Philip A. Moffat Presents on TSCA CBI Expirations at SASSI Fall Meeting

/in , ,

Verdant Law is pleased to share that attorney Philip A. Moffat presented on confidential business information (CBI) expirations at the Fall Meeting of the Synthetic Amorphous Silica and Silica Industry Association (SASSI) on October 1, 2026.

The presentation covered practical pitfalls that can arise when CBI claims expire and are renewed under the Toxic Substances Control Act (TSCA). Mr. Moffat also discussed ongoing litigation challenging EPA’s disclosure of CBI due to a procedural error, which may bear on the Agency’s disclosures of commercially sensitive information.

A copy of Mr. Moffat’s presentation is available here.

Fifth Circuit Vacates EPA’s Methylene Chloride Risk Management Rule

/in , ,

In a groundbreaking decision with significant implications for the regulation of existing chemicals under the Toxic Substances Control Act (TSCA), the Fifth Circuit vacated EPA’s risk management rule for the solvent methylene chloride (“MC”) on September 15, 2026.

“At every juncture of its scientific analysis, EPA has gone with the most extreme position,” the decision states. “EPA cannot justify the MC Rule in light of the TSCA’s requirements, the more demanding substantial-evidence standard that the TSCA requires, and the arbitrary and capricious standard.”

The ruling rejects policy positions developed under the Biden administration that were not defended by the Trump EPA. These include “whole chemical” risk determinations and the assumption that workers do not wear personal protective equipment (PPE)—policies EPA proposed to reverse in September 2025.

The ruling also addresses the meaning of “unreasonable risk,” the threshold for regulation under TSCA, by emphasizing that TSCA is not a zero-risk statute.

In addition to siding with industry-aligned petitioners, including the American Chemistry Council, the decision rejects a challenge from the Sierra Club that the MC rule is insufficiently protective.

The decision may implicate numerous previously conducted risk evaluations, which are already mired by delays. It also calls into question elements of EPA’s other risk management rules, including rules for carbon tetrachloride, perchloroethylene, and trichloroethylene, which are currently being litigated. EPA is reconsidering at least part of all three rules.

Finalized in 2024, the MC rule prohibits MC’s distribution for consumer use and most commercial uses. Uses not banned are subject to stringent workplace exposure limits. As discussed in a previous post, the Fifth Circuit appeared skeptical of EPA’s justifications for these restrictions during oral argument in June 2025.

“Whole Chemical” Approach and Assumption Workers do not Wear PPE

EPA completed its initial risk evaluation for MC in 2020 under the first Trump administration. The Biden EPA issued a revised risk evaluation in 2022. The revised evaluation replaced the initial evaluation’s condition-of-use-specific risk determinations with a determination that MC presents unreasonable risk “as a whole chemical substance.” Unlike the initial evaluation, the revision also assumed that exposed workers do not wear PPE. The panel held that both policy reversals were unlawful.

The court first examined the “whole chemical” approach. Emphasizing TSCA’s repeated use of the phrase “conditions of use” when describing how risk evaluations must be conducted, the court held that a whole-chemical determination exceeds EPA’s authority under the statute.

“There is no getting around the conclusion that the TSCA focuses on both determining and regulating risk according to the actual, separate ‘conditions of use’ for a given chemical or substance,” the decision states.

The court also found that EPA erred when issuing whole-chemical determinations under the Trump EPA’s regulations for risk evaluations, which the court held expressly require use-by-use determinations. Those regulations were replaced by the Biden EPA in 2024.

Turning to PPE, the court held that PPE use is encompassed by the definition of “conditions of use.” EPA justified its reversal on assumed usage by arguing that some workplaces may not be covered by OSHA standards or comply with OSHA requirements. But the court found that this position was undermined by the initial MC risk evaluation. There, EPA found some evidence of PPE use and concluded that PPE use was reasonably foreseeable because EPA had no basis to assume noncompliance with OSHA requirements.

