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 requires 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 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.
Fifth Circuit Vacates EPA’s Methylene Chloride Risk Management Rule
/in 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 requires 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 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.
Interagency MOU Addresses Chemical Contaminants in Meat, Poultry, and Egg Products
/in EPA, FDA, PesticidesIn a move described as advancing the Make America Healthy Again (MAHA) initiative, the Department of Agriculture (USDA), Department of Health and Human Services (HHS), and EPA have updated a memorandum of understanding (MOU) addressing drug residues, pesticide residues, and chemical contaminants in meat, poultry, and egg products.
Announced July 10, 2026, the MOU is intended to coordinate federal activities concerning chemical residues and contaminants that have the potential to adulterate those foods. It supersedes a prior 1984 agreement between the same agencies.
According to a USDA press release, as part of the effort, USDA’s Food Safety and Inspection Service (FSIS) has implemented a new laboratory method to monitor levels of 18 heavy metals in foods. USDA says that elevated levels will lead to further assessment and possible regulatory response. The press release adds that FSIS will “expand its surveillance for heavy metals to include processed foods, such as sausages and ready-to-eat meals, which combine ingredients from multiple sources.”
Coordinating Federal Oversight of Chemical Residues
FSIS primarily oversees the safety and regulation of meat, poultry, and egg products and tests these products for chemical residues through programs such as the National Residue Program. FDA oversees most other foods, live food-producing animals before slaughter, animal food, and animal drugs. EPA regulates pesticides and establishes allowable pesticide residue levels in food, including food for food-producing animals.
Under the MOU, FSIS, FDA, and EPA will coordinate on sampling and testing, tolerances and screening levels, and potential regulatory violations. Among other things, FSIS will provide FDA with weekly residue reports and keep FDA and EPA informed of its sampling and testing programs. FDA and EPA will also notify FSIS when they establish or amend certain tolerances, exemptions, action levels, or safe levels that may relate to FSIS-regulated products.
The agencies also agree to notify one another of information concerning the actual, suspected, or anticipated presence of chemical residues or contaminants that may constitute or result in violations of applicable federal food safety laws. FDA will review reports of potentially adulterated food and, when appropriate, investigate the circumstances that may have caused food-producing animals to be exposed before slaughter. EPA will similarly review reports of pesticide misuse or other potential violations and, when appropriate, investigate or refer the matter to the appropriate state enforcement authority.
A Senior Executive Council with representatives from each of the three agencies will oversee the arrangement and meet at least annually. The MOU also establishes procedures for sharing confidential and non-public information among the agencies, subject to applicable confidentiality requirements.
Oregon Packaging EPR Program Survives Constitutional Challenge
/in EPR, Regulatory Litigation, Sustainable PackagingIn a lengthy ruling with significant implications for similar schemes across the country, a federal judge has upheld Oregon’s extended producer responsibility (EPR) program for packaging, printing, and food serviceware, holding that it does not violate the U.S. Constitution’s dormant Commerce Clause or Due Process Clause.
Oregon is one of seven states to have enacted a packaging EPR program, which require manufacturers to pay volume- and material type-based fees to cover the costs of managing packaging waste. Litigation challenging California’s and Colorado’s programs is also ongoing. Those cases involve the same plaintiff, the National Association of Wholesaler-Distributors (NAW), as well as other plaintiffs.
Prior to issuing its August 27, 2026, decision, the court granted a preliminary injunction enjoining enforcement against NAW’s members and conducted a five-day bench trial. NAW has issued a statement saying that the trade association is “consider[ing] its next steps.”
Dormant Commerce Clause
NAW advanced three theories under the dormant Commerce Clause, arguing that that Oregon’s Recycling Modernization Act (RMA) (1) discriminates against interstate commerce, (2) imposes an unreasonable “user fee,” and (3) places an undue burden on interstate commerce.
Discrimination. Finding insufficient evidence of purposeful discrimination, the court considered whether the RMA is facially discriminatory. NAW argued that the scheme grants preferential “small producer” status to certain in-state governmental entities like the University of Oregon but not to similar out-of-state institutions. As a result, NAW alleged, obligated producers must pay more than their fair share of the program’s costs.
