EPA Designates PFOA and PFOS as CERCLA Hazardous Substances, Releases CERCLA Enforcement Discretion Policy

On April 19, 2024, the U.S. Environmental Protection Agency (EPA) announced a final rule that will designate perfluorooctanoic acid (PFOA), perfluorooctanesulfonic acid (PFOS), and their salts and structural isomers as hazardous substances under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA). EPA states that under the rule, entities are required to report immediately releases of PFOA and PFOS that meet or exceed the reportable quantity (RQ) of one pound within a 24-hour period to the National Response Center (NRC), state, Tribal, and local emergency responders. According to EPA, “[t]he designation of PFOA and PFOS as hazardous substances under CERCLA enables the agency to use one of its strongest enforcement tools to compel polluters to pay for or conduct investigations and cleanup, rather than taxpayers.” EPA issued a separate PFAS Enforcement Discretion and Settlement Policy Under CERCLA (CERCLA Enforcement Discretion Policy) “that makes clear that EPA will focus enforcement on parties who significantly contributed to the release of [per- and polyfluoroalkyl substances (PFAS)] … into the environment, including parties that have manufactured PFAS or used PFAS in the manufacturing process, federal facilities, and other industrial parties.” EPA posted a prepublication version of the final rule, which will take effect 60 days after publication in the Federal Register.

Final Rule

Default RQ

The final rule sets the RQ by operation of law at the statutory default of one pound pursuant to CERCLA Section 102(b) for PFOA, PFOS, and their salts and structural isomers. EPA notes that it did not propose, nor is it including in this final action, an RQ adjustment for these substances. EPA states that if it chooses to propose adjusting the RQ in the future, it will do so through notice-and-comment rulemaking.

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

Release Reporting Requirements

CERLA Section 103 requires any person in charge of a vessel or facility to notify immediately the NRC when there is a release of a hazardous substance, as defined under CERCLA Section 101(14), in an amount equal to or greater than the RQ for that substance. EPA states that as of the effective date of this action, any person in charge of a vessel or facility as soon as he or she has knowledge of a release from such vessel or facility of one pound or more of PFOA or PFOS, their salts, or structural isomers in any 24-hour period is required to notify immediately the NRC in accordance with 40 C.F.R. Section 302.6. CERCLA Section 111(g) requires owners or operators of any vessel or facility to “provide reasonable notice to potential injured parties by publication in local newspapers serving the affected area” of a release of a hazardous substance.

In addition to these CERCLA reporting requirements, Emergency Planning and Community Right-to-Know Act (EPCRA) Section 304 requires owners or operators of facilities to notify immediately their State Emergency Response Commission (SERC) (or Tribal Emergency Response Commission (TERC)) and Local Emergency Planning Committee (LEPC) (or Tribal Emergency Planning Committee (TEPC)) when there is a release at or above the RQ of PFOA or PFOS, their salts, or structural isomers in a 24-hour period. EPCRA Section 304 also requires these facilities to submit a follow-up written report to the SERC (or TERC) and LEPC (or TEPC) within 30 days of the release. EPA states that some states provide less than 30 days to submit the follow-up written report and encourages facilities to contact the appropriate state or Tribal agency for additional reporting requirements.

EPA notes that EPCRA and CERCLA are “separate, but interrelated, environmental laws that work together to provide emergency release notifications to Federal, State, Tribal, and local officials.” Notice given to the NRC under CERCLA serves to inform the federal government of a release so that federal personnel can evaluate the need for a response in accordance with the National Oil and Hazardous Substances Contingency Plan, the federal government’s framework for responding to both oil and hazardous substance releases. The NRC maintains all reports of hazardous substance and oil releases made to the federal government.

Relatedly, release notifications under EPCRA given to the SERC (or TERC) and to the LEPC (or TEPC) are crucial so that these state, Tribal, and local authorities have information to help protect the community.

Requirements upon Transfer of Government Property

Under CERCLA Section 120(h), when federal agencies sell or transfer federally owned, real property, they must provide notice of when any hazardous substance “was stored for one year or more, known to have been released, or disposed of” and covenants concerning the remediation of such hazardous substances in certain circumstances.

Requirement of the U.S. Department of Transportation (DOT) to List and Regulate CERCLA Hazardous Substances

CERCLA Section 306(a) requires substances designated as hazardous under CERCLA to be listed and regulated as hazardous materials by DOT under the Hazardous Materials Transportation Act.

CERCLA Enforcement Discretion Policy

EPA states that the CERCLA Enforcement Discretion Policy is intended to clarify when EPA intends to use its CERCLA enforcement authorities or decide not to pursue a particular party. EPA notes that “[t]his Policy applies only to the exercise of EPA’s enforcement discretion when requiring action to address releases of PFAS under CERCLA; it does not apply to enforcement under other EPA programs or statutes, including other EPA programs that may address PFAS.”

