PFAS and the EPA Strategic Roadmap: Progress and Challenges

Widespread contamination of PFAS (per- and polyfluoroalkyl substances) threatens public health and the environment. The scale of PFAS contamination is significant, its impact may rival other historic environmental contamination liabilities such as asbestos and PCBs (polychlorinated biphenyls).

In October 2021, EPA issued a PFAS Strategic Roadmap, leveraging multiple legal authorities to collect data on the chemicals, impose restrictions on their future use, and to remediate existing contamination. EPA has proposed or finalized rules and released enforcement guidance, accounting for concerns about high compliance costs.

Because the science of PFAS is rapidly evolving and improving, the regulatory status of PFAS is currently in a dynamic state; comprehensive PFAS regulation will likely follow an iterative process over the coming years. It is unknown how EPA will proceed with the roadmap under the Trump administration.

1. Introduction – Describes PFAS, the scale of the problem caused by the chemicals, and provides an overview of the Biden administration’s regulatory approach. Also explores the legal questions EPA and other regulators are facing as scientists continue to improve their understanding of the public health and environmental risks of PFAS.
2. CERCLA – Discusses the implications of EPA’s final rule designating two PFAS subtypes as hazardous substances under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA).
3. SDWA – Summarizes EPA’s final rule under the Safe Drinking Water Act (SDWA) setting standards for certain PFAS and examine the legal and financial implications for drinking water providers.
4. Other legal authorities – Looks at other legal authorities EPA has used or is using to develop PFAS rulemakings and guidance.
5. Enforcement – Discusses EPA’s enforcement priorities, including the agency’s intention to focus on “significant” polluters.

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Introduction

There are complex legal and policy challenges for regulators to reduce the effects of per- and polyfluoroalkyl substances (PFAS) on public health and the environment. The impact of PFAS contamination has the potential to rival or even surpass other historic environmental health liabilities such as asbestos and PCBs (polychlorinated biphenyls).[1] In this explainer, I describe PFAS, the scale of the problem caused by the chemicals, and provide an overview of the Biden administration’s regulatory approach. I also explore the legal questions EPA and other regulators are facing as scientists continue to improve their understanding of the public health and environmental risks of PFAS.[2] With the second Trump administration, it will be important to see what regulatory actions it may take as well as the responses by industry, states, and the environmental legal community.

In 2021, EPA’s PFAS Strategic Roadmap outlined the agency’s approach to mitigate the harms from PFAS exposure through a coordinated approach leveraging multiple legal authorities to collect data on the chemicals, impose restrictions on their future use, and to remediate existing PFAS contamination.[3] Consistent with that roadmap, EPA proposed or finalized PFAS rules consistent with its authority under various environmental statutes, including:

• Comprehensive Environmental Response Compensation and Liability Act (CERCLA, informally Superfund)
• Safe Drinking Water Act (SDWA) and Clean Water Act (CWA)
• Toxic Substances Control Act (TSCA)
• Resource Conservation and Recovery Act (RCRA)

During the Biden administration, EPA also released enforcement guidance in response to regulated entities’ concerns about high compliance costs potentially resulting from each regulation. EPA’s guidance indicates that it intends to limit its enforcement to significant contributors of PFAS contamination.

Forever Chemicals

PFAS are a family of per- and polyfluoroalkyl substances, commonly known as “forever chemicals” because they do not readily degrade in nature.[4] They are ubiquitous—found in our soil, water, and air—due to their persistence and widespread commercial use. PFAS have many commercial applications ranging from non-stick cookware to firefighting products and have been manufactured for decades.[5] The hundreds of PFAS substances each have a distinct chemical configuration and name, but their common characteristic of strong carbon-fluorine bonds causes them to be resistant to degradation.[6] As a result, PFAS are constantly spreading in the environment. Scientists have found them in water, air, soil, fish, wildlife, and humans across the nation.[7] Studies have shown the chemicals spreading to remote Arctic and Antarctic sites after decades-long journeys through the biosphere.[8]

The first PFAS resulted from the invention of Teflon in 1938, which was used in coatings to resist heat, oil, staining, greases, and water.[9] Today, PFAS are currently used in many types of products, including[10]:

• Fabrics (nylon, yoga pants, waterproofing);
• Paints, furniture, adhesives, insulations, carpeting;
• Food packaging, plastics, mobile phones screens;
• Firefighting equipment and foams;
• Cooking materials;
• Cosmetics and personal care (floss, shampoo, feminine products, lipstick, eye liner, mascara, foundation, concealer, blush, lip balm, and nail polish);
• Common prescription drugs such as statins and antidepressants.[11]

Since 2015, as the result of voluntary action, domestic manufacturing of certain PFAS substances has ended.[12] However, PFAS are still imported in bulk into the country in large numbers of products and created as by-products of certain industrial processes. In 2023, the global market for PFAS was estimated at over $28 billion dollars.[13]

The Centers for Disease Control and Prevention (CDC) estimates that PFAS can remain in the human body for years, and researchers have found that exposure to these chemicals can harm human health.[14] Studies have found that high levels of PFAS contamination are associated with testicular and kidney cancers, children’s development delays, decreases in fertility, liver damage, thyroid disease, ulcerative colitis, obesity, and increases in cholesterol levels and high blood pressure.[15] No “safe” levels of human PFAS exposure have been identified so far, making PFAS regulation more difficult. For example, EPA’s drinking water standards are set at the lowest PFAS detection limits.

Toxicologists and other researchers continue to study the variety of ways PFAS can enter the human body. The uptake of PFAS chemicals by humans through food is a primary PFAS exposure route due to the chemicals’ bioaccumulation up the food chain.[16] Historically, studies have focused on workplace exposures at PFAS manufacturing locations and the ingestion of the chemicals through contaminated food and water near the sites.[17] More recent studies have also found that PFAS can impact humans through dermal contact from clothing, equipment, and personal care products, airborne contamination, indoor dust, carpeting, upholstery, and food packaging.[18]

The potential scale of PFAS’s impact on public health and the environment is significant. EPA has identified PFAS contamination at various levels in public drinking water systems serving millions of Americans.[19] EPA also estimates there are over 26,000 sites contaminated with PFAS in the United States, including 126 military bases through their use of firefighting foams.[20]

Effectively addressing PFAS through remediation, monitoring, filtering drinking water, and replacing the chemicals in materials and consumer products will be a lengthy and expensive undertaking. As with any environmental regulation, the cost of compliance is a concern for industry, but for PFAS the compliance costs will also have implications for local governments.[21]

Many local drinking water authorities are concerned about the expense of meeting EPA’s federal PFAS drinking water standards.[22] Additionally, importers of products or materials are concerned about how to ensure PFAS do not enter their supply chains and how to comply with EPA’s new tracking and reporting requirements.[23] Entities that used or manufactured PFAS are concerned about the potential broad reach of CERCLA’s liability provisions, especially because of the widespread nature of PFAS contamination.[24]

EPA’s PFAS Strategic Roadmap

In April 2021, EPA embarked on a broad, agency-wide effort to reduce PFAS-related environmental and human health risks, establishing the Council on PFAS, comprised of the leadership of multiple departments within EPA. Recognizing the scope of the challenge of effectively addressing the public health and environmental harms caused by PFAS, the council created the EPA PFAS Strategic Roadmap, a non-binding agency guidance document.[25] The PFAS Strategic Roadmap outlines EPA’s whole-of-agency approach to address PFAS by leveraging multiple agency legal authorities.

EPA’s PFAS Strategic Roadmap focuses on achieving three objectives using five principals:

Objectives:

• Research to improve PFAS detection and better understand the chemical’s impact on human health and the environment;
• Restrict to prevent further PFAS releases into the air, land, and water; and
• Remediate to clean up existing PFAS contamination.[26]

Principals:

• Accounting for the lifecycle of PFAS;
• Encouraging replacement of PFAS where possible;
• Holding PFAS polluters accountable;
• Using science-based decision-making; and
• Prioritizing protection of disadvantaged communities.[27]

In November 2024, EPA released its third annual PFAS Strategic Roadmap report, highlighting the progress EPA has made regarding PFAS in the last three years and reiterating the commitment to its original PFAS objectives and principals.[28] In the report, EPA concludes the progress made under the PFAS Strategic Roadmap “has delivered on essential policies, investments, and research to protect all people and the environment from the harms associated with PFAS” and that its “progress provides a critical foundation of principles, knowledge, tools, and resources upon which the Agency will continue to build for years to come.”[29]

Legal Challenges and Uncertainties

The regulatory status of PFAS is currently in a dynamic state. The science of PFAS including the public health and environmental harms at different concentration levels, detection technologies, and remediation strategies, continue to evolve and improve. As a result, comprehensive PFAS regulation will likely need to follow an iterative process over the coming years.

In addition to evolving PFAS science, there are also additional legal and political realities that will shape PFAS regulations. Opponents of EPA’s CERCLA PFAS listing rule and the SDWA rule have filed challenges in the DC Circuit.[30] Additional legal challenges will occur as enforcement and implementation of the regulation occurs.[31] Citizen’s suits authorized under federal statutes may also shape the PFAS law, even if EPA were to slow enforcement of existing PFAS regulations.[32]

Thus, it will likely take years to have clarity regarding specific portions of federal PFAS rules. Court decisions will likely require lengthy appeal processes, potentially resulting in conflicting appeals court opinions that might require resolution at the Supreme Court. The near-term future of PFAS regulation may also be significantly shaped by the Trump administration’s approach to EPA, environmental regulation, and enforcement.[33]

In addition to federal EPA activities, state governments are rapidly proposing new PFAS regulations, and the European Union is also considering additional PFAS rules.[34] Private tort lawsuits and suits brought by state attorneys general under common law nuisance theories also continue to play out in courts, potentially proceeding at a faster pace than regulatory processes.[35]

Predicting how any one of these legal activities might impact PFAS regulation is difficult; trying to anticipate the cumulative impact of them on future regulations is even harder. The legal and regulatory uncertainty in combination with the rapid developments in PFAS science creates challenges for businesses and communities to assess their risks and potential liabilities.[36]

Current PFAS Regulatory Challenges

Two fundamental regulatory challenges for PFAS are worth noting. First, there is no universal regulatory definition of a PFAS chemical.[37] Second, assuming a consensus is reached to define which chemicals are considered PFAS, scientists and regulators will need to determine which specific PFAS sub-types are the highest risk or whether regulating the entire family of PFAS chemicals is appropriate given the cumulative risks.[38]

