As part of EPA Administrator Lee Zeldin’s “Powering the Great American Comeback” initiative, the EPA announced in a press release its intent to reconsider the Toxic Substances Control Act (TSCA) “regulation governing the review of chemicals already in commerce by initiating a rulemaking that will ensure the agency can efficiently and effectively protect human health and the environment and follow the law.”
Defining TSCA
TSCA provides the EPA with responsibility for reviewing the thousands of chemicals already in commerce to make sure they don’t harm people or the environment. It was signed into law on October 11, 1976, by President Gerald Ford.
“The act authorizes EPA to gather and disseminate information about production, use, and possible adverse effects to human health and the environment of existing chemicals, and to issue ‘test rules’ that require manufacturers and processors of potentially dangerous chemicals to conduct and report the results of scientific studies to fill information gaps,” states a Congressional research report for Congress. “For chemicals new to U.S. commerce, TSCA requires pre-market screening and regulatory tracking of new chemical products. If EPA identifies unreasonable risks associated with existing or new chemicals, TSCA requires the agency to initiate rulemaking to reduce risks to a reasonable level. EPA may regulate the manufacture, importation, processing, distribution, use, and/or disposal of chemicals. TSCA provides a variety of regulatory tools to EPA, ranging in severity from a total ban on production, import, and use to a requirement that a product must bear a warning label at the point of sale.”
However, the Act does require the EPA to select the least burdensome option to mitigate any risks associated with use of a chemical.
Areas announced for review
In its decision to review the TSCA regulation, the EPA’s release says it “completed a review of the Biden-era regulation, Procedures for Chemical Risk Evaluation under TSCA (2024 Risk Evaluation Framework Rule), which outlines the process EPA must follow when conducting chemical risk evaluations. After completing this review and considering public comments and concerns, including those from other Federal agencies, the agency intends to initiate further rulemaking in the near future that will reexamine multiple aspects of this rule for consistency with the law and Administration policy.”
The aspects up for review include:
- “Whether the approach taken by the Biden Administration to make a single risk determination for a chemical is consistent with TSCA”;
- “Whether the agency must evaluate all conditions of use of a chemical at the same time in the three years generally allotted by Congress to conduct this review”; and
- “Whether and how the use of personal protective equipment (PPE) and industrial controls in an occupational work environment should be incorporated into risk evaluations.”
Room for improvement
Under TSCA, the Agency has 90 days to review and reach a determination on new chemicals but can extend the review period another 90 days if necessary.
“Of the 445 new chemicals under TSCA review, 38 are active and currently under review within the 90-Day TSCA-mandated review period,” according to an American Chemistry Council (ACC) article. “405 new chemicals, representing 91% of active PMN cases, have been under EPA review for more than 90 days. The 90-day backlog of PMN cases increased by 5.7% since February 3, 2025. 295 active PMN cases, or 66%, have been under review for 365 days or more. The 365-day backlog has increased by 18% since February 23, 2025.
“As the demand for innovative chemistries grows, the backlog of new chemicals awaiting TSCA review beyond the 90-day period is impeding investments in the production of new and innovative chemicals here in the United States.”
As the current administration persists in reducing the EPA’s labor force, this backlog is expected to continue increasing.
Burden of proof
Environmentalists have called for improvements to TSCA for many years.
A 2009 Environmental Law Reporter article by Richard Denison, a senior scientist at the Environmental Defense Fund (EDF) at the time, cited “Ten Essential Elements in TSCA Reform.”
Among the many points made in the article was the call to shift the burden of proof from the government demonstrating harm to industry demonstrating safety.
“Those who produce and use chemicals bear no burden of demonstrating or even being routinely required to provide the information necessary to determine whether their chemicals are safe. This policy stands in marked contrast to those affecting other classes of chemicals, most notably pharmaceuticals and pesticides, which are regulated under other statutes. Producers must generate extensive data demonstrating the safety of these chemicals, and government review and approval are required as conditions for their entering or remaining on the market,” the EDF article says.
ACC
On January 22, 2025, in a House Subcommittee on the Environment hearing, ACC President Chris Jahn urged Congress to immediately make specific improvements to the TSCA program to end industry uncertainty.
Specifically, in concluding his testimony, he asked Congress to consider the following recommendations:
- “A 90-day shot-clock for new chemicals reviews: EPA should implement a shot-clock counting down the number of days it takes the Agency’s to complete new chemical reviews. The shot-clock should include an enforcement mechanism when EPA misses the 90-day deadline to review new chemicals coming to the market.
- Use the best available science when assessing existing chemicals in commerce: Regulations for existing chemicals need to be risk-based and appropriately scoped, must rely on the best available science and weight-of-scientific evidence and recognize the use of personal protective equipment (PPE) when evaluating workplace exposure.”
Current administration recommendations
Insights into the current administration’s plans can be found within the House Appropriations Committee report and the Project 25 EPA chapter, according to law firm Beveridge & Diamond P.C. Those recommendations include:
- “Developing an improvement plan for new chemical reviews and revising the applicable regulations to expedite the review process.
- Ensuring that risk evaluations are risk-based, rather than relying on hazard-based approaches like the Integrated Risk Information System (IRIS).
- Focusing risk evaluations on exposure pathways not covered by other environmental statutes.
- Applying real-world use of chemicals when assessing conditions of use for risk evaluations.
- Revising the proposed framework rule for risk evaluations (since finalized) to assume that workers are using OSHA-required personal protective equipment (PPE) and to maintain the definitions of ‘best available science’ and ‘weight of scientific evidence.’
- Developing a framework rule for risk management rulemaking.
- Limiting TSCA’s fees rule so that it does not cover the costs of EPA inefficiency or overreach.”
Takeaway
Although specific changes haven’t been recommended to date, recommended changes to TSCA are expected to happen quickly.
“It will be necessary for companies to maintain or improve their current TSCA compliance programs; monitor regulatory and legislative developments; advocate for or against proposed changes (directly or through their trade associations); and be prepared to implement appropriate changes to their programs,” Beveridge & Diamond advises. “Continued attention to developments will be important.”