Industry Groups Tell Third Circuit That EPA’s TCE Exemption Is Unworkable

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Companies granted an exemption from EPA’s ban on trichloroethylene (TCE) are asking the Third Circuit to vacate key conditions of that exemption, arguing that the requirements are so stringent they defeat the exemption’s purpose under the Toxic Substances Control Act (TSCA).

The brief, filed May 13, 2026, is one piece of consolidated litigation in which industry groups, environmental organizations, and labor unions are contesting EPA’s TCE prohibition.  EPA has placed the delayed prohibitions for critical uses on hold pending resolution of the case.

The petitioners include a trade association, a manufacturer of a lead-acid battery component, and a company that produces a specialty material used in passports.  EPA granted exemptions to the TCE ban for both uses under TSCA section 6(g), which permits exemptions when compliance “would significantly disrupt the national economy, national security, or critical infrastructure.”

However, the exemption came with a stringent 0.2 parts per million (ppm) worker exposure limit—a threshold the petitioners argue violates TSCA’s requirement that exemption conditions still “achiev[e] the purposes of the exemption.”

Even with state-of-the-art controls, the petitioners contend that the interim existing chemical exposure limit (ECEL) would require workers to wear bulky, full-facepiece respirators at all times.  That level of PPE use is infeasible, they argue: some workers cannot wear it for medical reasons, it impedes communication, hearing, and movement, and it is intolerable to wear for an entire shift.

“EPA admits that respiratory PPE creates health and safety hazards, and the record demonstrates that respiratory PPE cannot feasibly be worn all day, every day, by employees in Petitioners’ manufacturing facilities,” the brief states.

“Petitioners will thus be unable to invoke the section 6(g) exemption and will have to shut down their operations in the United States—the very outcome the exemption was intended to avoid,” the petitioners allege.

The petitioners suggested alternative interim ECELs, including a limit aligning with the European Union and United Kingdom’s 6 ppm restriction, but say EPA “merely nodded at this figure without providing any reasoned analysis for rejecting it.”

Best Available Science

The petitioners also challenge the scientific basis for the 0.2 ppm threshold.  Their brief focuses on a rodent oral-exposure study that allegedly underpinned the interim ECEL, arguing it was methodologically flawed in multiple respects, including that its experimental and control groups were not run concurrently.  Most importantly, they argue, its linkage between low TCE exposures and congenital heart defects has not been replicated in a dozen other experiments.

“TSCA’s best-available-science requirement is meant to prevent precisely this kind of selective reliance,” the brief contends.

The petitioners also challenge EPA’s decision to limit the TCE exemption for lead-acid battery separator manufacturing to 20 years rather than the 25 years requested, arguing that the shorter duration was arbitrary.

The brief asks the court to vacate both the interim ECEL requirement and the 20-year cap on the battery-separator exemption.  (The exemption for TCE used to manufacture specialty polymeric microporous sheet materials runs for 15 years and is not at issue on this point).

The consolidated proceedings were formerly captioned United Steelworkers v. EPA, No. 25-1055 (3d Cir.).  The brief can be found in the docket for Microporous LLC v. EPA, No. 25-1080 (3d Cir.).

EPA Cannot Use Low Exposure to Justify DecaBDE Inaction, Ninth Circuit Rules

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The Ninth Circuit has ruled that EPA’s decisions not to regulate certain decabromodiphenyl ether (decaBDE) exposures under the Toxic Substances Control Act (TSCA) were not supported by substantial evidence, ordering the agency to regulate or better justify its inaction in four areas: recyclable articles, disposal, wastewater, and sewage sludge.

The May 13, 2026, ruling leaves EPA’s regulations for decaBDE intact but remands them back to agency to regulate—or better defend its decision not to regulate—those areas.  It is the first time a court has weighed in on TSCA section 6(h), which requires EPA to reduce exposures to certain persistent, bioaccumulative, and toxic chemicals (PBTs) “to the extent practicable.”

Congress added section 6(h) in 2016.  EPA issued a risk management rule for decaBDE in 2021 and amended it in 2024, targeting the flame retardant’s use in products.  But the agency declined to regulate various other exposures, citing low exposures and prohibitively high costs.

