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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 trichloroethylene (TCE). 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 has determined that TCE 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-2019-0500, with additional information in docket EPA-HQ-OPPT-2016-0737. EPA's final rule, Trichloroethylene (TCE); Regulation Under the Toxic Substances Control Act (TSCA), published on December 17, 2024, and is in docket EPA-HQ-OPPT-2020-0642.

Statement of Need: As promulgated in December 2024, the TSCA risk management action addressed the unreasonable risk of injury to health presented by trichloroethylene under its conditions of use by requiring various workplace exposure controls for most conditions of use, prohibiting certain industrial and commercial uses, and establishing other requirements. 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: The primary alternative regulatory action considered by EPA combines prohibitions and requirements for a workplace chemical protection program (WCPP). While in some ways it is similar to the proposed regulatory action, the primary alternative regulatory action differed from the proposed regulatory action by providing longer timeframes for prohibitions, and by describing an existing chemical exposure limit (ECEL) based on a different health endpoint (i.e., immunotoxicity instead of developmental toxicity), as part of the WCPP that would be required for the conditions of use of TCE that would be permitted to continue for longer than one year after publication of the final rule until the prohibition compliance dates. EPA requested comment on the primary alternative regulatory action and whether any elements of this primary alternative regulatory action described in this unit should be considered as EPA developed the final regulatory action. EPA also requested comment on the practicability of the timeframes outlined in primary alternative regulatory action compared to the timeframes identified for the proposed regulatory action. For the primary alternative regulatory action, EPA also analyzed the need for additional exemptions for essential uses of open-top and closed-loop batch vapor degreasing for aerospace use (including for rayon fabric scouring for rocket booster nozzle production) as well as narrow tubing used in medical devices. 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, trichloroethylene 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.