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PFOA and PFOS designated as hazardous substances under Superfund

The EPA has finalized a rule to designate PFOA and PFOS – two prevalent PFAS chemicals – as hazardous substances under the federal Superfund law. The designation will kickstart a wide array of actions across the U.S., including cleanups, remediation and litigation. Although a companion enforcement policy intends to exempt certain entities as responsible parties, questions on liability remain.

BY WALKER LIVINGSTON, ESQ | APR 22, 2024 4:31 PM CDT

Background: PFAS

  • Per- and polyfluoroalkyl substances (PFAS) are a group of synthetic organic chemicals that have been used in the U.S. for decades in many different industrial, commercial and consumer applications. These include textiles, high-performance coatings, semiconductor production, and firefighting foams (aqueous film-forming foams, or AFFFs).
  • These chemicals have at least one or two fully fluorinated carbon atoms, where each hydrogen bond has been replaced with a fluorine atom. These carbon-fluorine bonds are extremely strong, allowing the chemicals to repel both water and oil and maintain stability through a wide range of environmental stressors.
  • The EPA has previously defined PFAS as any chemical that contains at least one of the following three structures: (1) R-(CF2)-CF(R’)R’’, where both the CF2 and CF moieties are saturated carbons; (2) R-CF2OCF2-R’, where R and R’ can either be F, O, or saturated carbons; and (3) CF3C(CF3)R’R’’, where R’ and R’’ can either be F or saturated carbons. This means that at least one carbon atom has had all hydrogen atoms replaced with fluorine atoms. However, other groups, like the Organisation for Economic Co-operation and Development (OECD), have also issued their own definitions for PFAS.

Background: CERCLA

  • In 1980, Congress passed the Comprehensive Environmental Response, Compensation and Liability Act ( CERCLA or Superfund), establishing a liability scheme which authorizes the federal government to clean up contaminated sites and force potentially responsible parties (PRPs) to pay for those cleanup costs.
  • Although CERCLA technically grants authority to the President, this authority is delegated to the EPA, which acts as the primary enforcer of the program. Under this program, the government can respond in circumstances where there is an actual or threatened release of a hazardous substance, or of a chemical or pollutant that may endanger public health and welfare, into the environment. Responses fall into two general categories: 1) Removal actions, or short-term actions to address immediate risks; and 2) Remedial actions, or long-term actions meant to completely remove contamination from a site.
  • Section 107 of CERCLA covers liability for four different types of PRPs: (1) current owner or operators of a facility (or vessel), (2) a person who owned or operated a facility at the time hazardous substances were disposed of, (3) a person who arranged for the disposal or treatment of hazardous substances at a facility, and (4) a person who transported hazardous substance for disposal or treatment at a facility.
  • CERCLA liability is strict, retroactive, and joint and several. This means that a polluter is liable whether or not they knew they were polluting. Additionally, the federal government may “look back” on previous polluters at the site and all polluters can be targeted for all costs at the site.

Background: PFAS and CERCLA

  • In late 2021, the EPA published the PFAS Strategic Roadmap for 2021-2024, which noted the intention to include certain PFAS under CERCLA. Under the roadmap – which set timelines for developing new policies and researching the impacts of these chemicals – the Office of Land and Emergency Management declared its intention to designate perfluorooctanoic acid (PFOA) (CAS RN 335-67-1) and perfluorooctanesulfonic acid (PFOS) (CAS RN 1763-23-1) as hazardous substances under CERCLA. These designations were to be issue in a proposed rule in Spring 2022, with a final rule in Summer 2023.
  • The proposed rule (although released on a slight delay in September 2022) followed through with the intended plan to designate PFOA and PFOS under CERCLA, noting that the chemicals may present a substantial danger to public health or welfare. These dangers included several adverse human health effects, such as high cholesterol, changes in liver enzymes, decreased immune response to vaccination, thyroid disorders, and cancer. Per the EPA, the weight of the evidence was more than sufficient to satisfy the CERCLA Section 102(a) standards. The proposed rule received over 64,000 comments, of which slightly over 600 were posted to the Regulations.gov docket.
  • On December 6, 2023, the Office of Information and Regulatory Affairs (OIRA) received the final rule for review. The office typically takes slightly under 90 days to review EPA rules. However, the CERCLA designation took much longer, with the office completing its review of the regulation 129 days later on April 12.
  • On March 20, 2024, the Senate Committee on Environment & Public Works (EPW) held a hearing focused on this very topic, entitled Examining PFAS as Hazardous Substances. The hearing was led by Chairman TOM CARPER (D-Del.) and Ranking Member SHELLEY MOORE CAPITO (R-W.Va.). Although legislators and testifying witnesses alike broadly agreed on the plan to designate PFOA and PFOS as hazardous substances, they disagreed on some specifics, such as how that designation and the resulting litigation to recover cleanup costs should work. Both Carper and Capito highlighted the urgency of PFAS regulations while citing concerns about public utilities which may receive PFAS being unintentionally swept into CERCLA litigation. [ See AgencyIQ’s in-depth review of the hearing here].
  • One possible solution discussed at the hearing: Grant blanket exemptions to “passive receivers” of PFAS. Two witnesses testified in support of a Congressional exemption for landfills, water utilities and other receivers of PFAS that do not manufacture the substances. However, another witness argued that the exemptions should be handed out on a case-by-case basis after the entity has settled with the federal government, where it could be covered by another exemption. The previous two witnesses responded skeptically to this proposal, noting that the federal government is often slow and inefficient at processing these settlements which may present significant obstacles for receivers to reduce their liability.

