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

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

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

Undefended Policies

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

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

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

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

Scientific Evidence

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

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

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

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

“I Survived”

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

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

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

Sierra Club Arguments

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

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

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

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

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

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

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

Irene Hantman Presents on TSCA Developments at A&WMA ACE 2025

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Verdant Law is pleased to announce that Irene Hantman presented at the Air & Waste Management Association’s (A&WMA’s) 118th annual conference and exhibition (ACE) on June 11, 2025, in Raleigh, North Carolina.

Ms. Hantman’s “TSCA 2025” presentation covered recent regulatory developments under the Toxic Substances Control Act (TSCA).  Topics included the framework rule for new chemicals, litigation over EPA’s risk management rule for trichloroethylene, and the section 8(a)(7) PFAS reporting rule.

In addition to outlining TSCA developments, Ms. Hantman provided a window into real-world compliance by discussing engagement with EPA regarding a significant new use rule (SNUR).  Throughout the presentation, she also touched on how TSCA implementation may continue to evolve under the current Trump administration.

If you have questions about the topics of the presentation, please contact Ms. Hantman.

Court Blocks Prop 65 Acrylamide Warning for Food Products

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On May 2, 2025, the District Court for the Eastern District of California ruled that California’s Proposition 65 (Prop 65) warning requirement for dietary acrylamide constitutes unconstitutional compelled speech, granting a permanent injunction barring its enforcement in California Chamber of Commerce v. Bonta, No. 2:19-cv-02019.

The court acknowledged that the entirety of the warning requirement—which included a notice of possible exposure to acrylamide and a reference to findings by one of several organizations regarding its cancer risks—was literally true. However, the court held that the warning was nonetheless “misleading and controversial,” and therefore unconstitutional, because it ignored a “vigorous scientific debate” over whether acrylamide’s cancer findings in rodents can be extrapolated to humans.

“[M]isleading statements about acrylamide’s carcinogenicity do not directly advance” California’s interest in “preserving the health of its citizens,” the ruling states.  “Accordingly, Prop 65’s warning requirement as to acrylamide in food fails intermediate scrutiny under the First Amendment.”

The court also rejected California’s arguments that the warning was not compelled because businesses are exempted if they can demonstrate that the chemical does not pose a significant risk at the product’s exposure levels.  Because businesses relying on the exemption “run the risk of incurring substantial costs in defending against enforcement actions,” the court held that the exemption does not offer a true “reprieve from Prop 65’s warning requirement.”

The court had previously enjoined a Prop 65 warning for dietary acrylamide in 2021. The California Office of Environmental Health Hazard Assessment (OEHHA) subsequently revised the warning language and weakened it further following a 2023 Ninth Circuit decision striking down a similar Prop 65 warning for glyphosate.

That Ninth Circuit decision provided the basis for much the court’s ruling, including its position that a literally true disclosure can still be misleading in context.  A blog post on that case can be found here.

Apple Moves to Dismiss Watch Band PFAS Suit

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A proposed class action alleging that Apple Watch bands contain PFAS should be dismissed for lack of standing, Apple told the District Court for the Northern District of California on April 14, 2025.

The plaintiffs in Cavalier v. Apple, Inc., No. 5:25-cv-713, claim that a published study detected PFHxA (a type of PFAS) and “significantly elevated levels of fluorine” in Apple Watch bands, despite Apple’s “health and environmental promises to the contrary.”  The complaint alleges violations of California’s unfair competition law and false advertising law, as well as various fraud claims.

In its motion to dismiss, Apple argues that the plaintiffs failed to link the study results—which were anonymized—to specific Apple products.  “The [study] does not show that Apple Watch bands contain PFAS generally, nor that the particular Watch bands purchased by Plaintiffs contain PFAS,” the motion states, alleging that the complaint fails to plead an injury in fact.

Apple also objects to the plaintiffs’ characterization of PFHxA as “a dangerous form of PFAS that pose significant harms to people and the environment.”  Apple argues that the plaintiffs “provide no evidence” that PFHxA in particular has adverse health effects, and contends that they attempt to “blur the distinctions among PFAS chemicals and create a toxic scare where none exists.”

In addition, Apple argues that its advertising claims—which include statements like “[t]he ultimate device for a healthy life”—are vague and nonspecific and cannot serve as the basis for the plaintiffs’ fraud claims.

The suit is one of several recent cases targeting consumer products alleged to contain PFAS, as plaintiffs increase scrutiny of so-called “forever chemicals” in everyday items.  A hearing on the motion to dismiss is scheduled for July 31, 2025.

Court Reinstates Suit Alleging Roundup “Expiration” Due to Impurity

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Allegations that Monsanto’s popular Roundup-brand weedkillers degrade into a carcinogenic impurity will proceed, after the Ninth Circuit reinstated a proposed class action a district court had dismissed for failure to state a claim.