Presently, the lack of consensus defining PFAS and on which sub-types cause the highest health risks, combined with different structures of federal and state regulatory regimes, has led to regulation of different PFAS sub-types among states, and by EPA under different federal regulations.[39] For example, in EPA’s CERCLA and SDWA rules, EPA focused on a few individual PFAS chemical subtypes, such as perfluorooctanesulfonic acid (PFOS) and perfluorooctanoic acid (PFOA).[40] In contrast, EPA’s TSCA PFAS rule, which requires businesses to report their manufacture or importation of PFAS, identifies PFAS broadly as a family of chemicals.[41]

Despite the PFAS Strategic Roadmap’s intent to coordinate EPA’s PFAS-related actions, as scientists’ understanding of PFAS continues to improve EPA’s treatment of PFAS under different statutory authorities continues to evolve. For example, EPA’s CERCLA regulation focuses on two PFAS chemicals but its proposed RCRA hazardous waste precursor rule lists nine chemicals, the SDWA rule regulates up to six chemicals, and the TSCA rule applies to the entire family PFAS chemicals.[42]

States are also taking different approaches to defining and regulating PFAS, sometimes even differing within the same state.[43] California’s rules governing PFAS in cookware and textiles broadly define PFAS as “any PFAS (including fluoropolymers) containing one fully fluorinated carbon atom.”[44] In contrast, California’s consumer notification law, Proposition 65, regulates PFAS variants individually, currently listing only three specific chemical sub-types.[45]

Detection and Treatment of PFAS

Researchers’ ability to detect PFAS in various environmental media continues to improve, driven by increasing demand for extremely sensitive detection technologies.[46] Current regulations that aim to restrict the use, manufacture, or cleanup of PFAS are limited by the sensitivity of detection technologies, even if health research indicates no safe exposure level of PFAS.[47] Because of the wide variety of PFAS chemical sub-types, detecting them in economical and accurate ways is challenging. Currently, only about 50 of potentially many thousands of PFAS chemical sub-types can be reliably detected and quantified.[48]

There are two types of PFAS testing methodologies: “selective” and “inclusive.” Selective testing looks only for a specific PFAS chemical sub-type and cannot identify or quantify other co-located PFAS chemicals. There are effective tests for measuring 29 PFAS sub-types in drinking water.[49] In contrast, inclusive test methods estimate total PFAS concentrations in a given sample. These methods use total organic fluorine as a proxy for estimating total PFAS.[50] However, the inclusive test method can be biased because inorganic fluorine, which is not harmful and is found in many products, such as toothpaste, can inaccurately suggest PFAS are present.[51] Much technical work remains to be done regarding the accurate measuring of PFAS in the environment.[52]

Once detected, removing PFAS is also challenging because the persistent nature of the chemicals makes their destruction difficult. Few treatment methodologies are effective at degrading the strong carbon-fluorine bonds and the chemicals persist when moved from one environmental media to another. Currently, the incineration of PFAS remains the most widespread approach. However, this method is expensive, leaves behind contaminated residues, and the final incineration does not fully destroy the PFAS, potentially resulting in air dispersion.[53]

New remediation approaches are being explored, including thermal treatment and composting, as well as the potential for biological microbial breakdown, though no microbe has yet been identified to effectively removes PFAS at scale.[54] Most recently, researchers developed a potentially promising technology using common reagents boiled in water to break down the PFAS into harmless byproducts. However, the scalability of the approach remains unclear.[55]

As EPA moves forward, the PFAS Strategic Roadmap and guidance documents provide some general clarity regarding the direction of the regulatory landscape at the federal level. However, regulatory and legal liability uncertainty remains, as scientists, state lawmakers, regulatory agencies, and the courts are only beginning to clarify the rules and science regarding PFAS contamination. It is also unclear how the Trump administration will approach PFAS contamination and regulations.

We will continue to monitor the state of PFAS regulation and report on significant developments. Much policy, legal, and scientific work remains to be done to effectively address these “forever chemicals.” [56]

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Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA)

On April 19, 2024, EPA finalized a rule designating two PFAS, perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS) and their salts and structural isomers, as hazardous substances under CERCLA section 102(a).[57] CERCLA[58] is a remedial and liability statute, providing EPA broad authority to order, conduct, and recover costs for the cleanup of hazardous substances.[59]

Section 102(a) requires EPA evaluate available scientific and technical information to determine if a chemical warrants listing as a hazardous substance. Based on that assessment EPA’s final rule concluded that PFOA and PFOS “may present a substantial danger to the public health or welfare or the environment.”[60] EPA also conducted an additional “totality of the circumstances analysis,” weighing the potential benefits and costs of the designation to conclude that the benefits outweigh its costs.[61]

Implications of Designating the Two PFAS as Hazardous Substances

EPA’s CERCLA final rule notes that the agency’s authority to respond to hazardous substances is comprehensive, providing authority to address contamination in air, surface water, groundwater, sediment, and soil.[62] This authority extends chronologically from EPA’s initial response to a release of a hazardous substance through the final cleanup.[63] Explaining the benefits of using CERCLA’s broad authority to address PFAS contamination, EPA states “no other environmental statute provides the breadth of authority to fully address PFAS contaminated sites.”[64]

As a result of the PFAS designation, “CERCLA’s two main objectives, (1) the cleanup of seriously contaminated sites, and (2) ensuring that those responsible for the contamination, known as potentially responsible parties (PRPs), pay for the cleanup,”[65] now apply to PFOA and PFOS contamination.[66] Without the designation, EPA’s ability to address PFAS under CERCLA was limited. For example, the agency’s authority under CERCLA to respond to releases of other “pollutants and contaminants,” (materials not designated as hazardous substances) requires EPA to first make a finding of “imminent and substantial endangerment,” requiring a high level of immediate risk and limits EPA to conducting agency-led and -funded cleanups, as opposed to requiring PRPs to undertake or pay for the response.[67]

However, with the designation of the two PFAS as hazardous substances, EPA’s authority is much broader, granting the agency use of its full range of CERCLA enforcement authorities to either compel PRPs to address PFAS contamination, or to repay EPA for agency led cleanup actions.[68]

In response to EPA’s proposed rule, many commentors expressed concern about the potential economic implications CERCLA’s broad liability scheme could have given the widespread extent of PFAS contamination.[69] EPA notes in the final rule that “CERCLA’s liability framework operates in a rational way regarding liability for over 800 CERCLA hazardous substances already within its purview, some of which are similar to PFOA and PFOS in terms of ubiquity, mobility, and persistence.”[70] To address commenters’ concerns over CERCLA’s broad liability scheme, simultaneous to the final rule EPA issued a guidance memorandum clarifying that the agency will only focus its enforcement authority on “significant” contributors of PFAS.[71]

Further Legal Implications of EPA’s PFAS CERCLA Rule

In addition to unlocking CERCLA’s authority to address PFAS contamination, the designation of the two PFAS chemicals as hazardous substances triggers several reporting requirements for industry, property owners, and federal agencies.

First, under CERCLA section 103 and 111(g) and the related regulations, any release of PFOA and PFOS at or above the specified quantity must now be reported to the National Response Center within 24 hours of a release.[72] For PFOA and PFOS, the final rule sets the reportable quantity (RQ) at one pound, which is the lowest reportable weight under CERCLA for hazardous substances.[73]

Second, section 304 of the Emergency Planning and Community Right-to-Know Act (EPCRA) requires facilities to immediately notify the local emergency planning committee for any area likely to be affected by a release of the two PFAS chemicals above the RQ and to notify the State Emergency Response Commission.[74]

Third, designating the two PFAS as hazardous substances also triggers the application of CERCLA section 120(h), which requires federal agencies that transfer real estate to provide notice of PFOS or PFOA presence to potential buyers. Additionally, agencies transferring such properties must ensure that all cleanup actions necessary to protect human health and the environment are completed prior to any transfer. Any additional clean up required following the sale also remains the responsibility of the federal government.[75]

In addition to the reporting requirements, CERCLA section 306 requires the Department of Transportation (DOT) to regulate any designated hazardous substance as a DOT hazardous material for commercial transportation purposes under the Hazardous Materials Transportation Act (HMTA). Under the HMTA, DOT regulates the shipping of hazardous materials, requiring various packaging, labeling, placarding, and accident response actions by shippers.[76] DOT must conduct a rulemaking to add the two PFAS to its list of regulated hazardous materials.[77] Once that rule is finalized, shippers of the two PFAS substance must meet labeling requirements for any package containing greater than the PFAS RQ and may need to meet new “incident” notifications and reporting requirements for PFAS.[78]

CERCLA’s Response Framework

EPA’s CERCLA program to remediate contamination is independently funded through the Superfund tax on chemical manufacturers.[79] This unique funding authority provides EPA the ability to conduct cleanups itself, in addition to requiring PRPs to perform cleanups. Under CERCLA, EPA can either remove or remediate areas where there has been a release of a hazardous substance.[80] With the final rule’s addition of the two PFAS chemicals as hazardous substances, both CERCLA response authorities are now available to EPA to address PFAS contamination.[81]

• 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.” Generally, removal actions address the immediate risks from a release of a hazardous substance, such as containing a spill and excavating the contaminated soil, responding to chemical fire or explosion, or evacuating threatened residents.[82]
• Remedial Actions (RAs) are “longer-term and more complex cleanup actions designed to provide permanent solutions to mitigate risks associated with chronic exposures.”[83] RAs follow a formal regulatory process set out in the National Contingency Plan, the regulations governing EPA CERCLA response actions. The process may include listing a contaminated site on the National Priorities List, conducting remedial investigations feasibility studies, risk assessments, and long-term operation and maintenance of the remedy.[84]

CERCLA’s Liability for PFAS

The liability for PFAS under CERCLA is far reaching. The statute provides that any PRP that releases a designated hazardous substance into the environment may have liability, even if they were in compliance with applicable laws at the time of the release and did not intend any harm.[85]

CERCLA also provides the ability for parties that incur CERCLA-related PFAS removal or RA costs to recover their costs from other PRPs. These actions, known as contribution lawsuits, historically have brought many parties into lengthy litigation over who should pay for what share of a cleanup. Additionally, EPA has the authority under CERCLA to issue an administrative order requiring PRPs to clean up contamination,[86] or EPA can undertake the response action itself using designated funds from the Superfund tax and later seek reimbursement from PRPs.[87] If ultimately found liable, a PRP is financially obligated to reimburse the government’s response for costs incurred.[88]

EPA recognized in the final rule that this broad liability and enforcement structure raised concerns for those who may be found responsible for PFAS contamination given the chemicals’ widespread presence in the environment. Many commentors noted that parties, including municipalities and small businesses, are likely considered PRPs even if their contribution to a contaminated site was minimal. For example, a business could have unknowingly contributed a small amount of PFAS to a contaminated area many years ago, but if their PFAS is comingled and indistinguishable from other PFAS at the site, that business might face significant liability for the cleanup.[89] Some CERCLA sites involve hundreds, and even thousands of PRPs, making cleanup negotiations and settlements complex and costly for all parties.[90]

EPA sought to address these concerns by issuing enforcement guidance at the same time it finalized the PFAS rule.[91] The guidance makes clear that the agency intends to focus its PFAS CERCLA enforcement authority on only “significant” contributors of PFAS to the environment.[92] Additionally, EPA explicitly states that it does not intend to pursue community-based drinking water systems and publicly owned water treatment works (POTWs), municipal separate storm water systems (MS4s), publicly owned or operated municipal solid waste landfills (MSWs), publicly owned airports and fire departments, or farms that applied PFAS contaminated sludges as fertilizers.[93]

Next Steps

As EPA implements the rule, EELP will be monitoring how EPA applies its authority under CERCLA to address PFAS contamination and any efforts by the agency or Congress to limit its application for certain PFAS chemical sub-types, or to limit liability for certain classes of PRP.

