has the authority to list PFOA and PFOS sites to the NPL, and the rule has no impact on that authority. Indeed, EPA has already listed sites on the NPL in part due to the presence of these substances at a site, and this practice would continue. For example, Saint-Gobain Performance Plastics, Blades Groundwater, and Galey and Lord mention PFOA, PFOS, or both PFOA and PFOS, in their listing proposal. Designation does not automatically make sites eligible for placement on the NPL because of the presence of PFOA and PFOS. Designation does not change the Hazard Ranking System (HRS), which is EPA’s primary tool for evaluating releases to determine NPL eligibility. (40 CFR part 300, Appendix A). The HRS broadly defines ‘‘hazardous substance’’ as including CERCLA hazardous substances, pollutants, and contaminants as defined in CERCLA section 101(14) and 101(33). Available scientific data demonstrate that PFOA and PFOS meet the definition of pollutant or contaminant, and therefore sites with PFOA and PFOS are evaluated in the NPL listing process, regardless of designation. The HRS process considers several factors for the purpose of scoring a site and determining its eligibility for listing on the NPL. The HRS is designed to assesses the relative potential of sites to pose a threat to human health or the environment. Scores are based on three categories, including the likelihood that a site has released or has the potential to release hazardous substances and/or pollutants or contaminants into the environment; characteristics of the waste (toxicity and waste quantity); and people or sensitive environments (targets) affected by the release. These scores are calculated for one or more pathways including ground water migration, surface water migration, soil exposure and subsurface intrusion, and air migration. If the combined scores meet or exceed the threshold listing VerDate Sep<11>2014 18:22 May 07, 2024 Jkt 262001 score of 28.5, the site is eligible for the NPL. Even when a site is eligible for the NPL, EPA may choose to not list the site and look to other options. Alternatives to NPL listing may include the Superfund Alternative Approach, State cleanup, cleanup by other Federal agencies, EPA removal action, deferral to another EPA program, or various other enforcement mechanisms. Thus, PFOA or PFOS releases may be addressed through non-NPL mechanisms even after designation. Between FY 2003 and FY 2022, only about four percent of all contaminated sites added to EPA’s Active Site Inventory were placed on the NPL. Since 2013, EPA has, on average, added 11 non-federal sites per year to the NPL,71 and EPA does not expect the rate at which annual additions to the NPL occur to increase as a result of this rule. Moreover, NPL listing does not trigger any immediate actions, liability, or requirements for the site.72 A hazardous substance designation under section 102(a) of CERCLA does not lead automatically to any response actions. Response actions, which include investigations of releases of hazardous substances and determining if removal or remedial action is necessary, are contingent, discretionary, and site-specific. 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; and cost considerations, 71 This estimate is based on data from EPA’s SEMS database with respect to non-federal NPL sites. EPA determined that it was appropriate to assess the designation’s impact with respect to nonfederal NPL sites only, because federal sites are generally expected to address PFOA and PFOS in the absence of designation consistent with CERCLA section 104. As discussed in Chapter 2 of the RIA, federal sites are addressing PFAS in the baseline as authorized by CERCLA section 104 and corresponding Executive Orders, as required by the NDAA, and consistent with federal facilities agreements under CERCLA section 102. Therefore, EPA expects that federal sites will address PFOA and PFOS contamination in the absence of the final rule. With federal sites taking action to address PFAS in the baseline, indirect impacts of the final rule will likely be related to actions taken at nonfederal sites. For additional context, since FY 2000 EPA has added 8 federal sites to the NPL. 72 EPA considered the portion of non-federal NPL sites that may be impacted by designation depending on site-specific circumstances. Of final, proposed, or deleted non-federal NPL sites that have been tested for PFOA and/or PFOS, an estimated 33.1% of NPL sites have detectable levels of PFOA and/or PFOS. See Section 3.3 of the RIA for more details about this estimate. In evaluating the designation’s impact on non-federal NPL sites, this estimate is instructive and serves as a benchmark for assessing designation’s potential impact to those sites. There are currently 5 sites where either PFOA or PFOS contributed to NPL listing. PO 00000 Frm 00055 Fmt 4701 Sfmt 4700 39177 among other important factors such as protectiveness, are part of CERCLA’s site-specific cleanup approach. EPA disagrees with the commenter that designation of PFOA and PFOS will slow the Agency’s ability to remediate Superfund sites. Designation itself does not affect the length of time it may take to fully implement a remedial action. However, in some cases, there may need to be additional work to address PFOA and PFOS contamination, depending on what other contaminants of concern (COCs) are located at a site and whether the responses to those other contaminants have the co-benefit of addressing PFOA and PFOS contamination. Typically, remedial actions address a number of COCs at once. In some cases, the remedy for other COCs will also address PFOA and PFOS contamination; in other cases, additional work will be needed. For instance, if PFOA and PFOS are not part of a remedy for the site, adding them to the remedy would then have the potential to increase efforts and cost of the remedy (e.g., by increasing the frequency of GAC replacement). In all cases, EPA should evaluate whether the remedy can mitigate any unacceptable risk from PFOA or PFOS contamination or whether additional actions may need to be taken. CERCLA section 121 provides that if an action is needed to assure protectiveness as a result of findings of a five-year review, those actions can be taken. In some cases, it may be necessary to revise or expand the previous risk assessment as part of a five-year review. For example, the risk assessment may need to be revised when there is a new exposure pathway, a new potential contaminant of concern, or an unanticipated toxic byproduct of the remedy. Five-year reviews (FYR) can also recommend further investigation to determine whether an additional response action is needed. See CERCLA section 121(c); 40 CFR 300.430(f)(4)(ii). Additionally, several commenters stated that without first ensuring PFOA and PFOS are no longer entering the environment, ongoing and unmitigated releases could potentially cause a site to be cleaned up multiple times. First, PFOA and PFOS contamination stems largely from historic releases. Even though there will likely be future releases, the use of PFOA and PFOS has diminished, and EPA does not expect releases at particular sites to result in additional widespread, significant contamination at or from that site, in part because the designation will allow EPA to act earlier. Second, EPA notes that (as discussed in Section III.C.), it has committed to a comprehensive and E:\FR\FM\08MYR3.SGM 08MYR3 39178 Federal Register / Vol. 89, No. 90 / Wednesday, May 8, 2024 / Rules and Regulations ambitious whole-of-Agency plan to address PFAS. Under this approach, EPA has identified a variety of authorities, including TSCA, SDWA, and RCRA, that it intends to use to prevent or minimize ongoing PFOA and PFOS releases into the environment. Additionally, EPA has considered the economic impacts of designation, including a consideration of potential impacts of designation on the NPL listing process. Please see chapter 5 of the RIA for this final rule. lotter on DSK11XQN23PROD with RULES3 F. Regulate PFAS as a Class Comment: A few commenters stated that EPA should regulate PFAS as a class rather than listing chemicals one by one. Response: PFOA and PFOS are prevalent because they have been produced and used since the 1940s, were among the most widely used of the PFAS constituents and persist in the environment for a substantial period of time. EPA considered the available scientific and technical information, and concluded each of these substances may present substantial danger to public health or welfare of the environment. EPA also evaluated the totality of the circumstances, including available scientific and technical information, and concluded that designation is warranted. The Agency also recently sought input and data regarding potential future hazardous substance designation of categories of PFAS and is still evaluating the feedback it received on this issue. See Addressing PFAS in the Environment, 88 FR 22399 (Apr. 13, 2023). G. Phase-Out & PFOA Stewardship Program Comment: Several commenters also argued that the production of PFOA and PFOS is being phased out, thus the value of this rulemaking is questionable. Response: EPA disagrees with the commenter’s assertion that the value of designating PFOA and PFOS is questionable since these chemicals have been phased out in many cases. First, although PFOA is not produced domestically by the companies participating in the 2010/2015 PFOA Stewardship Program, PFOA may still be produced domestically by nonparticipating companies. PFOS may still be produced or used domestically as well. Second, EPA has also published Significant New Use Rules (SNURs) to require notification to EPA before manufacture (including import) of certain PFAS, including PFOA and PFOS. This notification process would allow EPA the opportunity to evaluate the new use and, if necessary, take VerDate Sep<11>2014 18:22 May 07, 2024 Jkt 262001 action to prohibit or limit the activity. However, these SNURs exempted certain ongoing uses, including a few specifically limited, highly technical uses. In the absence of any notices received under these SNURs, EPA has limited sources of data regarding the ongoing use of PFOA and PFOS. Currently, the CDR generally requires manufacturers (including importers) to report for PFOA and PFOS if they meet a 2,500-pound production volume threshold at a single site. TRI reporting requires facilities to report releases of PFOA and PFOS if the facility manufacture, produce, or otherwise use at or above 100 pounds per year. Recent TRI reports indicate there maybe ongoing uses of these substances. While TRI reports show on-going uses, EPA is unable to definitively state the extent to which PFOA and PFOS are still in commerce in the United States.73 Regardless of the phase-out, designation is warranted based on the scientific and technical data available, suggesting that releases into the environment pose a hazard; are persistent and mobile (fate and transport); and prevalent in the environment. EPA has existing data that suggest that, despite the phase-out, PFOA and PFOS will continue to be detected in the environment. For example, EPA has detected PFOA and PFOS at approximately 400 NPL sites. These sites are mainly locations associated with AFFF use, textile coating operations, metal plating facilities, and landfills. As appropriate, these sites, and others like them, should be investigated, and site-specific risk assessments should be performed to assess whether further response actions, if any, are necessary to protect human health and the environment. Designation will allow EPA to address the legacy of sites that are contaminated with these substances and address future releases. H. Managing PFOA and PFOS Contaminated Waste Comment: Several commenters claimed that the designation of PFOA and PFOS will result in a significant increase in the generation of hazardous wastes; these commenters also argued that EPA has not provided sufficient disposal capacity or storage requirement guidance to address the ramifications of the designation. Multiple commenters also stated that the Agency may not be able to satisfy the requirements of 73 The Agency expects to receive additional information about ongoing use of PFAS as part of the TSCA section 8(a)(7) PFAS reporting rule that was finalized on October 11, 2023 (88 FR 70516). PO 00000 Frm 00056 Fmt 4701 Sfmt 4700 CERCLA section 104(c)(9), which requires States to assure the availability of hazardous waste treatment or disposal facilities that have adequate capacity to manage the hazardous waste reasonably expected to be generated within the State over 20 years, prior to EPA providing funding for any remedial actions. Relatedly, some commenters noted that EPA has not disclosed whether it has entered into any agreements with States to ensure that they possess the capacity to destroy, treat, or securely dispose of material contaminated with PFOA and PFOS. Further, several commenters argued that EPA has not considered whether Subtitle C landfill capacity is available to accommodate PFOA or PFOScontaminated hazardous waste. Some commenters also alleged that EPA has not described disposal methods for contaminated soils or other media from new Superfund sites that could be created in the wake of this rulemaking. Finally, several commenters argued that EPA must finalize its Interim Guidance on the Destruction and Disposal of Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS) and Materials Containing PFAS-Substances (‘‘Interim Guidance’’) and estimate available waste disposal capacity before finalizing this rulemaking. Response: Comments suggest a misunderstanding of waste disposal requirements under CERCLA. The Agency disagrees with the assumption that all waste containing PFOA and PFOS must be disposed of in Subtitle C facilities. EPA’s Interim Guidance on the Destruction and Disposal of Perfluoroalkyl and Polyfluoroalkyl Substances and Materials Containing Perfluoroalkyl and Polyfluoroalkyl Substances—Version 2 (2024), acknowledges that PFAS wastes could be sent to both hazardous waste and municipal solid waste landfills. For CERCLA cleanups, section 121(d)(3) of CERCLA, as implemented by 40 CFR 300.440 (‘‘Offsite Rule’’), applies to any CERCLA response action involving the off-site transfer of any hazardous substance or pollutant or contaminant (CERCLA wastes). The Offsite Rule requires that CERCLA wastes are transferred to a facility operating in compliance with applicable Federal and State requirements for the waste at issue. As such, for CERCLA cleanups, only hazardous wastes listed or identified under RCRA section 3001 (or an authorized State program) are required to be managed at RCRA Subtitle C facilities. EPA rejects the assertion that it has not evaluated if sufficient capacity exists for disposal and storage of PFOA E:\FR\FM\08MYR3.SGM 08MYR3 Federal Register / Vol. 89, No. 90 / Wednesday, May 8, 2024 / Rules and Regulations lotter on DSK11XQN23PROD with RULES3 and PFOS contaminated materials. EPA also acknowledges that CERCLA section 104(c)(9) does not allow the Agency to provide any remedial action funding to a State, unless the State first enters into a Superfund State Contract or Cooperative Agreement (CA) that assures the availability of adequate capacity to manage hazardous wastes generated in the State for 20 years following the date of the response agreement. EPA is designating PFOA and PFOS as CERCLA hazardous substances. No PFAS are currently listed, or being proposed to be listed, as hazardous wastes under RCRA,74 However, PFOA- and PFOS-containing waste is and will likely continue to consume a fraction of hazardous waste treatment and disposal capacity. Although waste containing PFOA and PFOS is not necessarily hazardous waste (unless the particular wastes are hazardous for some other reason), some waste generators, perhaps to be cautious, have been sending PFAScontaining wastes to hazardous waste facilities. To ensure hazardous waste landfill capacity is available in the future, EPA reviews and analyzes the Biennial Hazardous Waste Report and other data to develop and then publish an assessment of national capacity for hazardous waste management. The last such capacity assessment indicated that there is adequate capacity nationwide through 2044, and it would have incorporated PFOA and PFOS as wastes in the category of ‘‘Not RCRA FederallyDefined Hazardous Wastes.’’ Of these wastes, no assumption regarding a certain percentage of PFOA and PFOS was made. Anew assessment is currently underway to incorporate new information and extend the time horizon.75 EPA will continue to work with States to monitor waste treatment and disposal capacity and report on the status. The science on treating, destroying, and disposing of PFAS is evolving. The National Defense Authorization Act for Fiscal Year 2020 (FY 2020 NDAA) directed the Agency to publish interim guidance on the destruction and 74 EPA has proposed to amend its RCRA regulations to add multiple PFAS compounds, including PFOA and PFOS, as hazardous constituents. These PFAS would be added to the list of substances identified for consideration in RCRA facility assessments and, where necessary, further investigation and cleanup through the corrective action process at hazardous waste treatment, storage and disposal facilities. Although this is one step toward listing a hazardous waste, it is not a regulatory hazardous waste listing. 75 Background information and links to related documents are available at https://www.epa.gov/ hwpermitting/assessment-national-capacityhazardous-waste-management. VerDate Sep<11>2014 18:22 May 07, 2024 Jkt 262001 39179 disposal of PFAS and materials containing PFAS. Subsequently, on December 18, 2020, EPA developed and issued the Interim Guidance (U.S. EPA, 2020), which outlines the current state of science on techniques and treatments that may be used to destroy or dispose of PFAS and PFAS-containing materials from non-consumer products. Consistent with the FY 2020 NDAA, EPA is also required to publish revisions to the interim guidance as appropriate, but not less frequently than once every three years. EPA recently posted the Interim Guidance on the Destruction and Disposal of Perfluoroalkyl and Polyfluoroalkyl Substances and Materials Containing Perfluoroalkyl and Polyfluoroalkyl Substances—Version 2 (2024). future actions will be taken since CERCLA decisions are made on a sitespecific basis. EPA also asserts that the scope of costs counted by the Agency as direct costs—including an estimated low and high range of potential notification requirement frequencies and associated costs—is consistent with the requirements of E.O. 12866 and OMB Circular A–4. Consistent with the guidance of Office of Management and Budget’s (OMB’s) Circular A–4, this RIA includes an assessment of potential indirect costs, benefits, and transfers to provide the public with insights related to these impacts. Please see chapters 3, 4, and 5 of the RIA for more information about EPA’s methodologies and discussion of direct and indirect costs, benefits, and transfers. I. Comments on Economic Assessment/ Regulatory Impact Analysis Comment: Several commenters asserted that EPA must prepare and publicly issue a full economic analysis of the rulemaking. These commenters claimed that EPA’s economic assessment is insufficient for failing to provide any quantitative assessment of anticipated indirect costs, particularly those related to increased response actions. Several commenters called upon the Agency to issue a complete RIA while other commenters stated that EPA is required to prepare a regulatory cost benefit analysis consistent with Executive Order 12866. These commenters also asserted that EPA should conduct a full RIA pursuant to OMB Circular A–4 that considers the full compliance and cleanup costs, including the direct and indirect costs and benefits, associated with the designation. One commenter stated that the rulemaking cost estimates prepared by EPA do not appropriately reflect the total costs associated with the designation. Response: With new information received during the public comment period, EPA updated its analysis of direct costs. As part of this rulemaking, EPA has expanded its economic assessment and has conducted an RIA consistent with E.O. 12866 and OMB Circular A–4 in support of designation. As required by the E.O. and Circular A– 4, the RIA assesses reasonably foreseeable indirect costs, transfers, and benefits. Specifically, for costs, transfers and benefits, EPA has developed estimates under a range of scenarios based on historic information about response costs and benefits. These ranges reflect the uncertainty associated with estimating potential response costs, transfers, and benefits, as it is difficult to assess with certainty what 1. Liability and Costs to Public Utilities Comment: Numerous comments claim that EPA has failed to consider the potential impact of the designation on public water utilities/water systems and ratepayers with respect to potential litigation costs. These comments also argue that the designation does not account for the potential remediation costs associated with PFOA and PFOS cleanups (which the commenters assert could be passed on to local communities and public clean water utility ratepayers). These commenters also claim that local drinking water and wastewater agencies will incur substantial costs to remove PFOA and/ or PFOS from water sources and propose that all such direct and indirect costs should be evaluated in a full RIA. One commenter asserted that EPA’s approach to designation could potentially harm sectors and facilities that provide essential daily functions to communities, such as wastewater treatment facilities and municipal landfills (i.e., facilities that do not generate or use PFAS but that may, in the regular course of business, receive waste or wastewater containing PFAS). Response: The Agency recognizes that certain stakeholders are concerned about CERCLA liability resulting from the designation of PFOA and PFOS as hazardous substances. The most significant direct impact of this CERCLA designation is the requirement that any person in charge of a vessel or facility report a release of PFOA and/or PFOS of one pound or more within a 24-hour period. Neither a release nor a report of a release automatically triggers cleanup action under CERCLA. EPA makes CERCLA response decisions based on site-specific information, which includes evaluating the nature, extent, and risk to human health and/or the environment from the release. In PO 00000 Frm 00057 Fmt 4701 Sfmt 4700 E:\FR\FM\08MYR3.SGM 08MYR3 39180 Federal Register / Vol. 89, No. 90 / Wednesday, May 8, 2024 / Rules and Regulations lotter on DSK11XQN23PROD with RULES3 addition, designation does not automatically result in CERCLA liability for any specific release. Whether an entity may be subject to litigation or held liable under CERCLA are sitespecific and fact-dependent inquiries. Likewise, CERCLA affords the EPA broad discretion as to whether or how to respond to a release. For those reasons, EPA cannot assess with reasonable certainty what liability outcomes may indirectly result from this designation since those outcomes are often linked to EPA’s discretionary decisions with respect to CERCLA response actions as well as site-specific and fact-dependent court rulings. Nevertheless, EPA considered these issues in its totality of the circumstances analysis. For further information regarding the interplay between the designation and potential liability concerns please see sections VI.B.2 and VI.B.3. Efforts to address PFAS in public drinking water and wastewater treatment have already been initiated prior to this designation, and the associated costs of those efforts are attributable to those separate efforts. In the case of drinking water utilities, EPA’s 2024 NPDWR mandates that certain drinking water utilities (community water systems and nontransient, noncommunity water systems) should deliver drinking water with PFOA and PFOS concentrations below the MCLs. The costs of monitoring, treatment, administration, disposal of drinking water treatment media residuals, and other costs have been considered in the associated Economic Analysis as part of that rulemaking effort. Please see 2024 NPDWR. https://www.epa.gov/sdwa/ and-polyfluoroalkyl-substances-pfas, or visit www.regulations.gov, Docket No. EPA–HQ–OW–2022–0114. For potential cleanups of private drinking water wells, EPA acknowledges it has expanded its economic assessment to estimate a subset of potential health benefits where data was available to allow quantification. This subset includes those populations who rely on private drinking water wells within one mile of sites that may have response and cleanup as a result of the final rule. Refer to RIA Chapter V. 2. Consideration of Costs for Small Entities Comment: One commenter expressed concern that the designation may create significant costs for small entities associated with monitoring and analyzing samples for PFOA and PFOS to ensure compliance with CERCLA. The commenter recommended EPA VerDate Sep<11>2014 18:22 May 07, 2024 Jkt 262001 evaluate and consider the real costs associated with the designation through an evaluation of the number and types of facilities that may release reportable quantities of PFOA or PFOS, to determine what monitoring and analysis costs these facilities may incur to ensure compliance with CERCLA. Then, the commenter suggested that if EPA determines that costs should not be considered as part of the designation, costs should be considered as a factor of complying with CERCLA. Response: EPA disagrees with the commenter that designation of PFOA and PFOS as CERCLA hazardous substances will lead to significant cost impacts for small businesses. First, this rule does not require monitoring and analysis specifically. Second, in its RIA, EPA demonstrated that the rule would not result in a significant impact to a substantial number of small entities; in fact, consistent with long-standing EPA policy regarding the implementation of the Regulatory Flexibility Act, the RIA considered small entity impacts related to the direct cost impacts of the rule and found that they are limited to the costs associated with the reporting of PFOA/ PFOS releases at or above the RQ. 3. Direct Costs for Rule Familiarization Comment: One commenter stated that EPA failed to consider the cost of ‘‘regulatory familiarization’’ in its economic analysis of the rulemaking. The commenter described ‘‘regulatory familiarization costs’’ as accounting for the value of time and effort that every potentially affected individual or business must undertake to determine if a regulation applies to their situation or not, and how their activities must adapt to comply. Response: Rule familiarization constitutes a negligible cost of the rule. Facilities are expected to be familiar with the baseline requirements associated with reporting releases of non-PFOA/PFOS CERCLA hazardous substances to the NRC and to the State, Tribal and local emergency planning and response agencies. While the final rule is adding PFOA and PFOS to CERCLA’s list of hazardous substances, this designation does not change or add requirements to CERCLA section 103, CERCLA section 111, and EPCRA section 304 release notification requirements. 4. Costs, Benefits, and the Economic Assessment Comment: One commenter states that the rulemaking will result in a net social cost as markets over-adjust to concerns regarding CERCLA’s joint and several liability scheme. The commenter also PO 00000 Frm 00058 Fmt 4701 Sfmt 4700 contends that any transfer of costs from the public to polluters could occur even in the absence of the designation, thereby concluding that the rulemaking is unnecessary. Finally, the commenter states that any consistency between the designation and ongoing actions to address PFOA and PFOS contamination is irrelevant to a determination as to whether the designation meets a compelling public need. Response: EPA disagrees with the commenter that the designation will cause the market to over-adjust in response to CERCLA’s liability provisions. Market efficiency generally increases as more information becomes available. EPA is unaware of data suggesting that an over-adjustment is likely, and the commenter provided no such data. Further, once CERCLA’s notification requirements and broadened enforcement authorities are applicable to PFOA and PFOS releases, the likelihood that costs will be shifted from the Federal government to polluters will increase. Specifically, reporting will facilitate increased transparency regarding releases of PFOA and PFOS, which will, in turn, both inform the Agency’s understanding of the presence of these substances in the environment and allow EPA to respond to contamination in a timely manner. EPA disagrees with the commenter that the consistency between the designation and other ongoing actions to address PFOA and PFOS contamination is irrelevant to a determination that the rule meets a compelling public need. Designation is still warranted independent of other Agency actions and is consistent with EPA’s Agencywide approach outlined in the Roadmap. As noted by the commenter, OMB Circular A–4 states that an agency ‘‘should try to explain whether the action is intended . . . to meet some other compelling public need such as improving governmental processes or promoting intangible values such as distributional fairness or privacy.’’ Greater consistency between actions will ‘‘improve governmental processes’’ by allowing for greater efficiency and effectiveness in addressing PFOA and PFOS contamination across the United States. Additionally, when EPA is able to transfer certain response costs to PRPs, this represents an improvement in societal equity. Comment: One commenter argues that EPA has not explained how designation encourages better waste management practices or how PFOA or PFOScontaminated materials should be disposed of. This commenter also argues that EPA has failed to support its assertion that the designation will E:\FR\FM\08MYR3.SGM 08MYR3 lotter on DSK11XQN23PROD with RULES3 Federal Register / Vol. 89, No. 90 / Wednesday, May 8, 2024 / Rules and Regulations produce public health benefits. Here, the commenter points out that EPA identifies the regulatory requirement to report a release of one pound of PFOA or PFOS as a particular benefit of the proposed rulemaking but contends that the quantity of material that would need to be released for reporting requirements to attach would be significant. Finally, the commenter states that the designation may have the unintended consequence of increasing treatment costs in both drinking water and wastewater. Response: EPA agrees with the commenters that reports of releases at or above the RQ represent a meaningful benefit of the rule, as reporting will allow EPA to evaluate and respond to such releases in a timely manner. EPA disagrees with the commenter that the rule will not lead to improvements in the management of PFOA and PFOS contaminated materials. A potential direct benefit that may result from the reporting requirement is better waste management and/or treatment by facilities handling PFOA or PFOS, resulting from improved efforts to further reduce potential releases. Greater transparency provided by release reporting can lead to fewer releases to the environment and thus to potential health benefits associated with avoided exposure. For additional information regarding the potential benefits of the designation, including other benefits of release reporting, see Section VI of this preamble. In this final action, EPA has expanded its economic assessment of indirect benefits to include illustrative quantified and unquantified health benefits. EPA quantified a small subset of potential health benefits. This includes an illustrative assessment of reduced incidence of cardiovascular disease, birthweight impacts, and renal cell carcinoma under a range of scenarios. This considers potential benefits to those populations which rely on private drinking wells, where there may be response and cleanup as a result of the final rule. Additionally, EPA assessed additional unquantified health benefits. See RIA Chapter 5. EPA does not agree with the commenter that the proposed rule will hinder water treatment or efforts to remove background levels of PFOA or PFOS in wastewater and drinking water. When, how, and why the water sector would remove these substances from drinking water and whether they dispose of it in a hazardous waste landfill is complex and will depend on the volume and concentration of PFAS captured, availability of disposal sites, decisions made at individual public VerDate Sep<11>2014 18:22 May 07, 2024 Jkt 262001 water systems, and State and Federal regulatory actions and enforcement actions. EPA also disagrees with the claim that designation will increase the costs associated with managing drinking water treatment residuals. As discussed in section VII.I.1, efforts to address PFAS in drinking water and wastewater treatment have already been initiated prior to this designation, and the associated costs of those efforts are attributable to those separate efforts. The NPDWR Economic Assessment Appendix H includes a sensitivity analysis that accounts for potential cost increases associated with treatment of residuals as hazardous waste. The designation of PFOA/PFOS as CERCLA hazardous substances does not require disposal or treatment of water treatment residuals as hazardous waste. Comment: One commenter challenged whether the designation would have the benefits that EPA claims. The commenter asserts that existing tools at EPA’s disposal, as well as those in development, can provide the Agency with the authority it needs to address PFOA and PFOS releases and obviate the need for designation. The commenter also states that EPA’s failure to quantify the likely costs and purported benefits of this rule are especially egregious in light of the Agency’s alleged failed to consider alternative actions to achieve its goals. The commenter also encouraged EPA to conduct a full RIA. Finally, the commenter claimed that there are negligible positive effects associated with the designation, and challenged EPA’s assertion that substantial benefits will flow from the designation as flawed. Response: EPA disagrees with the commenter that the rule is unlikely to lead to the benefits the Agency has identified. EPA has identified a significant body of scientific evidence demonstrating 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. Therefore, to the extent that this designation results in reduced or eliminated exposure to PFOA/PFOS, as EPA expects it will, there may be potentially significant human health benefits associated with designation. EPA further explains its reasoning regarding these benefits in Section VI.A of this preamble and in the RIA. For example, the notification requirement under the designation will facilitate earlier notification of EPA and State authorities regarding releases of PFOS and PFOA. Relatedly, designation will enable EPA to exercise its statutory PO 00000 Frm 00059 Fmt 4701 Sfmt 4700 39181 authorities to address PFOA and PFOS contamination in a timely manner. With respect to the commenter’s claims that the Agency has failed to substantiate its quantification of potential costs, transfers, and benefits, the RIA accompanying the final rule has quantitatively assessed such impacts to the extent possible. Additional benefits and costs remain unquantified due to a lack of available data and highly uncertain circumstances, as further discussed in the rule and RIA. Additionally, EPA has included an analysis of potential alternative policy options associated with the reporting requirement; details of this analysis are found in the Appendix of the RIA. a. Indirect Costs Comment: One commenter points out that EPA’s economic assessment estimates only the costs associated with reporting activity. The commenter also stated that all costs related to potential increases in response activities and increases in the speed of response activities are only qualitatively described, and that EPA refers to these costs as indirect costs. However, when EPA discusses the benefits of the proposed rule, all the reported benefits related to health protection stem from these ‘‘indirect’’ effects. The commenter also said that costs associated with conducting response activities, including the significant costs associated with complex litigation that frequently occurs under CERCLA, is a direct impact of designating substances as CERCLA hazardous substances and must be considered in a regulatory impact analysis. EPA has a wealth of information to inform the frequency at which sites are placed on the NPL; data also exist to inform the costs of final cleanup decisions, as memorialized in public Superfund decision documents. The commenter asserts that while these analyses may not be perfect, they would be far superior to simply ignoring costs which are an inevitable and direct result of the proposed rule. A commenter asserts that EPA has not fully considered the potential cost impacts of the Proposed Designation and it is evidenced by the lack of information provided by EPA as to the magnitude and scope of those impacts. The commenter states that the limited economic analyses that EPA performed to support the proposal is flawed and its analysis about airports is particularly deficient. The commenter states that the airport analysis simply does not make sense, and seems to have been completed in a vacuum, with little or no outreach to airport operators or others with airport expertise. Another E:\FR\FM\08MYR3.SGM 08MYR3 lotter on DSK11XQN23PROD with RULES3 39182 Federal Register / Vol. 89, No. 90 / Wednesday, May 8, 2024 / Rules and Regulations commenter pointed out that the cost for the airport industry to transition to a new foam is not insignificant and many airports will struggle to transition absent any Federal grant funding. Response: EPA disagrees with the commenter’s assertion that potential response costs are direct; such actions are discretionary, contingent, and made on a site-by-site basis. EPA also disagrees that the Agency ignored the potential indirect costs of the proposed designation of PFOA and PFOS as CERCLA hazardous substances; the economic assessment developed for the proposed rule included a detailed qualitative assessment of these potential indirect costs. The RIA accompanying the Final Rule provides quantified estimates of potential indirect costs and cost transfers associated with response, as well as certain related indirect benefits. These estimates are in part based on the data suggested by the commenter, e.g., NPL listing process, RODs, etc. EPA does not agree with the commenter that a more detailed evaluation of direct costs is necessary. EPA provides, in the RIA, an estimated low and high range of potential reporting requirement frequencies and associated costs. Consistent with the guidance of Office of Management and Budget’s (OMB’s) Circular A–4, this RIA includes an assessment of potential indirect costs, benefits, and transfers to provide the public with insights related to these impacts. To better inform the public of potential indirect costs and benefits, EPA has expanded its analyses of indirect costs, cost transfers, and benefits in the final rule RIA relative to the analysis developed for the proposed rule. For many of the potential impacts that could result from the designation, EPA has developed estimates under a range of scenarios designed to reflect uncertainty in response activity. EPA also considered quantitative and qualitative benefits and costs as part of its totality of the circumstances analysis. Please see Section VI of this preamble. EPA appreciates the information provided by commenters on potential PFAS cleanup costs at airports regarding the costs to replace AFFF delivery systems. However, EPA disagrees that the designation would lead to a significant increase in costs of transitioning to use of PFAS-free foam for airports. Independent of EPA’s CERCLA hazardous substance rulemaking, Congress has taken certain actions to address PFAS contamination, including directing the transition away from PFAS-containing AFFF, protecting fire fighters, preventing runoff from airports, and requiring DOD to prepare VerDate Sep<11>2014 18:22 May 07, 2024 Jkt 262001 a remediation schedule and develop information about associated costs. The aviation industry is already in the process of transitioning away from AFFF to other types of firefighting foam that do not contain PFAS. The costs associated with this transition are unrelated to the proposed designation of PFOA and PFOS as CERCLA hazardous substances. Once this transition is complete and AFFF is no longer used at airports, EPA expects no or minimal releases from airports. In the interim, any direct costs incurred by airports as a result of a designation would be limited to the costs of reporting in the event that a PFOA/PFOS release of one pound or more occurs in a 24-hour period. Comment: Many commenters disagree with EPA’s proposition that the uncertainties are too great to conduct a robust analysis and stated that EPA should conduct a more detailed analysis of the potential direct and indirect effects of the proposed designation. Some commenters asserted that the costs of the designation would dramatically outweigh any benefits. A commenter stated that their analysis, PFOS and PFOA Private Cleanup Costs at Non-Federal Superfund Sites (referred to as the Cleanup Cost Analysis), estimates that the costs of cleanup for potentially responsible parties (PRP) could total over $17.4 billion dollars for existing non-Federal national priority sites alone, and annualized private party cleanup costs at existing non-federal sites could cost $700–$900 million annually. The commenter asserts that despite any existing uncertainties, these costs are simply too large for EPA to ignore. The commenters also pointed to DoD’s ongoing remediation work which can provides example cost data that EPA could use to build estimates. EPA has acknowledged cleanup cost uncertainties in the past and has still estimated these costs. A commenter suggested that EPA should follow OMB guidance and conduct a formal quantitative analysis of relevant uncertainties (e.g., the number of sites to be remediated, the cost of available cleanup technologies, the cleanup level goals for each possible media). Regardless of whether this proposal exceeds the billion-dollar threshold for formal probabilistic uncertainty analysis, Circular A–4 does not prevent an agency from conducting such an analysis if it would inform agency decision making. Response: EPA has conducted a more thorough and robust RIA that characterizes uncertainties to better describe potential direct and indirect PO 00000 Frm 00060 Fmt 4701 Sfmt 4700 costs, benefits and transfers associated with the designation. EPA provides, in the RIA, an estimated low and high range of potential reporting requirement frequencies and associated costs. Consistent with the guidance of Office of Management and Budget’s (OMB’s) Circular A–4, this RIA includes an assessment of potential indirect costs, benefits, and transfers to provide the public with insights related to these impacts. To better inform the public of potential impacts, EPA has expanded its analyses of indirect costs, benefits, and transfers in the final rule RIA relative to the analysis developed for the proposed rule. For costs, transfers, and benefits, EPA has developed estimates under a range of scenarios designed to reflect uncertainty in indirect costs, transfers, and benefits. EPA disagrees that the commenter’s cost analysis provides a reasonable representation of the costs associated with the proposed designation of PFOA and PFOS as hazardous substances. The analysis is based on several unfounded or inaccurate assumptions that lead to the overestimation of costs. For example, it assumes that the proposed designation would require all existing non-Federal NPL sites to search for PFOS/PFOA contamination. The designation, however, does not by itself require any systematic re-evaluation of NPL sites. Throughout the Superfund process, from the remedial investigation through site cleanup to five-year reviews, EPA evaluates potential risks posed by actual and threatened releases of hazardous substances, pollutants or contaminants. Since PFOA and PFOS are already considered as pollutants or contaminants, this rulemaking, by itself, should not result in any change to the investigation, cleanup and review processes for sites that are currently on the NPL. Any policy decisions to address PFOA/PFOS subsequent to the hazardous substance designation would likely apply to a subset of NPL sites where potential PFOA/PFOS contamination is not already being addressed rather than systematically to all existing non-federal NPL sites. Chapter 5 of the RIA also presents cost estimates for response at non-NPL sites. As noted in the Final Rule, EPA expects that response costs to address PFOS/ PFOA will fall within typical response cost ranges for actions to address other hazardous substances and recognizes that response costs will be significant in some cases. Additionally, EPA disagrees with the commenter’s suggestion for EPA to use cost data for Department of Defense E:\FR\FM\08MYR3.SGM 08MYR3 Federal Register / Vol. 89, No. 90 / Wednesday, May 8, 2024 / Rules and Regulations lotter on DSK11XQN23PROD with RULES3 (DoD) PFAS response efforts as the basis for estimating costs likely to result from the proposed designation. Data for DoD sites (i.e., military installations, facilities of the National Guard, and Formerly Used Defense Sites (FUDS) in the United States) would not be representative of costs associated with non-Federal CERCLA sites as the types, quantity, and handling of PFAS are expected to vary greatly. DoD’s cost estimates represent one reference point for potential PFAS response costs with a focus specifically on applications related to national defense. EPA also expects the size and scope of, and therefore costs associated with, Federal PFOA and PFOS cleanup sites to be substantially larger than non-federal sites in part because Federal sites are generally larger in size than non-federal sites. The costs associated with addressing PFAS released by Federal agencies are not representative of nonfederal facilities as the types, quantity, and handling of PFAS vary greatly. Among other factors, this may also reflect that AFFF use is disproportionately higher at military sites relative to other sites; AFFF is a major source of PFAS contamination. J. Enforcement Comment: Numerous commenters expressed support for the rulemaking, noting that designation facilitates CERCLA’s ‘‘polluter-pays’’ principle by placing the burden of investigating, responding to, and addressing PFOA/ PFOS contamination to the parties responsible for the release. These commenters also stated that designation could potentially accelerate the Superfund cleanup process. One commenter requested that EPA ensure that the costs of cleanup are borne by manufacturers and users of PFOA and PFOS, not the public. Response: The Agency agrees that designation clearly supports the timely cleanup of contaminated sites and facilitates CERCLA’s polluter-pays principle. EPA also notes that, as discussed in Section III.C of this preamble, it expects to focus on implementing the objectives of the PFAS Strategic Roadmap by holding responsible those who significantly contribute to the releases of these substances into the environment. Comment: Numerous commenters expressed concerns that the designation will shift the costs of CERCLA cleanups of PFOA and PFOS from chemical and product manufacturers to various third parties, including water utilities, waste management utilities, airports, fire departments, State governments, farmers, and landowners. Another VerDate Sep<11>2014 18:22 May 07, 2024 Jkt 262001 commenter claimed that utilities could be implicated as PRPs at both NPL and non-NPL sites—despite being potentially de minimis contributors to contamination—and, because of CERCLA’s joint and several liability scheme, such parties could theoretically be held responsible for the entire cost of cleanup. Many commenters argued that EPA’s use of enforcement discretion will neither adequately address the liability concerns of certain public sector entities nor ensure that cleanups and settlements assign primary responsibility to parties that significantly contributed to contamination or otherwise profited from the conditions resulting in contamination. Some commenters also requested that the Agency clarify how enforcement discretion would function in the context of PFOA- or PFOS-related contamination, particularly for water utilities. Finally, several commenters asked EPA to clarify that a CERCLA designation will not impact the land application of municipal biosolids in any way before finalizing this rulemaking. Response: While EPA acknowledges that the designation has the potential to impact municipalities, EPA does not have information suggesting that designation will result in unusual liability outcomes. EPA recognizes that some parties who do not bear primary responsibility for contamination may be sued and face uncertain litigation costs. EPA believes that CERCLA’s liability limitations, coupled with EPA enforcement discretion policies, should operate to minimize hardship for parties that did not significantly contribute to contamination. EPA expects that designation should not change CERCLA’s liability framework and that CERCLA will continue to operate as it has for decades (with respect to the more than 800 existing hazardous substances) to resolve who should pay for the cleanup and how much. EPA also disagrees with the commenters’ position that designation will necessarily result in a shift of cleanup costs from PFOA or PFOS manufacturers, to utilities and other sectors. As the Agency describes in sections II.E.7 and VI.B., CERCLA liability does not inevitably flow from any particular release. The question of whether an entity may be subject to litigation or could be held liable under CERCLA involves both site and factspecific analyses. Additionally, while one commenter raised the issue of incurring potential CERCLA liability despite de minimis contribution to PO 00000 Frm 00061 Fmt 4701 Sfmt 4700 39183 contamination at Superfund sites, EPA notes that—as described in Section VI.B.2—the statute already includes several provisions that may limit liability or the financial impact of liability, including for de minimis parties. EPA gave careful consideration to CERCLA’s liability scheme, and the impact designation may have on CERCLA liability. EPA concluded that designation will not change CERCLA’s liability framework. Designation does not automatically confer liability, nor does it alter CERCLA’s statutory or regulatory framework for liability. EPA determined that existing limitations in CERCLA coupled with existing CERCLA enforcement policies are sufficient to mitigate concerns about liability that may arise after designation. No additional action is necessary to ensure that those limitations and policies continue to operate as they have for decades. Nonetheless, EPA intends to develop a policy, consistent with those limitations and policies, that explains EPA’s priorities for CERCLA enforcement in the context of PFOA and PFOS releases. Please see Section VI.C. for a more detailed discussion. See also FY 2024–2027 National Enforcement and Compliance Initiatives. Regarding the question about application of biosolids, please refer to section VII.A.3. VIII. Summary of This Final Rule The designation of PFOA and PFOS as hazardous substances would have three direct effects: (1) Reporting and notification obligations when there is a release of PFOA or PFOS, their salts or structural isomers above the reportable quantity, (2) obligations on the U.S. Government when it transfers or sells certain properties, and (3) an obligation on DOT to list and regulate CERCLA designated hazardous substances as HMTA hazardous materials. A. Default Reportable Quantity EPA is setting the RQ by operation of law at the statutory default of one pound pursuant to section 102(b) of CERCLA for PFOA and PFOS and their salts and structural isomers. EPA did not propose, nor is it including in this final action, a RQ adjustment for these substances. If the Agency chooses to propose adjusting the RQ in the future, it would do so through notice-andcomment rulemaking. E:\FR\FM\08MYR3.SGM 08MYR3 39184 Federal Register / Vol. 89, No. 90 / Wednesday, May 8, 2024 / Rules and Regulations B. Direct Effects of Designating PFOA, PFOS, and Their Salts and Structural Isomers as Hazardous Substances lotter on DSK11XQN23PROD with RULES3 1. Release Reporting Requirements 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. As of the effective date of this action, 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, their salts or structural isomers in any 24-hour period is required to immediately notify the NRC in accordance with 40 CFR 302.6. CERCLA section 111(g) requires owners or operators of any vessel or facility to ‘‘provide reasonable notice to potential injured parties by publication in local newspapers serving the affected area’’ of a release of a hazardous substance. In addition to these CERCLA reporting requirements, EPCRA section 304 requires owners or operators of facilities to immediately notify their SERC (or TERC) and LEPC (or TEPC) when there is a release at or above the reportable quantity of PFOA or PFOS, their salts or structural isomers in a 24hour period. EPCRA section 304 also 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. VerDate Sep<11>2014 18:22 May 07, 2024 Jkt 262001 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. https:// www.govinfo.gov/content/pkg/USCODE2021-title42/pdf/USCODE-2021-title42chap103-subchapI-sec9620.pdf. 3. Requirement of DOT To List and Regulate CERCLA Hazardous Substances Section 306(a) of CERCLA requires substances designated as hazardous under CERCLA to be listed and regulated as hazardous materials by DOT under the Hazardous Materials Transportation Act. IX. 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. A. Executive Order 12866: Regulatory Planning and Review and Executive Order 14094: Modernizing Regulatory Review This action is a ‘‘significant regulatory action’’, as defined under section 3(f)(1) of Executive Order 12866, as amended by Executive Order 14094. Accordingly, EPA, submitted this action to the Office of Management and Budget (OMB) for Executive Order 12866 review. Documentation of any changes made in response to the Executive Order 12866 review is available in the docket. EPA prepared an analysis of the potential costs and benefits associated with this action. This analysis, ‘‘Regulatory Impact Analysis of the Final Rulemaking to Designate Perfluorooctanoic Acid and Perfluorooctanesulfonic Acid as CERCLA Hazardous Substances’’, is also available in the docket and briefly summarized in Section I, Executive Summary of this action. B. Paperwork Reduction Act The information collection activities in this final rule have been submitted PO 00000 Frm 00062 Fmt 4701 Sfmt 4700 for approval to the OMB under the Paperwork Reduction Act. The Information Collection Request (ICR) document that EPA prepared has been assigned EPA ICR number 2708.02, OMB Control No. 2050–0227. You can find a copy of the ICR in the docket for this rule, and it is briefly summarized here. The information collection requirements are not enforceable until OMB approves them. The designation of PFOA and PFOS, and their salts and structural isomers, as hazardous substances 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 and section 111 of CERCLA and section 304 of EPCRA. Estimated number of respondents: 0 to 614 releases per year. Frequency of response: Varies. Total estimated burden: 6,889 hours (per year) maximum. Burden is defined at 5 CFR 1320.3(b). Total estimated cost: Approximately $1,630,000 (per year) maximum, includes approximately $585,000 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 EPA’s regulations are listed in 40 CFR part 9. When OMB approves this ICR, the Agency will announce that approval in the Federal Register and publish a technical amendment to 40 CFR part 9 to display the OMB control number for the approved information collection activities contained in this 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, including importers and importers of articles that contain these E:\FR\FM\08MYR3.SGM 08MYR3 Federal Register / Vol. 89, No. 90 / Wednesday, May 8, 2024 / Rules and Regulations lotter on DSK11XQN23PROD with RULES3 substances, are: (1) PFOA and/or PFOS manufacturers; (2) PFOA and/or PFOS processors; (3) manufacturers of products containing PFOA and/or PFOS; (4) downstream users of PFOA and PFOS; (5) downstream users of PFOA and/or PFOS products; (6) waste management facilities; and (7) wastewater treatment facilities. (Note: PFOA and PFOS noted here include their salts and structural isomers). The Agency has estimated that there may be up to 614 reported releases of PFOA or PFOS in any one year and that a small percentage of the annual reports will be submitted by small entities. As further context, even if the maximum number of reports (614) were created to account for every estimated release in a given year and all 614 of these reported releases were from the smallest of the small entities (as described in the RIA, defined using SBA size standards), only 2.5 percent of the 24,836 smallest of the small businesses identified by EPA would be affected. The estimated cost of $2,658 to report a release of PFOA or PFOS is not greater than one percent of the annual revenues for the typical small entity in any impacted industry. For example, estimated annual breakeven costs per facility are lowest for Reupholstery and Furniture Repair (NAICS 811420) at $3,591 at the one percent threshold. Given the estimated notification costs per release of $2,658, EPA does not expect a small business facility’s cost to cross even the one percent threshold. Additionally, EPA considered how direct reporting costs may impact small governmental jurisdictions. The $2,658 reporting cost per release associated with the final rule represents 0.001 percent of average local government revenues serving a population of 50,000 or less, which is well below one percent. Further, for a local government serving just 100 residents, the $2,658 in costs for reporting represents 0.5 percent of these revenues, also well below a one percent threshold. Details of this analysis are presented in Section 6.2 of the Regulatory Impact Analysis of the Final Rulemaking to Designate Perfluorooctanoic Acid and Perfluorooctanesulfonic Acid as CERCLA Hazardous Substances, available in the docket. 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. The action imposes no enforceable duty on any State, local or Tribal governments VerDate Sep<11>2014 18:22 May 07, 2024 Jkt 262001 that may result in expenditures, in the aggregate, or to the private sector, of $100 million or more in any one 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. A. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments This action does not have Tribal implications as specified in Executive Order 13175. 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. Thus, Executive Order 13175 does not apply to this action. Designating PFOA and PFOS, and their salts and isomers as CERCLA hazardous substances triggers release reporting requirements under EPCRA section 304 in addition to the release notification requirement under CERCLA section 103. Under EPCRA section 304, facilities are required to immediately report any releases of these substances at or above the default RQ of one pound to the State, Tribal, and local implementing agencies. The associated reporting burden of this effort on Tribes is expected to be minimal and if release were to occur, and Tribal agencies would be able to take action, if necessary, to protect their community from exposure to these substances. If Tribal agencies do not have the resources to respond to an emergency situation, they may request assistance from the State or local emergency response agencies. Executive Order 13175 does not apply to this action. Consistent with EPA’s Policy on Consultation with Tribal Nations, EPA offered government-to-government consultation to all federally recognized Tribes during the development of this action. No Tribe requested consultation. EPA hosted a national Tribal informational webinar on September 7, 2022, to explain the action and answer questions (https://clu-in.org/conf/tio/ TribesPFOAPFOS_090722/.) G. Executive Order 13045: Protection of Children From Environmental Health Risks and Safety Risks Executive Order 13045 directs Federal agencies to include an evaluation of the PO 00000 Frm 00063 Fmt 4701 Sfmt 4700 39185 health and safety effects of the planned regulation on children in Federal health and safety standards and explain why the regulation is preferable to potentially effective and reasonably feasible alternatives. This action is subject to Executive Order 13045 because it is a significant regulatory action under section 3(f)(1) of Executive Order 12866, and EPA believes that the environmental health or safety risk addressed by this action may have a disproportionate effect on children. Evidence indicates that exposure to PFOA and/or PFOS are associated with adverse health effects relevant to children, including developmental effects to fetuses during pregnancy or to breast-fed infants, cardiovascular effects and immune effects in children. Other evidence suggests that these substances are associated with endocrine and reproductive effects that impact development. Both PFOA and PFOS are known to be transmitted to the fetus via the placenta and to the newborn, infant, and child via breast milk. Further information on all health effects of PFOA and PFOS is in section V. A. PFOA and PFOS Pose a Hazard. Accordingly, we have evaluated the environmental health or safety effects of PFAS exposures on children. The protection offered by using the suite of tools CERCLA provides to address prevalent PFAS contamination may be especially important for children because childhood represents a life stage associated with increased susceptibility to PFAS-related health effects, such as developmental effects. Furthermore, EPA’s Policy on Children’s Health also applies to this action. Information on how the Policy was applied is available under ‘‘Children’s Environmental Health’’ in section V. A. PFOA and PFOS Pose a Hazard of this preamble. 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 designates PFOA and PFOS as CERCLA hazardous substances and does not involve the supply, distribution or use of energy. I. National Technology Transfer and Advancement Act This action does not involve technical standards. E:\FR\FM\08MYR3.SGM 08MYR3 lotter on DSK11XQN23PROD with RULES3 39186 Federal Register / Vol. 89, No. 90 / Wednesday, May 8, 2024 / Rules and Regulations J. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations and Executive Order 14096: Revitalizing Our Nation’s Commitment to Environmental Justice for All Executive Order 14096 (88 FR 25,251, Apr. 26, 2023) directs Federal agencies to advance the goal of environmental justice (EJ) for all. This action builds upon and supplements the efforts of Executive Order 12898 (59 FR 7629, February 16, 1994) to address EJ concerns. EPA believes that the human health or environmental conditions that exist prior to this action result in or have the potential to result in disproportionate and adverse human health or environmental effects on communities with EJ concerns. The demographic analysis of plastics manufacturers, facilities reporting to the TRI, and U.S. airports found that people of color and low-income populations are disproportionately represented (except near small/medium airports). In particular, these sites have a higher percentage of people of color surrounding them relative to the national average. This finding holds whether focusing on assessing all populations within one or three miles of these sites or only populations served by private wells. EPA believes that this action is likely to reduce existing disproportionate and adverse human health or environmental effects on communities with EJ concerns. To the extent that the final rule leads to additional response actions to mitigate or eliminate exposure to PFOA/PFOS, or to actions that mitigate exposure earlier, health risks for populations communities living near sites where releases occur may decline. Based on the above analysis, the proportion of the population near these sites identified as racial or ethnic minorities with various potential communities with EJ concerns or (in some cases) people living in structures with a higher probability of containing lead paint (built before 1960) exceeds the national average. Thus, EPA expects that the final rule will at least partially mitigate the existing burden of PFOS/ PFOA exposure that falls disproportionately on communities with EJ concerns. Potential exposure across several key demographic categories were analyzed relative to facilities with known historical use, releases, and/or known contamination of PFOA and PFOS (U.S. EPA, 2024e). Due to uncertainty regarding the location of future PFOA/ VerDate Sep<11>2014 18:22 May 07, 2024 Jkt 262001 PFOS releases, this analysis uses these facilities as a proxy for identifying where response actions for PFOA and PFOS may occur and provides demographic information about the surrounding populations. This analysis examines the following site types as proxies for facilities that may potentially be affected: • Sites owned/operated by plastics material and resin manufacturing firms identified as having produced PFOS and/or PFOA 76 • Sites owned/operated by companies reporting PFOS and PFOA releases (including PFOA and PFOS salts) to EPA’s Toxic Release Inventory (TRI) (U.S. EPA, 2023e) 77 • Operating U.S. airports and airfields 78 D Large U.S. airports and airfields D All other U.S. airports and airfields (i.e., medium and small) Areas around plastics material and resin manufacturer sites and/or sites reporting releases to TRI, on average, are in areas with higher concentrations of people of color, Black/African American residents, and households with a ratio of income to poverty level of two and below compared with national average. These areas also have much higher rates of structures built before 1960 which 76 Data acquired from: Environmental Protection Agency, ‘‘Enforcement and Compliance History Online (ECHO)’’, August 2023. Because not all plastic material and resin manufacturers use PFAS, only a fraction of the facilities reported in ECHO as plastics material and resin manufacturers were used in this analysis. To filter facilities involved in the use or manufacture of PFAS, this analysis uses proxy sites identified using sites owned/operated by companies that participated in EPA’s PFOA Stewardship Program, under the assumption that the likelihood of PFOA/PFOS contamination is potentially high at these sites. 77 TRI reporting is not currently required for isomers of PFOA and PFOS. 78 Because the National Plan of Integrated Airport Systems (NPIAS) public facing dataset presented by the Federal Aviation Administration (FAA) does not contain geographic information, this analysis relies on data from the United Nations Office for the Coordination of Humanitarian Affairs. To assess the coverage of the UN database, this analysis crossreferenced the list of airports represented in both datasets; this exercise found that the UN data contained 98% of all airports listed in the NPIAS. Of the 2% of sites listed in the NPIAS but not in the UN database, about half were located in rural Alaska. Full citations of these datasets are presented below: (1) United Nations Office for the Coordination of Humanitarian Affairs, ‘‘The Humanitarian Data Exchange: Airports in the United States of America’’, June 2021. Downloaded on June 18, 2021. Accessed at: https://data.humdata.org/ dataset/ourairports-usa. The dataset categorized airports by the following size categories: small, medium, and large. (2) Federal Aviation Administration. ‘‘National Plan of Integrated Airport Systems (NPIAS)— Current—Airports’’, October 07, 2020. Downloaded February 2022. Accessed at: https://www.faa.gov/ airports/planning_capacity/npias/current/. PO 00000 Frm 00064 Fmt 4701 Sfmt 4700 can have lead paint and lead to higher exposures of lead. These findings suggest that releases related to manufacturing facilities could have EJ implications, such as disproportionate adverse impacts on local communities. Additionally, on average, airports across the U.S. are surrounded by populations that generally reflect national averages in relevant demographic categories. Large airports, however, are more likely to be surrounded by higher rates of people of color relative to the U.S. population. A complete discussion of the analysis behind these findings is available in Section 6.3 of the RIA 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 policy priorities outlined in Executive Orders 14096 (The White House, 2023) and 14008 (The White House, 2021), EPA expects this regulation will have a beneficial impact on disadvantaged communities as well as populations or communities with EJ concerns. While the locations that may be affected by this final rule are uncertain, to the extent that these proxy locations are representative of likely locations, this screening analysis suggests that the designation may improve conditions for 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 will determine the magnitude of effects on the surrounding human and natural environment. These details will likely become more apparent over time as EPA implements response actions and release reports are made, allowing for a more robust analysis of disproportionate and adverse outcomes experienced by populations communities with EJ concerns. This improved information would not increase risk for communities with EJ concerns and may improve the speed and design of response actions. Further, the information supporting this Executive Order review is contained in the following sections in the preamble to this action: II.C., VI.A. and B. These sections explain that the E:\FR\FM\08MYR3.SGM 08MYR3 Federal Register / Vol. 89, No. 90 / Wednesday, May 8, 2024 / Rules and Regulations designation of PFOA and PFOS as hazardous substances 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. K. Congressional Review Act (CRA) This action is subject to the CRA, and EPA will submit the rule report to each House of the Congress and to the Comptroller General of the United States. This action meets the criteria set forth in 5 U.S.C. 804(2). lotter on DSK11XQN23PROD with RULES3 References Ahrens, L., Yeung, L.W., Taniyasu, S., Lam, P.K., & Yamashita, N. (2011, Oct). Partitioning of perfluorooctanoate (PFOA), perfluorooctane sulfonate (PFOS) and perfluorooctane sulfonamide (PFOSA) between water and sediment. Chemosphere, 85(5), 731–737. https:// doi.org/10.1016/j.chemosphere. 2011.06.046 Ankley, G.T., Kuehl, D.W., Kahl, M.D., Jensen, K.M., Butterworth, B.C., & Nichols, J.W. (2004, Nov). Partial lifecycle toxicity and bioconcentration modeling of perfluorooctanesulfonate in the northern leopard frog (Rana pipiens). 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Science Advisory Board. Review of EPA’s analysis to support EPA’s national primary drinking water rulemaking for PFAS (EPA–SAB–22– 008). U.S. Environmental Protection Agency. U.S. EPA. (2023a). Fact sheet: 2010/2015 PFOA Stewardship Program. https:// www.epa.gov/assessing-and-managingchemicals-under-tsca/fact-sheet20102015-pfoa-stewardship-program U.S. EPA. (2023b). Hazard Ranking System (HRS). https://www.epa.gov/superfund/ hazard-ranking-system-hrs U.S. EPA. (2023c). PFOA Stewardship Program baseline year summary report. U.S. Environmental Protection Agency. https://www.epa.gov/assessing-andmanaging-chemicals-under-tsca/pfoastewardship-program-baseline-yearsummary-report U.S. EPA. (2023d). Risk management for perand polyfluoroalkyl substances (PFAS) under TSCA. https://www.epa.gov/ assessing-and-managing-chemicals- E:\FR\FM\08MYR3.SGM 08MYR3 lotter on DSK11XQN23PROD with RULES3 Federal Register / Vol. 89, No. 90 / Wednesday, May 8, 2024 / Rules and Regulations under-tsca/risk-management-andpolyfluoroalkyl-substances-pfas U.S. EPA. (2023e). Toxics Release Inventory (TRI) Program, 2022 TRI preliminary dataset: Basic data files. U.S. Environmental Protection Agency. https://www.epa.gov/toxics-releaseinventory-tri-program/tri-basic-datafiles-calendar-years-1987-present U.S. EPA. (2023f). What EPA is doing to reduce mercury pollution, and exposures to mercury. https://www.epa.gov/ mercury/what-epa-doing-reducemercury-pollution-and-exposuresmercury#discharged U.S. EPA. (2023g). Public Comment Draft: Toxicity assessment and proposed maximum contaminant level goal (MCLG) for perfluorooctane sulfonic acid (PFOS) (CASRN 1763–23–1) in drinking water (EPA–822–P–23–007). U.S. Environmental Protection Agency. U.S. EPA. (2023h). Public Comment Draft: Toxicity assessment and proposed maximum contaminant level goal (MCLG) for perfluorooctanoic acid (PFOA) (CASRN 335–67–1) in drinking water (EPA–822–P–23–005). U.S. Environmental Protection Agency. U.S. EPA (2023i) National Rivers and Streams Assessment: The Third Collaborative Survey. EPA 841–R–22– 004. U.S. Environmental Protection Agency, Office of Water and Office of Research and Development. https:// riverstreamassessment.epa.gov/ webreport U.S. EPA. (2024a). National Primary Drinking Water Regulation for PFAS. U.S. EPA. (2024b). Office of Water final human health toxicity assessment for perfluorooctane sulfonic acid (PFOS). U.S. EPA. (2024c). Office of Water final human health toxicity assessment for perfluorooctanoic acid (PFOA). U.S. EPA. (2024d). Office of Water final maximum contaminant level goals (MCLGs) for perfluorooctanoic acid (PFOA) and perfluorooctane sulfonic acid (PFOS) in drinking water. U.S. EPA. (2024e). Regulatory impact analysis of the final rulemaking to designate perfluorooctanoic acid and perfluorooctanesulfonic acid as CERCLA hazardous substances. U.S. Environmental Protection Agency. Uhlmann, D. M. (2023). Memorandum: FY 2024–2027 national enforcement and compliance initiatives. U.S. Environmental Protection Agency. https://www.epa.gov/system/files/ documents/2023-08/fy2024-27necis.pdf USDA. (2021). Analytical results for PFAS in 2018 produce sampling. U.S. Department of Agriculture. https://www.fda.gov/ media/127848/download?attachment Verner, M.A., Loccisano, A.E., Morken, N.H., Yoon, M., Wu, H., McDougall, R., Maisonet, M., Marcus, M., Kishi, R., Miyashita, C., Chen, M.H., Hsieh, W.S., Andersen, M.E., Clewell, H.J., 3rd, & Longnecker, M.P. (2015, Dec). Associations of perfluoroalkyl substances (PFAS) with lower birth weight: An Evaluation of potential VerDate Sep<11>2014 18:22 May 07, 2024 Jkt 262001 confounding by glomerular filtration rate using a physiologically based pharmacokinetic model (PBPK). Environ Health Perspect, 123(12), 1317–1324. https://doi.org/10.1289/ehp.1408837 Vieira, V.M., Hoffman, K., Shin, H.M., Weinberg, J.M., Webster, T.F., & Fletcher, T. (2013, Mar). Perfluorooctanoic acid exposure and cancer outcomes in a contaminated community: a geographic analysis. Environ Health Perspect, 121(3), 318–323. https://doi.org/10.1289/ ehp.1205829 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(4), 501–507. https://doi.org/10.1007/s11434-0080128-5 Waterfield, G., Rogers, M., Grandjean, P., Auffhammer, M., & Sunding, D. (2020, Apr 22). Reducing exposure to high levels of perfluorinated compounds in drinking water improves reproductive outcomes: evidence from an intervention in Minnesota. Environ Health, 19(1), 42. https://doi.org/10.1186/s12940-02000591-0 Wikstrom, S., Lin, P.I., Lindh, C.H., Shu, H., & Bornehag, C.G. (2020, May). Maternal serum levels of perfluoroalkyl substances in early pregnancy and offspring birth weight. Pediatr Res, 87(6), 1093–1099. https://doi.org/10.1038/s41390-0190720-1 Wisconsin DNR. (2020). DNR And DHS issue do not eat advisory for deer liver in fivemile area surrounding JCI/TYCO site in Marinette https://dnr.wisconsin.gov/ newsroom/release/37921 Yao, Q., Gao, Y., Zhang, Y., Qin, K., Liew, Z., & Tian, Y. (2021). Associations of paternal and maternal per- and polyfluoroalkyl substances exposure with cord serum reproductive hormones, placental steroidogenic enzyme and birth weight. Chemosphere, 285. https:// doi.org/10.1016/j.chemosphere. 2021.131521 Zahm, S., Bonde, J.P., Chiu, W.A., Hoppin, J., Kanno, J., Abdallah, M., et al. Carcinogenicity of perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS). Lancet Oncol, Published online 30 November 2023; https:// doi.org/10.1016/S1470-2045(23)00622-8 Zhang, Y., Mustieles, V., Wang, Y.X., Sun, Q., Coull, B., Sun, Y., Slitt, A., & Messerlian, C. (2023, Feb 14). Red blood cell folate modifies the association between serum per- and polyfluoroalkyl substances and antibody concentrations in U.S. adolescents. Environ Sci Technol, 57(6), 2445–2456. https://doi.org/10.1021/ acs.est.2c07152 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 PO 00000 Frm 00069 Fmt 4701 Sfmt 4700 39191 requirements, Superfund, Water pollution control, Water supply. Michael S. Regan, Administrator. For the reasons set forth in the preamble, EPA amends 40 CFR part 302 as follows: 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, 42 U.S.C. 9602, 42 U.S.C. 9603 2. Amend § 302.4: a. By revising ‘‘Note II to Table 302.4’’. ■ b. In ‘‘Table 302.4’’ by adding, in alphabetical order, entries for ‘‘Perfluorooctanesulfonic acid, salts, & structural isomersv’’, ‘‘Perfluorooctanesulfonic acidv’’, Perfluorooctanoic acid, salts, & structural isomersv’’, and ‘‘Perfluorooctanoic acidv’’; ■ c. In Appendix A to § 302.4 by adding in numerical order entries for ‘‘335–67– 1’’ and ‘‘1763–23–1’’. The revision and additions read as follows: ■ ■ § 302.4 Hazardous substances and reportable quantities. * * * * * 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 [40 CFR 116.4; 33 U.S.C. 1321(b)(2)(A)]. Statutory Code ‘‘2’’ indicates a CWA Toxic Pollutant [40 CFR 401.15, 40 CFR part 423 Appendix A, and/or 40 CFR 131.36; 33 U.S.C. 1317(a)]. Statutory Code ‘‘3’’ indicates a CAA HAP [42 U.S.C. 7412(b); Pub. L. 101–549 November 15, 1990; 70 FR 75047 December 19, 2005; 69 FR 69320 November 29, 2004; 61 FR 30816 June 18, 1996; 65 FR 47342 August 2, 2000; 87 FR 393 January 5, 2022]. Statutory Code ‘‘4’’ indicates Resource Conservation and Recovery Act (RCRA) Hazardous Wastes [40 CFR part 261 Subpart D—Lists of Hazardous Wastes; 42 U.S.C. 6921]. (Note: The ‘‘RCRA waste No.’’ column provides the waste identification numbers assigned by RCRA regulations). Statutory Code ‘‘5’’ indicates a hazardous substance designated under section 102(a) of CERCLA. The ‘‘Final RQ [pounds (kg)]’’ column provides the reportable quantity for each hazardous substance in pounds and kilograms. * E:\FR\FM\08MYR3.SGM * * 08MYR3 * * 39192 Federal Register / Vol. 89, No. 90 / Wednesday, May 8, 2024 / Rules and Regulations TABLE 302.4—LIST OF HAZARDOUS SUBSTANCES AND REPORTABLE QUANTITIES Hazardous substance RCRA waste No. * * * * Perfluorooctanesulfonic acid, salts, & structural isomers v .............................. Perfluorooctanesulfonic acid v .......................................................................... * N.A. 1763–23–1 5 5 * ........................ ........................ Perfluorooctanoic acid, salts, & structural isomers v ........................................ N.A. 5 ........................ Perfluorooctanoic acid v .................................................................................... 335–67–1 5 ........................ * v The * * * * * * Final RQ [pounds (kg)] * 1 (0.454) 1 (0.454) 1 (0.454) 1 (0.454) * Agency may adjust the statutory RQ for this hazardous substance in a future rulemaking; until then the statutory one-pound RQ applies. * * * * CASRN Appendix A to § 302.4—Sequential CAS Registry Number List of CERCLA Hazardous Substances CASRN * * 335–67–1 ...... lotter on DSK11XQN23PROD with RULES3 Statutory code CASRN VerDate Sep<11>2014 Hazardous substance * * * * * Perfluorooctanoic acid 18:22 May 07, 2024 Jkt 262001 Hazardous substance * * 1763–23–1 .... * * * * * * * * Perfluorooctanesulfonic acid * * [FR Doc. 2024–08547 Filed 5–7–24; 8:45 am] BILLING CODE 6560–50–P PO 00000 Frm 00070 Fmt 4701 Sfmt 9990 E:\FR\FM\08MYR3.SGM 08MYR3

