Resetting the Process: EPA Proposes Scaled-Back Requirements for Chemical Risk Evaluations

The US Environmental Protection Agency (EPA) has proposed a potential reset of the risk evaluation process under the Toxic Substances Control Act. If adopted, the proposal would roll back certain procedural requirements of the Biden administration’s 2024 risk evaluation rule (or the Framework Rule), restore elements of the 2017 framework, and create new clarity on when and how EPA can revise evaluations. Manufacturers (including importers) and processors should review the proposal closely and consider submitting comments, as the rule could directly shape the speed, scope, and transparency of chemical risk evaluations going forward.

For the regulated community, this proposal carries several important implications. Because EPA’s determinations of “unreasonable risk” under Toxic Substances Control Act (TSCA) section 6(b) form the legal foundation for future restrictions, bans, and workplace requirements, any changes to the evaluation process directly affect regulatory outcomes. The proposal would also scale back manufacturer obligations, limiting information requests to what is “known to or reasonably ascertainable” and reducing data requirements that had been expanded under the 2024 rule (for a deeper dive into the 2024 Framework Rule, see our prior analysis).

At the same time, EPA seeks to preserve momentum in the risk evaluation pipeline by allowing revisions to final risk evaluations without restarting the prioritization process—ensuring errors can be corrected and new information addressed without derailing progress on other chemicals.

KEY PROPOSED CHANGES

1. Scoping and Fit-for-Purpose Provisions

EPA proposes to delete the rule language that prohibited the agency from excluding conditions of use from a risk evaluation. Instead, EPA would revise and merge the “fit-for-purpose” provisions to make clear that the scope and level of analysis will be tailored to what EPA needs to decide for a given chemical. In practice, this means EPA may conduct more detailed analysis where risks are more likely and rely on screening-level data where risks appear minimal. For example, EPA might require detailed workplace exposure data for a solvent widely used in industrial degreasing but apply a simpler analysis for a niche use of the same solvent with very low potential for exposure.

Why it matters: This restores EPA’s discretion to focus on uses most likely to drive risk, helping to speed up evaluations and reduce the time spent on low-risk or peripheral uses, while giving industry greater clarity about what will be in scope.

2. Risk Determinations by Condition of Use

EPA seeks to return to making separate risk determinations for each use of a chemical (e.g., workplace use, consumer product use, or environmental release). This was the 2017 approach, whereas the 2024 rule allowed one broad “chemical-wide” decision. EPA also proposes to codify factors it must weigh—such as hazard severity, exposure levels, affected populations, and data quality—while retaining the ability to find unreasonable risk when multiple uses are considered together.

Why it matters: By requiring separate determinations for each condition of use, the proposal makes it more difficult for EPA to regulate uses that are not actually driving risk. Under the current single-determination approach, once EPA finds unreasonable risk overall, it can justify broad restrictions that sweep in lower-risk or non-risk-driving uses of a chemical. A use-by-use approach narrows the scope of regulation to the conditions of use EPA has specifically determined present unreasonable risk, giving industry more certainty and limiting overbroad compliance obligations.

3. Definition of Potentially Exposed or Susceptible Subpopulations

EPA proposes to remove the phrase “overburdened communities” from the regulatory definition of “potentially exposed or susceptible subpopulations” (PESS). The 2024 rule added this term to the statutory examples (children, workers, elderly), but commenters argued it was too vague and could expand risk evaluations beyond exposures tied to the chemical itself. EPA proposes to return to the statutory framework while noting it can still consider other vulnerable groups when supported by science.

Why it matters: The definition of PESS sets the boundaries for who is considered at risk. For example, evaluation of a chemical used in consumer cleaning products might reasonably focus on risks to children and household users. Narrowing the definition makes the scope more predictable and helps manufacturers avoid being pulled into risk evaluations that cover groups unrelated to their chemical or use.

4. Definition of ‘Weight of Scientific Evidence’

EPA proposes to add a definition of “weight of scientific evidence,” describing how it integrates multiple studies and data sources when making risk determinations.

Why it matters: A formal definition increases predictability. For example, if EPA considers both animal studies and human exposure data, companies will know how EPA balances these sources and can tailor submissions accordingly. It also strengthens the consistency and defensibility of risk evaluations, reducing uncertainty for industry.