The court also pointed to statements in EPA’s revised risk evaluation indicating that the policy change was not an indication of widespread OSHA noncompliance and that MC is subject to numerous regulations. Combined with EPA’s decision not to alter the exposure assessments in the revised risk evaluation, the court found that EPA’s explanations “are remarkably self-contradictory.”

EPA’s reversal was therefore contrary to law, arbitrary and capricious, and lacked substantial evidence, the court concluded.

The Fifth Circuit’s ruling aligns with changes EPA proposed in 2025. EPA’s proposed rule would require use-by-use risk determinations and eliminate language prohibiting the assumption of PPE use.

“Unreasonable Risk” and Exposure Limits

The industry petitioners’ central argument is that EPA treated any MC risk as unreasonable and regulated beyond what was required to remove unreasonable risk. The panel agreed, concluding that “EPA’s approach to ‘unreasonable risk’ was far more conservative than the statutory term connotes.”

TSCA is not a zero-risk statute, the court held, emphasizing that the word “unreasonable” “must allow for some risk.” Moreover, unlike other environmental statutes, TSCA does not incorporate a precautionary principle, the court noted.

The court also rejected EPA’s argument that unreasonable risk is a factual finding deserving judicial deference, describing it instead as a “legal conclusion” drawn from scientific findings.

The court then turned to the MC rule’s exposure limits, including a 16 ppm limit for acute exposures and a 2 ppm limit for chronic exposures. These limits “lack epidemiological support, reflect selective use of data and failures to consider alternative acceptable data, and were based on unrealistic benchmark margins of error,” the decision states.

“In sum, the risk analysis did not accord with the best available science as the TSCA requires, and the results more closely approximate the precautionary principle than the statute’s ‘unreasonable risk’ standard,” the court held.

According to the court, EPA calculated the acute exposure limit by taking a human study finding peripheral vision impairment at 478 ppm and dividing by thirty, in part to account for variability among humans. But EPA’s exclusive reliance on the study was problematic, the court held, because EPA did not show that another human study with less concerning results should be disregarded entirely. The court also noted the gap between the 16 ppm limit and the 2,300 ppm concentration EPA rated as “immediately dangerous,” as well as OSHA’s 125 ppm standard.

The court’s analysis of the 2 ppm chronic exposure limit was similar. EPA exclusively relied on a single imperfect animal study, improperly excluded results from human studies, and reached a chronic exposure limit less than one-tenth of OSHA’s, the court held.

Regulatory Response and Alternatives

Even if the exposure limits had been correctly derived, the court concluded that the rule would still regulate more than necessary to remove the unreasonable risk.

First, the panel rejected EPA’s decision to prohibit MC uses when it was unsure whether industrial and commercial users would be able to satisfy “dramatically reduced” limits. “EPA cannot simply ban a chemical substance whenever it is ‘uncertain’ whether a risk will remain reasonable,” the decision states.

Second, the court concluded that the rule did not meet TSCA’s command that EPA consider the availability of alternatives. The court held that EPA did not seriously consider numerous comments explaining the unavailability of alternatives. In addition, EPA repeatedly failed to consider economic, productivity, and environmental losses associated with the adoption of alternatives, the court held.

Excluding Exposures

A final key holding arose from the Sierra Club’s challenge. Among other arguments, the environmental group contends that EPA did not adequately consider air and drinking-water exposures. Those exposures were excluded from the scope of EPA’s risk evaluation, although EPA considered them in a subsequent, truncated analysis.

The panel was not persuaded, pointing to uncertainties EPA identified in the supplemental analysis. “We cannot say that EPA is prohibited from excluding exposure pathways and exposure types that it does not have a methodology to accurately assess,” the decision states. “A fair reading of the TSCA leaves ample latitude for EPA to exclude certain exposure pathways when the science or methodology is not developed.”

