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municipalauthorities.org | 53 EPA R eforms N ew C hemicals R eview P rocess to B etter P rotect P ublic H ealth , P romote E fficiency and C onsistency Final amendments will ensure that new PFAS and persistent, bioaccumulative and toxic (PBT) chemicals are subject to safety review process prior to manufacture WASHINGTON – On December 4, 2024, the U.S. Environmental Protection Agency (EPA) 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, 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. Today’s 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 EPA proposed in May 2023. “EPA’s review of new chemicals should encourage innovation, while also making sure that new chemistries can be used safely before they are allowed to enter commerce,” said Assistant Administrator for the Office of Chemical Safety and Pollution Prevention Michal Freedhoff. “Today, we’ve modernized our chemical reviews and continued to protect people from unsafe new PFAS.” Eliminate Exemptions for PFAS and PBTs with Potential for Human Exposure Today’s 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 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 action furthers the Biden-Harris Administration’s commitment to address the impacts of these “forever chemicals” and advances EPA’s PFAS Strategic Roadmap to confront the serious human health and environmental risks of PFAS. This final rule will help ensure that every community is protected from a potential range of severe health problems, including those that impact workers and children. In April 2021, EPA announced new PFAS would be unlikely to qualify for these exemptions going forward given the complexity of PFAS chemistry, potential health effects, and their longevity and persistence in the environment. As the Agency then explained, it is challenging to complete a review of PFAS exemption submissions in the 30 days the regulations allow. This rule makes new PFAS categorically ineligible for the LVE and LoREX exemptions and makes PBT chemicals ineligible when environmental releases are anticipated or there are potentially unreasonable exposures.