OMB Approves EPA TSCA Risk Assessment Final Rule

Yesterday, the OMB’s Office of Information and Regulatory Affairs (OIRA) announced that it had approved a final rule from the EPA on “Procedures for Chemical Risk Evaluation Under the Toxic Substances Control Act (TSCA)”. This final rule was submitted to OIRA on March 5^th, 2024. The notice of proposed rulemaking (NPRM) was published on October 30^th, 2023.

According to the Fall 2023 Unified Agenda entry for this rulemaking:

“As required under section 6(b)(4) of the Toxic Substances Control Act (TSCA), EPA published a final rule in 2017 that established a process for conducting risk evaluations to determine whether a chemical substance presents an unreasonable risk of injury to health or the environment, without consideration of costs or other non-risk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation, under the conditions of use. This process incorporates the science requirements of the amended statute, including best available science and weight of the scientific evidence. The final rule established the steps of a risk evaluation process including: scope, hazard assessment, exposure assessment, risk characterization, and risk determination. The Agency has reconsidered the procedural framework rule for conducting such risk evaluations and determined that certain aspects of that framework should be revised to better align with applicable court decisions and the statutory text, to reflect the Agency’s experience implementing the risk evaluation program following enactment of the 2016 TSCA amendments, and to allow for consideration of future scientific advances in the risk evaluation process without need to further amend the Agency’s procedural rule.”

This rule could be published in the Federal Register in the next couple of weeks. I do not expect to fully cover the provisions of the rule, but I will not the publication of the final rule in the appropriate Short Takes post.