Agencies

ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 89, Number 90 (Wednesday, May 8, 2024)]
[Rules and Regulations]
[Pages 39124-39192]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-08547]



[[Page 39123]]

Vol. 89

Wednesday,

No. 90

May 8, 2024

Part III





 Environmental Protection Agency





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40 CFR Part 302





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

Federal Register / Vol. 89, No. 90 / Wednesday, May 8, 2024 / Rules 
and Regulations

[[Page 39124]]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 302

[EPA-HQ-OLEM-2019-0341; FRL-7204-03-OLEM]
RIN 2050-AH09


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

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: Pursuant to the Comprehensive Environmental Response, 
Compensation, and Liability Act (``CERCLA'' or ``Superfund''), the 
Environmental Protection Agency (EPA) is designating two per- and 
polyfluoroalkyl substances (PFAS)--perfluorooctanoic acid (PFOA) and 
perfluorooctanesulfonic acid (PFOS), including their salts and 
structural isomers--as hazardous substances. The Agency reached this 
decision after evaluating the available scientific and technical 
information about PFOA and PFOS and determining that they may present a 
substantial danger to the public health or welfare or the environment 
when released. The Agency also determined that designation is warranted 
based on a totality of the circumstances analysis, including an 
analysis of the advantages and disadvantages of designation.

DATES: Effective July 8, 2024.

ADDRESSES: EPA has established a docket for this rulemaking under 
Docket ID No. EPA-HQ-OLEM-2019-0341. All documents in the docket are 
listed in https://www.regulations.gov/. Although listed, some 
information is not publicly available, e.g., Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute. Certain other material, such as copyrighted material, is 
not placed on the internet and will be publicly available only in hard 
copy. With the exception of such material, publicly available docket 
materials are available electronically in https://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Sicy Jacob, Office of Emergency 
Management (5104A), Environmental Protection Agency, 1200 Pennsylvania 
Avenue NW, Washington, DC 20460; telephone number 202-564-8019; email 
address: [email protected] or Linda Strauss, Office of Superfund 
Remediation and Technology Innovation, Environmental Protection Agency, 
1200 Pennsylvania Avenue NW, Washington, DC 20460; telephone number 
202-564-0797; 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, EPA defines the following terms and acronyms here:

AFFF Aqueous film-forming foam
ARARs Applicable or Relevant and Appropriate Requirements
ATSDR Agency for Toxic Substances and Disease Registry
CDC Centers for Disease Control and Prevention
CASRN Chemical Abstracts Service Registry Number
COC Contaminant of Concern
CDR Chemical Data Reporting
CERCLA Comprehensive Environmental Response, Compensation, and 
Liability Act
CFR Code of Federal Regulations
DoD Department of Defense
DOE Department of Energy
EA Economic Analysis
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
ICR Information Collection Request
LEPC Local Emergency Planning Committee
MCL Maximum contaminant level
MCLG Maximum Contaminant Level Goals (MCLGs)
NAICS North American Industrial Classification System
NCP National Oil and Hazardous Substances Pollution Contingency Plan
NECI National Enforcement Compliance Initiative
NHANES National Health and Nutrition Examination Survey
NPDWR National Primary Drinking Water Regulation
NPL National Priorities List
NRC National Response Center
OMB Office of Management and Budget
PCBs Polychlorinated biphenyls
PFAS Per- and polyfluoroalkyl substances
PFOA Perfluorooctanoic acid
PFOS Perfluorooctanesulfonic acid
PFOSA Perfluorooctanesulfonamide
PHGs Public health goals
ppt parts per trillion
PRG Preliminary remediation goal
PRP Potentially responsible party
PRSC Post-Removal Site Control
PWS Public water system
RCRA Resource Conservation and Recovery Act
RFA Regulatory Flexibility Act
RfD Reference dose
RQ Reportable quantity
SAB Science Advisory Board
SDWA Safe Drinking Water Act
SERC State Emergency Response Commission
SNURs Significant New Use Rules
TEPC Tribal Emergency Planning Committee
TERC Tribal Emergency Response Commission
TRI Toxic Release Inventory
TSCA Toxic Substances Control Act
UCMR Unregulated Contaminant Monitoring Rule
UMRA Unfunded Mandates Reform Act
U.S. United States
WWTP Wastewater treatment plant

Table of Contents

I. Executive Summary
II. General Information
    A. What action is the Agency taking?
    B. What are the Direct Effects of this Action?
    C. Does this action apply to me?
    D. What is the Agency's Authority for taking this Action?
    E. What are CERCLA's primary objectives, and how does it operate 
to protect human health and the environment?
    1. How does CERCLA authority and causes of action differ in key 
respects between ``hazardous substances'' and ``pollutants or 
contaminants''?
    2. What response actions does CERCLA authorize?
    3. What discretionary authority does CERCLA provide and how does 
CERCLA prioritize cleanup actions?
    4. What is the CERCLA cleanup process and what role does the 
National Priorities List (NPL) play in it?
    5. What is the process for identifying and selecting remedial 
actions under CERCLA?
    6. How does CERCLA's framework ensure that those responsible for 
contamination pay for cleanup?
    7. What enforcement discretion is available when exercising 
CERCLA authority?
    8. Why is understanding CERCLA's overarching provisions critical 
to understanding the importance of this rulemaking to EPA's ability 
to protect human health and the environment?
III. Background of this Rulemaking
    A. Summary of Proposed Designation.
    B. PFOA and PFOS Production and Use
    C. EPA's PFAS Strategic Map
IV. Legal Authority
    A. CERCLA section 102(a) Designation Considerations
    B. Consistency with other methodologies for identifying CERCLA 
hazardous substances.
    C. CERCLA Section 102(a) and Cost Considerations.
V. PFOA and PFOS may present a substantial danger to the public 
health or welfare or the environment when released into the 
environment.
    A. PFOA and PFOS Pose a Hazard.
    B. Information about the fate and transport of PFOA and PFOS 
demonstrate that they are Persistent and Mobile in the Environment.
    C. Other Information Considered.
VI. The totality of the circumstances confirms that designation of 
PFOA and PFOS as hazardous substances is warranted.
    A. Advantages of designation

[[Page 39125]]

    1. Designation enables earlier, broader, and more effective 
cleanups of contaminated sites.
    a. Designation opens up CERCLA's notification, response, 
enforcement, and cost recovery authorities, which allows EPA to more 
timely address contaminated sites.
    b. The availability of CERCLA enforcement and cost recovery 
authority ensures that polluters are financially responsible, which 
is consistent with CERCLA.
    c. EPA expects designation will increase Emergency Response and 
Removal Actions for PFOA/PFOS.
    d. EPA expects that shifting costs to PRPs to address PFOA/PFOS 
contamination at NPL sites will make Fund money available for other 
response work.
    2. Designation Brings Broad Health Benefits
    a. Qualitative potential benefits from decreased exposure after 
addressing PFOA/PFOS contamination
    b. Quantifiable health benefits of PFOA and PFOS exposure 
reduction.
    i. Quantified Developmental Effects
    ii. Quantified Cardiovascular Effects
    iii. Quantified Kidney Cancer Effects
    iv. Estimated health benefits of PFOA and PFOS exposure 
reduction.
    c. Cost Estimates of Burden of PFAS-Related Disease
    d. Environmental Justice (EJ) Analysis
    e. Summary of health benefits resulting from the designation.
    3. Property Reuse and Social, Economic, and Ecological Benefits 
that may Result from Designation
    4. Some facilities may adopt or improve best practices to 
prevent future releases of PFOA and PFOS
    B. Potential Disadvantages of Designation
    1. Direct costs
    2. Potential hardship for parties that did not contribute 
significantly to contamination.
    3. Potential litigation, liability, and uncertainty,
    C. Results of Totality of the Circumstances Analysis
VII. Summary of Public Comments and Responses
    A. Legal Authority
    B. Operation of CERCLA
    C. Toxicity, Human Health Effects/Mobility, Persistence, 
Prevalence/Release into the environment
    D. Effects of Designation
    E. National Priorities List (NPL) Sites--Existing and Future 
Contamination
    F. Regulate PFAS as a class.
    G. Managing PFOA and PFOS Contaminated Waste
    H. Comments on Economic Assessment/Regulatory Impact Analysis
    I. Enforcement
VIII. Summary of this Final Rule
    A. Default Reportable Quantity
    B. Direct Effects of Designating PFOA, PFOS, and their Salts and 
Structural Isomers as Hazardous Substances
IX. Statutory and Executive Order Reviews
    A. Executive Order 12866: Regulatory Planning and Review, as 
amended by Executive Order 14094: Modernizing Regulatory Review
    B. Paperwork Reduction Act
    C. Regulatory Flexibility Act
    D. Unfunded Mandates Reform Act (UMRA)
    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 and Executive Order 14096: Revitalizing our Nation's 
Commitment to Environmental Justice for All

References

I. Executive Summary

A. Overview

    Pursuant to section 102(a) of the Comprehensive Environmental 
Response, Compensation, and Liability Act (CERCLA), EPA is designating 
perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS), 
including their salts and structural isomers, as hazardous 
substances.\1\ Each of the actions adding PFOA, PFOS, and their salts 
and structural isomers, to CERCLA's hazardous substances list is 
independent, and severable from the others. The Agency evaluated the 
available scientific and technical information about those substances 
and concluded that designation of each substance is warranted under the 
criteria in section 102(a) because both PFOA and PFOS, and their salts 
and isomers, may present substantial danger to public health or welfare 
or the environment. Exercising its discretion with respect to when to 
make a finding under section 102(a), EPA as part of its decision-making 
process went beyond considering whether PFOA and PFOS ``may present a 
substantial danger to public health welfare or the environment'' within 
the meaning of section 102(a), and also performed an additional 
analysis that weighed the advantages and disadvantages of designation, 
including quantitative and qualitative benefits and costs. As part of 
that additional discretionary analysis, EPA determined that the 
advantages of designation outweigh the disadvantages. Among other 
advantages, designation best serves CERCLA's two primary objectives--
the timely cleanup of contaminated sites and holding polluters 
accountable for contamination they caused (i.e., the ``Polluter Pays'' 
principle). Designation provides necessary tools to address the 
challenge of PFOA and PFOS contamination in the environment. 
Designation will allow EPA to utilize all CERCLA's authorities, which 
will enable EPA to address more sites, take earlier action, and to 
expedite eventual cleanup. Designating PFOA and PFOS as CERCLA 
hazardous substances is thus critical to addressing PFOA and PFOS 
releases in the environment and to protecting public health.
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    \1\ PFOA and PFOS are part of a group of human-made chemicals 
known as per- and polyfluoroalkyl substances (PFAS). All references 
to PFOA and PFOS in this notice include their salts and structural 
isomers.
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B. ``May Present Substantial Danger to Public Health or Welfare or the 
Environment''

    EPA is taking final action on the proposed finding that both PFOA 
and PFOS ``may present substantial danger to public health or welfare 
or the environment'' when released into the environment after 
considering the available scientific and technical information and 
after considering comments on the proposed determination. Available 
information indicates that human exposure to PFOA and/or PFOS is linked 
to a broad range of adverse health effects, including developmental 
effects to fetuses during pregnancy or to infants (e.g., low birth 
weight, accelerated puberty, skeletal variations), liver effects (e.g., 
tissue damage), immune effects (e.g., antibody production and 
immunity), and other effects (e.g., cholesterol changes). Both PFOA and 
PFOS are known to be transmitted to the fetus via the placenta and to 
the newborn, infant, and child via breast milk.
    In addition, toxicity assessments in support of EPA's 2024 National 
Primary Drinking Water Regulation for PFAS (2024a) indicate that PFOA 
and PFOS may cause carcinogenic effects in humans and animals (Barry et 
al., 2013; Bartell & Vieira, 2021; Goodrich et al., 2022; Shearer et 
al., 2021; Vieira et al., 2013). In the final toxicity assessments, EPA 
assessed the weight of the evidence for the available cancer data and 
determined that PFOA and PFOS are Likely to Be Carcinogenic to Humans 
consistent with the Guidelines for Carcinogen Risk Assessment (U.S. 
EPA, 2005, 2024b, 2024c, 2024d). Additionally, in November 2023, the 
International Agency for Research on Cancer (IARC) evaluated the 
carcinogenicity of PFOA and PFOS and classified PFOA as carcinogenic to 
humans (Group 1) and PFOS as possibly

[[Page 39126]]

carcinogenic to humans (Group 2b) (Zahm, et al., 2023).
    The potential for adverse health effects is exacerbated by the fact 
that PFOA and PFOS are persistent in the environment, which can cause 
long-term exposure. PFAS, including PFOA and PFOS, are sometimes 
referred to as ``forever'' chemicals because of their strong carbon-
fluorine bonds in the ``tail group'' that cause them to be extremely 
resistant to degradation and to remain in the environment for long 
periods of time. This means that the potential for human exposure 
continues long after an immediate release has ended. PFOA and PFOS are 
also highly mobile in the environment and can migrate away from the 
point of initial release. Studies also show that PFOA and PFOS persist 
in humans and animals (i.e., bioaccumulate) with estimated elimination 
half-lives \2\ in humans ranging from about two to three years for PFOA 
to four or five years for PFOS \3\ (ATSDR, 2021). Because PFOA and PFOS 
can remain in the human body for these long durations, individuals who 
have consistent ongoing exposures to elevated concentrations of PFOA 
and PFOS (e.g., individuals exposed by drinking contaminated well 
water) can have elevated concentrations of these compounds in their 
bodies which may contribute to adverse health effects (Hall et al., 
2023; Hoffman et al., 2011; Kotlarz et al., 2020; Steenland et al., 
2009).
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    \2\ Elimination half-life is the length of time required for the 
concentration of a particular substance to decrease to half of its 
starting dose in the body.
    \3\ Data from two studies in Table 3-5 of ATSDR 2021 (Seals et 
al., 2011 and Zang et al., 2013) were not included in EPA's estimate 
of elimination half-life because their findings were significantly 
different for the other studies, and may not be the most 
representative.
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    PFOA and PFOS are prevalent in the environment and can be found in 
surface water, groundwater, soil, and air. PFOA and PFOS are prevalent 
because they have been produced and used since the 1940s, were among 
the most widely used of the PFAS constituents and persist in the 
environment for a long time. PFOA and PFOS have historically been used 
in a wide range of consumer products including carpets, clothing, 
fabrics for furniture, packaging for food and cookware, and 
firefighting foam, in addition to being used in a wide range of 
industrial processes. See Designation of Perfluorooctanoic Acid (PFOA) 
and Perfluorooctanesulfonic Acid (PFOS) as CERCLA Hazardous Substances, 
87 FR 54415, 54417 (proposed Sept. 6, 2022) (hereinafter ``Proposed 
Rule'' or ``Proposal'') (providing a brief history of PFOA and PFOS 
production and use). Domestic production and import of PFOA has been 
phased out by the companies participating in the 2010/2015 PFOA 
Stewardship Program (U.S. EPA, 2023c). Some uses of PFOS are ongoing. 
The sustained and broad use of PFOA and PFOS by industries means that 
many sites may be contaminated with high levels of PFOA and PFOS. 
Furthermore, these substances may still be released into the 
environment through use and disposal of legacy products and through 
limited ongoing uses.
    PFOA and PFOS have been detected in the drinking water of millions 
of Americans and are widely detected in surface water samples collected 
from various rivers, lakes, and streams in the United States (ATSDR, 
2021; Cadwallader et al., 2022; U.S. EPA, 2017, 2024a). This exposure 
potential is exacerbated by their persistence and mobility in the 
environment (Langenbach & Wilson, 2021). The prevalence of PFOA and 
PFOS is further demonstrated by the fact that these chemicals were 
detected in the blood of nearly all of the participants in the latest 
U.S. Centers for Disease Control and Prevention's (CDC) National Health 
and Nutrition Examination Survey (NHANES) for which data is available 
from 2017-2018. (CDC, 2022). This information indicates widespread 
though generally declining exposure to PFOA and PFOS in the U.S. 
population. From 1999-2000 to 2017-2018, blood PFOS levels declined by 
more than 85%. From 1999-2000 to 2017-2018, blood PFOA levels declined 
by more than 70%. While serum concentrations of PFOA and PFOS in the 
general population are declining, there is evidence that PFOA and PFOS 
releases continue to result in elevated environmental concentrations 
and the potential for human exposure. For example, under the 2018-2019 
National Rivers and Streams Assessment (NRSA) PFOS was detected in 91% 
of the 290 fish fillet composite samples analyzed, corresponding to 
PFOS being detected in 92% of the sampled population of 41,099 river 
miles (a statistically significant decrease of 6.7% from NRSA 2013-14) 
(U.S. EPA, 2023i).
    In consideration of the evidence of adverse effects to human health 
and the environment from PFOA and PFOS exposure, their persistence and 
mobility in the environment, and the significant potential for human 
exposure due to their prevalence in the environment, EPA concludes that 
PFOA and PFOS may present a substantial danger to public health or 
welfare or the environment when released into the environment. EPA 
further finds that populations located near highly contaminated sites 
are of particular concern because they are at risk of a 
disproportionately high potential of repeat exposure to PFOA and PFOS 
as compared to the general population and across demographic 
characteristics and repeated exposures increase the likelihood of 
adverse health effects, as discussed further in the Preamble, Section 
VI.A,2. d. For these reasons, designation of PFOA and PFOS as hazardous 
substances is warranted.

C. ``Totality of the Circumstances'' Analysis

    Along with concluding that PFOA and PFOS each, when released, ``may 
present a substantial danger'' to public health or welfare or the 
environment and therefore meet the statutory designation criteria, EPA 
also exercised discretion to conduct an additional totality of the 
circumstances analysis. The analysis looks to CERCLA section 102(a), 
and its broader context, to help identify the information to weigh and 
how to balance multiple considerations. In conducting the analysis as 
to PFOA and PFOS, EPA identified and weighed the advantages and 
disadvantages of designation relative to CERCLA's purpose alongside the 
formal benefit-cost analysis, including quantitative and qualitative 
benefits and costs, provided in the Regulatory Impact Analysis \4\ 
accompanying this final rule. That ``totality of the circumstances'' 
analysis confirmed EPA's conclusion that designation is warranted 
because the advantages of designation outweigh the disadvantages.
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    \4\ The RIA was conducted in a consistent manner with economic 
principles and governmental guidance documents for economic analysis 
(e.g., OMB Circular A-4 and EPA's Guidelines for Preparing Economic 
Analyses) and summarized monetized costs and benefits. The RIA is a 
neutral analysis tool that allows the federal government to consider 
potential benefits and costs that may result from designation. It 
does not consider whether designation is warranted.
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    EPA considered how designation supports CERCLA's primary objectives 
to clean up contaminated sites and ensure the ``Polluter Pays.'' EPA 
concluded that designation best serves those objectives and that CERCLA 
is the best tool to address the legacy of sites contaminated with these 
substances and to address additional releases of these chemicals in the 
future. EPA considered that designation would allow EPA to deploy the 
full suite of CERCLA tools to identify, characterize, and clean up the 
most contaminated sites expeditiously. It allows EPA to ensure that 
those parties responsible for significant

[[Page 39127]]

contamination bear the costs of cleaning it up. The use of these 
authorities will allow EPA to address more sites and to do so earlier 
in time than it otherwise could in the absence of designation. The 
ability to address more contaminated sites will provide meaningful 
health benefits to the communities near these sites by reducing the 
risk of exposure and the potential adverse health and environmental 
effects associated with such exposure. EPA expects these cleanups will 
have meaningful health benefits similar to health benefits typically 
associated with CERCLA actions. EPA also considered the potential 
quantifiable and qualitative costs and benefits of designation and the 
comments expressing concerns about widespread liability and litigation 
after designation. As explained below, EPA finds that the advantages of 
designation outweigh the disadvantages and that designation is 
warranted.
    EPA's totality of the circumstances analysis considered the adverse 
health impacts and environmental challenges posed by PFOA and PFOS 
contamination. PFAS, including PFOA and PFOS, are a nationwide concern 
because exposure to these chemicals is linked to significant adverse 
human health impacts, they were in wide use, and they persist and are 
mobile once released into the environment. CERCLA provides the tools 
for addressing such contamination and provides a framework to allow 
EPA, and other delegated Federal agencies,\5\ to make site-specific 
determinations and response decisions to address instances of PFOA and 
PFOS releases that pose unacceptable risk. Specifically, CERCLA 
provides authority to respond to releases of hazardous substances 
(including legacy releases). CERCLA's cleanup process is comprehensive 
in that it can address contamination to air, water, groundwater, and 
soil. EPA's CERCLA response authority also extends from initial 
investigations to cleanup. No other statute that EPA administers 
provides the breadth of authority to fully address highly contaminated 
sites. Thus, CERCLA is the best authority to address existing 
contamination to mitigate the disproportionate risk borne by 
communities impacted by those sites. Furthermore, CERCLA is a liability 
statute. The CERCLA cost recovery and enforcement provisions ensure 
that those parties responsible for significant contamination can be 
held accountable to pay for or conduct clean up. Designation is the 
best way for EPA to effectuate CERCLA's objectives with respect to 
releases of PFOA and PFOS.
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    \5\ Executive Order 12580 (Jan. 23, 1987, as amended) delegates 
CERCLA response authority to EPA, as well as the Secretaries of 
Defense, Interior, Agriculture, Commerce, and Energy with respect to 
releases from a facility or vessel under their jurisdiction, custody 
or control and to the U.S. Coast Guard with respect to releases 
involving the coastal zone, Great Lakes waters, ports, and harbors.
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    EPA also considered whether designation is warranted considering 
EPA's existing CERCLA authority, which allows the Agency to address 
PFOA and PFOS as ``pollutants or contaminants.'' CERCLA's authority to 
address pollutants or contaminants is much more circumscribed than the 
authority to address hazardous substances. Specifically, CERCLA's 
notification requirements for releases do not attach to pollutants or 
contaminants; EPA cannot address a release of pollutants or 
contaminants unless the Agency demonstrates that the release may 
present an ``imminent and substantial danger''; CERCLA does not provide 
cost recovery authority for actions taken solely in response to 
releases or threats of releases of pollutants or contaminants; and 
CERCLA authority to compel potentially responsible parties (PRPs) to 
conduct or pay for response work does not extend to pollutants or 
contaminants. Designating PFOA and PFOS as CERCLA hazardous substances 
eliminates those limitations. Elimination of those limitations provides 
meaningful advantages.
    EPA also considered the advantages of designation. The most 
significant direct costs associated with designation stem from the 
requirement for facilities to report releases of PFOA and PFOS that 
occur after designation. EPA determined these costs were fairly minimal 
and reasonable in light of the benefits of release notifications. 
Notification ensures transparency about new releases of PFOA and PFOS, 
and it allows EPA and affected States and communities to immediately 
evaluate a release and quickly respond, as necessary, to address risks 
to human health or the environment. Without notice, EPA is less able to 
obtain key information to help protect affected communities. Thus, the 
notification requirement is an advantage that is necessary to 
adequately protect the public from future releases. Designation also 
allows EPA to streamline the Federal government's response authority to 
address releases of PFOA and PFOS, which will allow EPA to take action 
sooner. EPA can also begin the lengthy process of identifying, 
characterizing, and cleaning up the most contaminated sites without 
delay, either through enforcement or EPA-funded action.
    Another key advantage to designation is that it best effectuates 
the Polluter Pays principle underpinning CERCLA. Designation improves 
equities by transferring costs of cleaning up PFOA and PFOS from the 
Superfund (``the Fund''),\6\ which has been historically funded by 
taxpayer dollars, to those responsible for contamination. Absent 
designation, costs incurred for addressing PFOA and PFOS as pollutants 
or contaminants are paid for by the Fund, rather than responsible 
parties. Preservation of the Superfund is critical because the monies 
in it are insufficient to clean up all the existing contamination 
across the country from the more than 800 CERCLA hazardous substances 
as well as additional/emerging pollutants and contaminants. The ability 
to require PRPs to pay for PFOA and PFOS response costs means that more 
money will be available in the Fund to address a multitude of 
priorities, particularly at those sites where there is no viable PRP. 
It also allows EPA to address more releases earlier than it otherwise 
could absent designation. Further, cleanup to address PFOA/PFOS 
supported by designation may allow for incidental cleanup of co-
contaminants, including other types of PFAS, which would also benefit 
human and environmental health. Because contaminated sites often have 
multiple contaminants of concern (``COCs''), the benefits from 
addressing co-contaminants may be substantial for some sites to the 
extent this occurs. It is critical to initiate more CERCLA actions to 
address PFOA and PFOS contamination now because the process from 
investigations to cleanups can take many years, if not decades. And, 
because PFOA and PFOS are persistent in the environment and highly 
mobile, further delay increases the extent of contamination, 
potentially increasing the number of individuals exposed to these 
substances, and also potentially increasing costs associated with 
cleanup.
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    \6\ Congress established the Hazardous Substances Trust Fund, 
otherwise known as the Superfund, to provide funding to address 
contamination. CERCLA also established liability for parties that 
contributed to releases of hazardous substances, CERCLA section 
107(a), which allows EPA to shift costs from the Fund to PRPs.
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    EPA's ability to address PFOA and PFOS contamination through 
enforcement and EPA-funded action means more communities will be 
protected from disproportionate and unacceptable health risks, 
including communities with environmental justice

[[Page 39128]]

(EJ) concerns. Published literature \7\ supports the conclusion that 
certain communities with EJ concerns have a higher likelihood of 
exposure to PFAS, including PFOA/PFOS. For more information, see RIA 
Section 6.3 Impacts on Communities with EJ concerns: Analysis. Cleaning 
up more sites with PFOA and PFOS contamination will help to decrease 
their exposure to PFOA and PFOS, thus reducing their risk of 
detrimental health effects, such as decreased immune response to 
vaccination, decreased birthweight, increased total cholesterol, and 
cancer. Cleaning up sites also promotes economic benefits, such as 
improved property values and making land available for reuse. Improving 
environmental quality can improve local economies by supporting local 
business, such as recreation companies or industries that rely on 
natural products like agriculture. Improved quality of natural 
resources can also contribute to ecosystem services.\8\
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    \7\ Northeastern University--The PFAS Project Lab, ``PFAS 
Contamination Is an Equity Issue, and President Trump's EPA Is 
Failing to Fix It'' October 31, 2019. Available at: https://pfasproject.com/2019/10/31/pfas-contamination-is-an-equity-issue-and-president-trumps-epa-is-failing-to-fix-it/.
    Lee, Susan, Avinash Kar, and Dr. Anna Reade, Dirty Water: Toxic 
``Forever'' PFAS Chemicals are Prevalent in the Drinking Water of 
Environmental Justice Communities. Natural Resources Defense 
Council, New York. 2021. https://www.nrdc.org/sites/default/files/dirty-water-pfas-ej-communities-report.pdf
    Stoiber, T., Evans, S., & Naidenko, O.V. (2020). Disposal of 
products and materials containing per- and polyfluoroalkyl 
substances (PFAS): A cyclical problem. Chemosphere 260, Accessed at: 
https://doi.org/10.1016/j.chemosphere.2020.127659.
    \8\ Ecosystem services produce the life-sustaining benefits we 
receive from nature--clean air and water, fertile soil for crop 
production, pollination, and flood control.
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    EPA also considered the quantitative and qualitative direct and 
indirect costs and benefits evaluated in the RIA as part of its 
totality of the circumstances analysis.\9\ EPA recognizes that 
designation will lead to both direct and indirect costs. The only 
quantifiable direct cost associated with designation is the 
notification requirement, for releases of PFOA and PFOS at or above 1 
pound within a 24-hour period. EPA estimates that the notification 
requirement will cost $2,658 per release and that the total cost of the 
notification requirement is not anticipated to exceed $1,630,000 per 
year.\10\ Notification is critical to ensuring that new releases are 
identified, evaluated, and addressed to the extent necessary to protect 
human health and the environment. EPA considers both the individual and 
total notification costs to be generally reasonable because of the 
value notification provides to impacted communities and regulatory 
agencies. Notification can avoid delays in evaluation of a new release. 
This is particularly important for persistent and mobile substances 
like PFOA and PFOS because early evaluation can determine whether the 
release poses an unacceptable risk that requires a response before PFOA 
and PFOA migrate away from the release. Such migration without 
intervention can lead to an increase in both the scope of the 
contamination and the costs necessary to address any identifiable 
risks.
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    \9\ The terms ``direct'' and ``indirect'' as used to describe 
potential impacts of this rule are based on established definitions 
used for analyses under the Regulatory Flexibility Act (RFA). EPA is 
aware that ``direct'' and ``indirect'' costs have distinct 
definitions for CERCLA purposes; those CERCLA-specific definitions 
were not used for estimating costs for the purpose of designation. 
Both EPA and SBA have applicable RFA guidance documents that were 
considered in developing this rule. For this rule, reporting 
requirements are direct effects because upon designation of PFOA and 
PFOS as hazardous substances, entities that release a reportable 
quantity within a 24-hour period are required to use established 
procedures to report the release immediately by telephone and 
provide a follow-up written report. Potential liability for response 
costs for addressing PFOA and PFOS releases or threatened releases 
is an indirect effect of designation. This is because CERCLA 
response actions are not required by this rule, and are 
discretionary and contingent upon a series of many site-specific 
determinations. See RIA Section 1.4 Scope of Analysis and RIA 
Section 6.2 Small Entity Analysis for more detail.
    \10\ The designation may also result in minimal costs to federal 
agencies associated with CERCLA section 120(h) notice requirements 
when selling or transferring federally owned real property where 
PFOA/PFOS may be present. Future federal property sales and 
transfers involving property where PFOA and/or PFOS may be present 
is unknowable and therefore such costs are unquantifiable.
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    With respect to indirect costs, EPA considered the costs associated 
with responding to releases of PFOA and PFOS at contaminated sites and 
with responding to future releases, either through direct EPA action 
with cost recovery or through enforcement. As stated above, EPA 
considers the ability to use the full suite of CERCLA authorities--
including cost recovery and enforcement--to be an advantage of the 
rule. Designation eliminates current barriers to timely cleanup of 
contaminated sites and enables EPA to pursue parties responsible for 
significant contamination, these are the parties that should bear the 
costs of cleaning it up. When parties responsible for contamination are 
required to bear the cost of cleanup, more resources are made available 
to address additional cleanups. For example, EPA can compel a PRP to 
take action to address PFOA and PFOS pursuant to CERCLA section 106(a), 
which will then allow EPA to use Superfund monies and human resources 
to address other releases at other sites. Further, every contaminated 
site that is addressed can reduce the disproportionate burden borne by 
some of the communities at risk of exposure to PFOA and PFOS from the 
contamination. EPA's totality of the circumstances analysis included an 
evaluation of the benefit-cost analysis in the RIA (including indirect 
costs) as well as additional qualitative considerations related to 
designation, such as how CERCLA functions.
    EPA is required to take a measured approach in responding to 
contamination. For instance, CERCLA ensures that costs are considered 
when determining the remedy. In addition, EPA, as well as other Federal 
agencies, have resource constraints that require CERCLA response 
actions to be prioritized to address the most urgent and highest risks 
as specified by the National Priorities List (NPL). The NPL is the list 
of sites of national priority among the known releases or threatened 
releases of hazardous substances, pollutants, or contaminants 
throughout the United States and its territories. It is intended 
primarily to guide EPA in determining which sites warrant further 
investigation. Eligibility for the NPL includes identifying priority 
sites based upon relative risk or danger that may be posed to public 
health or welfare or the environment, considering the population, the 
hazard potential of the hazardous substances at issue, the potential 
for contamination of drinking water supplies, the potential for direct 
human contact, the potential for destruction of sensitive ecosystems, 
and the damages to natural resources that may affect the human food 
chain when determining priority. Thus, CERCLA provides EPA with the 
ability to identify the sites with the highest human health and 
environmental risks and address those sites first, and the costs of 
addressing contamination are considered relative to the risks the 
contamination poses before a remedy is selected. before a remedy is 
selected.
    Between FY 2003 and FY 2022, only about four percent of all 
contaminated sites added to EPA's Active Site Inventory were placed on 
the NPL. Since 2013, EPA has, on average, added 11 sites \11\ per year 
to the NPL, and EPA

[[Page 39129]]

does not expect the rate at which annual additions to the NPL occur to 
increase as a result of this rule. Moreover, NPL listing does not 
trigger any immediate actions, liability, or requirements for the 
site.\12\
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    \11\ This estimate is based on data from EPA's SEMS database 
with respect to non-federal NPL sites. EPA determined that it was 
appropriate to assess the designation's impact with respect to non-
federal NPL sites only, because federal sites are generally expected 
to address PFOA and PFOS in the absence of designation consistent 
with CERCLA section 104. As discussed in Chapter 2 of the RIA, 
federal sites are addressing PFAS in the baseline as authorized by 
CERCLA section 104 and corresponding Executive Orders, as required 
by the NDAA, and consistent with federal facilities agreements under 
CERCLA section 102(a). Therefore, EPA expects that federal sites 
will address PFOA and PFOS contamination in the absence of the final 
rule. With federal sites taking action to address PFAS in the 
baseline, indirect impacts of the final rule will likely be related 
to actions taken at non-federal sites. For additional context, since 
FY 2000 EPA has added 8 federal sites to the NPL.
    \12\ EPA considered the portion of non-federal NPL sites that 
may be impacted by designation depending on site-specific 
circumstances. Of final, proposed, or deleted non-federal NPL sites 
that have been tested for PFOA and/or PFOS, an estimated 33.1% of 
NPL sites have detectable levels of PFOA and/or PFOS. See Section 
3.3 of the RIA for more details about this estimate. In evaluating 
the designation's impact non-federal NPL sites, this estimate is 
instructive and serves as a benchmark for assessing designation's 
potential impact to those sites. There are currently 5 sites where 
either PFOA or PFOS contributed to NPL listing.
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    CERCLA ensures that the most significant releases that pose the 
most risks to human health and the environment are prioritized, and 
designation will allow EPA to ensure more sites are evaluated sooner, 
thereby protecting more communities from PFOA and PFOS contamination. 
In Chapter 5 of the Regulatory Impact Analysis (RIA) for this 
rulemaking, EPA presents quantified potential response costs \13\ that 
may occur after designation despite the uncertainty of future response 
actions. Every site is unique and the extent of action necessary to 
mitigate risks depends on many factors, which leads to uncertainties 
regarding response activities and associated costs. Notwithstanding 
these uncertainties, EPA used existing data to estimate response costs 
for PFOA and PFOS. Specifically, EPA used response costs data for EPA-
lead response actions, potential costs associated with cleanup methods 
and technologies available to address PFOA and PFOS, and information 
about conditions at contaminated sites. EPA then used that data to 
assess the incremental costs of cleanup associated with addressing 
PFOA/PFOS contamination. Data available to EPA demonstrates that PFOA 
and PFOS generally are not found in isolation; rather, those substances 
are typically co-located or commingled with other ``contaminants of 
concern'' that on their own support a remedy. The estimated incremental 
costs to address PFOS and/or PFOS releases at NPL sites are those that 
the Agency believes it would incur absent the designation, which can be 
transferred to viable, liable parties as a result of designation. As 
EPA's funds would then be used for additional fund-led efforts to 
address contamination not addressed under the baseline, there will be a 
net increase in spending on response activities. This ability to 
transfer costs enables EPA to investigate and clean up additional NPL 
sites to address potential risks posed by any of the more than 800 
hazardous substances, including PFOA and PFOS. EPA estimated the 
potential transfer of response costs associated with NPL sites range 
from $10.3M to $51.7M per year (at a 2% discount rate), depending on 
the cost premium associated with the response work to address PFOA and/
or PFOS in addition to other Contaminants of Concerns (COCs) \14\ at a 
given NPL site. Because EPA would use these funds for additional fund-
led efforts to address contamination not addressed under the baseline, 
the transfer of $10.3M to $51.7M would result in additional costs of 
this same amount. Additionally, indirect costs associated with 
potential enforcement actions that may result in additional response 
activities for PFOA and PFOS at non-NPL sites are estimated to range 
from $327,000 to $18,100,000 per year (at the 2% discount rate), 
depending on the type of response actions taken at a given site. See 
RIA Section.
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    \13\ The term ``response'' may include actions including but not 
limited to: site assessment, investigation, remedial action, and 
removal action. See CERCLA section 101(25). For a description of 
details on the differences between remedial and removal actions and 
other response activities under CERCLA, please see Section 2.1 of 
the RIA.
    \14\ Contaminants of Concerns (COCs) are chemicals identified 
during in-depth site studies (Remedial Investigation/Feasibility 
Study) that need to be addressed by a cleanup action because they 
pose a potential threat to human health or the environment.
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5.1 Indirect Costs and Transfers
    EPA expects response costs to address PFOA and PFOS to represent an 
incremental increase above the cost of addressing other substances at 
NPL sites because, more often than not, PFOA and PFOS are likely to be 
co-located with or commingled with other substances. EPA also expects 
that costs to address PFOA and PFOS will fall within typical response 
cost ranges for actions to address other hazardous substances. This is 
because many of the same response and cleanup methods available, as 
noted in the Interim Guidance on the Destruction and Disposal of 
Perfluoroalkyl and Polyfluoroalkyl Substances and Materials Containing 
Perfluoroalkyl and Polyfluoroalkyl Substances--Version 2 (2024),\15\ to 
address other hazardous substances can be used to address PFOA and PFOS 
(e.g., dig and haul for soil and granulated activated carbon for 
water). Moreover, EPA expects that response and cleanup costs may 
decrease over time as associated methods improve. Finally, by 
addressing PFOA and PFOS releases earlier, EPA can mitigate the spread 
of contamination, which likely mitigates the costs of an otherwise more 
wide-spread cleanup.
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    \15\ Interim PFAS Destruction and Disposal Guidance; Notice of 
Availability for Public Comment was published in the Federal 
Register on April 16, 2024 (89 FR 26879) https://www.govinfo.gov/content/pkg/FR-2024-04-16/pdf/2024-08064.pdf.
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    EPA also considered liability and litigation that may arise after 
designation. CERCLA is designed to ensure that those responsible for 
contamination pay to clean it up. For PRPs that have significantly 
contributed to contamination, imposing CERCLA liability is wholly 
consistent with CERCLA and necessary to address the public health 
threat posed by PFOA and PFOS. However, EPA also gave serious 
consideration to potential liability for parties that have not played a 
significant role in contamination. Those parties include entities that 
did not generate PFOA- or PFOS-contaminated materials. EPA evaluated 
CERCLA liability limitations, EPA's enforcement policies, settlement 
protections for settling and non-settling parties, and parameters for 
CERCLA lawsuits to resolve who should pay and how much. Those 
mechanisms, combined with decades of historical practice, show that 
CERCLA liability is not unlimited; enforcement is targeted; and 
parties' ability to recover costs from other PRPs is constrained.
    Although CERCLA's liability structure is broad, both the statute 
and EPA enforcement discretion policies may constrain a party's ability 
to secure reimbursement of response costs.\16\ CERCLA includes 
liability exemptions as well as affirmative defenses against liability. 
See, e.g., CERCLA section 101(10), 107(b), (d), (k). Parties must incur 
response costs before they can recover those costs from other viable, 
liable parties. And parties must prove that response costs incurred are 
consistent with the National Contingency Plan, CERCLA's implementing 
regulations. Id. section 107(a)(4)(B). EPA's enforcement authorities 
and policies can serve as a deterrent for responsible parties to pursue 
entities that did not contribute

[[Page 39130]]

significantly to contamination.\17\ EPA has a well-proven track record 
of developing enforcement discretion policies that have been effective 
and well-received.\18\ EPA's enforcement policies, such as its policy 
regarding de minimis or de micromis parties and innocent landowner 
policies, have proven to be useful tools in convincing responsible 
parties not to pursue entities covered by these enforcement discretion 
policies. Finally, the statute provides that a party that resolves its 
potential liability with the United States or a State in a judicially 
approved settlement is entitled to contribution protection--the ability 
to block third-party claims for matters addressed in the settlement. 
These liability limitations and mitigation tools are more fully 
discussion in Section VI.B.2. EPA concludes that designation is not 
expected to result in excessive litigation and that CERCLA will 
continue to operate as it has for decades. Indeed, CERCLA's liability 
framework, coupled with EPA enforcement policies, has operated in a 
rational way for the more than 800 CERCLA hazardous substances already 
within its purview, some of which are similar to PFOA and PFOS in terms 
of ubiquity, mobility, and persistence. Heavy metals, such as arsenic 
and chromium, are persistent, and in at least some places, prevalent in 
the environment. Although EPA understands that designation will result 
in new litigation regarding PFOA and PFOS releases for responsible 
parties, forty years of CERCLA experience indicates that designation 
should not result in unusual CERCLA liability or litigation outcomes 
for parties who did not significantly contribute to the contamination 
as a result of this designation, and, therefore, the potential for 
litigation should not be a barrier to designation.
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    \16\ Other Federal agencies including DOD, DOE, USDA, and DOI 
have delegated CERCLA authority. EPA's policies apply only to EPA 
and its exercise of enforcement discretion. Please note that EPA's 
policies are not regulations and do not create new legal obligations 
or limit or expand obligations under any Federal, State, Tribal or 
local law.
    \17\ CERCLA is designed to achieve the cleanup of contaminated 
sites by ensuring that those responsible for the contamination pay 
to clean it up, which EPA supports through its longstanding 
``enforcement first'' policy. (``Guidelines for Using the Imminent 
Hazard, Enforcement and Emergency Response Authorities of Superfund 
and Other Statutes,'' 1982.) Furthermore, CERCLA's settlement 
provisions are designed to support and achieve those outcomes by 
making it efficient for EPA to secure clean up from those that have 
significantly contributed to contamination. See, e.g. Section 122(a) 
(``Whenever practical and in the public interest, . . . [EPA] shall 
act to facilitate agreements . . . that are in the public interest 
and minimize litigation.''); Section 122(g)(1) (allowing for 
``expedited'' de minimis settlements for ``minor portions of the 
response costs''). In practice, CERCLA's settlement parameters 
incentivize PRPs that likely bare a large share of responsibility to 
settle with EPA, which in turn can deter those same parties from 
pursuing other PRPs. Ultimately, settlement is generally less 
expensive than litigation and can serve as an effective mechanism 
for achieving the true goal of CERCLA--that the parties most 
responsible for contamination pay to clean it up.
    \18\ While EPA's enforcement discretion policies themselves are 
not regulations and do not create new legal obligations or limit or 
expand obligations under any federal, state, tribal or local law, 
such policies have influenced Congress to create new laws that have 
been upheld by courts. The Small Business Liability Relief and 
Brownfields Revitalization Act of 2002 (``Brownfields Amendments'') 
illustrate how EPA's policies have influenced Congressional action. 
The Brownfields Amendments amended CERCLA and promoted the cleanup, 
reuse, and redevelopment of sites by addressing potential liability 
concerns associated with contaminated, potentially contaminated, and 
formerly contaminated properties. The Brownfields Amendments 
provided important self-implementing liability limitations for 
certain categories of landowners, enabling private parties to save 
time and costs, in part, by reducing EPA involvement in most private 
party transactions. EPA launched the Brownfields Initiative in the 
1990s and developed guidance and tools to help further the 
Initiative's goals to empower states, communities, and other 
stakeholders to assess, safely clean up, sustainably reuse, and 
prevent future brownfield sites. EPA's Brownfields Initiative 
established a number of practices, policies, and guidances to 
support cleanup and reuse at contaminated property. In 2002, many 
elements of EPA's Brownfields Initiative were codified into CERCLA 
by the Brownfields Amendments.
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    EPA aims to further support reasonable liability and litigation 
outcomes through the implementation of its CERCLA enforcement program. 
EPA will continue to implement its ``Enforcement First'' policy 
(``Guidelines for Using the Imminent Hazard, Enforcement and Emergency 
Response Authorities of Superfund and Other Statutes,'' 1982)--in which 
EPA aims to compel viable PRPs to conduct and pay for investigation and 
cleanup before resorting to the Fund--which supports the Polluter Pays 
principle. EPA has a proven track record of developing and applying 
enforcement discretion policies that are effective and well-received by 
the public and interested parties, and courts have sanctioned this 
approach. Enforcement discretion policies historically have given EPA 
the needed flexibility to offer liability comfort or protections when 
circumstances warrant. For example, for more than 30 years, EPA has 
maintained its ``Policy Towards Owners of Residential Property at 
Superfund Sites,'' which generally provides that EPA will not take 
action against residential property owners provided their own actions 
do not cause a release that requires a response action.
    Although EPA believes existing limitations in CERCLA coupled with 
existing CERCLA enforcement policies mitigate concerns about liability 
that may arise after designation, EPA recognizes that some parties that 
do not bear primary responsibility for litigation may be sued and face 
uncertain litigation costs as a consequence. EPA believes that the 
statutory safeguards described above will likely limit this type of 
litigation, or at a minimum, limit adverse outcomes. Even if litigation 
costs are incurred by parties that do not bear primary responsibility, 
EPA does not believe that these potential costs will outweigh the 
substantial advantages from the rule.
    While some commenters shared concerns that these mechanisms may not 
mitigate concerns, these commenters did not support their concerns with 
any specific data or evidence. Generally, in enforcement matters, the 
facts, circumstances, and equities of a case help dictate which parties 
the Agency will pursue. EPA, intends to develop a policy, consistent 
with those limitations and policies, that explains EPA's priorities for 
enforcement in the context of PFOA and PFOS releases.\19\ As EPA states 
in the FY 2024-2027 National Enforcement and Compliance Initiatives 
(NECI), the Agency expects to ``focus on implementing EPA's PFAS 
Strategic Roadmap and holding responsible those who significantly 
contribute to the release of PFAS into the environment . . . much as 
[EPA] exercises CERCLA enforcement discretion in other areas.''.\20\ 
Available at https://www.epa.gov/system/files/documents/2023-08/fy2024-27necis.pdf.
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    \19\ EPA received valuable public input that EPA is considering 
in drafting a CERCLA PFAS enforcement discretion policy. EPA held 
two public listening sessions in March 2023 and several stakeholder 
meetings in 2023 with the agriculture sector, water sector, pulp and 
paper sector, solid waste management sector, and NGOs to hear 
stakeholder concerns regarding potential CERCLA PFAS enforcement 
concerns.
    \20\ https://www.epa.gov/enforcement/national-enforcement-and-compliance-initiatives.
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    In sum, EPA's additional ``totality of the circumstances'' analysis 
affirms that designation is warranted. The totality of the 
circumstances analysis gave particular weight to the scientific basis 
for designation--that PFOA and PFOS may present substantial danger when 
released into the environment. EPA also concluded that designation best 
addresses the problem posed by PFOA and PFOS in the environment, 
particularly for those communities living in and around highly 
contaminated sites, and that designation meaningfully furthers CERCLA's 
purposes. Designation ensures that EPA has the full suite of CERCLA 
tools necessary to address contamination and that EPA is able to take 
more timely response actions, including those necessary to address 
immediate risks. EPA's analysis shows that designation results in 
quantitative and qualitative benefits, including significant health

[[Page 39131]]

benefits. EPA's analysis accounts for potential direct and indirect 
costs that may result from designation. Direct costs, particularly for 
release notifications, are minimal and reasonable in light of the 
substantial benefits notification provides. EPA assessed the potential 
for litigation and liability costs, particularly for parties that have 
not significantly contributed to contamination. EPA was unable to 
quantify those costs with reasonable certainty but conducted a 
qualitative assessment of CERCLA's liability provisions and enforcement 
policies to assess the potential magnitude of such costs. EPA's 
analysis shows that designation should not result in excessive or 
unreasonable liability and litigation outcomes. Rather, CERCLA will 
continue to operate as it has for decades. EPA concludes that the 
substantial advantages of designation outweigh potential disadvantages, 
and that designation is warranted based on its additional totality of 
the circumstances analysis.

