Highlights
- The U.S. Environmental Protection Agency (EPA) published a Notice of Proposed Rulemaking (Proposed Rule) on Sept. 23, 2025, to amend the 2024 Toxic Substances Control Act (TSCA) Risk Evaluation Framework Rule (Framework Rule), a foundational rule that governs the agency's process for evaluating risks of existing chemical substances. Public comments on the Proposed Rule are being accepted until Nov. 7, 2025.
- The Proposed Rule seeks to reverse several policies codified in the Biden-era 2024 Framework Rule, reinstating approaches from the first Trump EPA 2017 Framework Rule, including requiring risk determinations for each condition of use, removing requirements to evaluate all conditions of use or exposure pathways, and changes to how personal protective equipment (PPE) is considered.
- The Framework Rule is expected to be finalized in 2026. Given the different interpretations and industry perspectives over the scope of the Framework Rule, it is anticipated the litigation over the scope of the rule will follow.
As covered in a previous Holland & Knight alert, the 2016 amendments to the Toxic Substances Control Act (TSCA) required the U.S. Environmental Protection Agency (EPA) to establish a regulatory process for evaluating the risks of existing chemicals, leading to the issuance of the 2017 Framework Rule under the first Trump Administration.1 The Biden Administration subsequently released the 2024 Framework Rule, which made substantive changes to the 2017 Rule, most notably requiring EPA to 1) evaluate every "condition of use" associated with the chemical substance, 2) issue a single risk determination for each chemical as opposed to determining risk on a use-by-use basis and 3) make certain assumptions about the use of personal protective equipment (PPE) by workers.2 Industry and labor associations challenged the 2024 Framework Rule in federal court, but litigation is currently stayed pending EPA's ongoing rulemaking to revise the Framework Rule.
Key Changes in Proposed Framework Rule
EPA's Proposed Framework Rule, published on Sept. 23, 2025, includes several substantial policy shifts from the 2024 Framework Rule, largely reverting the Framework Rule back to the 2017 Rule. These changes include:
- Discretion to Scope Conditions of Use. The Proposed Rule rescinds the 2024 rule's requirement that EPA evaluate all conditions of use and exposure pathways, instead stating that the agency has "discretion" to determine which conditions of use to evaluate and focus on uses that pose the greatest exposure risk.
- Risk Determination on a Use-by-Use Basis. The Proposed Rule restores the 2017 rule's requirement for EPA to make a determination of unreasonable risk for each of the conditions of use within the scope of a chemical's risk evaluation, reversing the 2024 rule's requirement to make "a single risk determination on the chemical substance as a whole."3
- Account for Use of PPE in Evaluating Exposures. The Proposed Rule reverses the 2024 Framework Rule's approach to consideration of the use of personal protective equipment by workers, which resulted in varying interpretations across industry groups regarding whether the approach to PPE applied at the risk evaluation or risk determination stage. Instead, the Proposed Rule allows EPA to account for "reasonably available information on the implementation and use of occupational exposure control measures such as engineering and administrative controls and personal protective equipment when evaluating exposure risks."4
- Removal of Overburdened Communities. The Proposed Rule removes the 2024 Framework Rule's addition of "overburdened communities" to the regulatory definition of "potentially exposed and susceptible subpopulations."5
- Manufacturer-Requested Risk Evaluations. The Proposed Rule scales back the information manufacturers would be required to provide to EPA for a manufacturer-requested risk evaluation from what was included in the 2024 Framework Rule and clarifies that "manufacturers that withdraw a request before it is granted do not incur fees."6
If finalized, EPA will apply the changes in the Proposed Rule "to all risk evaluations initiated on or after the date of the final rule and would be applied to risk evaluations that are in process as of the date of the final rule, but not yet finalized, to the extent practicable."7 Given the potential impact of the Proposed Rule on chemical regulation across numerous industries, it is likely that EPA will receive a substantial number of public comments and may ultimately modify these proposals in the Final Rule. It is anticipated that EPA will publish a final Framework Rule sometime in 2026.
Implications for Ongoing Risk Evaluations
The Proposed Rule, once finalized, will be the third version of a Framework Rule to be implemented by EPA. Though litigation on the 2017 Framework Rule resulted in a 2019 court decision that rejected that rule's exclusion of "legacy uses and associated disposals" from the conditions of use that EPA would include in risk evaluations, the court declined to rule on other policies (such as the requirement that EPA make risk determinations for each condition of use rather than for the whole chemical, as well as the discretion for EPA to exclude conditions of use or entire exposure pathways from the conditions of use). Similarly, although litigants raised some of the same (and additional) policy issues in litigation on the 2024 Framework Rule, that case has been stayed pending EPA's finalization of this Proposed Rule.
In the meantime, EPA has indicated its intent to revise the risk evaluation for 1,4-dioxane, one of the "first ten" chemicals to undergo TSCA risk evaluation,8 and remains under consent decrees to issue final risk evaluations for most of the "next twenty" chemicals to undergo TSCA risk evaluations.9 Though EPA has stated that it would continue to comply with the 2024 Framework Rule until this proposed Framework Rule is finalized and it would only incorporate the final provisions into ongoing risk evaluations to the extent practicable, the prolonged absence of settled foundational risk evaluation policies has created some regulatory uncertainty for the industry since TSCA's amendments were passed in 2016.
Finally, it is important to note the potential implications of these and other existing chemical developments on state preemption – one of industry's top priorities when U.S. Congress enacted the 2016 TSCA amendments. The finalization of risk management rules is the statutory trigger for TSCA's more stringent and permanent state preemption provisions; however, the majority of the risk evaluations initiated by EPA to date have not completed the risk management stage. Moreover, temporary "pause preemption" has expired for the "next 20" chemicals and has not begun for the five chemicals EPA designated as high priority in December 2024.10 Accordingly, states could, in theory, promulgate their own regulations on these chemicals, setting the stage for a potential regulatory patchwork morass.
Next Steps and Considerations
Companies who may be impacted by the Proposed Rule should consider submitting public comments to EPA by Nov. 7, 2025.
Footnotes
1 Procedures for Chemical Risk Evaluation Under the Amended Toxic Substances Control Act, 82 Fed. Reg. 33726 (July 20, 2017).
2 Procedures for Chemical Risk Evaluation Under the Amended Toxic Substances Control Act, 89 Fed. Reg. 37028 (May 3, 2024).
3 Procedures for Chemical Risk Evaluation Under the Toxic Substances Control Act (TSCA), 90 Fed. Reg. 45,690, 45,691, 45,703 (Sept. 23, 2025).
4 90 Fed. Reg. at 45,714.
5 90 Fed. Reg. at 45,705.
6 90 Fed. Reg. at 45,691.
7 90 Fed. Reg. at 45,691.
8 Designation of Ten Chemical Substances for Initial Risk Evaluations Under the Toxic Substances Control Act, 81 Fed. Reg. 91,927 (Dec. 19, 2016).
9 EPA Finalizes List of Next 20 Chemicals to Undergo Risk Evaluation under TSCA (Dec. 20, 2019).
10 Pause preemption begins when the risk evaluation scope is finalized. The statutory deadline for the risk evaluation scope for these five substances was in June 2025.
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