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 five 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.

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.

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.”

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 Carcinogenic 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.

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.

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 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.