EPA released its 2025 Annual Plan for Chemical Risk Evaluations under TSCA, providing transparency on upcoming regulatory activities. The plan confirms completion of final risk evaluations for DIDP and DINP by December 31, 2024, and documents the designation of five chemical substances as High-Priority for risk evaluation. Compliance teams should use this planning document to anticipate upcoming risk management actions and regulatory timelines for chemicals in their supply chains.
EPA announced availability of the latest update to the non-confidential TSCA Chemical Substance Inventory (Update #7). Inventory updates support determinations of whether a substance is listed as an existing chemical and provide updated activity status and regulatory flags used for compliance screening. Companies should refresh internal Inventory datasets and screening tools used for TSCA Section 5 and import/manufacture compliance checks.
EPA finalized amendments to the new chemicals procedural regulations under TSCA. These amendments 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, enacted on June 22, 2016. The rule improves the efficiency of EPA's review processes and updates the regulations based on existing policies and experience implementing the New Chemicals Program.
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 finalized amendments to the TSCA New Chemicals Regulations (40 CFR Parts 720, 721, 723, and 725). As highlighted by EPA, the changes remove eligibility for certain exemptions (e.g., LVE/LoREX) for PFAS and other PBT chemicals and require EPA to make one of the five statutory determinations for PMNs/SNUNs/MCANs before manufacture/processing begins. Compliance teams submitting PMNs/SNUNs or relying on exemptions should reassess exemption strategies, timelines, and documentation in light of the updated rules.
EPA finalized amendments to the TSCA new chemicals regulations governing EPA’s review of Premanufacture Notices (PMNs) and Significant New Use Notices (SNUNs). The research summary highlights changes that (a) make PFAS and other PBT chemicals ineligible for certain exemptions (e.g., Low Volume Exemption (LVE) / LoREX) and (b) require EPA to make one of the statutory determinations before manufacture/processing may begin. Compliance teams should review impacts on new chemical submissions, exemption strategies, and any PFAS/PBT-related R&D/manufacturing plans, and update internal submission workflows accordingly.
EPA finalized amendments to the TSCA New Chemicals Program regulations (including 40 CFR parts 720, 721, 723, and 725). The update includes substantive procedural and eligibility changes affecting PMNs/SNUNs and exemptions—highlighted in the research as making new PFAS categorically ineligible for Low Volume Exemptions (LVE) and Low Release and Exposure Exemptions (LoREX), and requiring EPA approval of LVE/LoREX notices prior to commencing manufacture. Compliance teams should review internal new-chemical submission workflows, exemption screening logic (including PFAS), and timing assumptions for starting manufacture/import after submissions.
EPA proposed changes to the scope of TSCA 8(a)(7) PFAS reporting regulations. The proposed exemptions apply to: PFAS manufactured (including imported) in mixtures or products at concentrations 0.1% or lower; imported articles; certain byproducts; impurities; research and development chemicals; and non-isolated intermediates. These changes are intended to reduce unnecessary or duplicative reporting requirements for manufacturers.
EPA finalized a rule under TSCA Section 8(d) requiring manufacturers (including importers) of 16 chemical substances to submit unpublished studies on environmental effects and occupational, general population, and consumer exposure. The 16 chemicals include: 4,4-Methylene bis(2-chloraniline) (CASRN 101-14-4), 4-tert-octylphenol (CASRN 140-66-9), Acetaldehyde (CASRN 75-07-0), Acrylonitrile (CASRN 107-13-1), Benzenamine (CASRN 62-53-3), Benzene (CASRN 71-43-2), Bisphenol A (CASRN 80-05-7), Ethylbenzene (CASRN 100-41-4), Hydrogen fluoride, and others.
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.