The court rejected this “free riding” argument for several reasons. Among them, the court found that NAW’s alleged injury would be the same regardless of which entity received the exemption. The court also held that in-state public entities “are not ‘similarly situated’ to out-of-state public entities, which do not support Oregon’s infrastructure.”
NAW separately argued that other small-producer criteria discriminate in effect. For example, an interstate business with global revenues above $5 million—but Oregon revenues below $5 million—would not qualify as a small producer, whereas a company solely doing business in Oregon with revenues under that threshold would. However, even if costs are borne primarily by out-of-state consumers, that does not make a scheme discriminatory in effect, the court held.
Unreasonable user fee. NAW’s “free rider” theory was also central to its unreasonable fees claim. The court, however, found the evidentiary record insufficient to establish that the exemptions resulted in an unreasonable fee. Because “no one” “has attempted to quantify the effects of any exemptions,” the court cannot determine whether these exemptions apply “with significant frequency,” the decision states.
A separate line of attack focused on the fees collected by the Circular Action Alliance (CAA), the nonprofit producer responsibility organization (PRO) that is implementing the program. While CAA collected $90 million more than it spent in 2025, the court held that is not “clearly excessive” because the excess was due to uncertainties and may reduce future fees.
Undue burden. NAW argued that the court should employ the balancing test established in Pike v. Bruce Church, Inc., which assesses whether a law’s burdens on interstate commerce are “clearly excessive in relation to [its] putative local benefits.” However, the court found the test inapplicable, noting that it is generally not applied unless a statute is discriminatory or is shown to impose a substantial or significant burden on interstate commerce. Anecdotal evidence that NAW’s members will face substantial costs is not enough, the court held, emphasizing that Pike protects the market as a whole—and not specific interstate firms—from burdensome regulations.
In any event, the court concluded that the RMA would survive Pike balancing even if the test applied. Oregon, the court found, “has a great and longstanding interest in protecting its citizens from the externalities created by waste and products at the end of their life, including plastics and other hard-to-recycle materials.”
Due Process Clause
NAW’s due process claims focused primarily on CAA’s role in administering the regulatory scheme. Although the RMA permits multiple PROs, CAA is currently the only PRO approved to implement the program.
Assuming without deciding that the RMA implicates a property interest protected by the Due Process Clause, the court first addressed NAW’s argument that the statute improperly delegates regulatory authority to CAA, including the power to regulate competitors.
That argument stems from allegations that CAA is controlled by certain large manufacturers who influence producer fees. But “because the RMA does not obligate NAW’s members to join CAA, CAA’s self-interestedness, [Oregon’s] review of CAA’s fee-setting methodology, and CAA’s contracts are not relevant to NAW’s due process challenge,” the decision states.
The court emphasized that producers are free to form their own PRO, even if doing so presents “practical difficulties.” Producers may also take advantage of the RMA’s “private recycling rule,” which exempts products recycled outside the comingled recycling stream and therefore provides an alternative to joining a PRO. Even with respect to CAA, the court found that Oregon retained sufficient decision-making authority because the state ultimately approved CAA’s fee-setting methodology.
The court also rejected arguments that the RMA fails to provide procedural safeguards against unlawful assessments and exactions of membership fees, holding that NAW’s members voluntarily relinquished their rights by joining CAA. The court further concluded that the RMA provides sufficient safeguards, noting in part that evidence presented at trial showed that CAA, Oregon, and individual producers “have been able successfully to resolve fee disputes informally.”
The case is National Association of Wholesaler-Distributors v. Feldon, No. 3:25-cv-1334 (D. Or.), filed July 30, 2025.
Ninth Circuit Upholds EPA’s 2024 New Chemicals Rule
/in EPA, New Chemicals, Regulatory Litigation, Transparency, TSCALess 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, New Chemicals, SNUR, TSCAEPA 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.