D. Conclusion

    EPA concludes that designation is warranted based solely on its 
finding that PFOA and PFOS may present a substantial danger to the 
public health or welfare or the environment when released into the 
environment. Additionally, EPA believes designation is warranted based 
on its totality of the circumstances analysis. The latest science is 
clear: human exposure to PFOA and PFOS is linked to significant health 
risks. CERCLA provides the tools necessary to address those risks posed 
by significant contamination of PFOA and PFOS in the environment. 
CERCLA is designed to target and prioritize sites that present 
unreasonable risk to human health and the environment and serves those 
communities that are most vulnerable to potential adverse health risks 
from exposure. Designation eliminates barriers to cleanup and enables 
EPA to secure more timely actions. It streamlines response authority, 
provides a mechanism for parties to recover response costs from PRPs, 
and makes available CERCLA enforcement authority to compel PRPs to 
conduct or pay for cleanup. Designation also requires facilities to 
notify Federal, State, local, and Tribal authorities, as well as 
potentially injured parties, of significant releases. EPA considered 
the potential costs that may arise after designation, including both 
quantified and unquantified costs, and finds that they are outweighed 
by the substantial advantages of designation. Further delay in 
accessing CERCLA's complete suite of tools to address contamination 
will allow PFOA and PFOS more time to migrate within the environment 
and exacerbate existing contamination. Thus, designation best achieves 
CERCLA's primary objectives--the timely cleanup of contaminated sites 
and ensuring that those responsible for contamination pay to clean it 
up. Designation will help protect communities near contaminated sites 
from potential health risks. For all these reasons, discussed in detail 
below, EPA concludes that designation of both PFOA and PFOS as CERCLA 
hazardous substances is warranted under the statute.

II. General Information

A. What action is the Agency taking?

    As proposed on September 6, 2022, EPA is designating PFOA and PFOS, 
including their salts and structural isomers, as hazardous substances 
under section 102(a) of CERCLA. See Designation of Perfluorooctanoic 
Acid (PFOA) and Perfluorooctanesulfonic Acid (PFOS) as CERCLA Hazardous 
Substances, 87 FR 54415 (Sept. 6, 2022). The list of hazardous 
substances in Table 302.4 of 40 CFR part 302 is amended to include 
PFOA, PFOS and their salts and structural isomers. (Note: EPA's CompTox 
Chemicals Dashboard (https://comptox.epa.gov/dashboard/) is a resource 
that can be used to identify salts and structural isomers of PFOA and 
PFOS. EPA periodically updates the CompTox Chemicals Dashboard to 
include new information on PFAS, including PFOA and PFOS.)

B. What are the direct effects of this Action?

    The designation of PFOA and PFOS, including their salts and 
structural isomers, as hazardous substances, can trigger the 
applicability of release reporting requirements under CERCLA sections 
103 and 111(g), and accompanying regulations, and section 304 of the 
Emergency Planning and Community Right-to-Know Act (EPCRA). Facilities 
must report releases of hazardous substances at or above the reportable 
quantity (RQ) within a 24-hour period. For PFOA and PFOS, a default 
\21\ reportable quantity (RQ) of one pound is assigned to these 
substances pursuant to CERCLA section 102(b). Therefore, consistent 
with CERCLA section 103(a), any person in charge of a vessel or 
facility is required, as soon as they have knowledge of any release 
(other than a federally permitted release) of any PFOA, PFOS, their 
salts or structural isomers from such vessel or facility in quantities 
equal to or greater than the RQ of one pound or more within 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). https://www.ecfr.gov/current/title-40/chapter-I/subchapter-J/part-302/section-302.6.
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    \21\ 42 U.S.C. 9602(b). https://www.govinfo.gov/content/pkg/USCODE-2021-title42/pdf/USCODE-2021-title42-chap103-subchapI-sec9601.pdf.
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    In addition to CERCLA 103(a), EPCRA section 304 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 of these substances. These entities may have specific release 
reporting requirements under the State, Tribal, and local EPCRA 
program. https://www.epa.gov/epcra/state-contact-information-epcra-section-304-emergency-release-notification.
    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. EPCRA section 304 requirements are 
codified in 40 CFR 355.30 to 355.43. https://www.ecfr.gov/current/title-40/chapter-I/subchapter-J/part-355/subpart-C.
    CERCLA section 111(g) requires that owners or operators of any 
vessel or facility ``provide reasonable notice to potential injured 
parties by publication in local newspapers serving the affected area'' 
of any release of these substances.
    CERCLA section 120(h) requires Federal agencies that sell or 
transfer real property to provide notice of the presence of hazardous 
substances in certain circumstances. CERCLA section 120(h) also 
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.''
    As provided by CERCLA section 306, the Department of Transportation 
(DOT) is required to regulate any substance added to the CERCLA list as 
hazardous materials in accordance with the Hazardous Materials 
Transportation Act (HMTA).

[[Page 39132]]

    While these are the only direct, automatic requirements of 
designating PFOA and PFOS as CERCLA hazardous substances, EPA has also 
considered other, indirect impacts in the Regulatory Impact Analysis 
(RIA) of the Final Rulemaking to Designate Perfluorooctanoic Acid 
(PFOA) and Perfluorooctanesulfonic Acid (PFOS) as CERCLA Hazardous 
Substances, available in the docket, including those that are expected 
to facilitate cleanups and reduce human and environmental exposure to 
these hazardous substances.

C. Does this Action apply to me?

    The seven broad categories of entities that may potentially be 
affected by this action include, but are not limited to: (1) PFOA and/
or PFOS manufacturers (including importers and importers of articles 
that contain these substances); (2) PFOA and/or PFOS processors; (3) 
manufacturers of products containing PFOA and/or PFOS; (4) downstream 
users of PFOA and PFOS; (5) downstream users of PFOA and/or PFOS 
products; (6) waste management facilities; and (7) wastewater treatment 
facilities.\22\ (Note: PFOA and PFOS noted here include their salts and 
structural isomers.) The following list of North American Industrial 
Classification System (NAICS) codes identifies entities that may be 
directly or indirectly affected by this action. It is not intended to 
be exhaustive, but rather a guide to help readers determine whether 
this action applies to them. Potentially affected entities may include:
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    \22\ The proposed rule listed 5 broad categories of entities 
potentially affected by this designation. This action separated two 
of these categories to be clearer. Entities listed as downstream 
product manufacturers and users of PFOA and/or PFOS products in the 
proposed rule are split into two separate categories in the final 
rule (see (4) and (5)). Entities listed as waste management and 
wastewater treatment facilities in the proposed rule are split into 
two categories in the final rule (see (6) and (7)).
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D. What is the Agency's authority for taking this action?

    CERCLA section 102(a) authorizes the EPA Administrator to 
``promulgate and revise as may be appropriate, 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[.]'' CERCLA section 102(b) establishes a default RQ of one 
pound for releases of designated hazardous substances. See Section IV 
of this document for additional details on EPA's authority, including 
statutory criteria.

E. What are CERCLA's primary objectives, and how does it operate to 
protect human health and the environment?

    CERCLA establishes broad Federal authority to address past, 
current, and future releases or threat of releases of hazardous 
substances and pollutants or contaminants. The statute's primary 
objectives are to promote the timely cleanup of contaminated sites and 
to ensure parties responsible for contamination bear site cleanup 
costs. CERCLA is unlike traditional environmental statutes that 
prospectively regulate, among other things, how facilities operate and 
provide limitations on discharges, emissions, releases, or disposal of 
certain chemicals into water, air, or land. Instead, CERCLA is designed 
to address contamination already in the environment on a site-specific 
basis, which includes evaluating the nature, extent, and risk to human 
health and/or the environment from the release. CERCLA affords EPA 
broad discretion as to whether or how to respond to a release. It 
includes cost-shifting mechanisms and liability provisions that support 
PRP cleanups rather than relying on the Fund.
1. How does CERCLA authority and causes of action differ in key 
respects between ``hazardous substances'' and ``pollutants or 
contaminants''?
    For hazardous substances,\23\ CERCLA section 103(a) requires 
reporting of releases. 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 in an amount equal to or greater than the RQ for 
that substance. 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 pursuant to CERCLA and its 
accompanying regulations, the National Oil and Hazardous Substances 
Pollution Contingency Plan (NCP). (40 CFR part 300).
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    \23\ CERCLA defines ``hazardous substance'' primarily by 
reference to other environmental statutes (i.e., the Clean Water 
Act, Solid Waste Disposal Act, Clean Air Act and the Toxic 
Substances Control Act) and includes substances designated as 
hazardous under CERCLA section 102. (CERCLA section 101(14)).
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    CERCLA response authorities apply to releases or the threat of 
releases into the environment of ``hazardous substances'' and/or 
``pollutants or contaminants'' \24\; however, the CERCLA authorities 
available to address each type of release differs. With respect to 
hazardous substances, the Agency can conduct response actions if there 
is a release or threatened release; however, for pollutants or 
contaminants, EPA can only respond if it establishes that the release 
may present an imminent and substantial danger. (CERCLA section 
104(a)).
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    \24\ CERCLA defines the term ``pollutant or contaminant'' to 
include, ``but not be limited to, any element, substance, compound, 
or mixture . . . which after release into the environment and upon 
exposure, ingestion, inhalation, or assimilation into any organism . 
. . will or may reasonably be anticipated to cause death, disease, 
behavioral abnormalities, cancer, genetic mutation, physiological 
malfunctions . . . or physical deformations.'' (CERCLA 104).
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    In addition, CERCLA's cost recovery and some specific enforcement 
authorities extend to hazardous substances but not pollutants or 
contaminants. (CERCLA section 107(a), 106(a)). For hazardous 
substances, EPA can recover all response costs (e.g., investigation and 
cleanup costs) from PRPs the Agency incurs that are not inconsistent 
with the NCP and require PRPs to conduct the response. CERCLA also 
authorizes non-governmental entities (including private parties) who 
conduct cleanup activities related to hazardous substance releases to 
recover response costs from liable parties provided the costs incurred 
are consistent with the NCP.
2. What response actions does CERCLA authorize?
    CERCLA authorizes two types of response actions--removal and 
remedial. (CERCLA section 101(25)). Removals include ``such actions as 
may be necessary taken in the event of the threat of release,'' 
including those ``necessary to prevent, minimize, or mitigate damage to 
the public health or welfare or the environment.'' (CERCLA section 
101(23)). Removals are typically short-term response actions that may 
be taken to address releases or threatened releases requiring prompt 
action; they are limited in cost and duration unless specific criteria 
are met. (CERCLA section 104(c)(1)). Remedial includes those actions 
consistent with ``permanent remedy taken instead of or in addition to 
removal actions in the event of a release or threatened release of a 
hazardous substance into the environment, to prevent or minimize the 
release of hazardous substances so that they do not migrate to cause 
substantial danger to present or future public health or welfare or the 
environment'' (CERCLA section 101(24)). Remedial actions (RAs) entail 
longer-term and more complex cleanup actions designed to provide 
permanent solutions to mitigate risks typically associated with chronic 
exposures often not immediately life-threatening.

[[Page 39138]]

3. What discretionary authority does CERCLA provide and how does CERCLA 
prioritize cleanup actions?
    EPA has broad discretionary authority to decide on a site-specific 
basis whether to respond to a release or threat of release and to 
prioritize the order in which it undertakes response actions determined 
to be necessary. (CERCLA section 105(a)(8)(A)). Site-specific decisions 
take into consideration factors such as relative risk, hazard 
potential, population at risk and the potential for drinking water 
contamination. Those considerations are embodied in the NCP. (See, 
e.g., 40 CFR 300.410, 300.415, 300.430).
4. What is the CERCLA cleanup process and what role does the National 
Priorities List (NPL) play in it?
    Before identifying an appropriate response action--removal or 
remedial--EPA or another lead agency, may first identify a release, 
investigate its scope and extent, and evaluate its potential risk to 
human health and the environment. 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 (CERCLA section 104(b); 40 CFR 
300.410, 300.430(b)). After an initial investigation, EPA has several 
options, including determining a release does not pose sufficient risk 
to warrant further action and deciding that the release warrants a 
CERCLA response action. EPA may also defer the site to the State where 
it is located.
    The NCP provides guidance on the process to determine whether to 
undertake a removal or a remedial action. For removal actions, the NCP 
provides that the lead agency may take such an action when it has 
determined ``that there is a threat to public health or welfare'' based 
on a set of factors such as actual or potential exposure to drinking 
water supplies, the potential for hazardous substances to migrate, and 
the availability of other appropriate Federal or State response 
mechanisms to address the release. (40 CFR 300.415(b)). For remedial 
actions, EPA first evaluates a site for consideration as an NPL site, 
(40 CFR part 300 App. A); only sites added to the NPL are eligible for 
Superfund monies to conduct remedial actions.
    A site's addition to the NPL does not trigger any immediate action 
but represents an initial step towards a site's potential long-term 
remedy; NPL sites are among the Nation's worst contaminated sites. EPA 
has placed on the NPL only about 3 percent of the 53,400 sites assessed 
since the program's beginning in 1980.
5. What is the process for identifying and selecting remedial actions 
under CERCLA?
    EPA can only begin the process to identify potential remedial 
actions after completing the careful and deliberate process to add a 
site to the NPL. CERCLA and the NCP together prescribe a comprehensive 
and detailed process for evaluating, selecting, and implementing 
remedies, which includes State and community roles. (40 CFR 300.430). 
The process' first step is conducting a remedial investigation and 
feasibility study (RI/FS) to assess site conditions and to evaluate the 
remedial alternatives identified. (40 CFR 300.430(a)(2)). Next, the NCP 
mandates consideration of several factors by which to evaluate remedial 
alternatives. (40 CFR 300.430(e)(9)). At a minimum, all eligible 
remedies must be protective of human health and the environment and 
comply with all applicable or relevant and appropriate requirements 
(ARARs).\25\ (CERCLA section 121(a), (d); 40 CFR 300.430(f)(1)(i)(A)). 
The alternatives satisfying these two threshold criteria are then 
further evaluated against one another using balancing criteria, 
including factors such as long-term effectiveness and permanence; 
toxicity, mobility or volume reduction; implementability; cost; and 
finally modifying criteria of State acceptance; and community 
acceptance. (40 CFR 300.430(e)(9), (f)).
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    \25\ ARARs may be waived under certain circumstances. (CERCLA 
section 121(d)(4)).
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    A remedial action's selection must include public review and 
comment on the lead agency's preferred alternative as presented in a 
proposed plan. (CERCLA section 117; 40 CFR 300.430(f)(2)). EPA 
documents its selection of a remedy in a record of decision. (40 CFR 
300.430(f)(1)(ii)).
    A site's selected remedy then enters the remedial design (RD)/
remedial action (RA) stage in which the remedy is designed and 
constructed, followed in some instances by an Operation & Maintenance 
(O&M) period.\26\ (40 CFR 300.435(a), (f)). Five-year reviews (FYR) 
\27\ are required at sites where completed remedial actions result in 
any hazardous substances, pollutants, or contaminants remaining onsite. 
(CERCLA section 121(c)). They also must be conducted where remedial 
actions result in any hazardous substances, pollutants, or contaminants 
remaining at the site above levels that allow for unlimited use and 
unrestricted exposure after the initiation of the selected remedial 
action. (40 CFR 300.430(f)(4)(ii)).
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    \26\ O&M is an important component of a Superfund response, 
ensuring that the remedy continues to perform as intended and 
remains protective of human health and the environment. O&M 
activities may include remedy operation, maintenance and monitoring, 
as well as monitoring of impacted media and monitoring and 
maintenance of implemented Institutional Controls (IC)s. ICs are 
non-engineered instruments, such as administrative and/or legal 
controls, that help minimize the potential for human exposure to 
contamination and/or protect the integrity of a remedy by limiting 
land or resource use. Examples include fishing restrictions, deed 
restrictions, and the posting of warning signs outside of a 
contaminated site.
    \27\ Five-year reviews evaluate the implementation and 
performance of a remedy to determine whether it remains protective.
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6. How does CERCLA's framework ensure that those responsible for 
contamination pay for cleanup?
    A critical CERCLA component is holding those responsible for the 
contamination accountable to perform or pay for its cleanup. EPA's 
preference, and one of CERCLA's main goals, is to have PRPs be 
responsible for the cleanup of releases of hazardous substances. EPA 
can compel a PRP to take action pursuant to a CERCLA enforcement 
instrument. (CERCLA section 106). EPA can also perform the response 
action using Fund money and then seek reimbursement of costs incurred 
from liable parties in litigation, (CERCLA section 107(a)), or 
subsequent cost recovery settlement (CERCLA section 122(a)). Under 
CERCLA, potentially liable parties include: (1) current owners and 
operators of facilities, (2) past owners and facility operators in 
place at the time of hazardous substance disposal, (3) any person who 
``arranged for disposal'' of that facility's hazardous substances, and 
(4) any person that accepts hazardous substances for ``transport to 
disposal or treatment facilities.'' (CERCLA section 107(a)(1)-(4)). If 
found liable under the statute, a PRP is financially responsible for 
the government's response costs incurred not inconsistent with the NCP 
in addition to other categories of costs. (CERCLA section 107(4)(A)-
(D).

[[Page 39139]]

7. What enforcement discretion is available when exercising CERCLA 
authority?
    EPA has a proven track record of developing and applying 
enforcement discretion policies that are effective and well-received, 
and courts have sanctioned this approach. CERCLA's limitations and 
EPA's enforcement discretion policies historically have given EPA the 
needed flexibility to provide assurances when circumstances warrant. 
Although CERCLA's liability scheme is broad, the statutory affirmative 
defenses and EPA's enforcement discretion policies provide mechanisms 
to narrow the scope of liability and focus on the significant 
contributors to contamination.
    Both the statute and EPA enforcement discretion policies may 
constrain a party's ability to secure reimbursement of response costs. 
CERCLA itself includes liability exemptions as well as affirmative 
defenses against liability. See, e.g., CERCLA section 101(10), 107(b), 
(d), (k). Additionally, parties must prove that response costs incurred 
are consistent with the National Contingency Plan, CERCLA's 
implementing regulations. Id. section 107(a)(4)(B). Parties must also 
incur response costs before they can recover those costs from other 
viable, liable parties. EPA's enforcement authorities and policies can 
serve as a deterrent for responsible parties to pursue parties that did 
not contribute significantly to contamination. EPA has a well-proven 
track record of developing enforcement discretion policies that have 
been effective and well-received by stakeholders. EPA's enforcement 
policies, such as its policy regarding de minimis or de micromis 
parties and innocent landowner policies, have proven to be useful tools 
in convincing responsible parties not to pursue parties covered by 
these enforcement discretion policies. Finally, the statute provides 
that a party that resolves its potential liability with the United 
States or a State in a judicially approved settlement is entitled to 
contribution protection--the ability to block third-party claims for 
matters addressed in the settlement. These liability limitations and 
mitigation tools are more fully discussion in Section VI.B.2.
8. Why is understanding CERCLA's overarching provisions critical to 
understanding the importance of this rulemaking to EPA's ability to 
protect human health and the environment?
    Understanding CERCLA's basic concepts, particularly its liability 
scheme and CERCLA's authority to address hazardous substances (versus 
its authorities to respond to pollutants or contaminants) are essential 
to understanding this regulatory action's importance in protecting 
human health and the environment. Designating PFOA and PFOS as 
hazardous substances is an important step for EPA to take because it 
makes available the full suite of CERCLA tools to address releases of 
these substances. Designation provides a more streamlined path to 
respond to PFOA and PFOS releases. It also makes available CERCLA 
enforcement authority that EPA can use to compel PRPs to pay for or 
conduct CERCLA response actions, rather than EPA using the Fund to 
clean up. Designation is expected to expediate PFOA and PFOS cleanups, 
and in turn, mitigate risks to public health and the environment from 
these substances.

III. Background for This Rulemaking

A. Summary of Proposed Designation

    On September 6, 2022 (87 FR 54415), EPA proposed to find that PFOA 
and PFOS and their salts and structural isomers warrant designation as 
hazardous substances pursuant to CERCLA section 102(a). EPA concluded 
that significant evidence indicates that PFOA and PFOS may present a 
substantial danger to public health or welfare or the environment when 
released. (87 FR 54417, 54423). In reaching the proposed conclusion, 
the Agency relied on a significant body of evidence showing that PFOA 
and PFOS are persistent and mobile in the environment and that exposure 
to such substances may lead to adverse health effects.
    The Agency primarily relied on evidence concerning the hazard and 
fate and transport, as well as other information that may be relevant 
to whether the statutory criteria are met. EPA looked at scientific and 
technical data regarding toxicity and toxicokinetics, chemical and 
physical characteristics, and environmental prevalence of PFOA and PFOS 
to support the proposed finding that these chemicals may present 
substantial danger when released into the environment. See Proposed 
Rule, 87 FR at 54423-29. In short, the evidence related to the chemical 
and physical characteristics indicated that PFOA and PFOS are 
persistent in the environment and that they bioaccumulate in both 
humans and wildlife. The evidence also showed that PFOA and PFOS are 
distinct from many other bioaccumulative chemicals because their water 
solubility allows PFOA and PFOS to more readily migrate from soil to 
groundwater; thus, their release into the environment has the potential 
to contaminate both surface water and groundwater used as drinking 
water sources.
    Concerning the toxicity and toxicokinetics, both human and animal 
studies supported a conclusion that exposure to PFOA and PFOS may cause 
adverse health effects, including effects on the immune system, the 
cardiovascular system, fetus development, and cancer. The evidence also 
showed that PFOA and PFOS are prevalent in the environment because they 
have been produced and used since the 1940s and are resistant to 
degradation. The evidence showed that PFOA and PFOS are not only 
prevalent in humans, but also prevalent in environmental media, wild 
animals, livestock, and plants. EPA concluded that the prevalence of 
these substances impacts the environment directly and increases the 
likelihood of exposures that may lead to additional human exposure.
    The adverse human health effects, mobility, persistence, 
prevalence, and other information about PFOA and PFOS combined to 
support EPA's proposed finding that these chemicals may present a 
substantial danger to public health or welfare or the environment when 
released such that designation of PFOA and PFOS as CERCLA hazardous 
substances is warranted.

B. PFOA and PFOS Production and Use

    PFOA and PFOS are part of a large family of human-made chemicals 
known as PFAS that have been in use in the U.S. since the 1940s. PFAS, 
including PFOA and PFOS, are used in industry and consumer products 
because of their useful properties, including their resistance to 
water, grease, and stains. These substances have 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 have also been 
used for firefighting and various industrial processes. 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. Once dissolved in water, the salt 
and the acid forms will dissociate into the respective ions. See 
Proposed Rule, 87 FR at 54417 (providing a brief history of PFOA and 
PFOS production and use).
    Production and use of these chemicals have resulted in releases 
into the

[[Page 39140]]

environment for many decades. Historic releases of PFOA and PFOS are 
significant sources of environmental contamination and present ongoing 
hazards to human health and the environment. Precursors of PFOA and 
PFOS can be converted to PFOA and PFOS 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 or in a landfill without environmental 
controls can discharge via leachates, groundwater pollution/migration, 
and atmospheric releases.
    PFAS have been detected in the ambient environment, in wildlife, 
and in humans around the globe, and PFOA and PFOS were among the most 
used PFAS from the beginning of their development in the 1940s (Blake & 
Fenton, 2020; Calafat et al., 2007; Domingo & Nadal, 2019; Hanssen et 
al., 2013; Olsen et al., 2017). The potential health risks associated 
with PFAS were first recognized in occupationally exposed workers in 
the 1980s and community level exposure concerns were first raised in 
1998. Since that time, the U.S. government, including EPA, and many 
other environmental and human health organizations both within the U.S. 
and internationally have researched PFAS to determine the risks posed 
by exposure to such chemicals. The additional evaluation since the late 
1990s has added support for early concerns that exposure to PFAS may 
present a risk and that exposure to long chain PFAS, such as PFOA and 
PFOS, are of particular concern because of, among other things, their 
prevalence in the environment, mobility, and resistance to degradation.
    In response to the growing body of evidence concerning the 
potential risks, Federal, State, and international agencies have taken 
steps to mitigate exposure to PFOA and PFOS. For example, in 2016, the 
FDA revoked a regulation that allowed the use of long chain PFAS in 
food contact applications in the U.S.; the DoD added PFOA and PFOS to 
its list of emerging chemicals of concern and is in the process of 
requiring any of its new firefighting foam it purchases to be made 
without PFAS per a January 2023 military specification; several States 
have established groundwater cleanup standards for PFOA and/or PFOS; 
and PFAS, including PFOA and PFOS, are addressed in several 
international treaties.\28\
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    \28\ See Proposed Rule, 87 FR at 54429-39 (providing a list of 
regulatory and other PFAS related actions at EPA, other Federal 
Agencies, states, and international agencies).
---------------------------------------------------------------------------

    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 (U.S. EPA, 2023c, 2023d). 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 (U.S. 
EPA, 2023a). The EPA Chemical Data Reporting (CDR) rule (see 40 CFR 
721.9582) under 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. The reports showed that these chemicals 
were still being produced or used in those reporting years, however 
manufacturers did not report PFOA and PFOS in excess of the reporting 
limit in subsequent reporting cycles. However, 2020-2022 Toxic Release 
Inventory (TRI) data show that PFOA and PFOS continue to be released 
into the environment, which means that there are on-going uses of these 
substances. Pursuant to TRI reporting requirements, regulated 
facilities must report annually on releases and other waste management 
of toxic chemicals that they manufacture, process, or otherwise use 
above certain threshold quantities. The TRI reporting threshold for 
PFOA and PFOS is 100 pounds. Between 2020 and 2022, TRI data on 
releases \29\ of PFOA, PFOS, and their salts \30\ reported by 21 
facilities amount to 71,411 lbs. In 2020, TRI data on releases of PFOA, 
PFOS, and their salts reported by nine facilities totaled 1,706 lbs. In 
2021 and 2022, reported releases increased to 24,351 lbs. and 45,384 
lbs., respectively.\31\ PFOA is not produced domestically or imported 
by the companies participating in the 2010/2015 PFOA Stewardship 
Program. However, based on the TRI report, it is possible that PFOA may 
still be produced domestically or imported by companies that did not 
participate in the PFOA Stewardship Program and that PFOS may be as 
well.
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    \29\ Facilities are required to report total releases per year 
of listed toxic chemicals into the environment (e.g., releases to 
land on-site, discharges to receiving streams or water bodies, 
etc.). https://www.ecfr.gov/current/title-40/part-372/subpart-E#p-372.85(b)(14) (40 CFR 372.85(b)(14).
    \30\ As of November 2023, the list of toxic chemicals under the 
TRI program include 8 salts, as well as PFOA and PFOS, that are also 
listed as CERCLA HSs in this final action.
    \31\ In addition to these releases, the TRI also includes data 
on PFOA and PFOS production-related waste. See U.S. Environmental 
Protection Agency. Toxic Release Inventory (TRI) Search. Available 
at: https://www.epa.gov/enviro/tri-search.
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    Environmental contamination and resulting human exposure to PFOA 
and PFOS are anticipated to continue for the foreseeable future due to 
their past wide-scale manufacture and use, environmental persistence, 
formation from precursor compounds, and continued limited domestic 
production and use. 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 (NHANES). This indicates 
humans are still being exposed to PFOA and PFOS.

C. EPA's PFAS Strategic Roadmap

    EPA issued the PFAS Strategic Roadmap (Roadmap) in October 2021, 
wherein the Agency recognized the potential dangers posed by exposure 
to PFAS and committed to a comprehensive whole-of-Agency plan to 
address PFAS (U.S. EPA, 2021a). EPA's integrated approach to PFAS is 
focused on three central directives: (1) Research. Invest in research, 
development, and innovation to increase understanding of PFAS exposures 
and toxicities, human health and ecological effects, and effective 
interventions that incorporate the best available science; (2) 
Restrict. Pursue a comprehensive approach to proactively prevent PFAS 
from entering air, land, and water at levels that can adversely impact 
human health and the environment; and (3) Remediate. Broaden and 
accelerate the cleanup of PFAS contamination to protect human health 
and ecological systems. The Roadmap committed to an Agency-wide 
approach, in which EPA would utilize the tools at its disposal to 
urgently address PFAS and bring tangible health benefits to communities 
impacted by PFAS. EPA identified a variety of authorities to address 
PFAS, including the TSCA, the Safe Drinking Water Act (SDWA), CWA, and 
RCRA, in addition to CERCLA. The Agency recognized that each authority 
has a unique set of tools to address discrete and specific 
environmental challenges posed by PFAS. Since 2021, EPA has taken 
several actions to address PFAS contamination under the Agency's 
various regulatory programs. Visit Agency's website at https://www.epa.gov/pfas/key-epa-actions-address-pfas.

[[Page 39141]]

IV. Legal Authority

A. CERCLA Section 102(a) Designation Considerations

    In this action, the Administrator is exercising his authority to 
designate PFOA and PFOS as hazardous substances pursuant to CERCLA 
section 102(a). CERCLA's definition of ``hazardous substances'' 
includes any substance designated pursuant to specified provisions in 
select environmental statutes (CWA, RCRA, CAA, and TSCA) and ``any 
element, compound, mixture, solution, or substance designation pursuant 
to [CERCLA section 102]. CERCLA section 101(14).\32\ Section 102(a), in 
turn, provides clear authority to designate hazardous substances in 
addition to substances designated automatically through the operation 
of CERCLA section 101(14). In relevant part, section 102(a) provides 
that, ``[t]he Administrator shall promulgate and revise as may be 
appropriate, regulations designating as hazardous substances, in 
addition to those referred to in section 101(14), 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. . . .'' The statutory language 
delegates to EPA the authority to identify and weigh the scientific, 
technical, and other factual information relevant to determining 
whether a substance ``may present a substantial danger,'' and then 
determine whether to promulgate regulations designating such 
substances.
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    \32\ The complete definition of ``hazardous substances'' is: 
``(A) any substance 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 substance 
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 subparagraphs (A) through (F) of this paragraph, and the term 
does not include natural gas, natural gas liquids, liquefied natural 
gas, or synthetic gas usable for fuel (or mixtures of natural gas 
and such synthetic gas).''
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    Reading Section 102(a) in context, including the broader context of 
CERCLA as a whole, EPA affirms the factors it proposed to evaluate for 
determining what constitutes ``substantial danger'' and designating 
hazardous substances under CERCLA section 102(a). 87 FR at 54421. To 
inform its decision whether a substance, when released, may present 
``substantial danger'' pursuant to CERCLA section 102(a), EPA considers 
two primary factors: the potential harm to humans or the environment 
from exposure to the substance (i.e., hazard), and how the substance 
potentially moves, persists and/or changes when in the environment 
(i.e., environmental fate and transport). EPA will then weigh this 
information in deciding whether the substance, when released, may 
present a substantial danger.
    In deciding whether a substance presents potential harm to humans 
or the environment from exposure to the substance (hazard), EPA may 
consider such information as human health toxicity, including 
carcinogenicity, neurotoxicity, developmental toxicity, reproductive 
toxicity, and other adverse health effects. EPA may also consider 
toxicity or adverse impacts to non-human organisms or ecosystems, such 
as adverse effects to wildlife, aquatic life, or other natural 
resources, including adverse impacts on populations of endangered or 
threatened species or significant degradation of environmental quality 
over broad areas. Additionally, EPA may consider chemical properties 
such as combustibility, flammability, reactivity, or corrosiveness. 
Regarding the environmental fate and transport of a substance, EPA may 
consider whether a substance moves readily through the environment, and 
whether it persists and/or changes in the environment.
    In weighing this information, EPA will consider the degree or 
magnitude of the danger posed based on the substance's hazard and 
environmental fate and transport characteristics. The hazard that a 
substance presents can be shown in a variety of ways. For example, it 
could be toxic to humans or other organisms in the environment, or it 
could exhibit a more physical hazard, such as corrosivity or 
explosivity.
    In assessing a substance's hazard if based on toxicity, EPA could 
consider whether the substance may be acutely toxic (and thus lead to 
an immediate health problem or even death) or may have chronic toxicity 
(and thus lead to detrimental health effects after long-term exposure). 
For example, there could be a substance that is acutely toxic but does 
not move far from the point of release. This substance might pose 
substantial danger due to its ability to immediately harm people and 
other organisms at the point of release. As another example, there may 
be a substance that exhibits chronic toxicity and is very persistent. 
In this case, the substance might also pose substantial danger when 
released because people and other organisms near the point of release 
could be exposed to the substance over a long period of time, 
potentially leading to adverse health effects. Designation may be 
appropriate if the hazard and fate and transport, when taken together, 
demonstrate there may be danger and the danger is substantial.
    Hazard and environmental fate and transport are the primary factors 
EPA will assess in evaluating whether to designate a substance under 
section 102(a). However, EPA may also consider additional information 
that could inform the degree of danger a substance may pose when 
released. This includes, but is not limited to, information such as 
frequency, nature, and geographic scope of releases (e.g., prevalence) 
and likelihood of human exposure. For example, the Agency may review 
accident history or other release data (e.g., TRI, UCMR) to determine 
how frequently a substance is released or found in the environment, and 
how or if the substance has caused any adverse health effects to the 
public or the environment. Together with hazard and environmental fate 
and transport, this additional information will inform EPA's conclusion 
on whether a substance, when released, may present a substantial danger 
to public health or welfare or the environment.
    EPA interprets section 102(a) as requiring that, at a minimum, 
there is a possibility the substance, when released into the 
environment, presents substantial danger. EPA need not have certainty 
that the substance poses a substantial danger or require proof of 
actual harm when released into the environment. This reading of CERCLA 
section 102(a) is consistent with the ordinary meaning of ``may'' which 
is defined as a term ``used to indicate possibility or probability.'' 
Merriam-Webster (https://www.merriam-webster.com/dictionary/may). It is 
also consistent with the caselaw interpreting the term ``may'' in the 
phrase ``may present an imminent and substantial endangerment'' under 
RCRA, which has been construed as not requiring certainty. See ME. 
People's Alliance v. Mallinckrodt, Inc., 471 F.3d 277, 288 (1st Cir. 
2006) (noting that ``at least four of our sister circuits have 
construed [section 7002(a)(1)(B)] expansively'' and that ``all four 
courts have emphasized the preeminence of the word `may' in

[[Page 39142]]

defining the degree of risk needed to support [section 7002(a)(1)(B)'s] 
liability standard'' and that certainty of harm is not required); Price 
v. United States Navy, 39 F.3d 1011, 1019 (9th Cir. 1994) (reasoning 
that the term ``may'' ``implies that there must be a threat which is 
present now, although the impact of the threat may not be felt until 
later'').
    The information that EPA may consider in determining whether the 
release of a substance may present a substantial danger is consistent 
with the criteria that the Agency uses in implementing CERCLA through 
the Hazard Ranking System (HRS) (U.S. EPA, 2023b). CERCLA section 
105(a)(8)(A) requires EPA to set criteria for determining priorities 
among releases or threatened releases throughout the United States for 
the purpose of taking remedial and removal action, to the extent 
practicable taking into account the potential urgency of such action. 
The statute directs EPA to develop criteria based upon relative risk or 
danger to public health or welfare or the environment, taking into 
account to the extent possible the population at risk, the hazard 
potential of the hazardous substances at such facilities, the potential 
for contamination of drinking water supplies, the potential for direct 
human contact, the potential for destruction of sensitive ecosystems, 
the damage to natural resources which may affect the human food chain 
and which is associated with any release or threatened release, and the 
contamination or potential contamination of the ambient air which is 
associated with the release or threatened release. EPA's regulations 
establishing criteria for placing sites on the National Priorities List 
are codified in EPA's Hazard Ranking System (HRS), 40 CFR part 300 App. 
A. Ultimately, the HRS factors are consistent with the information EPA 
considered in designating PFOA and PFOS under CERCLA section 102(a).
    The standard that EPA has adopted for CERCLA section 102(a) is also 
consistent with EPA's interpretation of similar statutory language. 
See, e.g., CERCLA section 104(a) (allowing for response to pollutants 
or contaminants that ``may present an imminent and substantial 
danger'') and CERCLA section 106(a) (granting enforcement authority 
``when there may be an imminent and substantial endangerment'').\33\ 
For example, CERCLA section 106(a) provides EPA with enforcement 
authority when ``there may be an imminent and substantial 
endangerment.'' EPA guidance provides that EPA should rely on 
``scientific evidence and documentation'' to determine if conditions 
may present an imminent and substantial endangerment (Breen et al., 
2001). This may include an evaluation of site-specific conditions that 
provide a ``reasonable cause for concern that someone or something may 
be exposed to a risk of harm by a release or a threatened release of a 
hazardous substance.'' B.F. Goodrich Co. v. Murtha, 697 F. Supp. 89, 96 
(D. Conn. 1988). ``Hazard'' and ``fate and transport'' are inherently a 
part of that analysis, and courts have long examined such 
considerations under CERCLA section 106(a). See, e.g., United States v. 
Northeastern Pharmaceutical and Chemical Co., Inc., 579 F. Supp. 823, 
832 (W.D. Mo. 1984), aff'd in part, rev'd in part, 810 F.2d 726 (8th 
Cir. 1986) (examining toxicological properties, hazard, fate and 
transport, as well as likelihood of exposure in determining whether 
substances posed an ``imminent and substantial endangerment''); United 
States v. E.I. du Pont de Nemours & Co., Inc., 341 F.Supp.2d 215, 247 
(W.D.N.Y. 2004) (collecting cases and concluding endangerment exists 
where, examining all impacts, ``there is reasonable cause for concern 
that someone or something may be exposed to a risk of harm by a release 
or a threatened release''); see also Cox v. City of Dallas, Tex., 256 
F.3d 281, 300 (5th Cir. 2001) (examining hazard and fate and transport 
posed from dangerous gases in concluding that old landfill ``may 
present an imminent and substantial endangerment'' under RCRA).\34\
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    \33\ These provisions concern enforcement and response actions 
and apply to and require analysis of narrow, site-specific 
circumstances relevant to a particular facility or person, and to a 
specific event. As a result, the Agency conducts an assessment of 
the particular situation at each site when it invokes those other 
authorities. That purpose is distinct from the purpose of CERCLA 
section 102(a), which requires a more generalized, non-site-specific 
evaluation.
    \34\ CERCLA section 106 sets forth a site-specific standard, 
which differs from the general applicability of CERCLA section 
102(a). The language between each section also slightly differs. The 
phrase ``imminent and substantial endangerment'' in section 106 is 
different from the phrase ``may present a substantial danger'' in 
section 102. However, given the similar language, the factors that 
courts have considered in analyzing whether a substance poses a 
threat under section 106 are instructive to determining whether a 
substance ``may pose a substantial danger'' under section 102.
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B. Consistency With Other Methodologies for Identifying CERCLA 
Hazardous Substances

    The two central factors that EPA considers in the context of CERCLA 
section 102(a)--hazard, as well as fate and transport--are consistent 
with other methodologies used for identifying CERCLA hazardous 
substances. CERCLA's list of ``hazardous substances'' includes more 
than 800 substances identified as hazardous or toxic by Congress or EPA 
under the following 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 chemicals.
    See 40 CFR Table 302.4 (list of hazardous substances).
    EPA has applied these authorities in a manner similar to how EPA is 
interpreting and applying its authority under CERCLA section 102(a) in 
this action. For this designation, under section 102(a), EPA evaluated 
toxicity data to assess ``hazard'' from exposure to PFOA and PFOS. 
Similarly, the statutes cited in CERCLA's definition of hazardous 
substance consider toxicity in some fashion in their listing or 
identification decisions. See RCRA section 3001 (providing that EPA's 
criteria for listing RCRA regulated hazardous wastes take into account 
``toxicity,'' along with other factors); CWA section 311(b)(2)(A) and 
42 FR 10474, 10475 (March 13, 1978) (describing ``toxicological 
selection criteria'' for hazardous substances designated under the CWA 
section 311); CWA section 307(a) (providing CWA authority to list 
``toxic pollutants'' taking into account ``toxicity of the 
pollutant''); CAA section 112(b)(2) (providing CAA authority to 
identify air toxics which ``present, or may present . . . a threat of 
adverse human health effects (including . . . substances which are 
known to be, or may reasonably be anticipated to be . . . acutely or 
chronically toxic)); TSCA section 7 (providing TSCA authority to 
identify a chemical substance or mixture as imminently hazardous when 
it ``presents an imminent and unreasonable risk of serious or 
widespread injury to health or the environment, without consideration 
of costs or other non-risk factors.'').
    EPA also evaluated data regarding the fate and transport of PFOA 
and PFOS in the environment. This analysis focused primarily on the 
chemical and physical characteristics of PFOA and PFOS, including 
mobility, resistance to degradation, and persistence in the

[[Page 39143]]

environment. Similarly, the CWA, RCRA, and CAA provisions referenced in 
CERCLA, also consider persistence and resistance to degradation in 
their listing and identification decisions. See CWA section 307(a) 
(providing that EPA may list toxic pollutants under the CWA that take 
into account ``persistence and degradability,'' alongside toxicity); 
RCRA section 3001 (providing that EPA's criteria for listing RCRA 
regulated hazardous wastes take into account ``persistence and 
degradability in nature,'' along with other factors); CAA section 
112(b)(2) (identifying ``bioaccumulation'' as a consideration for 
evaluating whether a pollutant may be identified as a hazardous air 
pollutant under CAA).

C. CERCLA Section 102(a) and Cost Considerations

    EPA proposed interpreting CERCLA section 102(a) as precluding the 
consideration of cost in designating CERCLA hazardous substances. EPA 
recognizes that, as a general matter, a statutory assessment of health- 
and environmental-based criteria like the criteria in section 102 does 
not typically allow for consideration of costs. See, e.g., Whitman v. 
American Trucking, 531 U.S. 457, 471 (2001) (finding that public health 
criteria provided in the Clean Air Act, interpreted in its statutory 
and historical context and with appreciation for its importance to the 
CAA as a whole, unambiguously bars cost considerations.''). EPA is not 
resolving in this final action whether section 102 is best construed as 
precluding or requiring consideration of costs in designating a 
hazardous substance. It need not resolve this question here because 
designation is appropriate under either construction. Specifically, as 
discussed in Section V, examining only whether PFOA and PFOS may 
present a substantial danger to public health or welfare or the 
environment, without considering costs and benefits, EPA has concluded 
that designation is warranted. In addition to the analysis of the 
health- and environmental-based criteria, EPA also conducted a 
totality-of-the-circumstances analysis, including an evaluation of 
quantitative and qualitative benefits and costs of designation. This 
additional analysis confirmed that designation is appropriate. In sum, 
designation is warranted either by examining the health- and 
environmental-based criteria alone or by examining these criteria along 
with the broader totality of the circumstances.

V. PFOA and PFOS May Present a Substantial Danger to the Public Health 
or Welfare or the Environment When Released Into the Environment

    In evaluating hazard with respect to PFOA and PFOS, EPA considered 
the substantial evidence, based on epidemiological and toxicological 
studies, indicating that human exposure to PFOA or PFOS is linked to 
adverse human health effects. Regarding environmental fate and 
transport, EPA considered evidence that PFOA and PFOS migrate through 
the environment from the point of release, that they persist in the 
environment for long durations, and that they bioaccumulate in humans 
and other organisms.
    For PFOA and PFOS, EPA considered other relevant information about 
the frequency, nature, and geographic scope of releases of the 
substances (i.e., prevalence) demonstrating that these substances have 
been widely detected in drinking water, surface water, wild animals, 
and humans in the United States. This other information about the 
prevalence of PFOA and PFOS is relevant to EPA's designation decision 
because widespread detections of these substances in the environment 
and people demonstrates a greater potential for communities to be 
exposed to the substances at concentrations that could result in 
adverse health effects. EPA weighed all of this information--hazard, 
environmental fate and transport, prevalence--in evaluating the degree 
or magnitude of danger posed. EPA concluded that PFOA and PFOS may 
present a substantial danger when released because of the potential for 
harm to human health, evidence of persistence and bioaccumulation, and 
high likelihood of exposure.