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Safe Drinking Water Act (SDWA)

On April 26, 2024, EPA finalized its PFAS National Primary Drinking Water Regulation  (NPDWR) setting drinking water standards for PFAS.[94] This rule is a significant step toward protecting public health as envisioned by EPA’s PFAS Strategic Roadmap,[95] establishing several deadlines for public drinking water systems to test for PFAS by 2027 and meet specific standards by 2029. EPA estimates that the rule “will reduce PFAS exposure for approximately 100 million people, potentially preventing thousands of deaths, and reducing tens of thousands of serious illnesses.”[96]

The Legal Implications of the SDWA Rule

Under EPA’s Safe Drinking Water Act (SDWA) authority, this rule establishes legally enforceable levels, called Maximum Contaminant Levels (MCLs), for five individual PFAS in drinking water systems. In addition, for PFOA and PFOS, specific sub-types of PFAS chemicals, EPA also sets Maximum Contaminant Level Goals (MCLGs), non-enforceable, health-based, public drinking water goals, at zero.[97] The final rule explains that the zero level MCLGs are based on recent science indicating any level of exposure to these contaminants is a health risk and that the MCL and MCLG levels are “data-driven drinking water standards” that “meet the requirements of SDWA.”[98]

Once EPA sets an MCLG at zero under the SDWA, it also must set MCLs at the practical quantification limit (PQLs) of the substance, assuming there are treatment options available at a reasonable cost.[99] With PFOA and PFOS, the PQL is the limiting factor for treatment, recognizing that it is not possible to set a treatment standard below the level of detection for the chemical. Conversely, for contaminants where the MCLG is higher than the PQL, EPA generally sets the MCL at the same level as the MCLG.[100]

The SDWA requires EPA to set drinking water standards based on the “best available” science and information. This structure reflects Congress’ recognition that EPA may need to act even with incomplete data and should update drinking water standards as science advances.[101] For the PFAS covered in this final rule, EPA concluded the science has progressed sufficiently to “satisfy the statutory requirements and fulfill SDWA’s purpose to protect public health by addressing contaminants in the nation’s public water systems.”[102]

Summary of NPDWR MCLs and MCLGs (see also Table 1 below):

• MCLs set at 4.0 parts per trillion (ppt) for PFAS sub-types PFOA and PFOS with MCLGs of zero for both. For these specific PFAS chemicals, the MCL is set at the PQL.[103]
• MCLs and MCLGs set at 10 parts per trillion for three other specific types of PFAS.[104]

• Hazard Index-based MCLs and MCLGs set for mixtures of two or more of certain PFAS.[105] The Hazard Index MCLs are enforceable health-based water concentration levels that account for mixtures of the chemicals. EPA determined that PFAS mix in the environment and that research shows these mixtures may have “dose-additive” combined health impacts greater than they would have individually.[106] Unlike the MCLs and MCLGs set for the individual PFAS chemicals, the Hazard Index-based standard[107] for PFAS mixtures involves an additional formula that requires that mixtures of the regulated PFAS must not surpass a Health-Based Water Concentration level equal to a Hazard Index of 1.[108]

Table 1: Final MCLs and MCLGs[109]

Chemical	Maximum Contaminant Level Goal (MCLG)	Maximum Contaminant Level (MCL)
PFOA	0	4.0 ppt
PFOS	0	4.0 ppt
PFHxS	10 ppt	10 ppt
HFPO-DA (GenX Chemicals)	10 ppt	10 ppt
PFNA	10 ppt	10 ppt
Mixture of two or more: PFHxS, PFNA, HFPO-DA, and PFBS	Hazard Index of 1 (unitless)	Hazard Index of 1 (unitless)

 

In addition to setting strict contamination limits, the rule also requires extensive testing and monitoring, and if necessary, remediation of drinking water systems.

• Public water systems have until April 26, 2027, to complete initial monitoring for PFAS. Following that initial assessment, water systems must conduct ongoing compliance monitoring and publicly release sampling results for PFAS.[110]
• By April 26, 2029, public water systems must be in compliance with the PFAS MCL standards.[111]
• After April 2029, public water systems that have PFAS in drinking water over the MCL will be in violation and must implement action to reduce levels of these PFAS as soon as possible and notify the public of the violation. Public water systems face potential penalties for every day they are in violation.[112]

Health and Financial Impacts of the Rule

EPA made significant changes to the final rule after review of over 120,000 comments, including tightening the final PFAS MCL and MCLG levels.[113] While many commenters raised concerns regarding compliance costs, EPA’s Economic Analysis (EA) supporting the rule concluded that the rule will result in significant health benefits from the reduction in PFAS in public drinking water.[114] EPA quantified the benefits based on estimated avoided cases of illness and deaths associated with exposure to the regulated PFAS, including negative impacts on birth weights, renal cell carcinomas, and bladder cancers. EPA also explained that limiting PFAS exposure in drinking water reduces negative “fetal developmental effects, cardiovascular effects, hepatic effects, immune effects, endocrine effects, metabolic effects, renal effects, reproductive effects, musculoskeletal effects, hematological effects, other non-cancer effects.”[115]

EPA estimated initial capital costs associated with complying with the rule to be $14.4 billion in undiscounted dollars.[116] EPA’s cost estimate reflected the compliance costs for public water servers, including the cost of installing and operating PFAS removal treatment technologies and other actions public water suppliers might be required to take, such as constructing new wells in uncontaminated aquifers or purchasing clean water from a neighboring provider.[117] Based on existing data and modeling, EPA estimated that between 4,100 to 6,700 public drinking water systems could currently be exceeding the set standards.[118]

Based on these estimated benefits and costs, EPA concluded the health benefits of the rule exceed its compliance costs.[119] Additionally, EPA noted federal funding of over $15 billion was available to support a substantial portion of the initial capital costs of the final rule.[120] EPA also created a Water Technical Assistance program to help small, rural, and disadvantaged communities’ access federal resources to respond to PFAS.[121]

EPA’s Legal Basis for the Rule

Section 1412(b)(1)(A) of the SDWA authorizes EPA to establish NPDWRs for contaminants in drinking water where the EPA administrator determines “that (i) the contaminant may have an adverse effect on the health of persons; (ii) the contaminant is known to occur or there is a substantial likelihood the contaminant will occur in public drinking water systems with a frequency and at levels of public health concern; and (iii) in the sole judgment of the Administrator, regulation of such contaminant presents a meaningful opportunity for health risk reductions for persons served by public water systems.”[122]

In order to determine which contaminants should be a priority for regulation, section 1412(b)(1)(B)(i) of the SDWA requires EPA to publish a Contaminant Candidate List (CCL) every five years.[123] Accordingly, EPA included PFOA and PFOS on the CCL lists published in 2009 and 2016.[124] EPA also included PFAS as a chemical group in its most recent CCL list in 2022.[125] Every five years, SDWA section 1412(b)(1)(B)(ii) also requires EPA to issue a determination on whether to regulate at least five contaminants on each CCL.[126] With this final rule, EPA determined that PFOA and PFOS met the SDWA’s statutory requirements for regulation, finding they may have an adverse effect on the health of persons; are known to occur in public water systems; and that their regulation presents a meaningful opportunity for health risk reduction for persons served by PWSs.[127]

For the other PFAS subtypes regulated under the final rule, EPA relied on section 1412(b)(1)(E) of the SDWA, which authorizes EPA to propose a NPDWR concurrent with the preliminary determination to regulate a contaminant.[128] As a result, in addition to regulating PFOA and PFOS, the final rule includes both a final determination to regulate four additional PFAS contaminants (individually and/or as part of a PFAS mixture) and the final standards for those contaminants.[129]

EPA’s final rule also relies on data collected pursuant to SDWA section 1445(a)(2), which requires EPA to implement a public water system monitoring program for unregulated contaminants (known as an UCMR). Between 2013 and 2015, water systems collected monitoring data for six PFAS (PFOA, PFOS, PFHxS, PFNA, PFBS, and perfluoroheptanoic acid (PFHpA)) as part of the third UCMR (UCMR 3) monitoring program. EPA’s determination in this final rule to establish NPDWRs for PFAS is supported by the extensive amount of data collected in UCMR 3.

Legal Challenge to the Rule

In June 2024, trade associations representing public water providers challenged the final rule in the DC Circuit, alleging, among other claims, that EPA did not use the best available science, took unlawful novel approaches in the rule, and underestimated the potential costs of the rule.[130] Multiple environmental groups have intervened in support of EPA’s final rule, with final briefs due later this year.[131]

Next Steps

As EPA implements the rule, EELP will be monitoring its impact, particularly focused on the ongoing litigation and the Trump administration’s approach for additional PFAS chemicals.

