Groups Challenge EPA Rule Allowing PBTs in TSCA Exemption Reviews

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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.

EPW to Hold October 23 Hearing on Chemical Regulation

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The Senate Committee on Environment and Public Works (EPW) will hold a hearing on chemical regulation this week, offering potential insight into Toxic Substances Control Act (TSCA) reform legislation reportedly being developed in the Senate.

The hearing, titled “Examining the Beneficial Use and Regulation of Chemicals,” is scheduled for 10:30am on October 23, 2025.  It will be convened by EPW’s Chemical Safety Subcommittee, which is chaired by Senator John Curtis (R-Utah).

According to EPW’s website, the hearing will include the following panelists:

  • Peter Huntsman, President and CEO of Huntsman Corporation, a chemical manufacturer.
  • Gwen Gross, Senior Technical Fellow at The Boeing Company.
  • Tracey Woodruff, Professor and Director of the Program on Reproductive Health and the Environment at the University of California, San Francisco. Dr. Woodruff previously worked as a scientist at EPA.

The hearing was originally scheduled for July but was postponed.

EPA Eliminates Backlog of TSCA Substantial Risk Notifications

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EPA has cleared the backlog of section 8(e) submissions under the Toxic Substances Control Act (TSCA) thanks to process improvements, the agency announced on October 10, 2025.

TSCA section 8(e) requires that persons notify EPA when they obtain information that “reasonably supports the conclusion” that a chemical they manufacture, process, or distribute “presents a substantial risk of injury to health or the environment.”

According to the announcement, EPA assembled a team to address the backlog, which reviewed more than 3,000 submissions.  Approximately 920 of those submissions were flagged as “high interest and distributed across the agency.”

To prevent future backlogs, the announcement notes that EPA has established a workgroup to develop process improvements, enhanced its categorization system for incoming submissions, and implemented an automated notification system that alerts staff to relevant submissions.

More on TSCA section 8(e) submissions can be found on EPA’s website.

Company Sues EPA to Block Disclosure of Chemical Identities Under TSCA

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A silicates manufacturer is suing EPA to prevent the disclosure of its confidential business information (CBI) under the Toxic Substances Control Act (TSCA), in what at least one source claims may be a case of first impression under the law.

At issue are the chemical identities of two substances that Burgess Pigment Co. initially failed to substantiate as CBI following the 2016 Lautenberg Amendments to TSCA, which introduced new requirements for companies that seek trade secret protection in their submissions to EPA.

Burgess claims it submitted adequate substantiation once it discovered its oversight, maintained its CBI claim in subsequent filings, and has stayed in “constant contact” with EPA.  According to the complaint, if EPA discloses the chemical identities anyway, it would violate the Administrative Procedure Act (APA).

“EPA’s unreasonable adherence to form over function caused it to fail to adhere to its regulations requiring nondisclosure of properly substantiated CBI and is otherwise arbitrary, capricious, and contrary to law,” the complaint states.

According to the complaint, Burgess was one of many companies that failed to respond to the 2017 rule implementing the new CBI requirements.  In 2021, EPA released a rule to reopen the reporting period, but it was never published in the Federal Register.

The case is Burgess Pigment Co. v. U.S. Environmental Protection Agency, No. 5:25-cv-00309 (M.D. Ga.), filed 7/18/25.

Trump Administration Proposes Overhaul of Biden-Era TSCA Risk Evaluation Framework

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On September 23, 2025, EPA published a proposed rule that would roll back key provisions of the agency’s May 2024 risk evaluation framework rule, which sets out the procedures EPA uses to assess the risks of existing chemicals under the Toxic Substances Control Act (TSCA).

According to EPA, the proposal is intended to “effectuate the best reading of the statute and ensure that the procedural framework rule does not impede the timely completion of risk evaluations or impair the effective and efficient protection of health and the environment.”

The rollback is a priority for the Trump administration, which first announced its intent to reconsider the rulemaking in March.  The 2024 rule—itself a revision of a rule issued during the first Trump administration—has been criticized by industry groups such as the American Chemistry Council and targeted for revision by the Heritage Foundation’s “Project 2025” initiative.

What Changes is EPA Proposing?