A. PFOA and PFOS Pose a Hazard

    EPA is confirming the proposed finding that exposure to PFOA and 
PFOS may pose a hazard, after evaluating the available scientific and 
technical information as well as public comments. There is evidence 
from both epidemiological and animal toxicological studies that oral 
exposure to either PFOA or PFOS has been associated with various 
adverse health effects across many health outcomes. Numerous health 
studies support a finding that PFOA and PFOS exposure can lead to 
adverse human health effects, including cancer (testicular and kidney 
for PFOA, liver cancer for PFOS), pregnancy-induced hypertension and 
preeclampsia, and decreased immune response to vaccination (ATSDR, 
2021). Toxicology studies suggest that PFOA and PFOS exposure is 
associated with decreases in serum thyroid hormone levels \35\ and 
adverse effects to the endocrine system (ATSDR, 2021; USEPA, 2024b; 
2024c).
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    \35\ Decreased thyroid hormone levels are associated with 
effects such as changes in thyroid and adrenal gland weight, hormone 
fluctuations, and organ histopathology (ATSDR, 2021; USEPA, 2024b; 
USEPA, 2024c).
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    Based on studies of PFOA and PFOS, in 2021, EPA found that PFOA and 
PFOS may have adverse effects on public health (''Announcement of the 
Final Regulatory Determinations for Contaminants on the Fourth Drinking 
Water Contaminant Candidate List,'' 2021). EPA determined that studies 
indicate human exposure to PFOA and/or PFOS is linked to a broad range 
of adverse health effects, including developmental effects to fetuses 
during pregnancy or to infants (e.g., low birth weight, accelerated 
puberty, skeletal variations), liver effects (e.g., tissue damage), 
immune effects (e.g., antibody production and immunity), and other 
effects (e.g., cholesterol changes). Both PFOA and PFOS are known to be 
transmitted to the fetus via the placenta and to the newborn, infant, 
and child via breast milk or formula made with contaminated water. Both 
compounds were also associated with carcinogenic effects in human 
epidemiological and long-term animal studies (NTP, 2020; U.S. EPA, 
2016a, 2016b). In November 2023, the International Agency for Research 
on Cancer (IARC) evaluated the carcinogenicity of PFOA and PFOS and 
classified PFOA as carcinogenic to humans (Group 1) and PFOS as 
possibly carcinogenic to humans (Group 2b) (Zahm, et al., 2023).
    These adverse health effects of PFOA and PFOS were further 
described in the final toxicity assessments and Final Maximum 
Contaminant Level Goals (MCLGs \36\) for Perfluorooctanoic Acid (PFOA) 
and Perfluorooctane Sulfonic Acid (PFOS) in Drinking Water (U.S. EPA, 
2024b, 2024c, 2024d). These toxicity assessments indicate that PFOA and 
PFOS are associated with adverse health effects at lower levels than 
previously recognized. In the final toxicity assessments, EPA assessed 
the weight of the evidence for the available cancer data and determined 
that PFOA and PFOS are Likely to Be Carcinogenic to Humans consistent 
with the Guidelines for Carcinogen Risk Assessment (U.S. EPA, 2005). 
For PFOA, this determination is based on

[[Page 39144]]

the evidence of kidney and testicular cancer in humans and Leydig cell 
tumors, pancreatic acinar cell tumors, and hepatocellular adenomas in 
rats. (U.S. EPA, 2024c, 2024d). For PFOS, this determination is based 
on the evidence of hepatocellular tumors in humans and rats, pancreatic 
islet cell carcinomas in male rats, and mixed but plausible evidence of 
bladder, prostate, kidney, and breast cancers in humans as described by 
U.S. EPA (2024b, 2024d).
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    \36\ Maximum Contaminant Level Goal (MCLG)--the maximum level of 
a contaminant in drinking water at which no known or anticipated 
adverse effect on the health of persons would occur, allowing an 
adequate margin of safety. (https://www.epa.gov/sdwa/how-epa-regulates-drinking-water-contaminants.)
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    The EPA's 2024 PFOA and PFOS toxicity assessments prioritized the 
following five health endpoint categories with the strongest weight of 
evidence and indicating that oral PFOA and PFOS exposure is associated 
with adverse health effects: immunological, hepatic, developmental, 
cardiovascular, and cancer effects. This prioritization was based on 
findings from conducting systematic review (including the study quality 
evaluation, evidence synthesis and evidence integration) on the 
available and relevant human epidemiological and animal toxicity 
studies (U.S. EPA, 2024b, U.S. EPA, 2024c). EPA evaluated sixteen non-
cancer health outcomes as part of the 2024 toxicity assessments and, in 
accordance with recommendations from the SAB {U.S. EPA, 2022, 
10476098{time}  and the IRIS Handbook {U.S. EPA, 2022, 10367891{time} , 
EPA's toxicity assessments prioritized the five categories of health 
outcomes above with either evidence demonstrating or evidence 
indicating associations between PFOA and PFOS exposure and adverse 
health effects. Accordingly, to support EPA's finding in this final 
rule that both PFOA and PFOS each individually pose a human health 
hazard, EPA gave weight to immunological, hepatic, developmental, 
cardiovascular, and cancer effects.
    For this final rule, EPA considered a wide range of potential 
health effects associated with exposure to PFOA and PFOS using five 
comprehensive peer-reviewed Federal government documents that summarize 
the recent literature on PFAS (mainly PFOA and PFOS) exposure and its 
health impacts: (1) EPA's 2016 Health Effects Support Documents for 
PFOA (U.S. EPA, 2016c); (2) EPA's 2016 Health Effects Support Documents 
for PFOS (U.S. EPA, 2016d); (3) U.S. Department of Health and Human 
Services Agency for Toxic Substances and Disease Registry's (ATSDR) 
2021 Toxicological Profile for Perfluoroalkyls (ATSDR, 2021); (4) EPA's 
2024 Final Human Health Toxicity Assessment for Perfluorooctanoic Acid 
(PFOA) (U.S. EPA, 2024b); and (5) EPA's 2024 Final Human Health 
Toxicity Assessment for Perfluorooctane Sulfonic Acid (PFOS), (U.S. 
EPA, 2024c). Each source presents comprehensive, systematic reviews of 
relevant, peer-reviewed literature on adverse health effects associated 
with PFOA and PFOS. The EPA assessments were prepared by the Office of 
Water.
    Data from human and animal studies indicate that PFOA and PFOS are 
well absorbed in the human body after being ingested and are 
distributed throughout the body by binding to proteins. PFOA and PFOS 
bioaccumulate in the human body as evidenced by the elimination half-
lives from about two to three years for PFOA and four to five years for 
PFOS (ATSDR, 2021). There is no evidence that humans or animals are 
able to break down these substances, and they can be distributed to 
tissues throughout the human body and are not readily eliminated, 
resulting in long elimination half-lives in the human body and 
bioaccumulation. Available evidence supports urine as the primary route 
of excretion in most species, though fecal elimination is prominent in 
rats. In rats, hair is another route of elimination in both males and 
females. In females, elimination pathways include menstruation, 
pregnancy (cord blood, placenta, amniotic fluid, and fetal tissues) and 
lactation (breast milk) (PFOA Toxicity Assessment 2024, PFOS Toxicity 
Assessment 2024). Thus, PFOA and PFOS remain in the body after exposure 
has ended and can potentially cause detrimental health effects even 
after an initial exposure has ceased. Continued exposures to PFOA and 
PFOS can lead to significantly elevated concentrations in the human 
body and result in adverse health effects due to this bioaccumulation 
(Ballesteros et al., 2017; Barry et al., 2014; Dhingra et al., 2016; 
Frisbee et al., 2010; Gallo V et al., 2012; Hall et al., 2023; Hoffman 
et al., 2011; Kotlarz et al., 2020; Savitz et al., 2012; Steenland et 
al., 2009; Steenland et al., 2018a; Steenland et al., 2018b).
    EPA's 2024 Final Human Health Toxicity Assessments for PFOA and 
PFOS integrated the available data on absorption, distribution, 
metabolism and elimination into the derivation of reference values for 
PFOA and PFOS. Collectively the adverse health effects evidence 
demonstrates that each PFOA and PFOS individually pose a human health 
hazard, and the substantial body of evidence for several individual 
adverse health effects also supports EPA's human health hazard finding 
for each of these substances. A discussion of some of the detrimental 
health effects follows.
    Developmental Effects: Adverse developmental effects can increase 
the likelihood of difficulties during labor through post-delivery. 
Evidence indicates that exposure to PFOA and PFOS is likely associated 
with developmental effects such as lower infant birth weight, lower 
birth length, smaller head circumference at birth, and other effects 
(Verner et al., 2015; U.S. EPA, 2016e; U.S. EPA, 2016f; Negri et al., 
2017; ATSDR, 2018; Waterfield et al., 2020; U.S. EPA, 2023b; U.S. EPA, 
2024c). Research suggests that exposure to PFOA and PFOS is associated 
with developmental effects, including decreased infant birth weight 
(ATSDR, 2021; Negri et al., 2017; U.S. EPA, 2016c, 2016d, 2024b, 2024c; 
Verner et al., 2015; Waterfield et al., 2020). Low birth weight is 
linked to a number of health effects that may be a source of economic 
burden to society in the form of medical costs, infant mortality, 
parental and caregiver costs, labor market productivity loss, and 
education costs (Behrman & Rosenzweig, 2004; Chaikind & Corman, 1991; 
Colaizy et al., 2016; Institute of Medicine, 2007; Joyce et al., 2012; 
Klein & Lynch, 2018; Kowlessar et al., 2013; Nicoletti et al., 2018).
    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 animals 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 
(ATSDR, 2021; U.S. EPA, 2016c, 2016d). The embryo and fetus are exposed 
prenatally to PFOA and PFOS through maternal blood via the placenta 
(ATSDR, 2021). Several epidemiological studies of the association 
between maternal serum PFOA/PFOS and birth weight have found evidence 
for decreased body weight of infants exposed in utero (Chu et al., 
2020; Darrow et al., 2013; Dzierlenga et al., 2020; Govarts et al., 
2016; Negri et al., 2017; Sagiv et al., 2018; Starling et al., 2017; 
Verner et al., 2015; Wikstrom et al., 2020; Yao et al., 2021). Other 
developmental associations with PFOA and PFOS include small for 
gestational age (SGA), decreased birth length, decreased head 
circumference at birth, and other effects (ATSDR, 2021; Negri et al., 
2017; U.S. EPA, 2016c, 2016d, 2024b, 2024c; Verner et al., 2015; 
Waterfield et al., 2020). Epidemiology evidence for SGA related to 
PFOA/PFOS exposure was mixed; some studies reported increased risk of 
SGA with PFOA/PFOS exposure, while other studies observed null results 
(USEPA,

[[Page 39145]]

2024b; USEPA, 2024c). SGA is a developmental health outcome of interest 
when studying potential effects of PFOA/PFOS exposure because SGA 
infants have increased health risks during pregnancy and delivery as 
well as post-delivery (Osuchukwu & Reed, 2022).
    Cardiovascular Effects: Cardiovascular Disease (CVD) is one of the 
leading causes of premature mortality in the United States (D'Agostino 
et al., 2008; Goff et al., 2014; Lloyd-Jones et al., 2017). Changes in 
total cholesterol and blood pressure are associated with changes in 
incidence of CVD events such as myocardial infarction (i.e., heart 
attack), ischemic stroke, and cardiovascular mortality occurring in 
populations without prior CVD event experience (D'Agostino et al., 
2008; Goff et al., 2014; Lloyd-Jones et al., 2017). Evidence indicates 
that exposure to PFOA and PFOS is likely associated with increased low-
density lipoprotein cholesterol (LDLC), total cholesterol, and high-
density lipoprotein cholesterol (ATSDR, 2021; U.S. EPA, 2024b, 2024c). 
High levels of LDLC lead to the buildup of cholesterol in the arteries, 
which can raise the risk of heart disease and stroke. Epidemiology 
studies showed a positive association between PFOA or PFOS exposure and 
LDLC or total cholesterol levels in children (U.S. EPA, 2024b, 2024c). 
In particular, the evidence suggested positive associations between 
serum PFOA and PFOS levels and LDLC levels in adolescents ages 12-18, 
while positive associations between serum levels and LDLC levels in 
younger children were observed only for PFOA (ATSDR, 2021). Other 
epidemiology studies have generally found a positive association 
between increasing serum PFOA and total cholesterol levels (ATSDR, 
2021).
    Cancer Effects: PFOA and PFOS are Consistent with the Guidelines 
for Carcinogen Risk Assessment (U.S. EPA, 2005), EPA determined that 
both PFOA and PFOS are Likely to Be Carcinogenic to Humans based on 
sufficient evidence of carcinogenicity in humans and animals (U.S. EPA, 
2024b, USEPA 2024c). Additionally, in November 2023, the International 
Agency for Research on Cancer (IARC) evaluated the carcinogenicity of 
PFOA and PFOS and classified PFOA as carcinogenic to humans (Group 1) 
and PFOS as possibly carcinogenic to humans (Group 2b) (Zahm, et al., 
2023). For PFOA, cancer evidence in epidemiological studies is 
primarily based on the incidence of kidney and testicular cancer, as 
well as some evidence of breast cancer, which is most consistent in 
genetically susceptible subpopulations or for particular breast cancer 
types (U.S. EPA, 2024c). Epidemiology studies indicated that exposure 
to PFOA was associated with an increased risk of renal cell carcinoma 
(RCC) (ATSDR, 2021; California EPA, 2021; U.S. EPA, 2016d, 2024d). For 
PFOS, the available epidemiology studies report elevated risk of liver 
cancer, consistent with increased incidence of liver tumors reported in 
long-term rat exposure studies. There is also mixed but plausible 
evidence of bladder, prostate, kidney, and breast cancers in humans 
after chronic exposure and evidence of pancreatic islet cell tumors in 
rats (U.S. EPA, 2024b).
    Liver Effects: High levels of the enzyme alanine transaminase (ALT) 
in the bloodstream may indicate liver damage. Evidence indicates that 
exposure to PFOS and PFOA is associated with increased liver enzymes 
(U.S. EPA, 2024b; 2024c). Epidemiology data provides evidence of a 
positive association between PFOS/PFOA exposure and ALT levels in 
adults (ATSDR, 2021; U.S. EPA, 2024b, 2024c). Studies of adults showed 
consistent evidence of a positive association between PFOA exposure and 
elevated ALT levels at both high exposure levels and exposure levels 
typical of the general population (U.S. EPA, 2024c). Associations 
between increasing serum PFOA concentrations and elevations in 
different serum enzyme levels were consistently observed in 
occupational cohorts, high-exposure communities and the U.S. general 
population that could indicate the potential for PFOA to affect liver 
function (ATSDR, 2021). There is also consistent epidemiology evidence 
of associations between PFOS and elevated ALT levels. A limited number 
of studies reported inconsistent evidence on whether PFOA/PFOS exposure 
is associated with increased risk of liver disease (U.S. EPA, 2024b). 
Results reported in animal toxicological studies are consistent with 
the observed elevated ALT indicative of hepatic damage in 
epidemiological studies. Specifically, studies in rodents found that 
oral PFOA or PFOS treatment resulted in biologically significant 
alterations in levels of at least one serum biomarker of liver injury 
(e.g., ALT) and evidence of histopathological alterations including 
hepatocyte degenerative or necrotic changes.
    Immune Effects: Proper antibody response helps maintain the immune 
system by recognizing and responding to antigens. Evidence indicates 
that exposure to PFOS and PFOA is associated with immunosuppression; 
(U.S. EPA, 2024b; U.S. EPA, 2024c); epidemiology studies showed 
suppression of at least one measure of the antibody response for 
tetanus and diphtheria among people with higher prenatal, childhood, 
and adult serum concentrations of PFOA (U.S. EPA, 2024c). Data 
reporting associations between PFOA exposure and antibody response to 
vaccinations other than tetanus and diphtheria are limited (ATSDR, 
2021; USEPA, 2024c). Several epidemiological studies have shown a 
relationship between increased PFOA and PFOS serum concentrations and 
decreased response to vaccinations in children (Budtz-Jorgensen & 
Grandjean, 2018; Grandjean et al., 2012; Grandjean, Heilmann, Weihe, 
Nielsen, Mogensen, & Budtz-Jorgensen, 2017; Grandjean, Heilmann, Weihe, 
Nielsen, Mogensen, Timmermann, et al., 2017; Timmermann et al., 2022; 
Zhang et al., 2023). Epidemiology evidence suggests that children with 
preexisting immunological conditions are particularly susceptible to 
immunosuppression associated with PFOA exposure (U.S. EPA, 2024c). 
Available studies supported an association between PFOS exposure and 
immunosuppression in children, where increased PFOS serum levels were 
associated with decreased antibody production (U.S. EPA, 2024b). 
Studies reporting associations between PFOA or PFOS and 
immunosuppression in adults are less consistent; there is a lack of 
high confidence data. (U.S. EPA, 2024b).
    In addition to the adverse health effects listed above, there was 
suggestive evidence that exposure to PFOS and PFOA is associated with 
the additional health effects summarized below.
    Endocrine Effects: Elevated thyroid hormone levels can accelerate 
metabolism and cause irregular heartbeat; low levels of thyroid hormone 
can cause neurodevelopmental effects, tiredness, weight gain, and 
increased susceptibility to the common cold. There is suggestive 
evidence of a positive association between PFOA/PFOS exposure and 
thyroid hormone disruption (ATSDR, 2021; U.S. EPA, 2024b, 2024c). 
Toxicology studies in animals indicated that PFOA and PFOS exposure can 
affect thyroid function \37\ (ATSDR, 2021; U.S. EPA, 2024b, 2024c). 
Changes to serum thyroid hormone levels in animals lead to adverse 
effects to the endocrine system (U.S. EPA, 2024b, 2024c). Despite 
uncertainty around the applicability of animal studies in this area, 
changes in serum

[[Page 39146]]

thyroid hormone levels in animals did indicate adverse effects after 
PFOS and PFOA exposure that is relevant to humans (U.S. EPA, 2024b; 
2024c).
---------------------------------------------------------------------------

    \37\ Decreased thyroid hormone levels are associated with 
effects such as changes in thyroid and adrenal gland weight, hormone 
fluctuations, and organ histopathology (ATSDR, 2021; U.S. EPA, 
2024b, 2024c).
---------------------------------------------------------------------------

    Metabolic Effects: Leptin is a hormone that controls hunger, and 
high leptin levels are associated with obesity, overeating, and 
inflammation (e.g., of adipose tissue, the hypothalamus, blood vessels, 
and other areas). Animal studies showed increases in serum leptin 
levels in mice that were exposed to low levels of PFOA (ATSDR, 2021). 
Based on a review of 69 human epidemiology studies, evidence of 
associations between PFOS and metabolic outcomes appears inconsistent, 
but in some studies, suggestive evidence was observed between PFOS 
exposure and leptin levels (U.S. EPA, 2024b).
    Reproductive Effects: Studies of the reproductive effects from 
PFOA/PFOS exposure have focused on associations between exposure to 
these pollutants and increased risk of gestational hypertension and 
preeclampsia in pregnant women (ATSDR, 2021; U.S. EPA, 2024b, 2024c). 
Gestational hypertension (high blood pressure during pregnancy) can 
lead to fetal health outcomes such as poor growth and stillbirth. 
Preeclampsia--instances of gestational hypertension where the mother 
also has increased levels of protein in her urine--can similarly lead 
to fetal problems and maternal complications. The epidemiology evidence 
yields mixed (positive and non-significant) associations, with some 
suggestive evidence supporting positive associations between PFOA/PFOS 
exposure and both preeclampsia and gestational hypertension (ATSDR, 
2021; U.S. EPA, 2024b, 2024c). 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 (U.S. EPA, 2016d).
    Musculoskeletal effects: Adverse musculoskeletal effects such as 
osteoarthritis and decreased bone mineral density impact bone integrity 
and cause bones to become brittle and more prone to fracture. There is 
limited evidence from studies pointing to effects of PFOS on skeletal 
size (height), lean body mass, and osteoarthritis (U.S. EPA, 2024b). 
Epidemiology evidence suggested that PFOA exposure may be linked to 
decreased bone mineral density, bone mineral density relative to bone 
area, height in adolescence, osteoporosis, and osteoarthritis (ATSDR, 
2021; U.S. EPA, 2024c). Evidence from four PFOS studies suggests that 
PFOS exposure has a harmful effect on bone health, particularly 
measures of bone mineral density, with greater statistically 
significance of effects occurring among females (U.S. EPA, 2024b).
    Taken together, the technical/scientific information above 
demonstrate that both PFOA and PFOS individually are each associated 
with considerable and varied adverse health effects.
    EPA also considered potential effects on children's health. EPA's 
Policy on Children's Health requires the Agency to consider early life 
exposures (from conception, infancy, early childhood and through 
adolescence until 21 years of age) and lifelong health consistently and 
explicitly in all human health decisions through identifying and 
integrating children's health data and information. As described 
throughout this section, information on PFOA and PFOS shows exposure to 
PFOA and/or PFOS is linked to adverse health effects relevant to 
children. These adverse health effects include developmental effects to 
fetuses during pregnancy or to infants, cardiovascular effects and 
immune effects in children and endocrine and reproductive effects that 
impact development. Suggestive evidence of associations found in human 
epidemiological studies between PFOA and PFOS and adverse development 
effects of include decreased infant birth weight (ATSDR, 2021; Negri et 
al., 2017; U.S. EPA, 2016c, 2016d, 2024b, 2024c; Verner et al., 2015; 
Waterfield et al., 2020). Animal studies have shown developmental 
health effects including associations with decreased offspring 
survival, low birth weight, accelerated puberty and skeletal variations 
(ATSDR, 2021; U.S. EPA, 2016c, 2016d). Cardiovascular effects include 
positive associations between serum PFOA and PFOS levels and LDLC 
levels in adolescents ages 12-18 (ATSDR, 2021). Several epidemiological 
studies have shown a relationship between increased PFOA and PFOS serum 
concentrations and decreased response to vaccinations in children 
(Budtz-Jorgensen & Grandjean, 2018; Grandjean et al., 2012; Grandjean, 
Heilmann, Weihe, Nielsen, Mogensen, & Budtz-Jorgensen, 2017; Grandjean, 
Heilmann, Weihe, Nielsen, Mogensen, Timmermann, et al., 2017; 
Timmermann et al., 2022). There is suggestive evidence of a positive 
association between PFOA and/or PFOS exposure and thyroid hormone 
disruption (ATSDR, 2021; U.S. EPA, 2024b, 2024c). The epidemiology 
evidence yields mixed (positive and non-significant) associations, with 
some evidence suggesting positive associations between PFOA and/or PFOS 
exposure and both preeclampsia and gestational hypertension which can 
lead to fetal health outcomes such as poor growth, stillbirth and 
maternal complications (ATSDR, 2021; U.S. EPA, 2024b, 2024c).
    EPA also considered the hazards associated with salts and 
structural isomers of PFOA and PFOS. The hazards associated with PFOA 
and PFOS can be associated with their respective salts and both their 
linear and branched isomers. Salts are deemed to have the same toxicity 
as the commonly referenced acid versions because, once put in water 
(and likewise when in the human body), the acid and salt forms will 
dissociate to the ionic form. Further, many toxicity studies on PFAS 
were often performed using the salt form. For example, while Emmett et 
al. (2006) toxicity studies were performed on the acid version of PFOA, 
Butenhoff et al. (2012) used the ammonium salt of PFOA. The potassium 
salt of PFOS was generally used in animal toxicity studies such as 
Ankley et al. (2004).
    Additionally, PFOA and PFOS exist as linear and branched isomers, 
and the linear and branched isomers have been found in environmental 
media and in human sera. For example, in the last NHANES for which 
results are available (2017-2018), branched PFOS was detected in 99% of 
those sampled, while branched PFOA was found in 10%. Most animal 
toxicity studies using isomeric mixtures do not state the ratio of 
linear and branched isomers in the test material, and, therefore, it is 
not feasible to distinguish the toxicity of the individual isomers. 
However, in a few studies, including Butenhoff et al. (2012), Lau et 
al. (2006), and Lou et al. (2009) for PFOA, and Ankley et al. (2004) 
for PFOS, the authors stated that the PFAS test substance was not 100% 
linear, and thus, any effects indicated in these studies can only be 
associated with the isomeric mixture of linear and branched and not 
specifically with linear isomers or branched isomers. Further, Loveless 
et al. (2006) compared the toxicity of linear ammonium PFOA, branched 
ammonium PFOA, and a mixture of linear and branched ammonium PFOA in 
rodents and demonstrated that both linear and branched isomers exhibit 
similar types of toxicity.

B. Information About the Fate and Transport of PFOA and PFOS 
Demonstrate That They Are Persistent and Mobile in the Environment

    Available information about the fate and transport of PFOA and PFOS

[[Page 39147]]

support EPA's conclusions that these substances remain in the 
environment for many years (i.e., persistency) and that they can move 
through air, land, and water (i.e., mobility) after release. Both PFOA 
and PFOS are considered surfactants due to their chemical structures 
that consists of a hydrophobic perfluorinated alkyl ``tail group'' and 
a hydrophilic carboxylate (for PFOA) or sulfonate (for PFOS) ``head 
group.'' Surfactants decrease the surface tension between two liquids 
(i.e., oil and water), a gas and a liquid, or a solid and a liquid. 
This attribute means they increase mixing and transport between soil 
and groundwater or air and water, and thus PFOA and PFOS move between 
environmental media more easily.
    These chemicals are sometimes referred to as ``forever'' chemicals 
because of their strong carbon-fluorine bonds in the ``tail group'' 
that cause PFOA and PFOS to be extremely resistant to degradation 
through biological degradation and also through chemical degradation 
(i.e., photooxidation and hydrolysis). Photooxidation describes the 
process of oxidation through light exposure and hydrolysis describes 
the chemical breakdown of compound due to reaction with water. 
Degradation data from 3M for PFOA states ``Hydrolysis half-life >92 
years @ pH 7 & 25 [deg]C (ammonium salt tested); Photolysis in water: 
half-life > = 342 days; neither direct nor indirect photolysis in water 
observed based on loss of PFOA; Biodegradation-OECD 301C, 28 days, 5% 
BOD/ThOD; Biodegradation-Aerobic sludge, 18 days, no degradation 
observed (ammonium salt tested); Biodegradation-Anaerobic sludge, 94 
days, no degradation observed.'' Degradation date from 3M for PFOS 
states ``Biodegradation-Anaerobic sludge, 105 days, no degradation 
observed; Biodegradation-OECD 301C (MITI-I), 28 days, 0% BOD/ThOD (3M 
2021).'' The resistance to degradation causes PFOA and PFOS to remain 
in the environment for long periods of time. This means that the 
potential for human exposure continues long after a release has ended.
    PFAS are mobile in the environment and have been found in remote 
locations, indicating they are widespread in the environment (Giesy & 
Kannan, 2001). PFAS have been found in outdoor air at locations in the 
United States, Europe, Japan, and over the Atlantic Ocean (ATSDR, 
2021). PFOA and PFOS are water soluble and thus may be found in 
groundwater and surface water (U.S. EPA 2024a). Further, PFOA and PFOS 
have water-soil/sediment partition coefficients of 15-708 L/kg and 7-
120 L/kg, respectively (3M, 2021). These values are on the order of 
many metals, indicating that PFOA and PFOS are fairly mobile and will 
move from soil and sediment to water. Experimental data indicates in 
the marine environment, where suspended solid concentrations are 
generally low, PFOA and PFOS are mainly transported in the dissolved 
phase rather than being adsorbed to suspended solids (Ahrens et al., 
2011). Their presence in the water column means that they will be 
transported further and are available for long range transport and 
bioaccumulation (Ahrens et al., 2011).
    In a 2001 study investigating the global distribution of PFAS, 
wildlife samples were collected on four continents including North 
America and Antarctica and PFAS was found to be widely distributed on a 
global scale.^{38 39} Over 30 different species had measurable 
levels of PFOS (European Food Safety Authority, 2008; Giesy & Kannan, 
2001). PFOA and PFOS have been shown to persist in humans and animals, 
with estimated half-lives in humans ranging from about two to three 
years for PFOA to four or five years for PFOS (ATSDR, 2021). Organisms 
that are exposed to PFOA and PFOS cannot break them down inside the 
body and excrete very little. Because PFOA and PFOS can remain in human 
and animal bodies for long durations, individuals with consistent 
ongoing exposures to PFOA and PFOS (e.g., individuals consistently 
exposed by drinking contaminated water or eating contaminated food) can 
have elevated concentrations of these substances in their bodies 
(Bangma et al., 2017; Burkhard, 2021; Ng & Hungerbuhler, 2014).
---------------------------------------------------------------------------

    \38\ Global Distribution of Perfluorooctane Sulfonate in 
Wildlife; John P. Giesy and Kurunthachalam Kannan; Department of 
Zoology, National Food Safety and Toxicology Center, Institute for 
Environmental Toxicology; Michigan State University.
    \39\ https://www.efsa.europa.eu/en/efsajournal/pub/653.
---------------------------------------------------------------------------

C. Other Information Considered

    Other information that EPA considered includes, the frequency, 
nature, and geographic scope of releases of these substances. This 
information demonstrates that PFOA and PFOS are prevalent, including in 
the U.S., and there is likelihood of exposure to humans and the 
environment. PFOA and PFOS are prevalent throughout the environment 
because of their widespread use since the 1940s in a wide range of 
commercial and consumer products and because of their persistence. 
Currently, the public can be exposed to PFOA and PFOS through a variety 
of sources, including water, food, and environmental media. See 
Proposed Rule, 87 FR at 54418-19 (Discussion on the uses of PFOA and 
PFOS).
    Major causes of PFOA and PFOS environmental contamination include 
historical uses, limited ongoing uses, and ongoing uses of precursors. 
These activities include past direct industrial discharges of PFOA and 
PFOS to soil, air, and water and disposal of these substances or 
products that contain these substances. Precursor chemicals 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. 
See Proposed Rule, 87 FR at 54426 (providing a brief history of sources 
of PFOA and PFOS to the environment).
    PFOA and PFOS have been detected in groundwater in monitoring 
wells, private drinking water wells, and public drinking water systems 
across the country. The most vulnerable drinking water systems are 
those in close proximity to sites contaminated with PFOA and PFOS 
(ATSDR, 2021). Under the third Unregulated Contaminant Monitoring Rule 
(UCMR), EPA worked with the States and local communities to monitor for 
six PFAS, including PFOA and PFOS, 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 was detected above the minimum reporting level (minimum 
reporting level = 20 nanogram/liter (ng/L)) in 379 samples in 117 PWSs 
serving a population of approximately 7.6 million people located in 28 
States, Tribes, or U.S. territories. PFOS was found in 292 samples at 
95 systems above the UCMR 3 MRL (40 ppt). These systems serve a 
population of approximately 10.4 million people located in 28 States, 
Tribes, or U.S. territories (U.S. EPA, 2017).
    More recent available data collected by States show continued 
occurrence of PFOA and PFOS in drinking water supplies in multiple 
geographic locations throughout the country, as well as occurrences at 
lower concentrations and significantly greater frequencies than were 
measured under the UCMR3 (``PFAS National,'' 2023). PFOA and PFOS are 
also widely detected in surface water samples

[[Page 39148]]

collected from various rivers, lakes, and streams in the United States. 
Municipalities and other entities may use surface water sources for 
drinking water and that creates an additional potential exposure 
pathway to PFOA and PFOS.
    PFOA and PFOS can reach soil due to atmospheric transport and wet/
dry deposition (ATSDR, 2021). These substances have been found in 
outdoor air at locations across the globe around PFAS production 
facilities and facilities that use PFAS. PFOA and PFOS have been 
detected in surface and subsurface soils. Levels of PFOA and PFOS 
generally increased with increasing depth at sampled locations (PFAS 
manufacturing facilities), suggesting a downward movement of the 
contaminants and the potential to contaminate groundwater (ATSDR, 
2021).
    PFOA and PFOS can be taken up by plants, as evidenced by their 
presence in produce analyzed by the U.S. Food and Drug Administration 
(2021). PFOA and PFOS have also been found in wild and domestic animals 
such as fish, shellfish, alligators, deer, and avian eggs and in humans 
(ATSDR, 2021). 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 (Bangma et al., 2017; Falk 
et al., 2012; Gewurtz et al., 2016; Holmstrom et al., 2005; Michigan 
PFAS Action Response Team, 2021; Morganti et al., 2021; U.S. EPA, 
2016a, 2016b; Wang et al., 2008; Wisconsin DNR, 2020).
    There is a significant potential for human exposure to PFOA or PFOS 
because of their persistence, mobility, and prevalence in the 
environment (Langenbach & Wilson, 2021). PFOA and PFOS contamination in 
the environment can lead to human exposure through ingestion of 
contaminated water, plants, wild animals, and livestock. PFOA and PFOS 
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. 
Human exposure can occur through the consumption of wild animals that 
have been contaminated by environmental exposure. Several States have 
issued advisories recommending that hunters and fishers avoid eating 
deer, turkey, or fish due to high levels of PFOS detected in the 
animals (MDIFW, 2023; Michigan PFAS Action Response Team, 2023; NCDHHS, 
2023). Contaminated water also results in the contamination of 
livestock such as 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 (Christensen et al., 2017; FDA, 
2021; U.S. EPA, 2019b). Food can also be contaminated through food 
packaging made with these chemicals. However, in 2016, the Food and 
Drug Administration revoked the regulations authorizing the remaining 
uses of long-chain PFAS in food packaging (see 81 FR 5, January 4, 
2016, and 81 FR 83672, November 22, 2016). Therefore, PFOA and PFOS 
should not be in food packaging now. Humans can also be exposed through 
incidental ingestion of contaminated soil and dust. Numerous studies 
have shown that PFOA and PFOS can be found in residences, offices, and 
other workplaces, and in consumer goods (Gaines, 2023; Hall et al., 
2020; Strynar & Lindstrom, 2008).
    PFOA and PFOS have been detected in nearly all of the blood of the 
participants in the NHANES. This indicates widespread exposure to these 
PFAS in the U.S. population (CDC, 2022). As part of the continuous 
NHANES, 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. As of the 2017-2018 data, PFOA and PFOS were still detectable in 
99% of the population, although the mean concentrations of PFOA and 
PFOS in the serum have been steadily decreasing since 1999-2000 (CDC, 
2021; U.S. EPA, 2019a).
    Communities drinking water or eating food contaminated with PFAS 
can have significantly elevated blood levels of PFAS compared to 
national average concentrations (Graber et al., 2019; Kotlarz et al., 
2020). Because PFOA and PFOS can remain in the human body and for long 
durations, individuals who have consistent ongoing exposures to PFOA 
and PFOS (e.g., those exposed by drinking contaminated water or eating 
contaminated food) can have high concentrations of these compounds in 
their bodies. Epidemiological studies measuring PFAS levels in humans 
have noted that people living near contaminated sites have higher 
concentrations of these chemicals than the general population and that 
drinking water is an important contributor to exposure (Emmett et al., 
2006).
Conclusion
    In light of the evidence regarding hazard and the fate and 
transport of these chemicals, and consideration of the degree or 
magnitude of danger posed, EPA concludes for several reasons described 
above that PFOA and PFOS each may present a substantial danger when 
released into the environment.\40\ Furthermore, the other information 
EPA considered, such as environmental prevalence and the likelihood of 
exposure, reinforce its conclusion. individuals living in communities 
located near sites with high levels of PFOA and PFOS (e.g., sites where 
PFOA and PFOS were manufactured or used in the manufacture of products) 
are the populations (i.e., non-occupationally exposed populations) most 
likely to be exposed to PFOA or PFOS and are thus more likely to 
experience associated adverse health effects.
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    \40\ EPA need only determine that PFOA and PFOS ``may present'' 
a substantial danger to designate as hazardous substances pursuant 
to CERCLA. CERCLA section 102(a). Other actions taken by EPA, 
pursuant to other statutory authorities, may require a different or 
more stringent finding. The scientific and technical data that EPA 
is relying on in this action may be relevant to those determinations 
and may support a finding under a more stringent standard.
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    At the same time, the mobility of PFOA and PFOS means that these 
substances have the potential to migrate away from a highly 
contaminated site into sources of drinking water, both groundwater and 
surface water. And the mobility and persistence combine to create an 
ever-expanding area of contamination if it is not contained and/or 
cleaned up. The persistence, mobility, and prevalence of PFOA and PFOS 
create more opportunities for exposure to humans and the environment, 
thereby increasing the likelihood of adverse health effects and adverse 
ecological burdens stemming from the toxicity of these compounds. See 
Proposed Rule, 87 FR 54415. In sum, communities located near sites with 
the highest concentrations of PFOA and PFOS are subject to a 
disproportionately higher risk of exposure to those substances as 
compared to the general population.
    For all these reasons, EPA finds that both PFOA and PFOS, and their 
salts and isomers, each may present a substantial danger to the public 
health, or welfare, or the environment when released.

[[Page 39149]]

VI. The Totality of the Circumstances Confirms That Designation of PFOA 
and PFOS as Hazardous Substances Is Warranted

    Along with concluding that both PFOA and PFOS ``may present a 
substantial danger,'' EPA also independently exercised its discretion 
and conducted an additional ``totality of the circumstances'' analysis 
to evaluate whether designation was warranted. The analysis looks to 
the evidence showing that PFOA and PFOS ``may present a substantial 
danger'' along with CERCLA section 102(a) and its broader context. 
CERCLA section 102(a) and its broader context help identify the 
information to weigh and how to balance multiple considerations. In 
conducting the analysis as to PFOA and PFOS, EPA identified and weighed 
the advantages and disadvantages of designation. This analysis included 
consideration of the formal benefit-cost analysis, including 
quantitative and qualitative benefits and costs provided in the 
Regulatory Impact Analysis accompanying this final rule.
    The totality of the circumstances analysis first considered the 
evidence that both PFOA and PFOS may present a substantial danger to 
public health or welfare or the environment when released, see CERCLA 
section 102(a). Specifically, EPA examined the scientific basis for 
designation. EPA gave the scientific evidence considerable weight. As 
discussed in Section V above, PFOA and PFOS exposure has been connected 
to a wide range of adverse human health and environmental effects. PFOA 
and PFOS bioaccumulate in humans and animals, including the fish and 
other wild animals we eat. And PFOA and PFOS are persistent and mobile 
in the environment. If not addressed, PFOA and PFOS will continue to 
migrate, further exacerbating exposure risk and potential cleanup 
costs.
    EPA then evaluated CERCLA section 102(a) in the broader context of 
CERCLA. Section 102(a) provides EPA with health- and environmental-
based criteria to evaluate whether a substance can be designated as 
hazardous. A hazardous substance designation, in turn, makes available 
the full suite of CERCLA authorities. EPA examined the ways in which 
designation serves CERCLA's express purposes and functions: ensuring 
that the ``Polluter Pays'' for cleanup (CERCLA sections 107(a), 
106(a)); allowing for timely cleanup of contaminated sites (CERCLA 
sections 104, 106, 121); and authorizing response that protects human 
health and the environment (CERCLA sections 104, 106, 121).
    With these statutory purposes in mind, EPA considered the core 
problem posed by PFOA and PFOS in the environment and whether 
designating PFOA and PFOS as hazardous substances would meaningfully 
improve EPA's ability to address the problem. EPA believes that the 
likelihood of the public being exposed to PFOA and PFOS is high. The 
science demonstrates that human exposure to these chemicals is linked 
to a broad range of adverse health effects. These concerns apply 
particularly to those communities living near former manufacturing 
sites, where PFOA and PFOS were produced (and then widely used) since 
the 1940s. As a result, communities may be exposed to existing 
contamination at and near sites where those substances were 
manufactured and used for decades. These contaminated sites have the 
potential to disproportionately harm nearby communities and ecosystems. 
Because of this potential risk, such sites need to be investigated, 
evaluated for risk to human health and the environment, and cleaned up 
as appropriate. EPA concluded that CERCLA is best suited to address the 
problem posed by legacy PFOA and PFOS contamination.
    EPA next considered whether the hazardous substances designation is 
warranted considering EPA's existing authority that allows the Agency 
to address PFOA and PFOS as CERCLA ``pollutants and contaminants.'' EPA 
weighed how designation may promote cleanups that might otherwise be 
delayed or not occur. EPA's current authority to is limited in 
meaningful ways.\41\ This rule, however, will allow EPA to utilize the 
full suite of CERCLA authorities and enable EPA to address more sites, 
allow for earlier action, and expedite eventual cleanup. This is, in 
large part, because EPA will be able to employ CERCLA's liability and 
enforcement provisions to require parties responsible for significant 
pollution to address existing contamination. As a consequence, 
designation greatly expands societal resources available (both 
financial and human capital) for investigation and cleanup that would 
not be available absent designation.
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    \41\ As described in Section II.E., CERCLA authority differs 
with respect to ``hazardous substances'' and ``pollutants or 
contaminants.'' Designation of PFOA and PFOS as ``hazardous 
substances'' streamlines response authority, makes available cost 
recovery authorities allowing parties to recover response costs from 
PRPs, and makes available CERCLA enforcement authority to compel 
PRPs to conduct or pay for cleanup. See CERCLA sections 104(a), 
106(a), 107(a). Designation also requires facilities to notify 
federal, state, local, and tribal authorities, as well as 
potentially injured parties, of significant releases. See CERCLA 
sections 103(a), 111(g); EPCRA section 304.
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    EPA also weighed the quantitative and qualitative costs and 
benefits evaluated in the RIA.\42\ EPA considered the estimated direct 
and indirect monetized costs. These costs include direct costs to 
comply with release notification requirements and indirect costs for 
response actions, including potential costs for existing and future NPL 
sites as well as potential costs that may arise from enforcement 
actions taken at non-NPL sites. EPA also considered qualitative costs, 
which are those that EPA could not quantify with reasonable certainty. 
Qualitative costs encompass the potential costs of litigation and 
liability. Although EPA was unable to quantify these potential costs, 
EPA evaluated how designation may affect CERCLA liability and 
litigation. EPA analyzed whether CERCLA's statutory provisions (e.g., 
liability limitations, cost recovery provisions and settlement 
authorities) and existing enforcement discretion policies could 
mitigate those potential costs. Next, in evaluating benefits, EPA 
considered the quantified baseline benefits associated with 
transferring response costs from EPA to PRPs as well as quantified 
health benefits that may result from the designation. These health 
effects include those associated with birth weight, cardiovascular 
disease (CVD) and renal cell carcinoma (RCC)-avoided morbidity and 
mortality associated with reductions in PFOA and/or PFOS. Unquantified 
health benefits include health effects such as immune, liver, 
endocrine, metabolic, reproductive, musculoskeletal, as well as certain 
cancers such as combined hepatocellular adenomas and carcinomas.
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    \42\ EPA conducted a Regulatory Impact Analysis (RIA) consistent 
with E.O. 12866. The E.O. requires, among other things, that the 
Agency quantify costs and benefits to the extent possible and that 
it qualitatively address the costs and benefits that cannot be 
quantified. The analyses required under the E.O. do not determine 
the appropriate consideration of advantages and disadvantages for 
EPA final actions. Instead, the EPA statute, in this case CERCLA, 
must be evaluated to determine the intended benefits of the statute 
as determined by it terms.
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    EPA also considered the ways in which the accompanying RIA does not 
fully capture the quantitative costs or benefits of the rule due to 
data limitations. As discussed throughout this preamble, CERCLA 
response actions are discretionary, contingent, and site-specific 
determinations. Whether it is appropriate to take any action--such as 
through CERCLA

[[Page 39150]]

response authority under section 104 or CERCLA enforcement authority 
under section 106--is based on a myriad of factors and most importantly 
whether the releases at the site pose unacceptable risk. Because EPA 
cannot fully assess and characterize the magnitude and number of 
instances where the rule would reduce impacts associated with PFOA or 
PFOS exposure, the benefits are difficult to fully ascertain and 
estimate with certainty. In addition, there is considerable uncertainty 
regarding the cost of health burdens that may result from exposure to 
PFOA or PFOS, and associated cost savings from reducing the incidence 
of these burdens because of designation.
    Relatedly, future response costs are also difficult to quantify due 
to the site-specific nature of CERCLA. Unlike with benefits, though, 
EPA concluded that it has sufficient information to reasonably estimate 
anticipated future costs for NPL and non-NPL sites. EPA was able to 
utilize existing data to estimate a high and low range for response 
costs at these sites. As explained in Section VI.A, the investigative 
and remedial technologies available to address PFOA and PFOS are, in 
large part, the same remedial technologies used to address other 
hazardous substances (e.g., the costs to pump and treat groundwater; to 
dig and haul contaminated soil; or to provide alternative drinking 
water). Therefore, EPA can use historic response cost information to 
reasonably assess PFOA and PFOS response costs. EPA acknowledges, 
however, that there remains uncertainty concerning the location and 
number of sites that will be identified as needing remediation and the 
extent of contamination at those sites. There is also uncertainty 
regarding the potential incremental increase in cost (if any) of 
addressing PFOA or PFOS at a site along with other COCs present.\43\
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    \43\ Designation does not require any specific response actions 
or confer liability. Whether response costs will be incurred is 
wholly dependent on site-specific discretionary decisions. Before 
taking any action, EPA evaluates the level of risk posed by any 
given release.
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    EPA concluded that a ``totality of the circumstances'' analysis is 
a useful benchmark for assessing whether action is warranted under a 
unique statute like CERCLA. Unlike other environmental statutes which 
are premised on ``command and control'' regulation, CERCLA is a 
remedial statute. It does not set prospective limits on the amount of 
permissible contamination. Instead, CERCLA imposes financial liability 
on those responsible for existing contamination that presents 
unacceptable risk to public health and the environment. In many 
instances (e.g., at NPL sites) cost considerations are evaluated on a 
site-specific basis. A totality of the circumstances analysis best 
reflects the advantages and disadvantages of designation and allows for 
a more holistic assessment of designation.
    The totality of the circumstances analysis is provided below. 
Section VI.A discusses the numerous advantages of designation. 
Designation allows EPA to deploy the full suite of CERCLA tools to 
identify, characterize, and cleanup the most contaminated sites 
expeditiously. It also allows EPA to hold responsible those parties 
that have contributed to significant contamination so that they bear 
the costs of cleaning it up. This, in turn, makes more resources 
available, allowing for additional and/or earlier cleanups relative to 
what could occur absent designation. These additional, earlier cleanups 
will protect vulnerable populations and communities living near 
contaminated sites. Further, these cleanups will have meaningful health 
benefits similar to other CERCLA actions by reducing a broad range of 
potential adverse human health effects. Thus, cleaning up PFOA and PFOS 
contamination that is posing unacceptable risk to human health, or the 
environment will improve quality of life and reduce health care 
expenditures for the communities living in and around PFOA and PFOS 
contaminated sites.
    Section VI.B evaluates the disadvantages of designation such as 
direct costs of the rule, the potential for the rule to create hardship 
for parties that did not significantly contribute to contamination, and 
the potential for uncertainty for PRPs. EPA estimates that direct 
costs, particularly release notification costs, are fairly minimal. EPA 
recognizes that some parties that do not bear primary responsibility 
for contamination may be sued and face uncertain litigation costs. EPA 
believes that CERCLA's liability limitations, coupled with EPA 
enforcement discretion policies, should operate to minimize hardship 
for parties that did not significantly contribute to contamination. EPA 
expects that designation should not change CERCLA's liability framework 
and that CERCLA will continue to operate as it has for decades (with 
respect to the more than 800 existing hazardous substances) to resolve 
who should pay for the cleanup and how much.
    In Section VI.C, EPA explains the results of the totality of the 
circumstances analysis to demonstrate that potential costs and 
disadvantages are not unreasonable when weighed against the numerous 
advantages of designation.

A. Advantages of Designation

    EPA examined the advantages of designation, including its positive 
impacts on public health, the Superfund program, local economies and 
ecosystems, and the importance of shifting response costs to parties 
responsible for significant contamination. Unlike other environmental 
statutes which are premised on ``command and control'' regulation, 
CERCLA is a remedial statute. It does not set prospective limits on the 
amount of permissible contamination. Instead, CERCLA imposes financial 
liability on those responsible for existing contamination that presents 
unacceptable risk to public health and the environment. As a 
consequence, benefits of the designation flow from CERCLA's liability 
framework--which leads to more cleanups of existing contaminated 
sites--rather than the prospective regulation of releases at regulated 
sources.
    Designating PFOA and PFOS as CERCLA hazardous substances eliminates 
barriers to timely cleanup of contaminated sites, enables EPA to shift 
responsibility for cleaning up certain sites from the Fund to PRPs, and 
allows EPA to compel PRPs to address additional contaminated sites. 
Ensuring the timely cleanup of sites, and that the parties responsible 
for significant contamination bear the costs of cleaning it up, are the 
primary objectives of CERCLA. EPA gave significant weight to these 
considerations because, absent designation, the cleanup of PFOA and 
PFOS contamination would be significantly hampered. PFOA and PFOS 
contamination is widespread, and EPA's current authority is limited.
    Earlier and more timely responses at contaminated sites will better 
address the urgent public health issue of PFOA and PFOS contamination. 
As discussed above in Section V, the latest science is clear: human 
exposure to PFOA and PFOS is linked to a broad range of adverse health 
effects. EPA gave significant weight to its finding that both PFOA and 
PFOS may present substantial danger. The potential for harm to public 
health is unabated if PFOA and PFOS remain in the environment, and 
designation is necessary to facilitate swift action. EPA also gave 
significant weight to the substantial health benefits--realized by 
communities nationwide--that are expected to result from designation. 
Earlier, expeditious response to PFOA

[[Page 39151]]

and PFOS releases will reduce exposure to PFOA and PFOS across the 
country and will minimize the likelihood of adverse health effects, 
particularly for sensitive groups such as pregnant woman and children. 
As discussed supra in Section V, PFOA and PFOS exposure is linked to 
serious health conditions, including cancer and cardiovascular disease. 
Reducing PFOA and PFOS exposures can improve community health while 
potentially saving Americans billions of dollars in health care and 
other expenses. PFOA exposure alone has been estimated to have caused 
billions of dollars of health care and other economic costs (Malits et 
al., 2018). EPA also quantified certain potential health benefits 
associated with reducing PFOA and PFOS exposure in private drinking 
water wells. Designation allows for earlier, and additional, CERCLA 
response activities to address areas with high levels of PFOA and PFOS 
contamination, which translates to lower risk of adverse health effects 
for the most exposed communities. Ensuring that EPA can utilize CERCLA 
to the fullest extent is critical to address this serious public health 
issue.
1. Designation Enables Earlier, Broader, and More Effective Cleanups of 
Contaminated Sites
    Designation of PFOA and PFOS as hazardous substances is critical to 
EPA's ability to address the public health threats posed by PFOA and 
PFOS in the environment. CERCLA imposes notification requirements and 
potential liability on those that release hazardous substances and 
makes available authorities that promote timely cleanup of hazardous 
substances. This includes release notification under CERCLA section 
103, response authority under CERCLA section 104, enforcement authority 
under CERCLA section 106, and cost recovery under CERCLA section 107. 
Thus, designation allows EPA to employ a broader suite of CERCLA 
authorities to address contamination, which in turn allows EPA to 
address more sites, enables earlier and more expeditious responses to 
PFOA and PFOS releases, and makes available additional resources 
allowing for cleanup of other COCs at NPL sites. It also provides EPA 
with authority to pursue those responsible for the most significant 
contamination so that they bear the financial responsibility for 
cleaning it up.
a. Designation Opens Up CERCLA's Notification, Response, Enforcement 
and Cost Recovery Authorities, Which Allows EPA to More Timely Address 
Contaminated Sites
    This action will make PFOA and PFOS subject to CERCLA's 
notification, response, enforcement, and cost recovery authorities. 
This is because those authorities either do not apply, or are limited, 
with respect to pollutants or contaminants (which PFOA and PFOS are 
currently).
    A direct consequence of designating PFOA and PFOS as hazardous 
substances is that, once designated, entities that release PFOA and 
PFOS at or above the reportable quantity must provide notification of 
the release. The requirements include notification to the National 
Response Center for releases that meet or exceed the reportable 
quantity, CERCLA section 103; newspaper notice to parties potentially 
injured by a release, CERCLA section 111(g); and State, local, and 
Tribal notice, as appropriate, for reportable releases, EPCRA section 
304. These notifications allow EPA to assess whether CERCLA response 
actions are necessary to mitigate risks to public health and the 
environment and to respond promptly where response actions are 
necessary. Swift action to address harmful releases can prevent further 
migration of PFOA and PFOS from the source of the release and reduce 
the need for more expensive, more expansive cleanup in the future.
    Designation also allows EPA to streamline the Federal government's 
response authority under CERCLA section 104 to address releases or 
threatened releases using removal or remedial authority. Absent 
designation, EPA (and other Federal agencies) can only address PFOA and 
PFOS as pollutants or contaminants. This means that, for each 
individual response, EPA (or another agency) needs to find that a 
release, or threat of release, ``may present an imminent and 
substantial danger to the public health or welfare.'' 42 U.S.C. 
9604(a)(1). After designation, agencies will be able to respond to a 
release or threatened release without first making this determination, 
allowing for action sooner.
    Designation also makes CERCLA's enforcement and cost recovery 
authorities available for PFOA and PFOS. In the absence of designation, 
CERCLA authority to compel PRPs to conduct or pay for response work 
does not extend to ``pollutants or contaminants'' and CERCLA does not 
provide cost recovery for actions taken solely in response to releases 
or threats of releases of ``pollutants or contaminants.'' Having access 
to these authorities will allow EPA to hold PRPs responsible for 
addressing PFOA/PFOS contamination, which can lead to the timely 
cleanup of more contaminated sites.
    Designation will allow EPA to take enforcement actions against PRPs 
under CERCLA section 106(a) when there may be an imminent and 
substantial endangerment from an actual or threatened release of PFOA 
or PFOS. EPA will be able to use CERCLA section 106(a) to compel PRPs 
to take immediate action to start the time-consuming process of 
investigating, scoping, and cleaning up PFOA and PFOS releases. This 
authority also helps to ensure that PRPs are financially accountable 
for releases of PFOA and PFOS by enabling EPA to compel PRPs to 
undertake response action. This, in turn, enables earlier and more EPA 
response work by diversifying EPA's options. Enforcement actions are 
also complementary to Fund-financed response activities (``Guidelines 
for Using the Imminent Hazard, Enforcement and Emergency Response 
Authorities of Superfund and Other Statutes,'' 1982). EPA aims, 
whenever possible, to seek cleanup by responsible parties prior to 
recourse to either the Fund or litigation. This allows EPA to preserve 
the valuable resources of the Fund to address as many priorities as 
possible.
    Enforcement authority contributes to timely response actions at the 
most contaminated sites. Because PRPs, rather than EPA, are best 
positioned to know the location and extent of potential contamination 
at and from their facilities, PRP-led cleanups can be more efficient. 
PRP-led cleanups can also be faster because EPA need not secure access 
orders with PRPs if the PRP is conducting the response actions. Also, 
EPA generally takes enforcement actions to address sites that pose the 
highest relative risks; therefore, making enforcement authority 
available supports EPA's ability to target and prioritize existing 
sites where PFOA and PFOS releases pose substantial risk to public 
health and the environment.
    Additionally, designation will allow EPA to use CERCLA section 107 
to recover costs expended by EPA to clean up PFOA and PFOS 
contamination. CERCLA section 107 provides that liable parties are 
responsible for the costs associated with responding to hazardous 
substances. Liable parties under CERCLA include: (1) Current owners and 
operators of facilities, (2) past owners and facility operators in 
place at the time of hazardous substance