Siding with environmental groups, the Ninth Circuit rejected EPA’s low-exposure rationale outright.  Because TSCA does not require EPA to conduct a risk evaluation before regulating section 6(h) PBTs, Congress already determined that any exposure warrants a regulatory response, the court held.

“[I]t is beyond EPA’s authority to justify a decision not to regulate based on there being low levels of decaBDE,” the opinion states.  “TSCA § 6(h)(4) permits EPA to consider decaBDE levels for the purpose of deciding between regulatory tools, but not in deciding whether to use a regulatory tool at all.”

The court stopped short of holding that high costs can never justify a decision not to regulate under section 6(h), but it found EPA’s cost evidence consistently inadequate.  For recyclable articles, for example, EPA’s economic analysis relied on studies not specific to decaBDE and failed to consider regulatory options short of an outright ban.

Substantial Evidence

EPA’s other justifications fared no better under TSCA’s “substantial evidence” standard, which the court characterized as a “searching review.”

On disposal, EPA argued regulations were unnecessary because the Resource Conservation and Recovery Act (RCRA) already reduces exposures to the extent practicable.  But the court held that “EPA cannot evade its responsibilities under TSCA to regulate decaBDE disposal merely by invoking EPA’s compliance with another statute regulating solid waste disposal,” while also observing that RCRA does not cover all possible disposals.

For wastewater, the court found that EPA had ignored data contradicting its position that decaBDE is not released to water.  And, on recycling, it held that the agency gave “undue weight” to its position that regulation would undermine its general pro-recycling stance.

The court also rejected EPA’s fallback argument that staged regulation justifies its current inaction.  Section 6(h) “expressly places regulation of decaBDE on an expedited timeline,” the court held, and EPA has made no commitment to address these exposures in future rulemaking.

The case is Alaska Cmty. Action on Toxics v. United States EPA, No. 21-70168 (9th Cir.).

Trump Administration Proposes Overhaul of Biden-Era TSCA Risk Evaluation Framework

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On September 23, 2025, EPA published a proposed rule that would roll back key provisions of the agency’s May 2024 risk evaluation framework rule, which sets out the procedures EPA uses to assess the risks of existing chemicals under the Toxic Substances Control Act (TSCA).

According to EPA, the proposal is intended to “effectuate the best reading of the statute and ensure that the procedural framework rule does not impede the timely completion of risk evaluations or impair the effective and efficient protection of health and the environment.”

The rollback is a priority for the Trump administration, which first announced its intent to reconsider the rulemaking in March.  The 2024 rule—itself a revision of a rule issued during the first Trump administration—has been criticized by industry groups such as the American Chemistry Council and targeted for revision by the Heritage Foundation’s “Project 2025” initiative.

What Changes is EPA Proposing?

If finalized, the rule would:

  • Grant EPA discretion to narrow the scope of risk evaluations by excluding conditions of use and exposure pathways from its assessments.
  • Require that separate risk determinations be made for each of a chemical’s conditions of use, instead of a single risk determination for the chemical as a whole.
  • Remove language prohibiting EPA from assuming worker protections through PPE usage.
  • Eliminate “overburdened communities” from the list of “potentially exposed or susceptible subpopulations” that must be considered in evaluations.
  • Provide EPA with greater flexibility to revise or supplement scope or risk evaluation documents without restarting the prioritization process.
  • Scale back information collection requirements for manufacturers requesting a risk evaluation.
Stakeholder Responses

The proposal has drawn criticism from environmental groups, who warn that the changes—particularly EPA’s ability to exclude conditions of use and exposure pathways—will jeopardize public health.

“Rather than looking at the full picture of a chemical’s toxic risk, EPA wants to downplay the links these chemicals have to cancer and chronic disease and give the chemical industry a handout at the expense of our health and safety,” an Environmental Defense Fund official said in a statement.

“The chemicals in the pipeline for review under TSCA have been prioritized specifically because of the risks they pose to our health, and rewriting this process to lowball risks will only rig the rules to benefit the chemical industry,” she continued.

