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.
Spray Foam Producer Challenges California’s Compelled Research Funding
/in California, DTSC, Green Chemistry, Regulatory Litigation, Safer Consumer ProductsA producer of spray polyurethane foam is mounting a constitutional challenge to a California Department of Toxic Substances Control (DTSC) action requiring the company to fund research into replacement technology.
At issue is a DTSC determination requiring producers of spray foam to pay two cents for every pound sold in California into a fund supporting a green research grant. According to the plaintiff, Quadrant Performance Materials, the grant may be used either to develop spray foam containing less unreacted methylene diphenyl diisocyanates (MDI) or to reengineer the tools used to apply spray foam to reduce MDI exposures.
In a complaint filed September 21, 2026, Quadrant says it cannot conduct its own research with the grant money, is ineligible to receive a grant, has no say in what or how the recipient conducts its research, and has no right to use or profit from any resulting innovation.
“DTSC has left Quadrant with a Hobson’s choice: fund research aimed at replacing its own product—using methods and assumptions it has no control over, and that could put it out of business—or stop selling spray foam in California,” the complaint states.
Quadrant alleges that the requirement violates the First Amendment because it compels the company to subsidize speech and research with which it disagrees. It also alleges violations of the dormant Commerce Clause and Import-Export Clause, contending that the requirement unlawfully burdens interstate commerce and imposes a duty on goods brought into California from other states.
Regulatory Background
The lawsuit arises under California’s Safer Consumer Products Program (SCP), which allows DTSC to regulate “priority products” containing “candidate chemicals.”
MDI is one such candidate chemical. In 2014, DTSC identified spray foam products containing MDI as a priority product based on concerns that unreacted MDI in spray foam might cause workplace asthma. Quadrant, however, states that “DTSC has never identified a single person” harmed by spray foam products in the state.
According to the complaint, Quadrant submitted an abridged alternatives analysis to DTSC in 2025 that did not identify any feasible alternatives. In May 2026, DTSC issued a final determination imposing requirements on the continued sale of spray foam containing MDI in California. In addition to the green research fund fees, those requirements include labeling and training provisions that Quadrant does not challenge in the lawsuit.
The two-cent-per-pound fee is required from all spray foam producers for five years or until DTSC collectively receives $4 million, whichever occurs later. Based on its sales, Quadrant expects to pay approximately $10,000 into the fund each quarter.
Constitutional Claims
Quadrant seeks declaratory and injunctive relief based on three constitutional claims.
First, Quadrant argues that the fee violates the First Amendment because it forces the company to subsidize speech to which it objects. Quadrant contends that the research funded by the fees is not “neutral, disinterested science” because DTSC “has predetermined its premises and its objective.”
“DTSC, without substantiation, asserts that Quadrant’s product is harmful; the research being funded is attempting to find a replacement for MDI which Quadrant maintains does not exist or is not feasible; and California requires that this research uses green chemistry and/or green engineering principles,” the complaint states.
Quadrant further argues that the fee does not fall within exceptions for compelled funding of government speech or comprehensive regulatory schemes. Among other things, it points to the fact that the research fund is administered by a third party rather than DTSC.
Second, Quadrant argues that the requirement violates the dormant Commerce Clause by placing an excessive burden on interstate commerce. Citing Pike v. Bruce Church, Inc., Quadrant asserts that the scheme’s burdens on interstate commerce exceed its putative local benefits. Quadrant and “virtually all” other spray foam manufacturers operate outside California, the complaint states, meaning the requirement’s practical effects fall “almost entirely on interstate commerce.”
By contrast, the lawsuit alleges that the requirement’s asserted benefits are speculative because there is no guarantee that any funded project will succeed, become commercially viable, or ultimately be made available to manufacturers. “California has therefore imposed present burdens on interstate commerce in exchange for uncertain future benefits that will likely never materialize,” Quadrant states.
Third, Quadrant alleges that the scheme violates the Import-Export Clause because it imposes duties on goods imported from other states without congressional consent. The complaint acknowledges that the Supreme Court has held that the clause applies only to imports from foreign countries, but argues that it should be interpreted more broadly.
