Highlights
- The U.S. Environmental Protection Agency (EPA) under the second Trump Administration has begun to shift the Biden Administration's policies related to the review of existing chemicals under Section 6 of the Toxic Substances Control Act (TSCA). However, ongoing litigation and court-approved and statutory deadlines could complicate these efforts, and delays raise the possibility that states could take action on some chemicals before TSCA's more stringent preemption provisions take effect (when risk management rules are finalized).
- The Biden-era 2024 Risk Evaluation Framework Rule (2024 Rule) and all five of the chemical risk management rules finalized by the Biden Administration EPA have been challenged in federal court by industry, labor and environmental groups. The litigation has been largely placed on pause as a result of the Trump Administration EPA's expressed intent to reconsider and revise the 2024 Rule and risk management rules finalized by the Biden Administration EPA, but courts may hear arguments and/or make decisions in the weeks and months ahead. EPA's focus on these reconsideration efforts is likely to slow the pace at which the agency prioritizes new chemicals for review, conducts new risk evaluations and promulgates new risk management rules.
- The Trump Administration has continued to prioritize increased resources for EPA's Office of Chemical Safety and Pollution Prevention (OCSPP), the office that oversees the implementation of TSCA. However, departures of OCSPP personnel and scientists, engineers, managers and lawyers in EPA's Office of General Counsel could also impact the speed at which Section 6 chemical reviews are completed and/or amended.
Three days before President Donald Trump took office in January 2025, the U.S. Environmental Protection Agency (EPA) under the Biden Administration published its 2025 Annual Plan for Chemical Risk Evaluations Under the Toxic Substances Control Act (TSCA). The 2025 Annual Plan identified the chemicals currently undergoing TSCA's Section 6 chemical review process, along with the anticipated schedule for the draft and final risk evaluations to be released. EPA created these timelines under the assumption that it would evaluate the chemicals under the Biden-era EPA's 2024 Risk Evaluation Framework Rule (2024 Rule), which sets forth the regulatory processes and standards under which risk evaluations must be conducted. The 2025 Annual Plan also included several timelines and requirements for EPA to comply with pursuant to two consent decrees it entered into with environmental and industry groups in 2024 (2024 Consent Decrees).
This Holland & Knight alert provides an overview of the Trump Administration EPA's recent regulatory and policy actions surrounding the TSCA's chemical review and risk evaluation processes, including reconsideration of the 2024 Rule, as well as a status update on EPA's compliance with TSCA's statutory risk evaluation deadlines and those set forth in the Biden Administration's 2025 Annual Plan.
Status of Risk Evaluation Framework Rule
The 2016 Amendments to TSCA directed EPA to promulgate regulations outlining a process for conducting risk evaluations of existing chemicals. The first Trump Administration issued regulations in response to this statutory directive in 2017 (2017 Rule). Thereafter, the Biden Administration published the 2024 Rule, which made several substantive revisions to the 2017 Rule in addition to responding to an earlier court decision following litigation over the 2017 Rule. These revisions included assumptions related to the use of personal protective equipment (PPE) for workers, the scope of "conditions of use" of the chemicals that would be evaluated and some changes to EPA's scientific review processes. Notably, the 2024 Rule included a requirement for risk evaluations to culminate in a single risk determination on a chemical substance, rather than individual risk determinations for each chemical condition of use in isolation.
Throughout the first quarter of 2025, EPA undertook efforts to align its policies and regulations with those of the new Trump Administration. These efforts included reevaluating the agency's existing rulemakings related to chemical risk evaluation and risk management plans. As part of this effort, EPA has expressed its intention to act promptly to reconsider and revise the 2024 Rule via notice and comment rulemaking, with a final rule to be issued by summer 2026. In the interim, EPA will continue to enforce the 2024 Rule until it is replaced.
The 2024 Rule was also challenged in federal court by industry and labor associations in mid-2024, with briefing of the matter concluding in early February 2025 and oral argument heard by the U.S. Court of Appeals for the District of Columbia Circuit in March 2025. However, due to EPA's intent to revise and reconsider the 2024 Rule, the court granted EPA's request to hold the case in abeyance on April 20, 2025, and directed the parties to file status reports every 90 days, beginning in July 2025.
Status of Ongoing Section 6 Existing Chemical Efforts
There are currently more than 20 existing chemicals that are in the process of undergoing a TSCA risk evaluation, many of which have been ongoing for years. For example, EPA has not yet finalized most of the existing chemical risk evaluations for the 20 chemicals initially prioritized in late 2019. Moreover, ongoing litigation and actions taken by the Trump Administration EPA in early 2025 are likely to cause delays in finalizing the risk evaluations and promulgating risk management rules for many of these chemicals. For instance, throughout spring 2025, EPA extended the comment and reporting periods for several chemicals in various stages of the Section 6 process.