Unlike the many personal injury suits over Roundup, the plaintiffs in this case assert purely economic harms.  They allege that consumers would have paid less for concentrated Roundup products had they known that glyphosate—the active ingredient—gradually degrades into harmful levels of N-Nitrosoglyphosate (NNG) over time from exposure to nitrites in “everyday air and water,” effectively causing the products to “expire.”

The District Court for the Northern District of California dismissed the case in December 2023, finding two key allegations implausible: that NNG is substantially certain to form at levels of 1 part per million (ppm), and that 1 ppm NNG is unsafe.

The Ninth Circuit disagreed, emphasizing that plausibility does not require probability.  While no regulation sets a specific 1 ppm limit for NNG, the panel found that an expert opinion combined with EPA statements sufficed to support a plausible claim regarding NNG’s hazard.

Similarly, although the complaint failed to allege that any products purchased by the plaintiffs or other consumers contained 1 ppm NNG, the court held that a variety of factual allegations—including that “Monsanto had discovered NNG at levels above 1 ppm in relevant products in its own possession”—were enough to make the plaintiffs’ claim about the occurrence of 1 ppm NNG plausible.

However, the Ninth Circuit affirmed the dismissal of claims against Roundup distributor The Scotts Co., finding that plaintiffs failed to allege that Scotts had “unbridled control” over the challenged conduct or knowledge of the alleged expiration.

The Ninth Circuit also criticized the lower court’s reliance on an incomplete version of a key study submitted by Monsanto, which likely presented findings in a more favorable light.  “The parties and the court should be concerned about submission of and reliance upon an incomplete document,” the opinion states.

The case is Koller v. Monsanto Co., No. 24-43, opinion filed March 27, 2025.

Gore-Tex Maker Faces PFAS Greenwashing Allegations

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A proposed federal class action has been filed against W.L. Gore & Associates, accusing the company of systematically misleading customers about the sustainability of its widely used Gore-Tex Fabric.

The February 11 complaint alleges that Gore-Tex is produced using PFAS, chemicals that pose “extremely dangerous health and environmental effects” and allegedly shed from Gore-Tex during ordinary use.  Despite this, the plaintiffs argue that Gore markets the fabric as “non-toxic and safe for the user” and “environmentally sound,” creating a false impression about its safety and sustainability.

“Instead of coming clean on its use of PFAS and their environmental consequences, Gore…embark[ed] on a significant greenwashing campaign full of material misrepresentations and omissions designed to deceive eco-conscious consumers and safeguard Gore’s profits,” the complaint states.

The suit also challenges “[Perfluorinated Chemical (PFC)]* Free Laminate” claims on tags affixed to Gore-Tex products.  According to the complaint, the claim “misconstrues the common definition of the term ‘PFC’ by unilaterally excluding well-known PFC-based chemicals, such as PTFE and ePTFE,” which are PFAS allegedly used to make several Gore products—despite efforts by the company to phase out their use.

The plaintiffs allege that Gore’s practices violate laws in 28 states and DC, including consumer protection, fraudulent concealment, and unfair competition laws.  They seek damages, disgorgement, and an order enjoining Gore from continuing its allegedly unlawful business practices.

The suit comes shortly after Maryland’s Attorney General sued Gore in December 2024, alleging that Gore knowingly “polluted the air and water around its facilities with” PFAS.  Additionally, in 2022, a former employee sued Gore over health effects allegedly stemming from PFAS exposure.

Gore-Tex is used in a variety of companies’ outdoor apparel, including outerwear and athletic shoes.  According to the complaint, Gore-Tex has a 70% market share in the waterproof-breathable textile market.

The case is Mason v. W.L Gore & Associates, No. 2:25-cv-49 (E.D. Wash.).

EPA’s PFAS Fluorination Rulemaking Survives Legal Challenge

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The D.C. District Court has dismissed a Toxic Substances Control Act (TSCA) citizen suit seeking to speed up the agency’s rulemaking on PFAS formation during plastic fluorination.  The court held that an EPA request for information satisfied TSCA’s requirement that the agency “initiate…action” within 180 days to mitigate “significant risk.”

The environmental groups behind Public Employees for Environmental Responsibility v. Regan, No. 24-2194, argued that TSCA section 4(f) required EPA to issue a rule prohibiting PFOA formation during fluorination within that timeframe.  However, the court ruled that EPA’s September 30, 2024, request for information—which sought details on the number and uses of fluorinated containers, alternatives to fluorination, and risk mitigation measures—was sufficient.

“That request plainly ‘initiate[d] . . . action’…by kickstarting the information-gathering process, and it therefore successfully completed the necessary first step of any rulemaking,” the December 11 opinion states.

