Current Status
On May 3, 2024, the Biden EPA finalized the rule, Procedures for Chemical Risk Evaluation Under the Toxics Substances Control Act.
On March 10, 2025, EPA announced it is reconsidering the Biden chemical risk assessment rule. Litigation challenging the rule is currently held in abeyance.
Why it Matters
The Toxics Substances Control Act (TSCA) governs the production, importation, and use of chemicals. It authorizes EPA to regulate potentially dangerous chemicals in commerce to prevent unreasonable risks to human health and the environment. Since TSCA’s enactment in 1977, an ongoing concern for stakeholders has been the tension between EPA’s legal requirement to conduct thorough chemical risk assessments and the business need to avoid assessment backlogs that delay the use of the chemicals.
In 2016, Congress amended TSCA, requiring EPA develop new regulations to identify priority chemicals and conduct timely risk assessments for them while also improving the risk assessment process to ensure the chemicals are safe for their intended purposes.
Timeline
April 30, 2025 The D.C. Circuit agreed to hold the case challenging the Biden rule in abeyance with status reports due every 90 days. United Steel, Paper and Forestry, Rubber, Manufact v. EPA, Docket No. 24-01151 (D.C. Cir. May 21, 2024). The Biden rule remains in effect until EPA finalizes a new rule.
March 18, 2025 The D.C. Circuit court ordered the parties to address EPA’s motions at a hearing on March 21, 2025. NGOs supporting the Biden-era rule and unions in favor of making the Biden rule stricter regarding PPE, both opposed EPA’s motions on the grounds that the underlying issue of what TSCA requires for a chemical risk assessment must be decided by the court under the Supreme Court’s decision in Loper Bright Enterprises v Raimondo which limited the deference courts should give the agency’s in interpreting statutory language.
March 10, 2025 EPA announced its intent to undertake a new rulemaking process to reevaluate the 2024 Biden rule, Procedures for Chemical Risk Evaluation. EPA also requested the court remand the rule to EPA without vacatur and hold the litigation in abeyance.
May 21, 2024 Industry groups challenged the chemical risk assessment rule, arguing, for example, that the 2017 Trump rule correctly interpreted TSCA as it focused on uses with the greatest exposure potential rather than every possible use. Unions also challenged the rule, arguing EPA did not have the authority to consider whether worker exposure to chemicals would be limited by the use of PPE, but rather that TSCA prohibits EPA from considering any PPE use. United Steel, Paper and Forestry, Rubber, Manufact v. EPA, Docket No. 24-01151 (D.C. Cir. 2024).
May 3, 2024 EPA finalized the Procedures for Chemical Risk Evaluation Rule, amending the 2017 Trump EPA rule, determining that EPA’s chemical risk assessment process must evaluate a chemical holistically, based on all conditions of its use, and that EPA should not assume worker exposure will be limited by the use of PPE.