The U.S. Environmental Protection Agency (USEPA) 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 proposal includes the following amendments that address changes to USEPA’s process for conducting TSCA risk evaluations:
- USEPA is required 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.
- Clarifies how USEPA will consider occupational exposure controls such as personal protective equipment and industrial controls when conducting risk evaluations and making risk determinations.
- Clarifies USEPA’s discretionary authority to determine which conditions of use, exposure routes, and exposure pathways it will consider in a risk evaluation.
- Revises regulatory definitions to ensure consistency with President Donald Trump’s Executive Order 14303 “Restoring Gold Standard Science” and to ensure transparency and accountability in conducting risk evaluations.
- Revises procedures and requirements USEPA would follow when revising or supplementing risk evaluation documents to better enable the regulatory agency to meet statutory deadlines to assess and manage risk.
- Adjusts the process and information collection obligations for manufacturers requesting an USEPA-conducted TSCA risk evaluation.
USEPA will accept comments on the proposed rule via the Federal Register through November 7, 2025.