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a rule under the Toxic Substances Control Act (TSCA) requiring manufacturers of 16 chemical substances to submit unpublished health and safety studies to EPA.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Once the rule takes effect on January 13, 2025, covered entities will have 60 days to report unpublished health and safety information, which includes environmental monitoring data, studies on environmental effects, and tests on biological, photochemical, and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.

First Trials Scheduled in Long-Running Paraquat Litigation

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The first three trials have been scheduled to begin in October 2025 in a multidistrict litigation with over 5,800 plaintiffs claiming that exposure to the pesticide paraquat dichloride caused them to develop Parkinson’s disease.  A second set of trials is scheduled to begin in April 2026.

The case was filed in June 2021.  A previous set of trial cases were tossed in April 2024 after the court ruled that expert testimony linking the herbicide to Parkinson’s disease relied on “methodological contortions and outright violations of…scientific standards.”

Defendants Syngenta and Chevron maintain that there is no causal link.  They also argue that the litigation is “burdened by cases alleging implausible theories of paraquat exposure,” despite court efforts to clean the docket of cases that “should never have been filed.”

EPA has not found a “clear link” between paraquat exposure from labeled uses and Parkinson’s disease or cancer.  However, on January 17, 2025, EPA asked the Ninth Circuit to allow the agency to withdraw a 2021 interim decision on paraquat to give the agency more time to consider its health risks.

According to EPA, paraquat is one of the most widely used pesticides in the US.  It often referred to as Gramoxone, the name of a popular end-use product manufactured by Syngenta.  Chevron stopped manufacturing and distributing paraquat in 1986.

The case is In Re: Paraquat Products Liability Litigation v. Syngenta Crop Protection, LLC, No. 3:21-md-03004 (S.D. Ill.).

EPA’s PFAS Fluorination Rulemaking Survives Legal Challenge

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

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

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

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

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

Industry Pushback

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

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

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

EPA’s TSCA Pre-Prioritization Webinar

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

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

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

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

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

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

 

Work Plan Chemicals:

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

Non-Work Plan Chemicals:

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

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.

EPA Initiates Risk Evaluations for Five Chemicals, Begins Prioritizing Five More

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On December 18, 2024, EPA designated five chemicals as high-priority substances, automatically initiating risk evaluations for them under the Toxic Substances Control Act (TSCA).  In a separate rulemaking, EPA also initiated the prioritization process for another round of five substances.

The five chemicals now undergoing risk evaluations are:

  • Vinyl chloride (CASRN 75-01-4)
  • Acetaldehyde (CASRN 75-07-0)
  • Acrylonitrile (CASRN 107-13-1)
  • Benzenamine (CASRN 62-53-3)
  • 4,4’-methylene bis(2-chloroaniline) (MBOCA) (CASRN 101-14-4)

More on those substances can be found here.

The five chemicals newly identified for prioritization are:

  • 4-tert-Octylphenol (CASRN 140-66-9);
  • Benzene (CASRN 71-43-2);
  • Ethylbenzene (CASRN 100-41-4);
  • Napthalene (CASRN 91-20-3); and
  • Styrene (CASRN 100-42-5).

According to EPA, benzene is a known carcinogen while ethylbenzene, naphthalene, and styrene are probable carcinogens.  4-tert-octylphenol may cause kidney inflammation and impaired fertility.  All five chemicals were selected from the 2014 TSCA Work Plan and have uses in consumer products.  National production volumes range from tens of millions to tens of billions of pounds annually, according to Chemical Data Reporting (CDR) data.

Comments on EPA’s initialization of prioritization are due March 18, 2025.  There will be another opportunity for comment when the agency formally proposes to designate these substances as high priority, which will likely occur in summer 2025.

All 10 chemicals are also covered by a recently finalized health and safety reporting rule, which applies to 16 substances in total.  A blog post on the rule is forthcoming.

EPA to Release Phthalate Cumulative Risk Assessment

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On December 10, 2024, EPA announced its schedule for completing Toxic Substances Control Act (TSCA) risk evaluations for five phthalates: BBP, DBP, DEHP, DIBP and DCHP.  In the next few weeks, EPA expects to release a draft risk evaluation for DCHP and a slew of supporting documents—including a first-of-its-kind cumulative risk assessment (CRA) for six phthalates as a class.

The CRA will mark the first time EPA has evaluated the combined risk to health from multiple chemicals with similar effects under TSCA section 6.  It is intended to inform, rather than replace, individual risk evaluations for each phthalate.

EPA justified the CRA in a draft proposal released in February 2023.  According to the agency, studies have shown “widespread exposure to some phthalates and that humans may become co-exposed to multiple phthalates at the same time,” possibly due to their use in food contact materials.  A particular concern is “phthalate syndrome,” a collection of adverse effects on the developing male reproductive system.

In the draft proposal, EPA announced the agency’s plan to address phthalate syndrome by focusing on the most sensitive effect rather than assessing the syndrome as a whole.  EPA also proposed to consider exposures to these substances from “non-TSCA exposures,” such as dietary intake, and to assess the phthalates “under an assumption of dose addition” using “a relative potency factor approach.”

Meanwhile, final risk evaluations for two additional phthalates, DIDP and DINP, are nearing release.  The risk evaluations for these substances were initiated at the request of the companies that produce them.  EPA intends to include DINP—but not DIDP—in its cumulative risk analysis.

Draft risk evaluations for BBP, DBP, DEHP, and DIBP are expected in the first quarter of 2025.  According to the December 10 announcement, final risk evaluations “will be released by December 2025.”