The U.S. Environmental Protection Agency (EPA) announced on May 16, 2023, that it will propose amendments to the new chemicals procedural regulations under the Toxic Substances Control Act (TSCA). According to the pre-publication version of the proposed rule, the amendments are “intended to align the regulatory text with the amendments to TSCA’s new chemicals review provisions contained in the  Frank R. Lautenberg Chemical Safety for the 21st Century Act [Lautenberg],” improve EPA’s efficiency in the review process, and “update the regulations based on existing policies and experience implementing the New Chemicals Program.” EPA states that the proposal includes amendments that would “reduce the need to redo all or part of the risk assessment by improving information initially submitted in new chemicals notices, which should also help reduce the length of time that new chemicals notices are under review.” EPA will also propose several amendments to the regulations for low volume exemptions (LVE) and low release and exposure exemptions (LoREX), which include requiring EPA approval of an exemption notice prior to commencement of manufacture, making per- and polyfluoroalkyl substances (PFAS) categorically ineligible for these exemptions, and providing that certain persistent, bioaccumulative, and toxic (PBT) chemical substances are ineligible for these exemptions, consistent with EPA’s 1999 PBT policy. Publication of the proposed rule in the Federal Register will begin a 60-day comment period. For more information, please read the full memorandum.
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