EPA Stands by CERCLA PFAS Designation Amid Legal Challenge

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EPA under the Trump administration will defend a rule issued by the Biden administration designating two PFAS as hazardous substances under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA), the agency told the D.C. Circuit Court of Appeals on September 17, 2025.

“EPA has completed its review and has decided to keep the Rule in place,” the agency wrote in a court filing.

The case, Chamber of Commerce of the USA v. EPA, No. 24-1193, consolidates challenges to the May 2024 rule.  It has been held in abeyance since February at EPA’s request while the Trump administration determined how to proceed.

EPA’s decision to defend the rule is somewhat unexpected.  Last month, the New York Times reported that internal EPA documents recommended its repeal, stating that its “cons outweigh pros.”

Key Impacts of the CERCLA Designation

The rule has significant consequences for EPA’s ability to respond to contamination and assign cleanup responsibility for PFOA and PFOS, the two PFAS covered by the designation.

“Designating PFOA and PFOS as CERCLA hazardous substances eliminates barriers to timely cleanup of contaminated sites, enables EPA to shift responsibility for cleaning up certain sites from the Fund to [potentially responsible parties (PRPs)], and allows EPA to compel PRPs to address additional contaminated sites,” the rule states.

Due to the designation, entities that release PFOA and PFOS above reportable quantities must notify authorities.  When releases occur, EPA (and other agencies) can more quickly respond, because they no longer need to first determine that the release “may present an imminent and substantial danger.”

Crucially, the designation also allows EPA to compel PRPs to take action in response to significant PFOS or PFOA contamination—often at their own expense.

The rule justifies listing PFOA and PFOS based on their health hazards, persistence and mobility in the environment, and bioaccumulation in humans and other organisms.  EPA also conducted a “totality of the circumstances” analysis, which weighed the pros and cons of their designation.

More on EPA’s PFAS and CERCLA actions can be found on our CERCLA archive.

EPA Requests Information on Addressing PFAS in the Environment for the Superfund Program

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EPA has published a notice of proposed rulemaking, Addressing PFAS in the Environment, asking for public input, which the Agency will use to develop future per- and polyfluoroalkyl substance (PFAS) regulations under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA). The Agency asked for information on the potential future hazardous substance designation of a number of PFAS, categories of PFAS, and several PFAS precursors.

Request for Public Input Regarding Potential Future Hazardous Substance Designation of Seven PFAS

EPA had previously proposed designating PFOA and PFOS and their salts and structural isomers as hazardous substances under CERLA. The present notice requested feedback as to whether the agency should initiate action designating an additional seven PFAS and their salts and structural isomers or a subset thereof as CERCLA hazardous substances as well. The seven PFAS being considered for designation are:

  • Perfluorobutanesulfonic acid (PFBS), CASRN 375–73–5
  • Perfluorohexanesulfonic acid (PFHxS), CASRN 355–46–4
  • Perfluorononanoic acid (PFNA), CASRN 375–95–1
  • Hexafluoropropylene oxide dimer acid (HFPO–DA), CASRN 13252–13–6
  • Perfluorobutanoic acid (PFBA) CASRN 375–22–4
  • Perfluorohexanoic acid (PFHxA) CASRN 307–24–4
  • Perfluorodecanoic acid (PFDA) CASRN 335–76–2

EPA asked interested parties to submit information on whether any of these compounds may present substantial danger to public health or welfare or the environment. Such information could include data on mobility, persistence, and prevalence.

Request for Public Input Regarding Potential Future Hazardous Substance Designation of Precursors to PFOA, PFOS, and PFAS

The Agency is also considering initiating action that would designate certain PFAS precursors as hazardous substances under CERCLA. To make this determination, EPA requested information to help the Agency identify compounds that degrade to these PFAS through environmental processes such as biodegradation and hydrolysis.

Request for Public Input Regarding Potential Designation, or Designations, of Categories of PFAS as Hazardous Substances

Additionally, EPA is considering initiating action that would designate groups or categories of PFAS as CERCLA hazardous substances. These groups or categories would be based on characteristics that determine risk to human health and the environment, such as chemical structure, physical and chemical properties, mode of toxicological action, and precursors or degradants. To inform its decision-making, the Agency solicited the following information:

  • Published scientific literature that can inform whether categories of PFAS could or could not be designated as hazardous substances. This could include findings on the similarities or differences of a specific characteristic among PFAS. Also useful would be data on the relationship between different characteristics, such as the relationship between chemical structure and specific chemical, physical, or toxicological properties.
  • Other information that could inform EPA’s determination of whether to designate one or more categories of PFAS as hazardous substances.
  • Information that would contribute to economic analysis of the potential costs and benefits, including impacts on small entities, associated with a potential rulemaking designating categories of PFAS as hazardous substances. (Although CERCLA section 102(a) precludes EPA from taking cost into account in the designation of a hazardous substance, the Agency is requesting this information to help the Agency understand the potential costs and benefits associated with any potential future regulatory action.)