To the extent any delays are significant, it is possible that regulatory changes to the 2024 Rule could impact the outcome of these actions, as well as the deadlines set forth in the 2025 Annual Plan. Additionally, it may become increasingly difficult for EPA to meet some of the deadlines set forth in the 2024 Consent Decrees. It is currently unclear whether EPA will seek, and whether the court will grant, modifications to these Consent Decrees or if EPA's failure to adhere to the Consent Decrees will result in additional legal challenges.
Furthermore, because finalization of risk management rules is the statutory trigger for TSCA's more stringent state preemption provisions (and pause preemption has expired for all of the chemicals whose risk evaluations were initiated in 2019), further delay on completion of the rest of the next 20 risk evaluations and development and finalization of associated risk management rules could result in new state actions.
The ongoing TSCA Section 6 chemical reviews currently fall into four categories that are at varying stages in the process and subject to different statutory and/or court-ordered deadlines:
- First 10 Chemicals Prioritized for Risk Evaluation in December 2016
- 20 Chemicals Prioritized for Risk Evaluation in December 2019
- 5 Chemicals Prioritized for Risk Evaluation in December 2024
- 5 Chemicals Initiated for Prioritization in December 2024
An overview of the current status and timelines for each of these categories is provided below.1
First 10 Chemicals Prioritized for Risk Evaluation in December 2016
- Of the first 10 chemicals prioritized for risk evaluation in December 2016, the Biden Administration EPA finalized risk management rules for five of the chemicals and proposed risk management rules for an additional three. Risk evaluations have been completed for the final two chemicals, but the risk management rules have yet to be proposed.
- All five of the risk management rules finalized by the Biden Administration EPA (asbestos part 1, methylene chloride, PCE, TCE and carbon tetrachloride) have been challenged in court with varying statuses, including the challenge to the methylene chloride rule moving forward to oral argument and others currently on pause. As such, it is unclear when the courts will reach final decisions.
20 Chemicals Prioritized for Risk Evaluation in December 2019
- All 20 of the chemicals prioritized for risk evaluation in December 2019 by the first Trump Administration missed the statutory deadline for their completion, which led to lawsuits being filed in September 2023 by several environmental groups. These lawsuits resulted in two consent decrees between EPA and environmental and industry groups that were signed in late 2024, which established deadlines that EPA must meet between 2024 and 2026 to finalize the risk evaluations for these 20 chemicals.
- EPA met the 2024 deadlines set forth in the Consent Decrees after seeking and receiving an amendment to one of the Consent Decrees. However, it remains unclear whether EPA is on track to meet the Consent Decrees' 2025 deadlines, some of which fall in the coming days or weeks.
5 Chemicals Prioritized for Risk Evaluation in December 2024
- On Dec. 18, 2024, EPA designated the following five chemicals as "high-priority," signaling that the agency will move forward with risk evaluation: acetaldehyde, acrylonitrile, benzenamine, vinyl chloride and 4,4'-methylene bis(2-chloroaniline). EPA began the prioritization process for these chemicals in December 2023.
- On Jan. 15, 2025, EPA issued the draft scope for vinyl chloride and opened it for public comment for 45 days, or until March 3, 2025. The comment period was subsequently extended until April 2, 2025.
- As of the date of this Holland & Knight alert, no additional draft scopes for this next set of prioritized chemicals have been released. The statutory deadline for EPA to publish final scopes is six months from initiation of risk evaluation, or by June 18, 2025, for the five chemicals prioritized in December 2024.
5 Chemicals Initiated for Prioritization in December 2024
- On Dec. 18, 2024, EPA initiated the prioritization process for five additional chemicals: 4-tert-octylphenol, benzene, ethylbenzene, naphthalene and styrene. The result of this process, which includes two mandatory 90-day public comment periods, will be a determination on whether the chemical is considered "high-priority" and thus should move forward with risk evaluation.
- The first public comment period for these five chemicals closed on March 18, 2025. However, EPA extended the reporting period for health and safety studies on these chemicals from March 13, 2025, to Sept. 9, 2025. Therefore, it may be challenging for EPA to conduct the second 90-day comment period and finalize the prioritization of these chemicals for risk evaluation within the 12-month statutory deadline (i.e., by Dec. 18, 2025).
Conclusion
As a result of the anticipated delays in the Section 6 review process, there remains considerable uncertainty as to how and when courts and EPA will address significant policy issues that are of interest to industry stakeholders and whether states will act on their own to address risks associated with any of these chemicals in the meantime.
Holland & Knight's Public Policy & Regulation Group is distinctly qualified to assist with TSCA considerations, with the primary drafters and negotiators of the Frank R. Lautenberg Chemical Safety for the 21st Century Act and a litigation team that worked on behalf of industry challenging the 2024 Rule. The group continues to expand its Chemicals Team, with the recent addition of Dr. Michal Freedhoff, assistant administrator for the EPA OCSPP from 2021 to 2025. Members of Holland & Knight's Environmental Team focused on TSCA and chemicals continue to monitor ongoing developments and evaluate the potential impacts to businesses and industries.
Footnote
1 For more details on the current status of specific chemicals, please refer to EPA's Ongoing and Completed Chemical Risk Evaluations under TSCA.
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