Company Sues EPA to Block Disclosure of Chemical Identities Under TSCA

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

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

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

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.

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

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

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.

EPA Requests Comment on Reconsideration of PCE Rule

On July 30, 2025, EPA published a request for comment as it reconsiders its regulation of perchloroethylene (PCE) under the Toxic Substances Control Act (TSCA).  The request marks the first step toward potentially amending the rule issued in December 2024, which prohibited or phased out most uses of the solvent.

EPA is particularly interested in receiving comment on:

  • Whether the existing chemical exposure limit of 0.14 parts per million (ppm) should be replaced by a different limit, such as the non-cancer exposure limit of 0.5 ppm or the lifetime cancer exposure limit of 0.47 ppm;
  • Conditions of use that may be better managed through workplace protections rather than bans; and
  • Use of PCE in industrial dry cleaning processes, including workplace controls and the performance of alternatives in those operations.

EPA first announced its intent to revisit the rule in a May 12 motion requesting that the Fifth Circuit place a consolidated legal challenge to the regulation on indefinite hold.  The court denied that request, instead granting a 90-day stay.

The PCE rule was primarily driven by concerns over the solvent’s neurotoxicity.  It bans all consumer uses of PCE as well as many industrial and commercial uses, including a 10-year phaseout for use in dry cleaning.  Many of the uses that are not prohibited, such as use in aircraft and petrochemical manufacturing, will be subject to workplace exposure controls.

According to EPA’s May 12 filing, any revisions to the rule are expected to take 12 to 18 months.  Comments on the notice are due August 29, 2025.

EPA Updates Safer Choice Program’s Ingredients List

On July 21, 2025, EPA added 18 chemicals to the Safer Chemicals Ingredients List (SCIL).  The move may signal that the agency plans to continue the Safer Choice program, despite earlier speculation that the Trump administration might transition it to the private sector.

With the update, there are now 983 chemicals on the SCIL.  The list is designed to help manufacturers find safer alternatives to hazardous chemicals.  Products that meet the criteria of the Safer Choice program are eligible to carry the “Safer Choice” label.  The SCIL can be found here.

The voluntary program was targeted for elimination by the Heritage Foundation’s “Project 2025” initiative.  However, industry groups such as the American Cleaning Institute urged the Trump administration to retain it.

In a press release announcing the update, EPA states that the additions “support[] Administrator Zeldin’s commitment to transparency, innovation and safer chemistry.”  The agency also notes that using existing SCIL-listed chemicals can help companies avoid delays tied to the approval of new substances—an acknowledgment of industry concerns about the backlog in EPA’s review process.

“Without an approval from EPA under the Toxic Substances Control Act, new chemistries don’t make it to market, which simultaneously holds back the manufacturing and innovation sectors and keeps older chemistries in regulation,” the release states.

The 18 additions represent a variety of functional classes, including emollients, polymers, and surfactants.  All but one are either verified or expected to be of low concern based on experimental and modelled data.

The exception, sodium polyphosphates, is only allowed as an oxidant stabilizer due to possible hazards.  Its “yellow triangle” designation indicates that it is one of the safest chemicals available for its function, but that its function is in need of safer chemistry innovation.

Last year, EPA expanded the Safer Choice program by introducing sustainable packaging criteria and a Safer Choice Cleaning Service certification.  More on that update can be found here.

DOD Requests Information on Chemicals Undergoing TSCA Risk Evaluation

Last month, the Defense Department (DOD) issued a request for information (RFI) seeking input on critical military uses of 11 chemicals currently undergoing Toxic Substances Control Act (TSCA) risk evaluation.

The “ability to identify critical applications earlier in the TSCA Section 6 risk evaluation process will allow [DOD] to investigate the availability of alternatives, inform industry and interagency engagement, and better manage chemicals critical to national defense,” the RFI states.

DOD will likely use the information it collects to help ensure that critical applications are protected in any future TSCA risk management rule.

The 11 chemicals include 1,3-Butadiene, 1,1-Dichloroethane, 1,2-Dichloroethane, D4, and seven phthalates: BBP, DBP, DCHP, DEHP, DIBP, DIDP, and DINP.  Some, like DIDP, have finalized risk evaluations.  For others, such as D4, EPA has yet to release a draft.

The RFI focuses on identifying specific DOD applications that require these substances and their industrial criticality.  It asks for details such as annual usage quantities, whether viable alternatives exist, and which TSCA condition of use best matches each application.

According to the RFI, DOD currently relies on safety data sheets (SDSs) for chemical ingredient data, which contain limited information.  As a result, DOD “lacks visibility in tracking upstream applications to understand the implications of developing regulatory drivers, such as TSCA.”

Responses to the RFI were due June 20, but DOD will consider late comments to the extent practicable.  The department also stated that it “will continue to issue RFIs to consider additional TSCA chemicals.”