The Ninth Circuit has held that TSCA’s directive requiring EPA to publish risk evaluation scoping documents based on the conditions of use it “expects to consider” does not authorize EPA to exclude conditions of use. But the Fifth Circuit found that precedent inapposite because that case concerned EPA’s regulations governing the conduct of risk evaluations rather than a specific risk evaluation.

In a footnote, the court added that it did not necessarily agree with the Ninth Circuit’s reasoning, pointing to a separate provision of TSCA that might provide EPA with discretion.

That issue, too, is the subject of EPA’s proposed regulatory changes. EPA’s proposed revisions to the risk evaluation framework regulations would grant EPA discretion to exclude conditions of use and exposure pathways from risk evaluations.

The case is East Fork Enterprises v. Zeldin, No. 24-60227 (5th Cir.), filed May 10, 2024. Unless expedited, the court will issue its mandate November 7, 2026.

TSCA Fee Authority Extended Through December 11

/in ,

Congress has extended EPA’s authority to collect Toxic Substances Control Act (TSCA) user fees from industry through December 11, 2026. The extension, included in a continuing resolution signed into law on September 2, moves the expiration date from September 30 to shortly after the midterm elections.

The short-term extension comes as Congress considers whether to pair long-term fee reauthorization with substantive amendments to TSCA. Earlier this year, Senate Republicans released the Toxic Substances Control Act Fee Reauthorization and Improvement Act of 2026, a discussion draft that would reauthorize the fee program for 10 years while making significant revisions to reviews of new chemicals under TSCA Section 5. House Republicans have also released a discussion draft.

TSCA fees are assessed when EPA requires manufacturer testing under Section 4, when manufacturers submit new chemical applications under Section 5, and when EPA evaluates existing chemicals under Section 6. Should EPA’s fee authority expire, it could strain the Agency’s resources and exacerbate the backlog of new chemical applications awaiting EPA action.

EPA Finds Unreasonable Risk in Four Draft TSCA Risk Evaluations

/in , ,

In August and early September, EPA released draft risk evaluations for 1,2-dichloropropane, trans-1,2-dichloroethylene, o-dichlorobenzene (oDCB), and p-dichlorobenzene (pDCB) under the Toxic Substances Control Act (TSCA). EPA preliminarily determined that all four substances present unreasonable risk, driven primarily by certain conditions of use analyzed in the draft risk evaluations.

EPA will consider public comments before finalizing the evaluations. If EPA continues to find unreasonable risk, the agency will propose risk management actions under TSCA Section 6(a) to address those exposures.

1,2-Dichloropropane

1,2-Dichloropropane is an industrial chemical used in laboratory and industrial applications. According to EPA, it was previously used in cleaners, polishes, and waxes, and the Agency is evaluating those uses because imported products may still contain the substance. EPA has recognized 1,2-dichloropropane as likely to be carcinogenic to humans.

EPA’s draft evaluation identifies significant contributions to unreasonable risk to workers and occupational non-users from inhalation and dermal exposure under 11 conditions of use. Three consumer uses involving cleaners, polishes, and waxes were also preliminarily found to contribute to unreasonable risk. EPA did not identify unreasonable risk to the general population or the environment.

trans-1,2-Dichloroethylene

trans-1,2-Dichloroethylene is used in industrial and commercial cleaning and degreasing, as a processing aid, and in consumer products such as cleaners, degreasers, and foam insulation.

EPA’s draft evaluation identifies significant contributions to unreasonable risk to workers and occupational non-users from inhalation exposure under 19 conditions of use. One consumer use of trans-1,2-dichloroethylene—as a cleaner or degreaser—was also preliminarily found to contribute to unreasonable risk. EPA did not identify unreasonable risk to the general population or the environment.

oDCB and pDCB

oDCB and pDCB are used in household and commercial products and can evaporate into the air. pDCB is used in some air-care and deodorizing products, making indoor air a potential route of consumer exposure.