FDA Proposes to Make GRAS Notifications Mandatory
/in FDA, FFDCAFor decades, companies have been able to “self-affirm” that a substance is generally recognized as safe (GRAS) without notifying FDA, allowing certain substances to enter the food supply without direct agency review. That framework could soon change.
In a proposed rule published August 11, 2026, FDA would require any person who introduces a substance into interstate commerce under the Federal Food, Drug, and Cosmetic Act’s (FFDCA’s) GRAS provision to notify FDA of the basis for that conclusion, with a handful of exceptions and a streamlined option for substances already in commerce.
Existing Regulatory Framework
Since 1958, the FFDCA has required premarket review and approval for food additives. Section 201(s) defines “food additive” to include substances that are intended or expected to directly or indirectly become a component of or otherwise affect the characteristics of food. Importantly, however, it excludes substances that are GRAS from this definition, thereby exempting them from premarket review.
Overy the years, FDA regulated GRAS substances through several mechanisms, including promulgating regulatory lists of GRAS substances and allowing interested parties to petition the agency to affirm a substance’s GRAS status. In 1997, FDA pivoted to a voluntary “GRAS notification” system, under which a firm can notify FDA of its determination that a substance is GRAS under the conditions of its intended use. Firms that submit a GRAS notice can immediately begin introducing the substance into interstate commerce without waiting for a response from FDA.
FDA typically responds to GRAS notices in one of three ways:
But GRAS notices are optional. Under the current framework, a firm can simply determine that a substance is GRAS introduce it into commerce without direct FDA oversight. According to the proposed rule, in 2011, it was estimated that of the more than 10,000 additives used in food, 1,000 were substances for which firms had claimed independent conclusions of GRAS status.
Last year, Health and Human Services Secretary Robert F. Kennedy, Jr., directed FDA to explore revising its regulations to eliminate the self-affirmed GRAS pathway. In the meantime, several lawmakers have introduced federal legislation to eliminate self-affirmed GRAS, and state legislators have proposed bills that would require manufacturers of self-affirmed GRAS to report information supporting the determination to their states.
What is FDA Proposing?
The proposed rule would amend 21 CFR parts 170 and 570 to make the current GRAS notification program mandatory. Under proposed § 170.205(a), any person introducing a substance into interstate commerce under the FFDCA’s GRAS provision must notify FDA of the basis for their GRAS conclusion.
Notably, this requirement would extend to substances already in the food supply. However, FDA is proposing a time-limited, streamlined reporting option for these substances. Firms exercising this option would only be required to describe the substance’s conditions of intended use, including the foods in which the substance is used or is in contact with, its levels of use, and its purpose. Submission of the statutory basis for the GRAS conclusion would be voluntary but recommended.
The proposed rule lists seven exceptions to the mandatory GRAS notification requirement:
The proposed rule does not create a premarket approval framework. Firms could continue marketing a substance before submitting a GRAS notification or while a notification is pending before FDA. Noncompliance would not be subject to direct enforcement; instead, it would serve as a factor in the agency’s prioritization of a substance for post-market review.
FDA would continue to publicly post GRAS notices and related correspondence on its GRAS Notices Inventory.
Who Is Affected?
What to Watch Next
FDA proposes a 60-day effective date, an 18-month compliance date for the notification requirement, and a one-year window for streamlined legacy submissions. The comment period on the proposed rule closes December 9, 2026.
D.C. Circuit Upholds EPA’s CERCLA Designation of PFOA and PFOS
/in CERCLA, EPA, PFAS, Regulatory LitigationThe D.C. Circuit has upheld EPA’s designation of two PFAS, perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS), as hazardous substances under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA). In Chamber of Commerce v. EPA, decided August 18, 2026, the court denied every petition challenging the designation, leaving the 2024 rule in place.
What the Court Decided
Industry petitioners, led by the U.S. Chamber of Commerce and joined by chemical, fuel, waste, recycling, construction, and paper trade associations, raised three lines of attack: (1) that EPA misread CERCLA’s “may present substantial danger” standard; (2) that its cost-benefit analysis violated the Administrative Procedure Act’s notice requirement and was arbitrary and capricious; and (3) that regulating amid scientific and economic uncertainty was itself unreasonable. The panel rejected all three.
