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The EPA is considering a proposed rule to amendments to the Toxic Substances Control Act (TSCA) regulation for reporting and recordkeeping requirements for perfluoroalkyl and polyfluoroalkyl substances (PFAS). As promulgated in October 2023, the regulation requires manufacturers (including importers) of PFAS in any year between 2011-2022 to report certain data to EPA related to exposure and environmental and health effects. EPA plans to propose the incorporation of certain exemptions and other modifications to the scope of the reporting rule.

Statement of Need:

This rulemaking is needed to address the data gaps related to PFAS exposure and environmental effects. The Agency would request information from manufacturers between the years 2011-2022 for information on PFAS.

Summary of the Legal Basis:

EPA is proposing this rule pursuant to its authority in TSCA section 8(a)(7) (15 U.S.C. 2607(a)(7)). The National Defense Authorization Act for Fiscal Year 2020 (NDAA) (Pub. L. 116-92, section 7351) amended TSCA section 8(a) in December 2019, adding TSCA section 8(a)(7), titled “PFAS Data.” TSCA section 8(a)(7) requires EPA to promulgate a rule “requiring each person who has manufactured a chemical substance that is a [PFAS] in any year since January 1, 2011” to report information described in TSCA section 8(a)(2)(A) through (G). TSCA section 8(a)(2)(A) through (G) includes a broad range of information, such as information related to chemical identity and structure, production, use, byproducts, exposure, disposal, and health and environmental effects.

Alternatives:

EPA is proposing an alternative approach to the data collection rule it finalized on October 11, 2023 (88 FR 70516 (FRL-7902-02-OCSPP). EPA is proposing to amend the one-time PFAS reporting and recordkeeping regulation) to incorporate the following exemptions to the scope of reportable manufacturing activities: a de minimis exemption of 0.1%; imported articles; byproducts; impurities; research and development (R&D); and non-isolated intermediates. These exemptions would maintain important reporting on PFAS, consistent with statutory requirements, while exempting reporting on activities about which manufacturers are least likely to know or reasonably ascertain.

Anticipated Costs and Benefits:

Under the proposed rule, EPA estimates a total industry burden reduction of 10-11 million fewer total hours, or a cost savings of $786-843 million compared to the October 11, 2023, TSCA section 8(a)(7) final rule (88 FR 70516) (FRL-7902-02-OCSPP) requirements. Affected small businesses are expected to be relieved of 9.3-9.9 million total hours, or $703-761 million in costs. The Agency is not expected to incur incremental costs. The total incremental social cost savings of the proposed rule compared to the October 11, 2023, TSCA section 8(a)(7) final rule (88 FR 70516) (FRL-7902-02-OCSPP) is therefore estimated to be approximately $786-843 million.

Risks:

This is a data collection rule and the EPA will use the information collected on PFAS to determine future risk management efforts. In the future, EPA may issue risk management requirements so that this chemical substance no longer presents an unreasonable risk. For more information, visit: https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/risk-management-existing-chemicals-under-tsca.