EPA’s draft evaluation for oDCB identifies contributions to unreasonable risk to workers from 14 conditions of use through inhalation, with dermal exposure contributing to risk in seven conditions of use. The draft also identifies unreasonable risk to consumers from one condition of use through inhalation.

For pDCB, EPA identified contributions to unreasonable risk to workers from seven conditions of use through inhalation and dermal exposure, as well as to consumers through inhalation from air-care products.

For both substances, EPA evaluated developmental, liver, and respiratory toxicity. EPA’s worker risk estimates do not assume the use of personal protective equipment (PPE), although the draft evaluations separately discuss how PPE and other controls could reduce exposure. EPA did not identify unreasonable risk to the general population through ambient outdoor air, including fenceline communities, or to the environment.

EPA’s draft evaluation for pDCB also concludes that the substance is not likely to be carcinogenic to humans. EPA acknowledges, however, that the International Agency for Research on Cancer and the National Toxicology Program have classified pDCB differently. EPA is specifically seeking comments and data on its assessment.

What This Means in the Context of EPA’s TSCA Evaluations

EPA is behind schedule on legally required risk evaluations under TSCA. In November 2024, EPA entered into consent decrees with the D.C. District Court concerning 22 risk evaluations, none of which were completed within TSCA’s 3.5-year deadline. The consent decrees created a court-enforceable schedule for EPA to complete the overdue evaluations.

The consent decrees have since been modified. In March 2025, EPA asked the court to extend by 60 days the deadlines for two draft risk evaluations and the final risk evaluation for 1,1-dichloroethane. The court granted the extensions on March 7, 2025.

The release of these four draft evaluations reflects EPA’s continuing effort to complete years-overdue TSCA risk evaluations under the court-ordered schedule established to address the Agency’s backlog.

Ninth Circuit Upholds EPA’s 2024 New Chemicals Rule

/in , , , ,

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.

EPA’s Battery-Cathode SNURs Test the Limits of “Significant New Use”

/in , , ,

EPA has proposed two significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA) that would extend restrictions across the full lifecycle of the cathode substances in lithium-ion batteries, including recycling and reclamation.  Industry stakeholders note that this is a departure from ordinary SNUR practice.  The rules, published on April 24, 2026, cover two generically identified “cobalt lithium manganese nickel oxide, metals-doped” substances used as cathode active materials (CAMs) in lithium-ion batteries.  The comment period, extended once, closed July 10, 2026.  As of this writing, EPA has not finalized, withdrawn, or re-proposed the rules.

What the Proposal Would Do

Under the proposed rules, EPA would regulate the CAMs even after the substances have been manufactured into articles.  Usually, the agency exempts substances in articles from SNUR obligations.

The proposed rules impose a labeling requirement for the articles—the batteries—that contain these substances.  In addition, recycling and reclamation restrictions would apply when the batteries are shredded or otherwise handled in a manner that generates dust.  These restrictions include 99% dust-control efficiency, no release to water, hazardous-waste disposal, and respiratory protection.  In other words, it would be a significant new use to manufacture, process, recycle, or reclaim the material without these controls.

The Federal Register notice explained that the proposed SNURs merely extend restrictions from the Section 5(e) consent orders imposed on the original premanufacture notice (PMN) submitters to all manufacturers and processors.

Why the Approach is Contested

Comments on the proposed rule assert that much of what EPA proposed is impracticable if not impossible.  The Alliance for Automotive Innovation argued that the proposed SNUR would “impose responsibility for the future management of individual chemical constituents throughout a downstream recycling infrastructure that is outside of the manufacturer’s ownership or control.”  Their comments note that while such regulation may be permissible under TSCA, regulating an article through its lifecycle base on the chemicals within the article is not the intent of the statute.