If finalized, the rule would:

  • Grant EPA discretion to narrow the scope of risk evaluations by excluding conditions of use and exposure pathways from its assessments.
  • Require that separate risk determinations be made for each of a chemical’s conditions of use, instead of a single risk determination for the chemical as a whole.
  • Remove language prohibiting EPA from assuming worker protections through PPE usage.
  • Eliminate “overburdened communities” from the list of “potentially exposed or susceptible subpopulations” that must be considered in evaluations.
  • Provide EPA with greater flexibility to revise or supplement scope or risk evaluation documents without restarting the prioritization process.
  • Scale back information collection requirements for manufacturers requesting a risk evaluation.
Stakeholder Responses

The proposal has drawn criticism from environmental groups, who warn that the changes—particularly EPA’s ability to exclude conditions of use and exposure pathways—will jeopardize public health.

“Rather than looking at the full picture of a chemical’s toxic risk, EPA wants to downplay the links these chemicals have to cancer and chronic disease and give the chemical industry a handout at the expense of our health and safety,” an Environmental Defense Fund official said in a statement.

“The chemicals in the pipeline for review under TSCA have been prioritized specifically because of the risks they pose to our health, and rewriting this process to lowball risks will only rig the rules to benefit the chemical industry,” she continued.

The American Chemistry Council, on the other hand, applauded the move.  “This proposed approach demonstrates EPA’s commitment to refining its processes in a way that is both protective and practical,” an official said in a press release.  “The proposal reflects meaningful progress toward a more science-driven regulatory framework for conducting TSCA risk evaluations.”

Comments on the proposed rule are due November 7, 2025.  More on the 2024 rule can be found here.

EPA to Fast-Track Chemical Reviews for AI and Data Center Projects

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EPA will prioritize review of premanufacture notices (PMNs) for chemicals tied to artificial intelligence (AI) and data center projects, the agency announced on September 18, 2025.

“We inherited a massive backlog of new chemical reviews from the Biden Administration which is getting in the way of projects as it pertains to data center and artificial intelligence projects,” EPA Administrator Lee Zeldin said.  “The Trump EPA wants to get out of the way and help speed up progress on these critical developments, as opposed to gumming up the works.”

The policy implements President Trump’s Executive Order 14318, “Accelerating Federal Permitting of Data Center Infrastructure,” which directs the agency to expedite permitting for qualifying projects under a variety of environmental statutes, including the Toxic Substances Control Act (TSCA).

What Projects are Eligible?

Two types of projects can qualify for expedited review:

  1. Data center projects requiring more than 100 megawatts (MW) of new load dedicated to AI inference, training, simulation, or synthetic data generation.
  2. Covered component projects, which include the materials, products, and infrastructure needed to build or operate such facilities—such as energy infrastructure, power plants, semiconductors, networking equipment, and data storage systems or software.

To be eligible, a project must also meet at least one of the following criteria:

  • A commitment of $500 million or more in capital expenditures.
  • An incremental electric load addition of more than 100 MW.
  • Direct relevance to national security.
  • Official designation as a qualifying project by a federal department.
How to Request Priority Review

According to updated EPA guidance, the new priority review process will take effect on September 29, 2025. To request it, PMN submitters must:

  • Attach a cover letter to their PMN submission via EPA’s Central Data Exchange (CDX).
  • Identify the specific data center or covered-component project the chemical will support.
  • Show that the project meets at least one of the executive order’s qualifying criteria.
  • Provide supporting documentation, such as permitting records, project announcements, or letters of support, plus details on how the chemical will be used.

EPA has posted detailed instructions for companies seeking priority review on its PMN guidance webpage.

Coalition Letter to Congress Calls for Streamlined TSCA Chemical Reviews

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A collection of over 100 trade associations is calling on Congress to reform the Toxic Substances Control Act (TSCA) to “ensure a regulatory system that balances human health and environmental concerns with domestic supply chain and innovation needs and supports growth in our manufacturing sector.”

The American Alliance for Innovation (AAI) letter, sent to congressional leaders on September 8, 2025, suggests a number of “improvements and clarifications” to the statute, including:

  • Ensuring timely and predictable reviews of new chemicals;
  • Avoiding unnecessary regulation, including overuse of Consent Orders (COs) and Significant New Use Rules (SNURs) that discourage adoption of innovative and sustainable chemicals;
  • Following a risk-based approach to regulating a chemical’s intended use in commerce that is rooted in actual uses and real-world scenarios;
  • Strengthening the scientific standards included in TSCA for what constitutes “the weight of the scientific evidence;” and,
  • Providing additional clarity to other sections of TSCA that govern testing, regulatory petitions, and data sharing.

