EPA Releases Proposal to Increase Efficiency, Better Protect Health and the Environment in Chemical Reviews under TSCA
WASHINGTON – Today, U.S. Environmental Protection Agency (EPA) released a proposed rule to revise the process for conducting risk evaluations for chemicals already in commerce under the Toxic Substances Control Act (TSCA). The proposed amendments would ensure that EPA can more efficiently and effectively protect human health and the environment and follow the law while responding to public comments and concerns, including from other Federal agencies, on the current Framework Rule.
“The American public and the businesses that drive our nation’s great economy need to have confidence in the safety of chemicals reviewed by EPA. That’s why today’s proposal lays out a clear, predictable, commonsense approach that’s grounded in the law and the science,” said EPA Administrator Lee Zeldin. “This work is yet another example of how we can and will protect human health and the environment while allowing manufacturing and industrial sectors to thrive.”
On March 10, 2025, EPA announced its intent to reconsider this rule consistent with President Trump’s Executive Order 14219 requiring the review of regulations to ensure consistency with Administration policy and agencies’ statutory authority. The proposed amendments support Administrator Zeldin’s “Powering the Great American Comeback” by ensuring chemicals that are already in the marketplace are reviewed in a way that adheres to Congress’s intent for the law, uses the best available science and provides certainty for the regulated community.
The proposed rule includes the following proposed amendments that address targeted changes to EPA’s process for conducting TSCA risk evaluations made in the 2024 Biden-era regulation titled Procedures for Chemical Risk Evaluation under TSCA (2024 Risk Evaluation Framework Rule):
- A requirement for EPA to make a determination of unreasonable risk for each of the conditions of use within the scope of the chemical’s risk evaluation as dictated by Congress in TSCA, as amended by the Lautenberg Chemical Safety for the 21st Century Act, instead of a single risk determination on the chemical substance as a whole.
- Clarifications as to how EPA will consider occupational exposure controls such as personal protective equipment and industrial controls when conducting risk evaluations and making risk determinations.
- Clarifications regarding EPA’s discretionary authority to determine which conditions of use, exposure routes, and exposure pathways it will consider in a risk evaluation.
- Revisions to certain regulatory definitions to ensure consistency with Executive Order 14303 Restoring Gold Standard Science and to ensure transparency and accountability in conducting risk evaluations.
- Revisions to the procedures and requirements EPA would follow when revising or supplementing risk evaluation documents to better enable EPA to meet the statutory deadlines to assess and manage risk.
- Adjustments to the process and information collection obligations for manufacturers (including importers) for requesting an agency-conducted TSCA risk evaluation.
Upon publication of the Federal Register notice, EPA will accept comments on the rule for 45 days in docket EPA-HQ-OPPT-2025-0260.
Please visit the pre-publication version of the Risk Evaluations for Existing Chemicals under TSCA for more information.