5. Aggregate Exposure Assessments

EPA proposes to drop the 2024 rule’s requirement that it provide an explanation each time it does not perform an aggregate exposure assessment (which looks at combined exposures from multiple sources). EPA will still conduct these assessments when supported by science but will not be required to justify their absence.

Why it matters: This change will reduce paperwork and keep evaluations moving. For example, if exposures from a chemical’s industrial use and consumer use are both low, EPA doesn’t need to spend time writing a justification for not combining them. That helps avoid delays while preserving EPA’s authority to perform aggregate assessments when needed.

6. Revisions to Final Risk Evaluations

The 2024 rule restricted EPA from revising final risk evaluations unless it restarted the prioritization process, except to protect health or the environment. EPA now proposes to remove that restriction. Instead, EPA could revise or supplement a final evaluation if needed while still ensuring transparency through draft and final documents, public comment, and peer review.

Why it matters: This allows EPA to correct errors or add new information without derailing work on other chemicals. For example, if new data show that a workplace exposure model overestimated risk, EPA could fix the evaluation directly rather than reopening the entire prioritization process. That balance helps protect companies from faulty conclusions while keeping the evaluation pipeline on track.

7. Manufacturer Requests for Risk Evaluations

EPA proposes to scale back the broad information requirements placed on manufacturers by the 2024 rule. Manufacturers would only need to provide information “known to or reasonably ascertainable” for the specific conditions of use they identify. EPA would rely on its other TSCA authorities to gather information on other uses—such as Section 4(a)(2), which allows EPA to require new data from any manufacturer or processor—to gather information on uses not identified by the requester.

If EPA determines that additional information is needed for a comprehensive evaluation, it may develop a strategy to obtain that information using these authorities and, if necessary, delay initiation of the evaluation for up to one year. EPA also clarifies that withdrawn requests do not incur fees.

Why it matters: This reduces burdens on companies by limiting requirements to information they reasonably control. For example, if a company requests evaluation of a chemical it produces for coatings, it must submit data about that use but not about unrelated uses like plastics production. EPA can then turn to other manufacturers or processors for additional data.

TOP 5 OPPORTUNITIES FOR INDUSTRY COMMENT

EPA is seeking public comment on 13 separate subjects in the proposed rule, but the following five may be of particular interest to manufacturers (including importers) and processors because they directly affect compliance obligations, regulatory certainty, and the standards EPA will apply in future risk evaluations.

1. Scope and Conditions of Use: EPA is asking whether its proposed revisions to the “fit-for-purpose” scoping provisions are clear and appropriate and how to handle conditions of use identified after an evaluation is complete. This will shape how narrowly or broadly future evaluations are framed.
2. Risk Determinations and Occupational Exposure: EPA invites comment on changes to how it makes and documents risk determinations, including assumptions about workplace exposures. These decisions are central because they drive regulatory outcomes under TSCA.
3. Definitions of Scientific Standards: EPA is seeking comment on the proposed definition of “weight of scientific evidence,” whether to restore the 2017 definition of “best available science,” and whether to define “systematic review.” These definitions will guide how EPA evaluates data and how companies should generate or present information.
4. Revisions to Final Risk Evaluations: EPA requests input on when and how final evaluations may be reopened—such as to correct errors or account for new information—and what circumstances should not warrant reopening. This directly impacts regulatory certainty and reliance interests.
5. Manufacturer-Requested Risk Evaluations: EPA seeks comment on whether to scale back the broad information obligations imposed in 2024, limiting requests to information “known to or reasonably ascertainable by” the manufacturer. This directly affects the scope and cost of the industry’s compliance burden.

Comments must be received on or before November 7, 2025.

These issues will shape how EPA conducts and documents risk evaluations going forward. Stakeholders should carefully review the proposed rule (published in the Federal Register on September 23, 2025) and consider submitting comments to ensure that industry perspectives on burden, scope, and scientific standards are reflected in the final rule.

HOW WE CAN HELP

Our team is closely tracking these developments and is available to assist manufacturers and processors in evaluating the potential impact of the proposed rule and preparing effective comments.

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