Procedures for Chemical Risk Evaluation Under the Toxic Substances Control Act (TSCA)

ENVIRONMENTAL PROTECTION AGENCY <CFR>40 CFR Part 702</CFR> <DEPDOC>[EPA-HQ-OPPT-2025-0260; FRL-8529.1-01-OCSPP]</DEPDOC> <RIN>RIN 2070-AL27</RIN> <SUBJECT>Procedures for Chemical Risk Evaluation Under the Toxic Substances Control Act (TSCA)</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Environmental Protection Agency (EPA). <HD SOURCE="HED">ACTION:</HD> Proposed rule. <SUM> <HD SOURCE="HED">SUMMARY:</HD> The U.S. Environmental Protection Agency (EPA, “the Agency”) is proposing to amend the procedural framework rule for conducting existing chemical risk evaluations under the Toxic Substances Control Act (TSCA). When conducting an existing chemical risk evaluation under TSCA, EPA must determine whether a chemical substance presents an unreasonable risk of injury to health or the environment, without consideration of costs or non-risk factors, including unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant to the risk evaluation, under the conditions of use. In this action, EPA proposes to rescind or revise certain 2024 amendments to the procedural framework rule to effectuate the best reading of the statute and ensure that the procedural framework rule does not impede the timely completion of risk evaluations or impair the effective and efficient protection of health and the environment. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> Comments must be received on or before November 7, 2025. Under the Paperwork Reduction Act, comments on the information collection provisions are best assured of consideration if the Office of Management and Budget (OMB) receives a copy of your comments on or before October 23, 2025. </EFFDATE> <HD SOURCE="HED">ADDRESSES:</HD> Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2025-0260, through the Federal eRulemaking Portal at <E T="03">https://www.regulations.gov.</E> Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at <E T="03">https://www.epa.gov/dockets.</E> <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> <E T="03">For technical information contact:</E> Kelly Summers, Existing Chemicals Risk Management Division, Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: (202) 564-2201; email address: <E T="03">TSCA_Framework_Rule@epa.gov.</E> <E T="03">For general information contact:</E> The TSCA Assistance Information Service Hotline, Goodwill of the Finger Lakes, 422 South Clinton Ave., Rochester, NY 14620; telephone number: (800) 471-7127 or (202) 554-1404; email address: <E T="03">TSCA-Hotline@epa.gov.</E> </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <HD SOURCE="HD1">I. Executive Summary</HD> <HD SOURCE="HD2">A. Does this action apply to me?</HD> EPA is proposing to amend procedural requirements that apply to the Agency's activities in conducting risk evaluations under TSCA section 6(b) (15 U.S.C. 2605(b)). As part of this action, EPA is proposing certain amendments to the process and requirements that manufacturers (including importers) would be required to follow when requesting that the Agency conduct a risk evaluation on a particular chemical substance. You may be potentially affected by this action if you manufacture or import chemical substances regulated under TSCA. Since other entities may also be interested, the Agency has not attempted to describe all the specific entities and corresponding North American Industrial Classification System (NAICS) codes for entities that may be interested in or affected by this action. The following list of NAICS codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this proposed action would apply to them. Potentially affected entities may include: • Petroleum Refineries (NAICS code 324110); • Chemical Manufacturing (NAICS code 325); • Unlaminated Plastics Film and Sheet (except Packaging) Manufacturing (NAICS code 326113); • Unlaminated Plastics Profile Shape Manufacturing (NAICS code 326121); • Plastics Pipe and Pipe Fitting Manufacturing (NAICS code 326122); • Laminated Plastics Plate, Sheet (except Packaging), and Shape Manufacturing (NAICS code 326130); • Polystyrene Foam Product Manufacturing (NAICS code 326140); • Urethane and Other Foam Product (except Polystyrene) Manufacturing (NAICS code 326150); • Plastics Bottle Manufacturing (NAICS code 326160); • Plastics Plumbing Fixture Manufacturing (NAICS code 326191); • All Other Plastics Product Manufacturing (NAICS code 326199); • Tire Manufacturing (except Retreading) (NAICS code 326211); • Tire Retreading (NAICS code 326212); • Rubber and Plastics Hoses and Belting Manufacturing (NAICS code 326220); • Rubber Product Manufacturing for Mechanical Use (NAICS code 326291); • All Other Rubber Product Manufacturing (NAICS