The Chemical Users Coalition—whose members include Airbus, Boeing, Intel, Lockheed Martin, and RTX—asked EPA to withdraw the proposal.  Their comments argued that the terms “processing” and “use” are unclear as applied to repair, import of batteries containing the SNUR substances, either by themselves or as part of larger articles, and recycling.  In addition, according to the Coalition, EPA failed to satisfy the threshold requirement of TSCA Section 5(a)(5) which requires that the Administrator make an affirmative finding that the reasonable potential for exposure to the chemical substance through the article “justifies notification” before imposing a SNUR for the “import or processing of a chemical substance as part of an article.  The Coalition also flagged that it is possible that there are ongoing uses of the substance that would not have been subject to TSCA Section 5 notice requirements—e.g., the import of the substances when incorporated into an article and the subsequent recycling of such articles.  This, the Coalition argues, was not addressed in the proposed rule.

Who is Affected, and What to Watch

The proposed rule reaches broadly beyond chemical manufacturers to battery producers, automakers, and recyclers, and importers of batteries and battery-containing articles. The regulation would be especially onerous for importers.  In most cases chemical composition of articles is not readily available, which may make it hard to know whether an imported battery contains a covered substance or if one needs to request an applicability determination from the supplier.

If the final rule keeps the article and recycling requirements in their current form, industry is likely to challenge the agency’s statutory authority for the rulemaking.

Court Rejects EPA Bid to Dismiss TSCA Confidentiality Suit

/in , ,

A federal judge in the Middle District of Georgia has denied EPA’s motion to dismiss a lawsuit brought by Burgess Pigment Company, which is seeking to stop the agency from publicly disclosing the identity of one of its chemical substances.  The dispute stems from Burgess’s failure to timely file a required notice under EPA’s “Active/Inactive Rule”—a mistake the company acknowledges, but which it argues does not justify the loss of confidential treatment it had maintained for two decades.

The July 31, 2026, order, which the court described as an easy call at this stage, may be a case of first impression on how confidential business information (CBI) claims are handled under the Toxic Substances Control Act (TSCA).  The question has implications beyond this single dispute, particularly as EPA works through the first wave of CBI expirations and renewals under the amended statute.

How We Got Here

The dispute traces back to 2016, when Congress passed the Lautenberg amendments to TSCA.  Among other changes, the amendments tightened the requirements for companies seeking to keep specific chemical identities confidential and directed EPA to determine which chemicals on the TSCA Inventory—EPA’s master list of chemicals in U.S. commerce—were active in commerce.

EPA implemented that requirement through its 2017 “Active/Inactive Rule,” which required manufacturers and processors to file a Notice of Activity Form A (NAA) for each active chemical.  Companies that wanted to keep a chemical identity confidential had to assert that claim in the NAA.  If no timely NAA was filed, EPA’s position is that it becomes statutorily obligated to disclose the substance’s identity.

Burgess missed the NAA for two chemical substances, which it admits was an error.  Burgess, a Georgia-based kaolin processor, has claimed confidential treatment for its chemical identities since at least 2000, and it argues that disclosure now would give competitors access to information they have not previously had, threatening its very existence.

EPA’s Basis for Denial

In April 2020, EPA informed Burgess that both chemical identities were no longer entitled to confidential treatment, triggering a 30-day window under TSCA for Burgess to seek judicial review.  EPA’s stated basis was not the missed NAA deadline—according to Burgess, EPA instead claimed that another company had waived protection for the substances’ identities.  Burgess disputed that characterization and pushed back through counsel.

In 2022, EPA reversed itself as to one chemical, agreeing to preserve its CBI status.  As to the second—the one now at issue in this case—EPA maintained that it was ineligible for CBI treatment but changed its rationale, instead relying on Burgess’s failure to file a timely NAA.

Burgess has continued to claim confidential treatment for that remaining substance in subsequent TSCA submissions.  Each time, EPA has responded by informing the company that it is not entitled to confidentiality, that EPA plans to disclose it, and that Burgess has 30 days to seek judicial review.  Yet despite years of these notices, EPA has never actually published the chemical’s identity on the public Inventory.