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RCRA, TSCA, CWA, and other EPA Legal Authorities

Under EPA’s PFAS Strategic Roadmap,[132] various departments are leveraging different legal authorities to develop PFAS rulemakings and guidance. In addition to the two PFAS rules finalized in 2024 under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) and the Safe Drinking Water Act (SDWA), the agency has finalized or proposed several other PFAS-related rules and has issued multiple technical guidance documents.[133]

Resource Conservation and Recovery Act (RCRA)

On Feb 8, 2024, EPA proposed to clarify its regulatory authority to implement RCRA’s requirement for corrective action to address the release of any substance defined as a hazardous waste from solid waste management units at permitted hazardous waste treatment, storage and disposal facilities (TSDFs).[134] While the proposal does not specifically address PFAS, it facilitates the use of RCRA corrective action authority to address PFAS at TSDFs. The RCRA Corrective Action Program requires TSDF operators to investigate and clean up contaminated soil, groundwater, and surface water. EPA states “the proposed rule will strengthen protections for communities and drinking water supplies located near the 1,740 permitted hazardous waste facilities across the nation.”[135]

On the same date, EPA proposed amending its regulations under the RCRA by adding nine specific PFAS substances, their salts, and their structural isomers, to its list of hazardous constituents.[136] These PFAS would be added to the list of substances identified for consideration in facility assessments and, where necessary, further investigation and cleanup through the corrective action process at hazardous waste TSDFs.[137]

Toxics Substances Control Act (TSCA)

On January 11, 2024, EPA finalized a Significant New Use Rule (SNUR) prohibiting the manufacturing or processing of 329 “inactive” PFAS chemicals without EPA approval.[138] Pursuant to the rule, inactive PFAS are substances that have not been manufactured or imported since 2006.[139] Under this rule, any entity that intends to manufacture or import any of the inactive PFAS chemicals must submit a Significant New Use Notice (SNUN) to EPA for approval before they can proceed.[140]

Prior to issuing the PFAS SNUR, in October 2023, EPA finalized a rule that creates a public dataset of PFAS that have been manufactured and imported into the United States since 2011.[141] The rule initially required all manufacturers and importers of PFAS and PFAS-containing articles to report information to EPA beginning November 2024, on their PFAS use including data on production, waste, exposure, and hazards.[142] This TSCA rule uses a broader structural definition to identify PFAS collectively, instead of specifically identifying individual chemical sub-types, which EPA, in the preamble, acknowledges still might not capture all potential PFAS chemicals.[143]

On September 5, 2024, EPA finalized a direct rule[144] delaying the reporting deadline for data on PFAS importation and manufacture by eight months.[145] The new rule pushed the start of the six-month data submission window from November 12, 2024, to July 11, 2025. EPA explained that it needed additional time to create an internal reporting system to manage the large volume of required PFAS data.

Toxics Release Inventory (TRI)[146]

In January 2024, EPA finalized a rule adding seven PFAS chemical sub-types to the list of chemicals covered by the Toxics Release Inventory (TRI), consistent with the Fiscal Year 2020 National Defense Authorization Act (NDAA). As a result, companies must report releases of these seven PFAS into the environment starting in 2024. Previously, for reporting year 2023, EPA had added nine other PFAS chemical sub-types to the TRI list.[147]

Relatedly, on January 17, 2025, EPA proposed to amend the TRI regulations to clarify when suppliers must notify customers that supplied materials include PFAS. EPA proposed this rule to better align the supplier notification provisions with the effective date for addition of chemicals to the TRI list, including the PFAS automatically added pursuant to NDAA section 7321.[148]

In October 2023, EPA finalized a related rule to eliminate an exemption that allowed facilities to avoid reporting information on PFAS when those chemicals were used in small concentrations.[149]

Clean Water Act (CWA)

On January 14, 2025, EPA’s Office of Water released a draft risk assessment evaluating the risks of PFAS chemicals in sewage sludge biosolids. The assessment concluded there may be human health risks associated with all three current disposal methods of sewage sludge biosolids: land application as fertilizer, landfilling, and incineration. The study focused on nearby human populations and did not evaluate the safety of the general food supply.

On October 1, 2024, EPA finalized Aquatic Life Quality Criteria and Benchmarks for ten PFAS chemicals.[150] The criteria and benchmarks were finalized under CWA section 304(a)(3) to assist states and Tribes as they adopt their own water quality standards.[151] After taking public comment and considering the latest available studies and science, the final per- and polyfluoroalkyl substances (PFAS) criteria are more stringent than what EPA proposed in 2022.[152] EPA notes that “PFAS are not naturally occurring and have no biologically important functions or beneficial properties to aquatic life.”[153]

EPA’s recommended water quality criteria and benchmarks are not enforceable until states use them to develop their own water quality standards based on the designated use they assign to each of their water bodies.[154] States establish their own water quality standards by adopting EPA’s recommended criteria, modifying EPA’s recommended criteria to reflect site-specific conditions, or by developing their own proposed standards based on scientifically defensible methods.[155] State water quality standards are not legally enforceable under the CWA until they are approved by EPA.[156] Final state standards, in turn, inform discharge limits set in CWA National Pollutant Discharge Elimination System (NPDES) permits.[157]

In January 2023, EPA finalized Effluent Limitations Guidelines (ELGs) Plan 15,[158] which concluded that revised ELGs and pretreatment standards are necessary to reduce PFAS found in leachate discharges from landfills. EPA is currently determining the new ELG levels and plans to include them in a new proposed rule. ELG Plan 15 also calls for the expansion of an ongoing EPA study of PFAS discharges from textile manufacturers and requires the implementation of a new EPA study of influents to publicly owned treatment works (POTWs).[159]

Water Testing Methodologies (Sampling and Monitoring Guidance)

In December 2024, EPA’s Office of Water published two proposed methods to better measure PFAS in the environment:

• Final EPA Method 1633, to test for 40 PFAS sub-types in wastewater, surface water, groundwater, soil, biosolids, sediment, landfill leachate, and fish tissue.[160]
• Final EPA Method 1621, which broadly screens for the presence of chemical substances that contain carbon-fluorine bonds, including PFAS, in wastewater.[161]

Clean Air Act (CAA)

On August 29, 2024, New Mexico, New Jersey, and North Carolina, submitted a petition to EPA pursuant to section 112(b)(3) of the CAA, requesting that EPA add four PFAS chemical sub-types[162] to the agency’s list of hazardous air pollutants (HAPs).[163] The states urge EPA to initiate the action because the agency already possesses “the authority and the necessary substantive information to grant the petition.”[164]

The states’ petition recognize EPA’s broad efforts to address PFAS, they note that “EPA has not established an air pollution control program for PFAS, and PFAS emissions in ambient air remain largely unmeasured and unregulated.”[165] The petition states that CAA section 112 allows EPA to address that regulatory gap, and that EPA’s addition of PFAS to the list of HAPs will “expand the partnership between EPA and the states through the cooperative federalism embodied in the CAA.”[166] The petition also stresses that EPA’s other efforts to address PFAS contamination on land and in waters may “result in the air dispersion of these chemicals into communities or other geographic areas of our environment. By shifting PFAS pollution from one medium, such as water, to another medium, such as air, the responsible party for cleanup may become less clear, consequently resulting in [greater] federal or state liability.”[167]

Pursuant to section 112 of the CAA, a petition must show “that there is adequate data on the health or environmental effects of the pollutant or other evidence adequate to support the petition,” and that, “the Administrator shall add a substance to the list upon a showing by the petitioner or on the Administrator’s own determination that the substance is an air pollutant and that emissions, ambient concentrations, bioaccumulation or deposition of the substance are known to cause or may reasonably be anticipated to cause adverse effects to human health or adverse environmental effects.”[168]

The states assert that PFAS, in particular PFOA, PFOS, PFNA, and GenX are air pollutants that are “known to cause or may reasonably be anticipated to cause adverse effects to human health or adverse environmental effects,”[169] and that “EPA is equipped to make the necessary findings to support adding these PFAS to the list of HAPs under CAA Section 112(b)(3)(B).”[170]

While acknowledging that specific emissions controls for PFAS listed as HAPs are beyond the scope of the petition, the states nonetheless ask EPA to identify categorical sources of PFAS emissions under CAA section 112(c), and to establish technology-based emissions controls for those sources under CAA section 112(d).[171] The petitioners also argue that “as EPA advances an PFAS regulatory program under CAA Section 112, strong Generally Available Control Technology (GACT) standards are needed to complement any Maximum Achievable Control Technology (MACT) standards”[172], and that, “EPA should also consider the use of surrogates (such as total organic fluorine) to accurately account for PFAS transformation products and for demonstrating compliance with PFAS emission standards.”[173]

To date EPA has not responded to the petition, and it is unclear how the Trump administration will respond.

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Enforcement

In August 2023, EPA’s Office of Enforcement and Compliance Assurance (OECA) finalized its National Enforcement and Compliance Initiatives (NECIs) for 2024-2027, adding “Addressing Exposure to PFAS” as one of the six NECIs.[174] The NECIs prioritize enforcement activities across all of EPA’s offices for the next several years.[175] OECA explains in the document that while it has already taken several enforcement actions regarding PFAS, it will increase its efforts, “particularly to protect drinking water supplies” using its enforcement and compliance tools to mitigate PFAS contamination in vulnerable communities.[176]

EPA has established national enforcement priorities for over 25 years.[177] For the FY 2024-2027 cycle, OECA used three criteria to develop its priorities:[178] (1) widespread environmental concerns impacting human health and the environment, particularly in communities overburdened by environmental issues; (2) where federal enforcement authority is necessary to stop significant pollution and to promote fair competition in the regulated community; and (3) alignment with EPA’s overall Strategic Plan.[179]

The NECI document also describes how EPA intends to use its enforcement tools to support EPA’s PFAS Strategic Roadmap by focusing on “significant” PFAS polluters. EPA clarifies that significant PFAS polluters means large PFAS manufacturers and users, federal facilities that released PFAS, and other entities that contributed in a major way to the release of PFAS into the environment. EPA’s limit of enforcement, was intended to address concerns that smaller parties could be embroiled in costly PFAS-related legal matters.[180]

New CERCLA PFAS Enforcement Guidance

While the NECI document describes how EPA intends to use its enforcement authority for PFAS contamination, EPA also released a more specific PFAS enforcement guidance document related to its final rule designating two PFAS chemical types, PFOS and PFOA, as hazardous substances under CERCLA.[181]

Issued on April 19, 2024, the CERCLA-specific guidance, “PFAS Enforcement Discretion and Settlement Policy Under CERCLA,” explains how EPA plans to prioritize CERCLA enforcement authority against “significant” PFAS polluters.[182] EPA states it will use its enforcement discretion to prioritize entities that meet four “equitable factors” (discussed below), and explicitly mentions that it does not intend to pursue community-based drinking water systems and publicly owned water treatment works (POTWs), municipal separate storm water systems (MS4s), publicly owned or operated municipal solid waste landfills (MSWs), publicly owned airports and fire departments, or farms that applied PFAS-contaminated sludges as fertilizers.[183]

The four equitable factors that EPA will consider before pursuing an enforcement action are:

(1) “Whether the entity is a state, local, or tribal government, or works on behalf of or conducts a service for a government entity.

(2) Whether the entity performs a public service role.[184]

(3) Whether the entity manufactured or used PFAS as part of an industrial process.

