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 Updates Safer Choice Program’s Ingredients List

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On July 21, 2025, EPA added 18 chemicals to the Safer Chemicals Ingredients List (SCIL).  The move may signal that the agency plans to continue the Safer Choice program, despite earlier speculation that the Trump administration might transition it to the private sector.

With the update, there are now 983 chemicals on the SCIL.  The list is designed to help manufacturers find safer alternatives to hazardous chemicals.  Products that meet the criteria of the Safer Choice program are eligible to carry the “Safer Choice” label.  The SCIL can be found here.

The voluntary program was targeted for elimination by the Heritage Foundation’s “Project 2025” initiative.  However, industry groups such as the American Cleaning Institute urged the Trump administration to retain it.

In a press release announcing the update, EPA states that the additions “support[] Administrator Zeldin’s commitment to transparency, innovation and safer chemistry.”  The agency also notes that using existing SCIL-listed chemicals can help companies avoid delays tied to the approval of new substances—an acknowledgment of industry concerns about the backlog in EPA’s review process.

“Without an approval from EPA under the Toxic Substances Control Act, new chemistries don’t make it to market, which simultaneously holds back the manufacturing and innovation sectors and keeps older chemistries in regulation,” the release states.

The 18 additions represent a variety of functional classes, including emollients, polymers, and surfactants.  All but one are either verified or expected to be of low concern based on experimental and modelled data.

The exception, sodium polyphosphates, is only allowed as an oxidant stabilizer due to possible hazards.  Its “yellow triangle” designation indicates that it is one of the safest chemicals available for its function, but that its function is in need of safer chemistry innovation.

Last year, EPA expanded the Safer Choice program by introducing sustainable packaging criteria and a Safer Choice Cleaning Service certification.  More on that update can be found here.

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 Again Delays PFAS Reporting Rule

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On May 13, 2025, EPA issued an interim final rule delaying implementation of the PFAS reporting requirements under the Toxic Substances Control Act (TSCA), citing technical difficulties.

The submission period is now scheduled to begin on April 13, 2026, instead of July 11, 2025.  It will close on October 13, 2026, with an alternate deadline of April 13, 2027, for small manufacturers reporting exclusively as article importers.

The rule states that the delay will “ensure that the project team has adequate time to complete development and testing” of the Central Data Exchange (CDX) reporting tool.  EPA also notes that it will give the agency time to consider reopening elements of the PFAS reporting rule in light of Executive Order 14192: Unleashing Prosperity Through Deregulation, issued by the Trump administration.

This is the second delay to the rule’s implementation.  In September 2024, EPA postponed the original November 2024 start date, also citing incomplete software development.  At the time, the agency attributed the delay to reduced funding.

Congress has since appropriated additional funds for TSCA’s information technology infrastructure in the FY2025 Continuing Resolution, passed just two days before EPA issued the May 13 rule.

Once implemented, the PFAS reporting rule will require all persons who manufactured or imported PFAS for commercial purposes from 2011–2022 to report information to EPA.  More on its requirements can be found here.

Environmental Groups Urge EPA to Block Motiva Chemical Applications

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Environmental groups are urging EPA to deny 17 new chemical applications submitted by Motiva Enterprises for production at its refinery in Port Arthur, Texas, arguing that the new chemicals would endanger nearby residents who already experience disproportionately high exposures to pollution.

Joint comments on the premanufacture notices (PMNs) were submitted by Community In-Power and Development Association and Earthjustice on March 26.  The groups argue that at minimum, there is sufficient cause for EPA to conclude that the chemicals “may present” an unreasonable risk—triggering the agency’s duty under the Toxic Substances Control Act (TSCA) to prohibit or restrict them.

The comments claim that the publicly available versions of the PMNs provide evidence of carcinogenicity and other serious health harms, even though Motiva “unlawfully withheld and redacted critical information” from the submissions.  These hazards are compounded by high estimated production volumes, which the groups say exceed 450 million pounds annually across the 17 chemicals.

Much of the focus is on Port Arthur, “one of the nation’s most severely polluted communities.”  Decades of chemical exposures have led to elevated rates of cancer, heart disease, and respiratory illnesses, especially in the predominantly Black neighborhoods adjacent to the Motiva plant and other industrial facilities, according to the comments.  EPA should treat these neighborhoods as a “potentially exposed or susceptible subpopulation” under amended TSCA, the comments argue.

The groups also point to what they call “Motiva’s long history of malfunctions, accidents, and other chemical incidents” at the Port Arthur site, arguing that future incidents are “reasonably foreseen” and therefore fall within the “conditions of use” EPA must consider in evaluating the PMNs.

All 17 PMNs were submitted by Motiva in January 2025.  Most are generically described as “Hydrocarbon, processed.”

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.

Health and Safety Reporting Rule Finalized for 16 Chemicals

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On December 13, 2024, EPA finalized a rule under the Toxic Substances Control Act (TSCA) requiring manufacturers of 16 chemical substances to submit unpublished health and safety studies to EPA.  The agency will use this information to inform possible evaluation and regulation of these substances under TSCA section 6.

Once the rule takes effect on January 13, 2025, covered entities will have 60 days to report unpublished health and safety information, which includes environmental monitoring data, studies on environmental effects, and tests on biological, photochemical, and chemical degradation.  Manufacturers must also submit lists of planned, ongoing, and known studies, even if the studies are not in their possession.

The rule requires manufacturers to submit these studies regardless of the level at which the substances are present in the evaluated media (e.g., air, soil, water, sediment, or biota).  That is, EPA opted not to include a minimum concentration level for these substances.  Historically, EPA has exempted studies in which a listed substance was only present as an impurity.  That is not the case here.

A complete list of the 16 chemicals can be found in a previous blog post.  On December 18, 2024, EPA initiated risk evaluations for five of these substances and began the prioritization process—an initial step before risk evaluation—for another five.  More on those actions can be found here.

Update

On March 6, 2025, EPA announced in an email that the agency will issue a rule to extend the reporting deadline by 90 days to June 11, 2025, for vinyl chloride and 180 days to September 9, 2025, for the other chemicals covered under the rule.

EPA and OSHA Reach TSCA Section 6 Information Sharing Agreement

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On January 13, 2025, EPA and OSHA released a new memorandum of understanding (MOU) governing the agencies’ coordination on “existing chemical substances that are subject to prioritization, risk evaluation, and risk management by EPA under section 6 of the Toxic Substances Control Act (TSCA).”

The MOU provides for regularly scheduled updates between the agencies on workplace chemical matters, establishes protocols for the transfer of confidential business information (CBI), and includes an intent to coordinate on outreach and communications materials.  The agencies also agreed to share information on “complaints, inspections, potential violations and EPA’s planned enforcement,” as well as information on each agency’s enforcement focus areas.

EPA and OSHA anticipate that the agreement “will result in improved workplace health and safety protections for workers using existing chemical substances and allow for effective implementation of our national workplace and environmental protection statutes.”

Regulation of workplace chemical exposures come at the intersection of EPA’s TSCA obligations and OSHA’s authorities under the Occupational Safety and Health (OSH) Act.  However, the MOU notes that “TSCA differs from the OSH Act in several respects including jurisdiction and covers a wider range of workers”—arguments that EPA has invoked to defend stricter TSCA exposure limits than those required by OSHA regulations.

EPA and OSHA previously entered an MOU on coordination under TSCA section 5, which governs EPA’s regulation of new chemicals.  That 2021 agreement is similarly structured, with provisions implementing regularly scheduled updates on EPA activities and CBI protocols.