EPA finalized updates to TSCA New Chemicals Program regulations (40 CFR parts 720, 721, 723, 725). Key compliance impacts include making PFAS categorically ineligible for Low Volume Exemptions (LVE) and Low Release and Exposure Exemptions (LoREX), and requiring EPA approval of LVE/LoREX before manufacture can commence, along with broader procedural updates aligning with Lautenberg amendments. Companies submitting PMNs/SNUNs/MCANs or relying on exemptions should update internal review timelines, exemption eligibility screening (including PFAS determination), and submission completeness processes.
EPA announced a proposal to modify the TSCA §8(a)(7) PFAS reporting and recordkeeping rule to make requirements more practical and implementable. EPA highlighted proposed exemptions/adjustments including: PFAS in mixtures/products at ≤0.1% concentration, imported articles, certain byproducts, impurities, R&D substances, and non-isolated intermediates, plus technical corrections and potential changes to the data submission period. EPA stated comments would be accepted for 45 days upon Federal Register publication. Compliance teams should monitor the proposal because it could materially change which entities (especially article importers) must report and what data must be submitted.