EPA Announces Final Rule Amending TSCA Risk Evaluation Process

Overview of the New Rule

The Environmental Protection Agency (EPA) has published its Final Rule, which amends the risk evaluation process for chemicals under the Toxic Substances Control Act (TSCA). The new procedures will be effective from July 2, 2024, and will apply to all chemical risk evaluations initiated on or after August 1, 2024. This Final Rule represents a significant shift in how the EPA evaluates chemical risks, impacting a broad range of chemicals.

Key Changes Under the Final Rule

How will the new EPA rule enhance risk evaluation procedures?

1. Real-World Exposure Scenarios: The EPA must now consider multiple exposure pathways and combined risks from multiple chemicals. (40 CFR 702.33)
2. Comprehensive Evaluations: Risk evaluations must include all conditions of use and exposure pathways. (40 CFR 702.49)
3. Worker Risks: Evaluations will now explicitly account for risks to all workers. (40 CFR 702.33)
4. National Security Considerations: Chemical uses critical to national security or infrastructure must be factored in. (40 CFR 702.39)
5. Scientific Integrity: The EPA is required to use the best available science, base decisions on scientific evidence, and undergo peer review. (40 CFR 702.43, 702.45)
6. Fit-for-Purpose Approaches: Risk evaluations will allow for varying types and levels of analysis. (40 CFR 702.41)
7. Single Risk Determination: Evaluations will result in a single risk determination for the chemical substance, rather than for individual conditions of use. (40 CFR 747)
8. Improved Communication: Enhanced standards for communicating chemical risks. (40 CFR 702.41)
9. Revised Procedures: New criteria for revising scope and risk evaluation documents to improve transparency. (40 CFR 702.43)
10. Alignment of Processes: Submission and review processes for manufacturer-requested evaluations will align with EPA-initiated evaluations. (40 CFR 702.49)
11. Consideration of Overburdened Communities: Risk evaluations will explicitly consider overburdened communities. (40 CFR 702.33)

Impact on Chemical Manufacturers and Importers

The Final Rule is expected to increase the complexity and costs of chemical risk evaluations. It also emphasizes environmental justice by factoring in the risks to overburdened communities. Businesses should review the Final Rule and stay informed about chemicals currently under risk evaluation.