(4) Whether, and to what degree, the entity was actively involved in the use, storage, treatment, transport, or disposal of PFAS.”[185]

CERCLA Enforcement Provisions 

EPA also emphasizes in its PFAS guidance that CERCLA includes statutory provisions that it will use to limit the enforcement impacts of the PFAS hazardous substance listing to significant contributors.[186] These provisions include:

• De minimis or de micromis parties: CERCLA provides EPA the ability to settle with parties whose contribution is minimal in comparison to other parties and provides a statutory exemption to de micromis parties.[187]
• 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.[188]
• 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.[189]
• Bona Fide Prospective Purchasers (BFPP): Parties that meet the threshold criteria and continuing obligations for a BFPP are provided with CERCLA liability protection.[190]
• 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.[191]
• Contiguous Property Owners (CPO): This provision protects parties that are victims of contamination caused by a neighbor’s action.[192]
• Permit Shield Defense: CERCLA liability is limited for certain releases that fall within the federally permitted release provision of CERCLA.[193]
• 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.[194]

EPA also explains that it “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 PFAS contamination” noting that “CERCLA will continue to operate as it has for decades to resolve who should pay for PFAS cleanups.”[195]

Next Steps

It is unclear how the Trump administration will use EPA’s enforcement authority to address PFAS contamination. EELP will continue to monitor and report out on EPA enforcement activities regarding PFAS in the coming months and years.

 

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[1] Various media stories, trade associations, and law firms have commented on potential PFAS costs. For example, see New York Times, Prepare for ‘Astronomical’ PFAS Lawsuits, Hiroka Tabuchi, (May 28, 2024) at https://www.nytimes.com/2024/05/28/climate/pfas-forever-chemicals-industry-lawsuits.html.

[2] While this series focuses on EPA’s PFAS strategy, EPA’s activities are part of a broader government-wide effort to address PFAS. See https://www.whitehouse.gov/briefing-room/statements-releases/2021/10/18/fact-sheet-biden-harris-administration-launches-plan-to-combat-pfas-pollution/.  See also, James B. Pollack, with contributing authors Isabel Carey and Victor Xu, PFAS Deskbook, Environmental Law Institute (2023)

[3]EPA, PFAS Strategic Roadmap, (2021). See https://www.epa.gov/system/files/documents/2021-10/pfas-roadmap_final-508.pdf.

[4] Id., at 5

[5] Id.

[6] National Institute of Health (NIH), “Perfluoroalkyl and Polyfluoroalkyl Substances”, (March 2019) at https://www.niehs.nih.gov/sites/default/files/health/materials/perfluoroalkyl_and_polyfluoroalkyl_substances_508.pdf. Depending on how one defines PFAS chemicals, there are potentially thousands of chemical sub-types.

[7] EPA, “PFAS Explained,” (updated October 2024), at https://www.epa.gov/pfas/pfas-explained.

[8] NIH, “Cross-cutting studies of per- and polyfluorinated alkyl substances (PFAS) in Arctic wildlife and humans”, Lohman et al, (September 2024), at https://pubmed.ncbi.nlm.nih.gov/39304148/.

[9] See https://www.teflon.com/en/news-events/history.

[10] EPA, “Our Current Understanding of Human Health and Environmental Risks of PFAS,” (updated May 16,2024), at https://www.epa.gov/pfas/our-current-understanding-human-health-and-environmental-risks-pfas.

[11] Cary Institute, “High organofluorine concentrations in municipal wastewater affect downstream drinking water supplies for millions of Americans, edited by William Schlessinger et al. (January 6, 2025) at https://www.pnas.org/doi/full/10.1073/pnas.2417156122.

[12] Long-chain PFAS chemicals such as PFOS are no longer manufactured in the United States as a result of an EPA-led voluntary corporate phase-out agreement with major PFOS producing companies. Under the PFOA Stewardship Program (2010–2015), major chemical manufacturers agreed to eliminate the use of PFOA and PFOA-related chemicals in their products and emissions from their facilities. See https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/fact-sheet-20102015-pfoa-stewardship-program#mfg.

[13] See https://www.statista.com/statistics/1454326/global-perfluoroalkyl-and-polyfluoroalkyl-market-value/.

[14] ATSDR, ToxGuide for Perfluoralkyls, (March 2020), at https://www.atsdr.cdc.gov/toxguides/toxguide-200.pdf. Certain PFAS have a half-life of up to 10 years in the human body.

[15] EPA, “Our Current Understanding of Human Health and Environmental Risks of PFAS”, (updated May 16,2024), at https://www.epa.gov/pfas/our-current-understanding-human-health-and-environmental-risks-pfas. See also EPA, PFAS, (updated Sept 2024) at https://www.epa.gov/pfas, and NIH, PFAS Toxicity and Human Health Review, Environ Toxicol Chem., (2020), at https://pmc.ncbi.nlm.nih.gov/articles/PMC7906952/#:~:text=Epidemiological%20studies%20have%20revealed%20associations,and%20developmental%20outcomes%2C%20and%20cancer.

[16]  The Lancet, “Forever chemicals: the persistent effects of perfluoroalkyl and polyfluoroalkyl substances on human health,” eBioMedicine, Volume 95, 104806, at https://www.thelancet.com/action/showCitFormats?doi=10.1016%2Fj.ebiom.2023.104806&pii=S2352-3964%2823%2900372-9.

[17] Schumacher, B., et al, “Distribution of select per- and polyfluoroalkyl substances at a chemical manufacturing plant,” Journal of Hazardous Materials, (2024), at https://doi.org/10.1016/j.jhazmat.2023.133025.

[18] Parker, B., et al., “In vitro modeling of the post-ingestion bioaccessibility of per- and polyfluoroalkyl substances sorbed to soil and house dust.” Toxicological Sciences, Society of Toxicology, (2024), at https://doi.org/10.1093/toxsci/kfad098.     

[19] EPA, “PFAS Resources, Data, and Tools”, (Updated Sept. 2024), at https://www.epa.gov/pfas/pfas-resources-data-and-tools.

[20] NIH, Hu Xindi C, “Detection of Poly- and Perfluoroalkyl Substances (PFASs) in U.S. Drinking Water Linked to Industrial Sites, Military Fire Training Areas, and Wastewater Treatment Plants”, (July 14, 2017), at https://pmc.ncbi.nlm.nih.gov/articles/PMC5954436/#:~:text=There%20are%20an%20estimated%2026%2C000,sites%20where%20AFFFs%20were%20used.

[21] NIH, Allison Ling, “Estimated Scale of Costs to Remove PFAS From the Environment at Current Emission Rates”, (March 24, 2024), at https://pubmed.ncbi.nlm.nih.gov/38325453/.

[22] See generally public comments to EPA’s PFAS related CERCLA, SDWA, and TSCA rules (discussed in more detail in our other articles in this series).

[23] EPA, “Toxic Substances Control Act Reporting and Recordkeeping Requirements for Perfluoroalkyl and Polyfluoroalkyl Substances” (October 11, 2023), Federal Register Vol. 88, No. 195. For many product importers, determining if the product contains PFAS is difficult, akin to companies trying to determine their scope 3 carbon emissions. Supply chains are complex and not readily transparent.

[24]  See public comments to EPA’s PFAS related CERCLA, SDWA, and TSCA rules (also, discussed in more detail in our other articles in this PFAS series). For example, under CERCLA, current owners of a property where PFAS contamination is located may have liability for past disposal of the chemicals. Additionally, under CERCLA, liability for harms caused from widespread contamination may be hard to distinguish, potentially leaving parties jointly and severally liable for large swaths of contamination.

[25] EPA, PFAS Strategic Roadmap

[26] Id., at 5 and 9.

[27] Id., at 6-8.

[28] EPA, PFAS Strategic Roadmap: Three Years of Progress, (November 2024), at https://www.epa.gov/system/files/documents/2024-11/epas-pfas-strategic-roadmap-2024_508.pdf. As the administrations change it is currently unclear what aspects of the PFAS Strategic Roadmap might be modified. For example, the principal of prioritizing disadvantaged communities might run afoul of the Trump administration’s stated goal of eliminating environmental justice concepts from EPA activities.

[29] https://www.epa.gov/system/files/documents/2024-11/epas-pfas-strategic-roadmap-2024_508.pdf  at 16.

[30] Both new rules face legal challenges. Multiple industry groups and water authorities have filed challenges to the rules, arguing EPA mischaracterized potential costs of compliance and exceeded its authority in promulgating the final rules. For the SDWA Petitions for Review see https://www.epa.gov/system/files/documents/2024-06/awwa-v-epa-no-1188-dc-cir-filed-petition.pdf and https://www.epa.gov/system/files/documents/2024-06/24-1191_nam-v-epa.pdf. For the CERCLA Petition for Review see Chamber of Com. v. EPA, D.C. Cir., No. 24-01193, petition 6/10/24.

[31] For example, in a case involving an EPA enforcement action under TSCA related to PFAS, the 5^th Circuit recently vacated EPA’s administrative order requiring a company to stop using PFAS in its products. The court found that EPA was not authorized to issue the orders under TSCA section 5 because the company’s decades old manufacturing process could not be considered a significant new use and ruled that EPA should have followed the more stringent process required under TSCA section 6, which includes conducting a cost-benefit analysis. See Enhance Technologies v. EPA, Docket No. 23-60620 (5th Cir.), March 23, 2024. For further discussion of EPA’s PFAS related actions under TSCA, please see the other article in this series.

[32] Federal environmental statutes such RCRA, CERCLA, CWA, CAA, and SDWA all contain citizen suit provisions.

[33] As of the date of publication little detail regarding EPA and PFAS is available yet. The new EPA administrator has released a high-level document regarding EPA’s priorities, see https://www.epa.gov/newsreleases/epa-administrator-lee-zeldin-announces-epas-powering-great-american-comeback.

[34] Maine, New Hampshire, Vermont, California, and New Jersey are examples. For a summary of EU PFAS regulation, see EU, European Chemicals Agency, PFAS, https://echa.europa.eu/hot-topics/perfluoroalkyl-chemicals-pfas.

[35] For a discussion of a private PFAS litigation, see American Bar Association Business Law Section, Establishing and Challenging Standing in PFAS Litigation, Blumenthal, (Feb 14, 2024), at https://www.americanbar.org/groups/business_law/resources/business-law-today/2024-february/establishing-challenging-standing-pfas-litigation/. For an example of a state AG PFAS action, see Colorado Attorney General site at https://coag.gov/pfas/.

[36] For example, local public water suppliers may be able to estimate the future costs of meeting the new SDWA standards, but only in regard to the limited set of PFAS that are currently regulated.

[37] See https://pfas-1.itrcweb.org/2-2-chemistry-terminology-and-acronyms/#:~:text=The%20definition%20of%20PFAS%20continues,universally%20accepted%20definition%20of%20PFAS.

[38] Kwiatkowski et.al, “Scientific Basis for Managing PFAS as a Chemical Class”, Environ Sci Technol Lett., (August 11, 2020). See https://pmc.ncbi.nlm.nih.gov/articles/PMC8297807/#:~:text=Toxicological%20and%20epidemiological%20studies%20have,with%20all%20PFAS%2C%20including%20polymers. For opposing view from the American Chemistry Council see https://www.americanchemistry.com/chemistry-in-america/chemistries/fluorotechnology-per-and-polyfluoroalkyl-substances-pfas/pfas-grouping-an-emerging-scientific-consensus.