[[Page 39152]]

disposal, (3) any person who ``arranged for disposal'' of that 
facility's hazardous substances, and (4) any person that accepts 
hazardous substances for ``transport to disposal or treatment 
facilities.'' (CERCLA section 107(a)). If a person is liable for a 
release of hazardous substances, that person may be responsible to pay 
for response costs, natural resource damages, and assessment costs, and 
costs pertaining to certain health assessment or health effects 
studies. CERCLA section 107(a)(4)(A)-(D).
b. The Availability of CERCLA Enforcement and Cost Recovery Authority 
Ensures That Polluters Are Financially Responsible, Which Is Consistent 
With CERCLA
    This action will allow EPA to hold polluters responsible for 
addressing significant contamination. After designation, EPA will have 
authority under CERCLA section 106 to compel PRPs to take response 
actions at their facilities. This may allow EPA to reach more sites 
more quickly. After designation, EPA can also rely on authority under 
CERCLA section 107 to recover costs expended by EPA to clean up PFOA 
and PFOS contamination.
    The availability of CERCLA enforcement authority to address PFOA 
and PFOS releases aligns with the Polluter Pays principle, a central 
objective of CERCLA, and is an important advantage of the rule. CERCLA 
is specifically designed to hold responsible those parties that 
contributed to dangers to human health and the environment by releasing 
hazardous chemicals into the environment. See H.R. Rep. No. 99-253, pt. 
3, at 15 (1985), as reprinted in 1978 U.S.C.C.A.N. 3038, 3038 (stating 
that a goal of CERCLA is ``to hold responsible parties liable'' for 
cleanup costs); H.R. Rep. No. 96-1016, pt 1, at 1 (1980) (acknowledging 
that CERCLA establishes ``strict liability to enable the Administrator 
to pursue rapid recovery of costs . . . and to induce [liable parties] 
voluntarily to pursue appropriate environmental response actions . . . 
.''). The ability to require liable parties to pay for cleanup is the 
cornerstone of ensuring that sites are cleaned up to protect public 
health from ``one of the most pressing environmental problems.'' See 
H.R. Rep. No. 99-253, pt 1, at 54 (1986), as reprinted in 1986 
U.S.C.C.A.N. 2835, 2836. In reauthorizing CERCLA, Congress acknowledged 
that, ``[I]t is clear from the accumulating data on waste sites that 
EPA will never have adequate monies or manpower to address the problem 
itself. As a result, an underlying principle . . . is that Congress 
must facilitate cleanups of hazardous substances by the responsible 
parties . . . .'' H.R. Rep. No. 99-253 at 55. Consistent with these 
legislative goals, this rule enables EPA to hold PRPs, particularly 
those that have contributed significantly to PFOA and PFOS 
contamination, financially responsible for addressing such 
contamination. Designation also signals to the market that there is 
value in the prevention of releases and mitigation of existing 
releases.
    EPA considered the additional costs that PRPs may face and 
concluded that these potential costs do not outweigh the advantages of 
designating PFOA and PFOS. Potential costs associated with CERCLA 
enforcement actions that may occur after designation are difficult to 
assess. Nonetheless, EPA used historical cost data to assess the 
potential for additional costs to PRPs associated with response work at 
non-NPL sites that may result from enforcement actions, see Chapter 5 
of the RIA for more detail. EPA cannot ascertain with certainty the 
number of sites that may be subject to a CERCLA enforcement action over 
the next several years. Depending on the circumstances, EPA may 
determine that authority provided under a different statute, such as 
RCRA, SDWA, CWA, or TSCA, may be best suited to address the 
environmental harm. In addition, the site could be referred to the 
State for further action rather than EPA; or site activity could be 
Fund-lead, which may occur when there is no viable PRP or when 
immediate action is required. Should EPA proceed using CERCLA 
enforcement, the scope of the enforcement action--including the 
response activities required and the amount of time it may take to 
implement them--is also difficult to estimate absent a preliminary 
assessment of the scope of contamination at a specific site.
    Ensuring that the PRPs responsible for significant contamination 
bear the costs of cleanup is one of the express purposes of CERCLA and 
can only be realized through designation. This is an important 
advantage of designation. Bringing PFOA and PFOS into CERCLA's 
liability framework is a critical and essential advantage of 
designation, considering that PFOA and PFOS are prevalent in the 
environment, threaten communities across the country, and PRPs are best 
situated to address releases from their facilities. And while it cannot 
be determined with specificity where or when enforcement and response 
actions will occur, EPA attempted to estimate anticipated expenditures 
to the best of its ability. Considering all of this together, EPA 
concluded that designation achieves a principal objective of CERCLA--
the polluter pays. The payment of these costs by those responsible for 
significant contamination represents an improvement in social welfare 
as a result of the rule.
c. EPA Expects Designation Will Increase Emergency Response and Removal 
Actions for PFOA/PFOS
    EPA expects that designation will result in more removal actions, 
including emergency actions, to address PFOA and PFOS releases, which 
in turn may increase health benefits. These removal actions can be 
taken by EPA (i.e., Fund-lead actions) or a PRP (i.e., PRP-lead 
actions).\44\ Additional removal actions are expected to occur because 
EPA prioritizes responses to hazardous substances and in particular 
those with the greatest threat to human health, and EPA expects an 
increase in State referrals, each of which are explained in turn.
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    \44\ This section only discusses designation impacts on Fund-
lead removals. Designation impacts pertaining to PRP-lead actions, 
including removal orders, are discussed in section VI.1.b.
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    After designation, EPA expects to take more Fund-lead removal 
actions for PFOA and PFOS contamination because existing limitations on 
response authority and cost recovery will no longer apply. EPA's 
removal program, although not limited to responses to hazardous 
substance releases, prioritizes responses to hazardous substance 
releases. This is in part because the removal budget is limited, and 
the administrative burden for addressing hazardous substances is 
reduced relative to addressing PFOA/PFOS as pollutants or contaminants. 
Absent designation, to respond to PFOA or PFOS contamination utilizing 
CERCLA section 104(a), the statute requires EPA to determine the 
release or threat of release may pose an imminent and substantial 
endangerment. The statute also does not allow EPA to cost recover for 
actions exclusive to pollutants or contaminants. A hazardous substance 
designation removes those statutory limitations, as EPA need not 
demonstrate on a case-by-case basis that releases of hazardous 
substances may pose an ``imminent and substantial endangerment.'' 
Designation thus enables additional Fund-lead removal actions to 
address immediate risks.\45\

[[Page 39153]]

EPA can then later recover costs for cleanup of these substances. 
Recovered costs for each removal action that EPA takes to address sites 
contaminated with PFOA and/or PFOS are costs that would be shifted from 
taxpayers to PRPs.
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    \45\ When a removal action is appropriate, EPA should take 
action ``as soon as possible,'' (40 CFR 300.415(b)(3)), and may 
often choose to take a Fund-lead removal rather than pursing a PRP-
lead action through use of CERCLA enforcement authority. Negotiating 
an enforcement order can be a time-consuming effort, which can in 
turn delay a response. When immediate action is required, EPA will 
use Fund dollars to initiate a removal and later cost recover.
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    Removal actions to address PFOA and PFOS releases may also increase 
as a result of State referrals, which often trigger a Fund-lead removal 
action. States refer sites to EPA when they do not have the capacity, 
technical expertise, or funding to take action under their own 
authorities. EPA expects an increase in State referrals to EPA for PFOA 
and PFOS removal actions because State budgets are limited. And because 
State budgets are limited, Federal involvement may be the only 
financially viable path toward responding to PFOA and PFOS releases. 
EPA is not required to initiate a removal in response to referrals; 
however, EPA must evaluate the need for removal actions as promptly as 
possible after receiving the notification and determine the appropriate 
response. (40 CFR 300.405(f)(1), 300.410(b)). EPA may determine that a 
Fund-lead removal is the appropriate response or, if not, EPA may 
continue monitoring the situation should EPA involvement be appropriate 
at a later point in time.
    EPA expects that removal costs for addressing PFOA and PFOS 
releases will likely be roughly similar to removal costs for other 
substances. The same response methods that exist for addressing other 
hazardous substances are available for PFOA and PFOS. As one example, 
in cases where PFOA and PFOS are contaminating drinking water, removal 
actions would primarily focus on risk reduction for exposure to 
contaminated drinking water. Methods of addressing exposure may include 
granulated activated carbon, ion exchange, connecting customers to the 
nearest public water system, and/or temporarily providing bottled 
water. Any contamination left in place would be managed using post-
removal site controls \46\ or referred to a cleanup program (e.g., 
State, local, or the Superfund remedial program),\47\ dependent on 
relative risk. EPA expects that Fund-led removal actions to address 
PFOA and PFOS releases may range from $160,000 to $503,000 per site. 
See RIA Chapter 5. Where PFOA and/or PFOS are the sole driver for 
initiating a removal action, the cost estimate above represents the 
estimated cost of the action. Where EPA may be responding to multiple 
COCs, the cost of addressing PFOA/PFOS would represent an incremental 
increase to the overall cost of response in addition to those other 
COCs.
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    \46\ Post-removal site control (PRSC) means ``those activities 
that are necessary to sustain the integrity of a Fund-financed 
removal action following its conclusion.'' (40 CFR 300.5). This may 
include, for example, replacing water treatment system filters or 
collecting leachate. Once field actions end, and all EPA resources 
are demobilized, any additional actions required are PRSCs. PRSCs 
continue until they are no longer necessary or until such time as a 
PRP, state or local government, or EPA's remedial program implements 
a remedy. (40 CFR 300.415(l)).
    \47\ After EPA takes a removal action, it may be appropriate to 
refer the site back to the state to maintain PRSCs. The NCP provides 
that EPA should provide for PRSC, to the extent practicable, before 
the removal action begins. (40 CFR 300.415(l)). EPA often 
coordinates with states to obtain a commitment that the state will 
maintain PRSCs after the removal ends. States may not have funding 
to undertake the initial removal action, but often are able to 
budget PRSC costs.
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    An increase in removal actions for PFOA and PFOS releases is 
expected to produce meaningful health benefits. Fund-lead removal 
actions are the fastest way for EPA to respond to the most urgent 
situations. Removal actions are typically quick responses to immediate 
threats to eliminate or mitigate a threat to the public. Thus, EPA is 
able to initiate a removal action more quickly than it can remedial 
action--actions which often take decades to develop and implement. 
Through removal actions, EPA can more quickly eliminate or mitigate 
exposure pathways. For example, if it becomes known to EPA that a 
resident's drinking water is contaminated with PFOA and PFOS above 
risk-based levels, EPA can take action to eliminate that exposure 
pathway by providing alternative drinking water or connecting the 
resident to an alternative water source. Such actions mitigate the risk 
of adverse health outcomes associated with chronic and cumulative 
exposures to PFOA and PFOS. See Section VI.A.2 of this document, 
discussion of health benefits.
d. EPA Expects That Shifting Costs to PRPs To Address PFOA/PFOS 
Contamination at NPL Sites Will Make Fund Money Available for Other 
Response Work
    Through this action, EPA may compel viable PRPs to clean up PFOA/
PFOS contamination. EPA may thus conserve use of the Fund for 
addressing other COCs or sites where there are no viable PRPs, 
expanding EPA's ability to provide meaningful benefits for public 
health and the environment across the country. Absent designation, EPA 
would continue to spend Fund resources to clean up PFOA and PFOS 
releases at non-Federal facility NPL sites under EPA's authority to 
address PFOA and PFOS as ``pollutants or contaminants.'' Prior to this 
rule, EPA evaluated PFOA and PFOS releases as pollutants and 
contaminants as part of its process to identify potential NPL sites, in 
its selection of a remedy, and in evaluation of the remedy. See supra--
Section II.E.4, 5. After designation, EPA will continue to evaluate 
PFOA and PFOS releases as part of the Superfund process, but now EPA 
can transfer these costs to PRPs--the entities responsible for the 
contamination and associated hazards to human health and the 
environment.\48\ Designation or not, EPA has been and will continue to 
evaluate hazardous substances, pollutants or contaminants, at NPL sites 
and, if necessary, address releases that present unacceptable risk to 
human health or the environment. A major difference this designation 
makes for NPL sites is who bears responsibility.
---------------------------------------------------------------------------

    \48\ As detailed in the RIA accompanying this rule, these ``cost 
transfers'' from EPA to the PRP do not result in a net increase in 
economic costs--rather, they just change ``who pays'' for these 
cleanup costs.
---------------------------------------------------------------------------

    After designation, parties responsible for significant 
contamination may bear liability. As discussed in Section VI.A.1.b., 
the transfer of costs from EPA to PRPs directly advances CERCLA's 
objective that those that contributed to contamination bear the cost of 
cleaning it up. While these cost transfers at NPL sites are an 
important outcome of the designation, the designation itself does not 
lead to greater response costs at particular NPL sites. Absent 
designation, EPA would incur these costs, which would be paid by the 
Superfund. After designation, EPA can transfer these costs to viable 
PRPs by compelling PRPs to implement response actions at NPL sites or 
through cost recovery.
    The transfer of costs to viable PRPs leads to more total resources 
available for cleanups. Superfund resources that otherwise would have 
been used for PFOA and PFOS response actions can now be available for 
other priorities. Such monies could be made available for additional 
Superfund response activities at NPL sites to be spent addressing any 
of the more than 800 hazardous substances, including PFOA and PFOS, as 
well as other pollutants and contaminants. EPA estimates that this will 
result in $10.3M to $51.7M (at a 2% discount rate) of Fund resources 
available each year for NPL response work because of designation. While 
EPA cannot fully quantify the benefits attributable to funds being 
available for more response work at NPL sites, EPA

[[Page 39154]]

believes these benefits will be meaningful. More money for NPL response 
work means that EPA will be able to better address threats to public 
health and our natural environment from contamination.
    Addressing PFOA and PFOS contamination may lead to an incremental 
increase in the costs associated with addressing NPL sites depending on 
what other COCs are located at a given site. It is unusual for a remedy 
to address a sole ``contaminant of concern,'' many of which are 
hazardous substances. Typically, remedial actions address a number of 
COCs at once. In some cases, the remedy for other COCs will also 
address PFOA and PFOS contamination; in other cases, there will need to 
be additional work to address PFOA and PFOS contamination. For 
instance, if PFOA and PFOS are not already part of a remedy for the 
site, adding them to the remedy would then have the potential to 
incrementally increase the overall cost of the remedy (e.g., by 
increasing the frequency of GAC replacement). Any costs of cleaning up 
PFOA and PFOS contamination could then be transferred to PRPs, instead 
of borne by the Fund. EPA estimates that the incremental cost for 
addressing PFOA and PFOS releases at NPL sites may range from $10.3 
million annually to $51.7 million annually (at a 2% discount rate). See 
RIA Chapter 5. These represent estimated response costs that the Fund 
would incur absent designation; designation is not expected to result 
in an overall increase in cost to EPA to address NPL sites. However, 
the recovery of $10.3M to $51.7M (at a 2% discount rate) of Fund 
resources each year because of designation will result in EPA 
continuing to spend that same amount on other Superfund response 
activities. This represents an increase in resources expended on 
Superfund response as EPA continues to spend as before and parties 
responsible for PFOA and PFOS contamination also must spend to address 
contamination at NPL sites. This represents an indirect incremental 
cost of the rule.
    In sum, EPA concludes that significant advantages of designation 
are that it will enable earlier, broader, and more effective cleanups 
of contaminated sites. Designation will provide additional or enhanced 
notification, response, liability, and enforcement authority under 
CERCLA. This enhanced authority may allow EPA to address more 
contaminated sites more quickly. Designation will also ensure that 
polluters pay for cleaning up contamination that poses unacceptable 
risks to human health and the environment, which is consistent with 
CERCLA's objectives. EPA expects to conduct more removal and emergency 
response actions and that more resources will be available for NPL site 
response actions. These are significant advantages of the rule because 
it effectuates the two primary objectives of CERCLA's statutory 
framework--timely cleanup of contaminated sites and polluter pays--by 
bringing widespread, persistent chemicals--PFOA and PFOS--under the 
umbrella of CERCLA's liability framework, which in turn makes more 
resources available to address this widespread public health threat.
2. Designation Brings Broad Health Benefits
    EPA also weighed the health benefits that may indirectly result 
from designation. EPA considered quantified and unquantified health 
benefits associated with reducing exposure to PFOA and PFOS, as well as 
from additional response work at NPL sites. While it is hard to 
determine with certainty the nature and scope of future response 
actions, EPA expects that reducing PFOA and PFOS exposure will reduce 
the risk of adverse health effects, as detailed below.
a. Qualitative Potential Benefits From Decreased Exposure After 
Addressing PFOA/PFOS Contamination
    EPA weighed the indirect potential health benefits associated with 
removing PFOA and PFOS from the environment. When exposure pathways are 
mitigated or eliminated, communities living around contaminated sites 
would be expected to have lower rates of adverse health effects because 
they are exposed to less PFOA and PFOS. Historical data, such as NPL 
sites with soil lead contamination and cleanups, demonstrates improved 
health outcomes after Superfund cleanups.\49\ So here, one advantage 
from designation is that EPA expects overall reductions of adverse 
health outcomes for exposed communities to occur sooner, in addition to 
wholly avoided exposure in some instances. EPA expects that additional 
response actions to address PFOA/PFOS at non-NPL sites resulting from 
more removals and enforcement actions will reduce or in some cases 
eliminate exposure to PFOA and PFOS from contaminated sites, resulting 
in several categories of non-quantified health benefits realized as 
avoided adverse health effects. As described in section V.A. of this 
document, PFOA and PFOS exposure can be associated with the following 
adverse health outcomes:
---------------------------------------------------------------------------

    \49\ Heather Klemick, Henry Mason, and Karen Sullivan. 2020. 
``Superfund Cleanups and Children's Lead Exposure,'' Journal of 
Environmental Management, 100. doi: 10.1016/j.jeem.2019.102289. For 
more information: https://www.epa.gov/superfund/lead-superfund-sites#sites.
---------------------------------------------------------------------------

     Developmental birth effects such as low infant birth 
weight, birth length, and head circumference
     cardiovascular effects such as changes in cholesterol and 
blood pressure
     cancer, including renal cell carcinoma
     changes in liver enzymes
     decreased immune response to vaccination
     endocrine effects, including thyroid disorders
     reproductive effects (for PFOA)
     nervous system effects (for PFOS).
    Designation provides a robust mechanism to minimize the potential 
for these adverse health effects from PFOA and PFOS exposure. To the 
extent that adverse health effects are reduced or avoided, healthcare 
expenditures to address these outcomes could be reduced, and worker 
productivity and overall quality of life would be enhanced due to 
reduced illness and chronic health conditions.
    Given that PFOA and PFOS are often expected to be co-located and/or 
commingled with other chemicals, cleanup at non-NPL sites because of 
enforcement actions may simultaneously clean up co-contaminants other 
than PFOA and PFOS that would otherwise go unaddressed, potentially 
including other types of PFAS. This may include cleanup of co-
contaminants from private drinking water wells as well as the source 
water used for public water supply (to the extent contamination entered 
source waters and will be cleaned up as a result of this rule). As a 
result, addressing these co-contaminants has the potential to result in 
additional health and ecological benefits.
    Despite the array of adverse health and environmental risks 
associated with exposure to PFOA and PFOS, it is technically 
challenging to quantitatively estimate adverse effects from exposure 
that will occur absent the designation of PFOA and PFOS as hazardous 
substances. Furthermore, it is challenging to quantitatively estimate 
the benefits that may result from designation. In fact, many important 
benefits (including those associated with possible immune, hepatic, 
endocrine, metabolic, reproductive, musculoskeletal outcomes) of 
cleaning up PFOA and PFOS can only be

[[Page 39155]]

described in qualitative terms due to the lack of robust data. They 
cannot be quantified or monetized due to data gaps, and due to 
uncertainty regarding where and when cleanups will occur. But that does 
not mean that these benefits are small, insignificant, or nonexistent, 
particularly to the communities CERCLA exists to protect. Quantifying 
benefits from cleanup of PFOA and PFOS requires data to characterize 
the risk and quantify the magnitude of expected (cancer and noncancer) 
health outcomes. Generally, robust data needed to quantify the 
magnitude of expected adverse noncancer impacts are unavailable, and 
full quantification of these benefits is made even more challenging by 
the overlap of effects from PFOA and PFOS exposure. For these reasons, 
EPA was able to estimate only a few of the many potential benefits from 
reduced exposure to PFOA and PFOS. The quantified illustrative benefits 
of addressing PFOA/PFOS contamination discussed below are in addition 
to the potential qualitative benefits discussed above. EPA believes 
that the advantages of this action outweigh the disadvantages even 
without consideration of quantified benefits. The quantified benefits 
account for only a portion of the overall benefits from the designation 
of PFOA and PFOS as hazardous substances. That is, addressing PFOA and 
PFOS contamination in private drinking water wells also results in 
additional health benefits for additional health endpoints that cannot 
be quantified, and addressing PFOA/PFOS contamination more broadly 
brings health and ecological benefits well beyond private drinking 
water wells. The quantitative benefits described below, however, make 
clear the meaningful health benefits achieved from reduced exposure to 
PFOA and PFOS.
b. Quantifiable Health Benefits of PFOA and PFOS Exposure Reduction
    In the RIA supporting this final regulation, EPA performed an 
illustrative estimate of benefits calculated using monetized health 
benefits estimates per unit reduction of PFOA and PFOS derived for 2024 
National Primary Drinking Water Regulation (U.S. EPA, 2024a). The 
estimated benefits attributable to this rule due to reduced PFOA and 
PFOS levels in private wells (which are not subject to the PFAS NPDWR) 
are distinct from those attributable to the PFAS NPDWR from reduced 
PFOA and PFOS in public and community water systems. A portion of 
benefits from this rule derive from reduced PFOA and PFOS in private 
wells used for drinking water that may result from addressing 
contaminated sites, both in the baseline (at NPL sites) and under this 
final rule (at non-NPL sites). The benefits estimation methodology and 
results are discussed here. Quantified benefits in the PFAS NPDWR were 
assessed as avoided cases of illness and deaths (or morbidity and 
mortality, respectively) associated with exposure to PFOA and PFOS. The 
PFAS NPDWR provided a quantitative estimate of birth weight and 
cardiovascular disease (CVD)--avoided morbidity and mortality 
associated with reductions in PFOA and PFOS. A quantitative estimate of 
renal cell carcinoma (RCC)--avoided morbidity and mortality for 
reductions in PFOA was also developed. EPA was not able to quantify or 
monetize other health benefits, including those related to other 
reported health effects including immune, liver, endocrine, metabolic, 
reproductive, musculoskeletal, as well as certain cancers such as 
combined hepatocellular adenomas and carcinomas. EPA assesses potential 
benefits quantitatively if evidence of exposure and health effects is 
likely, it is possible to link the outcome to risk of a health effect, 
and there is no overlap in effect with another quantified endpoint in 
the same outcome group. Particularly, the most consistent 
epidemiological associations with PFOA and PFOS include decreased 
immune system response, decreased birthweight, increased serum lipids, 
and increased liver enzymes (particularly Alanine Transaminase (ALT)). 
The available evidence indicates effects across immune, developmental, 
cardiovascular, and hepatic organ systems at the same or approximately 
the same level of exposure.
i. Quantified Developmental Effects
    Research indicates that exposure to PFOA and PFOS is associated 
with developmental effects, including infant birth weight (ATSDR, 2021; 
Negri et al., 2017; U.S. EPA, 2016c, 2016d, 202bg, 2024c; Verner et 
al., 2015; Waterfield et al., 2020). The route through which the embryo 
and fetus are exposed prenatally to PFOA and PFOS is maternal blood 
serum via the placenta. Most studies of the association between 
maternal serum PFOA/PFOS and birth weight report negative relationships 
(Dzierlenga et al., 2020; Negri et al., 2017; Verner et al., 2015). EPA 
quantified and valued changes in birth weight-related risks associated 
with reductions in exposure to PFOA and PFOS in drinking water.
    Low birth weight is linked to a number of health effects that may 
be a source of economic burden to society in the form of medical costs, 
infant mortality, parental and caregiver costs, labor market 
productivity loss, and education costs (Behrman & Rosenzweig, 2004; 
Chaikind & Corman, 1991; Colaizy et al., 2016; Institute of Medicine, 
2007; Joyce et al., 2012; Klein & Lynch, 2018; Kowlessar et al., 2013; 
Nicoletti et al., 2018). Recent literature also linked low birth weight 
to educational attainment and required remediation to improve students' 
outcomes, childhood disability, and future earnings (Chatterji et al., 
2014; Dobson et al., 2018; Elder et al., 2020; Hines et al., 2020; 
Jelenkovic et al., 2018; Temple et al., 2010).
    EPA's analysis focuses on two categories of birth weight impacts 
that are amenable to monetization associated with incremental changes 
in birth weight: (1) medical costs associated with changes in infant 
birth weight and (2) the value of avoiding infant mortality at various 
birth weights.
ii. Quantified Cardiovascular Effects
    Cardiovascular Disease (CVD) is one of the leading causes of 
premature mortality in the United States (D'Agostino et al., 2008; Goff 
et al., 2014; Lloyd-Jones et al., 2017). As discussed in Section V.A 
above, exposure to PFOA and PFOS is associated with increased serum 
PFOA and PFOS concentrations and potentially elevated levels of total 
cholesterol and elevated levels of systolic blood pressure (U.S. EPA, 
2024b; U.S. EPA, 2024c). Changes in total cholesterol and blood 
pressure are associated with changes in incidence of CVD events such as 
myocardial infarction (i.e., heart attack), ischemic stroke, and 
cardiovascular mortality occurring in populations without prior CVD 
event experience (D'Agostino et al., 2008; Goff et al., 2014; Lloyd-
Jones et al., 2017).
iii. Quantified Kidney Cancer Effects
    The strongest evidence of an association between PFOA exposure and 
cancer in human populations is from studies of kidney cancer (e.g., 
renal cell carcinoma (RCC)). Epidemiology studies indicated that 
exposure to PFOA was associated with an increased risk of kidney cancer 
(ATSDR, 2021; California EPA, 2021; U.S. EPA, 2016d, 2024c, U.S. EPA 
2024d). The C8 Science Panel (2012) characterized the evidence for PFOA 
effects on kidney cancer as ``probable'' based on two occupational 
population studies (Raleigh et al., 2014; Steenland & Woskie, 2012) and 
two high-exposure community studies (Barry et al., 2013; Vieira et al., 
2013). A recent study of the relationship

[[Page 39156]]

between PFOA and RCC in U.S. general populations found a statistically 
significant positive exposure-response association between 
prediagnostic serum PFOA concentrations and subsequent risk of RCC 
within a population-based US prospective cohort (Shearer et al., 2021). 
This study also observed associations with RCC for PFOS and PFHxS in 
models unadjusted for other PFAS. However, after mutual adjustment for 
these 3 chemicals, only the association with PFOA remained 
statistically significant. As such, EPA selected RCC as a key outcome 
when assessing the health impacts of reduced PFOA exposures.
    In the PFAS NPDWR, EPA quantified and valued the changes in RCC 
risk associated with reductions in serum PFOA levels that are in turn 
associated with reductions in drinking water PFOA concentrations. For 
more details regarding the quantification of benefits from potential 
reduced developmental, CVD, and RCC impacts, as well as key limitations 
and uncertainties in that analysis, See Chapter 6 of the EA for the 
2024 NPDWR Final Rule. (U.S. EPA, 2024a).
2. Estimated Health Benefits of PFOA and PFOS Exposure Reduction
    For this final CERCLA rule, the quantitative benefit estimates from 
reducing the adverse health effects described throughout this rule are 
characterized as illustrative because, in addition to several 
uncertainties regarding potential cleanups at these sites, it is not 
possible to estimate the precise magnitude of potential health-related 
benefits from reducing PFOA/PFOS at these sites. Chapter 3 of the RIA 
supporting this final rule describes other limitations of the benefits-
estimate transfer approach adopted from the PFAS NPDWR, including the 
simplifying assumption of combining PFOA and PFOS concentrations into 
one metric and the assumption that benefits per person are linear per 
PFOA and PFOS part per trillion (ppt) removed.\50\
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    \50\ The extent to which PFOA or PFOS or both will be reduced at 
any given site where EPA may implement CERCLA response action is 
unknown at this time. While PFOA and PFOS are typically found 
together, to the extent that any CERCLA response action only reduces 
PFOS concentrations and not PFOA concentrations, the potential 
health benefits associated with reducing renal cell carcinoma 
presented here would be overestimated because RCC is associated with 
PFOA exposure and not PFOS. Further limitations and potential bias 
are described in more detail in Section 3.5 of the accompanying RIA.
---------------------------------------------------------------------------

    For context of baseline benefits associated with addressing PFOA/
PFOS at NPL sites, the low-end annualized baseline benefits under the 
assumption 10% of wells within one mile of NPL sites are impacted with 
10 ppt reduction in PFOA/PFOS exposure are $430,000 (2% discount rate). 
The high-end annualized baseline benefits under the assumption 30% of 
wells near NPL sites are impacted with 200 ppt reduction in PFOA/PFOS 
exposure are $25,800,000 (2% discount rate). Exhibit 1 shows the 
results of the illustrative baseline benefits estimates under the 
scenarios analyzed. Note that these estimates are associated with 
potential cost transfers as described in Section VI.A.1.d. above and 
are expected to occur in the baseline (absence of the designation), 
therefore they are not a result of designation. However, these and 
other health benefits are expected to be conferred earlier than without 
designation because designation as hazardous substances reduce the 
administrative burden on the Agency and makes available enforcement 
authorities that allow EPA to address PFOA/PFOS contamination sooner.
[GRAPHIC] [TIFF OMITTED] TR08MY24.005

    As noted previously, the final rule is likely to result in 
enforcement actions brought by EPA to address PFOA and PFOS releases at 
non-NPL sites, which are expected to reduce exposure thereby mitigating 
or eliminating adverse health effects for nearby communities. Due to 
uncertainties regarding the level of contamination at affected sites, 
the level of exposure avoided, populations near these sites of concern, 
and response actions taken, it is not possible to estimate the precise 
magnitude of potential health-related benefits from reducing PFOA/PFOS 
at these sites. Given this uncertainty, EPA presents a range of 
illustrative potential health benefits associated with this

[[Page 39157]]

designation. Consistent with the assessment of baseline benefits at NPL 
sites presented above, the analysis presented here is limited to 
benefits related to reductions in PFOA/PFOS concentrations in private 
wells that lead to a reduced incidence of developmental effects, 
cardiovascular effects, and renal cell carcinoma. This analysis focuses 
on sites where EPA may address PFOA/PFOS contamination at non-NPL sites 
using enforcement authorities made available by designation. These 
sites may include those that are owned/operated by plastics material 
and resin manufacturing firms identified as having produced PFOS/
PFOA,\51\ and sites owned/operated by companies reporting PFOS/PFOA 
releases (including PFOA/PFOS salts) to EPA's TRI.^{52 53}
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    \51\ Data acquired from: Environmental Protection Agency, 
``Enforcement and Compliance History Online (ECHO).'' Because not 
all plastic material and resin manufacturers use PFAS, only a 
fraction of the facilities reported in ECHO as plastics material and 
resin manufacturers were used in this analysis. To filter facilities 
involved in the use or manufacture of PFAS, this RIA uses proxy 
sites identified using sites owned/operated by companies that 
participated in EPA's PFOA Stewardship Program, under the assumption 
that the likelihood of PFOA/PFOS contamination is potentially high 
at these sites.
    \52\ Environmental Protection Agency, ``Toxics Release Inventory 
(TRI) Program, 2022 TRI Preliminary Dataset: Basic Data Files,'' 
July 2023. Accessed at: https://www.epa.gov/toxics-release-inventory-tri-program/2022-tri-preliminary-dataset-basic-data-files.
    \53\ TRI reporting is not currently required for isomers of PFOA 
and PFOS.
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    Under the low-end assumptions, estimated annualized benefits range 
from as low as $8,990 to as high as $539,000. These low-end values 
reflect an assumption that clean up actions are completed in year 19 
for each group of sites analyzed. The corresponding range based on the 
high-end assumptions is $13,000 to $779,000. These high-end values 
reflect the assumption that response actions are completed in year 1 
for each group of sites. Exhibit 2 below shows the results of the 
illustrative range of benefits estimates under the low-end and high-end 
scenarios analyzed. For more information about this analysis, see 
Section 5.2.2 of the RIA.
[GRAPHIC] [TIFF OMITTED] TR08MY24.006

c. Cost Estimates of Burden of PFAS-Related Disease
    EPA also considered the potential for designation to contribute to 
reduction in the burden of PFAS-related disease by looking at published 
studies related to PFAS disease burden. Expanding upon the exposure-
response literature for PFAS, a recent study published by Obsekov et 
al. (2023) estimated a total United States disease burden of $5.52 
billion related to PFOA and PFOS in the U.S. in 2018. Based on PFAS 
exposure data from the NHANES, the study stratified the population into 
percentile groups according to PFAS concentrations. The incidence of 
five adverse health effects was then estimated for each group based on 
exposure-response relationships from the literature. These health 
effects include: (1) Low birth weight, (2) Childhood obesity, (3) 
Kidney cancer, (4) Testicular cancer, and (5) Hypothyroidism in women. 
These health effects were chosen based on the existence of 
statistically significant associations for each effect derived from 
published meta-analyses of epidemiological studies. To value the 
economic costs associated with these health effects, the study relies 
on a combination of cost-of-illness data (e.g., the costs of 
hospitalization), human capital-based metrics (e.g., reduction in 
lifetime income associated with lost IQ points related to low birth 
weight), and the value of disability-adjusted life years (related to 
kidney cancer). The study also includes a sensitivity analysis that 
expands the scope of health effects examined to include health 
conditions for which relationships with PFAS had been identified in the 
literature but had not been meta-analyzed. These additional health 
effects include adult obesity, type 2 diabetes in females, gestational 
diabetes due to exposure during pregnancy, endometriosis, polycystic 
ovarian syndrome, couple infertility, female breast cancer, and 
pneumonia. With these health effects added, the sensitivity analysis in 
Obsekov et al. (2023) estimates a PFOS-

[[Page 39158]]

and PFOA-related disease burden of $62.6 billion in 2018. However, the 
authors recognize ``that some studies for each of the included outcomes 
might have reported null findings, [and that] the lower bound of 
economic cost added for this group of outcomes is zero.'' (Id.)
e. Environmental Justice (EJ) Analysis
    EPA believes that the human health and environmental conditions 
that exist prior to this action result in or have the potential to 
result in disproportionate and adverse human health or environmental 
effects on communities with EJ concerns. The demographic analysis of 
plastics manufacturers, facilities reporting to the Toxic Release 
Inventory (TRI), and U.S. airports found that people of color and low-
income populations are disproportionately represented (except near 
small/medium airports). In particular, these sites have higher rates of 
Black, Asian, and Hispanic people surrounding them relative to the 
national average. This finding holds whether focusing on all such 
populations within one or three miles of these sites or only such 
populations served by private wells.
    Consequently, EPA believes that this action is likely to reduce 
existing disproportionate and adverse effects on communities with EJ 
concerns. To the extent that the final rule leads to additional 
response actions to mitigate or eliminate exposure to PFOA/PFOS, or to 
actions that mitigate exposure earlier, health risks for populations 
living near sites where releases occur may decline. Based on the 
detailed analysis found in Section 6.3 of the RIA, the proportion of 
the population near these sites identified potential communities with 
EJ concerns, or (in some cases) people living in structures with a 
higher probability of containing lead paint (built before 1960) exceeds 
the national average. Thus, EPA expects that the final rule will at 
least partially mitigate the existing burden of PFOS/PFOA exposure that 
falls disproportionately on communities with EJ concerns.
    As further context for EJ effects potentially associated with the 
final rule, published literature concludes that communities with 
potential EJ concerns, and other socio-economic burdens, have a higher 
likelihood of exposure to PFAS, including PFOA/PFOS. For instance, 
reported data from Northeastern University's Social Science 
Environmental Health Institute published in 2019 show that people of 
color and low-income populations are disproportionately exposed to PFAS 
as nearly 39,000 more low-income households (15% more than the expected 
based on U.S. census data) and approximately 295,000 more people of 
color (22% more than expected) live within five miles of a site 
contaminated with PFAS (PFAS Project Lab, 2019). In addition, 
information on the broader links between PFAS exposure and communities 
with EJ concerns continues to emerge. An August 2021 Natural Resources 
Defense Council (NRDC) report examined exposure to PFAS in drinking 
water in California and found that at least 69 percent of State-
identified disadvantaged communities have PFAS contamination in their 
public water systems, and a number of these communities have levels of 
PFAS contamination that are higher than the State average PFAS 
concentrations. In their report, NRDC examined the relationship between 
the PFAS results and California's CalEnviroScreen 3.0 (CES) scores, 
which measure the environmental burden at the census-tract level. CES 
identifies communities that are disproportionately burdened by and 
vulnerable to multiple sources of pollution. The top 25 percent most 
impacted communities are identified as ``disadvantaged communities'' 
for the purpose of allocating funds from the State's cap-and-trade 
climate program (Senate Bill 535). By examining the overlap of CES 
scores and PFAS results at the census level, NRDC identified census 
tracts that may be the most vulnerable to PFAS contaminated drinking 
water. (Lee, Susan, Avinash Kar, and Dr. Anna Reade, Dirty Water: Toxic 
``Forever'' PFAS Chemicals are Prevalent in the Drinking Water of 
Environmental Justice Communities. Natural Resources Defense Council, 
New York. 2021). Therefore, this final rulemaking may improve 
conditions for exposed populations and communities, including 
communities with EJ concerns that may have greater PFAS exposure than 
the general population. Designation of PFOA and PFOS as hazardous 
substances would allow EPA to address more sites and to implement 
response actions earlier in time at sites contaminated with PFOA/PFOS, 
including those near exposed populations and communities, than the 
Agency could otherwise address in the absence of designation.
f. Summary of Potential Health Benefits Resulting From the Designation
    EPA estimates that a portion of potential health benefits 
associated with reduced exposure resulting from addressing PFOA and 
PFOS contamination in private drinking water around non-NPL sites that 
may result from EPA exercising enforcement authorities range from 
$8,900 to $779,000 (2% discount rate) per year, depending on the 
percentage of private wells impacted, the reduced level of PFOA/PFOS 
exposure at each well, and when the cleanup is expected to occur. Note 
that additional health benefits could also arise through other routes 
of exposure and for other health effects and non-health effects related 
to PFOA and PFOS that did not have adequate information for 
monetization in the PFAS NPDWR, which was used to develop estimates of 
potential indirect benefits of this designation. Remediation of PFOA 
and PFOS contaminated sites under CERCLA, including sites with 
contaminated sediment in water bodies, may reduce the transport of 
these substances to waters that can be sources of water to public water 
systems (PWS). There are potential health benefits to customers of 
public PWSs if source waters are cleaned up to levels below the PFAS 
NPDWR MCLs \54\ or are cleaned up before the PWSs take action to comply 
with the PFAS NPDWR; EPA cannot quantify these potential benefits.
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    \54\ MCL--Once the MCLG is determined, EPA sets an enforceable 
standard. In most cases, the standard is a maximum contaminant level 
(MCL). The MCL is the maximum level allowed of a contaminant in 
water which is delivered to any user of a public water system. 
(https://www.epa.gov/sdwa/how-epa-regulates-drinking-water-contaminants.)
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    EPA expects that health benefits that would accrue absent this 
designation through addressing PFOA and PFOS as pollutants or 
contaminants under CERCLA, and the additional health benefits due to a 
potential increase in enforcement actions and removal actions, will be 
realized sooner rather than later because of this designation. Low-end 
annualized estimated baseline benefits associated with addressing PFOA/
PFOS as pollutants or contaminants at NPL sites under the assumption 
10% of wells near NPL sites are impacted with 10 ppt reduction in PFOA/
PFOS exposure are $430,000 (2% discount rate). The high-end annualized 
baseline benefits under the assumption that 30% of wells near NPL sites 
are impacted with 200 ppt reduction in PFOA/PFOS exposure are 
$25,800,000 (2% discount rate). Designation is expected to result in 
earlier response actions because the rule will make EPA aware of PFOA/
PFOS contamination earlier than in the baseline (at both NPL and non-
NPL sites). As described previously, designation allows EPA access to 
enforcement authorities to investigate potential releases and compel 
PRPs to address releases and requires notification of releases above 
the RQ. These factors may allow for

[[Page 39159]]

timelier cleanup relative to a world without the rule. EPA also expects 
that industry may improve best practices and handling procedures to 
prevent or mitigate releases of PFOA and PFOS that, in turn, could 
result in less expensive cleanups over the long run.
3. Property Reuse and Social, Economic, and Ecological Benefits That 
May Result From Designation
    Superfund cleanups have a proven track record of contributing to 
social, economic, and ecological benefits. EPA expects similar benefits 
to accrue as a result of more PFOA and PFOS cleanups that will occur 
after designation. As a first step, EPA considered studies that 
evaluated property value trends for communities living around 
contaminated sites that were cleaned up. Some studies evaluated 
communities surrounding Superfund sites and other RCRA facilities. RCRA 
studies examining the effects of remediating hazardous waste sites are 
also illustrative of how cleanups can improve property values for 
nearby communities. Thus, EPA considered both sets of studies in 
evaluating how designation may contribute to increased property values.
    Many studies demonstrate that cleaning up contaminated sites can 
positively improve property values. Residential property values within 
3 miles (4.8 kilometers) of Superfund sites may increase as much as 
18.7 to 24.4 percent when sites are cleaned up and deleted from the 
NPL. Research specific to RCRA cleanups also suggest that property 
values may improve from cleanup, perhaps as much as five percent 
(Taylor et al., 2016). Improved property values also have social equity 
and environmental justice benefits. Communities near Superfund sites 
tend to be more disadvantaged than those living farther from the sites, 
and so increased housing values may provide the most benefit to the 
poorest segments of the population as opposed to other population 
groups. Cleanup may help correct sociodemographic disparities in access 
to a clean and safe environment.
    EPA also considered the potential for designation to support 
returning property to beneficial use. Superfund cleanups also make 
property usable for various purposes. Many Superfund sites--often 
vacant and underused areas--can become valuable local assets after 
cleanup. Many once-blighted properties across the country are now in 
use for a wide range of purposes, including shopping centers, offices, 
public parks, recreational fields, wildlife habitat, neighborhoods, and 
renewable energy facilities. Cleanups can also deter blight, vandalism 
and trespassing. https://www.epa.gov/superfund/superfund-program-protecting-healthy-communities-advancing-environmental-protection#community_anchor.
    Sites in reuse and continued use can revitalize a local economy 
with economic benefits such as jobs, new businesses, tax revenues, and 
local spending. As of FY 2022, more than 1,040 Federal and non-federal 
\55\ NPL sites support new and ongoing uses. EPA has collected data on 
more than 10,250 businesses at 671 non-Federal NPL sites. In FY 2022, 
these businesses generated $74.1 billion in sales and employed more 
than 236,802 people who earned a combined income of more than $18.6 
billion. Over the last 12 years (2011-2022), these businesses' ongoing 
operations have generated over $589 billion (inflation adjusted) in 
sales. https://www.epa.gov/superfund/superfund-remedial-annual-accomplishments-metrics#redevelopment.
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    \55\ While all NPL sites are overseen by the federal government, 
the term non-federal NPL sites is used in this context to refer to 
sites that are not federally owned.
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    EPA considered the potential for designation to contribute to 
ecological benefits, such as ecological reuse and ecosystem services. 
Superfund cleanups can reduce or reverse damage to ecosystems and 
generate ecological or recreational reuse activities. These 
improvements can contribute to a thriving local community and spark 
local investment, which can improve local well-being, quality of life, 
employment rates, property values, and tax revenue generation. While 
the exact monetary value of ecosystem services and ecological reuse can 
be challenging to measure, historical evidence shows they provide 
meaningful benefits to communities. Ecosystem services support all 
facets of human systems, providing trillions of dollars in amenities 
and important natural capital. New or restored ecosystems as a result 
of Superfund actions can generate important economic benefits. See EPA 
document on the Agency's website, Ecosystems at Superfund Sites, Reuse 
and the Benefit to Community. https://semspub.epa.gov/work/HQ/100003256.pdf. Cleanups can produce a range of ecosystem services--
timber, purification of surface water and recreation opportunities, 
habitat to use for new hives to support pollinators, and enhance flora 
and fauna, among others. It can lead to ecological and recreational 
reuse activities, which include waterbodies, wildlife sanctuaries, 
nature preserves, wetlands, pollinator habitats, forests, grasslands, 
beaches, and forests. Recreational reuse can also include the 
installation of athletic fields, parks, playgrounds, and trails. Now 
there are nearly 2,000 ecological and recreational reuse activities at 
about 460 Superfund sites. EPA expects that PFOA and PFOS cleanups can 
contribute to similar benefits.
    In summary, past experience shows that cleaning up Superfund sites 
can restore ecosystems, allow for beneficial reuses of the sites (e.g., 
shopping centers, parks, ecological or wildlife sanctuaries) spurring 
and revitalizing local community economies, increase property values 
and tax revenues, create jobs, and improve the quality of life and 
well-being those living on or near sites. EPA expects similar benefits 
to accrue from designation. EPA expects, as a result of designation, 
that these economic, social, and ecological benefits will also be 
realized sooner rather than later. Designation will bring PFOA/PFOS 
entirely into the Superfund program, including investigation, cleanup, 
enforcement, and liability.
4. Some Facilities May Adopt or Improve Best Practices To Prevent 
Future Releases of PFOA and PFOS
    To the extent they have not done so already, some facilities that 
use or have legacy stocks of PFOA and PFOS and products that contain 
these substances may adopt best practices to prevent any future 
releases and adopt best practices to manage waste that contains these 
substances and products. Other facilities, such as landfills, 
firefighting training facilities, metal plating facilities and textile 
coating operations--may improve their best practices as a result of 
designation.
    Congress considered this benefit when enacting CERCLA: 
``Expenditures to prevent a threatened release, discharge, or disposal 
may be necessary if damages are to be avoided while also providing 
considerable savings when compared to the costs of removal after a 
release, discharge or disposal has occurred.'' S. Rep. No. 96-848, at 
51 (1980). Better waste management practices could result in fewer 
releases and in cost-savings.

B. Potential Disadvantages of Designation

    EPA assessed potential disadvantages of designation and weighed 
those against the advantages. The disadvantages include direct costs, 
indirect costs associated with potential response activities, and the 
potential for uncertainty. For indirect costs, at the outset, EPA 
acknowledges that there is

[[Page 39160]]

uncertainty associated with both quantified and unquantified potential 
costs; including response costs, costs that may arise from a judgment 
of liability, and litigation costs. The magnitude of costs arising from 
liability and litigation are linked to response costs, and future 
response costs that may arise after designation are uncertain. 
Additionally, CERCLA is a discretionary statute and decisions are made 
on a site-by-site basis. 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 described below. In addition, future 
discretionary decisions about cleanup and response are difficult to 
quantify due to numerous 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 at each individual site. Designation alone does 
not require EPA to take response actions, does not require any response 
action by a private party, and does not determine liability. As such, 
none of the indirect costs associated with response, liability, or 
litigation that EPA estimates are costs that are certain to be incurred 
after designation.
    EPA also considered potential liability, including the risk of a 
judgment of liability and associated litigation costs, that may arise 
after designation. EPA was unable to quantify these costs. Liability 
and litigation are directly tied to response actions taken for any 
given release, and as explained, future response costs are uncertain. 
EPA assessed data that may inform potential liability and litigation 
costs, but ultimately determined that such data was insufficient to 
quantify these costs given the number of variables that inform 
potential liability and litigation. Nonetheless, EPA gave careful 
consideration to CERCLA's liability scheme, and the impact designation 
may have on CERCLA liability. EPA concludes that designation will not 
change CERCLA's liability framework. Designation does not automatically 
confer liability, nor does it alter CERCLA's statutory or regulatory 
framework for liability. This conclusion is supported by an analysis of 
CERCLA's statutory limitations, EPA's existing enforcement discretion 
policies, CERCLA settlement authorities, and CERCLA's parameters for 
cost recovery and contribution actions.
    The disadvantages from designation are discussed in turn.
1. Direct Costs
    EPA evaluated direct costs that may result from designation and 
determined that there are three categories of direct effects that 
result from designation: notification and reporting requirements 
pursuant to CERCLA section 103(a) and section 111(g), as well as EPCRA 
section 304(a); Federal property sale and transfer requirements 
pursuant to CERCLA section 120(h); and designation of these substances 
as hazardous materials under the HMTA, see CERCLA section 306(a). EPA 
analyzed direct costs that may arise from those requirements, as 
explained below.
    Direct costs that may result from designation are limited to costs 
associated with notification requirements and are expected to not 
exceed $1,630,000 in annualized costs. EPA estimated potential 
notification costs for facilities that must comply with CERCLA section 
103(a), CERCLA section 111(g), and EPCRA section 304. Reporting and 
notification requirements are only triggered in the event of a PFOA or 
PFOS release that meet or exceed the reportable quantity. Per release, 
the estimated cost for a facility is expected to be no more than 
$2,658. This is a minimal financial burden compared to the benefit of 
having more immediate information about significant releases of PFOA 
and PFOS. Reporting will result in increased transparency about 
releases of PFOA and PFOS, which will inform our understanding of these 
substances in the environment and allow EPA to respond as necessary. In 
addition, State, Tribal and local officials will receive immediate 
notification of these releases so these entities can take actions to 
protect the community where release occurs.
    EPA also considered direct costs that may be associated with DOT 
regulations under CERCLA section 306 and Federal property sales and 
transfers under CERCLA section 120(h). EPA has not estimated the cost 
to DOT to implement this requirement but expects it to be minimal; 
additionally, EPA estimates the subsequent indirect incremental costs 
to shippers as zero or negligible. The number and magnitude of future 
Federal property sales and transfers involving property contaminated 
with PFOA and/or PFOS is highly uncertain and cannot be known at this 
time. Due to this uncertainty, EPA does not attempt to quantify these 
costs.
2. Potential Hardship for Parties That Did Not Contribute Significantly 
to Contamination
    EPA also considered how designation may impact CERCLA liability for 
PRPs. As discussed in Section VI.A, as an advantage of designation, it 
ensures that parties that contributed to releases of PFOA and PFOS are 
responsible for response costs necessary to cleanup those releases. For 
PRPs that have significantly contributed to PFOA and PFOS 
contamination, imposing liability is appropriate and necessary to 
address this public health threat. However, EPA also gave serious 
consideration to potential liability for parties that have not played a 
significant role in contamination, such as parties that did not 
generate PFOA- or PFOS- contaminated waste.
    For those parties that have not played a significant role in 
contamination, EPA examined the role of CERCLA's liability limitations 
and protections in safeguarding against liability. EPA also considered 
how EPA's existing CERCLA enforcement discretion and settlement 
policies may offer protection from litigation in some situations that 
may arise after designation. EPA also considered the role that CERCLA 
settlements may play in resolving potential liability and limiting 
litigation risk. Taken together, EPA expects that designation should 
not change CERCLA's liability framework and that CERCLA will continue 
to operate as it has for decades to resolve who should pay for the 
cleanup and how much. EPA expects that those parties that are primarily 
responsible for contamination will bear the brunt of costs to address 
PFOA and PFOS releases while parties that are not primarily responsible 
can rely on statutory protections to limit liability, settlement with 
EPA to secure contribution protection, and EPA enforcement discretion 
to provide additional comfort. Indeed, this is how CERCLA has operated 
for decades with respect to the more than 800 hazardous substances 
already covered by CERCLA. Below, EPA examines CERCL's liability 
framework, including CERCLA's limiting provisions, EPA's enforcement 
discretion policies, and relief available under CERCLA's primary causes 
of action.
    CERCLA includes a number of provisions that may limit liability or 
the financial impact of liability. These include:
     De minimis or de micromis parties: CERCLA provides EPA the 
ability to settle with parties whose contribution is

[[Page 39161]]

minimal in comparison to other parties and provides a statutory 
exemption to de micromis parties. CERCLA section 107(o).
     Third-Party Defense: Parties may have a defense to 
liability if they can show that the contamination was solely caused by 
acts or omissions of a third party. CERCLA section 107(b)(3).
     Residential, small business and non-profit generators of 
municipal solid waste (MSW) Exemption: This exemption provides an 
equitable methodology for resolving CERCLA liability of certain MSW 
generators and transporters. CERCLA section 107(p).
     Bona Fide Prospective Purchasers (BFPP): Parties that meet 
the threshold criteria and continuing obligations for a BFPP are 
provided with CERCLA liability protection. CERCLA section 101(40).
     Innocent Landowners (ILO): Certain entities that acquire 
contaminated property with no knowledge of the contamination at the 
time of purchase may be protected from CERCLA liability. CERCLA section 
101(35).
     Contiguous Property Owners (CPO): This provision protects 
parties that are victims of contamination caused by a neighbor's 
action. CERCLA section 101(q).
     Permit Shield Defense: CERCLA liability is limited for 
certain releases that fall within the federally permitted release 
provision of CERCLA. CERCLA section 101(10).
     Normal Application of Fertilizer: CERCLA provides that the 
``normal application of fertilizer'' does not constitute a release and, 
therefore, does not trigger liability under the statute. CERCLA section 
101(22).22).
    EPA also considered the Agency's existing CERCLA enforcement 
policies that may mitigate liability concerns and litigation risks. EPA 
will continue to follow its ``Enforcement First'' policy, which 
provides that EPA will aim to compel viable PRPs to conduct and pay for 
cleanup before resorting to the Fund. EPA's existing enforcement 
discretion policies generally reflect EPA's interest in pursuing major 
PRPs over minor PRPs. For example, EPA's ``Policy Towards Owners of 
Residential Properties at Superfund Sites'' (U.S. EPA, 1991) is 
designed to relieve residential owners of the fear that they might be 
subject to an enforcement action involving contaminated property, even 
though they had not caused the contamination of the property. EPA's 
``Final Policy Toward Owners of Property Containing Contaminated 
Aquifers'' (U.S. EPA, 1995) similarly provides assurance to certain 
property owners that EPA will not take enforcement actions against them 
when the landowner did not cause, contribute or exacerbate release of 
the hazardous substances.
    CERCLA's limiting provisions and EPA's enforcement policies work 
together to support equitable outcomes. Residential landowner PRPs 
provide a helpful example of how these provisions may work together. 
Residential landowners may avail themselves of statutory protections 
such as those available to Bona Fide Prospective Purchasers, Contiguous 
Property Owners, or ``innocent landowners.'' These protections are 
self-implementing, which means the protections provided under the 
statute are automatic, and all a landowner must do to be protected is 
comply with the requirements of the statute. EPA also has policies in 
place that provide further comfort to residential landowners, such as 
the residential landowner policy mentioned above.
    Existing limitations in CERCLA coupled with existing CERCLA 
enforcement policies are sufficient to mitigate concerns about 
liability that may arise after designation. No additional action is 
necessary to ensure that those limitations and policies continue to 
operate as they have for decades. Nonetheless, although unnecessary to 
justify designating PFOA and PFOS as hazardous substances, EPA intends 
to develop a policy, consistent with those limitations and policies, 
that explains EPA's priorities for CERCLA enforcement in the context of 
PFOA and PFOS releases.\56\ As EPA states in the FY 2024-2027 National 
Enforcement and Compliance Initiatives (NECI) (August 17, 2023) 
(Uhlmann, 2023), the Agency expects to ``focus on implementing EPA's 
PFAS Strategic Roadmap and holding responsible those who significantly 
contribute to the release of PFAS into the environment . . . .'' The 
NECI also clarifies that EPA ``does not intend to pursue entities where 
equitable factors do not support CERCLA responsibility, such as 
farmers, water utilities, airports, or local fire departments, much as 
[EPA] exercises CERCLA enforcement discretion in other areas.'' EPA may 
exercise enforcement discretion on a site-by-site basis informed by 
site-specific circumstances.
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    \56\ To help EPA develop a CERCLA PFAS enforcement discretion 
and settlement policy, EPA held two public listening sessions to 
solicit individual public input on CERCLA PFAS enforcement concerns. 
The input received will be reviewed and considered by EPA in 
drafting the policy. EPA's CERCLA PFAS enforcement discretion and 
settlement policy is aimed at addressing stakeholder concerns and 
reducing uncertainties by clarifying when EPA intends to use its 
CERCLA enforcement authorities or its CERCLA enforcement discretion.
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    CERCLA has additional mechanisms that may operate to temper 
financial responsibility if a party is potentially liable to equitably 
resolve how much each party should pay for the costs of cleanup. Under 
CERCLA section 113(f), liable parties that believe they paid more than 
their fair share of response costs at a site may, in certain 
circumstances, seek contribution from other liable parties. In 
resolving contribution claims, courts consider equitable factors. See 
infra-Section VI.B.3. CERCLA settlements can also operate to balance 
equities. CERCLA settlements include protection from CERCLA 
contribution claims by other PRPs related to the matters addressed in 
the settlement, CERCLA section 122(h)(4), which should help limit 
litigation and associated costs. In addition, EPA settlements with 
major PRPs may provide contribution protection for non-settling 
parties. For example, if EPA settles with a PFAS manufacturer, EPA may 
secure a waiver of rights providing that the PFAS manufacturer cannot 
pursue contribution against certain non-settling parties to that 
settlement. The waiver of rights helps provide some protection to 
parties that EPA does not intend to pursue from both the costs of 
litigation and the costs of cleanup. Without such a waiver, settling 
major PRPs could pursue contribution under CERCLA from those parties 
for a portion of the CERCLA cleanup.
    CERCLA has several mechanisms that can operate to mitigate 
liability concerns and temper CERCLA's liability scheme. EPA expects 
these mechanisms to continue to operate as they have for decades to 
ensure that designation does not result in inequitable outcomes. This 
conclusion is supported by the fact that PFOA and PFOS are similar to 
other hazardous substances, and CERCLA's liability scheme has 
functioned in a rational way as to these hazardous substances. 
Specifically, several designated hazardous substances have a similar 
fate and transport to PFOA and PFOS and are similarly ubiquitous. See 
40 CFR 302.4. CERCLA hazardous substances, such as the chlorinated 
solvents trichloroethene (TCE) and tetrachloroethene (PCE), as well as 
heavy metals like mercury and arsenic are prevalent in the environment. 
TCE and PCE, for example have been found at over 800 NPL sites as well 
other contaminated sites from their use as industrial solvents 
including TCE's use for degreasing manufactured metal parts and PCE's 
use for dry cleaning. Heavy metals, like mercury and arsenic, are