Consistent with CERCLA’s objectives, EPA states that it will focus on holding accountable those parties that have played a significant role in releasing or exacerbating the spread of PFAS into the environment, “such as those who have manufactured PFAS or used PFAS in the manufacturing process, and other industrial parties.” For purposes of the CERCLA Enforcement Discretion Policy only, EPA refers to these parties as major potentially responsible parties (PRP). EPA also intends to pursue federal agencies or federal facilities when they are responsible for PFAS contamination. EPA intends to pursue major PRPs and federal agencies to conduct investigations and cleanup to protect communities from high-risk, high-concentration PFOA and PFOS exposures.

EPA states that it does not intend to pursue otherwise PRPs where equitable factors do not support seeking response actions or costs under CERCLA, including, but not limited to, the following entities:

• Community water systems and publicly owned treatment works (POTW);

• Municipal separate storm sewer systems (MS4);

• Publicly owned/operated municipal solid waste landfills;

• Publicly owned airports and local fire departments; and

• Farms where biosolids are applied to the land.

EPA states that it may extend enforcement discretion under the CERCLA Enforcement Discretion Policy to additional parties even if they do not fall within the categories listed above, based on equitable factors.

In addition to potential EPA action, EPA states that it understands that entities are concerned about being sued by other PRPs for PFAS cleanup costs under CERCLA. According to EPA, in CERCLA settlements with major PRPs, EPA will seek to require those settling parties to waive their rights to sue parties that satisfy the equitable factors. The major PRPs would then not be able to sue those non-settling parties for matters addressed under the settlement. EPA notes that these settlement protections are consistent with settlement protections regularly applied by EPA in other CERCLA contexts.

According to EPA, consistent with current CERCLA enforcement practice to mitigate these litigation risk concerns, EPA can enter settlements with concerned parties under its statutory authorities when appropriate. EPA states that such settlements would help to mitigate litigation risk concerns and associated costs by providing protection from CERCLA contribution claims by other PRPs seeking a portion of PFAS response costs.

Additional Resources

EPA has posted Questions and Answers about Designation of PFOA and PFOS as Hazardous Substances under CERCLA that address the rule requirements, when the requirements go into effect, whether designation requires response actions (e.g., investigation, cleanup), and how the rule will impact liability. EPA has also posted a factsheet on release notification requirements.

Commentary

The Acta Group (Acta^®) agrees with EPA’s conclusion under CERCLA Section 102(a) that PFOA and PFOS and their salts “may present a substantial danger to public health or welfare or the environment.” We acknowledge, however, that the science upon which EPA relies for its extremely low concern levels has been questioned. For example, the Agency for Toxic Substances and Disease Registry (ATSDR) expressed concerns over EPA’s use of decreased antibody response in humans to vaccination on a different PFAS (i.e., perfluorohexanesulfonic acid) that is applicable to EPA’s identified hazard concerns on PFOA and PFOS. Even though scientists may disagree about what a safe level of exposure to PFOA or PFOS might be, EPA’s designation of both as CERCLA hazardous substances is supportable, even if questions remain, for example, about whether EPA’s default RQ of one pound within a 24-hour period is overly conservative or not conservative enough.

Acta agrees in general with EPA’s use of enforcement discretion. It gives EPA flexibility with administering CERCLA in situations where there would be significant disruption to the economy or significant inequities that arise from enforcement of a rule as written. In this case, EPA promulgated the final rule and immediately drew boundaries around which EPA would not enforce the final rule. We question, however, whether enforcement discretion was the most appropriate means for EPA to address those circumstances as not being worthy of enforcement. We mention this because of the uncertainties with EPA’s decision-making for PFOA and PFOS and its other regulatory initiatives on these substances. For example, EPA did not create exclusions for certain uses of PFOA and PFOS in the final rule, noting that it “believes that section 102(a) [of CERCLA] is best read to preclude exclusions for certain uses of PFOA and PFOS-relative to other uses-without a factual or scientific basis…” EPA is, however, currently conducting a refined risk assessment for PFOA and PFOS in biosolids. We, therefore, question whether EPA has the factual or scientific basis for including PFOA and PFOS in biosolids, until it has completed its risk assessment.

Potential targets of enforcement, such as farms where biosolids were applied, should not take comfort that they will not be the target of future enforcement. EPA could, without further notice or opportunity for comment, begin enforcing against such sites. Our concern is that EPA must immediately rely upon enforcement discretion for equitable enforcement, rather than using exclusions for those instances where the factual or scientific basis are currently lacking. For example, EPA could have exempted application of biosolids under CERCLA Section 101(22), which excludes the typical application of fertilizers from the definition of a release. This approach would have allowed EPA to complete its risk assessment activities on PFOA and PFOS in biosolids and then, if necessary, to determine if it should include this use in a future rulemaking, which would have provided for notice and comment to revise the regulations.

As we stated in our memorandum dated March 17, 2023, Acta anticipates that EPA’s designation of PFOA and PFOS as hazardous substances will lead to significant clean-up costs. We are concerned that EPA’s decision to use enforcement discretion in the final rule may lead to changes in this discretion without notice, thereby expanding the universe of PRPs to accommodate EPA’s preference based on decision-making that is not necessarily grounded in science to support those goals, and entities will not have fair notice of EPA’s change of view.