code 326299); • Pottery, Ceramics, and Plumbing Fixture Manufacturing (NAICS code 327110); • Clay Building Material and Refractories Manufacturing (NAICS code 327120); • Flat Glass Manufacturing (NAICS code 327211); • Other Pressed and Blown Glass and Glassware Manufacturing (NAICS code 327212); • Glass Container Manufacturing (NAICS code 327213); • Glass Product Manufacturing Made of Purchased Glass (NAICS code 327215); • Cement Manufacturing (NAICS code 327310); • Ready Mix Concrete Manufacturing (NAICS code 327320); • Concrete Block and Brick Manufacturing (NAICS code 327331); • Concrete Pipe Manufacturing (NAICS code 327332); and • Other Concrete Product Manufacturing (NAICS code 327390). If you have any questions regarding the applicability of this proposed action to a particular entity, consult the technical information contact listed under <E T="02">FOR FURTHER INFORMATION CONTACT</E> . <HD SOURCE="HD2">B. What is the Agency's authority for this proposed action?</HD> The statutory authority for this proposed action is TSCA section 6(b)(4)(B), which requires EPA to establish, by rule, a process to conduct risk evaluations that meet applicable statutory requirements (15 U.S.C. 2605(b)(4)(B)). As detailed in Units II.A and II.B of this preamble, EPA originally promulgated the procedural framework rule for risk evaluations under TSCA section 6(b)(4)(B) in 2017 and subsequently revised the procedural framework rule in 2024. Unless provided otherwise by law, agencies may reconsider, revise, or rescind prior rules by acknowledging the change, offering a reasonable basis for the change, and taking any significant reliance interests into account. <E T="03">See FDA</E> v. <E T="03">Wages & White Lion Invs., L.L.C.,</E> 145 S. Ct. 898, 917 (2025); <E T="03">FCC</E> v. <E T="03">Fox Television Stations, Inc.,</E> 556 U.S. 502, 515 (2009); <E T="03">Motor Vehicle Mfrs. Ass'n</E> v. <E T="03">State Farm Mut. Auto. Ins. Co.,</E> 463 U.S. 29, 42 (1983). For the reasons set out in Units II and III of this preamble, EPA is proposing to rescind or revise many of the changes made through the 2024 amendments to effectuate the best reading of the statute and address serious concerns arising from Agency and stakeholder experience in application of the amended procedural framework rule. EPA is not currently aware of any significant reliance interests in the 2024 amendments to the procedural framework rule at issue in this proposal, which remain fairly recent and apply almost exclusively to internal Agency process. EPA seeks comment on the changes proposed in this action, including on whether stakeholders have any significant reliance interests on the 2024 amendments at issue and, if so, how such interests should be accounted for in any final action. <HD SOURCE="HD2">C. What action is the Agency proposing to take?</HD> EPA is proposing to amend the procedural framework rule that governs how the Agency conducts risk evaluations on existing chemical substances under TSCA section 6(b) (15 U.S.C. 2605(b)). These proposed amendments are specifically targeted towards changes made in the 2024 final rule that may not be consistent with the best reading of TSCA and that may impede the timely completion of risk evaluations and unnecessarily impair the effective and efficient protection of health and the environment. Provisions being reconsidered include whether TSCA necessitates a single risk determination for each chemical substance evaluated versus a risk determination for each condition of use of the given chemical substance, outlined in Unit III.B; whether EPA must evaluate all conditions of use and all exposure routes and pathways in a risk evaluation, outlined in Unit III.A.3; whether and how the use of personal protective equipment and engineering and administrative controls in an occupational work environment should be considered, outlined in Unit III.C.1; certain regulatory definitions and whether regulatory definitions should be broader than the statutory definitions, outlined in Unit III.D.2; and what process EPA should follow when reconsidering aspects of a risk evaluation, outlined in Unit III.E. EPA is also proposing certain amendments to the process and requirements that manufacturers (including importers) would be required to follow when they request an Agency-conducted TSCA risk evaluation on a particular chemical substance, outlined in Unit III.F. Specifically, EPA is proposing to amend the regulations at: 40 CFR 702.31 so that the changes to the procedures as part of this rulemaking would be applied to all risk evaluations initiated on or after the date of the final rule ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 209k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━