The case is Quadrant Performance Materials, LLC v. Butler, No. 2:26-cv-10704 (C.D. Cal.), filed September 21, 2026.
Philip A. Moffat Presents on TSCA CBI Expirations at SASSI Fall Meeting
/in News & EventsVerdant 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.
New Jersey Introduces “Protecting Against Microplastics Act”
/in MicroplasticsA New Jersey lawmaker has introduced legislation to prohibit the sale or distribution of certain products containing microplastics and require product labeling in the interim.
The “Protecting Against Microplastics Act,” Assembly Bill 5452, was introduced September 14, 2026. Importantly, the bill’s labeling requirements and prohibition would reach beyond products with intentionally added microplastics—they would also apply to products that have the potential to generate synthetic polymer microparticles or other secondary microplastics.
The labeling requirements would apply to four product categories: cleaning products, cosmetics, foodware, and potentially ingestible products. The sales prohibition would apply to the same products, except foodware.
The bill defines “microplastic” as “a material, five millimeters or less in diameter, composed of synthetic polymers and chemical additives, that has been added to a product over the course of the manufacturing or industrial process.”
“Potentially ingestible product” includes “any product which is edible, designed to be applied to the facial area, or capable of being swallowed or inhaled.” The bill lists chewing gum, tea bags, coffee grounds, talcum powder, and pet food as examples.
Phased Rollout
The bill’s requirements would take effect in three phases.
One year after enactment: Manufacturers of covered products sold in the state must disclose, on an exterior product label, the presence of intentionally added microplastics or the potential to generate secondary microplastics.
Two years after enactment: Manufacturers of products that contain intentionally added microplastics, or that could generate synthetic polymer microparticles or other secondary microplastics, must include the statement “This product contains microplastics” in both English and Spanish. The statement must appear on the product handle or on any surface that contacts food or beverages, and in online product listings. Manufacturers also could not claim a product is “free of microplastics” if microplastics were intentionally added.
The labeling requirement would not apply if microplastics are present only in electronic or internal components. It would also not apply to products that are too small to fit a two-square-inch label and have no exterior container, wrapper, or attached tag. A product that already carries a microplastics label under another state or federal law would be deemed compliant.
Three years after enactment: Selling, offering for sale, or distributing for sale any cleaning, cosmetic, or potentially ingestible product would be prohibited if it contains intentionally added microplastics or could generate synthetic polymer microparticles or other secondary microplastics. Technically unavoidable trace quantities would not trigger a violation.
Notably, the bill’s accompanying Statement describes only the second-year labeling requirement and does not mention the first-year disclosure, which overlaps with it.
Enforcement and Funding
The Division of Consumer Affairs could audit manufacturers and impose civil administrative penalties of $1,000 to $20,000 per violation, with each day of a continuing violation counted separately.
The bill appropriates $3 million: $2.5 million to the Department of Environmental Protection for a source reduction program and microplastics research and monitoring, and $500,000 to the Department of Law and Public Safety for enforcement.
What to Watch
The bill’s definition of microplastics resembles the one in California’s microplastics candidate chemicals listing, which covers plastics less than five millimeters in their longest dimension. By contrast, Rhode Island legislation introduced earlier this year used a definition closer to the European Union’s. That bill died in committee.
State-level microplastics regulation is still in its infancy, and it remains unclear which definition states will ultimately adopt.
The bill has been referred to the Assembly Environment and Solid Waste Committee.
NAW Appeals Oregon Packaging EPR Decision to Ninth Circuit
/in EPR, Regulatory Litigation, Sustainable PackagingThe National Association of Wholesaler-Distributors (NAW) has appealed the first-ever merits ruling on extended producer responsibility (EPR) program for packaging, the trade association announced on September 24, 2026.
The appeal, before the Ninth Circuit, challenges the District of Oregon’s decision upholding Oregon’s Plastic Pollution and Recycling Modernization Act. The outcome could have major ramifications for packaging EPR programs enacted by other states.