The deadline for submitting comments was extended from June 12 to August 11, 2023, during which period over 600 comments were submitted. The comments can be reviewed here.

EPA Hosts CERCLA PFAS Enforcement Listening Sessions

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In March, EPA hosted two public listening sessions requesting individual feedback regarding concerns about PFAS liability under CERCLA. The listening sessions follow the Agency’s August 2022 proposed rule, which would designate two of the most widely used PFAS as hazardous substances under the Comprehensive Environmental Response, Compensation, and Liability Act (“CERCLA”). EPA  has stated that the information gathered during these sessions and any written comments submitted on the topic will be reviewed and considered in drafting its enforcement and discretion policy.

The webinars each began with presentations summarizing CERCLA, detailing the potential harms of PFAS substances, and describing EPA’s plan to issue an enforcement discretion and settlement policy. In addition to comments voiced during the webinars, EPA is reviewing written comments received on the proposed rule. The Agency stated it intends to focus enforcement efforts on manufacturers, federal facilities, and other industrial parties whose actions result in the release of significant amounts of PFAS. EPA clarified that parties that resolve their liability with EPA through settlement would not be liable for third-party claims. Therefore, settlements may provide CERCLA contribution protection to some parties. The Agency’s enforcement discretion policy will be contingent on a party’s cooperation, and it retains the ability to address any situations which present imminent and substantial endangerment.

The Agency also commented on parties against which it does not intend to pursue CERCLA enforcement for PFAS contamination, including:

  • Water utilities and publicly owned treatment works;
  • Publicly owned and/or operated municipal solid waste landfills;
  • Farms that apply biosolids; and
  • Certain airports and fire departments.

EPA further commented that enforcement discretion under this policy would be limited to CERCLA and not impact EPA enforcement actions under any other applicable statute.

EPA has posted the recordings of the sessions, which can be viewed here.

EPA Publishes ANPRM Seeking Information to Assist in Consideration of Future CERCLA Regulations Regarding PFAS

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On April 13, 2023, EPA published an advance notice of proposed rulemaking (ANPRM) seeking input and data regarding potential future hazardous substance designation under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) of a number of PFAS substances. The ANPRM identifies PFOA, PFOS, seven other PFAS and their salts and structural isomers, precursors to PFOA and PFOS, and several categories of PFAS as candidates for this designation.

EPA is requesting public input to assist in the potential development of future regulations under CERCLA Section 102(a). Section 102(a) authorizes the EPA Administrator to promulgate regulations designating as hazardous substances that, when released into the environment, may present a substantial danger to the public health or welfare or the environment. The seven PFAS for which EPA is requesting input on are:

  • Perfluorobutanesulfonic acid (PFBS), Chemical Abstracts Service Registry Number (“CAS RN”) 375-73-5;
  • Perfluorohexanesulfonic acid (PFHxS), CAS RN 355-46-4;
  • Perfluorononanoic acid (PFNA), CAS RN 375-95-1;
  • Hexafluoropropylene oxide dimer acid (HFPO-DA), CAS RN 13252-13-6 (sometimes called GenX);
  • Perfluorobutanoic acid (PFBA), CAS RN 375-22-4;
  • Perfluorohexanoic acid (PFHxA), CAS RN 307-24-4; and
  • Perfluorodecanoic acid (PFDA), CAS RN 335-76-2.

Regarding these seven PFAS, EPA solicited the following information:

  • Published scientific literature regarding the environmental fate and transport.
  • Information that EPA could consider in preparing an economic analysis of the potential direct and indirect costs and benefits associated with a potential rulemaking designating any of the above-mentioned compounds as hazardous substances.

Regarding information around the PFAS precursors, EPA is requesting the following :

  • Published scientific literature or data regarding the environmental degradation of the precursors to PFOA, PFOS, PFBS, PFHxS, PFNA, HFPO-DA, PFBA, PFHxA, and/or PFDA.
  • Published scientific literature that characterizes the environmental prevalence of these substances.
  • Methods for measuring these substances in environmental samples.

EPA is also requesting information to help inform its decision-making on whether to designate further PFAS groups or categories as hazardous substances under CERCLA. It is requesting information on published scientific literature that can inform whether categories of PFAS could be designated as hazardous substances:

In addition, EPA asked for input on whether there are other PFAS that the Agency could consider designating as hazardous substances in a possible future rulemaking. The ANPRM requests references to published scientific information these on the hazards for substances that commentors identify in response to this request.

