Groups Challenge EPA Rule Allowing PBTs in TSCA Exemption Reviews
New persistent, bioaccumulative, and toxic chemicals (PBTs) should not be eligible for expedited reviews under the Toxic Substances Control Act (TSCA) known as the low volume exemption (LVE) and low releases and exposures exemption (LoREX), environmental groups told the Ninth Circuit on October 17, 2025.
The lawsuit challenges EPA regulations finalized in December 2024 that allow companies to continue to continue to apply those exemptions for certain PBTs. In their opening brief, the petitioners argue that the rule violates TSCA’s requirement that exemptions protect against unreasonable risk.
“The record, including EPA’s own findings, establishes that the category of new PBTs may—indeed, will likely—present unreasonable risk even when complying with the terms of the LVE and LoREX Exemptions,” the brief states.
Disputed Eligibility Standards
The 2024 rule made PFAS categorically ineligible for the exemptions, as well as PBTs “with anticipated environmental releases and potentially unreasonable exposures to humans or environmental organisms.” The petitioners contend that this “turns the statute on its head” because it requires that EPA affirmatively determine “that a specific PBT is unsafe” for it to be ineligible.
“In effect, the rule treats an absence of evidence as a reason to expedite the approval of a new PBT chemical, rather than a reason to deny an exemption application,” their brief states.
EPA justified its decision to allow certain PBTs to remain eligible by suggesting that PBT use may not always result in exposure, “such as chemical substances used in a closed system to make semiconductors.” In the rule, EPA also stated that it “expects that most exemptions for PBT chemical substances will not be granted.”
The petitioners, however, describe EPA’s “zero-release-zero-exposure” scenarios as “fanciful.” All “new PBTs will eventually be released into the environment, cause exposures, and thereby result in serious injury,” they argue.
Speedier Reviews
LVE and LoREX applications are subject to a 30 day review period, compared to 90-to-180 days for standard reviews, though review backlogs mean reviews often take much longer in practice. The petitioners claim that LVE and LoREX reviews are less “detailed and comprehensive” than standard reviews, and observe that EPA does not require testing or impose additional restrictions on approved exemption applications—incentivizing companies to use them.
Publicly available EPA data shows that 221 valid LVEs were submitted in fiscal year 2025, which was greater than the number of standard review applications. No LoREX submissions were received during the year, however.
In August 2025, EPA announced that it had made substantial progress on the LVE backlog thanks to process improvements. However, its continued progress may be jeopardized by the ongoing government shutdown.
More on EPA’s 2024 new chemicals procedural rule can be found in a previous post. The case is Alaska Community Action on Toxics v. EPA, No. 25-158 (9th Cir.), filed 1/10/2025.
