The U.S. Environmental Protection Agency on December 4 finalized amendments to the regulations that govern the Agency’s review of new chemicals under the Toxic Substances Control Act (TSCA) to ensure that new per- and polyfluoroalkyl substances (PFAS) and persistent, bioaccumulative and toxic (PBT) chemicals with potential for human exposure are always subject to the full, robust safety review process prior to manufacture.
Under TSCA, the EPA plays an important role by reviewing the potential risks of new chemicals before they can enter U.S. commerce and, when necessary, putting safeguards in place to protect human health and the environment. The final rule also improves efficiency and aligns with the 2016 bipartisan TSCA amendments under the Frank R. Lautenberg Chemical Safety for the 21st Century Act, and is largely similar to the rule the EPA proposed in May 2023.
This final rule ensures that new PFAS are always subject to the full, robust safety review process prior to manufacture by eliminating their eligibility for a low volume exemption (LVE) or low release and exposure exemption (LoREX). Existing regulations allow the EPA to grant safety review exemptions for the manufacturing of chemicals with low production quantities, environmental releases, or human exposures. These exemptions allow the chemicals (which historically have included some PFAS) to undergo a shorter review instead of the full, robust review prior to manufacture.
This rule will go into effect 30 days after publication in the Federal Register.
Click here to read a prepublication version of the rule.
Click here for more information on the rule.