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.

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.

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 Revises New Chemicals Review Process

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On December 18, 2024, EPA published a final rule revising the new chemicals review provisions under the Toxic Substances Control Act (TSCA).  The rule:

  • Requires an EPA determination on each notice before a submitter may begin manufacturing or processing the chemical, as mandated by amended TSCA;
  • Clarifies the level of detail expected for premanufacture notices (PMNs), significant new use notices (SNUNs), and exemption notices;
  • Modifies EPA’s review process for PMNs and SNUNs, including procedures for handling incomplete or inaccurate submissions;
  • Revises the regulations for low volume exemptions (LVEs) and low releases and low exposures exemptions (LoREXs) to require submitters to wait for EPA approval prior to manufacture; and
  • Prohibits PFAS and certain PBTs from qualifying for LVE and LoREX exemptions.

EPA’s clarification of existing PMN requirements includes greater detail on products that would contain the chemical, manufacturing processes, worker exposures, and releases.  To effectuate these changes, EPA is introducing new reporting fields to the PMN form.

One key change to the procedures for handling incomplete submissions is that EPA will now declare a submission incomplete and restart the review process if a submitter provides required information that was known or reasonably ascertainable at the time of the original submission.  Previously, EPA’s “longstanding practice” was to accept the amendments along with a request to suspend the review period.

Restrained Approach

The final rule largely follows EPA’s May 2023 proposal.  In response to comments, EPA agreed to proactively notify current LVE and LoREX holders about significant new use rules (SNURs) that apply to their chemicals, rather than only providing notice prospectively as originally proposed.  EPA also agreed to expressly codify that the agency has authority to strengthen protections in TSCA section 5 orders based on new information from any source.

Environmental organizations urged EPA to revoke previously granted LVEs for PFAS, but the agency declined to do so in the rule.  However, EPA left open the possibility of future revocations, stating that it “may take future action on a case-by-case basis.”  In general, EPA has not granted new LVEs for PFAS since 2021.

Industry groups, on the other hand, unsuccessfully pushed for more streamlined TSCA section 5 notices.  Among their rejected proposals was a request that EPA only require specific data elements on a case-by-case basis.

The rule takes effect January 17, 2025, shortly before the presidential transition.

Briefs Filed in Sweeping Challenge to EPA’s Methylene Chloride Rule

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Opening briefs have been filed by industry petitioners, the Sierra Club, and EPA in a case challenging EPA’s 2024 rule banning most uses of methylene chloride.  The lawsuit has critical implications not only for EPA’s regulation of the solvent but for future risk management rules and risk evaluations promulgated under the Toxic Substances Control Act (TSCA).

The case, East Fork Enterprises Inc. v. EPA, No. 24-60256, is before the Fifth Circuit.  Industry petitioners are requesting that the court vacate the methylene chloride rule and its underlying risk evaluation in their entirety.  The Sierra Club, taking the opposite position, contends the rule does not go far enough but seeks only a remand to EPA without vacatur.

“Extreme” Risk Evaluation

One of the central arguments in the industry petitioners’ October 9 brief is that EPA’s methylene chloride risk evaluation conflated the potential for any harm with “unreasonable risk,” the threshold for regulation under TSCA.  “EPA treated a use as risky if there was even a theoretical possibility of health risks,” the brief states, a stance described as “contrary to the statutory text and Congress’s regulatory structure.”

The industry petitioners argue this approach represents massive EPA overreach.  “Under EPA’s extreme (and incorrect) reading of TSCA, EPA can prohibit a wide range of commercial activities simply by saying a chemical substance poses unreasonable risk,” the brief continues.

In its opening brief, filed December 13, EPA argues that the agency has sole discretion to determine what constitutes unreasonable risk.  “Congress assigned to EPA the task of determining what risks are ‘unreasonable’ for a given chemical substance based on EPA’s scientific and technical expertise,” the agency states.  “Applications of that expertise are entitled to the Court’s respect.”

Last term, the Supreme Court struck down Chevron deference—a longstanding precedent requiring courts to defer to “permissible” agency interpretations of statutes they administer—in Loper Bright v. Raimondo. Nevertheless, EPA cites Loper Bright, emphasizing language clarifying that the Administrative Procedure Act “mandate[s] that judicial review of agency policymaking and factfinding be deferential.”

The industry petitioners also contend two policy reversals made by the Biden EPA regarding risk evaluations: the adoption of a “single determination” of a chemical’s risk and the removal of the assumption that workers use personal protective equipment. These changes led the Biden EPA to replace a Trump-era methylene chloride risk evaluation with a revised version in 2022.

“Assumption Upon Assumption”

Other industry attacks focus on the risk management rule’s stringent limits on methylene chloride exposure concentrations, which are significantly lower than OSHA’s.  According to the industry petitioners, EPA ignored human exposure studies, relied on a single rat study, and “piled assumption upon assumption upon uncertainty” to reduce the acceptable exposure level “100-fold.”

In response, EPA contends that the industry petitioners misunderstand the toxicology underlying the limits. The agency also defends its use of “uncertainty factors” to extrapolate findings from limited studies, including a policy of basing certain calculations on the 1st percentile of human susceptibility to ensure more conservative protections.

These strict exposure limits prompted EPA to ban many uses of methylene chloride in the risk management rule. EPA argues that it had reason to believe compliance with the limits was not feasible for the banned uses, while the industry petitioners claim the bans were implemented “simply because EPA was uncertain whether businesses would be able to comply with EPA’s new exposure limits.”

Fenceline Communities

The Sierra Club’s challenge is comparatively narrow, primarily focusing on methylene chloride’s risks to fenceline communities.  In a supplement to its risk evaluation, EPA found that methylene chloride air releases elevated cancer risks in these communities.  However, EPA “never determined whether those risks are unreasonable” and “fail[ed] to address those risks” in the risk management rule, the Sierra Club’s October 9 brief states.

In its brief, EPA acknowledges that it “identified some existing risk to fenceline communities” but argues that the risk management rule “adequately address[es] that risk.”  TSCA does not require EPA to “formally determine” whether the risks identified in the supplement were unreasonable because it was conducted after the risk evaluation was completed, the brief argues.  Instead, EPA “opted to factor in the potential risk to fenceline communities as a human health effect that informed the Rule’s choice of restrictions.”

The Sierra Club also challenges EPA’s failure to evaluate the risk methylene chloride poses to the ozone layer, while EPA maintains that the chemical “is not an ozone depleting substance.”

More on EPA’s methylene chloride risk management rule can be found here.

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.