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a rule under the Toxic Substances Control Act (TSCA) requiring manufacturers of 16 chemical substances to submit unpublished health and safety studies to EPA.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Once the rule takes effect on January 13, 2025, covered entities will have 60 days to report unpublished health and safety information, which includes environmental monitoring data, studies on environmental effects, and tests on biological, photochemical, and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

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.”

Court Approves Tight Deadlines for Overdue Risk Evaluations

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The D.C. District Court has entered two consent decrees concerning over twenty overdue Toxic Substances Control Act (TSCA) risk evaluations, holding the incoming administration’s EPA to aggressive deadlines for completing the chemical reviews.

The consent decrees, approved November 22, concern 20 risk evaluations initiated by EPA in December 2019 and two manufacturer-requested risk evaluations initiated in January 2020.  None were completed within TSCA’s 3.5-year deadline.

Under the consent decrees, linked here and here, EPA will be required to complete:

  • Draft risk evaluations for six of the substances, including 1,3-butadiene, by December 31, 2024;
  • Final risk evaluations for TCEP, formaldehyde, 1,1-dichloroethane, and DIDP by December 31, 2024;
  • A final risk evaluation for DINP by January 15, 2025;
  • A draft risk evaluation for one of the remaining substances by March 31, 2025;
  • Final risk evaluations for seven of the substances, including 1,3-butadiene, by December 31, 2025; and
  • Final risk evaluations for the remaining 10 substances by December 31, 2026.

The deadlines are largely unchanged from those in the proposed consent decrees, released in April and discussed in a previous blog post.  Since then, EPA has released a final risk evaluation for TCEP and drafts for 1,1-dichloroethane, DINP, and 1,3-butadiene.  However, as it stands, EPA will be required to complete three more final risk evaluations before the end of 2025—and a fourth before the presidential transition.

Meanwhile, EPA looks likely to designate another five chemicals as “high priority” this December, automatically triggering new risk evaluations.  More on those chemicals can be found here.

Industry Petitioners Challenge EPA’s Use of TSCA to Regulate Workplace Chemical Exposures

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Industry petitioners are arguing before the D.C. Circuit that EPA has overstepped its authority under the Toxic Substances Control Act (TSCA) by assuming powers to regulate worker chemical exposures—powers that they argue that rightfully belong to OSHA.

United Steel Workers v. EPA, No. 24-1151, consolidates multiple cases challenging EPA’s May 2024 revisions to the procedures for TSCA risk evaluations.  That rule reversed key Trump-era policies by requiring the agency to consider all possible uses of a chemical, issue a single risk determination, and not assume PPE usage.

The industry petitioners, which include the Texas Chemistry Council and the American Chemistry Council, are challenging these changes in full.  However, their October 10 brief also questions EPA’s ability to circumvent OSHA’s role in regulating workplace chemical exposures, arguing that “TSCA is not, and was not intended to be, a worker protection law.”

Their arguments center on TSCA section 9, which allows EPA to report a chemical’s unreasonable risks to another agency if EPA believes they could mitigate the risks.  “In context, TSCA requires EPA to refer regulation of TSCA chemicals that pose unreasonable risks to workers to OSHA if regulation under the OSH Act may prevent or reduce risks of chemical exposure in the workplace,” the industry petitioners’ brief states.  “Only if the referral agency fails to act may EPA proceed to regulate those risks to workers.”

The industry petitioners additionally argue that EPA should give greater consideration to existing OSHA regulations, including those requiring the use of PPE, when considering chemical exposures to workers.  However, a collection of labor petitioners in the case contend that EPA should be prohibited from considering PPE entirely during risk evaluations, asserting that the agency’s approach “confuses risk evaluation with risk management.”

EPA has declined to exercise its referral powers in recent rulemakings, arguing that “gaps exist between OSHA’s authority to set workplace standards under the OSH Act and EPA’s obligations under TSCA section 6 to eliminate unreasonable risk.”  For example, according to EPA, OSHA must consider the economic and technological feasibility of regulation in circumstances where EPA does not.