Now, the final rule has been released

  • On April 19, 2024, the EPA announced the final rule, releasing a prepublication version and enforcement discretion policy alongside a news release. The rule follows through with the proposed plan to designate PFOA and PFOS as hazardous substances under CERCLA, for two reasons: (1) these substances may present a substantial danger to public health and welfare or the environment when released; and (2) under a “totality of the circumstances analysis,” designation is warranted. The rule will be effective 60 days after it is published in the Federal Register, which will likely be in the next two weeks.
  • In the rule, the agency explained that it had considered “the substantial evidence, based on epidemiological and toxicological studies,” that human exposure to PFOA and PFOS is linked to adverse health effects and that the substances persist in the environment and bioaccumulate in humans and other organisms. Additionally, information on the frequency, nature and geographic scope of the release of PFOA and PFOS was also considered, as well as evidence that the chemicals had been detected in a wide range of plants, animals, humans and environmental matrices around the country. Specifically, the EPA concluded that PFOA and PFOS may present a substantial danger when released based on the “potential for harm to human health, evidence of persistence and bioaccumulation, and high likelihood of exposure.”
  • Human health effects: Utilizing both animal toxicological and epidemiological studies, the agency noted that PFOA and PFOS exposure may lead to many different adverse health effects, including cancers, pregnancy-induced hypertension, and decreased immune responses to vaccination.
  • Environmental dangers: Due to the environmental prevalence of PFOA and PFOS, as well as their ability to migrate from a contaminated site into sources of drinking water, the EPA concluded that both substances may present a substantial danger to the environment. These factors all combine to create a situation in which an extended duration of contamination will result in a larger plume of contamination and increased opportunities for exposure; this growth will continue unless the source is properly contained or remediated.
  • “Totality of the circumstances”: This analysis, which was not presented in the proposed rule, was conducted by the EPA under its independent discretion. Although the exact reason for the analysis was not provided, it may have stemmed from concerns about legal challenges to the rule. The analysis evaluated the “core problem” of PFOA and PFOS exposures, and whether designation would “ meaningfully improve” the ability to combat the problem. Since designating the substances as hazardous will allow use of the full suite of CERCLA enforcement authorities, the agency will be capable of designating more sites and will also be better able to pursue PRPs for remediation costs. The agency explained that the designation expands the available “societal resources (both financial and human capital).”

What the rule will require immediately

  • There is no immediate response action required once a chemical is designated, although the rule adds many future requirements. Once effective, the regulation will require that facilities notify the National Response Center within 24 hours of the release of at least one pound of PFOA or PFOS, their salts, or structural isomers (the statutory default amount, which the EPA did not proposed to change). The regulation will also require that owners or operators “provide reasonable notice to potential injured parties by publication in local newspapers serving the affected area” once a release has occurred.
  • Federal agencies that transfer or sell federal property must also provide notice of PFOA or PFOS that was stored, released or disposed of on the property. The entity must also provide assurances that it has either cleaned up any contamination or will remediate any resulting contamination in the future if required under the CERCLA statute. Additionally, the Department of Transportation will need to list and regulate PFOA and PFOS as hazardous materials under the Hazardous Materials Transportation Act.