AAI suggests that these changes be incorporated into any legislation to extend TSCA’s fee authority, which expires at the end of fiscal year 2026.

EPA Withdraws SNURs for 18 Chemicals Following Community Challenge

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EPA has withdrawn proposed Toxic Substances Control Act (TSCA) significant new use rules (SNURs) for 18 chemical substances developed by Chevron USA, after a community organization argued that EPA’s regulation failed to address “extreme health risks” to residents near industrial sites in Mississippi.

EPA previously withdrew the corresponding TSCA section 5(e) order and premanufacture notice (PMN) determinations for the chemicals in December 2024, following a voluntary remand in a D.C. Circuit challenge to the order, Cherokee Concerned Citizens (CCC) v. EPA, No. 23-01096.

“Consistent with the withdrawal of the TSCA 5(e) Order” and received comments, “EPA is withdrawing the proposed rules,” EPA’s July 9, 2025, Federal Register notice states.

Petitioner Arguments

In the associated case, CCC argued that the 5(e) order—which restricted uses of the chemicals beyond those proposed by Chevron in its PMNs and mandated worker protections—did nothing to protect fenceline communities from health risks identified by EPA in its analyses.

“[T]he Order summarizes numerous risks that exceed by orders of magnitude the risk levels EPA has consistently defined as ‘unreasonable’ and then recites trivial requirements for Chevron’s production and use of the waste plastic chemicals that could not possibly mitigate the risks to people living near the refinery,” CCC’s opening brief stated.

Among the risks identified by EPA was a one-in-four chance that people exposed to long-term air pollution generated by one chemical would develop cancer—a risk 250,000 times greater than EPA’s one-in-a-million cancer risk benchmark, according to CCC.  In its motion for voluntary remand, EPA acknowledged it had “substantial concerns that the Section 5 Order may have been made in error.”

The SNURs identified significant new uses to include uses that did not conform to the 5(e) order, as well as the manufacture or processing of the chemicals using feedstocks containing PFAS or other chemicals of concern.

The PMNs stated that the chemicals would be used as a fuel, fuel additive, fuel blending stock, or refinery feedstock.  EPA reports that their manufacture had not yet commenced at the time the order was withdrawn.

Phil Moffat to Present at Chemical Watch Regulatory Summit North America 2025

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Verdant Law is pleased to announce that Phil Moffat will speak at Chemical Watch’s Regulatory Summit North America 2025, which will take place September 15–18 in Alexandria, Virginia.

On September 15 at 11:50 am, Mr. Moffat will present on the Trump administration’s implementation of the Toxic Substances Control Act (TSCA) New Chemicals Program.  At 12:40 pm, Mr. Moffat will join an extended Q&A panel titled “Stakeholder perspectives on new chemical trends.”

Registration for the summit is open for both in-person and virtual attendance.

Update – September 16, 2025

Slides from Mr. Moffat’s presentation, “Balancing Innovation and Risk Management: TSCA’s New Chemical Review Process,” are now available here.

CEH Settles with Chemical Importer over Alleged CDR Omissions

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Last month, the Center for Environmental Health (CEH) announced a “legally binding agreement” with Wego Chemical Group over alleged failures to disclose chemical imports to EPA.  The agreement is the latest negotiated by CEH, which has aggressively pursued violations of the Toxic Substances Control Act’s (TSCA’s) Chemical Data Reporting (CDR) requirements.

“Between 2016-2019, Wego imported tens of millions of pounds of chemicals but failed to submit any reports of these imports to the EPA in 2020 as required by TSCA,” CEH’s press release states.  The company allegedly failed to report a total of 104 chemicals, including ethylene thiourea, which EPA classifies as a potential carcinogen.

CEH uncovers possible CDR violations by cross-referencing import data with CDR submissions.  The environmental organization has reached a number of settlements with chemical companies, including an October 2024 agreement with AOC LLC, discussed in a previous blog post.

Wego, based in New York, describes itself as a “chemical supply and distribution group.”  The full text of the settlement agreement has not been made publicly available.