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On September 23, 2025, EPA proposed 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 proposed 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. After considering public comments, EPA intends to promulgate a final rule in 2026.

Statement of Need: EPA reviewed the May 3, 2024, final rule entitled Procedures for Chemical Risk Evaluation Under the Toxic Substances Control Act ("2024 final rule"), which amended the July 20, 2017, final rule entitled Procedures for Chemical Risk Evaluation Under the Amended Toxic Substances Control Act ("2017 final rule") that established procedures and requirements for chemical risk evaluation under TSCA, in consideration of: the statutory text and structure and congressional intent; Executive Order 14219, "Ensuring Lawful Governance and Implementing the President's 'Department of Government Efficiency' Deregulatory Initiative," which directs agencies to initiate a process to review existing rules for consistency with law and Administration policy and to identify certain regulations for potential rescission or modification (90 FR 10583, February 19, 2025); and Executive Order 14303, "Restoring Gold Standard Science" (90 FR 22601, May 23, 2025). As a result of this review, the Agency proposed targeted amendments to the 2024 final rule and associated regulatory text.

Summary of the Legal Basis: TSCA section 6(b)(4) directed EPA to establish the process for conducting risk evaluations on chemical substances under TSCA to identify any unreasonable risk of injury to health or the environment. 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. See FDA v. Wages & White Lion Invs., L.L.C., 145 S. Ct. 898, 917 (2025); FCC v. Fox Television Stations, Inc., 556 U.S. 502, 515 (2009); Motor Vehicle Mfrs. Ass'n v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29, 42 (1983). EPA is proposed 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.

Alternatives: Alternatives will not be developed as part of the rulemaking.

Anticipated Costs and Benefits: The incremental impacts of the proposed rule are associated with revisions to procedural requirements that apply to manufacturers when manufacturers (including importers) voluntarily request that EPA perform a risk evaluation on a particular chemical substance. The total estimated annual burden is 166 hours and $91,831 (per year), which is based on an estimated per request burden of 166 hours. Because this proposed action focuses on the activities that a manufacturer must perform in voluntarily requesting a risk evaluation, the estimated incremental costs to the public are expected to be negligible. However, there are Paperwork Reduction Act (PRA) related burden and costs if industry chooses to submit a manufacturer requested risk evaluation to the Agency. This rulemaking is expected to reduce the regulatory burden associated with these submissions resulting in an estimated PRA activity cost savings of $23,880 per year (assuming one submission per year) as compared to the 2024 final rule.

Risks: This is a procedural rule related to risk evaluations and is not intended to directly address any particular risk. However, the rule would establish procedures by which EPA will evaluate whether a chemical substance presents an unreasonable risk of injury to health or the environment under its conditions of use, including unreasonable risks to potentially exposed or susceptible subpopulation. Rigorous procedures that support accurate identification of unreasonable risks are necessary to inform subsequent risk management action.