The American Chemistry Council, on the other hand, applauded the move.  “This proposed approach demonstrates EPA’s commitment to refining its processes in a way that is both protective and practical,” an official said in a press release.  “The proposal reflects meaningful progress toward a more science-driven regulatory framework for conducting TSCA risk evaluations.”

Comments on the proposed rule are due November 7, 2025.  More on the 2024 rule can be found here.

EPA Requests Comment on Reconsideration of PCE Rule

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

EPA is particularly interested in receiving comment on:

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

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

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

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

EPA Finalizes TSCA Risk Evaluation for Solvent 1,1-Dichloroethane

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EPA has determined that 1,1-dichloroethane presents an unreasonable risk of injury to human health in its final Toxic Substances Control Act (TSCA) risk evaluation for the chlorinated solvent, released June 20, 2025.

The agency identified worker risks from three specific conditions of use (COUs): processing for recycling, and processing as a reactant as an intermediate in certain chemical and chemical product manufacturing.  Five other evaluated COUs did not significantly contribute to the risk determination, and the agency did not identify unreasonable risks to the general public or the environment.

The evaluation found that exposure to 1,1-dichloroethane may increase the risk of non-cancer renal, olfactory, and reproductive effects, as well as tumor formation, based on hazard read-across data from 1,2-dichloroethane, an isomer of the solvent.

Because EPA determined that 1,1-dichloroethane presents an unreasonable risk, the agency is statutorily required to issue a final rule that mitigates those risks within two years, with up to two years of extensions possible.

Narrowed Findings

Notably, the final risk evaluation reached significantly less conservative conclusions about 1,1-dichloroethane’s risks than the draft risk evaluation, released in July 2024.  The draft found that seven COUs significantly contributed to the determination instead of three, and identified unreasonable risks to the environment based on risks to algae and invertebrates.

Among the changes made in the final risk evaluation were revisions to the “considerations of risk factors” for repackaging and disposal, use of “central tendency instead of the high-end for dermal exposure” for all COUs, and the incorporation of “considerations of personal protective equipment (PPE) use.”

According to EPA, 1,1-dichloroethane is primarily used to produce other chlorinated solvents with “broad industrial applications.”  The final risk evaluation notes that, in 2020, between 200 million and one billion pounds were manufactured by two corporations in the Southern US, with none imported.

More information on the risk evaluation can be found on EPA’s website.

DOD Requests Information on Chemicals Undergoing TSCA Risk Evaluation

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

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

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

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

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

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

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

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

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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.

Phthalates DBP and DEHP Present an Unreasonable Risk, EPA Drafts Say

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EPA has preliminarily determined that dibutyl phthalate (DBP) and diethylhexyl phthalate (DEHP) present an unreasonable risk to human health and the environment in separate draft risk evaluations released on June 5, 2025, under the Toxic Substances Control Act (TSCA).

Both chemicals are primarily used as plasticizers for polyvinyl chloride (PVC), according to EPA.  Chemical Data Reporting (CDR) rule data indicates that 1–10 million pounds of each was manufactured or imported into the US in 2019, the most recent year with available information.

DBP’s unreasonable risk finding was based on risks to workers from 20 conditions of use (COUs), risks to consumers from four COUs, and risks to the environment from one COU.  For the other 19 COUs, the draft risk evaluation did not identify an unreasonable risk.

DEHP’s unreasonable risk finding was based on risks to workers from 13 COUs and risks to the environment from 20 COUs.  The draft risk evaluation did not identify unreasonable risk from the remaining 23 COUs, including all evaluated consumer uses.

The drafts follow the “single determination” approach established by the Biden administration’s framework rule for risk evaluations, which provides an overall risk determination instead of separate determinations for each COU.  In March, EPA announced it would reconsider the framework rule and asked the D.C. Circuit to hold a consolidated lawsuit challenging it in abeyance.  The court granted the request on April 30.

Both drafts also incorporate findings from EPA’s first-of-its-kind cumulative risk assessment (CRA) for six phthalates as a class.  The CRA focuses on phthalate syndrome, a collection of adverse effects on the developing male reproductive system.

