United States: EPA Seeking Public Input On Potential CERCLA Hazardous Substance Designation For Additional PFAS

On April 13, 2023, the US Environmental Protection Agency (EPA or Agency) issued an advance notice of proposed rulemaking (ANPRM),¹ seeking public input regarding potential hazardous substance designation under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA or Superfund),² for the following:

Comments on the ANPRM are due by June 12, 2023. The ANPRM follows the notice of proposed rulemaking (NPRM),³ issued by EPA on September 6, 2022, to designate two PFAS — PFOA and?PFOS, and their salts and structural isomers — as hazardous substances under CERCLA.

If finalized, these rulemakings would have various direct and indirect effects, such as reporting obligations and responsibility for cleanup costs regarding releases of the PFAS substances. A wide range of entities could be impacted by the rulemakings, including manufacturers (including importers) and processors of the PFAS substances or of products that contain the PFAS substances.

Summary of the CERCLA PFAS Rulemakings

CERCLA was enacted to promote the timely cleanup of contaminated sites and to ensure that parties responsible for contamination bear the costs of such cleanups.⁴ Under CERCLA, the federal government has the authority to respond to releases or threatened releases of hazardous substances pollutants and contaminants in order to protect public health, welfare, and the environment.⁵

The term "hazardous substance" is defined in CERCLA § 101(14),⁶ primarily by reference to other environmental statutes. There are two ways that a substance can be defined as a "hazardous" substance under CERCLA. The first is automatic, where a substance is identified as hazardous or toxic pursuant to certain other environmental statutes. The second is where a substance is designated as hazardous pursuant to CERCLA § 102, which states that the EPA Administrator shall promulgate regulations designating as hazardous substances:

On October 18, 2021, EPA announced its PFAS Strategic Roadmap, which lays out a whole-of-agency approach to addressing PFAS.⁸ One of the key actions identified in the roadmap was the development of an NPRM to designate PFOA and PFOS as CERCLA hazardous substances.⁹ EPA explained that the hazardous substance designations would require facilities across the country to report on releases that meet or exceed the reportable quantity assigned to these substances. Additionally, the hazardous substance designations would enhance the ability of federal, ribal, state, and local authorities to obtain information regarding the location and extent of releases. EPA or other agencies could also seek cost recovery or contributions for costs incurred for cleanup.¹⁰

On September 6, 2022, EPA issued an NPRM to designate PFOA and PFOS, including their salts and structural isomers, as CERCLA hazardous substances.¹¹ EPA stated that it believes the totality of evidence regarding PFOA and PFOS demonstrates that they can pose substantial danger to public health or welfare or the environment.¹² According to the Agency, "this level of evidence is more than sufficient to satisfy the CERCLA section 102(a) standard."¹³

EPA explained that, if finalized, the proposed CERCLA hazardous substance designations would have certain direct effects. The first direct effect would involve requiring that any person in charge of a vessel or facility report releases of PFOA and PFOS of one pound or more within a 24-hour period, pursuant to CERCLA section 103.¹⁵ Additionally, under section 304 of the Emergency Planning and Community Right-to-Know Act (EPCRA), owners or operators of facilities would be required to report releases of PFOA and PFOS of one pound or more within a 24-hour period.¹⁶ EPCRA section 304 requires that these facilities submit a follow-up written report within 30 days of the release.¹⁷

The second direct effect would involve requiring federal agencies to meet the property transfer requirements in CERCLA section 102(h), which includes "providing notice of when any hazardous substances 'was stored for one year or more, known to have been released, or disposed of' and covenants concerning the remediation of such hazardous substances in certain circumstances."¹⁸

The third direct effect involves a requirement that substances designated as hazardous under CERCLA be listed and regulated as hazardous materials by the US Department of Transportation under the Hazardous Materials Transportation Act, pursuant to CERCLA section 306(a).¹⁹

EPA stated that, in addition to these direct effects, there would be indirect, downstream impacts of designating PFOA and PFOS as CERCLA hazardous substances. Such indirect impacts could include, for example, EPA responding to releases and threatened releases without making the imminent and substantial danger finding that is required for releases now; EPA requiring potentially responsible parties to address releases that pose an imminent and substantial endangerment to public health or welfare or the environment; EPA recovering cleanup costs from potentially responsible parties; and private parties that conduct cleanups that are consistent with the National Oil and Hazardous Substances Contingency Plan recovering PFOA and PFOS cleanup costs from potentially responsible parties.²⁰

EPA sought comments on the rulemaking. The Agency is currently reviewing the comments received on the NPRM.

