By Maureen O’Dea Brill, Peter N. Coneski, K&L Gates

The US Environmental Protection Agency (EPA) has proposed a new rule to revise how it evaluates the risks of chemicals currently in use under the Toxic Substances Control Act (TSCA). This initiative follows a review prompted by Executive Order 14219 and aims to streamline evaluations while aligning with the current administration’s interpretation of TSCA. In response to concerns from the chemical industry and other stakeholders about the burden and complexity of the current risk evaluation process, the proposed modifications aim to streamline evaluations, increase transparency, and ensure a more predictable regulatory process for manufacturers (including importers) of chemical substances.

TSCA requires the EPA to prioritize and evaluate high-priority substances from the TSCA inventory. Risk evaluations under TSCA are primarily initiated by the EPA, either through its prioritization process or in response to manufacturer requests.¹ These evaluations are triggered by statutory requirements, emerging scientific evidence, or industry interest in clearing regulatory uncertainty around specific chemicals.²

The EPA uses risk evaluations to determine whether an existing chemical poses an unreasonable risk of injury to health or the environment—based solely on scientific risk, not costs or other non-risk factors. These evaluations include unreasonable risks to a potentially exposed or susceptible subpopulation identified as relevant to the risk evaluation under the specified conditions of use (COUs). COUS are the circumstances under which a chemical is intended, known, or reasonably foreseen to be manufactured, processed, distributed, used, or disposed of.

The EPA initially issued its procedural framework rule in 2017 and then revised it in 2024 under the Biden administration to require a single, comprehensive risk determination for each chemical across all COUs. EPA wants to return to evaluating each COU separately, reversing the 2024 rule and returning to the approach established during the first Trump administration.³ The EPA is seeking public comment on whether the procedural framework rule should include regulatory text specifying that the EPA has discretion to exclude COUs, exposure pathways, and routes and to coordinate actions with other EPA-administered laws to ensure that chemical risks “could be eliminated or reduced to a sufficient extent” by other EPA actions, as permitted under TSCA section 9(b). Notably, if the proposed rule is finalized and subsequently challenged, as anticipated, the courts will not defer to either of the EPA’s interpretations. Instead, they will focus on determining the best interpretation of the statute consistent with the Supreme Court’s recent decision in Loper Bright Enterprises v. Raimondo, 603 U.S. 369 (2024).

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