Advocacy Comments on EPA’s Proposed Changes to its Procedures for Risk Evaluations under TSCA

In 2017, the U.S. Environmental Protection Agency (EPA) published procedures for chemical risk evaluations under TSCA, as amended by the 2016 Frank R. Lautenberg Chemical Safety for the 21st Century Act. This rule established the 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.

EPA announced changes to these procedures in 2021, including expanding the scope of risk evaluation to include exposure pathways otherwise covered by other federal statutes, assuming that personal protective equipment (PPE) would generally not be used in occupational settings, and making unreasonable risk determinations based on each chemical as a whole rather than separately for each the conditions of use of the chemical. On October 30, 2023, EPA published a proposed rule to codify these and other changes. Advocacy held a Small Business Environmental Roundtable on this proposal on November 17, 2023.

On December 14, 2023, Advocacy filed public comments on this proposed rule. Advocacy is concerned that the policy changes EPA announced in 2021 and these proposed risk evaluation procedures create a significant risk that the resulting risk management regulations will impose unnecessary and duplicative burdens on small businesses with minimal public health benefits.

Advocacy recommends that EPA focus its limited resources to bolster outreach and consult with small entities, other federal agencies, and peer reviewers, to better understand the diversity of the conditions of use of each chemical and the risks presented by existing chemicals as they are actually used in commerce.

For more information, please contact Dave Rostker at 202-205-6966, or


Comment Letter, Procedures for Chemical Risk Evaluation under the Toxic Substances Control Act (PDF, 215 KB)