[[Page 39162]]

commonly found in soil and groundwater. Arsenic has been found at over 
1100 NPL sites and mercury at over 600 sites. Some municipalities also 
encounter these substances on a regular basis from industrial 
wastewater discharges. Property owners may also handle these substances 
as a result of home renovations or gardening or normal activities. For 
example, TCE can be found in some cleaners sold for household use, 
including paint removers, glue, spot and stain removers, carpet spot 
removers, metal cleaners, and gun cleaners. Mercury is found in 
fluorescent light bulbs and is also found in some water bodies as a 
consequence of pollution from industrial and mining wastes, powerplant 
emissions, and other sources. This mercury contamination in turn 
affects fish and those that consume these fish (U.S. EPA, 2023f). In 
addition, americium, a radioactive element that is on the hazardous 
substances list is found in household smoke detectors. Similarly, PFOA 
and PFOS were historically manufactured on a broad scale, have past and 
continued releases to the environment (e.g., through legacy disposal, 
release of precursors, or manufacture as a byproduct), and are detected 
widely in multiple environmental media, including groundwater, surface 
water, wild animals, livestock, and plants. Despite the fact that 
people come into contact with these hazardous substances on a regular 
basis, CERCLA has continued to operate in a rational way, generally 
protecting those that have played little to no role in significant 
environmental contamination from liability.
3. Potential Litigation, Liability, and Uncertainty
    EPA considered the potential for litigation costs, such as 
attorney's fees and costs associated with negotiating settlements, 
following the designation. EPA was unable to quantify these costs given 
the number of variables that inform potential litigation. In addition 
to threshold issues associated with liability considerations described 
previously, variables that inform litigation may include, among others: 
whether EPA takes a response action; whether there are viable PRPs; the 
number of parties involved in the litigation; whether it is cost 
effective for a party to pursue litigation; and whether litigation 
results in settlement or goes to trial. There also remains an open 
question of how many actions are taken pursuant to CERCLA or taken 
pursuant to a State Superfund law. Whether an action is taken pursuant 
to CERCLA or State law creates an additional level of uncertainty that 
makes it difficult for EPA to fully evaluate and quantify the potential 
litigation costs associated with designation.
    CERCLA is, in part, a liability statute and is designed to ensure 
that those responsible for the contamination pay to clean it up. Some 
amount of litigation to resolve ``who should pay'' is an expected, and 
intended, aspect of CERCLA, and this is true in the context of actions 
to address PFOA and PFOS releases as well as the more than 800 
hazardous substances that are already within CERCLA's scope. EPA 
considered how CERCLA may operate to minimize the risks posed by 
litigation. EPA evaluated how CERCLA's primary causes of action--cost 
recovery and contribution--operate to resolve liability. EPA also 
considered the role that CERCLA settlements may play in minimizing 
risks posed by litigation. EPA weighed these considerations against 
CERCLA's objective of ensuring the polluter pays.
    EPA determined that CERCLA cost recovery and contribution provide 
parameters that safeguard against excessive litigation, and 
furthermore, that CERCLA settlements may further mitigate future 
litigation. The presence of a hazardous substance does not create 
liability under CERCLA. Under section 107, there must be a ``release'' 
or ``threat of release'' of a hazardous substance and the entity must 
fall within one of the categories of liable parties. CERCLA section 
107(a)(1)-(4). In addition, an entity can only recover response costs 
that are ``consistent with the NCP.'' Section 107(a)(4)(B). Further, a 
party's potential liability may be limited as a result of contribution 
or settlement, CERCLA section 113(f). The statute provides that a party 
that resolves its potential liability with the United States or a State 
in a judicially approved settlement is entitled contribution 
protection--the ability to block third-party claims for matters 
addressed in the settlement.
    In addition to CERCLA's limiting provisions, litigation may also be 
constrained by the relief available. Private party CERCLA cost recovery 
actions are limited to relief associated with certain costs and 
damages. Most notably is the relief permitted for response costs, which 
is limited to costs incurred ``consistent with the NCP.'' The NCP 
provides a technical and detailed process for implementing response 
actions and creates benchmarks that may limit actions that have no 
discernible human health, welfare, or environmental benefit. Parties 
also may only receive reimbursement for response costs incurred, and so 
a party would need to have the financial means to conduct a cleanup 
before obtaining any recovery. Those parameters may operate to limit 
frivolous lawsuits or excessive litigation.
    Courts' assessment of equitable factors in allocating cleanup costs 
can also serve as an important limitation on liability. In resolving 
contribution claims, courts typically allocate a particular party's 
share of costs based on equitable factors. As a result, courts aim to 
resolve claims in an equitable manner, which generally results in those 
that contributed significantly to contamination bearing the most 
liability; those that did not will bear only a small percentage of 
response costs, if any. The equitable factors that courts generally 
apply include: the volume and toxicity of the hazardous substances and 
their wastes contributed to the contamination by each party; the degree 
of involvement in generating the hazardous substances or wastes 
released/deposited; the degree of care exercised in handling the 
hazardous substances; and the degree of cooperation by the parties with 
government officials in preventing further harm to public health or the 
environment.\57\ These factors are designed to ensure that those who 
have contributed significantly to contamination bear financial 
responsibility for cleanup. Given the information before the Agency, 
including the comments on the proposal, EPA does not believe that 
designation is going to result in widespread, significant liability 
consequences for parties that lack meaningful responsibility for the 
contamination at issue.
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    \57\ See, e.g., United States v. A&F Materials Co., 578 F. Supp. 
1249, 1256 (S.D. Ill. 1984) (establishing equitable factors for 
apportioning financial responsibility (i.e., the ``Gore Factors'')); 
see also In re Bell Petroleum Services, Inc., 3 F.3d 889, 894 (5th 
Cir. 1993) (discussing considerations for apportioning liability 
among contributors); Waste Mgmt. of Alameda County, Inc. v. East Bat 
Reg'l Park, 135 F. Supp. 2d 1071, 1089-90 (N.D. Cal. 2001) (in 
exercising its discretion on allocation, court does not need to 
limit itself to any particular set of factors, courts may consider 
factors appropriate to balance the equities in the totality of 
circumstances).
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    Contribution claims are further limited by CERCLA settlements that 
provide contribution protection, and such settlements may serve to 
prevent contribution lawsuits against settling parties. A party that 
resolves its liability through a CERCLA settlement with the United 
States will not be liable for third-party contribution claims related 
to the matters addressed in the settlement. This means that PRPs will 
not be able to pursue the settling parties for

[[Page 39163]]

contribution costs under CERCLA related to the settlement, thus 
minimizing litigation costs and discouraging third-party litigation. In 
certain situations, parties may qualify for de minimis or de micromis 
settlements under the terms of the Agency's 2002 enforcement 
discretion/settlement policy. On a case-by-case basis, EPA may enter 
into limited ``ability to pay'' settlements with parties to resolve 
CERCLA response costs, where payment could result in undue financial 
hardship for the PRP. Further, parties may also be asked to perform 
actions such as in-kind services, including PFAS monitoring activities 
and implementing institutional controls.
    EPA also considered the potential for CERCLA litigation that may 
arise as the result of ``voluntary'' private-party cleanup or as the 
result of cleanup conducted or ordered pursuant to a State program. The 
safeguards and limitations on CERCLA liability discussed in this 
section are equally applicable in the context of CERCLA litigation 
arising from voluntary or state-led cleanups. Such litigation is 
subject to the same paradigms as litigation that arises out of a 
Federal-led CERCLA action.
    EPA acknowledges though that some parties that do not bear primary 
responsibility for contamination may be sued and face litigation costs 
as a consequence. These costs cannot be known at this juncture with 
reasonable certainty. Notwithstanding this, EPA believes that statutory 
safeguards described above will likely limit this type of litigation or 
adverse outcomes. Even if litigation costs are incurred by parties that 
do not bear primary responsibility, EPA does not believe that the 
potential for such costs will outweigh the substantial advantages of 
designation discussed above.

C. Results of Totality of the Circumstances Analysis

    Taken together, weighing the advantages and disadvantages of the 
designation alongside EPA's determination that both PFOA and PFOS may 
present a ``substantial danger,'' EPA concludes that designation of 
PFOA and PFOS as hazardous substances is warranted. First, the 
scientific evidence establishes that PFOA and PFOS releases into the 
environment pose diverse and serious health hazards to exposed 
populations. The full scope of the hazards from PFOA and PFOS is not 
yet known, and scientists continue to gain greater understanding of the 
effects of these human-made chemicals on public health and the 
environment. Among other things, the current body of scientific and 
technical literature establishes that PFOA and PFOS exposure are 
associated with adverse impacts on pregnant women and developing 
fetuses, such as an increased likelihood of pregnant women getting 
preeclampsia and hypertension or that babies will be born with a lower 
birth weight and smaller head circumference. PFOA and PFOS exposure are 
associated with increased risk for renal cell carcinoma, a type of 
kidney cancer. Exposure is associated with an increased risk for many 
other adverse health effects including cardiovascular effects, such as 
changes to blood pressure and cholesterol, and thyroid disorders, which 
in turn can impact heart rate, mood, energy level, metabolism, bone 
health, pregnancy, and many other functions. [See section V.A.] PFOA 
and PFOS exposure are also associated with decrease immune response to 
vaccinations, in turn leaving vaccinated individuals more vulnerable to 
harmful disease. These health risks are documented in an extensive body 
of scientific and technical literature that is continuing to develop as 
more is learned about the widespread adverse impacts of PFOA and PFOS 
exposure.
    In addition to the serious potential health hazards posed by these 
substances, available information about the fate and transport of PFOA 
and PFOS support EPA's conclusions that these substances remain in the 
environment for many years (i.e., persistence) and that they can move 
through air, land, and water (i.e., mobility) after release. These 
chemicals are sometimes referred to as ``forever'' chemicals because of 
their strong carbon-fluorine bonds in the ``tail group'' that cause 
PFOA and PFOS to be extremely resistant to degradation through 
biological degradation and also through chemical degradation (i.e., 
photooxidation and hydrolysis).
    Other information that EPA considered demonstrates that PFOA and 
PFOS are prevalent and there is a likelihood of exposure to humans and 
the environment. PFOA and PFOS are prevalent throughout the environment 
because they are persistent and have been widely used since the 1940s 
in a wide range of commercial and consumer products. Currently, the 
public can be exposed to PFOA and PFOS through a variety of sources, 
including drinking water, food, and environmental media. PFOA and PFOS 
have been detected in the drinking water of millions of Americans and 
are widely detected in surface water samples collected from various 
rivers, lakes, and streams in the United States (ATSDR, 2021; 
Cadwallader et al., 2022; U.S. EPA, 2017, 2024a). The prevalence of 
PFOA and PFOS is further demonstrated by the fact that these chemicals 
were detected in the blood of nearly all of the participants in NHANES. 
This information indicates widespread exposure to PFOA and PFOS in the 
U.S. population.
    Addressing PFOA and PFOS contamination, including cleaning up 
contaminated soils and water supplies, can reduce PFOA and PFOS 
exposure to affected communities, and bring substantial benefits. In 
particular, individuals living near heavily contaminated sites--that 
is, those sites that are most likely to be targeted for EPA enforcement 
action, removal action, or designation on the NPL list for more complex 
cleanup--often include communities with EJ concerns. These communities 
are at particular risk from adverse health impacts from PFOA and PFOS 
exposure as well and so are vulnerable to further cumulative harm.
    Designation of PFOA and PFOS as hazardous substances under CERCLA 
section 102(a) will have concrete, on the ground impact, and reduce 
serious harm. CERCLA's scheme gives EPA authority to cleanup both 
pollutants and contaminants (which PFOA and PFOS have long been 
considered) and hazardous substances. But only once a chemical is 
designated as a hazardous substance, can EPA employ the full suite of 
CERCLA authorities. These include: the requirement that authorities be 
notified of certain releases; the authority to compel PRPs to 
investigate and cleanup contamination where there may be an imminent 
and substantial endangerment; and the authority to recover response 
costs where EPA takes Fund-lead actions. These authorities are critical 
to addressing existing and future PFOA and PFOS contamination and 
reducing risk of ongoing exposure to these harmful chemicals.
    EPA's analysis shows that designation of PFOA and PFOS as hazardous 
substances will allow EPA to address more sites and to implement 
response actions earlier in time than it otherwise could in the absence 
of designation. This is because designation allows EPA to complement 
Fund-lead actions with PRP-lead actions. Shifting costs to PRPs to 
address PFOA and PFOS contamination at NPL sites will make Fund money 
available for cleanup work at Superfund sites. More cleanups promote 
economic benefits, such as improved property values and making land 
available for reuse, which can revitalize a local economy with economic 
benefits such as jobs, new businesses, tax revenues and local

[[Page 39164]]

spending. Designation also removes barriers to taking removal actions, 
which is expected to result in more short-term actions to address 
immediate risks. Collectively, these actions are expected to have 
meaningful benefits to human health and the environment, limit further 
exposure to PFOA and PFOS, and reduce the spread of PFOA and PFOS 
contamination. Expeditious response to mitigate PFOA and PFOS releases 
is particularly important given the chemical properties of these 
substances which make them persistent and mobile in the environment. 
While the full extent of health, social, economic, and ecological 
benefits of the designation cannot be quantified, such benefits are 
expected to be substantial, bringing particular benefit to vulnerable 
populations.
    Designation also serves CERCLA's key purpose of ensuring that those 
entities that are primarily responsible for contamination bear the 
economic burden of cleaning it up. Without designation, EPA actions to 
address PFOA and PFOS are more limited, and response costs may only be 
paid for through the Fund. After designation, EPA will have authority 
to compel action by and recover costs from PRPs, which effectively 
places financial responsibility on those entities responsible for 
contamination. When EPA is able to transfer NPL site costs addressing 
PFOA and PFOS contamination, as described previously, it improves 
societal equity by ensuring that the Polluter Pays for cleanup rather 
relying exclusively on Fund resources. Further upholding the Polluter 
Pays principle of CERCLA, designation allows EPA to compel PRPs to 
address PFOA and PFOS contamination at sites outside of the NPL. This 
means that additional sites can be addressed, and contamination can be 
addressed earlier. ``Polluter pays'' is a central objective of CERCLA 
as a liability statute. Response costs at NPL sites enabled by 
transfers from EPA to PRPs are estimated to be $10.3 million annually 
to $51.7 million annually (2% discount rate). Indirect costs associated 
with response work at non-NPL sites compelled through enforcement 
actions is estimated to be $327,000 to $18,100,000 annually (2% 
discount rate). (See RIA Chapter 5). EPA recognizes that designation 
will result in economic costs borne by PRPs. While CERCLA's primary aim 
is to ensure that PRPs bear cleanup costs, EPA acknowledges that the 
costs parties expend to clean up PFOA and PFOS is a burden for them. 
Notwithstanding this, EPA views the cleanup monies spent by PRPs as an 
advantage of the rule for the reasons stated above. In addition, EPA 
believes that these cleanup costs will substantially reduce the hazards 
posed by exposure to PFOA and PFOS, providing significant health 
benefits (particularly to sensitive populations) that justify the 
costs.
    EPA recognizes that, under CERCLA, a PRP--including those parties 
that significantly contributed to contamination and those that did 
not--may be jointly and severally liable to the government for the 
entire amount of response costs unless it proves that the harm from the 
release of hazardous substances is divisible. This is true of all 
listed hazardous substances. EPA's experience over the past four 
decades administering CERCLA shows that the statute, combined with 
EPA's existing enforcement discretion policies, ensure that CERCLA will 
continue to function in a rational manner, with those primarily 
responsible for pollution bearing the costs of cleanup.
    The decision to designate PFOA and PFOS as CERCLA hazardous 
substances is supported by CERCLA's legislative aims underpinning 
CERCLA's enactment. CERCLA was enacted to promote the timely cleanup of 
contaminated sites and to ensure that those responsible for 
contamination pay to clean it up. H.R. Rep. No. 99-253, pt. 3, at 15 
(1985); Burlington Northern and Santa Fe Railroad Co. v. U.S., 556 U.S. 
599, 602 (2009) (``The Act was designed to promote the `cleanup of 
hazardous waste sites' and to ensure that the costs of such cleanup 
efforts were borne by those responsible for the contamination.''). 
Designation ensures that CERCLA activities to address PFOA and PFOS 
contamination conforms to those objectives. Moreover, CERCLA was 
enacted to address the challenge of community exposure to hazardous 
chemicals, like PFOA and PFOS, released into the environment.\58\ EPA's 
decision to designate aligns with Congress's vision for CERCLA as an 
important Federal tool in removing chemicals from the environment that 
have the potential to pose serious risks to human health and the 
environment. Indeed, CERCLA designation is necessary to adequately 
tackle the threat posed by PFOA and PFOS contamination to communities 
across the country.
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    \58\ Congress enacted CERCLA to address contaminated sites 
across the nation, which was considered one of ``the most serious 
health and environmental challenge[s] of the decade.'' S. Rep. No. 
96-848, at 2 (1980). Congress acknowledged that ``the potential 
impact of toxic chemicals on the general public and environment 
through unsound hazardous disposal sites and other releases of 
chemicals is tremendous.'' Id. And in fact, expert testimony 
solicited by Congress stated that the breadth and scope of the 
effect of exposure to hazardous chemicals nearly ``extend[ed] to the 
entire population of the United States.'' Id.
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    CERCLA authority provides EPA with tools to address immediate and 
long-term needs for mitigating and eliminating PFOA and PFOS exposures 
that present unreasonable risk. CERCLA's approach to identifying, 
investigating, and cleaning up contamination is also designed to 
promote response for the subset of releases that present the most 
urgent risks. This is evidenced through CERCLA's removal authorities, 
NPL listing process, the remedial process, and enforcement authority 
for imminent and substantial endangerments. CERCLA directs Federal 
agencies to assess risks by considering the population, the hazard 
potential of hazardous substances, the potential for drinking water 
contamination, the potential for direct human contact, the potential 
for destruction of sensitive ecosystems, and the damages to natural 
resources that may affect the human food chain. Indeed, with those 
considerations in mind, a small fraction of sites qualifies for the NPL 
every year.\59\ CERCLA also includes safeguards against excessive 
cleanup costs relative to the effectiveness of a remedy, and those 
safeguards are reinforced by CERCLA's cost recovery mechanisms. 
Collectively, these tools ensure that CERCLA prioritizes and targets 
releases that pose the most risk to human health and the environment; 
ensures that EPA can respond quickly when necessary and design durable, 
long-term remedies that ensure protection for public health and the 
environment; and that site-specific remedies are cost-effective.
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    \59\ The hazardous substance designation is not expected to 
change the approach EPA uses for identifying potential NPL sites. 
EPA already has the authority to add PFOA and PFOS releases to the 
NPL. EPA evaluates a number of options before determining the most 
effective approach for site cleanup. Alternatives to NPL listing may 
include: Superfund Alternative Approach, state cleanup, cleanup by 
other federal agencies, EPA removal, deferral to another EPA program 
and various enforcement mechanisms. Therefore, releases that contain 
PFOA or PFOS are more likely to be addressed through non-NPL 
mechanisms than through the NPL. Between FY 2003 and FY 2022, only 
about four percent of all contaminated sites evaluated by EPA for 
placement on the NPL were added to it. Since 2013, EPA has, on 
average, added 11 non-federal sites per year to the NPL and EPA does 
not expect the rate at which annual additions to the NPL occur to 
increase as a result of this rule.
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    In conclusion, the totality of the circumstances analysis confirms 
that designation of PFOA and PFOS as CERCLA hazardous substances is 
warranted. An analysis of the advantages and disadvantages of 
designation, including weighing of

[[Page 39165]]

quantitative and qualitative benefits and costs, demonstrates that the 
advantages outweigh the disadvantages. Further, designation best 
achieves CERCLA's dual objectives--the timely cleanup of contaminated 
sites and ensuring that those responsible pay for cleanup. Designation 
provides additional tools that allow for earlier, broader, more 
effective cleanups, allowing EPA to protect communities that are 
exposed to high concentrations of PFOA and PFOS.

VII. Summary of Public Comments and Responses

    In this final action, EPA is designating PFOA and PFOS, including 
their salts and structural isomers, as hazardous substances pursuant to 
CERCLA section 102(a).
    In response to the September 6, 2022, proposed rule (2022 
Proposal), EPA received approximately 64,000 comments, including mass 
mail. EPA received comments from a variety of sources, including the 
regulated community, trade associations, and State, Tribal and local 
agencies. The Agency received comments generally supporting and 
opposing the designation of PFOA and PFOS as CERCLA hazardous 
substances. EPA also received a number of comments requesting clarity 
on the various issues that EPA considered in support of the 2022 
Proposal. EPA has taken the submitted comments into consideration in 
preparing this final action. Comments have been summarized and EPA has 
provided detailed responses to the significant comments either here in 
this final action or in the Response to Comments on the Designation of 
Perfluorooctanoic Acid (PFOA) and Perflurooctanesulfonic Acid (PFOS) as 
CERCLA Hazardous Substances, which is available in the rulemaking 
docket. This section includes responses to a selection of the 
significant comments received on various topics addressed in the 2022 
Proposal.

A. Legal Authority

1. Consideration of Cost and Section 102(a)
    Comment: Several commenters assert that EPA must consider costs 
when designating a hazardous substance pursuant to CERCLA section 
102(a). These commenters disagreed with EPA's proposed interpretation 
of CERCLA section 102(a) ``as precluding consideration of costs in 
hazardous substance designations.'' Those commenters generally remarked 
that EPA's position is inconsistent with U.S. Supreme Court case law on 
considering costs in regulatory actions. Commenters that disagreed with 
EPA's position also generally argued in the alternative that, at a 
minimum, EPA has discretion to consider cost. Conversely, some 
commenters agreed with EPA's proposed position that CERCLA section 
102(a) precludes the consideration of cost.
    Commenters that disagreed with EPA's position assert that CERCLA 
section 102(a) requires the consideration of cost. Commenters assert 
that the phrase ``as may be appropriate'' in CERCLA section 102(a) 
means that EPA must consider cost in considering whether to promulgate 
regulations to designate hazardous substances. Commenters support this 
interpretation by: (1) Asserting that CERCLA provides no textual basis 
to preclude cost citing Michigan v. EPA, 576 U.S. 743, 752 (2015), 
where the court held that the phrase ``appropriate and necessary'' as 
used in section 112(n)(1)(A) of the CAA must include some consideration 
of cost; and (2) distinguishing Whitman v. American Trucking Ass'ns, 
Inc., 531 U.S. 457 (2001), and Utility Solid Waste Activities Group v. 
EPA, 901 F.3d 414 (D.C. Cir. 2018), in which the courts upheld EPA 
determinations that health-based statutory provisions precluded 
consideration of costs. A few commenters further supported their 
position by asserting that CERCLA's definition of ``hazardous 
substance,'' CERCLA section 101(14), incorporates by reference other 
environmental statutes with listing or identification criteria that 
include cost considerations.
    These commenters also argued in the alternative that even if EPA is 
not required to consider cost, it at least has discretion to do so. 
Looking to the Court's decision in Entergy Corp. v. Riverkeeper, Inc., 
one commenter implied that ``. . . silence [as to cost] is meant to 
convey nothing more than a refusal to tie the agency's hands as to 
whether cost-benefit analysis should be used, and if so to what 
degree.'' 556 U.S. 208, 222 (2009).
    EPA also received comments agreeing with its proposed 
interpretation that CERCLA section 102(a) precludes the consideration 
of cost. As one commenter stated, EPA's proposed interpretation 
``accords with CERCLA's unambiguous text, statutory structure, and 
judicial interpretations of comparable provisions of other 
environmental laws.'' The commenter notes that ``CERCLA's text contains 
a single criterion for the designation of a hazardous substance: 
whether the substance, `when released into the environment[,] may 
present substantial danger to the public health or welfare or the 
environment.' '' The commenter also states that ``[c]ompliance costs do 
not constitute `substantial danger to the public health or the 
environment' and are not attributed to the `release[ ]' of a hazardous 
substance into the environment. . . .'' The commenter contrasts CERCLA 
section 102(a) with other CERCLA provisions that authorize or require 
cost considerations to conclude that Congress intended a difference in 
meaning. Finally, the commenter suggests that CERCLA section 102(a) is 
akin to other ``health-focused provisions of other environmental laws'' 
that courts have interpreted to exclude cost considerations.
    Response: EPA proposed interpreting CERCLA section 102(a) as 
precluding the consideration of cost in designating CERCLA hazardous 
substances. EPA recognizes that, as a general matter, a statutory 
assessment of health and environmental-based criteria like the criteria 
in section 102 does not generally allow for consideration of costs. As 
discussed in Section V of this document, examining only the statutory 
criteria--whether PFOA or PFOS ``may present a substantial danger to 
public health or welfare or the environment'' and without considering 
costs and benefits--EPA has concluded that designation is warranted.
    EPA considered comments supporting and disagreeing with the 
position that CERCLA section 102(a) precludes the consideration of 
cost. In taking final action, EPA decided it need not determine whether 
section 102(a) precludes consideration of costs and benefits because 
designation is warranted either by examining the health- and 
environmental-based criteria alone or by examining these criteria along 
with the broader totality of the circumstances. The Agency first 
evaluated the available scientific and technical information about 
those substances and concluded that designation of each is warranted 
based solely on a finding that PFOA and PFOS may present substantial 
danger to public health or welfare or the environment. The Agency next 
conducted a separate totality-of-the-circumstances analysis, which did 
consider costs and benefits. EPA considered the available scientific 
and technical information, along with the advantages and disadvantages 
of designation, including quantified and unquantified benefits and 
costs, and concluded this analysis reinforced that designation was 
warranted as reflected in section VI of this preamble. Because EPA's 
designation is warranted when considering benefits and costs as part of 
a totality of the circumstances analysis, EPA need not resolve whether 
CERCLA

[[Page 39166]]

section 102(a) precludes EPA from taking into account costs.
2. Interpretation of the Phrase ``May Present Substantial Danger''
    Comment: Commenters posit that the standard for designation 
proposed by EPA is overbroad, vague, and arbitrary and capricious. Some 
commenters argue that EPA's alleged vague articulation of this standard 
provides little guidance on how or why PFOA and PFOS satisfy that 
standard. Commenters go on to assert that the lack of clarity regarding 
EPA's proposed interpretation of ``may present a substantial danger'' 
suggests that the Agency has deprived the public of the ability to 
meaningfully comment on its proposed rule. Relatedly, these commenters 
state that EPA must clearly state the level of evidence that is 
sufficient to demonstrate ``substantial danger'' before proceeding with 
the designation. Commenters also asserted that EPA failed to 
demonstrate how PFOA and PFOS qualify as toxic, persistent, and 
prevalent.
    Commenters also argue that EPA must address the likelihood of 
exposure to PFOA and PFOS in evaluating whether designation of PFOA and 
PFOS is consistent with section 102(a). Another commenter suggests that 
EPA propose a standard for designating substances consistent with 
102(a) in a separate rulemaking before proceeding with designating any 
substances.
    Commenters further claim that the standard EPA articulated makes it 
unclear how EPA may apply CERCLA section 102(a) in the future to 
designate additional substances. A commenter asserts that EPA has not 
identified an ``intelligible principle'' to apply when making listing 
decisions, and therefore, any level of risk is sufficient to support a 
listing of a chemical so long as it is also mobile, persistent, and 
prevalent. Commenters also argue that there should be a level of 
predictability for potential future designations; for example, EPA 
should identify a bright-line risk threshold at which a substance poses 
``substantial danger'' for the purposes of section 102(a). One 
commenter suggests that EPA must explain the characteristics that a 
substance must exhibit to be designated as a hazardous substance under 
section 102(a). Another commenter stated that the criteria articulated 
for CERCLA section 102(a) should have a level of specificity similar to 
the criteria for listing decisions made under the environmental 
statutes incorporated by reference through CERCLA's definition of 
hazardous substances.
    Several commenters also suggest that EPA's interpretation of 
``substantial danger'' for the purposes of CERCLA section 102(a) is 
inconsistent with a reading of that phrase offered by EPA in an 
Advanced Notice of Proposed Rulemaking released on January 14, 2021. 
Finally, one commenter argues that EPA should explain how ``substantial 
danger'' aligns with the NCP's risk thresholds for cancer and noncancer 
risks.
    Response: EPA disagrees with the commenters' position that the 
information the Agency considered in proposing to designate PFOA and 
PFOS as hazardous substances under CERCLA section 102(a) was overbroad, 
vague, and arbitrary and capricious. In the final rule, EPA identified 
the information it considered in evaluating whether a substance 
satisfies CERCLA section 102(a) and described the information it 
considered in reaching its conclusion that PFOA and PFOS satisfy CERCLA 
section 102(a). Specifically, as detailed in section IV.A., the two 
primary factors the Agency considered in the context of CERCLA section 
102(a)--hazard, and fate and transport--are consistent with other 
statutory methodologies used for identifying CERCLA hazardous 
substances. Under section 102(a) of CERCLA, EPA has been delegated the 
authority to identify and weigh information relevant to determining 
whether a substance, when released, may present a substantial danger 
and the approach we have adopted is reasonable and consistent with 
EPA's other authorities. In the final rule, EPA also conducted an 
additional, discretionary analysis of the totality of the 
circumstances.
    EPA also disagrees with commenters that EPA should identify a 
bright-line risk threshold at which a substance poses ``substantial 
danger'' for the purposes of section 102(a). The plain language of 
CERCLA section 102(a) does not require a ``bright-line'' risk threshold 
applicable to any and all substances. Further, the Agency does not know 
how it would establish such a line, including because exposures at 
different levels are associated with a variety of health effects, 
carcinogenic and non-carcinogenic risk are calculated separately, risk 
must consider, acute, sub-chronic, and chronic exposure, and risk is 
calculated for all site contaminants combined,\60\ and the commenters 
do not provide suggestions for how such an approach would work. 
Instead, EPA is utilizing the discretion provided in CERCLA section 
102(a) to conduct individual analyses of substances that account for 
all of their characteristics to determine whether, when released, the 
substances may present substantial danger. Moreover, EPA also finds 
that a bright-line test is not appropriate because the plain language 
of CERCLA section 102(a) (``may present a substantial danger'') does 
not require certainty that a release of a substance in fact presents a 
substantial danger in any given location it is found.
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    \60\ USEPA. 1986a. Guidelines for the Health Risk Assessment of 
Chemical Mixtures. EPA 630-R-98-002. Available on the internet at: 
https://www.epa.gov/risk/guidelines-health-risk-assessment-chemical-mixtures.
---------------------------------------------------------------------------

    EPA disputes the commenter's position that the NCP's risk 
thresholds for cancer are relevant to its interpretation of whether 
PFOA or PFOS may present a substantial danger to public health or the 
environment under section 102(a) of CERCLA. EPA's cancer risk 
thresholds are used on a site-specific basis--during EPA's remedy 
selection process--to take into account an individual's lifetime cancer 
risk. By contrast, the analysis of whether a substance ``may present a 
substantial danger'' for the purposes of designation as a CERCLA 
hazardous substance does not require certainty and is not site-
specific. It would be inconsistent with the plain language of section 
102(a) for EPA, at this stage and for the purpose of designating 
hazardous substances, to evaluate the specific releases in which 
exposure to PFOA and PFOS pose actual risk. Those determinations are 
left for later stages in the CERCLA process and evaluated on a site-by-
site basis.
    EPA also rejects the commenter's assertion that CERCLA section 
102(a) requires the Agency to promulgate a standard for designating 
hazardous substances in advance of today's action. CERCLA section 
102(a) includes no such requirement, and neither do the other 
environmental statutes that authorize EPA to list or designate 
substances as hazardous. Rather, CERCLA section 102(a) provides that, 
``[t]he Administrator shall promulgate and revise as may be 
appropriate, regulations designating . . . hazardous substances . . .'' 
CERCLA section 102(a) (emphasis added). This language is distinct from 
other places in CERCLA where Congress directed EPA to promulgate 
regulations or procedures for various CERCLA activities. For example, 
CERCLA section 112 explicitly provides that EPA shall ``prescribe 
appropriate forms and procedures'' for filing CERCLA claims. CERCLA 
section 112(b)(1). Likewise, CERCLA section 105 directs EPA to 
``establish procedures and standards for responding to releases of 
hazardous substances.'' CERCLA section 105(a). Section 102(a) does not 
include similar

[[Page 39167]]

language and does not require that EPA promulgate a standard for 
designating hazardous substances in advance of doing so. Nonetheless, 
EPA identified two primary factors--hazard, as well as fate and 
transport--relevant to the designation of hazardous substances. To 
further inform its decision, EPA concluded that other information may 
be relevant to evaluating releases of the substance, such as the 
frequency, nature, and geographic scope of releases of the substances 
and likelihood of exposure. EPA's evaluation of the scientific and 
technical information pertaining to those factors support the Agency's 
finding that both PFOA and PFOS may present substantial danger to 
public health and the environment.\61\
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    \61\ To support EPA's finding in this final rule that both PFOA 
and PFOS each individually pose a human health hazard, EPA gave 
weight to immunological, hepatic, developmental, cardiovascular, and 
cancer effects. These health outcomes had the strongest evidence of 
associations between PFOA and PFOS exposure and adverse health 
effects.
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    EPA further disagrees with the commenter's claim that Congress 
failed to provide an ``intelligible principle'' to guide EPA's 
authority to designate hazardous substances pursuant to section 102(a) 
of CERCLA. The non-delegation doctrine provides that ``Congress 
generally cannot delegate its legislative power to another Branch.'' 
Mistretta v. United States, 488 U.S. 361, 371-72 (1989). This test 
requires that Congress ``lay down by legislative act some intelligible 
principle'' to which the recipient must conform. Id. (quoting J.W. 
Hampton. Jr. & Co. v. United States, 276 U.S. 394, 409 (1928)). 
Congress's delegation of authority to EPA in the context of CERCLA 
section 102(a) amply satisfies the constitutional standard set forth in 
controlling Supreme Court precedent because Congress has clearly 
provided an ``intelligible principle'' in the provision limiting EPA's 
discretion in designating substances under the statute. Specifically, 
section 102(a) provides that the Agency may designate those substances 
which, ``when released into the environment may present substantial 
danger to the public health or welfare or the environment.'' 42 U.S.C. 
9602(a). Contrary to the commenter's claim, the authority conferred by 
Congress is neither open-ended nor otherwise so imprecise as to provide 
no principles for the Agency to apply in designating hazardous 
substances. Rather, CERCLA section 102(a) requires EPA to base its 
designation decisions on certain specified principles, including 
whether the substance in question poses a substantial danger to either 
public health, welfare, or the environment. These considerations 
intelligibly confine EPA's discretion to designate substances under the 
statute and the Agency's listing decision is not only based upon the 
criteria prescribed by Congress but is firmly within the bounds of the 
Court's nondelegation precedents. See, e.g., American Power & Light 
Co., 329 U.S. at 104 (upholding the authority of the Securities and 
Exchange Commission to modify the structure of holding company systems 
so as to ensure that they are not ``unduly or unnecessarily 
complicate[d]'' and do not ``unfairly or inequitably distribute voting 
power among security holders.''); Yakus v. United States, 321 U. S. 
414, 420, 423-26 (1944) (approving the wartime conferral of agency 
power to fix the prices of commodities at a level that ``will be 
generally fair and equitable and will effectuate the [in some respects 
conflicting] purposes of the] Act.'' (internal quotations omitted); 
National Broadcasting Co. v. United States, 319 U.S. 190, 225-26 (1943) 
(finding an ``intelligible principle'' in the Federal Communication 
Commission's power to regulate airwaves in the ``public interest.''). 
In sum, CERCLA section 102(a) provides an intelligible principle that 
guides the Agency in the exercise of its authority under section 
102(a).
    EPA also disagrees with the assertion that its interpretation of 
``substantial danger'' is inconsistent with its past interpretation of 
this phrase or EPA's interpretation of similar phrases. In the context 
of CERCLA section 102(a), EPA has never authoritatively issued an 
interpretation of ``substantial danger'' prior to this designation. In 
2021, EPA issued an Advanced Notice of Proposed Rulemaking (ANPRM) 
seeking comment and data to assist in the consideration of the 
development of future regulations pertaining to PFOA and PFOS. See 
Addressing PFOA and PFOS in the Environment: Potential Future 
Regulation Pursuant to the Comprehensive Environmental Response, 
Compensation, and Liability Act and the Resource Conservation and 
Recovery Act (Jan. 14, 2021). The ANPRM represented a preliminary 
effort by the Agency to obtain public input on certain issues to inform 
its thinking on any future proposed rulemaking regarding PFAS. EPA 
never received feedback on the ANPRM's discussion of ``substantial 
danger'' as the document was withdrawn shortly after it was issued and 
never published in the Federal Register. Since that time, the Agency 
has proposed an interpretation of section 102(a) and solicited and 
obtained comments through this rulemaking process that have informed 
the development of EPA's final interpretation of ``substantial 
danger.'' \62\
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    \62\ Both interpretations of 102(a)--the preliminary 
interpretation offered in the 2021 ANPRM and today's final rule--
allow for consideration of similar information to assess whether a 
release into the environment may present substantial danger. Hazard 
can encompass ``the degree of danger posed;'' fate and transport can 
encompass temporal considerations as in whether a substance remains 
in the environment ``more than fleeting in terms of time;'' and the 
consideration of additional information may include a consideration 
of the ``geographic scope'' of the substance in the environment. The 
standard that EPA is affirming today more accurately describes the 
type of scientific information needed to consider whether a 
substance, when released in the environment, may present substantial 
danger.
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    As EPA explained in section IV.A., the Agency's interpretation of 
CERCLA section 102(a) is consistent with the proposed rule and in 
harmony with its application of similar language in site-specific 
provisions. Section 102(a) does not require certainty that the 
substance poses a substantial danger or require proof of actual harm 
when released into the environment.
    EPA also disagrees with the commenters assertions that the Agency 
failed to substantiate EPA's conclusion that PFOA and PFOS may present 
a substantial danger to public health and the environment. The proposed 
rule established, and this final action confirms that the available 
scientific and technical information demonstrate that both PFOA and 
PFOS may present substantial danger to public health and the 
environment. That conclusion is supported by the scientific and 
technical evidence of adverse effects to human health and the 
environment from PFOA and PFOS exposure, their persistence and mobility 
in the environment, and the significant potential for human exposure 
due to their prevalence in the environment.
3. Authority To Create Exclusions From the Designation
    Comment: Several commenters suggest that section 102(a) grants EPA 
authority to create exclusions from designation for certain uses of or 
materials containing PFOA and PFOS. According to one commenter the 
phrase ``as may be appropriate'' in section 102(a) grants EPA broad 
authority to include and exclude substances from a designation. 
Commenters also argue that CERCLA's definition of ``hazardous 
substance'' in section 101(14) supports this interpretation. CERCLA 
section 101(14) incorporates substances or chemicals regulated under 
select provisions of the CWA, RCRA, CAA, and TSCA, and at least some of 
those statutory provisions include exclusions;

[[Page 39168]]

therefore, according to commenters, Congress would have expected EPA to 
have the authority to create exclusions pursuant to a CERCLA 102(a) 
designation.
    Some commenters suggested that EPA can create exclusions that 
mirror other exclusions or defenses in CERCLA. For example, some 
commenters suggested that application of biosolids should be excepted 
from designation consistent with CERCLA's definition of release in 
section 101(22), which excludes ``the normal application of 
fertilizer.'' Another commenter suggested that EPA create an exclusion 
that reflects the liability defense in CERCLA section 107(d) for 
government ``actions taken in response to an emergency created by the 
release . . . of a hazardous substance generated by or from a facility 
owned by another person.''
    Commenters requested that EPA create exclusions for: (1) paper mill 
residuals that are beneficially land applied as a fertilizer or soil 
conditioner; (2) land application of municipal biosolids; and (3) PFOA 
and PFOS contained in AFFF used in response to a fire or other 
emergency. Another commenter suggested that EPA should only designate 
PFOA and PFOS contained in specific mixtures or compounds generated by 
specific sources.
    Some commenters suggest that an exclusion for certain materials or 
uses of PFOA and PFOS is necessary to avoid unintended consequences 
from the designation or over-broad impacts. For example, commenters 
expressed concern that designating PFOA and PFOS would result in 
liability for entities, such as farms applying biosolids or airports 
using AFFF for fire-fighting activities in emergency situations, that 
should not bear responsibility for generating or creating the 
contamination. Finally, one commenter claimed that CERCLA should not be 
used to designate PFOA and PFOS because designation will have the end-
result of negatively impacting ``good actors.''
    Response: EPA declines to create exclusions for certain uses of 
PFOA and/or PFOS in this rulemaking. EPA believes there is a strong 
argument that section 102(a) does not authorize exclusions for certain 
uses of a substance where EPA has concluded that the substance (here, 
PFOA and PFOS) may present substantial danger to the public health or 
welfare or environment, based on its review and analysis of a 
significant body of scientific and technical information. In this 
circumstance, EPA believes that section 102(a) is best read to preclude 
exclusions for certain uses of PFOA and PFOS--relative to other uses--
without a factual or scientific basis showing that a particular use 
does not meet the standard articulated by Congress. See CERCLA section 
102(a) (authorizing EPA to designate substances that, when released 
into the environment, ``may present substantial danger to the public 
health or welfare of the environment''). Even if EPA had authority to 
create exclusions for certain uses, it lacks the basis to do so here. 
Commenters did not provide information or data to support a conclusion 
that certain types of releases of PFOA and PFOS do not present a 
substantial danger, including an exclusion for AFFF as used for fire-
fighting purposes and an exclusion for PFOA and PFOS contained in 
biosolids or soil amendments.\63\ Given EPA's conclusion that PFOA and 
PFOS do present a substantial danger, and in the absence of evidence 
that certain releases of PFOA and PFOS do not present a substantial 
danger to public health or welfare or the environment, EPA lacks a 
scientific or factual basis for the exclusions requested.
---------------------------------------------------------------------------

    \63\ EPA received requests for exclusions from liability from 
specific sectors--namely, water utilities, municipal landfills, 
local governments, landowners or utilities that land apply biosolids 
or paper mill sludge, and landowners adjacent to offsite sources--
for the use of certain materials (i.e., biosolids), and for the 
disposal of particular types of waste, including landfill leachate, 
research waste, and medical waste. However, the commenters did not 
present data supporting their claims that certain releases, either 
from specific types of entities, uses, or kinds of waste, do not 
present a substantial danger to public health, welfare, or the 
environment.
---------------------------------------------------------------------------

    Commenters also did not provide a persuasive justification for EPA 
to otherwise carve out specific uses of PFOA and/or PFOS from this 
designation irrespective of scientific or factual evidence relative to 
potential public health and environmental impacts. Commenters appear to 
be proposing that EPA create an exclusion to liability via CERCLA 
section 102(a); the Agency, however, does not believe that section 102 
is the appropriate mechanism to establish liability exclusions, and EPA 
questions whether it has the authority to do so, through this 
provision. For example, the D.C. Circuit has held that, in enacting 
CERCLA, Congress reserved resolution of liability issues to the 
judiciary, not the Agency.\64\ See Kelley v. EPA, 15 F.3d 1100, 1108 
(D.C. Cir. 1994) (``Congress . . . has designated the courts and not 
EPA as the adjudicator of the scope of CERCLA liability.''). Congress 
explicitly identified CERCLA's liable parties in section 107. In fact, 
Congress has enumerated many exclusions to CERCLA's liability scheme 
over the years--and courts have regularly interpreted and applied those 
provisions. For example, CERCLA section 107(d) provides a mechanism to 
account for liability concerns arising out of an emergency response, 
which appears similar to one commenter's request for an exclusion for 
the use of AFFF in response to an emergency. See, e.g., CERCLA section 
107(d)(1)-(2) (providing a defense to costs and damages in the event of 
an incident creating danger to public health or in the event of an 
emergency).). EPA believes this Congressionally-established framework, 
discussed in further detail below, is more appropriate for the type of 
exclusions that commenters suggest.
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    \64\ Although a court is the final arbiter of whether a party is 
liable under CERCLA section 107, EPA intends to develop a policy 
that explains the Agency's priorities for CERCLA enforcement in the 
context of PFOA and PFOS releases. Enforcement discretion policies 
are not exclusions from liability but instead describe circumstances 
in which the Agency may exercise its discretion to not pursue 
enforcement actions against certain parties that may fall within a 
category of liable parties under CERCLA section 107. EPA's 
enforcement discretion is guided by the unique circumstances of each 
case.
---------------------------------------------------------------------------

    EPA also concludes that the commenter's request for an exclusion 
for the application of biosolids containing PFOA or PFOS is not 
appropriate for resolution in this rulemaking under section 102(a). 
Section 102(a) provides for designation of a substance that, when 
``released into the environment,'' may present substantial danger to 
the public health or welfare or environment. CERCLA section 102(a). As 
stated above, EPA considered a significant body of scientific and 
technical information in concluding that both PFOA and PFOS--
irrespective of use--may present a substantial danger to public health 
or welfare or the environment.
    Against this backdrop, EPA considered commenters' request for EPA 
to exclude from designation PFOA and PFOS when contained in biosolids 
consistent with the language in CERCLA section 101(22). EPA 
acknowledges that the CERCLA definition of ``release'' explicitly 
excludes the ``normal application of fertilizer.'' CERCLA section 
101(22)(D). EPA believes this language is best read as requiring a 
site-specific analysis and that a categorical exclusion for all 
contaminated biosolid application using section 102(a) risks exceeding 
the limits of the exclusion as envisioned by Congress. See, e.g., 
Sierra Club, Inc. v. Tyson Foods, Inc., 299 F. Supp. 2d 693, 714 (W.D. 
Ky. 2003) (defendant did not qualify for the normal application of 
fertilizer

[[Page 39169]]

exemption because it was not applying ammonia to farm fields as 
fertilizer when it vented the ammonia into the atmosphere); City of 
Waco v. Schouten, 385 F. Supp. 2d 595, 602 (W.D. Tex. 2005) 
(defendants' agricultural practices (namely, the improper storage and 
maintenance of manure waste storage areas) did not fall within the 
``normal application of fertilizer'' exclusion)). EPA also does not 
believe an exclusion under section 102(a) is necessary, because it 
would be duplicative of the exclusion in section 101(22)(D). And 
because liability under CERCLA section 107 is tied to a ``release'' or 
threat of a ``release,'' any entity facing potential liability for the 
application of biosolids contaminated with PFOA or PFOS will have the 
opportunity to make site-specific arguments as to whether its actions 
fall within the ``normal application of fertilizer'' exclusion to the 
definition of ``release.'' \65\
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    \65\ Not all releases warrant response under CERCLA, and not all 
release lead to litigation and liability for all PRPs. Whether a 
party may be exposed to any liability in the first instance is 
ultimately a function of whether a response action is taken to 
address the release. As an initial matter, EPA has discretion to 
determine whether to respond to a release and only responds to those 
releases that pose unacceptable risk to human health and the 
environment. Even then, EPA may assess relative risk among releases 
to determine which releases should be prioritized for investigation 
and, potentially, clean up. Further, whether a PRP may be pursued 
for costs, found liable by a court, and required to pay some portion 
of costs remain uncertain for any given release.
---------------------------------------------------------------------------

    EPA also rejects the commenters' assertion that creating an 
exclusion for this designation is necessary to address concerns 
regarding over-broad or unintended liability, such as for farmers or 
water utilities. Designation does not alter CERCLA's liability 
framework, which EPA expects to continue to operate as it has for 
decades to equitably resolve who should pay, or automatically confer 
liability. First, potential plaintiffs must establish a legal basis for 
CERCLA liability; to recover costs from the parties responsible for 
contamination requires a plaintiff to show that a ``release'' or 
``threatened release'' of a ``hazardous substance'' from a ``facility'' 
has caused it to incur cleanup costs. CERCLA section 107(a). The 
defendant must also fall within at least one of four classes of covered 
persons: (1) the owner or operator of the facility, (2) the owner or 
operator of the facility ``at the time of disposal'' of hazardous 
substances, (3) persons who ``arranged for disposal'' or treatment of 
hazardous substances, and (4) certain transporters of hazardous 
substances. Id.
    Although liability under CERCLA section 107(a) is strict, subject 
only to a few limited defenses specified in section 107(b), it is not 
unlimited, and courts may decide to apportion costs among defendants 
where the harm is divisible and there is a reasonable basis for doing 
so. Burlington N., 556 U.S. at 613-15. Further, if a defendant is found 
jointly and severally liable for response costs under CERCLA section 
107(a), the defendant may also seek contribution from other potentially 
responsible parties pursuant to CERCLA section 113(f).
    In addition, CERCLA provides defenses to and exemptions from 
Superfund liability for certain parties that are otherwise liable. For 
example, under CERCLA section 107(b), liability is limited in 
situations in which the release or threat of release of a hazardous 
substance was caused by an act of God, an act of war, or an act or 
omission of a third party (or some combination thereof). CERCLA section 
107(b)(1)-(4). CERCLA also contains several statutory limitations on 
liability, which are more fully described in section VI.B. These 
include liability exemptions for contiguous property owners, innocent 
landowners under certain circumstances, de minimis or de micromis 
parties, and ``federally permitted'' releases, among others. And a 
party may not be subject to CERCLA at all if the release is considered 
a ``normal application of fertilizer.'' EPA also notes that--as 
detailed in section VI.B.--it has well-established enforcement policies 
that help the Agency prioritize sites that pose the most risk.
    Finally, the commenters' concerns regarding liability do not 
account for the intervening steps between designation and site-specific 
cleanup or enforcement decisions. A designation alone does not require 
EPA or others to take response actions, does not require any response 
action by a private party, and does not determine liability. Response 
actions are contingent, discretionary, and site-specific decisions that 
are made after a hazardous substance release or threatened release. 
Site-specific decisions are also the more appropriate opportunity to 
evaluate unacceptable risk posed by specific releases, rather than a 
blanket exclusion for certain uses or PFAS-containing materials that 
may not account for site-specific risk.
    The first steps in the CERCLA process are to identify a release, 
investigate the scope and extent of such a release, and evaluate its 
potential risk to human health and the environment. CERCLA is a largely 
discretionary statute that gives EPA leeway to determine whether, after 
that investigatory stage, it is appropriate to move forward with a 
cleanup. CERCLA speaks to this evaluation of releases and risk. For 
example, Congress provided that EPA shall identify ``criteria for 
determining priorities among releases or threatened releases throughout 
the United States for the purpose of taking remedial action and, to the 
extent practical taking into account the potential urgency of such 
action, for the purpose of taking removal action.'' CERCLA section 
105(a)(8)(A). CERCLA goes on to provide that ``[c]riteria and 
priorities . . . shall be based upon relative risk or danger to public 
health or welfare or the environment . . . taking into account to the 
extent possible the population at risk, the hazard potential of the 
hazardous substances at such facilities, the potential for 
contamination of drinking water supplies, the potential for direct 
human contact,'' among other considerations embodied in the NCP. The 
NCP provides guidance on when it may be appropriate to cleanup releases 
either through a removal or remedial action. For example, for removal 
actions, the NCP provides that the lead agency may take action when the 
agency has determined ``that there is a threat to public health or 
welfare'' based on a set of factors such as actual or potential 
exposure to drinking water supplies, the potential for hazardous 
substances to migrate, and the availability of other appropriate 
Federal or State response mechanisms to address the release. 40 CFR 
300.415(b).
    Even if EPA determines that it is appropriate to move forward with 
a cleanup and a site is listed on the NPL, a listing does not require 
any immediate action. Rather, an NPL listing is the initial step 
towards a potential long-term remedy for a site. Listing also allows 
EPA to prioritize which sites warrant further investigation to better 
understand potential risks to human health and the environment. This 
process identifies less than 10% of CERCLA sites as NPL sites.
    Only after those very careful and deliberative steps to investigate 
and prioritize sites does EPA begin the process of identifying 
potential cleanup actions. Because of this significant narrowing of 
sites that will receive EPA attention, it follows that not every 
instance of contamination by a hazardous substance--including a PFOA 
and/or PFOS release--will lead to enforcement and liability. And, as 
previously noted, EPA has a long history of focusing its enforcement on 
significant polluters, potentially further narrowing the extent of 
liability. While there may be independent third-party cleanups, those 
too are not immediately triggered by designation and just like with 
EPA-focused cleanups, parties

