The TSCA Risk Evaluation Rule is set up for significant changes in the coming year.
On March 10, 2025, the Trump administration announced its intent to reconsider the 2024 Risk Evaluation Framework Rule (“2024 Rule”) governing the review of chemicals already in commerce. To this end, EPA intends to initiate a rulemaking that will “reexamine multiple aspects of this rule for consistency with the law and Administration policy.” These “aspects” include, but are not limited to, whether the agency must evaluate all conditions of use of a chemical at once, whether and how the use of personal protective equipment and industrial controls should be incorporated into a risk evaluation, and regulatory definitions the current administration says were expanded under the Biden administration.
The 2024 Rule has also been subject of recent litigation in the U.S. Court of Appeals for the District of Columbia Circuit, United Steel, Paper and Forestry, Rubber, Manufacturing, Energy, Allied Industrial and Service Works International Union (USW) v. EPA, Consolidated Case No. 24-1151, where challengers (including various labor groups, NGOs, industry, and industry groups) allege differing views on the legal sufficiency of the rule. On March 10, 2025, EPA filed a motion for voluntary remand, stating the EPA wished to reconsider the 2024 rule and would not defend the rule.
At oral argument on March 21, 2025, the Appeals court appeared skeptical of the government’s request, including that the case be held in abeyance pending reconsideration. EPA also informed the court of its intent to revise and issue a new final risk evaluation rule by April 2026, a claim that the court’s members questioned as unrealistic, and that it would enforce the 2024 rule while the case was held in abeyance and through the impending rulemaking process. Despite indications at oral argument, on April 30, 2025, the Appeals court issued an order holding the consolidated cases in abeyance. The Order specifically noted that EPA “intends to act promptly to pursue notice and comment rulemaking and then promulgate new regulations to replace the 2024 Rule”; the various industry petitioners and intervenors no longer sought a judgment on the merits, “lack adversity with respect to the 2024 Rule”, and also favor the case being held in abeyance; and that the court had substantial doubts that the labor groups petitioning the court demonstrated Article III standing. The parties were ordered by the court to file status reports by July 29, 2025, and every 90 days thereafter.
Background
EPA finalized an earlier version of the risk evaluation rule in 2017, but that rule was challenged in court by several organizations in a consolidated case in front of the Ninth Circuit. Safer Chemicals Healthy Families, et al. v. U.S. EPA., Case No. 17-72260. Those organizations took issue with several parts of the 2017 rule, including that the rule excluded consideration of a chemical substance’s legacy uses when conducting a risk evaluation. In a mixed ruling for the Plaintiffs, the Ninth Circuit in November 2019 ruled that TSCA requires consideration of legacy uses in risk evaluations, while rejecting several other challenges. On April 23, 2024, EPA finalized the 2024 Rule, which it claimed would strengthen risk evaluations conducted under TSCA. The final rule improved upon the process by which EPA conducts TSCA risk evaluations and, according to EPA at the time, enhanced environmental protections for communities overburdened by pollution. According to the Biden administration EPA, the 2024 Rule included numerous changes to the risk evaluation process, many of which were made in response to the Ninth Circuit ruling and were announced in 2021, having been incorporated into risk evaluations since that time Some of those changes included:
- “Consideration of real-world exposure scenarios such as multiple exposure pathways (e.g., in air and water) to the same chemical, and combined risks from multiple chemicals when EPA has the scientific information to do so, which may be particularly important for communities who face greater exposures or susceptibilities to chemicals than the rest of the general population.
- A requirement that risk evaluations are comprehensive in scope and do not exclude conditions of use or exposure pathways.
- Clarifications to ensure EPA appropriately considers risks to all workers in its risk evaluations.
- Assurance the agency will continue to use the best available science to conduct risk evaluations, that decisions are based on the weight of the scientific evidence and that risk evaluations will be peer reviewed in accordance with both federal and EPA guidance.
- A clear requirement for risk evaluations to culminate in a single risk determination on the chemical substance, rather than on individual chemical conditions of use in isolation, and improved communications regarding the uses that significantly contribute to the unreasonable risk.
