On May 15, 2025, the Center for Environmental Accountability (CEA) filed a petition under Section 21 of the Toxic Substances Control Act (TSCA) requesting that the U.S. Environmental Protection Agency (EPA) reconsider the 2024 final rule regarding procedures for chemical risk evaluation under TSCA and initiate a rulemaking to amend certain provisions in 40 C.F.R. Part 702, subpart B. According to CEA, the current process "has led to overly conservative risk conclusions and, in turn, unnecessary risk management rules that force industry to abandon well-studied chemistries that provide beneficial uses in our daily lives." The petition states that EPA's risk evaluation procedural regulations should:
- Provide additional definitions for key terms, offering increased transparency and clarity regarding methods and goals of the risk evaluation process;
- Bolster intra- and interagency collaboration throughout the risk evaluation process, including requirements that EPA document the outcome of those efforts;
- Confirm EPA's authority to determine which conditions of use (COU) fall within the scope of a risk evaluation;
- Explain the criteria EPA may use in determining the COUs it expects to consider;
- Provide for a de minimis level below which EPA may exclude COUs from the scope of the risk evaluation;
- Explicitly require consideration of existing regulations administered by EPA and other agencies when determining exposure estimates for each COU for a chemical substance;
- Require that any assumptions, uncertainty factors, models, and/or screening approaches used in the risk evaluation reasonably reflect the COUs of the chemical substance in practice;
- Require EPA to make an unreasonable risk determination for each COU of a chemical substance assessed in a risk evaluation;
- Clarify when determinations regarding unreasonable risk or no unreasonable risk are considered final agency actions;
- Explicitly require peer review for all risk evaluations;
- Create a clear regulatory pathway for the development and submission of draft risk evaluations by requesting manufacturers and other interested persons; and
- Extend applicable comment periods and include opportunities for further extensions.
Under TSCA Section 21, EPA has 90 days from the date of receipt to grant or deny the petition. More information on EPA's 2024 procedural framework rule for conducting TSCA risk evaluations is available in our May 14, 2024, memorandum.
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