[[Page 39170]]

would typically have the benefit of CERCLA's liability protections, 
equitable divisions of responsibility by the courts, and so forth.
    EPA also notes that concerns about the cost of liability, the cost 
of cleanup, and the costs that certain facilities will bear managing 
PFOA and PFOS in waste to mitigate CERCLA liability risk are costs that 
Congress had front of mind in enacting CERCLA and chose to proceed 
anyway. The statutory language of CERCLA clearly provides 
interconnected response, enforcement and liability authorities that 
impose costs on PRPs enumerated in the statute. First, CERCLA section 
104(a) authorizes EPA to respond to a release (or substantial threat of 
a release) of a hazardous substance into the environment, or of a 
pollutant or contaminant that may present an ``imminent and substantial 
danger to the public health or welfare.'' CERCLA section 104(a). In 
addition, CERCLA section 106 gives EPA the authority to compel action 
by liable parties in response to a release or threatened release of a 
hazardous substance that may pose an ``imminent and substantial 
endangerment'' to public health or welfare or the environment. CERCLA 
section 106(a). Finally, under CERCLA section 107, when the United 
States, states, or Tribes perform cleanup work and incur costs, section 
107(a) authorizes them to recover those costs from potentially 
responsible parties. See CERCLA section 107(a).
    Legislative history also shows that one of Congress' aims was to 
incentivize better waste management practices: ``In correcting the 
historic neglect of hazardous substances disposal, it is essential that 
this incentive for greater care focus on the initial generators of 
hazardous wastes since they are in the best position to control the 
risks. Generators create the hazardous wastes, they have more knowledge 
about the risks inherent in their wastes and how to avoid them, and 
they determine whether and how to dispose of these wastes.'' S. Rep. 
No. 96-848, at 14 (1980). Congress' expectation was that better waste 
management practices could ultimately result in cost savings by 
reducing the need for expensive remedies to clean up hazardous waste in 
the environment: ``Expenditures to prevent a threatened release, 
discharge, or disposal may be necessary if damages are to be avoided 
while also providing considerable savings when compared to the costs of 
removal after a release, discharge or disposal has occurred.'' Id. 
Ultimately, Congress' calculation was that the benefit to human health 
and the environment to prevent exposure to hazardous chemicals is worth 
the costs borne by industry to improve waste management practices, 
prevent releases, and minimize the costs of retroactive efforts to 
clean up hazardous waste.
    EPA concludes that it would be inappropriate to carve out certain 
uses or materials containing PFOA or PFOS from the designation because 
any PFOA or PFOS release ``may present substantial danger,'' and 
subsequent steps in the CERCLA process are more appropriate for 
determining whether any specific release poses risk sufficient for 
further investigation and, potentially, cleanup.
4. Designating PFOA and PFOS as ``Hazardous Substances'' Under CERCLA 
Section 102(a) Does Not Present a ``Major Question''
    Comment: Commenters contend that EPA's use of section 102(a) of 
CERCLA to designate PFOA and PFOS as hazardous substances--as well as 
the Agency's interpretation of the scope of the authority granted by 
this provision--run afoul of the ``major questions doctrine'' 
articulated by the Supreme Court in West Virginia v. EPA, 142 S.Ct. 
2587 (2022). To support this assertion, the commenters argue that the 
designation will have a substantial ``economic, social, and legal 
impact'' and point to the fact that EPA is utilizing section 102(a) of 
CERCLA for the first time to contend that today's action represents a 
novel and transformative expansion of the Agency's regulatory 
authority.
    Response: EPA disagrees that this rulemaking raises a major 
question as defined in West Virginia v. EPA, 142 S. Ct. 2587 (2022).
    The designation of PFOA and PFOS pursuant to section 102(a) of 
CERCLA does not represent a radical change to CERCLA's statutory 
scheme. Rather, the designation is well within the statutory framework 
that Congress provided. CERCLA by its express terms authorizes EPA to 
designate hazardous substances and the designation is consonant with 
the Agency's longstanding practice of adding other chemicals to 
CERCLA's hazardous substances list through CERCLA's ``automatic'' 
designation process in section 101(14). That provision cross-references 
listing authorities in the CAA, CWA, RCRA, and TSCA. CERCLA's automatic 
designation process has resulted in the addition of more than 800 
hazardous substances to the statute's list of hazardous substances 
through separate actions. And just like it did when making designations 
under those other statutes, here EPA examined scientific and technical 
factors, including hazard and fate and transport, when evaluating 
whether PFOA and PFOS met the statutory standard and may present 
substantial danger to the public health or welfare or the environment. 
See supra-Section IV. Further, as discussed in Section VI.B, PFOA and 
PFOS are not different in kind from the other substances added to 
CERCLA's hazardous substance list.
    While EPA's action today utilizes a different mechanism for 
designation than the procedure outlined in CERCLA section 101(14)--
which defines the term ``hazardous substance'' by reference to 
provisions in other environmental statutes and to substances designated 
under CERCLA section 102--Congress specifically provided EPA with 
multiple pathways to address the varied threats posed by hazardous 
substances in various media. Although the commenters argue that EPA's 
approach to PFOA and PFOS represents an unprecedented expansion of 
EPA's authority, EPA has added similarly ubiquitous substances to 
CERCLA's hazardous substance list for decades. For example, 
polychlorinated biphenyls (PCBs) became hazardous substances when EPA 
initially promulgated its list of hazardous substances on April 4, 
1985, Notification Requirements; Reportable Quantity Adjustments, 50 FR 
13456, 13475 (1985), and are generally considered ``ubiquitous 
contaminants in the environment.'' Rouzbeh Tehrani and Benoit Van Aken, 
Hydroxylated Polychlorinated Biphenyls in the Environment: Sources, 
Fate, and Toxicities, 21 Environmental Science and Pollution Research, 
6334-6345 (2014); see also U.S. Dept. of Health and Human Services, 
Toxicological Profile for Polychlorinated Biphenyls (PCBs), at 291 
(November 2000) (``PCBs are ubiquitous and continuously circulating in 
the global environment. . . .''); U.S. Environmental Protection Agency, 
Remediation of PCBs at Superfund Sites, at 7 (2001) (noting that as of 
publication ``[o]f the 1,229 Superfund sites currently on the NPL, PCBs 
have been detected at 357 sites.''). PCBs, however, are far from the 
only highly prevalent contaminant of concern that EPA has routinely 
grappled with at Superfund sites for decades. In fact, at the 1,548 
Superfund sites with a selected remedy, arsenic has been identified at 
919 facilities, lead at 897, benzene at 885, and trichloroethene at 
816. See U.S. Environmental Protection Agency, Contaminant of Concern 
Data for Decision Documents by Media, fYs 1982-2021 (Final NPL, Deleted 
NPL, and Superfund Alternative Approach Sites) (2024), available at 
https://

[[Page 39171]]

www.epa.gov/superfund/superfund-data-and-reports. Ultimately, EPA's 
decision to designate PFOA and PFOS under section 102(a) is not an 
expansion of the Agency's authority that would cause a ``radical'' or 
``fundamental'' shift in CERCLA's statutory scheme.
    For these reasons, EPA's regulatory action to designate PFOA and 
PFOS as CERCLA hazardous substances does not present a major question.

B. Operation of CERCLA

1. Comments Suggesting That Other Authorities Are Better Suited To 
Address PFAS Contamination
    Comment: Several commenters argued that CERCLA is not the 
appropriate tool to address PFOA and PFOS in the environment. 
Commenters also argued that EPA already possesses the authority to 
protect public health, welfare, and the environment from any potential 
risks posed by PFOA and PFOS without designating these substances as 
hazardous under section 102(a). Instead, these commenters contend that 
EPA should utilize existing tools under SDWA, RCRA, CWA, and other laws 
to address PFAS-contaminated sites.
    Multiple commenters also argued that EPA should not use CERCLA to 
designate PFOA and PFOS as hazardous substances because the Agency has 
not yet regulated PFOA and PFOS under other statutes (e.g., CWA, RCRA, 
SDWA), and accordingly--because CERCLA site cleanup standards and 
responsibilities are informed by other statutes' regulatory 
frameworks--potentially responsible parties lack the necessary 
structure to conduct CERCLA cleanups of PFOA and PFOS.
    In arguing that CERCLA is not the appropriate tool to address the 
problem posed by PFOA and PFOS, one commenter also specifically claimed 
that the statute was designed to address only inactive hazardous waste 
sites and facilities impacted by groundwater plumes contaminated by 
specific hazardous substances, rather than ``problematic class[es] of 
chemicals with widespread contamination across the country.'' Another 
commenter stated that it appears ARARs do not yet exist and urges EPA 
to delay this rulemaking until such standards are developed.
    Response: EPA disagrees with the commenters' position that CERCLA 
is not the appropriate tool to address the challenges posed by PFOA and 
PFOS contamination. Congress enacted CERCLA to provide EPA with the 
ability to timely clean up contaminated sites that pose risk to human 
health and the environment. CERCLA is the right tool for addressing 
wide-spread, existing PFOA and PFOS contamination, which is a 
nationwide concern. CERCLA includes authorities to investigate and 
scope releases to better understand the extent of contamination. CERCLA 
includes response authority to implement short-term and long-term 
actions to address contamination and risks to public health and the 
environment. CERCLA removal authority is available to address emergency 
situations, such as when immediate action is necessary to mitigate 
consumption of contaminated drinking water. It also includes authority 
to take remedial actions that are designed to provide a more permanent 
remedy to mitigate or reduce unacceptable risk from highly contaminated 
sites. CERCLA also provides mechanisms to ensure that those responsible 
for the contamination pay to clean it up rather than using Fund 
resources. By designating PFOA and PFOS as CERCLA hazardous substances, 
EPA can utilize the full suite of CERCLA tools to address 
contamination.
    CERCLA is the best tool to address the legacy of sites contaminated 
with these substances and to address additional releases of these 
chemicals in the future. As EPA noted in its Strategic Roadmap, ``[t]he 
risks posed by PFAS demand that the Agency attack the problem on 
multiple fronts at the same time. EPA must leverage the full range of 
statutory authorities to confront the human health and ecological risks 
of PFAS.'' The Roadmap looked at a variety of authorities to address 
PFAS, including TSCA, SDWA, CWA, RCRA, and CAA, and identified CERCLA 
as a tool to accomplish one of its three central directives: Research, 
Restrict, Remediate. CERCLA is applicable to address all environmental 
media: air, surface water, groundwater, and soils. And CERCLA can apply 
to any type of industrial, commercial, or noncommercial facility, 
regardless of whether there are specific regulations that affect that 
type of facility or how that facility might affect the environment.
    The Agency also disputes the commenters' assertion that designation 
under CERCLA is premature in the absence of pre-existing regulatory 
standards for PFOA and PFOS. The plain language of CERCLA section 
102(a) includes no such explicit limitation. The statute requires only 
that EPA determine that a substance ``may present substantial danger to 
public health or welfare or the environment'' to designate. Considering 
the significant, and growing, body of evidence that PFOA and PFOS, when 
released in the environment, may present substantial danger, 
designation is warranted. Such a limitation also runs counter to the 
``automatic'' designation that occurs through CERCLA section 101(14) 
when a substance is identified as toxic or hazardous under another 
statutory authority. When a substance is designated pursuant to the 
specified CWA, CAA, RCRA, and TSCA authorities, there aren't 
necessarily pre-existing regulatory standards for that substance. For 
example, a substance could be listed under RCRA as a regulated 
hazardous waste, but not be subject to regulatory standards under the 
Clean Water Act or the Safe Drinking Water Act. The absence of such a 
regulatory framework is not a bar to listing under RCRA and nor should 
such a limitation be read into CERCLA section 102(a).
    EPA also disagrees that, at present, there is no regulatory 
framework in place that allows EPA to respond effectively to PFOA and 
PFOS releases. While it is true that PFOA and PFOS regulations, 
environmental standards, and remediation technologies are evolving, 
CERCLA and the NCP provide a process to identify cleanup standards on a 
site-by-site basis that ensure that a remedy is protective of human 
health and the environment. CERCLA section 121(a) provides that a 
remedial action must be ``protective of human health and the 
environment.'' All remedies selected must satisfy that requirement. 
Cleanup standards often help define remedy protectiveness. CERCLA 
cleanup standards are generally those standards that are determined to 
be ``applicable or relevant and appropriate requirements'' (ARARs).\66\ 
ARARs are Federal, or more stringent State, standards, requirements, 
criteria, or limitations. CERCLA section 121(d)(2)(A). ARARs apply to 
hazardous substances or pollutants and contaminants that remain on-site 
at the completion of a remedy. A final remedy must attain ARARs by the 
completion of the remedy, unless compliance with the ARAR is waived. 
CERCLA section 121(d)(2)(A), (d)(4). ARARs frequently are determinant 
in establishing preliminary remediation goals, which become site 
cleanup levels.
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    \66\ The NCP provides that Fund-financed removal actions (or 
removals under CERCLA section 106) must comply with ARARs to the 
extent practicable considering the exigencies of the situation. 40 
CFR 300.415. For the sake of discussion, EPA's response focuses on 
compliance with ARARs in the remedial context.
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    The current regulatory landscape for PFOA and PFOS is sufficient to 
inform future remedies, and regulatory actions to address PFOA and PFOS 
are

[[Page 39172]]

increasing. Currently, there are certain Federal standards that may be 
considered as ARARs. For example, a potential ARAR for drinking water 
cleanups may be the final PFOA and PFOS MCLs. For PFOA and PFOS, the 
MCLs are 4.0 parts per trillion (PPT) each. A number of States have 
also promulgated cleanup numbers for PFOA and PFOS, which may be 
evaluated as potential ARARs at sites. For example, Pennsylvania \67\ 
promulgated an MCL of 14 ppt for PFOA and 18 ppt for PFOS. In addition, 
New Jersey \68\ has adopted an MCL of 14 ppt for PFOA and 13 ppt for 
PFOS (NJ DEQ, 2023).
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    \67\ https://www.pacodeandbulletin.gov/Display/pabull?file=/secure/pabulletin/data/vol53/53-2/46.html.
    \68\ https://dep.nj.gov/pfas/standards/.
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    There are also non-chemical specific ARARs that may be relevant to 
a potential remedy. Those include ``location-specific'' and ``action-
specific'' ARARs. Location-specific ARARs are restrictions placed on 
the concentration of hazardous substances or the conduct of activities 
solely because they are in specific locations. Some examples of 
specific locations include floodplains, wetlands, historic places, and 
sensitive ecosystem habitats. An example of a location-specific 
requirement is the substantive CWA section 404 prohibitions regarding 
unrestricted discharge of dredged or fill material into wetlands. 
Action-specific ARARs are usually technology- or activity-based 
requirements or limitations on actions taken with respect to hazardous 
wastes. These requirements are triggered by particular remedial 
activities that are selected to accomplish a remedy. Examples of 
action-specific ARARs include activities such as ground-water 
diversion, dredging, and landfill closure with waste in place.
    EPA has also developed an Interim Guidance on the Destruction and 
Disposal of Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS) and 
Materials Containing PFAS-Substances--Version 2 (2024), which outlines 
the current science on techniques and treatments that may be used to 
destroy or dispose of PFAS and PFAS-containing materials from non-
consumer products, along with screening methods to assess vulnerable 
populations near destruction and disposal sites. In sum, the evolving 
regulatory landscape with respect to PFOA and PFOS cleanup standards is 
not a barrier to designation nor is it a barrier to evaluating, 
identifying, and selecting protective remedies. The Agency is also 
striving to ensure regulatory actions do not overlap with one another 
and duplicate efforts. EPA also disagrees with the commenter's claim 
that CERCLA is designed solely to address inactive hazardous waste 
sites and facilities subject to groundwater contamination from specific 
contaminants of concern. The commenter's view of CERCLA runs counter to 
the plain language of the statute. CERCLA's language does not include 
any limitation on response authority to only ``inactive'' waste sites. 
Rather, CERCLA makes clear that authority extends to inactive and 
active ``facilities.'' CERCLA defines a facility as ``any building, 
structure, equipment, pipe or pipeline (including any pipe into a sewer 
or publicly owned treatment works) . . . .'' CERCLA section 101(9)(A). 
Moreover, CERCLA provides authority to respond to past, current, and 
future releases. Response authority extends to releases and the threat 
of release of ``any hazardous substance'' and ``any pollutant or 
contaminant which may present an imminent and substantial danger to 
public health or welfare.'' CERCLA section 104(a). CERCLA's definition 
of the term ``release'' also makes clear that it encompasses past and 
current releases. See CERCLA section 101(22) (defining release to 
include ``any spilling, leaking, pumping, pouring, emitting, emptying, 
discharging, injecting, escaping, leaching, dumping, or disposing into 
the environment (including the abandonment or discarding of barrels, 
containers, and other closed receptacles . . .)''). This language is 
broad enough to encompass inactive and active sites.
    Although one impetus for CERCLA was a growing concern about the 
public health threats posed by improperly disposed toxic waste, 
Congress's interest in addressing issues associated with environmental 
contamination was more holistic. Addressing the challenge of widespread 
community exposure to hazardous chemicals such as PFOA and PFOS--when 
released into the environment--is the exact kind of environmental 
threat that Congress sought to ameliorate in enacting CERCLA. Moved to 
action by the Love Canal incident, Congress crafted CERCLA to address 
contaminated sites across the nation, which it considered one of ``the 
most serious health and environmental challenge[s] of the decade.'' S. 
Rep. No. 96-848, at 2 (1980). Congress acknowledged at that time that 
``more than 43,000 chemical substances are in commercial production and 
thousands of new ones are introduced each year . . . As a result, the 
potential impact of toxic chemicals on the general public and 
environment through unsound hazardous disposal sites and other releases 
of chemicals is tremendous.'' Id. Indeed, expert testimony solicited by 
Congress stated that the breadth and scope of the impact of exposure to 
hazardous chemicals nearly ``extend[ed] to the entire population of the 
United States.'' Id. Designating PFOA and PFOS is wholly consistent 
with Congress' vision for CERCLA as an important Federal tool in 
removing widespread toxic chemicals from the environment that have the 
potential to pose substantial danger to human health, welfare, and the 
environment.
2. Addressing PFOA/PFOS as ``Pollutants or Contaminants''
    Comment: Several commenters contend that EPA should use its 
existing authority to address PFOA and PFOS as pollutants or 
contaminants rather than designate these substances as hazardous under 
section 102(a) of CERCLA. One commenter also argued that PFOA and PFOS 
must be specifically designated as pollutants or contaminants before 
they are designated as hazardous substances. Finally, a commenter 
claimed that EPA has failed to demonstrate that PFOA and PFOS qualify 
as pollutants or contaminants under section 101(33) of CERCLA because 
the Agency has not indicated why these substances ``cause or are 
reasonably expected to cause death, disease, physiological 
malfunctions, or any other conditions in the definition of `pollutant 
or contaminant' in CERCLA [s]ection 101(33).''
    Response: EPA disagrees with the commenters' position that the 
Agency should treat PFOA and PFOS contamination by relying solely on 
its authority to address these substances as CERCLA pollutants or 
contaminants. See CERCLA section 101(33) (defining ``pollutants or 
contaminants''). As EPA has explained, EPA's authority to address 
``pollutants and contaminants'' is limited. Designation of hazardous 
substances provides the Agency with a suite of tools necessary to 
identify, characterize, and clean up the most contaminated sites 
without delay, either through PRP- or Fund-lead actions.
    EPA also disagrees with the commenters that the Agency must 
designate PFOA and PFOS as a pollutant or contaminant under section 
101(33) of CERCLA before utilizing its authority under section 102(a) 
to designate PFOA and PFOS as hazardous substances. Section 102(a) 
requires only a determination that the substance ``may present . . . 
substantial danger to the

[[Page 39173]]

public health or welfare or the environment'' when released into the 
environment. Moreover, a substance's status as a pollutant or 
contaminant is determined on a site-specific basis. And, in fact, EPA 
has already identified and treated PFOA and PFOS as pollutants and 
contaminants at multiple Superfund sites, including the Saint-Gobain 
Performance Plastics facility in Hoosick Falls, New York, and the 
Blades Groundwater site in Blades, Delaware.
    The Agency further disagrees that PFOA and PFOS do not qualify as 
pollutants or contaminants because EPA has not shown that these 
substances either ``cause or are reasonably expected to cause'' human 
health effects. In fact, the commenter misstates the qualifying 
criteria for a pollutant or contaminant.
    The statute requires only that pollutants or contaminants may 
``reasonably be anticipated'' to impact human health. In keeping with 
this broad standard, multiple courts have consistently reaffirmed the 
principle that section 101(33) ``. . . refers to, basically, any 
substance which may reasonably be anticipated to cause harm'' to human 
health when released into the environment. Eagle-Picher Industries, 
Inc. v. EPA, 759 F.2d 922, 931 (D.C. Cir. 1985); see also APWU, et al. 
v. Potter, 343 F.3d 619 (2d Cir. 2003) (anthrax); Lozar v. Birds Eye, 
Inc., 678 F.Supp.2d 589 (W.D. Mich. 2009) (iron, manganese, arsenic, 
chloride, and sodium); Jastram, et al. v. Phillips Petroleum Co., et 
al., 844 F. Supp. 1139 (E.D. La. 1994) (produced water). PFOA and PFOS 
readily meet the definition of pollutants or contaminants, particularly 
given the weight of scientific evidence--as discussed in section V--
indicating that exposure to PFOA and PFOS is associated with a host of 
negative health effects. Accordingly, EPA has determined PFOA and PFOS 
to be pollutants or contaminants on a site-specific basis, further 
demonstrating that PFOA and PFOS satisfy the definition in section 
101(33) of CERCLA.
3. Relationship Between SDWA and CERCLA
    Comment: Commenters stated that the 2022 interim Health Advisory 
Levels (HALs) of 0.004 ppt for PFOA and 0.02 ppt for PFOS are below the 
value that laboratory methods can accurately quantify, creating 
uncertainties with the proposed designation. Another commenter stated 
that EPA should provide additional clarity as to how the Agency's SDWA 
process will impact the setting of cleanup goals. A few commenters 
stated that while ``[the health advisories] are not regulations and 
should not be construed as legally enforceable Federal standards,'' 
they do shape public perception and almost certainly influence people's 
(including organizations') behavior. Similarly, there were comments 
concerning whether EPA was coordinating internally on how the SDWA rule 
to regulate PFOA and PFOS may impact the CERCLA program.
    Response: As stated in the proposed rule, EPA did not rely on the 
interim PFOA or PFOS HALs or draft toxicity values as support for the 
proposed designation decision. EPA's 2022 interim PFOA and PFOS HALs 
are beyond the scope of today's action. EPA HALs are non-enforceable 
advisory levels that provide information to drinking water systems and 
officials responsible for protecting public health when emergency 
spills or other contamination situations occur. Based on the record 
before the Agency, with today's action EPA is designating PFOA and PFOS 
as hazardous substances.
    EPA's actions establishing NPDWR for PFOA, PFOS, and other PFAS, 
pursuant to SDWA are beyond the scope of this action. Nonetheless, EPA 
has closely coordinated these actions to ensure consistency. For 
information about EPA's PFAS NPDWR, please see https://www.epa.gov/sdwa/and-polyfluoroalkyl-substances-pfas, or visit regulations.gov 
under docket id EPA-HQ-OW-2022-0114. The 2024 NPDWR pursuant to the 
Safe Drinking Water Act, EPA established a maximum contaminant level 
(MCL) of 4.0 ppt for both PFOA and PFOS and a maximum contaminant level 
goal (MCLG) of 0 ppt for both PFOA and PFOS. Consistent with CERCLA, 
EPA may evaluate MCLs and non-zero MCLGs as Applicable or Relevant and 
Appropriate Requirements (ARARs) cleanup levels on a site-specific 
basis. 42 U.S.C. 9621(d).
    For any Superfund site, EPA evaluates the risk and determines the 
appropriate cleanup level for the site, including for PFOA and PFOS. 
The risk is evaluated according to guidance, mainly Risk Assessment 
Guidance for Superfund using final toxicity information, and exposure 
information, and according to guidance, mainly Risk Assessment Guidance 
for Superfund (https://www.epa.gov/risk/risk-assessment-guidance-superfund-rags-part). PFOA and PFOS toxicity information used in CERCLA 
for any risk calculations are based on toxicity values that support 
EPA's 2024 NPDWR. Once a basis for action has been determined, the risk 
at a site has been assessed, and the need for a response action is 
determined, then the MCLs for PFOA and PFOS will potentially be 
considered as ARARs on a site-specific basis and documented in a 
decision document. While MCLs, MCLGs, and HAs are potentially 
appropriate to consider at CERCLA sites, other standards may be 
considered for other media evaluated at a site, such as soil, air, and 
biota such as fish.

C. Toxicity, Human Health Effects/Mobility, Persistence, Prevalence/
Release Into the Environment

1. Data Supporting Designation
    Comment: Several commenters argued that EPA has not presented 
sufficient information regarding the environmental and human health 
effects of PFOA and PFOS salts and structural isomers to support the 
designation of such substances as hazardous under CERCLA section 
102(a). Multiple commenters contend that additional scientific study is 
needed prior to designation of PFOA and PFOS as CERCLA hazardous 
substances to enhance an understanding of the risks posed by these 
substances to human health and the environment.
    Response: EPA believes that the available data clearly supports the 
conclusion that PFOA and PFOS, as well as their salts and structural 
isomers, present a hazard to human health and the environment. For 
further discussion of this issue, see Section V of this document, which 
describes the scientific and technical information supporting the 
Agency's conclusion that both PFOA and PFOS may present substantial 
danger to public health or welfare or the environment when released 
into the environment.
    EPA disagrees with the commenters' position regarding the need for 
additional data prior to designation. As discussed in detail in 
Sections I and V, EPA has determined that a robust body of 
epidemiological and toxicological studies support the Agency's 
conclusion that exposure to PFOA or PFOS are associated with serious 
and wide-ranging adverse health effects.
    Comment: Several commenters asserted that EPA could not utilize 
draft toxicity assessments developed as part of the PFAS NPDWR 
rulemaking process (draft MCLG documents) to substantiate the 
designation of PFOA and PFOS as CERCLA hazardous substances (See 
Response to Comment Document, Section 3B). Specifically, these 
commenters argued that the draft MCLG documents are flawed because the 
Science Advisory Board identified certain methodological issues with 
the initial approaches the Agency used to derive PFOA and PFOS MCLGs. 
Relatedly, one commenter also

[[Page 39174]]

challenged EPA's purported reliance on interim Health Advisories (HAs) 
issued by the Agency in 2021, arguing that the underlying toxicity 
assessments supporting the interim HAs are flawed and have not been 
finalized by the Agency.
    Finally, several commenters critiqued the reliability of several 
studies cited by EPA as part of this rulemaking, including certain 
epidemiological studies conducted in the Faroe Islands that EPA used to 
develop non-cancer toxicity values (reference doses) in the draft MCLG 
documents.
    Response: As an initial matter, EPA disagrees with the commenters' 
characterization of the Agency's reliance on the draft MCLG documents 
and Interim HAs. EPA considered the peer-reviewed scientific studies 
underlying the toxicity assessments supporting the draft MCLG documents 
and the interim HAs as part of the Agency's comprehensive evaluation of 
available scientific information regarding the human health and 
environmental effects of exposure to PFOA and PFOS. To that point, as 
delineated in Section V, EPA considered hundreds of peer-reviewed 
publications in determining that exposure to PFOA or PFOS, when 
released into the environment, may present a substantial danger to the 
public health or welfare or the environment, including the 2016 EPA 
Health Effects Support Documents for PFOA and PFOS, the 2021 ATSDR 
Toxicological Profile for PFAS, and numerous peer-reviewed 
epidemiological and toxicological studies (ATSDR, 2021; U.S. EPA, 
2016c, 2016d).
    Secondarily, while beyond the scope of today's action, because 
these documents were finalized in 2024 as part of a separate, unrelated 
rulemaking after undergoing a robust peer-review and public comment 
process EPA rejects the commenter's assertion that the draft MCLG 
documents are inherently flawed because of issues identified by the 
Science Advisory Board (SAB). The Agency's final toxicity assessments 
reflect recommendations from both the Science Advisory Board (SAB) and 
the public comment process and address the SAB PFAS Review Panel's 
recommendations to improve the transparency of EPA's systematic review 
process. Additionally, EPA updated and expanded the protocols and 
methods based on SAB recommendations to improve the transparency of the 
process EPA used to derive the MCLGs for PFOA and PFOS and to improve 
consistency with the ORD Staff Handbook for Developing IRIS Assessments 
(U.S. EPA, 2022). EPA followed this transparent systematic review 
process to evaluate the best available peer-reviewed science to conduct 
the PFOA and PFOS toxicity assessments (U.S. EPA, 2024b, 2024c, 2024d). 
For information on EPA's PFAS NPDWR rule, visit EPA's website at 
https://www.epa.gov/sdwa/and-polyfluoroalkyl-substances-pfas, or visit 
www.regulations.gov, under Docket No. EPA-HQ-OW-2022-0114.
    EPA also disagrees with the commenter's claim that the Faroe 
Islands epidemiological studies fail to provide evidence of the impacts 
of PFOA and PFOS on vaccine response in children. The Faroe Islands 
epidemiological studies were peer-reviewed by the various scientific 
journals in which they were published. Additional studies, including 
one from a Greenland epidemiological study, provide support for 
associations between decreased vaccine response in children and 
exposure to PFOA and PFOS (Timmermann et al., 2022; Zhang et al., 
2023). Additionally, the Science Advisory Board--in their ``Review of 
EPA's Analyses to Support EPA's National Primary Drinking Water 
Rulemaking for PFAS''--agreed with the selection of the critical study, 
Grandjean et al. (2012), that identified an association between 
exposure to PFOA and PFOS and suppression of a vaccine response in 
children exposed during development, as appropriate for the derivation 
of chronic RfDs \69\ for PFOA and PFOS.
---------------------------------------------------------------------------

    \69\ Reference Dose (RfD)--An estimate (with uncertainty 
spanning perhaps an order of magnitude) of a daily oral exposure to 
the human population (including sensitive subgroups) that is likely 
to be without an appreciable risk of deleterious effects during a 
lifetime. It can be derived from a NOAEL, LOAEL, or benchmark dose, 
with uncertainty factors generally applied to reflect limitations of 
the data used. Generally used in EPA's noncancer health assessments. 
Generally used in EPA's noncancer health assessments. Durations 
include acute, short-term, subchronic, and chronic. (https://www.epa.gov/iris/basic-information-about-integrated-risk-information-system).
---------------------------------------------------------------------------

D. Effects of Designation

1. Reporting and Notification Requirements
a. Reportable Quantity (RQ) for PFOA and PFOS Should be Set Either 
Higher or Lower Than 1 Pound
    Comment: Some commenters stated that EPA should lower the RQ to 0.1 
pound while others expressed that the RQ should be higher than one 
pound. A few commenters stated that EPA should consider a RQ for 
cumulative releases, i.e., X pounds per year. One commenter argued that 
EPA's proposed RQ would allow companies to release massive amounts of 
PFAS-containing waste before triggering any CERCLA requirements.
    Response: Pursuant to CERCLA section 102, in this final rule the 
Agency is assigning a default RQ of one pound to PFOA and PFOS and 
their salts and structural isomers. The Agency believes that the 
statutory default RQ is appropriate in this instance because it will 
facilitate reliable reporting of substantial releases of PFOA or PFOS 
and allow government officials to evaluate and undertake timely 
response actions, if appropriate to do so. To ensure that it focuses 
its resources on those releases that threaten public health or welfare 
or the environment, EPA, may, however, consider adjusting the default 
RQ in the future if it receives data regarding the scope of releases of 
PFOA or PFOS indicating that one pound is not a suitable unit on which 
to base a notification requirement.
b. The Reportable Quantity (RQ) of One Pound Is Appropriate
    Comment: A few commenters expressed support for a RQ of one pound.
    Response: For the reasons provided in response to the prior comment 
(see 1.a.), the Agency agrees that it is appropriate to maintain a 
reportable quantity of one pound over a 24-hour period.
c. The Reportable Quantities (RQs) Should Be Chemical-Specific, Not 
Applied to PFAS as a Class
    Comment: One commenter argued that EPA's decision to establish a RQ 
of one pound is indicative of the fact that the Agency lacks sufficient 
risk information for PFOA and PFOS to set a chemical-specific RQ, 
thereby demonstrating that the rulemaking is premature. Another 
commenter stated that there is precedent for tailoring reportable 
quantities to the unique characteristics of a given class of hazardous 
substances; specifically, the commenter pointed to the RQ approach the 
Agency has adopted with respect to radionuclides as support for their 
proposed methodology.
    Response: This action is focused on designating PFOA and PFOS, and 
their salts and isomers as CERCLA hazardous substances. CERCLA 102(b) 
establishes a default of one pound and EPA has assigned 1 pound for 
each of these substances, including their salts and isomers. The Agency 
may revise the RQ in the future through notice and comment rulemaking 
after reviewing release information received pursuant to CERCLA 103.
    On May 25, 1983, the Agency proposed to adjust the statutory 
default

[[Page 39175]]

RQ of one pound for radionuclides. See Notification Requirements; 
Reportable Quantity Adjustments, 48 FR 23514, 23552 (May 25, 1983). EPA 
subsequently published a final rule and assigned a specific RQ for each 
radionuclide based on a methodology specific to those substances. See 
Reportable Quantity Adjustment Radionuclides, 54 FR 22405, 22524 (May 
24, 1989). Similarly, with respect to PFOS and PFOA, the Agency may 
exercise its discretion at any time after designation to adjust the RQ 
if it determines that the circumstances warrant doing so.
d. Effluent That Violates NPDES Permit Limits
    Comment: One commenter stated that effluent that violates any 
present or future NPDES permit covering PFAS needs to be reported under 
CERCLA to help attain the primary goal of this rulemaking: determining 
where releases of PFOA and PFOS occur and in what amount.
    Response: Whether a particular release of PFOA or PFOS is exempt 
from CERCLA reporting requirements requires a case-by-case evaluation 
based on specific permit language or applicable control requirements. 
Generally, any release that violates a standard or limit specified in a 
facility's NPDES permit must be reported pursuant to CERCLA section 103 
and EPCRA section 304. If the permit limit is below the RQ for these 
substances, those releases are not required to be reported.
d. The Reportable Quantity (RQ) Should Be Applied Over a Different Time 
Period Than 24 Hours
    Comment: One commenter argued that EPA should require reporting of 
releases on a monthly basis rather than over a 24-hour period. To 
support this proposition, the commenter argued that the conditions of 
water-borne discharges do not change on a day-to-day basis and 
reporting can therefore be handled through other statutory reporting 
structures, specifically, under the terms of NPDES permits issued under 
the CWA. The commenter also argued that this designation would result 
in inconsistent reporting requirements as between TSCA and CERCLA. 
Here, the commenter stated that, under EPA's Chemical Data Reporting 
(CDR) rule, PFOA and PFOS are subject to a 2,500-pound reporting 
threshold at a single site. The commenter then noted that, regardless 
of TSCA stipulations, if the reporting quantity threshold is one pound 
in 24 hours, a site could spill 0.99 pounds per day for 365 days a 
year, or nearly 360 pounds, with no reporting required. If, however, 
EPA imposed a weekly or monthly RQ reporting timeframe, the commenter 
contended that this issue would be addressed. Finally, the commenter 
noted that, pursuant to Toxics Release Inventory reporting 
requirements, facilities in regulated industry sectors must report 
annually on releases and the waste management of certain listed toxic 
chemicals that they manufacture, process, or otherwise use above 
certain threshold quantities (100 pounds for PFOA and PFOS).
    Response: EPA declines the commenter's request to amend the 
timeframe it uses to determine if a reportable release has occurred. 
The Agency believes that a 24-hour reporting period--which it has 
utilized successfully for 38 years and with which the regulated 
community is highly familiar--best serves the primary purpose of 
CERCLA's notification requirements, namely, to alert government 
officials to releases that may require timely and proper response 
action to prevent or mitigate damage to public health or welfare or the 
environment. To the extent facilities are aware of ongoing releases of 
hazardous substances below the reportable quantity, the Agency believes 
that regulated entities will conduct due diligence by reporting any 
releases that may cause substantial danger to the public health, or 
welfare or the environment. Finally, while the commenter identifies 
what it regards as inconsistencies in reporting thresholds between 
various regulatory programs, EPA notes that statutory and regulatory 
programs maintain reporting thresholds that are intended for different 
purposes. For example, EPCRA section 313 (Toxic Release Inventory 
(TRI)) requires certain facilities that manufacture, process, or 
otherwise use listed toxic chemicals in amounts above reporting 
threshold levels to report their environmental releases and other waste 
management quantities of such chemicals annually. TRI data can, in 
conjunction with other information, be used as a starting point in 
evaluating such exposures and the risks posed by such exposures. The 
purpose of the Chemical Data Reporting Rule under TSCA is to provide 
EPA with information on the production and use of chemicals in 
commerce. However, release reporting requirements under CERCLA section 
103 and EPCRA section 304 create a reporting process that inform 
government officials of releases that require immediate evaluation to 
determine the need for response action.
f. The Proposal Provides Little or No Guidance on How PFAS Quantities 
Are To Be Specifically Determined or Calculated for the Purposes of the 
RQ
    Comment: Several commenters argued that the designation would 
necessitate costly daily sampling for PFOA and PFOS; relatedly, these 
commenters also claimed that the designation fails to provide adequate 
guidance regarding the appropriate methodology for sampling of PFOA and 
PFOS.
    Response: This final designation under CERCLA does not require any 
testing and EPA does not intend to require any further testing beyond 
that which is already required by other statutes and their implementing 
regulations. Testing may be required on a site-specific basis, 
consistent with CERCLA section 104(b).
g. Reportable Quantities of PFAS May Be Difficult or Impossible To 
Identify Due to Being Proprietary, Being Disclosed Incompletely in 
Safety Data Sheets, or Not Meeting the 1 Percent Labeling Threshold
    Comment: Several commenters were concerned with the identification 
of reportable PFAS because in some cases, PFAS chemicals in products 
are listed as proprietary, not by name or Chemical Abstracts Service 
(CAS) number. Furthermore, because not all Safety Data Sheets (SDSs) 
accurately disclose PFAS constituents, these commenters argue that the 
designation will result in constant uncertainties regarding quantities, 
reporting and recordkeeping, even though EPA has taken the position 
that SDSs and Technical Data Sheets should be considered primary 
sources of information in ascertaining the presence of PFAS-containing 
compounds. One commenter also noted that compositions of products 
containing PFOS or PFOA, or other PFAS, are currently not required to 
be communicated on Safety Data Sheets or otherwise labeled normally 
below one percent, questioning how EPA proposes to make determinations 
on volumes if percent composition is not disclosed by manufacturers. 
One commenter stated that the rule should clarify expectations and 
requirements for PFOA and/or PFOS producers regarding the communication 
and/or disclosure of these substances when used as ingredients. By way 
of example, the commenter suggested that EPA should consider whether 
PFOA and PFOS producer reporting requirements should be effectuated 
through OSHA regulations such as the Hazard Communication Standard.

[[Page 39176]]

    One commenter noted that EPA's current proposal would designate not 
just PFOA and PFOS as hazardous substances with RQ requirements, but 
also ``their salts and structural isomers'' which often do not even 
have their own names. The commenter asserted that if a constituent has 
not even been named yet and/or is not currently detectable with the 
available sampling methods, then the regulation of that constituent is 
not practicably enforceable and puts regulated entities in an untenable 
situation.
    Response: According to OSHA's Hazard Communication Standard (HCS), 
a manufacturer, importer, or employer may claim ingredients in their 
product as proprietary if they meet the requirements of 29 CFR 
1910.1200(i). However, if a chemical ingredient is below the thresholds 
(i.e., 1% or 0.1%, depending on the specific health endpoint), it is 
required to be listed on an SDS if the chemical can cause a health 
hazard below the cut-offs.\70\ Downstream users of mixtures or products 
that contain PFOA, PFOS, or their salts and isomers are encouraged to 
contact their distributors as well as manufacturers to obtain (SDSs), 
which should include concentrations of each ingredient or constituent 
in a mixture or product. The specific requirements for developing SDS 
and its contents are regulated under OSHA HCS. See 29 CFR 1910.1200. 
(Note: EPA's CompTox Chemicals Dashboard (https://comptox.epa.gov/dashboard/) is a resource that can be used to identify salts and 
structural isomers of PFOA and PFOS. EPA periodically updates the 
CompTox Chemicals Dashboard to include new information on PFAS, 
including PFOA and PFOS.) EPA has amended Table 302.4 of 40 CFR part 
302 to designate PFOA, PFOS and their salts and structural isomers and 
parties that use such chemicals are responsible for knowing the makeup 
of their products and ingredients and ensuring compliance with the 
CERCLA and EPCRA reporting requirements if a release occurs. The 
regulations at 40 CFR 302.6 (b) provides requirements for release 
reporting of mixtures with known and unknown constituents or their 
quantities. https://www.ecfr.gov/current/title-40/chapter-I/subchapter-J/part-302/section-302.6.
---------------------------------------------------------------------------

    \70\ EPA coordinated with OSHA to develop this response.
---------------------------------------------------------------------------

h. EPA Should Clarify That Any NPDES Permit Violation for PFOA and PFOS 
Would Not Constitute a ``Federally Permitted Release'' and Must Be 
Reported
    Comment: One commenter argued that EPA should clarify that any 
releases of PFOA or PFOS in violation of the terms of a NPDES permit 
would not constitute a ``federally permitted release'' under CERCLA 
section 101(10)(C) and must therefore be reported in accordance with 
CERCLA section 103. This commenter also argued that EPA's ability to 
require monitoring of PFOA and PFOS through NPDES permits is limited 
because the Agency's April 2022 guidance--Addressing PFAS Discharges in 
National Pollutant Discharge Elimination System Permits and Through the 
Pretreatment Program and Monitoring Programs (Memorandum)--is directed 
only at federally issued NPDES permits.
    Response: CERCLA requires a person in charge of a vessel or a 
facility to report any release (other than a federally permitted 
release) of a hazardous substance over a certain quantity to the 
National Response Center as soon as they are aware of a release. See 42 
U.S.C. 9603(a). CERCLA section 101(10) defines the term ``federally 
permitted release,'' which includes NPDES permits issued under the 
Clean Water Act. See CERCLA 101(10)(A), (B), & (C). Whether a 
particular release is a ``federally permitted release'' such that it 
would be exempt from CERCLA section 103 reporting requirements requires 
a case-by-case determination based on the specific permit language or 
applicable control requirement. These provisions are sufficient to 
inform whether a release is a federally permitted release for any 
hazardous substance, including releases of PFOA and PFOS. EPA also 
notes that on December 5, 2022, it updated the Memorandum to provide 
guidance to States for addressing PFAS discharges when they are 
authorized to administer the NPDES permitting program and/or 
pretreatment program. https://www.epa.gov/system/files/documents/2022-12/NPDES_PFAS_State%20Memo_December_2022.pdf.
i. Default Reportable Quantity (RQ) of 1 Pound
    Comment: One commenter noted that EPA arbitrarily set the default 
reporting requirement at one pound, which is not supported by 
scientific analysis.
    Response: Although one commenter argues that EPA acted 
``arbitrarily'' in setting the reportable quantity (RQ) for PFOA and 
PFOS at one pound, in fact, the Agency is setting the RQ by operation 
of law at the statutory default of one pound pursuant to CERCLA section 
102(b). See 42 U.S.C. 9602(b) (``Unless and until superseded by 
regulations establishing a reportable quantity under subsection (a) of 
this section for any hazardous substance as defined in section 9601(14) 
of this title, (1) a quantity of one pound, or (2) for those hazardous 
substances for which reportable quantities have been established 
pursuant to section 1321(b)(4) of title 33, such reportable quantity, 
shall be deemed that quantity, the release of which requires 
notification . . .'').
2. Community Notification Requirement Under CERCLA Section 111(g)
    Comment: One commenter requested clarification regarding the impact 
of the rule on the community notification requirement of section 111(g) 
of CERCLA.
    Response: Upon finalization of this rulemaking, the owner or 
operator of a facility or vessel from which PFOA or PFOS have been 
released will be required to ``provide reasonable notice to potential 
injured parties by publication in local newspapers serving the affected 
area.'' CERCLA section 111(g). Note that the section 111(g) 
notification mechanism is independent of the reporting requirements of 
section 103(a). See Notification Requirements; Reportable Quantity 
Adjustments, 50 FR 13456, 13464 (Apr. 4, 1985) (``One commenter asked 
whether RQ notification requirements revoke section 111(g). The 
newspaper notification requirement established by section 111(g) of 
CERCLA is not affected by any of the notification requirements in 
today's rule.'').

E. National Priorities List (NPL) Sites--Existing and Future 
Contamination

    Comment: A number of commenters were concerned that the designation 
of PFOA and PFOS would result in the addition of a significant number 
of new sites to the NPL, thereby preventing EPA from focusing on 
significantly contaminated sites. One commenter noted that designation 
would require EPA to prioritize the cleanup of new Superfund sites, but 
also claimed that the Agency has not clarified how any prioritization 
process would occur. Another commenter noted their specific concern 
that the designation will result in the implication of a significant 
number of agricultural operations as Superfund sites.
    Several commenters also argued that designation could both extend 
the

[[Page 39177]]

remediation timeline for existing Superfund sites and slow down the 
rate at which sites can be deemed ``closed.'' Ongoing and unmitigated 
releases could result in a contaminated site having to be cleaned up 
multiple times. Finally, multiple commenters stated that EPA has not 
properly accounted for and considered the additional economic burden 
associated with the addition of multiple new Superfund sites, reopening 
of sites, and corresponding cleanup obligations.
    Response: EPA does not expect the number of sites on the NPL to 
substantially increase after designation. EPA already has the authority 
to list PFOA and PFOS sites to the NPL, and the rule has no impact on 
that authority. Indeed, EPA has already listed sites on the NPL in part 
due to the presence of these substances at a site, and this practice 
would continue. For example, Saint-Gobain Performance Plastics, Blades 
Groundwater, and Galey and Lord mention PFOA, PFOS, or both PFOA and 
PFOS, in their listing proposal. Designation does not automatically 
make sites eligible for placement on the NPL because of the presence of 
PFOA and PFOS.
    Designation does not change the Hazard Ranking System (HRS), which 
is EPA's primary tool for evaluating releases to determine NPL 
eligibility. (40 CFR part 300, Appendix A). The HRS broadly defines 
``hazardous substance'' as including CERCLA hazardous substances, 
pollutants, and contaminants as defined in CERCLA section 101(14) and 
101(33). Available scientific data demonstrate that PFOA and PFOS meet 
the definition of pollutant or contaminant, and therefore sites with 
PFOA and PFOS are evaluated in the NPL listing process, regardless of 
designation.
    The HRS process considers several factors for the purpose of 
scoring a site and determining its eligibility for listing on the NPL. 
The HRS is designed to assesses the relative potential of sites to pose 
a threat to human health or the environment. Scores are based on three 
categories, including the likelihood that a site has released or has 
the potential to release hazardous substances and/or pollutants or 
contaminants into the environment; characteristics of the waste 
(toxicity and waste quantity); and people or sensitive environments 
(targets) affected by the release. These scores are calculated for one 
or more pathways including ground water migration, surface water 
migration, soil exposure and subsurface intrusion, and air migration. 
If the combined scores meet or exceed the threshold listing score of 
28.5, the site is eligible for the NPL.
    Even when a site is eligible for the NPL, EPA may choose to not 
list the site and look to other options. Alternatives to NPL listing 
may include the Superfund Alternative Approach, State cleanup, cleanup 
by other Federal agencies, EPA removal action, deferral to another EPA 
program, or various other enforcement mechanisms. Thus, PFOA or PFOS 
releases may be addressed through non-NPL mechanisms even after 
designation.
    Between FY 2003 and FY 2022, only about four percent of all 
contaminated sites added to EPA's Active Site Inventory were placed on 
the NPL. Since 2013, EPA has, on average, added 11 non-federal sites 
per year to the NPL,\71\ and EPA does not expect the rate at which 
annual additions to the NPL occur to increase as a result of this rule. 
Moreover, NPL listing does not trigger any immediate actions, 
liability, or requirements for the site.\72\
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    \71\ This estimate is based on data from EPA's SEMS database 
with respect to non-federal NPL sites. EPA determined that it was 
appropriate to assess the designation's impact with respect to non-
federal NPL sites only, because federal sites are generally expected 
to address PFOA and PFOS in the absence of designation consistent 
with CERCLA section 104. As discussed in Chapter 2 of the RIA, 
federal sites are addressing PFAS in the baseline as authorized by 
CERCLA section 104 and corresponding Executive Orders, as required 
by the NDAA, and consistent with federal facilities agreements under 
CERCLA section 102. Therefore, EPA expects that federal sites will 
address PFOA and PFOS contamination in the absence of the final 
rule. With federal sites taking action to address PFAS in the 
baseline, indirect impacts of the final rule will likely be related 
to actions taken at non-federal sites. For additional context, since 
FY 2000 EPA has added 8 federal sites to the NPL.
    \72\ EPA considered the portion of non-federal NPL sites that 
may be impacted by designation depending on site-specific 
circumstances. Of final, proposed, or deleted non-federal NPL sites 
that have been tested for PFOA and/or PFOS, an estimated 33.1% of 
NPL sites have detectable levels of PFOA and/or PFOS. See Section 
3.3 of the RIA for more details about this estimate. In evaluating 
the designation's impact on non-federal NPL sites, this estimate is 
instructive and serves as a benchmark for assessing designation's 
potential impact to those sites. There are currently 5 sites where 
either PFOA or PFOS contributed to NPL listing.
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    A hazardous substance designation under section 102(a) of CERCLA 
does not lead automatically to any response actions. Response actions, 
which include investigations of releases of hazardous substances and 
determining if removal or remedial action is necessary, are contingent, 
discretionary, and site-specific. 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; and cost considerations, among other important factors such as 
protectiveness, are part of CERCLA's site-specific cleanup approach.
    EPA disagrees with the commenter that designation of PFOA and PFOS 
will slow the Agency's ability to remediate Superfund sites. 
Designation itself does not affect the length of time it may take to 
fully implement a remedial action. However, in some cases, there may 
need to be additional work to address PFOA and PFOS contamination, 
depending on what other contaminants of concern (COCs) are located at a 
site and whether the responses to those other contaminants have the co-
benefit of addressing PFOA and PFOS contamination. Typically, remedial 
actions address a number of COCs at once. In some cases, the remedy for 
other COCs will also address PFOA and PFOS contamination; in other 
cases, additional work will be needed. For instance, if PFOA and PFOS 
are not part of a remedy for the site, adding them to the remedy would 
then have the potential to increase efforts and cost of the remedy 
(e.g., by increasing the frequency of GAC replacement).
    In all cases, EPA should evaluate whether the remedy can mitigate 
any unacceptable risk from PFOA or PFOS contamination or whether 
additional actions may need to be taken. CERCLA section 121 provides 
that if an action is needed to assure protectiveness as a result of 
findings of a five-year review, those actions can be taken. In some 
cases, it may be necessary to revise or expand the previous risk 
assessment as part of a five-year review. For example, the risk 
assessment may need to be revised when there is a new exposure pathway, 
a new potential contaminant of concern, or an unanticipated toxic 
byproduct of the remedy. Five-year reviews (FYR) can also recommend 
further investigation to determine whether an additional response 
action is needed. See CERCLA section 121(c); 40 CFR 300.430(f)(4)(ii).
    Additionally, several commenters stated that without first ensuring 
PFOA and PFOS are no longer entering the environment, ongoing and 
unmitigated releases could potentially cause a site to be cleaned up 
multiple times. First, PFOA and PFOS contamination stems largely from 
historic releases. Even though there will likely be future releases, 
the use of PFOA and PFOS has diminished, and EPA does not expect 
releases at particular sites to result in additional widespread, 
significant contamination at or from that site, in part because the 
designation will allow EPA to act earlier. Second, EPA notes that (as 
discussed in Section III.C.), it has committed to a comprehensive and

[[Page 39178]]

ambitious whole-of-Agency plan to address PFAS. Under this approach, 
EPA has identified a variety of authorities, including TSCA, SDWA, and 
RCRA, that it intends to use to prevent or minimize ongoing PFOA and 
PFOS releases into the environment. Additionally, EPA has considered 
the economic impacts of designation, including a consideration of 
potential impacts of designation on the NPL listing process. Please see 
chapter 5 of the RIA for this final rule.

F. Regulate PFAS as a Class

    Comment: A few commenters stated that EPA should regulate PFAS as a 
class rather than listing chemicals one by one.
    Response: PFOA and PFOS are prevalent because they have been 
produced and used since the 1940s, were among the most widely used of 
the PFAS constituents and persist in the environment for a substantial 
period of time. EPA considered the available scientific and technical 
information, and concluded each of these substances may present 
substantial danger to public health or welfare of the environment. EPA 
also evaluated the totality of the circumstances, including available 
scientific and technical information, and concluded that designation is 
warranted. The Agency also recently sought input and data regarding 
potential future hazardous substance designation of categories of PFAS 
and is still evaluating the feedback it received on this issue. See 
Addressing PFAS in the Environment, 88 FR 22399 (Apr. 13, 2023).