“By taking into account cumulative exposure and risk…EPA is confident that it is not underestimating the risk of DEHP and is reflecting the best available science,” the DEHP draft states.

EPA released the draft CRA in January alongside the agency’s draft risk evaluation for the phthalate DCHP, which also incorporated its findings.

Comments on the draft DBP and DEHP risk evaluations are due August 4, 2025.  EPA will hold a virtual public meeting of the Science Advisory Committee on Chemicals (SACC) on August 4–8 to review the drafts, as well as documents that relate to all five phthalates currently undergoing risk evaluation.

EPA’s press release for DBP and DEHP notes that draft risk evaluations for two more phthalates, BBP and DIBP, will be released in July 2025.  More on the CRA and EPA’s schedule for phthalate reviews can be found here.

Scientists Critique EPA’s Draft Evaluation of Phthalate DCHP

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A collection of scientists, academics, and clinicians have called for “extensive revisions” to EPA’s draft risk evaluation for dicyclohexyl phthalate (DCHP), arguing that the assessment “failed to incorporate the best available science and makes a number of scientifically unsupported assumptions.”

The May 9 comments were submitted by the Program on Reproductive Health and the Environment at the University of California San Francisco.  The commenters raise a number of methodological concerns with EPA’s December 2024 draft, which preliminarily determined that nine of 24 evaluated conditions of use for DCHP raised concerns, all involving occupational exposures.

A central criticism is EPA’s reliance on central tendency estimates, rather than high-end exposure scenarios, for many conditions of use. This approach, the commenters argue, “sets a dangerous precedent that risks to more highly exposed individuals can be dismissed or downplayed without scientific support.”

The commenters also object to EPA’s blanket exclusion of human epidemiology studies from its dose-response assessment, justified by uncertainties over exposures and testing methods.  That rationale “demonstrates a bias against environmental epidemiology, rather than a thoughtful approach to evidence evaluation that is consistent with best practices in systematic review,” according to the comments.

The group additionally claims that EPA failed to conduct an up-to-date literature search, omitting certain studies conducted since 2019.  As a result, they argue that the draft overlooks newer evidence linking DCHP to liver toxicity.

Alongside the Toxic Substances Control Act (TSCA) risk evaluation, DCHP is also part of EPA’s first-ever cumulative risk assessment for a group of six phthalates. A blog post on that effort, published prior to the January 2025 draft, can be found here.

EPA Announces Intent to Reconsider Risk Evaluation Framework Rule

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The Trump EPA announced in a March 10, 2025 press release that it will reconsider the Biden-era risk evaluation framework rule governing assessments of existing chemicals under the Toxic Substances Control Act (TSCA).

As discussed in a previous blog post, the risk evaluation framework rule replaced regulations promulgated by the first Trump administration.  The Biden-era rule reversed key policies by requiring the agency to consider all conditions of use of chemical, issue a single risk determination rather than use-by-use determinations, and not assume that workers use PPE.

According to the press release, specific policies in the rule that EPA will review include:

  • The single risk determination approach;
  • Whether EPA “must evaluate all conditions of use of a chemical at the same time” during an evaluation;
  • “Whether and how” use of PPE and industrial controls in occupational work environments should be incorporated; and
  • “[R]egulatory definitions expanded by the Biden Administration.”

The rulemaking process is set to begin “in the near future.”

Ongoing Litigation

On the same day as the press release, EPA filed a motion for voluntary remand in a consolidated D.C. Circuit case challenging the risk evaluation framework rule.  The court previously denied EPA’s February motion to hold that case in abeyance.

“EPA’s reconsideration is consistent with agencies’ implicit authority to reconsider past decisions, particularly in light of a change of administration and attendant change in policy priorities and approach to statutory interpretation,” the motion for voluntary remand states.

There are also ongoing as-applied challenges to the rule, including a Fifth Circuit suit challenging EPA’s risk evaluation for methylene chloride.  The court granted an EPA motion to hold that case in abeyance in February despite industry opposition, but reversed its decision a week later without explanation.

A post on the D.C. Circuit case can be found here.  More on the methylene chloride suit can be found here.