[39] No consensus exists on whether all PFAS are harmful and should be regulated broadly as a family of chemicals, or if individual PFAS chemicals might have widely varying impacts and should be regulated separately. The EU is going through a similar debate, with some member countries favoring each approach for future regulation.

[40] These two rules are discussed in detail in the RCRA, TSCA, CWA, and other EPA Legal Authorities section of this explainer.

[41] EPA, Toxic Substances Control Act Reporting and Recordkeeping Requirements for Perfluoroalkyl and Polyfluoroalkyl Substances, (October 2023), at https://www.govinfo.gov/content/pkg/FR-2023-10-11/pdf/2023-22094.pdf, at page 3. “PFAS is defined as including at least one of these three structures: R-(CF2)-CF(R′)R″, where both the CF2 and CF moieties are saturated carbons; R–CF2OCF2-R′, where R and R′ can either be F, O, or saturated carbons; and  CF3C(CF3)R′R″, where R′ and R″ can either be F or saturated carbons.” EPA acknowledges however, that even this broad definition may not capture all potential PFAS chemicals.

[42] EPA’s TSCA PFAS actions are discussed in detail in the RCRA, TSCA, CWA, and other EPA Legal Authorities section of this explainer.

[43] Many state regulations include some form of a two-prong test to determine if a material is regulated under their rule. If a material contains a PFAS chemical that was “intentionally added” to the material in any amount, it is covered. Alternatively, a material is covered if it has more than 100ppm PFAS. See, for example, California AB-1200, section 109000. Other states only regulate PFAS that were intentionally added to a material.

[44] California Assembly Bill 1200 (AB 1200), at Bill Text – AB-1200 Plant-based food packaging: cookware: hazardous chemicals.

[45] Proposition 65 requires that companies provide a clear and reasonable warning prior to exposing a person to a chemical in a consumer product known to the state to cause cancer or reproductive toxicity.

[46] S Yahan Cui, Shenghui Wang, Dandan Han, Hongyuan Yan, “Advancements in detection techniques for per- and polyfluoroalkyl substances: A comprehensive review”, TrAC Trends in Analytical Chemistry, Volume 176, (2024), 117754, ISSN 0165-9936, at https://doi.org/10.1016/j.trac.2024.117754. (https://www.sciencedirect.com/science/article/pii/S0165993624002371.) Also see, EPA, National PFAS Testing Strategy, (updated 2024) at  https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/national-pfas-testing-strategy.

[47] The article in this series on PFAS and the SDWA discusses the issue of setting standards at detection limits.

[48] Supra, PFAS Deskbook, at 14.

[49] Id.

[50] Id.

[51] Id.

[52] Id., at 15.

[53] Id., at 13.

[54] Id., at 14.

[55] Id., at 13.  See also, Das, R., Ananthanarasimhan, J. & Rao, L. “PFAS” Exploring the Origins, Impact, Regulations and Remediation Technologies—An Overview. J Indian Inst Sci (2024), at https://doi.org/10.1007/s41745-024-00442-8

[56] The EPA Spring 2024 Unified Agenda provides a summary of ongoing and anticipated EPA rulemaking activities.  At the time this article was published, two PFAS related rulemakings under the CWA were listed on the agenda as being in the “proposed rule” phase, PFAS Requirements in NPDES Permit Applications, RIN Number 2040-AG34, and CWA Methods Update Rule for the Analysis of Contaminants in Effluent, Rin Number 2040-AG37.  See https://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202404&RIN=2040-AG34 and https://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202404&RIN=2040-AG37 respectively.  However, the impact of the new administration on EPA’s projected activities is currently unclear.

[57] EPA, Designation of Perfluorooctanoic Acid (PFOA) and Perfluorooctanesulfonic Acid (PFOS) as CERCLA Hazardous Substances, EPA 40 CFR Part 302 (April 19, 2024) (hereinafter referred to as “CERCLA final rule” or “final rule” ), at https://www.federalregister.gov/documents/2024/05/08/2024-08547/designation-of-perfluorooctanoic-acid-pfoa-and-perfluorooctanesulfonic-acid-pfos-as-cercla-hazardous. CERCLA, 42 U.S.C. § 9601 et seq, 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.”

[58] The Comprehensive Environmental Response Compensation and Liability Act (CERCLA), 42 U.S.C. § 9601 et seq.

[59] Pursuant to CERCLA, hazardous substances are designated on a list set out at 40 CFR Part 302.4. Under the statute, listed hazardous substances include contaminants already listed under other federal laws, including sections 307(a) and 311 of the CWA, section 112 of the CAA, and section 3001 of the Resource Conservation and Recover Act (RCRA), as well as any additional substances EPA lists pursuant to CERCLA section 102(a), as was the case in this final rule for these two PFAS chemical types. See https://www.epa.gov/epcra/cercla-hazardous-substances-defined.

[60] Id.

[61] CERCLA final rule at 39126. EPA went beyond considering whether PFOA and PFOS “may present a substantial danger to public health welfare or the environment” and performed an additional analysis considering the pros and cons of the designation, including an analysis of benefits and costs.

[62] Id., at 39127.

[63] Id.

[64] Id., at 39126.

[65] Under CERCLA, PRPs include current owners and operators of facilities where hazardous substances are disposed; past owners and facility operators at the time hazardous substances were disposed; any person who “arranged for disposal” of a hazardous substance; and any person who accepts a hazardous substance for “transport to disposal or treatment facilities.” CERCLA, 42 U.S.C. § 9601 et seq., section 107.

[66] Id., CERCLA final rule, at 39327. A hazardous substance designation gives EPA broader authority to address a release of a chemical than it has for addressing non-listed pollutants or contaminants.

[67] CERCLA, 42 U.S.C. § 9601 et seq., section 104(a) and see CERCLA final rule preamble at 39127. “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.”

[68] CERCLA section 104(a).

[69] CERCLA final rule at 39170. EPA notes commenters claimed that EPA’s designation of PFOA and PFOS as hazardous substances under CERCLA violates the major questions doctrine set out by the Supreme Court in West Virginia v. EPA, 142 S.Ct. 2587 (2022).

[70] CERCLA final rule at 39170. Many commenters expressed concern that CERCLA’s wide reaching liability scheme, explained later in this article, might entangle parties in costly litigation over liability for response costs. The commenters argued that EPA’s approach to PFOA and PFOS “represents an unprecedented expansion of EPA’s authority,” to which EPA responded that it “has added similarly ubiquitous substances to CERCLA’s hazardous substance list for decades.” EPA also stated that its “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.” EPA notes that “of the 1,229 Superfund sites currently on the NPL, PCBs have been detected at 357 sites… [and] 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.”

[71] PRP liability is set forth at CERCLA, 42 U.S.C. § 9601 et seq., section 107. For more detail see the “Enforcement” piece on this page. Also see https://www.epa.gov/system/files/documents/2024-04/pfas-enforcement-discretion-settlement-policy-cercla.pdf.

[72] See CERCLA final rule at at 39174 for EPA’s discussion on reportable quantities of PFAS. The reporting requirement applies to any release of PFAS over the RQ by any person regardless of CERCLA liability.

[73] Id.

[74] Id. at 39131.

[75] CERCLA, 42 U.S.C. § 9601 et seq, section 120(h).

[76] CERCLA final rule at 39151. Hazardous substances are required to be managed as hazardous materials under DOT shipping regulations. Generally, DOT regulations for hazardous materials require specific placarding, labeling, packaging, reporting, and manifesting paperwork for hazardous materials shipping. DOT will have to take additional actions to specify the requirements for these two PFAS. See the following footnote for details.

[77] According to the Fall 2024 Unified Agenda of Regulatory and Deregulatory Actions, DOT plans to conduct a rulemaking to add the two PFAS as to its list of Hazardous Materials in early 2025.

[78] “Incident” in this context meaning accident or spill of the hazardous materials during the shipping process.

[79] CERCLA final rule at 39127, footnote 6. “Congress established the Hazardous Substances Trust Fund, known as the Superfund, to provide EPA with funding to address contamination.”

[80] CERCLA, section 101(25), and see CERCLA final rule preamble at 39137.

[81] As of the time of publication, it is not clear if EPA has directly used its response authorities yet to address PFAS contamination. However, the CERCLA hazardous substances designation has already impacted response actions at federal facilities. For example, see https://www.afcec.af.mil/What-We-Do/Environment/Per-and-Polyfluoroalkl-Substances/.

[82] CERCLA, section 101(23), and id. at 39137.

[83] CERCLA, section 101(24), and id. Remedial Actions include long-term operation and maintenance, institutional controls, and five-year reviews, which ensure the remedy continues to effectively provide protection.

[84] The National Priorities List is the list of the highest priority contaminated sites, chosen for remediation pursuant to CERCLA. Placing a site on the list involves a regulatory-driven risk analysis process. Sites on the list are colloquially known as “Superfund” sites. Valley of the Drums in KY and Love Canal in NY were two of the first and most notorious Superfund sites. See https://www.epa.gov/superfund/superfund-history.

[85] CERCLA provides that liability for releases of hazardous substances under the statute is retroactive (meaning the release can predate the law), joint and several (meaning one PRP can be responsible for the entire cleanup if the harm caused by a release cannot be separated between polluting parties), and strict (meaning a PRP’s liability is not based on negligence or fault). Given that PFAS contamination will likely be traceable to multiple sources, and that the harm caused by each party’s PFAS release may be indistinguishable, PRPs fear they could face expensive cleanup costs and litigation regarding PFAS. See https://www.epa.gov/enforcement/superfund-liability.

[86] Known as a Unilateral Administrative Order or UAO, issued under CERCLA, 42 U.S.C. § 9601 et seq, section 106.

[87] CERCLA, section 122(a).

[88] CERCLA, section 107(a) (1-4).

[89] CERCLA final rule at 39170.

[90] Congress and EPA have taken steps to lessen the burdens on small contributors of hazardous substances to Superfund sites. These actions are discussed further in the Enforcement piece on this page.

[91] EPA, PFAS Enforcement Discretion and Settlement Policy Under CERCLA (April 19, 2024), at https://www.epa.gov/system/files/documents/2024-04/pfas-enforcement-discretion-settlement-policy-cercla.pdf.

[92]CERCLA, section 107.

[93] PFAS Enforcement Discretion and Settlement Policy at 7. EPA intends to deal with PFAS contamination in drinking water through action taken under the authority of the SDWA. For more information see the Safe Drinking Water Act [ANCHOR] section on this page.

