EPA Strengthens TSCA Risk Evaluation Process to Protect Workers and Communities

On October 19, 2023, the U.S. Environmental Protection Agency (EPA) introduced a new rule aimed at improving the evaluation of chemical risks under the Toxic Substances Control Act (TSCA). This proposal seeks to align EPA procedures with legal requirements, ensuring comprehensive assessments that safeguard workers and communities.

Key Changes Proposed in the New Rule:

1. Environmental Justice Emphasis: The rule commits to considering disproportionate harms in overburdened communities, including multiple exposure pathways and combined risks from multiple chemicals.
2. Comprehensive Evaluations: Risk evaluations must cover all conditions of use and exposure pathways.
3. Worker Protection: Clear provisions to ensure that risks to workers are properly assessed.
4. Scientific Rigor: EPA will use the best available science for evaluations and base decisions on scientific evidence.
5. Unified Determination: Risk evaluations will culminate in a single determination of unreasonable risk; not individual chemical uses.
6. Transparency and Procedural Requirements: New requirements for transparent risk evaluation document revisions.
7. Adjusted Manufacturer Requested Evaluations: Aligns the process with EPA-initiated evaluations and data collection.

These changes, previously announced in 2021, aim to provide certainty and predictability for EPA and stakeholders. Public comments on the proposed rule will be accepted for 45 days at docket EPA-HQ-OPPT-2023-0496 on www.regulations.gov. This proactive approach is part of a broader effort to ensure the safety of chemical substances and protect the environment and public health.

Background: The Three-Step Process

EPA's risk evaluation process for existing chemicals under TSCA is a structured, three-step procedure that begins with Prioritization, followed by Risk Evaluation, and concludes with Risk Management. The primary objective of the Risk Evaluation step is to determine whether a chemical substance poses an unreasonable risk to human health or the environment under its specific conditions of use.

During this evaluation, several key principles guide the assessment:

1. Hazard and Exposure Assessment: EPA examines both the hazards associated with the chemical, which may include factors such as toxicity and the extent of exposure. This approach disregards non-risk-related factors and ensures that scientific methods align with the best available science and a weight-of-scientific-evidence basis.
2. Initiation of the Risk Evaluation: Risk evaluations can be initiated by the EPA either through the Prioritization process or by accepting a manufacturer's request.
   • EPA-Initiated Risk Evaluations: The EPA, pursuant to the Lautenberg Act, initiated evaluations for the first 10 chemicals in December 2016, chosen from the 2014 Update to the TSCA Work Plan. Subsequently, EPA continues to conduct evaluations on High-Priority Substances designated through the Prioritization process.
3. Components of a Risk Evaluation: The risk evaluation process comprises several key components:
   • Scope of the Risk Evaluation: A draft scope is published in the Federal Register within three months of initiating the risk evaluation, followed by a 45-day public comment period. A final scope is published no later than six months after the evaluation's initiation, as required by law.
   • Hazard Assessment: EPA identifies the adverse health or environmental effects of exposure to the chemical, encompassing areas like cancer, mutation, reproductive, developmental, and respiratory impacts.
   • Exposure Assessment: This phase delves into the extent and nature of exposure under various conditions of use, as well as the populations exposed.
   • Risk Characterization: EPA integrates available information regarding hazards and exposure, including assessments of information quality and alternative interpretations.
   • Risk Determination: EPA produces a draft determination regarding whether the chemical poses an unreasonable risk to health or the environment.
4. Publication of the Risk Evaluation: The final risk evaluation is released within 3 to 3.5 years after identifying the chemical as a high priority for risk assessment.

Find the docket numbers, problem formulations, scope documents and supplemental documents for each chemical substance undergoing risk evaluation under TSCA here.