The appeal will focus on the dormant Commerce Clause and Due Process Clause claims NAW raised before the district court. In a 71-page ruling issued August 27, 2026, the court rejected those claims and upheld Oregon’s EPR program. The court’s analysis is discussed in detail in a previous post.
In the press release, NAW argues that the program imposes fees on wholesaler-distributors who do not control the packaging or final destination of their products. NAW also contends that Oregon regulators “anticipated producers would recover program costs from customers in other states, and cited that as a way to reduce price impacts on Oregonians.”
NAW further alleges that the producer responsibility organization (PRO) charged with implementing the program has “its own business interests,” calculated fees using a confidential methodology, and collected millions of dollars in excess funds.
“The Ninth Circuit reviews questions of law without deference to the district court,” NAW adds.
Before issuing its final decision, the district court granted a preliminary injunction enjoining enforcement of the scheme against NAW’s members and conducted a five-day bench trial.
The appeal is National Association of Wholesaler-Distributors v. Feldon, No. 26-6404 (9th Cir.), docketed September 30, 2026. The originating case is No. 3:25-cv-1334 (D. Or.). NAW’s opening brief is due December 17, 2026, and Oregon’s response is due January 18, 2027.
Philip A. Moffat Quoted in Chemical Watch Article on NM PFAS Litigation
/in News & EventsOn September 30, 2026, Verdant Law attorney Philip A. Moffat was quoted in a Chemical Watch article titled “New Mexico Faces PFAS Disclosure Dilemma After Court Halts Labelling Scheme.”
Mr. Moffat discussed New Mexico’s options following a federal court’s issuance of a preliminary injunction in litigation challenging the state’s far-reaching PFAS labeling requirement. He also addressed the status of a separate state-court challenge to the labeling mandate.
A copy of the article is available here.
EPA Seeks Scientific Input as Glyphosate Review Moves Forward
/in Chemical Screening, EPA, FIFRA, PesticidesEPA’s long-running review of glyphosate is entering a new phase, with the Agency soliciting scientific input and working with the Department of Health and Human Services (HHS) to reassess the pesticide’s potential effects on human health.
Last month, EPA requested comment on a list of studies that will inform its ongoing registration review of the pesticidal substance under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). This month, the Agency also announced a partnership with HHS to improve scientific coordination in the review.
Although FIFRA requires EPA to review pesticide registrations at least every 15 years, the Agency has not yet completed the registration review that began in 2009. The review has been prolonged, in part, by the Ninth Circuit’s 2022 vacatur of the human-health portion of EPA’s interim decision.
Glyphosate is best known as the active ingredient in the weed-killer Roundup. EPA has long taken the position that glyphosate is not a human carcinogen, a position shared by a number of other international regulatory authorities. However, in 2015, the International Agency for Research on Cancer (IARC) classified glyphosate as “probably carcinogenic to humans.”
IARC’s determination was a major catalyst for litigation over Roundup’s alleged carcinogenicity. Nearly 4,000 actions are currently pending in a federal multidistrict litigation concerning Roundup product liability claims, with numerous state suits also pending.
Those plaintiffs were dealt a significant blow earlier this year by the Supreme Court. In Monsanto Co. v. Durnell, the Court held that FIFRA preempts state-law failure-to-warn claims based on the absence of a cancer warning from EPA-approved Roundup labels.
EPA’s registration review could have significant implications for this ongoing litigation. And because glyphosate is one of the most widely used pesticides in the United States, the review may also have significant agricultural implications.
Background on EPA’s Glyphosate Review
In 2020, EPA issued an interim registration review decision concluding that glyphosate posed no human-health risks of concern when used according to its label and was “not likely to be carcinogenic to humans.” Environmental and farmworker organizations challenged that decision in the Ninth Circuit. In Natural Resources Defense Council v. EPA, the court vacated the human-health portion of EPA’s interim decision and remanded it to the Agency for further analysis and explanation.