On April 13, 2023, EPA issued an ANPRM, seeking input and data to assist in the potential development of future regulations pertaining to the designation of hazardous substances under section 102(a) of CERCLA.²¹ Specifically, EPA is seeking public input regarding the possible designation of the following:

1. Seven PFAS, besides PFOA and PFOS, and their salts and structural isomers, or some subset thereof, which include:
   • Perfluorobutanesulfonic acid (PFBS)
   • Perfluorohexanesulfonic acid (PFHxS)
   • Perfluorononanoic acid (PFNA)
   • Hexafluoropropylene oxide dimer acid (HFPO-DA) (also known as GenX)
   • Perfluorobutanoic acid (PFBA)
   • Perfluorohexanoic acid (PFHxA)
   • Perfluorodecanoic acid (PFDA)
2. Precursors to PFOA, PFOS, and other PFAS listed above
3. Categories of PFAS²²

EPA is seeking public input on its proposal. The ANPRM identifies specific questions and topics of interest, including information relevant to whether the seven compounds may present substantial danger to public health or welfare or the environment.²³ EPA noted that the seven compounds were identified based on the availability of toxicity information previously reviewed by EPA and other federal agencies.²⁴

Regarding the potential future designation of precursors to PFOA, PFOS, and other PFAS, EPA notes that a precursor is "a chemical that is transformed into another compound through the course of a degradation process."²⁵ EPA is seeking input regarding information that will assist the Agency in identifying compounds that degrade to these PFAS through environmental processes, such as biodegradation, photolysis, and hydrolysis.²⁶

Regarding the potential future designation of categories of PFAS, EPA notes that "a group or category refers to a set of PFAS that share one or more similar characteristics."²⁷ Characteristics of interest could include, for example, chemical structure (e.g., carbon chain length, functional group), physical and chemical properties, mode of toxicological action, precursors or degradants, or co-occurrence.²⁸

With respect to the Agency's next steps, EPA stated that it intends to carefully review all comments and information received in response to the ANPRM. Once EPA has completed its review, the Agency will supplement the collected information, as appropriate, with information that EPA has obtained independently, to determine whether a future rulemaking should address the designation of additional PFAS or precursors as CERCLA hazardous substances or whether one or more categories of PFAS can be designated as CERCLA hazardous substances.²⁹ If EPA decides to move forward with designating additional PFAS compounds as hazardous substances under CERCLA, the Agency will publish a proposed rule and seek public comment.³⁰

Additionally, EPA noted that it is already separately developing a CERCLA PFAS enforcement discretion and settlement policy and seeking individual public input on CERCLA PFAS enforcement/liability concerns through two public listening sessions.³¹

Analysis

The NPRM and ANPRM are further indications of the high priority that PFAS has at EPA. If finalized, the proposed CERCLA hazardous substance designations would have various direct effects, including requiring facilities across the country to report on releases of the PFAS substances that meet or exceed the reportable quantity assigned to the substances. The CERCLA hazardous substance designations would also have indirect effects, which could include requiring potentially responsible parties to address releases of the PFAS substances and to pay for, or contribute to, cleanup costs.

Broad categories of entities could potentially be affected by the CERCLA hazardous substance designations, including manufacturers of the PFAS substances (including importers and importers of articles), processors, manufacturers of products containing the PFAS substances, downstream product manufacturers and users of the PFAS products, and waste management and wastewater treatment facilities.

The ANPRM presents some concerns with respect to the scope of the potential CERCLA hazardous designations. For example, the potential designations for precursors to PFOA, PFOS, and the seven PFAS compounds, and for categories of PFAS, are concerning especially if EPA does not provide industry with a defined list of the specific substances that are covered under the rule. This could result in companies unintentionally violating CERCLA.

Conclusion

EPA has issued an NPRM to designate PFOA and?PFOS, and their salts and structural isomers, as hazardous substances under CERCLA. EPA has also issued an ANPRM regarding potential hazardous substance designation of seven other PFAS, and their salts and structural isomers, precursors to PFOA, PFOS, and other PFAS, and categories of PFAS. If finalized, the hazardous substance designations would have various direct and indirect effects on a broad range of entities. Entities that would potentially be affected should consider submitting comments on the ANPRM and should monitor any further developments related to these rulemakings.

Footnotes

1. 88 Fed. Reg. 22,399 (Apr. 13, 2023).

2. 42 U.S.C. §§ 9601 et seq.

3. 87 Fed. Reg. 54,415 (Sept. 6, 2022).

4. Id. at 54,420.

5. Id.

6. 42 U.S.C. § 9601(14).

7. 42 U.S.C. § 9602(a).

8. See EPA, PFAS Strategic Roadmap: EPA's Commitments to Action 2021-2024, https://www.epa.gov/system/files/documents/2021-10/pfas-roadmap_final-508.pdf.

9. Id. at 17.

10. Id.

11. 87 Fed. Reg. 54,415.

12. Id. at 54,417.

13. Id.

14. Id. at 54,416.

15. Id. at 54,429.

16. Id.

17. Id.

18. Id.

19. Id.

20. See id. at 54,418.

21. 88 Fed. Reg. 22,399.

22. Id. at 22,400.

23. Id. at 22,401.

24. Id.

25. Id. at 22,399.

26. Id. at 22,402.

27. Id.

28. Id. at 22,402-03.

29Id. at 22,403.

30. See Press Release, EPA Takes Important Step to Advance PFAS Strategic Roadmap, Requests Public Input and Data to Inform Potential Future Regulations under CERCLA (Apr. 13, 2023), https://www.epa.gov/newsreleases/epa-takes-important-step-advance-pfas-strategic-roadmap-requests-public-input-and-data.

31. 88 Fed. Reg. at 22,401.

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