Starting with the standard for designation, 42 U.S.C. § 9602(a) directs EPA to designate as hazardous those substances that, when released into the environment, “may present substantial danger to the public health or welfare or the environment.” Petitioners read that phrase to require a finding that harm will occur on release. Interpreting the statute de novo and without deference to EPA under Loper Bright Enterprises v. Raimondo, the court disagreed. “May” denotes possibility, not certainty, and the statute directs EPA to forecast the risk of harm at the time a substance is released, the court held. The phrase “substantial danger” means that the risk of harm must be serious and real, not hypothesized, which the court said answers the worry that EPA’s reading would let the agency reach something as innocuous as table salt. Requiring absolute certainty about every release, the court added, would paralyze a statute Congress designed to act on scientific probabilities.
The court rejected two related theories within the same challenge. First, it declined to read an inflexible hierarchy into CERCLA under which “hazardous substances” must clear a higher bar than “pollutants or contaminants.” The two are separate designation regimes, the court held, and a substance may begin as a pollutant or contaminant and later be designated a hazardous substance as the science develops. Second, the court found no nondelegation or void-for-vagueness problem. Tying EPA’s authority to scientific findings under a public-health standard supplies the “intelligible principle” the nondelegation doctrine requires, the decision states, and the prior regulation of PFOA and PFOS under CERCLA gave regulated parties fair notice that they could be listed.
On the notice challenge, the court held that EPA’s Regulatory Impact Analysis was a “logical outgrowth” of the earlier Economic Assessment, so the additional cost data introduced in the final rule required no fresh comment round. Notably, the court did not decide whether CERCLA requires EPA to weigh costs in a designation at all. EPA assumed it must, and the panel assumed the same without deciding, which leaves that question open for a future challenge.
As for regulating amid uncertainty, the court held that EPA acted reasonably in designating PFOA and PFOS despite acknowledged gaps in what it knows about where the chemicals are, what cleanup will cost, and the rule’s downstream effects. The decisive point was that designation is only the first of many steps before liability attaches. A long sequence of contingent regulatory actions, together with CERCLA’s statutory limits on liability, stands between listing a substance and any party actually bearing cleanup costs. Accordingly, the court concluded that EPA’s choice to regulate now rather than wait for certainty was not arbitrary and capricious.
Why It Matters
The designation, effective July 8, 2024, was EPA’s first use of 42 U.S.C. § 9602(a) to list a substance directly, rather than by reference to another environmental statute. Its practical consequences are now in force: releases of one pound or more of PFOA or PFOS in a 24-hour period trigger reporting obligations, federal property transfers carry notice duties, and most significantly, responsible parties face CERCLA’s strict, joint-and-several liability and cost-recovery regime.
The ruling reaches well beyond PFAS manufacturers. Waste management, recycling, construction, and other “passive receivers” that handled PFOA- and PFOS-containing materials without making them may now sit within the liability chain. As the court stressed in rejecting the uncertainty challenge, though, listing is not the same as liability: CERCLA’s defenses, including its act-of-God, third-party, de minimis, de micromis, and innocent-landowner provisions, continue to limit who ultimately pays.
What to Watch
The decision is recent, and the deadlines for a petition for rehearing en banc or a petition for certiorari have not yet run, so the litigation may not be over.
Several aspects of the ruling bear on future CERCLA designations. Because the court reviewed EPA’s reading de novo and still upheld it, the agency’s designation authority now rests on the statute’s best reading rather than on judicial deference, a firmer footing in the wake of Loper Bright. EPA committed to notice-and-comment rulemaking before updating this designation, and it has said it intends to develop a broader framework for § 9602(a) designations generally, though the scope and timing of any such rulemaking remain to be seen. And because the court left open whether cost must be weighed in a designation at all, that question is likely to return as EPA considers additional substances.
For background on the agency’s decision to defend the rule, see our previous post on the litigation.
The case is Chamber of Commerce v. EPA, No. 24-1193 (D.C. Cir.), filed June 10, 2024.
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