The court held that EPA’s selection of the “not likely to be carcinogenic to humans” hazard descriptor was not supported by substantial evidence because its reasoning was internally inconsistent and did not adequately follow the Agency’s Cancer Guidelines. Among other concerns, EPA acknowledged that the available evidence did not permit a conclusion regarding the association between glyphosate exposure and non-Hodgkin lymphoma, but nevertheless classified glyphosate as “not likely to be carcinogenic to humans.” The court also identified problems with EPA’s evaluation of animal-tumor studies. The court did not determine that glyphosate causes cancer; rather, it concluded that EPA had not adequately supported its classification.
The Ninth Circuit also held that EPA’s registration review decision constituted agency action triggering the requirements of the Endangered Species Act (ESA). It remanded the ecological portion of the decision without vacatur and directed EPA to complete additional review.
In September 2022, EPA withdrew the remaining portions of the interim decision, explaining that it needed additional time to address the ecological issues and satisfy its ESA obligations. EPA stated that its underlying scientific findings had not changed but that it would revisit and better explain its evaluation of glyphosate’s carcinogenic potential.
Open-Literature Search
On August 25, 2026, EPA released a list of studies screened by the Agency to inform its human health risk assessment for glyphosate. The list includes over 5,300 studies, including over one thousand studies classified as “potentially relevant.” In a separate document, EPA explained the methodology underlying the search.
The same day, EPA requested public input on the completeness of the search and asked commenters to identify additional peer-reviewed studies that may warrant consideration. The Agency initially established a September 24, 2026, deadline for comments.
On September 28, EPA extended the comment period on its search by 60 days, moving the deadline from September 24 to November 23, 2026. According to EPA, the extension is intended to provide additional time for meaningful stakeholder input.
EPA-HHS Memorandum of Understanding
On September 22, 2026, EPA and HHS announced a new interagency memorandum of understanding (MOU) intended to expand scientific coordination in EPA’s glyphosate registration review. Under the agreement, the agencies will exchange scientific information, identify research gaps, and coordinate additional research concerning potential human health effects of glyphosate.
EPA and HHS will establish a joint technical working group composed of experts from EPA’s Office of Pesticide Programs and several HHS components, including the National Institute of Environmental Health Sciences, National Toxicology Program, National Cancer Institute, National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention’s National Center for Environmental Health, and the Food and Drug Administration.
The agencies identified several areas for additional research and coordination, including the toxicology of glyphosate formulations and surfactants, occupational epidemiology, human exposure and biomonitoring, and dietary exposure. EPA stated that its updated human health assessment will evaluate evidence concerning cancer, genotoxicity, reproductive and developmental effects, as well as exposure from glyphosate-based formulations, occupational uses, and dietary sources, including preharvest applications.
The MOU creates no new authority for either agency and does not dictate the outcome of the registration review. EPA retains sole responsibility for registration decisions under FIFRA.
What to Watch
EPA currently anticipates completing the updated human health risk assessment in early 2027. That assessment will provide another opportunity for public comment and could inform subsequent regulatory decisions concerning glyphosate. In the meantime, under the MOU, EPA and HHS intend to make appropriate materials produced by the working group available in the glyphosate registration-review docket as they are finalized.
In addition, the first Roundup trial following Durnell is currently underway. While state-law failure-to-warn claims are no longer viable, the trial may be an early indicator of whether design defect or other torts can succeed. That case is Aretino v. Monsanto Co., No. 20SL-CC03676 (Mo. Cir. Ct., St. Louis County), filed July 10, 2020.
Fifth Circuit Vacates EPA’s Methylene Chloride Risk Management Rule
/in Regulatory Litigation, Risk Evaluations & Management, TSCAIn 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.
Federal Court Blocks New Mexico PFAS Labeling Rule
/in PFAS, Regulatory Litigation, Right-to-KnowA federal judge has issued a preliminary injunction against New Mexico’s far-reaching PFAS labeling requirements for consumer products, finding that the trade associations challenging the rules are likely to prevail on their First Amendment claim. The court’s order turns on its determination that the labeling mandate is not a “reasonable fit” for the state’s asserted interests.
Issued September 16, 2026, the injunction bars enforcement of the labeling mandate in its entirety while the litigation proceeds—less than four months before the requirements were set to take effect.
