On Tuesday, May 16, 2023, the U.S. Environmental Protection Agency (EPA) released a prepublication version of a proposed rule instituting reforms to EPA’s regulations implementing the Toxic Substances Control Act (TSCA). EPA maintains a TSCA Chemical Substance Inventory, which lists all chemical substances known to be in commerce in the United States. Under TSCA, manufacturers and importers must submit a premanufacture notice for a new chemical substance unless an exemption applies (e.g., research and development). EPA must complete its risk determination for the new chemical substance before manufacture or import may commence. The proposed rule now makes clear that EPA must complete its risk determination on 100% of new chemical substances or approve an exemption notice before the associated product can enter the market, which aligns with amendments to TSCA made in 2016.
The proposed rule also removes existing exemptions from EPA’s full review process for new per- and polyfluoroalkyl substances (PFAS), categorically prohibiting PFAS manufacturers from relying on the low-volume exemption or the low release and exposure exemption. Removing PFAS from those two exemptions follows EPA’s goals set forth in its 2021-2024 PFAS Strategic Roadmap issued on October 18, 2021. In addition to EPA’s push to increase PFAS-related manufacturing restrictions, California’s passage of Assembly Bill 2771 last year bans the sale of any cosmetic product that contains intentionally added PFAS starting on January 1, 2025.
Finally, the proposed rule adds efficiencies to EPA’s new chemical review process to , most notably, allow EPA to declare premanufacture notices incomplete and restart the review period rather than allowing manufacturers to amend notices submitted with errors or incomplete information known or reasonably ascertainable at the time of initial submission. EPA intends for these efficiencies to promote more complete submissions and reduce the need to redo all or part of its risk assessment; however, it remains to be seen whether EPA’s approach will result in frequent rejections of minor errors and omissions that would otherwise be most efficient to correct without restarting the review period.
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