EPA PFAS Strategic Roadmap

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EPA has compiled a roadmap outlining Key Actions to address the risks posed by PFAS.  The roadmap identifies key actions under TSCA and other statutes including the Clean Water Act, the Safe Drinking Water Act, and Superfund.

TSCA

The roadmap calls for EPA to “close the door” on abandoned PFAS; i.e., PFAS chemicals that are no longer produced.  Many of these substances have no restrictions under TSCA.  This leaves the door open for manufacturers to start producing the chemicals again.  The roadmap intends for EPA to designate all uses of these substances that are not current uses as Significant New Uses.  This will allow EPA to review and make determinations on the potential risks, and require safety measures, before allowing the manufacturing of those chemicals again.   The roadmap states that EPA plans to implement this action item during the summer of 2022.

There is an ongoing goal of completing toxicity assessments for two PFAS known as GenX chemicals.  EPA also has a goal to publish health advisories for GenX chemicals and PFBS in Spring 2022.

Other actions under TSCA include

  • Publish national PFAS testing strategy,
  • Review previous decisions on PFAS, and
  • Finalize new PFAS reporting under TSCA Section 8.

TRI

Another key action in the roadmap is for EPA to categorize PFAS on the Toxic Release Inventory (TRI) as “Chemicals of Special Concern” and to remove the de minimis eligibility from supplier notification requirements for all Chemicals of Special Concern.  Adding PFAS to TRI has a projected completion goal of 2022.

CWA

The roadmap calls for restricting PFAS discharges from industrial sources through a multi-faceted Effluent Limitations Guidelines (ELG) program.  EPA plans to undertake rulemaking to restrict PFAS discharges from organic chemicals, plastics and synthetic fibers, metal finishing, and electroplating operations.  A proposed rule for plastics and synthetic fibers is expected in Summer 2023, and a rule for metal finishing and electroplating is expected in Summer 2024.  Other industries EPA is considering issuing PFAS ELGs for include electrical and electronic components, textile mills, and landfills.

SDWA

EPA has goal to establish a national primary drinking water regulation for PFOA and PFOS.  EPA regulates drinking water for over 90 contaminants but that does not include any for PFAS.  EPA expects to issue a proposed regulation in Fall 2022.  The agency has a statutory deadline of March 2023 to complete this action.

Superfund

EPA is developing a Notice of Proposed Rulemaking to designate PFOA and PFOS as CERCLA hazardous substances.  This would require facilities to report on PFOA and PFOS releases that meet or exceed set reportable quantities.  The proposed rulemaking will be available for public comment in Spring 2022.   EPA is also asking for public comment on designating additional PFAS as hazardous substances under CERCLA.

CAA

The Clean Air Act requires EPA to regulate emissions of hazardous air pollutants, which do not currently include PFAS.  EPA plans to identify sources of PFAS air emissions, concentration levels, and cost-effective mitigation technologies.

ATSDR Announces Development of the Set 24 Toxicological Profiles

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ATSDR:

On September 9, the Agency for Toxic Substances and Disease Registry (ATSDR) of the Department of Health and Human Services announced the development of the Set 24 Toxicological Profiles.   According to the Federal Register notice, the profiles will be available to the public for review and comment on or about October 17, 2010.

ATSDR develops these profiles to fulfill its obligations under the Superfund Amendments and Reauthorization Act of 1986 (42 U.S.C. 9601 et seq.), which amended the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA) (42 U.S.C. 9601 et seq.)  Among the statutory requirements is a mandate for the Administrator of ATSDR to prepare toxicological profiles for each substance included on the Priority List of Hazardous Substances.  This list names 275 hazardous substances found at National Priorities List (NPL) sites that pose the most significant potential threat to human health as determined by ATSDR and EPA.  The list is not a list of “most toxic” substances, but rather a prioritization of substances based on a combination of their frequency, toxicity, and potential for human exposure at NPL sites.

The profiles are used to set cleanup priorities at waste sites, but the EPA also uses them to support regulatory actions under the Toxic Substances Control Act (TSCA) and other statutes.  Thus, companies manufacturing, processing, and using chemicals, as well as environmental and public health groups, are frequently interested in the development of ATSDR Toxicological Profiles.

The Set 24 Toxicological Profiles

The following toxicological profiles are now being developed:

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Toxicological profile                     CAS number
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Toxaphene………………………………………..       8001-35-2
Trichlorobenzene*
1,2,3-Trichlorobenzene…………………………         87-61-6
1,2,4-Trichlorobenzene…………………………        120-82-1
1,3,5-Trichlorobenzene…………………………        108-70-3
Trichlorobenzene…………………………..      12002-48-1
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* Denotes new profile.