Regulatory and Legal Background
New Mexico promulgated the PFAS labeling mandate in May 2026. If allowed to take effect, the rules would require all consumer products manufactured for sale or distribution in the state that contain intentionally added PFAS to bear a PFAS label after January 1, 2027. The required label consists of the term “PFAS” within an Erlenmeyer flask pictogram. Only used products and certain products subject to federal regulation, like pesticides and drugs, are exempt.
In July, the plaintiffs—which include the American Chemistry Council, Alliance for Automotive Innovation, American Coatings Association, National Association of Manufacturers, and several other industry groups—filed suit in the District of New Mexico. Their arguments revolve around which type of First Amendment scrutiny should apply to the labeling mandate.
While government-compelled speech is generally subject to heightened scrutiny, a lesser form of scrutiny applies to certain types of compelled commercial disclosures under Zauderer v. Office of Disciplinary Counsel. As discussed in a previous post, the plaintiffs argue that Zauderer does not apply and that the labeling mandate should therefore be subject to heightened scrutiny.
The Preliminary Injunction
Analyzing the label under Zauderer, the court first found that the required disclosure was likely to be purely factual and uncontroversial. However, the court then preliminarily determined that there was no reasonable connection between the labeling requirement and New Mexico’s asserted interests, making Zauderer inapplicable.
New Mexico asserted interests in protecting consumer health and safety, protecting the environment, and providing relevant information about the manufacturing process to consumers. In response to the plaintiffs’ argument that the label is not purely factual because it misleadingly communicates hazard, New Mexico stressed that the label is not a warning. Instead, the state argued, the label merely promotes consumer awareness of PFAS.
This proved to be the state’s undoing. “In characterizing the required label as a ‘consumer awareness label,’ and not a ‘warning label,’ Defendants destroy the connection between the purpose of the required disclosure – to promote consumer and environmental health – and the means employed to realize that purpose, which in other instances is achieved with a warning,” the order states.
“A label that conveys no information cannot, be ‘inextricably intertwined’ with the goal of reducing the health and environmental impact of PFAS for the label does not provide any advice or information about PFAS,” the order continues.
In the court’s view, New Mexico’s characterization of the label makes its goal more akin to addressing “consumer curiosity.” The court noted that other courts have found consumer curiosity to be an insufficient basis for compelled labeling.
The court also observed that New Mexico appears to want the label to operate as a warning, pointing to statements in the state’s expert declarations and on its website characterizing the label as a warning. “However, the Regulation cannot simultaneously, as Schrödinger would have it, be merely a consumer awareness label and not a warning label, and if it is a consumer awareness label it serves to promote consumer curiosity about the contents of various products,” the order states.
Because the court found no reasonable fit between the disclosure requirement and the state’s asserted interests, it concluded that the mandate could not survive heightened scrutiny either.
The case is Am. Chemistry Council v. Kenney, No. 1:26-cv-2130 (D.N.M.), filed July 1, 2026.
TSCA Fee Authority Extended Through December 11
/in TSCA, TSCA ReformCongress 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.
Verdant Law Earns Chambers Spotlight 2027 DC Recognition
/in News & EventsVerdant Law is pleased to announce that the Firm has been recognized in the forthcoming 2027 DC Metropolitan Area Guide from Chambers Spotlight.
Chambers Spotlight recognizes “exceptional small and mid-sized law firms” delivering “partner-level attention, deep regional knowledge and cost-effective solutions for sophisticated legal work.” Verdant Law will be included in the first-ever DC Metropolitan Area guide for the Environment practice area. The ranking will go live on Chambers.com on October 27, 2026.
The recognition reflects the Firm’s work advising clients on product stewardship and other complex environmental matters. It also reflects the Firm’s commitment to practical, sophisticated legal counsel.
We are grateful to our clients for their trust and to our team for the dedication and expertise reflected in this recognition.
Verdant Law
Washington, DC
1025 Connecticut Avenue, NW
Suite 1000
Washington, DC 20036
Recent News
Phone
+1 202-828-1233
Email
info@verdantlaw.com