[94] EPA, PFAS National Primary Drinking Water Regulation Rulemaking, 40 CFR Parts 141 and 142, (April 26,2024), at https://www.federalregister.gov/documents/2024/04/26/2024-07773/pfas-national-primary-drinking-water-regulation

[95] See EPA, Key Actions to Address PFAS, (updated May 2024), at https://www.epa.gov/pfas/key-epa-actions-address-pfas#:~:text=In%20April%202024%2C%20EPA%20issued,of%20thousands%20of%20serious%20illnesses

[96] Id., PFAS National Primary Drinking Water Regulation Rulemaking, at 32532.

[97] Id., at 32563. Under section 1412(a)(3) of the Safe Drinking Water Act (SDWA) EPA must issue a final MCLG simultaneously with an NPDWR that sets an MCL. The MCLG is set, per section 1412(b)(4)(A), at “the level at which no known or anticipated adverse effects on the health of persons occur and which allows an adequate margin of safety.”

[98] Id., at 32537. See also EPA, Office of Water presentation entitled, “Final PFAS National Primary Drinking Water Regulation” (undated) at https://www.epa.gov/system/files/documents/2024-04/general-overview-webinar-presentation-final-pfas-ndpwr.pdf.

[99] Id.

[100] Id.

[101] Id., PFAS National Primary Drinking Water Regulation Rulemaking, at 32532.

[102] Id.

[103] Id., at 32535 and 32574. EPA essentially set the standards at the practical quantification limit (PQL) for the PFAS chemicals.

[104] Id., Namely PFAS subtypes, PFNA, PFHxS, and HFPO-DA (commonly known as “GenX” Chemicals) have MCLs and MCLGs set at 10 ng/L (or ppt).

[105] Id. EPA finalized a Hazard Index (HI) of 1 (unitless) as the MCLG and MCL for any mixture containing two or more of PFHxS, PFNA, HFPO-DA, and PFBS. (PFBS does not have an MCL but is included in the HI mixture).

[106] Id., at 32562 and 32563.

[107] Id., at 32533.

[108] EPA FAQ PFAS National Primary Drinking Water Regulation FAQs for Drinking Water Primacy Agencies (undated) at https://www.epa.gov/system/files/documents/2024-04/pfas_npwdr_faqsstates_4.8.24.pdf. “The EPA has set limits for five individual PFAS: PFOA, PFOS, PFNA, PFHxS, and HFPO-DA (GenX Chemicals). And the EPA has set a Hazard Index MCL for mixtures of: PFHxS, PFNA, HFPO-DA, and PFBS.”

[109] Id.

[110] Id., PFAS National Primary Drinking Water Regulation Rulemaking, at 32620 and 32621.

[111] Id.

[112] Id., at 32533. After 2029, any testing result showing levels of PFAS above the standard is a violation of the SDWA and must be immediately remedied. Each day over the limit is considered a separate violation.

[113] EPA made significant changes to the final rule after review of the comments, most importantly issuing stricter final PFAS MCL and MCLG levels. See EPA, “Biden-Harris Administration Finalizes First Ever National Drinking Water Standard to Protect 100M people from PFAS Contamination,” (April 10, 2024), at https://www.epa.gov/newsreleases/biden-harris-administration-finalizes-first-ever-national-drinking-water-standard.

[114] Id., PFAS National Primary Drinking Water Regulation Rulemaking, at 32634, referencing the EA.

[115] Id.

[116] Id.

[117] Id. at 32639. Interestingly, the SDWA precludes EPA considering the costs and impacts associated with setting an MCL that do not result from the SDWA regulation itself. For example, under the Comprehensive Environmental Response and Recovery Act (CERCLA), MCLs can drive remedial contamination cleanup levels, potentially increasing the costs of cleanups under that law. See SDWA section 1412(b)(3)(C)(i)(III).

[118] See EPA, “Final PFAS national Primary Drinking Water Regulation,” (undated) at https://www.epa.gov/system/files/documents/2024-04/general-overview-webinar-presentation-final-pfas-ndpwr.pdf.

[119] Id., PFAS National Primary Drinking Water Regulation Rulemaking, at 32634. An additional cost concern for some local water providers is that the requirements of this rule overlap with their need to replace lead piping in the next decade under EPA’s final Lead and Copper Rule Improvements regulation issued on October 8, 2024. However, the Inflation Reduction Act also provides funding for local communities for that rule. See https://www.epa.gov/ground-water-and-drinking-water/lead-and-copper-rule-improvements.

[120] Id., at 32639 and 32534. The Bipartisan Infrastructure Law invests billions of dollars for drinking water, including $11.7 billion for the Drinking Water State Revolving Fund; $4 billion for the Emerging Contaminants program; and $5 billion in grants to small or disadvantaged communities.

[121] EPA, Water technical Assistance Programs, (updated February 2024), at https://www.epa.gov/water-infrastructure/water-technical-assistance-programs. The programs will assist communities develop plans, build

technical, managerial, and financial capacity, and to apply for water infrastructure funding.

[122] Safe Drinking Water Act, 42 U.S.C. § 300g et seq, section 1412(b)(1)(A).

[123] SDWA, section 1412(b)(1)(B)(i).

[124] Id., final rule at 32537.

[125] Id.

[126] SDWA, section 1412(b)(1)(B)(ii).

[127] Id., PFAS National Primary Drinking Water Regulation Rulemaking, at 32538.

[128] Id.

[129] Id.

[130] American Water Works Association, et al., v. EPA, DC Circuit, Case Number 24-1188 (6/24). See https://www.epa.gov/system/files/documents/2024-06/awwa-v-epa-no-1188-dc-cir-filed-petition.pdf.

[131] Id., see court docket for various scheduling orders. Eighteen states have filed an amicus curiae brief in support of EPA.

[132] EPA, “PFAS Strategic Roadmap”, (October 18,2021), at https://www.epa.gov/system/files/documents/2021-10/pfas-roadmap_final-508.pdf, and see generally EPA, “Key Actions to Address PFAS,” (updated May 7, 2024), at https://www.epa.gov/pfas/key-epa-actions-address-pfas.

[133] Id.

[134] EPA, Definition of Hazardous Waste Applicable to Corrective Action for Releases From Solid Waste Management Units, 89 FR 8598, (2/8/2024), at https://www.federalregister.gov/documents/2024/02/08/2024-02328/definition-of-hazardous-waste-applicable-to-corrective-action-for-releases-from-solid-waste.

[135] Id. at 8600. “These proposed revisions would more clearly provide EPA authority to address, through corrective action for solid waste management units, releases of the full universe of substances that the statute intended—not only hazardous waste and hazardous constituents listed or identified in the regulations, but all substances that meet the definition of hazardous waste in RCRA section 1004(5) at a facility.”

[136] EPA, Listing of Specific PFAS as Hazardous Constituents, 89 FR 8606, (02/08/2024). Namely, the following nine PFAS chemical subtypes, perfluorooctanoic acid (PFOA), perfluorooctanesulfonic acid (PFOS), perfluorobutanesulfonic acid (PFBS), hexafluoropropylene oxide-dimer acid (HFPO–DA or GenX), perfluorononanoic acid (PFNA), perfluorohexanesulfonic acid (PFHxS), perfluorodecanoic acid (PFDA), perfluorohexanoic acid (PFHxA), and perfluorobutanoic acid (PFBA), at https://www.federalregister.gov/documents/2024/02/08/2024-02324/listing-of-specific-pfas-as-hazardous-constituents.

[137] It is currently unclear when EPA will finalize these two rules.

[138] EPA, “Per- and Poly-Fluoroalkyl Chemical Substances Designated as Inactive on the TSCA Inventory,” 40 CFR Parts 9 and 721, at https://www.govinfo.gov/content/pkg/FR-2024-01-11/pdf/2024-00412.pdf

[139] EPA, “TSCA Inventory Notification (Active-Inactive) Requirements”, (August 2018), at https://www.regulations.gov/document/EPA-HQ-OPPT-2016-0426-0070, if no notice was received by EPA between 2006 and 2016 regarding a chemical substance subject to designation on the TSCA Inventory, then that substance was designated as inactive.

[140] Id.

[141] EPA, “Toxic Substances Control Act Reporting and Recordkeeping Requirements for Perfluoroalkyl and Polyfluoroalkyl Substances”, 40 CFR Part 705, (October 23, 2023),  at https://www.govinfo.gov/content/pkg/FR-2023-10-11/pdf/2023-22094.pdf, and EPA,”TSCA Section 8(a)(7) Reporting and Recordkeeping Requirements for Perfluoroalkyl and Polyfluoroalkyl Substances”,

(updated May 2024), at https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/tsca-section-8a7-reporting-and-recordkeeping.

[142] Id., at EPA website link above on TSCA Section 8(a)(7), “In accordance with obligations under TSCA, as amended by the National Defense Authorization Act for Fiscal Year 2020, EPA is requiring any person that manufactures or imports PFAS or PFAS-containing articles in any year since January 1, 2011, to electronically report information regarding PFAS uses, production volumes, disposal, exposures, and hazards.”

[143] Id., “Toxic Substances Control Act Reporting and Recordkeeping Requirements for Perfluoroalkyl and Polyfluoroalkyl Substances”, at 70518, “PFAS is defined as including at least one of these three structures: R-(CF2)-CF(R′)R″, where both the CF2 and CF moieties are saturated carbons; R–CF2OCF2-R′, where R and R′ can either be F, O, or saturated carbons; and  CF3C(CF3)R′R″, where R′ and R″ can either be F or saturated carbons.” Importers of large assortments of consumer products may have difficulty determining which products may contain a chemical that meets this broad EPA definition.

[144] A direct rule may be issued because it is technical in nature and no adverse comments are anticipated. The rule became effective, without further notice, on November 4, 2024. However, if any adverse comments had been received, EPA would have had to withdraw the rule and address the comments in a later final rule.

[145] See EPA’s direct final TSCA data inventory rule at https://www.federalregister.gov/documents/2024/09/05/2024-19931/perfluoroalkyl-and-polyfluoroalkyl-substances-pfas-data-reporting-and-recordkeeping-under-the-toxic.

[146] The TRI was required to be created by Section 313 of the Emergency Planning and Community Right- to- Know Act (EPCRA). See https://www.epa.gov/toxics-release-inventory-tri-program.

[147] EPA, “Addition of Certain Per- and Polyfluoroalkyl Substances to the Toxics Release Inventory,” 82 FR 4255,

40 CFR Part 372, at 4256, at https://www.epa.gov/toxics-release-inventory-tri-program/addition-certain-pfas-tri-national-defense-authorization-act.  Section 7321 of the National Defense Authorization Act for Fiscal Year 2020 (NDAA) immediately added certain per- and polyfluoroalkyl substances (PFAS) to the list of chemicals covered by the Toxics Release Inventory (TRI) under section 313 of the Emergency Planning and Community Right-to-Know Act (EPCRA) and provided a framework for additional PFAS to be added to TRI on an annual basis.

