EPA Action on PFAS Regulation

The U.S. Environmental Protection Agency (EPA) announced it has granted a petition under Section 21 of the Toxic Substances Control Act (TSCA). The petition requests the establishment of regulations under TSCA Section 6 to prohibit the manufacturing, processing, use, distribution, and disposal of three per- and polyfluoroalkyl substances (PFAS)—specifically perfluorooctanoic acid (PFOA), perfluorononanoic acid (PFNA), and perfluorodecanoic acid (PFDA)—that are formed during the fluorination of plastic containers. The EPA stated it will "promptly commence an appropriate proceeding under TSCA Section 6" to address these concerns.

The EPA's decision builds upon previous actions regarding PFAS. On December 1, 2023, the agency issued orders to Inhance Technologies, L.L.C., prohibiting the production of PFAS in its fluorinated high-density polyethylene (HDPE) plastic containers. The orders targeted PFOA, PFNA, and PFDA due to their highly toxic nature. However, these orders were challenged by Inhance and vacated by the U.S. Court of Appeals for the Fifth Circuit on March 21, 2024. The court found that EPA had exceeded its authority by issuing orders under Section 5 instead of Section 6, given that Inhance’s fluorination process was not a "significant new use" under TSCA.

Court’s Decision and EPA’s Response

The Fifth Circuit court’s decision does not preclude the EPA from regulating Inhance’s fluorination process but requires the agency to proceed under TSCA Section 6. The court emphasized that the EPA must adhere to procedural requirements and conduct a cost-benefit analysis for ongoing uses. Following this ruling, the EPA has opted to use its Section 6 authority to regulate the PFAS in question.

Details of the TSCA Section 21 Petition

The petition granted by the EPA on July 10, 2024, highlights the need to address risks from PFOA, PFNA, and PFDA formed during the fluorination of plastic containers. The EPA will evaluate several aspects:

- The number, location, and uses of fluorinated containers in the U.S.
- Alternatives to the fluorination process that generates these PFAS.
- Measures to mitigate risks associated with PFOA, PFNA, and PFDA.

This decision reflects a broader trend of utilizing TSCA’s citizen petition provision, as discussed at the TSCA Reform — Eight Years Later program on June 26, 2024.

Implications and Next Steps

The EPA’s decision is a significant step toward addressing environmental and health risks associated with PFAS. The agency will now begin an official rulemaking process under TSCA Section 6, which will involve collecting detailed information and assessing the impact of these substances. This action is part of a larger effort to manage risks associated with PFAS in various applications.

Commentary

The granting of the Section 21 petition underscores the value of TSCA’s citizen petition mechanism, especially in light of the recent legal challenges. The EPA’s move to proceed with a Section 6 rulemaking, as directed by the court, signals a commitment to regulatory actions that address potential hazards from long-standing industrial processes. The upcoming rulemaking will provide clarity on how the EPA will address these risks and whether the evidence supporting the petition meets the requirements for regulation under TSCA Section 6.

 

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