Overview
In a consequential policy shift, the US Environmental Protection Agency (EPA) under the Trump administration announced its intent to reevaluate a cornerstone of modern chemical regulation: the risk evaluation framework rule under the Toxic Substances Control Act (TSCA). This development signals a potential rollback of the Biden-era 2024 Risk Evaluation Framework Rule, which significantly expanded the scope of federal reviews for toxic chemicals like per- and polyfluoroalkyl substances (PFAS), also known as “forever chemicals.” The EPA’s March 10, 2025 announcement suggests a sharp pivot toward a more use-specific, industry-friendly framework that may reduce federal regulatory burdens while raising concerns about public health protection and state regulatory autonomy.
Risk Evaluation Framework Under TSCA
TSCA section 6 requires the EPA to determine whether a chemical substance presents an “unreasonable risk” under its “conditions of use,” and to issue a risk management rule if it does. The 2016 Lautenberg amendments directed EPA to develop a rule establishing the process for these risk evaluations. The first version of that rule, issued in 2017 under the Trump administration, was challenged in court and subsequently revised by the Biden EPA in 2024.
The 2024 rule made sweeping changes. Notably, it required EPA to issue a single risk determination for each chemical, encompassing all known conditions of use, and mandated that evaluations be comprehensive, explicitly prohibiting the exclusion of any exposure pathway or condition of use. It also required EPA to assume that workers are not consistently protected by personal protective equipment (PPE), thereby offering more conservative risk estimates. Ultimately, the rule broadened regulatory definitions and emphasized transparency, including the publication of risk-based occupational exposure values.
The Trump Administration’s Rule Shift
On March 10, 2025, EPA under the second Trump administration announced via press release and court filings that it intends to reconsider the 2024 rule in its entirety through a new notice-and-comment rulemaking process. The move followed the DC Circuit’s denial of EPA’s request to pause ongoing litigation challenging the 2024 rule, currently consolidated in United Steelworkers v. EPA, No. 24-1151 (DC Cir. 2024). A declaration from Nancy Beck, EPA’s newly appointed Principal Deputy Assistant Administrator for the Office of Chemical Safety and Pollution Prevention (OCSPP), revealed that internal deliberations had accelerated and that EPA now plans to propose a new rule by June 2025 and finalize it by April 2026.
Among the key areas flagged for reconsideration are:
- TSCA permits a single, chemical-wide risk determination or requires use-specific evaluations;
- The appropriateness of requiring risk evaluations to cover all conditions of use within the statutory three-year timeline;
- Whether assumptions about PPE and industrial controls should be integrated into risk assessments;
- Whether regulatory definitions used in the 2024 rule are too expansive;
- The process for companies to request EPA risk evaluations under section 6;
- How and when EPA can make substantive revisions to risk evaluations; and
- Whether risk-based occupational exposure values must be made public.
These issues strike at the heart of EPA’s authority and methodology under TSCA.
Implications for PFAS Regulation and State Preemption
Litigation over the 2024 rule is already underway, and the stakes for PFAS regulation are especially high. Under the Biden-era framework, the EPA could find that PFAS present an unreasonable risk when considered cumulatively across various uses—such as in cookware, food packaging, textiles and firefighting gear. This comprehensive approach supported aggressive federal restrictions and bolstered state efforts to ban PFAS-containing products. But if the Trump EPA finalizes a rule that returns to a use-specific risk determination model, the regulatory landscape could shift dramatically. The TSCA preemption clause could bar states from regulating PFAS in uses that EPA does not find risky. That could undercut aggressive state-level bans enacted in California, Maine and Colorado, and chill ongoing innovation in safer alternatives.
Public Health and Industry Considerations
Supporters of the proposed shift argue that it enhances regulatory clarity, avoids overreach, and allows EPA to focus its limited resources on high-risk uses. By incorporating PPE assumptions, for example, the agency could issue less restrictive findings for industrial uses, potentially easing burdens on manufacturers.
On the other hand, public health advocates and environmental groups counter that this approach ignores real-world exposure scenarios, particularly for workers, children, and vulnerable populations. They warn that a return to narrower, use-specific evaluations could delay or prevent meaningful federal action on hazardous chemicals that persist in the environment and bioaccumulate in humans.
Political Context and What Comes Next
The March 10 press release offers the clearest signal yet of how the Trump EPA plans to approach TSCA implementation. Although Administrator Lee Zeldin announced 31 deregulatory priorities on March 12, none of them involved TSCA, making the risk evaluation framework rule a key early indicator of the Agency’s direction.
EPA plans to release the proposed revisions in June 2025, followed by a 60-day public comment period. Given the breadth of the potential changes, stakeholders—including state regulators, industry, and environmental groups—should begin preparing now to engage meaningfully in the rulemaking process.
Conclusion
As the Trump EPA moves to reconsider the 2024 Risk Evaluation Framework Rule, the future of PFAS regulation hangs in the balance, with potential implications for both federal oversight and state-level protections. Stakeholders must stay engaged as the proposed rule takes shape, as it could fundamentally alter how these harmful chemicals are evaluated and regulated.