• For Reporting Year 2023 (reporting forms due by July 1, 2024), the NDAA automatically added nine PFAS to the TRI list. The addition of these nine PFAS was codified in a final rulein June 2023 at 40 CFR Part 372.
• For Reporting Year 2024 (reporting forms due by July 1, 2025), the NDAA automatically added seven additional PFAS to the TRI list. Facilities in TRI-covered industry sectors should begin tracking and collecting data on these chemicals during 2024.

EPA, Addition of Certain PFAS to the TRI by the National Defense Authorization Act, (updated May 2024), at

https://www.epa.gov/toxics-release-inventory-tri-program/addition-certain-pfas-tri-national-defense-authorization-act.

[148] EPA, Toxics Release Inventory (TRI); Clarification of Toxic Chemicals Due to Automatic Additions of Per- and Polyfluoroalkyl Substances Under the National Defense Authorization Act, (1,17,2025). See https://www.federalregister.gov/documents/2025/01/17/2024-31406/toxics-release-inventory-tri-clarification-of-toxic-chemicals-due-to-automatic-additions-of-per–and.

[149] EPA, Changes to TRI Reporting Requirements for Per- and Polyfluoroalkyl Substances and to Supplier Notifications for Chemicals of Special Concern, (updated October 2023), at https://www.epa.gov/toxics-release-inventory-tri-program/changes-tri-reporting-requirements-and-polyfluoroalkyl.

[150] EPA, “Final Recommended Aquatic Life Criteria and Benchmarks for Select PFAS”, 89 FR 81077, (October 1, 2024), at https://www.federalregister.gov/documents/2024/10/07/2024-23024/final-recommended-aquatic-life-criteria-and-benchmarks-for-select-pfas. The Final Criteria and Benchmarks are based on three separate EPA documents, “Final Recommended Freshwater Aquatic Life Ambient Water Quality Criteria and Acute Saltwater Aquatic Life Benchmarks for Perfluorooctanoic Acid (PFOA)”, “Final Recommended Freshwater Aquatic Life Ambient Water Quality Criteria and Acute Saltwater Aquatic Life Benchmarks for Perfluorooctane Sulfonate (PFOS),” and “Acute Freshwater Aquatic Life Benchmarks” for eight other data limited PFAS.

[151] Id.

[152] Id. For PFOA, EPA’s proposed water column acute freshwater criteria for PFOA of 49 milligrams per liter (mg/L) and 0.094 mg/L for chronic exposure. However, the final criteria were set significantly stricter, at 3.1 mg/L for acute exposure and 0.10 mg/L for chronic exposure. For PFOS, EPA proposed an acute water column value of 3.0 mg/L, a chronic value of 0.0084 mg/L, an invertebrate value at 0.937 mg/kg ww, a fish whole body value as 6.75 mg/kg ww, and a fish muscle value at 2.91 mg/kg ww. However, again the final values are stricter, set at 0.071 mg/L for acute exposure, and 0.00025 mg/L for chronic exposure. Final tissue values are 0.028 mg/kg ww for invertebrates, 0.201 mg/kg ww for fish whole body, and 0.087 mg/kg ww for fish muscle. For PFOA and PFOS in saltwater, EPA chose benchmarks of 7.0 mg/L and 0.55 mg/L, respectively. Finally, EPA set additional freshwater benchmarks for eight other PFAS chemicals at 5.3 mg/L for PFBA, 4.8 mg/L for PFHxA, 0.65 mg/L for PFNA, 0.5 mg/L for PFDA, 5.0 mg/L for PFBS, 0.21 mg/L for PFHxS, 0.037 mg/L for 8:2 FTUCA and 0.012 mg/L for 7:3 FTCA.        

[153] Id.

[154] Id.

[155] Id.

[156] Id.

[157] Id.

[158] EPA, Effluent Guidelines Program Plan 15, 88 FR 6258. “EPA continues to focus on assessing opportunities to limit per- and polyfluoroalkyl substances (PFAS) discharges from multiple industrial categories, as outlined in the 2021 PFAS Strategic Roadmap.” “EPA has determined that revisions to the effluent guidelines and standards for the Landfills Category (40 CFR part 445) are warranted.” EPA has also studied other industrial and commercial sectors for PFAS release limits under CWA discharge permits, see https://www.epa.gov/eg/current-effluent-guidelines-program-plan.

[159] Id.

[160] EPA, CWA Analytical Methods for Per- and Polyfluorinated Alkyl Substances (PFAS). “EPA expects to propose Method 1633 at 40 CFR Part 136 in the coming months. While the method is not nationally required for CWA compliance monitoring until the EPA has promulgated it through rulemaking, the EPA recommends it now for use in individual permits.”

[161] EPA, CWA Analytical Methods for Per- and Polyfluorinated Alkyl Substances (PFAS). EPA acknowledges that “Method 1621 is not nationally required for CWA compliance monitoring until the EPA has promulgated it through rulemaking”.

[162] Namely, Perfluorooctanoic acid (PFOA), Perfluorooctane sulfonic acid (PFOS), Perfluorononanoic acid (PFNA), and Hexafluoropropylene oxide dimer acid HFPO-DA (GenX).

[163] See petitioning states’ cover letter and submittal at https://www.fbm.com/content/uploads/2024/09/PFAS-HAP-Petition.pdf.

[164] Id.

[165] Id.

[166] Id. The states note that “CAA Section 112(b)(1) establishes a list of HAPs that EPA has used to identify sources for which EPA will promulgate emissions standards. CAA Section 112(b)(2) explicitly authorizes EPA to add pollutants to the list of HAPs based on periodic reviews, and CAA Section 112(b)(3) allows EPA to add a substance to the list of HAPs upon granting a petition filed by any person.”

[167] Id. Petitioning states note as an example, that EPA highlights in its own technical documents that various PFAs remediation treatment technologies increase the prospects of new “stationary sources of air emissions, including thermal destruction of PFAS through processes such as commercial incinerators, cement kilns, lightweight aggregate kilns, and activated carbon reactivation units with thermal oxidizers. EPA also describes the uncertainties related to the PFAS removal efficiencies by thermal treatment.”

[168] Clean Air Act, section 112(b)(3), 42 U.S.C. § 7412(b)(3).

[169] States’ petition.

[170] Id. The states also remind EPA that “exploration of air emissions mitigation options, including listing certain PFAS as HAPs, is a centerpiece of the EPA’s strategy to address PFAS air emissions in the 2021-2024 PFAS Strategic Roadmap.”

[171] Id., If EPA lists PFAS as HAPs, the agency must develop source specific, technology-based emissions controls standards applicable for sources of the HAPs. Essentially, requiring sources to take steps to limit HAPs emissions.

[172] Broadly speaking, Maximum Achievable Control Technology (MACT) is required for major sources of HAPs, while. Generally Available Control Technologies (GACT) or management practices are required for HAP area sources.

[173] Id., EPA has not yet responded to the petition and with the change of administrations it is not currently clear what EPA’s next step will be.

[174]EPA, FY 2024 – 2027 National Enforcement and Compliance Initiatives (August 17, 2023), at https://www.epa.gov/system/files/documents/2023-08/fy2024-27necis.pdf. “The six FY 2024-2027 NECIs are: Mitigating Climate Change (new); Addressing Exposure to PFAS (new); Protecting Communities from Coal Ash Contamination (new); Reducing Air Toxics in Overburdened Communities (modified); Increasing Compliance with Drinking Water Standards (continued); Chemical Accident Risk Reduction (continued).” EPA justifies including PFAS as a NECI “[d]ue to the toxicity and persistence of per- and polyfluoroalkyl substances (PFAS) chemicals, and the breadth and scope of PFAS contamination throughout the country.” See also https://www.epa.gov/enforcement/national-enforcement-and-compliance-initiatives.

[175] At the time of publication, the impact of the new administration on EPA’s strategic planning remains unclear.  Presumably, there will be significant prioritization differences in the new Trump administration.

[176] NECI document at 1 and 3.

[177] Id.

[178] Id., at 2, and additional related EPA enforcement materials at https://www.epa.gov/enforcement/national-enforcement-and-compliance-initiatives. EPA’s process for developing the NECI priorities includes OECA soliciting and receiving public comment from states, territories, tribes, environmental groups, regulated entities, and the public. EPA regional offices, which play a key role in the enforcement and implementation of each initiative, also were engaged by OECA.

[179] EPA’s FY 2022-2026 Strategic Plan can be found at https://www.epa.gov/system/files/documents/2022-03/fy-2022-2026-epa-strategic-plan.pdf.

[180] Id.

[181] EPA, Designation of Perfluorooctanoic Acid (PFOA) and Perfluorooctanesulfonic Acid (PFOS) as CERCLA Hazardous Substances, EPA 40 CFR Part 302 (April 19, 2024)(hereinafter referred to as CERCLA Final Rule ), at https://www.federalregister.gov/documents/2024/05/08/2024-08547/designation-of-perfluorooctanoic-acid-pfoa-and-perfluorooctanesulfonic-acid-pfos-as-cercla-hazardous.

[182] EPA, PFAS Enforcement Discretion and Settlement Policy Under CERCLA (April 19, 2024), at https://www.epa.gov/system/files/documents/2024-04/pfas-enforcement-discretion-settlement-policy-cercla.pdf

[183] PFAS Enforcement Discretion and Settlement Policy at 7.

[184] Id. For example, does the entity providing safe drinking water, handle municipal solid waste, treat or manage stormwater or wastewater, dispose of municipal biosolids or activated carbon filters, ensure beneficial application of products from the wastewater treatment process as a fertilizer substitute or soil conditioner, or perform emergency fire suppression services.

[185] Id. at 8. The guidance, while not legally binding, does inform EPA regional offices’ decision making.

[186] Id. at 2, see footnote 4, “Unique Parties and Superfund Liability” found at https://www.epa.gov/enforcement/unique-parties-and-superfund-liability.

[187] CERCLA, 42 U.S.C. § 9601 et seq., section 107(o).

[188] CERCLA, section 107(b)(3).

[189] CERCLA, section 107(p).

[190] CERCLA, section 101(40).

[191] CERCLA, section 101(35).

[192] CERCLA, section 107(q).

[193] CERCLA, section 101(10).

[194] CERCLA, section 101(22)(D). The definition of “release” explicitly excludes “the normal application of fertilizer.”

[195] CERCLA Rule preamble at 39160. Because EPA took the unusual step of issuing enforcement guidance simultaneously with the new rule, EPA discusses the impact of the guidance in the preamble to the final rule. Guidance related to a new rule often lags the release of the rule, often significantly, as EPA learns best practices related to the rule over time.