The court also rejected the petitioners’ interpretation of TSCA section 7(a)(2), which they argued required EPA to seek injunctive relief  if an “imminently hazardous” chemical exists without a rule addressing it.  That provision only applies if EPA has implemented a rule that is not “immediately effective,” the court held.

Both petitioners were among the organizations who successfully petitioned for EPA to initiate a rulemaking after the Fifth Circuit struck down previous EPA efforts to regulate fluorination in April 2024.  They filed the suit in July, two weeks after EPA granted their petition and before the agency published its information request.

Industry Pushback

Meanwhile, Inhance Technologies—the fluorination company that won the Fifth Circuit case—is arguing that EPA must restart its rulemaking from scratch.  In December comments submitted on EPA’s information request, Inhance stated that EPA “cannot skirt the prioritization process” and “must conduct a new risk evaluation” if it wants to regulate fluorination—steps that take as long as 4.5 years under TSCA.

In addition, Inhance contends that EPA regulations require the agency to consider the subject PFAS under all their conditions of use, not just fluorination.  “EPA cannot pursue a…rule selectively targeting fluorination,” the comments state.

For more on PFAS formed in plastic fluorination and the Inhance saga, explore our archive of blog posts on the topic.

EPA’s TSCA Pre-Prioritization Webinar

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On September 30, 2024, a lead toxicologist in the Data Gathering Management and Policy Division within the Office of Pollution Prevent and Toxics presented an overview of prioritization and pre-prioritization efforts for existing chemicals under the Toxic Substances Control Act (TSCA). The Agency’s goal was to collaborate with attendees to evaluate the potential risks of existing industrial chemicals regulated under TSCA. Topics covered included a high-level overview of TSCA authorities, requirements, and timelines for evaluating existing chemicals. Additionally, EPA covered the Agency’s approach for identifying the chemicals that may undergo prioritization.

Under TSCA, EPA is required to evaluate the potential risks of chemical substances comprehensively, taking into account their cradle-to-grave life cycle. This process involves assessing the chemical’s potential exposure and risks from production through disposal and includes all identified uses.  First, the webinar touched on the key aspects for the Risk Evaluation process.

  • Cradle-to-Grave Analysis
    • 6-Year Timeline for Risk Regulation
      • Initiation and Prioritization: 9-12 months.
      • Risk Evaluation: 3 to 3.5 years.
      • Regulation Development: Remainder of the timeline as needed.
  • Public Engagement and Information Gathering

EPA then noted that the prioritization process reflects the Agency’s evolving approach to addressing chemical risks efficiently and inclusively under TSCA. EPA identified 27 chemical substances that are being considered for prioritization under TSCA, focusing on their inclusion in the 2014 TSCA Work Plan, the interests of other agencies, and the availability of hazard and exposure data. The 2014 TSCA Work Plan identified approximately 90 chemicals as priorities for risk evaluation based on hazards, exposure risks, and their environmental or health impact. In addition, three chemical substances that were not listed in the 2014 Work plan are being considered for prioritization Two of these chemicals were identified through TSCA Section 21 petitions:  Hydrogen fluoride (HF) and 6PPD.  Bisphenol S (BPS) is also being considered for prioritization.  The Agency explained that BPS could become a priority if bisphenol A (BPA) undergoes prioritization, as BPS is a key alternative to BPA in the market.

EPA reminded participants that the Agency uses Section 4 and Section 8 under TSCA to gather data on the chemicals for prioritization, risk evaluation, and risk management. TSCA Section 4 provides authority for mandatory testing of chemicals to fill data gaps through test orders, test rules, and consent agreements. TSCA Section 8 allows for reporting and recordkeeping of existing chemical-related data, including reports of significant adverse health or environmental reactions.

The Agency noted that it prioritizes chemicals with robust existing data to streamline risk evaluation and reduce delays caused by insufficient information. The inclusion of both 2014 TSCA Work Plan chemicals and newly highlighted substances reflects intent to address historical priorities while also adapting to emerging concerns raised by stakeholders or other agencies.

 

Work Plan Chemicals:

1-Hexadecanol
2-Ethylhexyl
tetrabromobenzoate (TBB)
4-tert-Octylphenol (4-(1,1,3,3-Tetramethylbutyl)-phenol)
Benzene
bis(2-Ethylhexyl) – 3,4,5,6-Tetrabromophthalate (TBPH)
Bisphenol A
Creosote
Di-n-octyl phthalate (DnOP)
Ethylbenzene
Naphthalene
N-Nitroso-diphenylamine
p,p’-Oxybis(benzenesulfonylhydrazide)
Styrene
Tribromomethane
Triglycidyl isocyanurate
m-Xylene
o-Xylene
p-Xylene
Antimony & Antimony Compounds
Arsenic & Arsenic Compounds
Cobalt & Cobalt Compounds
Lead & Lead Compounds
Long-chain chlorinated paraffins (C18-20)
Medium-chain chlorinated paraffins (C14-17)

Non-Work Plan Chemicals:

Bisphenol S
Hydrogen fluoride
N-(1,3-Dimethylbutyl)-N’-phenyl-pphenylenediamine (6PPD)

D.C. Circuit Rejects Environmentalist Arguments, Sides with Industry over TSCA CBI Rule

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EPA’s 2023 rule revising confidential business information (CBI) claims under the Toxic Substances Control Act (TSCA) is only unlawful insofar as it could lead to certain inadvertent waivers of confidentiality by downstream entities, the D.C. Circuit ruled on December 20, 2024.

