Updates to New Chemicals Regulations under the Toxic Substances Control Act
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Rule Summary
In December 2024, EPA finalized amendments to the regulations that govern the Agency’s review of new chemicals under the Toxic Substances Control Act (TSCA) to improve efficiency and align with the 2016 bipartisan TSCA amendments under the Frank R. Lautenberg Chemical Safety for the 21st Century Act.
The final rule ensures that new per- and polyfluoroalkyl substances (PFAS) and other persistent, bioaccumulative, and toxic chemicals 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). This rule amends the regulations by specifying that EPA must make one of the five statutory determinations for each premanufacture, significant new use and microbial commercial activity notice before the submitter may commence manufacturing or processing the new chemical substance. The rule updates the regulations to list the actions required in association with each of those determinations. The rule also makes several other changes to add efficiencies to the new chemicals review process, including clarifying the level of detail needed in new chemical notices and amending the procedures for EPA’s review of notices that have errors or are incomplete.
Rule History
In May 2023, EPA issued proposed amendments to the regulations that govern the Agency’s review of new chemicals under TSCA to improve efficiency and consistency and to align with the 2016 bipartisan TSCA amendments under the Frank R. Lautenberg Chemical Safety for the 21st Century Act.