On December 4, 2024, U.S. Environmental Protection Agency (EPA) finalized amendments to the regulations for the review of new chemicals under Section 5 of the Toxic Substances Control Act (TSCA) to improve efficiency and align with the 2016 bipartisan TSCA amendments. These amendments are intended to promote both innovation while ensuring the safety of any substance prior to entering commerce. The final rule ensures that new per- and polyfluoroalkyl substances (PFAS) and persistent, bioaccumulative and toxic (PBT) chemicals are always subject to a full, robust safety assessment process prior to manufacture. This would be accomplished through the elimination of all eligibility exemptions for PFAS and PBT substances for a low volume exemption (LVE) or low release and exposure exemption (LoREX), requiring a full safety review.
The new rule also requires a formal safety determination for all chemical determinations as part of submission process for premanufacture notices (PMNs) for new chemical substances, significant new use notices (SNUNs) for significant new uses, and microbial commercial activity notices (MCANs) for microorganisms with commercial applications. These amendments require that EPA make one of the five specified statutory determinations for each PMN, SNUN, and MCAN prior to starting manufacturing or processing. The regulation was also updated to list of the actions required in association with each determination. The details on the different determinations can be found at: Regulatory Determinations made under Section 5 of the Toxic Substances Control Act (TSCA) | US EPA.
Additional changes were made to improve efficiency in the chemical review process including a clarification of the level of detail required for new chemical notices and amending the procedures for EPA’s review of notices that have errors or are incomplete. Although notices were previously allowed to be amended with information available at the time of submission, EPA will now declare the notice to be incomplete and only restart the review period when the completed notice is received.
This final rule will go into effect 30 days after publication in the Federal Register.
A pre-publication of the final rule can be found at: Microsoft Word – 7906-02_FR_Doc_AA_eSignature_Verified.docx
Published December 5, 2024
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