The U.S. Environmental Protection Agency (EPA) has released a final rule amending the procedural framework for conducting risk evaluations under the Toxic Substances Control Act (TSCA). Published in the Federal Register on May 3, 2024, this final rule revises certain framework aspects to better align with the statutory text, applicable court decisions, and EPA's experience since the 2016 TSCA amendments. The rule cited as 89 Fed. Reg. 37028, will take effect on July 2, 2024.

General Provisions

The amended general provisions at 40 C.F.R. Section 702.31 will apply to all risk evaluations initiated 30 days after the final rule's effective date. For manufacturer-requested risk evaluations (MRREs) in progress as of the final rule's date, EPA will apply the proposed changes "to the extent practicable," considering statutory requirements and deadlines.
The final rule includes a minor clarification regarding its applicability to risk evaluations on categories of chemical substances in 40 C.F.R. Section 702.31(d). The rule does not dictate how or whether EPA will identify categories for prioritization and risk evaluation. The criteria for establishing categories are specified in TSCA Section 26(c). If EPA categorizes chemicals, it will justify them on a case-by-case basis.

Technical Corrections and Reorganization

The final rule incorporates minor updates, corrections, and general organizational restructuring to improve the readability of provisions. These changes aim to enhance public understanding of EPA's TSCA risk evaluations. The rule reorganizes the sequence and structure of regulatory provisions to distinguish between the components of the risk evaluation clearly, the analytic considerations to be applied, and the associated procedural timeframes and actions. These improvements have been carried out into the final rule.

For more information, please refer to the final rule published in the Federal Register on May 3, 2024.