The Lawsuit

Following receipt of the latest denial letter in April 2025, Burgess filed suit in July 2025 under the Administrative Procedure Act (APA), alleging that EPA’s determination was arbitrary and capricious.  In its complaint, Burgess argued that the specific chemical identity is deserving of confidential treatment under TSCA, and that EPA’s approach “unreasonably elevate[s] form over function” by focusing solely on “an inadvertent mistake.”

EPA moved to dismiss in November 2025, arguing that the suit was untimely.  In EPA’s view, its latest letter simply reiterated the original 2020 determination, meaning the real target of Burgess’s challenge was a decision from years earlier—long outside TSCA’s 30-day review window.

The Court’s Ruling

The court was not persuaded, calling dismissal an easy call on the current record.  Much of the order walks through the case’s lengthy factual history, with the judge weaving in several notable observations along the way.  For example, the court appeared to emphasize that EPA has never actually disclosed the contested chemical identity despite years of warning that it would, and that EPA appears “mum on any assessment regarding the merits of Burgess’s potential assertion that the identity of its chemical substance is a trade secret” under the Freedom of Information Act.

The court’s most significant comment addressed Burgess’s argument that EPA itself recognizes the risk of irreparable harm when CBI is lost due to an inadvertent filing mistake.  If that’s true, the court stated, “it very well might be that the EPA’s refusal to withdraw its denial of the CBI claim . . . calls for judicial intervention via the APA.”

The court’s actual merits analysis is comparatively short.  Without appearing to take a definitive position on whether the 2020 or 2025 determination is really being challenged, the court pointed to statements on EPA’s website, cited by Burgess, that prior determinations are only one factor in a CBI review and that each claim is evaluated in the context of the submission in which it is received.  Because the sole reason EPA gave for its 2025 determination was that the chemical identity had already been denied, the court held that dismissal was not warranted on “such a limited record.”

“Until the Court can take a ‘hard look’ at the administrative record to determine whether the EPA has acted in an arbitrary or capricious manner, in an abuse of discretion, or otherwise not in accordance with law, the EPA’s efforts to dismiss Burgess’s APA fail at this early stage,” the order states.  In the order’s closing paragraph, the court cites Burgess’s allegation that nothing in TSCA authorizes EPA to disclose a confidential chemical identity because of a reporting entity’s mistake and notes that EPA’s “strict adherence to and unwillingness to budge on an overly technical rule may cement irreparable and irrevocable devastation to a small family-owned business.”

The case is Burgess Pigment Co. v. U.S. Environmental Protection Agency, No. 5:25-cv-309 (M.D. Ga.), complaint filed July 18, 2025.  EPA has agreed to maintain the confidentiality of the chemical identity for the duration of the litigation.

Coalition Argues TSCA Bars EPA From Weighing Data-Center Benefits in a New-Chemical Review

/in , , , , ,

A coalition of seventeen environmental organizations, led by Earthjustice, has asked EPA to deny a premanufacture notice (PMN) under the Toxic Substances Control Act (TSCA) for a fluorinated immersion-cooling fluid intended to cool data-center equipment.  The comments press three lines of attack: that the substance poses an unreasonable risk EPA must act on, that the substance’s asserted benefits for data centers are legally irrelevant to that judgment, and that the applicant redacted health and safety information it was required to disclose.

The comments, filed July 15, 2026, respond to EPA’s notice of receipt of the PMN.  The substance is 3-Hexene, 1,1,1,2,2,5,5,6,6,6-decafluoro-, (3E) (CASRN 1256353-26-0), also known as Opteon 2P50.  The PMN applicant’s identity was claimed as confidential business information (CBI).