- New procedures and criteria for whether and how EPA will revise scope and risk evaluation documents, to improve transparency.
- A requirement that risk evaluations must explicitly consider overburdened communities when identifying potentially exposed and susceptible populations as relevant to the risk evaluation.”
Among the changes to the 2017 rule, the 2024 Rule also rescinded a provision that authorized criminal penalties for the submission of “inaccurate or incomplete information” to EPA during a stakeholder requested risk evaluation. The final rule was effective July 2, 2024. See 89 FR 37028.
Analysis
The fluctuating scope of the Risk Evaluation Rule, both from changes in presidential administration and legal challenges, presents difficulties for industry and government. As to the latter, EPA is statutorily required to complete risk evaluations within 3.5 years of initiating the evaluation. See 15 U.S.C. § 2605(b)(4)(G)(i)/(ii). However, due in at least part to the constantly changing scope of risk evaluation requirements (in addition to funding, manpower, and other factors), EPA consistently struggles to meet those deadlines. Several risk evaluations have undergone multiple rounds of revisions across different presidential administrations and environmental groups have even sued EPA for failing to meet deadlines. For example, on September 18, 2023, the Sierra Club and Earthjustice, among other groups, filed a lawsuit against EPA alleging that EPA missed the statutory deadline for finishing risk evaluations for 22 different chemical substances. Community In-Power and Development Association, Inc. et al. v. U.S. EPA, Case No. 23-2715. The continued chaos over what needs to be included in a risk evaluation, and the process EPA must follow, no doubt will lead to further delays in the years ahead.
Industry is not unaffected by the regulatory uncertainty surrounding the risk evaluation process. Dictated in part by the risk evaluation rule, the risk evaluation and management process culminates in a risk management rule (assuming a finding of unreasonable risk to human health and/or the environment). The scope of that final rule is directly tied to what conditions of use substantially contribute to the unreasonable risk determination and what risks are identified in the risk evaluation. The uncertainty surrounding what is considered, how it is considered, and when it is considered, both within the process itself and as a general temporal matter after initiation of the risk evaluation process, make it difficult for businesses to anticipate potential disruptions to their operations or the potential scope of government orders/rules.
1,4-Dioxane presents a good example of this uncertainty. On November 13, 2024, the Biden administration finalized a supplement to the risk evaluation for and the risk determination for 1,4-dioxane, finding that the chemical poses an unreasonable risk of injury to human health. Of those included in the risk assessment, 22 out of the 26 evaluated conditions of use contributed to that finding. All this, however, came after the Biden administration already reversed course on the first Trump administration’s 2020 1,4-dioxane risk evaluation, resulting in the supplement to the risk evaluation and revised risk determination. Given that it is now up to the Trump administration to draft and promulgate a TSCA section 6 risk management rule for 1,4-dioxane, it is unclear how the risk management process for 1,4-dioxane will proceed. Will EPA revisit the risk evaluation completely, reversing to the initial 2020 risk evaluation? Will EPA seek to amend the supplement released in November of 2024? Will certain conditions of use no longer be considered in the risk management rule? If so, which one(s)? Will the risk management rule be delayed because of internal EPA deliberation on how to proceed? These and other open questions create uncertainty and unpredictability for industries that currently rely on 1,4-dioxane.
It is inevitable that the final Trump administration’s revised risk evaluation rule will face legal challenges from consumer, labor, and environmental groups, and those legal challenges will take time to play out in court. Further, any change in Presidential political party in 2028 will usher in new risk evaluation priorities, which would be incorporated (officially or unofficially) into the risk evaluation process, as the Biden administration did in 2021. And while the full impact of the new administration on on-going risk evaluations remains to be seen, the proposed budget cuts to EPA will certainly not expedite the process. One thing is clear, however: the chaos around TSCA risk evaluations will not end any time soon.
Contact
This article was written by attorneys Larry Silver, David Romine, and Wade Stephens. For questions pertaining to the TSCA Risk Evaluation Rule, please email Wade at wstephens@lssh-law.com.