The case, Environmental Defense Fund v. EPA, No. 23-01166, consolidated petitions from the Environmental Defense Fund (EDF) and the American Chemistry Council (ACC).  EDF’s arguments in favor of narrower confidentiality protections were rejected by the court, whose ruling leaves EPA’s CBI rule largely intact.

However, the court agreed with ACC’s challenge to a provision in the rule that allowed downstream entities to waive CBI protections put in place by the upstream manufacturer when reporting information to EPA.  Specifically, ACC argued that the rule’s requirement that downstream entities assert and substantiate confidentiality claims for chemical identities reported via an “accession number” is arbitrary and capricious.  Under the CBI rule, if “any submitting entity fails to substantiate a confidentiality claim for a chemical identity…the chemical identity is no longer entitled to confidential treatment.”

Accession numbers are non-confidential identifiers assigned to chemicals whose identities are claimed as CBI.  Downstream entities reporting information to EPA using an accession number may have no knowledge of the chemical’s actual identity, the court noted, and may not have any incentive to keep it secret.  Nor would they necessarily have the information needed to adequately substantiate a claim, the opinion continues.

“This regulatory scheme cannot be squared with the commands of the statute, which require EPA to protect from disclosure chemical identities for which CBI claims have been properly assessed,” the court held, vacating the CBI rule “to the extent it allows for the unlawful disclosure of confidential information.”

Key Provisions are “Best Reading”

EDF challenged three provisions of the CBI rule.  The court rejected these challenges, explaining that EPA’s positions were  consistent with the “best reading” of the statute—the new legal framework adopted by the Supreme Court in Loper Bright v. Raimondo, the decision that struck down Chevron deference.

EDF argued that the rule’s use of “permissive” language and revised timeframe for when a CBI claim must first be substantiated were arbitrary and capricious.  However, the court found that the CBI rule sufficiently justified why those changes were necessary.  The permissive language at issue included a provision allowing EPA discretion in whether to disclose information that has lost CBI protection, unlike earlier regulations requiring its immediate and automatic release.

EDF also challenged the scope of the CBI rule’s definition of a “health and safety study,” which are statutorily ineligible for CBI protection.  EDF contended that the definition should include the entirety of any written report submitted to EPA that presents findings of a health and safety study, including information like the identity of the company submitting the report and the name of the lab that conducted the study—information which is currently eligible for CBI protection.  The court disagreed, holding that the statutory definition of health and safety study “suggest[s] that the term refers only to the evaluation of a chemical’s health and environmental effects, not the entire document containing that evaluation.”

More on the CBI rule can be found in a previous blog post.  An earlier post on this case, written after EDF filed its statement of issues, can be found here.

Court Approves Tight Deadlines for Overdue Risk Evaluations

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The D.C. District Court has entered two consent decrees concerning over twenty overdue Toxic Substances Control Act (TSCA) risk evaluations, holding the incoming administration’s EPA to aggressive deadlines for completing the chemical reviews.

The consent decrees, approved November 22, concern 20 risk evaluations initiated by EPA in December 2019 and two manufacturer-requested risk evaluations initiated in January 2020.  None were completed within TSCA’s 3.5-year deadline.

Under the consent decrees, linked here and here, EPA will be required to complete:

  • Draft risk evaluations for six of the substances, including 1,3-butadiene, by December 31, 2024;
  • Final risk evaluations for TCEP, formaldehyde, 1,1-dichloroethane, and DIDP by December 31, 2024;
  • A final risk evaluation for DINP by January 15, 2025;
  • A draft risk evaluation for one of the remaining substances by March 31, 2025;
  • Final risk evaluations for seven of the substances, including 1,3-butadiene, by December 31, 2025; and
  • Final risk evaluations for the remaining 10 substances by December 31, 2026.

The deadlines are largely unchanged from those in the proposed consent decrees, released in April and discussed in a previous blog post.  Since then, EPA has released a final risk evaluation for TCEP and drafts for 1,1-dichloroethane, DINP, and 1,3-butadiene.  However, as it stands, EPA will be required to complete three more final risk evaluations before the end of 2025—and a fourth before the presidential transition.

Meanwhile, EPA looks likely to designate another five chemicals as “high priority” this December, automatically triggering new risk evaluations.  More on those chemicals can be found here.