The Risk the Comments Describe

The coalition’s core argument is that the fluid presents an unreasonable risk that TSCA section 5 obligates EPA to prevent.  It characterizes the substance as a PFAS and urges EPA to find unreasonable risk on that basis alone, citing concerns including persistence, mobility, bioaccumulation potential, and toxicity.  The substance’s status as a PFAS is contested: when chemical supplier Chemours launched the fluid in 2023, it stated that it does not consider the compound a PFAS, describing it as a hydrofluoroolefin (HFO) that degrades quickly in the atmosphere.  The coalition, on the other hand, characterizes HFOs as PFAS and argues that HFOs break down in the atmosphere into shorter-chain PFAS—principally perfluoropropanoic acid (PFPrA) and trifluoroacetic acid (TFA)—that are persistent, highly mobile in water, and difficult to remediate.  They also cite a recent European Chemicals Agency risk assessment committee’s June 2026 opinion—adopted by consensus, now before the European Commission—proposing that TFA be classified as toxic to reproduction.

The comments also argue that the limited information available on the substance raises additional concerns about its risks.  Available toxicity data, they say, come largely from rat studies that understate PFAS risk to humans, and a workplace exposure limit derived by a group the comments describe as industry-linked relied on assumptions it did not disclose.  They add that the fluid is acutely toxic to aquatic life and not readily biodegradable, and that a hyperscale data center could hold tens of thousands of liters of dielectric fluid, with routine evaporative losses and disposal creating recurring releases near workers, fenceline communities, and waters around data centers and disposal sites.

How EPA Must Conduct the Review

A second line of argument concerns EPA’s review process.  TSCA section 5 directs EPA to decide whether a new chemical presents an unreasonable risk “without consideration of costs or other nonrisk factors.” EPA announced in September 2025 that it would prioritize review of new chemicals intended for data-center projects, inviting manufacturers to seek that treatment under Executive Order 14318.  The applicant filed a request for priority review premised on an urgent national need for AI infrastructure, which the coalition contends is irrelevant to the risk determination.  Priority review, they argue, affects when EPA takes up a submission, not the standard it must apply.

Two related arguments target how EPA models exposure.  The comments say EPA cannot assume workers will wear protective equipment, because under the occupational hierarchy of controls such equipment is a last line of defense and, in any event, accounting for its use would violate TSCA by conflating risk evaluation with risk management.  They also argue that EPA must weigh aggregate exposures from many facilities and other reasonably foreseen uses in its analysis.  As an example, the comments claim that the substance is marketed for other cooling applications, including use in electric-vehicle batteries.

The Confidentiality Dispute

The comments separately challenge the applicant’s CBI redactions.  They contend that TSCA generally bars confidentiality claims over health and safety information, yet the filing withheld entire toxicity-profile slides, the toxicological section of the safety data sheet, the applicant’s occupational exposure assessment, and its list of prior substantial risk notices under TSCA Section 8(e).  Other redactions concern information available on Chemours’ website, the coalition argues.

These arguments coincide with litigation brought by Earthjustice-represented environmental groups, which contends that EPA systemically fails to disclose information in PMNs claimed as CBI when the covered information does not facially qualify as confidential.

The comment period for the notice of receipt of the PMN closed July 15, 2026.

Department of Defense Again Requests Information on TSCA-Prioritized Substances

/in , ,

On May 12, 2026, the Department of Defense’s (DOD’s) Chemical and Material Risk Management Program issued a request for information (RFI) seeking industry data on defense and defense industrial base applications that rely on ten substances undergoing EPA’s Toxic Substances Control Act (TSCA) Section 6 risk evaluation process. The RFI is intended to help DOD better understand applications that require these chemicals and their importance to industry and defense supply chains.

The Risk Evaluation Process

The TSCA Section 6 risk evaluation process mandated by the 2016 Lautenberg amendments to TSCA provides a pathway for EPA to evaluate chemicals currently in commerce to determine whether they present an unreasonable risk to human health or the environment. Where such risks are identified, the agency is required to develop rules to protect human health and the environment. Regulation can range from improved workplace protections to bans on specific uses. For examples, see our previous posts on risk management rules for n-methylpyrrolidone (NMP) and 1-bromopropane.