Enforcement discretion policy

  • A companion PFAS Enforcement Discretion Policy, published the same day as the rule, details plans for enforcement. The agency announced its intent to target entities that “significantly contributed to the release of PFAS into the environment, including parties that manufactured PFAS or used PFAS in the manufacturing process, federal facilities, and other industrial parties.” Conversely, the agency does not intend to pursue community water systems and publicly owned treatment works (POTWs), municipal separate storm sewer systems (MS4s), publicly owned or operated municipal solid waste (MSW) landfills, publicly owned airports and local fire departments, and farms where biosolids are applied.
  • Acknowledging the concerns discussed at the March EPW hearing, the EPA clarified that its enforcement discretion is wide, and that it will focus on holding accountable parties that actually manufactured PFAS or played a significant role into releasing the substances into the environment, rather than targeting water systems and other passive receivers of PFAS. In fact, the policy dedicates a section to each of the five parties which will be the recipients of enforcement discretion, providing an explanation as to why each should not be pursued by the agency.
  • A list of factors will be used to determine whether additional entities may qualify for enforcement discretion. The first two factors consider whether the entity is a government or provides a government service, and whether it performs a “public service role,” such as providing drinking water or disposing or reactivating pollution control residuals. The third and fourth factors (likely of the greatest importance) consider whether the entity had a hand in manufacturing PFAS or using it as part of an industrial process, as well as whether the entity is still actively involved in the “use, storage, treatment, transport, or disposal of PFAS.”
  • The agency plans to seek settlement agreements with these parties that will provide future contribution protection. Specifically, the EPA seeks to resolve its liability with these parties and ensure that the parties “will not be liable for third-party contribution claims related to the matters addressed in the settlement.” This will involve developing settlement approaches that allow the targeted entities to more quickly exit the CERCLA contribution process, avoiding significant time and litigation costs.

Expected impacts of the rule

  • The official designation of PFOA and PFOS as hazardous substances will have widespread effects throughout industry. For example, it may push manufacturers and users of PFAS to electively pursue methods to reduce environmental release.
  • This designation likely marks the beginning of a much wider set of enforcement actions, cleanups and remediation efforts for different PFAS beyond PFOA and PFOS. And the EPA’s continued efforts in assessing the environmental and health effects of discrete PFAS means that many more substances could be designated as hazardous in the future, widening the scope of facilities which could be designated under the Superfund law and the scope of owners and operators of facilities responsible for contribution. The next steps taken with these first two designated chemicals will set a baseline for how entities will react to designations in the future.
  • However, the EPA may have limited ability to effectively enforce the new rule. The EPA’s budget shrank in fiscal year 2024 even as most federal employees received a pay raise, further slashing the agency’s spending power for specific projects. To institute a powerful enforcement regime for PFOA and PFOS, staff may need to be pulled from other projects, which could cause existing enforcement regimes to languish.
  • New funding methods for the Superfund law may also introduce bumps in the road. According to E&E News, the EPA took in about $1.2 billion in Superfund tax receipts in 2024, less than half of what was expected; tax receipts expected in 2025 are only $2.2 billion. These taxes went into effect in 2022, with a focus on providing better and more consistent funding for the Superfund program. However, with the lower projections and collections, the EPA may face additional budget woes as it attempts to deal with PFOA and PFOS contamination.
  • Although the agency laid out an enforcement discretion plan for certain entities, that policy is neither official agency regulation nor required in statute, meaning it could be walked back at any time. Importantly, even if an entity is ultimately not required to contribute to the costs of remediating PFOA or PFOS contamination, it would still be responsible for the litigation costs incurred while fighting against those contribution claims. Therefore, the policy requires that the target parties settle with the agency as fast as possible to reduce the potential for expensive litigation.
  • That policy also does not exempt the parties from reporting requirements for releases of PFOA or PFOS, which may result in additional capital costs for the construction of notification systems (if those systems do not already exist). Thus, although the enforcement discretion policy is likely welcomed by many impacted entities, it may not provide the full level of desired protection.

To contact the author of this analysis, please email Walker Livingston ( [email protected]).
To contact the editor of this analysis, please email Chelsey McIntyre ( [email protected]).

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