G. Phase-Out & PFOA Stewardship Program

    Comment: Several commenters also argued that the production of PFOA 
and PFOS is being phased out, thus the value of this rulemaking is 
questionable.
    Response: EPA disagrees with the commenter's assertion that the 
value of designating PFOA and PFOS is questionable since these 
chemicals have been phased out in many cases. First, although PFOA is 
not produced domestically by the companies participating in the 2010/
2015 PFOA Stewardship Program, PFOA may still be produced domestically 
by non-participating companies. PFOS may still be produced or used 
domestically as well. Second, EPA has also published Significant New 
Use Rules (SNURs) to require notification to EPA before manufacture 
(including import) of certain PFAS, including PFOA and PFOS. This 
notification process would allow EPA the opportunity to evaluate the 
new use and, if necessary, take action to prohibit or limit the 
activity. However, these SNURs exempted certain ongoing uses, including 
a few specifically limited, highly technical uses. In the absence of 
any notices received under these SNURs, EPA has limited sources of data 
regarding the ongoing use of PFOA and PFOS. Currently, the CDR 
generally requires manufacturers (including importers) to report for 
PFOA and PFOS if they meet a 2,500-pound production volume threshold at 
a single site. TRI reporting requires facilities to report releases of 
PFOA and PFOS if the facility manufacture, produce, or otherwise use at 
or above 100 pounds per year. Recent TRI reports indicate there maybe 
on-going uses of these substances. While TRI reports show on-going 
uses, EPA is unable to definitively state the extent to which PFOA and 
PFOS are still in commerce in the United States.\73\
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    \73\ The Agency expects to receive additional information about 
ongoing use of PFAS as part of the TSCA section 8(a)(7) PFAS 
reporting rule that was finalized on October 11, 2023 (88 FR 70516).
---------------------------------------------------------------------------

    Regardless of the phase-out, designation is warranted based on the 
scientific and technical data available, suggesting that releases into 
the environment pose a hazard; are persistent and mobile (fate and 
transport); and prevalent in the environment. EPA has existing data 
that suggest that, despite the phase-out, PFOA and PFOS will continue 
to be detected in the environment. For example, EPA has detected PFOA 
and PFOS at approximately 400 NPL sites. These sites are mainly 
locations associated with AFFF use, textile coating operations, metal 
plating facilities, and landfills. As appropriate, these sites, and 
others like them, should be investigated, and site-specific risk 
assessments should be performed to assess whether further response 
actions, if any, are necessary to protect human health and the 
environment. Designation will allow EPA to address the legacy of sites 
that are contaminated with these substances and address future 
releases.

H. Managing PFOA and PFOS Contaminated Waste

    Comment: Several commenters claimed that the designation of PFOA 
and PFOS will result in a significant increase in the generation of 
hazardous wastes; these commenters also argued that EPA has not 
provided sufficient disposal capacity or storage requirement guidance 
to address the ramifications of the designation. Multiple commenters 
also stated that the Agency may not be able to satisfy the requirements 
of CERCLA section 104(c)(9), which requires States to assure the 
availability of hazardous waste treatment or disposal facilities that 
have adequate capacity to manage the hazardous waste reasonably 
expected to be generated within the State over 20 years, prior to EPA 
providing funding for any remedial actions. Relatedly, some commenters 
noted that EPA has not disclosed whether it has entered into any 
agreements with States to ensure that they possess the capacity to 
destroy, treat, or securely dispose of material contaminated with PFOA 
and PFOS. Further, several commenters argued that EPA has not 
considered whether Subtitle C landfill capacity is available to 
accommodate PFOA or PFOS-contaminated hazardous waste. Some commenters 
also alleged that EPA has not described disposal methods for 
contaminated soils or other media from new Superfund sites that could 
be created in the wake of this rulemaking. Finally, several commenters 
argued that EPA must finalize its Interim Guidance on the Destruction 
and Disposal of Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS) 
and Materials Containing PFAS-Substances (``Interim Guidance'') and 
estimate available waste disposal capacity before finalizing this 
rulemaking.
    Response: Comments suggest a misunderstanding of waste disposal 
requirements under CERCLA. The Agency disagrees with the assumption 
that all waste containing PFOA and PFOS must be disposed of in Subtitle 
C facilities. EPA's Interim Guidance on the Destruction and Disposal of 
Perfluoroalkyl and Polyfluoroalkyl Substances and Materials Containing 
Perfluoroalkyl and Polyfluoroalkyl Substances--Version 2 (2024), 
acknowledges that PFAS wastes could be sent to both hazardous waste and 
municipal solid waste landfills. For CERCLA cleanups, section 121(d)(3) 
of CERCLA, as implemented by 40 CFR 300.440 (``Offsite Rule''), applies 
to any CERCLA response action involving the off-site transfer of any 
hazardous substance or pollutant or contaminant (CERCLA wastes). The 
Offsite Rule requires that CERCLA wastes are transferred to a facility 
operating in compliance with applicable Federal and State requirements 
for the waste at issue. As such, for CERCLA cleanups, only hazardous 
wastes listed or identified under RCRA section 3001 (or an authorized 
State program) are required to be managed at RCRA Subtitle C 
facilities.
    EPA rejects the assertion that it has not evaluated if sufficient 
capacity exists for disposal and storage of PFOA

[[Page 39179]]

and PFOS contaminated materials. EPA also acknowledges that CERCLA 
section 104(c)(9) does not allow the Agency to provide any remedial 
action funding to a State, unless the State first enters into a 
Superfund State Contract or Cooperative Agreement (CA) that assures the 
availability of adequate capacity to manage hazardous wastes generated 
in the State for 20 years following the date of the response agreement. 
EPA is designating PFOA and PFOS as CERCLA hazardous substances. No 
PFAS are currently listed, or being proposed to be listed, as hazardous 
wastes under RCRA,\74\ However, PFOA- and PFOS-containing waste is and 
will likely continue to consume a fraction of hazardous waste treatment 
and disposal capacity. Although waste containing PFOA and PFOS is not 
necessarily hazardous waste (unless the particular wastes are hazardous 
for some other reason), some waste generators, perhaps to be cautious, 
have been sending PFAS-containing wastes to hazardous waste facilities. 
To ensure hazardous waste landfill capacity is available in the future, 
EPA reviews and analyzes the Biennial Hazardous Waste Report and other 
data to develop and then publish an assessment of national capacity for 
hazardous waste management. The last such capacity assessment indicated 
that there is adequate capacity nationwide through 2044, and it would 
have incorporated PFOA and PFOS as wastes in the category of ``Not RCRA 
Federally-Defined Hazardous Wastes.'' Of these wastes, no assumption 
regarding a certain percentage of PFOA and PFOS was made. Anew 
assessment is currently underway to incorporate new information and 
extend the time horizon.\75\ EPA will continue to work with States to 
monitor waste treatment and disposal capacity and report on the status.
---------------------------------------------------------------------------

    \74\ EPA has proposed to amend its RCRA regulations to add 
multiple PFAS compounds, including PFOA and PFOS, as hazardous 
constituents. These PFAS would be added to the list of substances 
identified for consideration in RCRA facility assessments and, where 
necessary, further investigation and cleanup through the corrective 
action process at hazardous waste treatment, storage and disposal 
facilities. Although this is one step toward listing a hazardous 
waste, it is not a regulatory hazardous waste listing.
    \75\ Background information and links to related documents are 
available at https://www.epa.gov/hwpermitting/assessment-national-capacity-hazardous-waste-management.
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    The science on treating, destroying, and disposing of PFAS is 
evolving. The National Defense Authorization Act for Fiscal Year 2020 
(FY 2020 NDAA) directed the Agency to publish interim guidance on the 
destruction and disposal of PFAS and materials containing PFAS. 
Subsequently, on December 18, 2020, EPA developed and issued the 
Interim Guidance (U.S. EPA, 2020), which outlines the current state of 
science on techniques and treatments that may be used to destroy or 
dispose of PFAS and PFAS-containing materials from non-consumer 
products. Consistent with the FY 2020 NDAA, EPA is also required to 
publish revisions to the interim guidance as appropriate, but not less 
frequently than once every three years. EPA recently posted the Interim 
Guidance on the Destruction and Disposal of Perfluoroalkyl and 
Polyfluoroalkyl Substances and Materials Containing Perfluoroalkyl and 
Polyfluoroalkyl Substances--Version 2 (2024).

I. Comments on Economic Assessment/Regulatory Impact Analysis

    Comment: Several commenters asserted that EPA must prepare and 
publicly issue a full economic analysis of the rulemaking. These 
commenters claimed that EPA's economic assessment is insufficient for 
failing to provide any quantitative assessment of anticipated indirect 
costs, particularly those related to increased response actions. 
Several commenters called upon the Agency to issue a complete RIA while 
other commenters stated that EPA is required to prepare a regulatory 
cost benefit analysis consistent with Executive Order 12866. These 
commenters also asserted that EPA should conduct a full RIA pursuant to 
OMB Circular A-4 that considers the full compliance and cleanup costs, 
including the direct and indirect costs and benefits, associated with 
the designation. One commenter stated that the rulemaking cost 
estimates prepared by EPA do not appropriately reflect the total costs 
associated with the designation.
    Response: With new information received during the public comment 
period, EPA updated its analysis of direct costs. As part of this 
rulemaking, EPA has expanded its economic assessment and has conducted 
an RIA consistent with E.O. 12866 and OMB Circular A-4 in support of 
designation. As required by the E.O. and Circular A-4, the RIA assesses 
reasonably foreseeable indirect costs, transfers, and benefits. 
Specifically, for costs, transfers and benefits, EPA has developed 
estimates under a range of scenarios based on historic information 
about response costs and benefits. These ranges reflect the uncertainty 
associated with estimating potential response costs, transfers, and 
benefits, as it is difficult to assess with certainty what future 
actions will be taken since CERCLA decisions are made on a site-
specific basis. EPA also asserts that the scope of costs counted by the 
Agency as direct costs--including an estimated low and high range of 
potential notification requirement frequencies and associated costs--is 
consistent with the requirements of E.O. 12866 and OMB Circular A-4. 
Consistent with the guidance of Office of Management and Budget's 
(OMB's) Circular A-4, this RIA includes an assessment of potential 
indirect costs, benefits, and transfers to provide the public with 
insights related to these impacts. Please see chapters 3, 4, and 5 of 
the RIA for more information about EPA's methodologies and discussion 
of direct and indirect costs, benefits, and transfers.
1. Liability and Costs to Public Utilities
    Comment: Numerous comments claim that EPA has failed to consider 
the potential impact of the designation on public water utilities/water 
systems and ratepayers with respect to potential litigation costs. 
These comments also argue that the designation does not account for the 
potential remediation costs associated with PFOA and PFOS cleanups 
(which the commenters assert could be passed on to local communities 
and public clean water utility ratepayers). These commenters also claim 
that local drinking water and wastewater agencies will incur 
substantial costs to remove PFOA and/or PFOS from water sources and 
propose that all such direct and indirect costs should be evaluated in 
a full RIA. One commenter asserted that EPA's approach to designation 
could potentially harm sectors and facilities that provide essential 
daily functions to communities, such as wastewater treatment facilities 
and municipal landfills (i.e., facilities that do not generate or use 
PFAS but that may, in the regular course of business, receive waste or 
wastewater containing PFAS).
    Response: The Agency recognizes that certain stakeholders are 
concerned about CERCLA liability resulting from the designation of PFOA 
and PFOS as hazardous substances. The most significant direct impact of 
this CERCLA designation is the requirement that any person in charge of 
a vessel or facility report a release of PFOA and/or PFOS of one pound 
or more within a 24-hour period. Neither a release nor a report of a 
release automatically triggers cleanup action under CERCLA. EPA makes 
CERCLA response decisions based on site-specific information, which 
includes evaluating the nature, extent, and risk to human health and/or 
the environment from the release. In

[[Page 39180]]

addition, designation does not automatically result in CERCLA liability 
for any specific release. Whether an entity may be subject to 
litigation or held liable under CERCLA are site-specific and fact-
dependent inquiries. Likewise, CERCLA affords the EPA broad discretion 
as to whether or how to respond to a release. For those reasons, EPA 
cannot assess with reasonable certainty what liability outcomes may 
indirectly result from this designation since those outcomes are often 
linked to EPA's discretionary decisions with respect to CERCLA response 
actions as well as site-specific and fact-dependent court rulings. 
Nevertheless, EPA considered these issues in its totality of the 
circumstances analysis. For further information regarding the interplay 
between the designation and potential liability concerns please see 
sections VI.B.2 and VI.B.3.
    Efforts to address PFAS in public drinking water and wastewater 
treatment have already been initiated prior to this designation, and 
the associated costs of those efforts are attributable to those 
separate efforts. In the case of drinking water utilities, EPA's 2024 
NPDWR mandates that certain drinking water utilities (community water 
systems and nontransient, noncommunity water systems) should deliver 
drinking water with PFOA and PFOS concentrations below the MCLs. The 
costs of monitoring, treatment, administration, disposal of drinking 
water treatment media residuals, and other costs have been considered 
in the associated Economic Analysis as part of that rulemaking effort. 
Please see 2024 NPDWR. https://www.epa.gov/sdwa/and-polyfluoroalkyl-substances-pfas, or visit www.regulations.gov, Docket No. EPA-HQ-OW-
2022-0114. For potential cleanups of private drinking water wells, EPA 
acknowledges it has expanded its economic assessment to estimate a 
subset of potential health benefits where data was available to allow 
quantification. This subset includes those populations who rely on 
private drinking water wells within one mile of sites that may have 
response and cleanup as a result of the final rule. Refer to RIA 
Chapter V.
2. Consideration of Costs for Small Entities
    Comment: One commenter expressed concern that the designation may 
create significant costs for small entities associated with monitoring 
and analyzing samples for PFOA and PFOS to ensure compliance with 
CERCLA. The commenter recommended EPA evaluate and consider the real 
costs associated with the designation through an evaluation of the 
number and types of facilities that may release reportable quantities 
of PFOA or PFOS, to determine what monitoring and analysis costs these 
facilities may incur to ensure compliance with CERCLA. Then, the 
commenter suggested that if EPA determines that costs should not be 
considered as part of the designation, costs should be considered as a 
factor of complying with CERCLA.
    Response: EPA disagrees with the commenter that designation of PFOA 
and PFOS as CERCLA hazardous substances will lead to significant cost 
impacts for small businesses. First, this rule does not require 
monitoring and analysis specifically. Second, in its RIA, EPA 
demonstrated that the rule would not result in a significant impact to 
a substantial number of small entities; in fact, consistent with long-
standing EPA policy regarding the implementation of the Regulatory 
Flexibility Act, the RIA considered small entity impacts related to the 
direct cost impacts of the rule and found that they are limited to the 
costs associated with the reporting of PFOA/PFOS releases at or above 
the RQ.
3. Direct Costs for Rule Familiarization
    Comment: One commenter stated that EPA failed to consider the cost 
of ``regulatory familiarization'' in its economic analysis of the 
rulemaking. The commenter described ``regulatory familiarization 
costs'' as accounting for the value of time and effort that every 
potentially affected individual or business must undertake to determine 
if a regulation applies to their situation or not, and how their 
activities must adapt to comply.
    Response: Rule familiarization constitutes a negligible cost of the 
rule. Facilities are expected to be familiar with the baseline 
requirements associated with reporting releases of non-PFOA/PFOS CERCLA 
hazardous substances to the NRC and to the State, Tribal and local 
emergency planning and response agencies. While the final rule is 
adding PFOA and PFOS to CERCLA's list of hazardous substances, this 
designation does not change or add requirements to CERCLA section 103, 
CERCLA section 111, and EPCRA section 304 release notification 
requirements.
4. Costs, Benefits, and the Economic Assessment
    Comment: One commenter states that the rulemaking will result in a 
net social cost as markets over-adjust to concerns regarding CERCLA's 
joint and several liability scheme. The commenter also contends that 
any transfer of costs from the public to polluters could occur even in 
the absence of the designation, thereby concluding that the rulemaking 
is unnecessary. Finally, the commenter states that any consistency 
between the designation and ongoing actions to address PFOA and PFOS 
contamination is irrelevant to a determination as to whether the 
designation meets a compelling public need.
    Response: EPA disagrees with the commenter that the designation 
will cause the market to over-adjust in response to CERCLA's liability 
provisions. Market efficiency generally increases as more information 
becomes available. EPA is unaware of data suggesting that an over-
adjustment is likely, and the commenter provided no such data. Further, 
once CERCLA's notification requirements and broadened enforcement 
authorities are applicable to PFOA and PFOS releases, the likelihood 
that costs will be shifted from the Federal government to polluters 
will increase. Specifically, reporting will facilitate increased 
transparency regarding releases of PFOA and PFOS, which will, in turn, 
both inform the Agency's understanding of the presence of these 
substances in the environment and allow EPA to respond to contamination 
in a timely manner.
    EPA disagrees with the commenter that the consistency between the 
designation and other ongoing actions to address PFOA and PFOS 
contamination is irrelevant to a determination that the rule meets a 
compelling public need. Designation is still warranted independent of 
other Agency actions and is consistent with EPA's Agency-wide approach 
outlined in the Roadmap. As noted by the commenter, OMB Circular A-4 
states that an agency ``should try to explain whether the action is 
intended . . . to meet some other compelling public need such as 
improving governmental processes or promoting intangible values such as 
distributional fairness or privacy.'' Greater consistency between 
actions will ``improve governmental processes'' by allowing for greater 
efficiency and effectiveness in addressing PFOA and PFOS contamination 
across the United States. Additionally, when EPA is able to transfer 
certain response costs to PRPs, this represents an improvement in 
societal equity.
    Comment: One commenter argues that EPA has not explained how 
designation encourages better waste management practices or how PFOA or 
PFOS-contaminated materials should be disposed of. This commenter also 
argues that EPA has failed to support its assertion that the 
designation will

[[Page 39181]]

produce public health benefits. Here, the commenter points out that EPA 
identifies the regulatory requirement to report a release of one pound 
of PFOA or PFOS as a particular benefit of the proposed rulemaking but 
contends that the quantity of material that would need to be released 
for reporting requirements to attach would be significant. Finally, the 
commenter states that the designation may have the unintended 
consequence of increasing treatment costs in both drinking water and 
wastewater.
    Response: EPA agrees with the commenters that reports of releases 
at or above the RQ represent a meaningful benefit of the rule, as 
reporting will allow EPA to evaluate and respond to such releases in a 
timely manner. EPA disagrees with the commenter that the rule will not 
lead to improvements in the management of PFOA and PFOS contaminated 
materials. A potential direct benefit that may result from the 
reporting requirement is better waste management and/or treatment by 
facilities handling PFOA or PFOS, resulting from improved efforts to 
further reduce potential releases. Greater transparency provided by 
release reporting can lead to fewer releases to the environment and 
thus to potential health benefits associated with avoided exposure. For 
additional information regarding the potential benefits of the 
designation, including other benefits of release reporting, see Section 
VI of this preamble.
    In this final action, EPA has expanded its economic assessment of 
indirect benefits to include illustrative quantified and unquantified 
health benefits. EPA quantified a small subset of potential health 
benefits. This includes an illustrative assessment of reduced incidence 
of cardiovascular disease, birthweight impacts, and renal cell 
carcinoma under a range of scenarios. This considers potential benefits 
to those populations which rely on private drinking wells, where there 
may be response and cleanup as a result of the final rule. 
Additionally, EPA assessed additional unquantified health benefits. See 
RIA Chapter 5.
    EPA does not agree with the commenter that the proposed rule will 
hinder water treatment or efforts to remove background levels of PFOA 
or PFOS in wastewater and drinking water. When, how, and why the water 
sector would remove these substances from drinking water and whether 
they dispose of it in a hazardous waste landfill is complex and will 
depend on the volume and concentration of PFAS captured, availability 
of disposal sites, decisions made at individual public water systems, 
and State and Federal regulatory actions and enforcement actions.
    EPA also disagrees with the claim that designation will increase 
the costs associated with managing drinking water treatment residuals. 
As discussed in section VII.I.1, efforts to address PFAS in drinking 
water and wastewater treatment have already been initiated prior to 
this designation, and the associated costs of those efforts are 
attributable to those separate efforts. The NPDWR Economic Assessment 
Appendix H includes a sensitivity analysis that accounts for potential 
cost increases associated with treatment of residuals as hazardous 
waste. The designation of PFOA/PFOS as CERCLA hazardous substances does 
not require disposal or treatment of water treatment residuals as 
hazardous waste.
    Comment: One commenter challenged whether the designation would 
have the benefits that EPA claims. The commenter asserts that existing 
tools at EPA's disposal, as well as those in development, can provide 
the Agency with the authority it needs to address PFOA and PFOS 
releases and obviate the need for designation. The commenter also 
states that EPA's failure to quantify the likely costs and purported 
benefits of this rule are especially egregious in light of the Agency's 
alleged failed to consider alternative actions to achieve its goals. 
The commenter also encouraged EPA to conduct a full RIA. Finally, the 
commenter claimed that there are negligible positive effects associated 
with the designation, and challenged EPA's assertion that substantial 
benefits will flow from the designation as flawed.
    Response: EPA disagrees with the commenter that the rule is 
unlikely to lead to the benefits the Agency has identified. EPA has 
identified a significant body of scientific evidence demonstrating 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. 
Therefore, to the extent that this designation results in reduced or 
eliminated exposure to PFOA/PFOS, as EPA expects it will, there may be 
potentially significant human health benefits associated with 
designation. EPA further explains its reasoning regarding these 
benefits in Section VI.A of this preamble and in the RIA. For example, 
the notification requirement under the designation will facilitate 
earlier notification of EPA and State authorities regarding releases of 
PFOS and PFOA. Relatedly, designation will enable EPA to exercise its 
statutory authorities to address PFOA and PFOS contamination in a 
timely manner.
    With respect to the commenter's claims that the Agency has failed 
to substantiate its quantification of potential costs, transfers, and 
benefits, the RIA accompanying the final rule has quantitatively 
assessed such impacts to the extent possible. Additional benefits and 
costs remain unquantified due to a lack of available data and highly 
uncertain circumstances, as further discussed in the rule and RIA. 
Additionally, EPA has included an analysis of potential alternative 
policy options associated with the reporting requirement; details of 
this analysis are found in the Appendix of the RIA.
a. Indirect Costs
    Comment: One commenter points out that EPA's economic assessment 
estimates only the costs associated with reporting activity. The 
commenter also stated that all costs related to potential increases in 
response activities and increases in the speed of response activities 
are only qualitatively described, and that EPA refers to these costs as 
indirect costs. However, when EPA discusses the benefits of the 
proposed rule, all the reported benefits related to health protection 
stem from these ``indirect'' effects. The commenter also said that 
costs associated with conducting response activities, including the 
significant costs associated with complex litigation that frequently 
occurs under CERCLA, is a direct impact of designating substances as 
CERCLA hazardous substances and must be considered in a regulatory 
impact analysis. EPA has a wealth of information to inform the 
frequency at which sites are placed on the NPL; data also exist to 
inform the costs of final cleanup decisions, as memorialized in public 
Superfund decision documents. The commenter asserts that while these 
analyses may not be perfect, they would be far superior to simply 
ignoring costs which are an inevitable and direct result of the 
proposed rule.
    A commenter asserts that EPA has not fully considered the potential 
cost impacts of the Proposed Designation and it is evidenced by the 
lack of information provided by EPA as to the magnitude and scope of 
those impacts. The commenter states that the limited economic analyses 
that EPA performed to support the proposal is flawed and its analysis 
about airports is particularly deficient. The commenter states that the 
airport analysis simply does not make sense, and seems to have been 
completed in a vacuum, with little or no outreach to airport operators 
or others with airport expertise. Another

[[Page 39182]]

commenter pointed out that the cost for the airport industry to 
transition to a new foam is not insignificant and many airports will 
struggle to transition absent any Federal grant funding.
    Response: EPA disagrees with the commenter's assertion that 
potential response costs are direct; such actions are discretionary, 
contingent, and made on a site-by-site basis. EPA also disagrees that 
the Agency ignored the potential indirect costs of the proposed 
designation of PFOA and PFOS as CERCLA hazardous substances; the 
economic assessment developed for the proposed rule included a detailed 
qualitative assessment of these potential indirect costs. The RIA 
accompanying the Final Rule provides quantified estimates of potential 
indirect costs and cost transfers associated with response, as well as 
certain related indirect benefits. These estimates are in part based on 
the data suggested by the commenter, e.g., NPL listing process, RODs, 
etc.
    EPA does not agree with the commenter that a more detailed 
evaluation of direct costs is necessary. EPA provides, in the RIA, an 
estimated low and high range of potential reporting requirement 
frequencies and associated costs. Consistent with the guidance of 
Office of Management and Budget's (OMB's) Circular A-4, this RIA 
includes an assessment of potential indirect costs, benefits, and 
transfers to provide the public with insights related to these impacts. 
To better inform the public of potential indirect costs and benefits, 
EPA has expanded its analyses of indirect costs, cost transfers, and 
benefits in the final rule RIA relative to the analysis developed for 
the proposed rule. For many of the potential impacts that could result 
from the designation, EPA has developed estimates under a range of 
scenarios designed to reflect uncertainty in response activity.
    EPA also considered quantitative and qualitative benefits and costs 
as part of its totality of the circumstances analysis. Please see 
Section VI of this preamble.
    EPA appreciates the information provided by commenters on potential 
PFAS cleanup costs at airports regarding the costs to replace AFFF 
delivery systems. However, EPA disagrees that the designation would 
lead to a significant increase in costs of transitioning to use of 
PFAS-free foam for airports. Independent of EPA's CERCLA hazardous 
substance rulemaking, Congress has taken certain actions to address 
PFAS contamination, including directing the transition away from PFAS-
containing AFFF, protecting fire fighters, preventing runoff from 
airports, and requiring DOD to prepare a remediation schedule and 
develop information about associated costs. The aviation industry is 
already in the process of transitioning away from AFFF to other types 
of firefighting foam that do not contain PFAS. The costs associated 
with this transition are unrelated to the proposed designation of PFOA 
and PFOS as CERCLA hazardous substances. Once this transition is 
complete and AFFF is no longer used at airports, EPA expects no or 
minimal releases from airports. In the interim, any direct costs 
incurred by airports as a result of a designation would be limited to 
the costs of reporting in the event that a PFOA/PFOS release of one 
pound or more occurs in a 24-hour period.
    Comment: Many commenters disagree with EPA's proposition that the 
uncertainties are too great to conduct a robust analysis and stated 
that EPA should conduct a more detailed analysis of the potential 
direct and indirect effects of the proposed designation. Some 
commenters asserted that the costs of the designation would 
dramatically outweigh any benefits. A commenter stated that their 
analysis, PFOS and PFOA Private Cleanup Costs at Non-Federal Superfund 
Sites (referred to as the Cleanup Cost Analysis), estimates that the 
costs of cleanup for potentially responsible parties (PRP) could total 
over $17.4 billion dollars for existing non-Federal national priority 
sites alone, and annualized private party cleanup costs at existing 
non-federal sites could cost $700-$900 million annually. The commenter 
asserts that despite any existing uncertainties, these costs are simply 
too large for EPA to ignore. The commenters also pointed to DoD's 
ongoing remediation work which can provides example cost data that EPA 
could use to build estimates. EPA has acknowledged cleanup cost 
uncertainties in the past and has still estimated these costs.
    A commenter suggested that EPA should follow OMB guidance and 
conduct a formal quantitative analysis of relevant uncertainties (e.g., 
the number of sites to be remediated, the cost of available cleanup 
technologies, the cleanup level goals for each possible media). 
Regardless of whether this proposal exceeds the billion-dollar 
threshold for formal probabilistic uncertainty analysis, Circular A-4 
does not prevent an agency from conducting such an analysis if it would 
inform agency decision making.
    Response: EPA has conducted a more thorough and robust RIA that 
characterizes uncertainties to better describe potential direct and 
indirect costs, benefits and transfers associated with the designation.
    EPA provides, in the RIA, an estimated low and high range of 
potential reporting requirement frequencies and associated costs. 
Consistent with the guidance of Office of Management and Budget's 
(OMB's) Circular A-4, this RIA includes an assessment of potential 
indirect costs, benefits, and transfers to provide the public with 
insights related to these impacts.
    To better inform the public of potential impacts, EPA has expanded 
its analyses of indirect costs, benefits, and transfers in the final 
rule RIA relative to the analysis developed for the proposed rule. For 
costs, transfers, and benefits, EPA has developed estimates under a 
range of scenarios designed to reflect uncertainty in indirect costs, 
transfers, and benefits. EPA disagrees that the commenter's cost 
analysis provides a reasonable representation of the costs associated 
with the proposed designation of PFOA and PFOS as hazardous substances. 
The analysis is based on several unfounded or inaccurate assumptions 
that lead to the overestimation of costs. For example, it assumes that 
the proposed designation would require all existing non-Federal NPL 
sites to search for PFOS/PFOA contamination. The designation, however, 
does not by itself require any systematic re-evaluation of NPL sites. 
Throughout the Superfund process, from the remedial investigation 
through site cleanup to five-year reviews, EPA evaluates potential 
risks posed by actual and threatened releases of hazardous substances, 
pollutants or contaminants. Since PFOA and PFOS are already considered 
as pollutants or contaminants, this rulemaking, by itself, should not 
result in any change to the investigation, cleanup and review processes 
for sites that are currently on the NPL. Any policy decisions to 
address PFOA/PFOS subsequent to the hazardous substance designation 
would likely apply to a subset of NPL sites where potential PFOA/PFOS 
contamination is not already being addressed rather than systematically 
to all existing non-federal NPL sites. Chapter 5 of the RIA also 
presents cost estimates for response at non-NPL sites. As noted in the 
Final Rule, EPA expects that response costs to address PFOS/PFOA will 
fall within typical response cost ranges for actions to address other 
hazardous substances and recognizes that response costs will be 
significant in some cases.
    Additionally, EPA disagrees with the commenter's suggestion for EPA 
to use cost data for Department of Defense

[[Page 39183]]

(DoD) PFAS response efforts as the basis for estimating costs likely to 
result from the proposed designation. Data for DoD sites (i.e., 
military installations, facilities of the National Guard, and Formerly 
Used Defense Sites (FUDS) in the United States) would not be 
representative of costs associated with non-Federal CERCLA sites as the 
types, quantity, and handling of PFAS are expected to vary greatly. 
DoD's cost estimates represent one reference point for potential PFAS 
response costs with a focus specifically on applications related to 
national defense. EPA also expects the size and scope of, and therefore 
costs associated with, Federal PFOA and PFOS cleanup sites to be 
substantially larger than non-federal sites in part because Federal 
sites are generally larger in size than non-federal sites. The costs 
associated with addressing PFAS released by Federal agencies are not 
representative of non-federal facilities as the types, quantity, and 
handling of PFAS vary greatly. Among other factors, this may also 
reflect that AFFF use is disproportionately higher at military sites 
relative to other sites; AFFF is a major source of PFAS contamination.

J. Enforcement

    Comment: Numerous commenters expressed support for the rulemaking, 
noting that designation facilitates CERCLA's ``polluter-pays'' 
principle by placing the burden of investigating, responding to, and 
addressing PFOA/PFOS contamination to the parties responsible for the 
release. These commenters also stated that designation could 
potentially accelerate the Superfund cleanup process. One commenter 
requested that EPA ensure that the costs of cleanup are borne by 
manufacturers and users of PFOA and PFOS, not the public.
    Response: The Agency agrees that designation clearly supports the 
timely cleanup of contaminated sites and facilitates CERCLA's polluter-
pays principle. EPA also notes that, as discussed in Section III.C of 
this preamble, it expects to focus on implementing the objectives of 
the PFAS Strategic Roadmap by holding responsible those who 
significantly contribute to the releases of these substances into the 
environment.
    Comment: Numerous commenters expressed concerns that the 
designation will shift the costs of CERCLA cleanups of PFOA and PFOS 
from chemical and product manufacturers to various third parties, 
including water utilities, waste management utilities, airports, fire 
departments, State governments, farmers, and landowners. Another 
commenter claimed that utilities could be implicated as PRPs at both 
NPL and non-NPL sites--despite being potentially de minimis 
contributors to contamination--and, because of CERCLA's joint and 
several liability scheme, such parties could theoretically be held 
responsible for the entire cost of cleanup.
    Many commenters argued that EPA's use of enforcement discretion 
will neither adequately address the liability concerns of certain 
public sector entities nor ensure that cleanups and settlements assign 
primary responsibility to parties that significantly contributed to 
contamination or otherwise profited from the conditions resulting in 
contamination.
    Some commenters also requested that the Agency clarify how 
enforcement discretion would function in the context of PFOA- or PFOS-
related contamination, particularly for water utilities. Finally, 
several commenters asked EPA to clarify that a CERCLA designation will 
not impact the land application of municipal biosolids in any way 
before finalizing this rulemaking.
    Response: While EPA acknowledges that the designation has the 
potential to impact municipalities, EPA does not have information 
suggesting that designation will result in unusual liability outcomes. 
EPA recognizes that some parties who do not bear primary responsibility 
for contamination may be sued and face uncertain litigation costs. EPA 
believes that CERCLA's liability limitations, coupled with EPA 
enforcement discretion policies, should operate to minimize hardship 
for parties that did not significantly contribute to contamination. EPA 
expects that designation should not change CERCLA's liability framework 
and that CERCLA will continue to operate as it has for decades (with 
respect to the more than 800 existing hazardous substances) to resolve 
who should pay for the cleanup and how much.
    EPA also disagrees with the commenters' position that designation 
will necessarily result in a shift of cleanup costs from PFOA or PFOS 
manufacturers, to utilities and other sectors. As the Agency describes 
in sections II.E.7 and VI.B., CERCLA liability does not inevitably flow 
from any particular release. The question of whether an entity may be 
subject to litigation or could be held liable under CERCLA involves 
both site and fact-specific analyses. Additionally, while one commenter 
raised the issue of incurring potential CERCLA liability despite de 
minimis contribution to contamination at Superfund sites, EPA notes 
that--as described in Section VI.B.2--the statute already includes 
several provisions that may limit liability or the financial impact of 
liability, including for de minimis parties.
    EPA gave careful consideration to CERCLA's liability scheme, and 
the impact designation may have on CERCLA liability. EPA concluded that 
designation will not change CERCLA's liability framework. Designation 
does not automatically confer liability, nor does it alter CERCLA's 
statutory or regulatory framework for liability. EPA determined that 
existing limitations in CERCLA coupled with existing CERCLA enforcement 
policies are sufficient to mitigate concerns about liability that may 
arise after designation. No additional action is necessary to ensure 
that those limitations and policies continue to operate as they have 
for decades. Nonetheless, EPA intends to develop a policy, consistent 
with those limitations and policies, that explains EPA's priorities for 
CERCLA enforcement in the context of PFOA and PFOS releases. Please see 
Section VI.C. for a more detailed discussion. See also FY 2024-2027 
National Enforcement and Compliance Initiatives.
    Regarding the question about application of biosolids, please refer 
to section VII.A.3.

VIII. Summary of This Final Rule

    The designation of PFOA and PFOS as hazardous substances would have 
three direct effects: (1) Reporting and notification obligations when 
there is a release of PFOA or PFOS, their salts or structural isomers 
above the reportable quantity, (2) obligations on the U.S. Government 
when it transfers or sells certain properties, and (3) an obligation on 
DOT to list and regulate CERCLA designated hazardous substances as HMTA 
hazardous materials.

A. Default Reportable Quantity

    EPA is setting the RQ by operation of law at the statutory default 
of one pound pursuant to section 102(b) of CERCLA for PFOA and PFOS and 
their salts and structural isomers. EPA did not propose, nor is it 
including in this final action, a RQ adjustment for these substances. 
If the Agency chooses to propose adjusting the RQ in the future, it 
would do so through notice-and-comment rulemaking.

[[Page 39184]]

B. Direct Effects of Designating PFOA, PFOS, and Their Salts and 
Structural Isomers as Hazardous Substances

1. Release Reporting Requirements
    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. As of the 
effective date of this action, 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, their salts or 
structural isomers in any 24-hour period is required to immediately 
notify the NRC in accordance with 40 CFR 302.6. CERCLA section 111(g) 
requires owners or operators of any vessel or facility to ``provide 
reasonable notice to potential injured parties by publication in local 
newspapers serving the affected area'' of a release of a hazardous 
substance.
    In addition to these CERCLA reporting requirements, EPCRA section 
304 requires owners or operators of facilities to immediately notify 
their SERC (or TERC) and LEPC (or TEPC) when there is a release at or 
above the reportable quantity of PFOA or PFOS, their salts or 
structural isomers in a 24-hour period. EPCRA section 304 also 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. 
https://www.govinfo.gov/content/pkg/USCODE-2021-title42/pdf/USCODE-2021-title42-chap103-subchapI-sec9620.pdf.
3. Requirement of DOT To List and Regulate CERCLA Hazardous Substances
    Section 306(a) of CERCLA requires substances designated as 
hazardous under CERCLA to be listed and regulated as hazardous 
materials by DOT under the Hazardous Materials Transportation Act.

IX. 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 14094: Modernizing Regulatory Review

    This action is a ``significant regulatory action'', as defined 
under section 3(f)(1) of Executive Order 12866, as amended by Executive 
Order 14094. Accordingly, EPA, submitted this action to the Office of 
Management and Budget (OMB) for Executive Order 12866 review. 
Documentation of any changes made in response to the Executive Order 
12866 review is available in the docket. EPA prepared an analysis of 
the potential costs and benefits associated with this action. This 
analysis, ``Regulatory Impact Analysis of the Final Rulemaking to 
Designate Perfluorooctanoic Acid and Perfluorooctanesulfonic Acid as 
CERCLA Hazardous Substances'', is also available in the docket and 
briefly summarized in Section I, Executive Summary of this action.

B. Paperwork Reduction Act

    The information collection activities in this final rule have been 
submitted for approval to the OMB under the Paperwork Reduction Act. 
The Information Collection Request (ICR) document that EPA prepared has 
been assigned EPA ICR number 2708.02, OMB Control No. 2050-0227. You 
can find a copy of the ICR in the docket for this rule, and it is 
briefly summarized here. The information collection requirements are 
not enforceable until OMB approves them.
    The designation of PFOA and PFOS, and their salts and structural 
isomers, as hazardous substances 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 and 
section 111 of CERCLA and section 304 of EPCRA.
    Estimated number of respondents: 0 to 614 releases per year.
    Frequency of response: Varies.
    Total estimated burden: 6,889 hours (per year) maximum. Burden is 
defined at 5 CFR 1320.3(b).
    Total estimated cost: Approximately $1,630,000 (per year) maximum, 
includes approximately $585,000 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 EPA's 
regulations are listed in 40 CFR part 9. When OMB approves this ICR, 
the Agency will announce that approval in the Federal Register and 
publish a technical amendment to 40 CFR part 9 to display the OMB 
control number for the approved information collection activities 
contained in this 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, including 
importers and importers of articles that contain these

[[Page 39185]]

substances, are: (1) PFOA and/or PFOS manufacturers; (2) PFOA and/or 
PFOS processors; (3) manufacturers of products containing PFOA and/or 
PFOS; (4) downstream users of PFOA and PFOS; (5) downstream users of 
PFOA and/or PFOS products; (6) waste management facilities; and (7) 
wastewater treatment facilities. (Note: PFOA and PFOS noted here 
include their salts and structural isomers). The Agency has estimated 
that there may be up to 614 reported releases of PFOA or PFOS in any 
one year and that a small percentage of the annual reports will be 
submitted by small entities. As further context, even if the maximum 
number of reports (614) were created to account for every estimated 
release in a given year and all 614 of these reported releases were 
from the smallest of the small entities (as described in the RIA, 
defined using SBA size standards), only 2.5 percent of the 24,836 
smallest of the small businesses identified by EPA would be affected. 
The estimated cost of $2,658 to report a release of PFOA or PFOS is not 
greater than one percent of the annual revenues for the typical small 
entity in any impacted industry. For example, estimated annual 
breakeven costs per facility are lowest for Reupholstery and Furniture 
Repair (NAICS 811420) at $3,591 at the one percent threshold. Given the 
estimated notification costs per release of $2,658, EPA does not expect 
a small business facility's cost to cross even the one percent 
threshold. Additionally, EPA considered how direct reporting costs may 
impact small governmental jurisdictions. The $2,658 reporting cost per 
release associated with the final rule represents 0.001 percent of 
average local government revenues serving a population of 50,000 or 
less, which is well below one percent. Further, for a local government 
serving just 100 residents, the $2,658 in costs for reporting 
represents 0.5 percent of these revenues, also well below a one percent 
threshold.
    Details of this analysis are presented in Section 6.2 of the 
Regulatory Impact Analysis of the Final Rulemaking to Designate 
Perfluorooctanoic Acid and Perfluorooctanesulfonic Acid as CERCLA 
Hazardous Substances, available in the docket.

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. The action imposes 
no enforceable duty on any State, local or Tribal governments that may 
result in expenditures, in the aggregate, or to the private sector, of 
$100 million or more in any one 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.

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

    This action does not have Tribal implications as specified in 
Executive Order 13175. 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. 
Thus, Executive Order 13175 does not apply to this action.
    Designating PFOA and PFOS, and their salts and isomers as CERCLA 
hazardous substances triggers release reporting requirements under 
EPCRA section 304 in addition to the release notification requirement 
under CERCLA section 103. Under EPCRA section 304, facilities are 
required to immediately report any releases of these substances at or 
above the default RQ of one pound to the State, Tribal, and local 
implementing agencies. The associated reporting burden of this effort 
on Tribes is expected to be minimal and if release were to occur, and 
Tribal agencies would be able to take action, if necessary, to protect 
their community from exposure to these substances. If Tribal agencies 
do not have the resources to respond to an emergency situation, they 
may request assistance from the State or local emergency response 
agencies. Executive Order 13175 does not apply to this action.
    Consistent with EPA's Policy on Consultation with Tribal Nations, 
EPA offered government-to-government consultation to all federally 
recognized Tribes during the development of this action. No Tribe 
requested consultation. EPA hosted a national Tribal informational 
webinar on September 7, 2022, to explain the action and answer 
questions (https://clu-in.org/conf/tio/TribesPFOAPFOS_090722/.)

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

    Executive Order 13045 directs Federal agencies to include an 
evaluation of the health and safety effects of the planned regulation 
on children in Federal health and safety standards and explain why the 
regulation is preferable to potentially effective and reasonably 
feasible alternatives. This action is subject to Executive Order 13045 
because it is a significant regulatory action under section 3(f)(1) of 
Executive Order 12866, and EPA believes that the environmental health 
or safety risk addressed by this action may have a disproportionate 
effect on children. Evidence indicates that exposure to PFOA and/or 
PFOS are associated with adverse health effects relevant to children, 
including developmental effects to fetuses during pregnancy or to 
breast-fed infants, cardiovascular effects and immune effects in 
children. Other evidence suggests that these substances are associated 
with endocrine and reproductive effects that impact development. Both 
PFOA and PFOS are known to be transmitted to the fetus via the placenta 
and to the newborn, infant, and child via breast milk. Further 
information on all health effects of PFOA and PFOS is in section V. A. 
PFOA and PFOS Pose a Hazard. Accordingly, we have evaluated the 
environmental health or safety effects of PFAS exposures on children. 
The protection offered by using the suite of tools CERCLA provides to 
address prevalent PFAS contamination may be especially important for 
children because childhood represents a life stage associated with 
increased susceptibility to PFAS-related health effects, such as 
developmental effects.
    Furthermore, EPA's Policy on Children's Health also applies to this 
action. Information on how the Policy was applied is available under 
``Children's Environmental Health'' in section V. A. PFOA and PFOS Pose 
a Hazard of this preamble.

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 designates PFOA and PFOS as 
CERCLA hazardous substances and does not involve the supply, 
distribution or use of energy.

I. National Technology Transfer and Advancement Act

    This action does not involve technical standards.

[[Page 39186]]

J. Executive Order 12898: Federal Actions To Address Environmental 
Justice in Minority Populations and Low-Income Populations and 
Executive Order 14096: Revitalizing Our Nation's Commitment to 
Environmental Justice for All

    Executive Order 14096 (88 FR 25,251, Apr. 26, 2023) directs Federal 
agencies to advance the goal of environmental justice (EJ) for all. 
This action builds upon and supplements the efforts of Executive Order 
12898 (59 FR 7629, February 16, 1994) to address EJ concerns.
    EPA believes that the human health or environmental conditions that 
exist prior to this action result in or have the potential to result in 
disproportionate and adverse human health or environmental effects on 
communities with EJ concerns. The demographic analysis of plastics 
manufacturers, facilities reporting to the TRI, and U.S. airports found 
that people of color and low-income populations are disproportionately 
represented (except near small/medium airports). In particular, these 
sites have a higher percentage of people of color surrounding them 
relative to the national average. This finding holds whether focusing 
on assessing all populations within one or three miles of these sites 
or only populations served by private wells.
    EPA believes that this action is likely to reduce existing 
disproportionate and adverse human health or environmental effects on 
communities with EJ concerns. To the extent that the final rule leads 
to additional response actions to mitigate or eliminate exposure to 
PFOA/PFOS, or to actions that mitigate exposure earlier, health risks 
for populations communities living near sites where releases occur may 
decline. Based on the above analysis, the proportion of the population 
near these sites identified as racial or ethnic minorities with various 
potential communities with EJ concerns or (in some cases) people living 
in structures with a higher probability of containing lead paint (built 
before 1960) exceeds the national average. Thus, EPA expects that the 
final rule will at least partially mitigate the existing burden of 
PFOS/PFOA exposure that falls disproportionately on communities with EJ 
concerns.
    Potential exposure across several key demographic categories were 
analyzed relative to facilities with known historical use, releases, 
and/or known contamination of PFOA and PFOS (U.S. EPA, 2024e). Due to 
uncertainty regarding the location of future PFOA/PFOS releases, this 
analysis uses these facilities as a proxy for identifying where 
response actions for PFOA and PFOS may occur and provides demographic 
information about the surrounding populations. This analysis examines 
the following site types as proxies for facilities that may potentially 
be affected:

 Sites owned/operated by plastics material and resin 
manufacturing firms identified as having produced PFOS and/or PFOA \76\
---------------------------------------------------------------------------

    \76\ Data acquired from: Environmental Protection Agency, 
``Enforcement and Compliance History Online (ECHO)'', August 2023. 
Because not all plastic material and resin manufacturers use PFAS, 
only a fraction of the facilities reported in ECHO as plastics 
material and resin manufacturers were used in this analysis. To 
filter facilities involved in the use or manufacture of PFAS, this 
analysis uses proxy sites identified using sites owned/operated by 
companies that participated in EPA's PFOA Stewardship Program, under 
the assumption that the likelihood of PFOA/PFOS contamination is 
potentially high at these sites.
---------------------------------------------------------------------------

 Sites owned/operated by companies reporting PFOS and PFOA 
releases (including PFOA and PFOS salts) to EPA's Toxic Release 
Inventory (TRI) (U.S. EPA, 2023e) \77\
---------------------------------------------------------------------------

    \77\ TRI reporting is not currently required for isomers of PFOA 
and PFOS.
---------------------------------------------------------------------------

 Operating U.S. airports and airfields \78\
---------------------------------------------------------------------------

    \78\ Because the National Plan of Integrated Airport Systems 
(NPIAS) public facing dataset presented by the Federal Aviation 
Administration (FAA) does not contain geographic information, this 
analysis relies on data from the United Nations Office for the 
Coordination of Humanitarian Affairs. To assess the coverage of the 
UN database, this analysis cross-referenced the list of airports 
represented in both datasets; this exercise found that the UN data 
contained 98% of all airports listed in the NPIAS. Of the 2% of 
sites listed in the NPIAS but not in the UN database, about half 
were located in rural Alaska. Full citations of these datasets are 
presented below:
    (1) United Nations Office for the Coordination of Humanitarian 
Affairs, ``The Humanitarian Data Exchange: Airports in the United 
States of America'', June 2021. Downloaded on June 18, 2021. 
Accessed at: https://data.humdata.org/dataset/ourairports-usa. The 
dataset categorized airports by the following size categories: 
small, medium, and large.
    (2) Federal Aviation Administration. ``National Plan of 
Integrated Airport Systems (NPIAS)--Current--Airports'', October 07, 
2020. Downloaded February 2022. Accessed at: https://www.faa.gov/airports/planning_capacity/npias/current/.
---------------------------------------------------------------------------

    [ssquf] Large U.S. airports and airfields
    [ssquf] All other U.S. airports and airfields (i.e., medium and 
small)

    Areas around plastics material and resin manufacturer sites and/or 
sites reporting releases to TRI, on average, are in areas with higher 
concentrations of people of color, Black/African American residents, 
and households with a ratio of income to poverty level of two and below 
compared with national average. These areas also have much higher rates 
of structures built before 1960 which can have lead paint and lead to 
higher exposures of lead. These findings suggest that releases related 
to manufacturing facilities could have EJ implications, such as 
disproportionate adverse impacts on local communities. Additionally, on 
average, airports across the U.S. are surrounded by populations that 
generally reflect national averages in relevant demographic categories. 
Large airports, however, are more likely to be surrounded by higher 
rates of people of color relative to the U.S. population. A complete 
discussion of the analysis behind these findings is available in 
Section 6.3 of the RIA 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 policy priorities outlined in 
Executive Orders 14096 (The White House, 2023) and 14008 (The White 
House, 2021), EPA expects this regulation will have a beneficial impact 
on disadvantaged communities as well as populations or communities with 
EJ concerns. While the locations that may be affected by this final 
rule are uncertain, to the extent that these proxy locations are 
representative of likely locations, this screening analysis suggests 
that the designation may improve conditions for 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 
will determine the magnitude of effects on the surrounding human and 
natural environment. These details will likely become more apparent 
over time as EPA implements response actions and release reports are 
made, allowing for a more robust analysis of disproportionate and 
adverse outcomes experienced by populations communities with EJ 
concerns. This improved information would not increase risk for 
communities with EJ concerns and may improve the speed and design of 
response actions.
    Further, the information supporting this Executive Order review is 
contained in the following sections in the preamble to this action: 
II.C., VI.A. and B. These sections explain that the

[[Page 39187]]

designation of PFOA and PFOS as hazardous substances 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.

K. Congressional Review Act (CRA)

    This action is subject to the CRA, and EPA will submit the rule 
report to each House of the Congress and to the Comptroller General of 
the United States. This action meets the criteria set forth in 5 U.S.C. 
804(2).

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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 amends 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, 42 U.S.C. 
9602, 42 U.S.C. 9603


0
2. Amend Sec.  302.4:
0
a. By revising ``Note II to Table 302.4''.
0
b. In ``Table 302.4'' by adding, in alphabetical order, entries for 
``Perfluorooctanesulfonic acid, salts, & structural isomers\v\'', 
``Perfluorooctanesulfonic acid\v\'', Perfluorooctanoic acid, salts, & 
structural isomers\v\'', and ``Perfluorooctanoic acid\v\'';
0
c. In Appendix A to Sec.  302.4 by adding in numerical order entries 
for ``335-67-1'' and ``1763-23-1''.
    The revision and additions read as follows:


Sec.  302.4  Hazardous substances and reportable quantities.

* * * * *

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 [40 CFR 116.4; 33 U.S.C. 
1321(b)(2)(A)]. Statutory Code ``2'' indicates a CWA Toxic Pollutant 
[40 CFR 401.15, 40 CFR part 423 Appendix A, and/or 40 CFR 131.36; 33 
U.S.C. 1317(a)]. Statutory Code ``3'' indicates a CAA HAP [42 U.S.C. 
7412(b); Pub. L. 101-549 November 15, 1990; 70 FR 75047 December 19, 
2005; 69 FR 69320 November 29, 2004; 61 FR 30816 June 18, 1996; 65 
FR 47342 August 2, 2000; 87 FR 393 January 5, 2022]. Statutory Code 
``4'' indicates Resource Conservation and Recovery Act (RCRA) 
Hazardous Wastes [40 CFR part 261 Subpart D--Lists of Hazardous 
Wastes; 42 U.S.C. 6921]. (Note: The ``RCRA waste No.'' column 
provides the waste identification numbers assigned by RCRA 
regulations). Statutory Code ``5'' indicates a hazardous substance 
designated under section 102(a) of CERCLA. The ``Final RQ [pounds 
(kg)]'' column provides the reportable quantity for each hazardous 
substance in pounds and kilograms.

* * * * *

[[Page 39192]]



                       Table 302.4--List of Hazardous Substances and Reportable Quantities
----------------------------------------------------------------------------------------------------------------
                                                                                                     Final RQ
               Hazardous substance                     CASRN      Statutory code  RCRA waste No.   [pounds (kg)]
----------------------------------------------------------------------------------------------------------------
                                                  * * * * * * *
Perfluorooctanesulfonic acid, salts, &                      N.A.               5  ..............       1 (0.454)
 structural isomers \v\.........................
Perfluorooctanesulfonic acid \v\................       1763-23-1               5  ..............               1
                                                                                                         (0.454)
Perfluorooctanoic acid, salts, & structural                 N.A.               5  ..............               1
 isomers \v\....................................                                                         (0.454)
Perfluorooctanoic acid \v\......................        335-67-1               5  ..............               1
                                                                                                         (0.454)
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
\v\ The Agency may adjust the statutory RQ for this hazardous substance in a future rulemaking; until then the
  statutory one-pound RQ applies.

* * * * *

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

------------------------------------------------------------------------
                 CASRN                         Hazardous substance
------------------------------------------------------------------------
                              * * * * * * *
335-67-1...............................  Perfluorooctanoic acid
                              * * * * * * *
1763-23-1..............................  Perfluorooctanesulfonic acid
------------------------------------------------------------------------

* * * * *

[FR Doc. 2024-08547 Filed 5-7-24; 8:45 am]
BILLING CODE 6560-50-P

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