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EPA is considering amendments to certain aspects of the December 2024 Toxic Substances Control Act (TSCA) section 6(a) rule addressing the unreasonable risk presented by perchloroethylene (PCE). Section 6 of TSCA requires EPA to address any unreasonable risk that the Administrator has determined is presented by a chemical substance under the conditions of use. Following a risk evaluation carried out under the authority of TSCA section 6(b), EPA determined that PCE presents an unreasonable risk of injury to health. EPA is initiating a rulemaking to amend previously promulgated provisions to address this unreasonable risk as appropriate. EPA will solicit public comment on potential amendments through a notice of proposed rulemaking. EPA's risk evaluation, describing the conditions of use and presenting EPA's determinations of unreasonable risk, is in docket EPA-HQ-OPPT-2019-0502, with the 2022 revised risk determination and additional information in docket EPA-HQ-OPPT-2016-0732. EPAs final rule, Perchloroethylene (PCE); Regulation Under the Toxic Substances Control Act (TSCA), published on December 18, 2024, and is in docket EPA-HQ-OPPT-2020-0720.

Statement of Need: As promulgated in December 2024, the TSCA risk management action addressed the unreasonable risk of injury to health presented by perchloroethylene under its conditions of use by requiring various workplace exposure controls, prohibiting certain industrial and commercial uses, and preventing consumer access to the chemical, among other provisions. Several legal challenges to the rule were initiated in 2025. EPA determined that the December 2024 risk management rule should be reconsidered and is initiating rulemaking efforts to seek further public comment.

Summary of the Legal Basis: Under TSCA section 6(a) (15 U.S.C. 2605(a)), if EPA determines through a TSCA section 6(b) risk evaluation that a chemical substance presents an unreasonable risk of injury to health or the environment under its conditions of use, EPA must by rule apply one or more requirements listed in TSCA section 6(a) to the extent necessary so that the chemical substance or mixture no longer presents such risk. Unless provided otherwise by law, an agency may change existing positions (e.g., reconsider, revise, or rescind prior actions) so long as it acknowledges the change in position, provides a reasoned explanation for the change, and takes any serious reliance interests into account. See, e.g., FDA v. Wages & White Lion Invs., L.L.C., 145 S. Ct. 898, 917 (2025); Encino Motorcars v. Navarro, 579 U.S. 211, 221 (2016); FCC v. Fox Television Stations, Inc., 556 U.S. 502, 515 (2009).

Alternatives: In accordance with TSCA section 6(c), EPA published a proposed rule in 2023 to address the unreasonable risk of injury to health presented by PCE under its conditions of use that presented a statement based on reasonably available information with respect to the reasonably ascertainable economic consequences of the rule, including consideration of the costs and benefits and the cost effectiveness of the proposed regulatory action and one or more primary alternative regulatory actions considered by the Agency. EPA identified two primary alternative regulatory actions in the proposed rule. The alternative regulatory actions addressed prohibitions and related compliance timeframes; workplace chemical protection program (WCPP) requirements to address risks from inhalation and dermal exposures, and related compliance timeframes; prescriptive controls, including workplace requirements for laboratory use; paperwork requirements; and exemptions. EPA's reconsideration of the December 2024 final rule will include, but may not be limited to, such considerations.

Anticipated Costs and Benefits: EPA will prepare an analysis of the incremental costs and benefits of potential regulatory changes during the rulemaking process.

Risks: As EPA determined in the TSCA section 6(b) risk evaluation, perchloroethylene presents an unreasonable risk of injury to human health under its conditions of use. EPA must issue risk management requirements so that this chemical substance no longer presents an unreasonable risk. For more information, visit: https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/risk-management-existing-chemicals-under-tsca.