Fifth Circuit Questions EPA’s Methylene Chloride Rule in Landmark TSCA Case

On June 3, 2025, the Fifth Circuit heard oral argument in a case consolidating industry and Sierra Club challenges to EPA’s regulation of methylene chloride under the Toxic Substances Control Act (TSCA).  The panel generally appeared to doubt EPA’s justification for banning certain uses of the solvent and imposing stringent workplace restrictions.

The background for East Fork Enterprises Inc. v. EPA, No. 24-60256, is discussed in a previous blog post.  It looks likely that this will be the first case in which a court of appeals rules on the merits of a TSCA risk management rule since EPA was granted expanded authority to regulate existing chemicals with the 2016 Lautenberg amendments to TSCA.

Undefended Policies

The industry petitioners’ attorney urged the court to rule on two Biden-era policies that the Trump EPA has declined to defend: the agency’s decision not to assume that workers use PPE, and its “single determination” approach to findings of unreasonable risk.

One judge asked the industry attorney whether there had been any statistical surveys or epidemiological work to determine the number of workers affected by methylene chloride, suggesting that EPA should base its review in terms of “reality.”  The industry attorney replied that isolated incidents were noted in the record, but that they should be considered against the size of the country.  “That there have been a given number of incidents is not enough to tell you the scale of the risk,” he said.

When a judge suggested that EPA’s use of conservative “uncertainty factors” helps the agency extrapolate from human studies in a way that “protect[s] those…most at risk,” the industry attorney pushed back.  “The uncertainty factors are going far beyond that…it is protective factor times protective factor times protective factor, and they’re doing that in a part of the analysis that is quite separate from what they’re doing for vulnerable populations,” he said.

Another judge inquired about the economics of the methylene chloride industry, claiming that “it’s not irrelevant to understand what the scope of the market is” when determining whether a regulation is reasonable.

Scientific Evidence

To defend its decision to impose significantly stricter worker exposure limits than OSHA, EPA argued that OSHA’s standard was based on cancer findings, rather than “the most common adverse effect, adverse liver effects.”  This drew pushback from one judge, who claimed that liver effects had only been found in animals, not humans.

“If you’re going to really show that there’s toxicity to the liver, it seems to me that you have to show toxicity to the liver, and that requires epidemiological testing, doesn’t it?” the judge said.  “EPA is tasked with finding unreasonable risk, and unreasonable risk, from a scientific standpoint, when you’re talking about humans, is epidemiology.”

EPA’s attorney acknowledged that “human studies are the first place you look” but said that “when [EPA doesn’t] have concrete information, they have to look [to] animals.”  Earlier in the argument, EPA’s attorney noted that animal testing allows for dissection, unlike human studies—which she argued can make some effects, like the early stages of liver disease, more apparent.

Both EPA and Sierra Club also pointed to the Lautenberg amendments’ explicit directive that EPA consider worker risks as evidence that Congress did not intend for EPA to defer to OSHA’s existing limitations.

I Survived”

In a notable exchange, one judge expressed concern with the breadth of the risk management rule: “It’s hard to say that any party can verify that they have never given a bit of methylene chloride to their friend who’s refinishing old furniture, a subject for which I’m particularly sensitive, because I’ve done it, and I survived.”

EPA’s attorney replied that the rule permits continued use of methylene chloride for furniture refinishing for another five years because no adequate alternative currently exists.  “This is not a case where EPA was just unilaterally deciding, ‘we don’t like this chemical, we’re going to regulate so there’s zero risk,’” she said.

EPA was also sharply pressed on the applicable standard of review.  “We noticed that EPA’s brief didn’t cite a single case that relied on the substantial evidence standard [used by TSCA] as opposed to the lower arbitrary and capricious standard,” a judge observed.

Sierra Club Arguments

The panel also appeared skeptical about the Sierra Club’s arguments, which claim that EPA’s regulations did not properly protect fenceline communities or address risks to the ozone layer.

“It’s a very, very, very, stringent regulation…I mean, what do you mean?” one judge asked.

When EPA noted that methylene chloride emissions are regulated under the Clean Air Act, one judge asked, “How does Sierra Club have a justification for coming in on this regulation at all, vis-à-vis fenceline communities, because this regulation does not cover ambient air emissions?”

EPA’s attorney responded that this was why risks to fenceline communities were not evaluated in the original 2020 risk evaluation for methylene chloride—though those risks were considered in a 2022 revision.

During rebuttals, the Sierra Club was also pressed about EPA’s one-in-a-million cancer benchmark.  “One in a million is pretty darn small…where’s the science that supports one in a million of anything being unreasonable?” one judge asked.

The Sierra Club’s attorney said that the benchmark was supported by the Science Advisory Committee on Chemicals (SACC), prompting the judge to respond, “We did a little looking at that, and it looked like some…members of the [SACC] had also themselves received EPA grants.”

But the Sierra Club argued that it does create a conflict of interest, because other members had been funded by methylene chloride manufacturers.  “I think EPA aims for a diverse range of views on the SACC,” its attorney said.