Ninth Circuit Upholds EPA’s 2024 New Chemicals Rule
Less than two weeks after oral argument, a Ninth Circuit panel has denied consolidated challenges to EPA’s 2024 rule governing reviews of new chemicals under the Toxic Substances Control Act (TSCA). The ruling upholds EPA’s case-by-case evaluations of persistent, bioaccumulative, and toxic substances (PBTs) for streamlined new-chemical reviews. It also upholds the Agency’s decision not to address a comment from workers’ unions advocating greater transparency around the substances to which workers are exposed.
The 2024 New Chemicals Rule
On December 18, 2024, EPA published a rule revising its new chemical review regulations for the first time since Congress substantively amended TSCA in 2016. Some revisions were designed to align the regulatory text with the 2016 amendments, while others addressed EPA’s procedures for reviewing new chemical applications.
At issue in the case, the rule narrowed eligibility for the Low Volume Exemption (LVE) and Low Releases and Low Exposures (LoREX) exemption. These exemptions are streamlined alternatives to the lengthy premanufacture notice (PMN) process typically required before a TSCA-regulated substance may be introduced into commerce. Under 40 CFR § 723.50(d)(2), PFAS are categorically ineligible for both exemptions, and PBTs are ineligible if they have “anticipated environmental releases and potentially unreasonable exposures to humans or environmental organisms.”
In the rule, EPA characterized the eligibility restrictions for PBTs as consistent with existing policy and stated that it “expects that most exemptions for PBT chemical substances will not be granted.” The Agency also noted that it had denied all LVE notices for PFAS submitted since 2021.
Environmental and Workers’ Union Challenges
The rule was separately challenged by environmental groups and a workers’ union.
The environmental groups—Alaska Community Action on Toxics and the Environmental Defense Fund—argued that the rule did not go far enough, contending that PBTs should be categorically ineligible for the LVE and LoREX exemptions. In their opening brief, they argued that TSCA Section 5(h) only allows EPA to create exemptions if its terms ensure that the substance “will not present an unreasonable risk.” Because EPA “recognize[s] that new PBTs are inherently risky,” they alleged that EPA acted arbitrarily and exceeded its authority by declining to make all PBTs ineligible. The groups further argued that the regulatory scheme “turns the statute on its head” by making PBTs presumptively eligible unless EPA affirmatively determines that the substance could result in potentially unreasonable exposure.
By contrast, the union—United Automobile, Aerospace and Agricultural Implement Workers of America (UAW)—challenged the rule for what it failed to address. During the rulemaking, UAW and other unions jointly filed a comment describing the difficulties workers and unions face in determining the substances workers are exposed to, arguing it means that unions cannot weigh in on appropriate worker protections or confirm that employers are complying with restrictions. In its lawsuit, UAW argued that EPA failed to consider the comment in violation of the Administrative Procedure Act (APA) and contrary to Congress’s intent that “the new chemical review process be transparent.”
The challenges were filed shortly before the presidential transition. After obtaining a stay to consider the rule, the incoming Trump administration decided to defend it.
The Ninth Circuit’s Ruling
The Ninth Circuit denied both petitions in its seven-page, not-for-publication disposition issued August 26, 2026.
Addressing the environmental groups’ arguments first, the court held that TSCA delegates discretionary authority to EPA. Section 5(h) allows EPA to consider exemptions “upon application,” the court explained, so case-by-case evaluations of PBTs are permissible. The panel also concluded that EPA’s decision is not arbitrary and capricious because EPA considered and rejected the environmental groups’ preferred approach. “Because the PBT Regulation governs new chemical substances, including those not yet developed, it was reasonable for EPA to reject a categorical ban,” the disposition states, noting heightened deference to agencies making predictive or scientific judgements.
As for UAW, the court held that the unions’ comment was only “tangential” to the proposed rule. “The only aspect of EPA’s proposed rule that UAW cited was EPA’s proposal to change how certain scientific information would be made public,” but “UAW’s comment did not discuss the relative benefits of publication through either medium or address any matter germane to EPA’s proposed rule,” so EPA could lawfully decline to address the comment, the court held.
The case is Alaska Community Action on Toxics v. EPA, No. 25-158 (9th Cir.), docketed January 10, 2025.