More on EPA’s 2024 revisions to the procedures for TSCA risk evaluations can be found in a previous blog post.

EPA Issues Test Order for PFAS 6:2 FTAc

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On October 9, 2024, EPA issued a test order under the Toxic Substances Control Act (TSCA) for the PFAS chemical 6:2 FTAc (CASRN 17527-29-6).  The order is the fifth issued under EPA’s National PFAS Testing Strategy, which was launched in 2021.

The order employs a tiered testing approach, as required by TSCA.  Studies on 6:2 FTAc’s physical and chemical properties and environmental fate and behavior will inform future testing on oral and inhalation health effects, reproductive and developmental toxicity, and bioaccumulation in fish.  The earliest test is due 255 days after the order took effect October 13, with most initial testing due within one year.

Depending on the results of hydrolysis testing, the companies subject to the order— Innovative Chemical Technologies, Chemours, Daikin America, Inc., Sumitomo Corp. of Americas, and Du Pont de Nemours and Co.—will also be required to conduct in vitro assays to assess skin absorption, genotoxicity, and/or mutagenicity.

According to an EPA press release, summaries of studies indicate 6:2 FTAc can “cause changes in blood cell counts, liver and kidney size, and animal behavior” in rodents.  However, EPA was unable to obtain the underlying data for these summaries and therefore determined that they did not meet the order’s data needs.

EPA also noted that 6:2 FTAc’s chemical structure “suggests that it may cause cancer.”  Like previous PFAS test orders, the agency plans to use the collected data to learn more about the potential human health effects of other structurally similar PFAS.

The order is the first issued since the D.C. Circuit’s July ruling in Vinyl Institute v. EPA, which vacated a test order due to insufficient justification in the public record.  The test order does not reference the case, which was discussed in a previous blog post.

6:2 FTAc is used to manufacture textiles, apparel, leather, and other basic organic chemicals.  Chemical Data Reporting indicates that 1–20 million pounds of 6:2 FTAc are manufactured annually.

EPA Proposes Adding Over 100 PFAS to TRI List

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Significantly more PFAS substances would be subject to Toxic Release Inventory (TRI) reporting under a proposed rule published by EPA on October 8, 2024.  The proposed rule would add 16 individual PFAS and 15 PFAS categories to the TRI list, which currently contains 196 PFAS.

The proposed additions would be made due to their potential human health effects, environmental effects, or both.  According to EPA, the 15 proposed category additions encompass over 100 individual PFAS.

The added PFAS would be subject to a reporting threshold of 100 pounds.  The manufacture, processing, and otherwise use of substances within a PFAS category would cumulatively count towards that category’s 100-pound threshold.

EPA is also proposing to add the proposed PFAS to the list of chemicals of special concern, which would make them ineligible for the de minimis exemption.  Under the de minimis exemption, facilities can disregard small concentrations of TRI chemicals in mixtures and trade name products when making threshold determinations.

EPA previously designated existing PFAS on the TRI list as chemicals of special concern in October 2023.  In that rulemaking, EPA argued that the move would “result in a more complete picture of the releases and waste management quantities for PFAS.”

The FY 2020 National Defense Authorization Act (NDAA) instructed EPA to add certain PFAS to the TRI list with a 100-pound reporting threshold.  “Congress’ use of this low reporting threshold demonstrates a concern for even relatively small quantities of these PFAS,” EPA said.

EPA was required to evaluate some of the proposed PFAS additions for possible inclusion by section 7321 of the NDAA.  However, the NDAA did not specify what the threshold should be for those additions.  In the proposed rule, EPA defended its proposed 100-pound threshold, saying that it would “maintain consistency for all chemicals added to TRI pursuant to the NDAA.”

The NDAA also instructs EPA to add PFAS automatically when certain conditions are met.  In the proposed rule, EPA clarified its interpretation of those conditions, which include when EPA “finalizes a toxicity value” for a PFAS.

Finally, EPA is proposing that it add related PFAS (like an acid and its associated salts) under the NDAA as a category going forward. The proposed rule would also consolidate certain existing individual PFAS on the list into categories.

Comments on the proposed rule are due November 7, 2024.