The RFI is intended to help DOD better understand potential impacts of future TSCA regulation on military applications and defense supply chains. In particular, DOD is seeking information about how the substances are used, their importance to defense applications, quantities needed, and the availability of alternatives.

Substances Covered by the RFI

The RFI focuses on ten TSCA high-priority substances:

  • Phthalic anhydride (CASRN 85-44-9)
  • o-Dichlorobenzene (o-DCB) (CASRN 95-50-1)
  • p-Dichlorobenzene (p-DCB) (CASRN 106-46-7)
  • 4,4’-(1-Methylethylidene)bis[2,6-dibromophenol] (TBBPA) (CASRN 79-94-7)
  • Tris(2-chloroethyl)phosphate (TCEP) (CASRN 115-96-8)
  • Phosphoric acid, triphenyl ester (TPP) (CASRN 115-86-6)
  • 1,1,2-Trichloroethane (CASRN 79-00-5)
  • trans-1,2-Dichloroethylene (DCE) (CASRN 156-60-5)
  • Formaldehyde (CASRN 50-00-0)
  • Vinyl Chloride (CASRN 75-01-4)

EPA has finalized risk evaluations for some of these substances, including TCEP. For others, like phthalic anhydride, EPA has released a draft risk evaluation. Some, such as TPP and vinyl chloride, remain at the scoping stage.

The RFI is for information and planning purposes only. DOD intends to use the information to identify critical applications earlier in the TSCA Section 6 process, investigate the availability of alternatives, and better manage chemicals important to national defense.

Continued DOD Information Gathering

This is not DOD’s first RFI on substances undergoing TSCA risk evaluation. In May 2025, DOD issued an RFI seeking information on critical military uses of 11 other substances. That RFI similarly sought information about chemical applications, supply-chain importance, and potential alternatives. The 2026 RFI expressly states that it continues that information-gathering effort and covers a new group of ten TSCA high-priority substances.

Responses to the RFI were due June 19, 2026. However, DOD’s webpage states that companies may continue to submit responses to closed RFIs.

EPA Takes TSCA Enforcement Action Against Chemical Importer

/in , , ,

EPA has initiated a far-reaching administrative enforcement action against Wego Chemical Group, alleging hundreds of violations of the Toxic Substances Control Act (TSCA) stemming from the New York-based chemical distributor’s chemical imports.

“Since at least 2016, Wego has imported hundreds of millions of pounds of hundreds of toxic chemicals, mostly from China, without meeting basic federal reporting requirements,” EPA stated in a press release announcing the action, which was filed May 22, 2026.

At the core of the complaint are allegations that Wego’s 2020 and 2024 Chemical Data Reporting (CDR) submissions were both late and incomplete.  EPA alleges the 2020 forms for more than 200 substances arrived more than four years after the reporting deadline.  The agency also claims that Wego reported all chemical use information as “not known or reasonably ascertainable” in both reporting cycles, despite allegedly relying on that same information in its sales and marketing materials.

The complaint also alleges that Wego:

  • Imported a chemical not listed on the TSCA Inventory without submitting a premanufacture notice (PMN) or import certification
  • Filed a notice of commencement (NOC) claiming importation of a substance that had not occurred
  • Failed to submit export notifications for two substances subject to proposed risk management rules
  • Distributed a substance in violation of its significant new use rule (SNUR) hazard communication requirements without filing a significant new use notice (SNUN)
  • Submitted a false certification of no manufacture

EPA seeks civil penalties under six of the complaint’s ten counts.  While no specific penalty figure is proposed, the agency notes that penalties of up to $49,772 could be assessed for each of 684 individual violations.

According to the complaint, EPA first requested TSCA compliance information from Wego in 2021 and entered into a tolling agreement with the company in July 2024.  Separately, in July 2025, an environmental organization announced it had reached its own settlement with Wego over alleged 2020 CDR violations involving 104 substances.