EPA Proposes to Request Unpublished Studies for 16 Chemicals

On March 26, 2024, EPA published a proposed rule that would require manufacturers of sixteen chemical substances to submit a wide breadth of unpublished studies to the Agency.

If finalized, the rule would amend the list of chemicals subject to health and safety reporting located at 40 CFR 716.120 by adding the following:

  • 4,4-Methylene bis(2-chloraniline) (CASRN 101–14–4)
  • 4-tert-octylphenol(4-(1,1,3,3- Tetramethylbutyl)-phenol) (CASRN140– 66–9)
  • Acetaldehyde (CASRN75–07–0)
  • Acrylonitrile (CASRN 107–13–1)
  • Benzenamine (CASRN 62–53–3)
  • Benzene (CASRN 71–43–2)
  • Bisphenol A (CASRN 80–05–7)
  • Ethylbenzene (CASRN 100–41–4)
  • Naphthalene (CASRN 91–20–3)
  • Vinyl Chloride (CASRN 75–01–4)
  • Styrene (CASRN 100–42–5)
  • Tribomomethane (Bromoform) (CASRN 75–25–2)
  • Triglycidyl isocyanurate; (CASRN 2451–62–9)
  • Hydrogen fluoride (CARN 7664– 39–3)
  • N-(1,3-Dimethylbutyl)-N′-phenyl-pphenylenediamine (6PPD) (CASRN 793– 24–8)
  • 2-anilino-5-[(4-methylpentan-2-yl) amino]cyclohexa-2,5-diene-1,4-dione (6PPD-quinone) (CASRN 2754428–18– 5).

EPA proposed to prioritize five of the listed chemicals (italicized above) for TSCA section 6 risk evaluation in December 2023.  The proposed rule also includes 10 chemicals EPA is considering including in its December 2024 initiation of prioritization.  The last substance, a 6PPD transformation product, was included as a result of EPA’s decision to grant a citizen’s petition on 6PPD.

Pursuant to 40 CFR 716.10 and 716.50, the requested information would include studies on health and safety, environmental effects, physical-chemical properties, exposure, and degradation.  Copies of unpublished studies, lists of known unpublished studies not in the submitter’s possession, and lists of ongoing studies would all be required.  Copies of each study previously listed as ongoing would also be required upon completion, regardless of the study’s completion date.

Studies previously submitted to EPA pursuant to a requirement under TSCA would be exempted from the request.  However, EPA proposes not to apply the typical exemption for persons manufacturing one of the 16 substances only as an impurity.

In addition to current manufacturers (including importers), persons who have manufactured or proposed to manufacture a listed substance within the past ten years would be required to submit the requested information.  Comments on the proposed rule are due on May 28, 2024.

PEER and CEH Request Court Injunction Against EPA

On February 15, 2024, the Public Employees for Environmental Responsibility (PEER) and the Center for Environmental Health (CEH) filed a lawsuit against EPA in the U.S. District Court for the District of Columbia stating that EPA failed to comply with a Freedom of Information Act (FOIA) request. The two nonprofit environmental groups said in their claim that they had filed a FOIA request on January 5, 2023, for numerous documents regarding Per-and Polyfluoroalkyl Substances (PFAS), specifically long-chain perfluoroalkyl carboxylate (LCPFAC) substances, created during the fluorination of plastic containers by Inhance Technologies LLC. PEER and CEH claim EPA failed to comply with the FOIA request and are now requesting an injunction for the courts to order EPA to disclose all the documents.

In their complaint, the two groups asserted that a document-by-document review by EPA is inefficient and unnecessary and requested that EPA instead adopt a class determination to expedite disclosure. PEER and CEH acknowledge they have received four interim releases but have yet to receive the full release and “unredacted documents have been produced in accordance with the disclosure requirements of section 14 of TSCA”.

The complaint details the timeline of EPA’s response to the FOIA request.  PEER and CEH note that EPA used an “Unusual Circumstances” exception to the standard time allowed for responding to a FOIA with a new estimated competition date of August 3, 2023. A Continuing Unusual Circumstance letter from EPA pushed the response date back further to December 1, 2023. This is an issue of contention for PEER and CEH, as they state that the FOIA statute allows for 20 working days to comply with FOIA requests and only an additional 10 working days for unusual circumstances. 5 U.S.C. § 552(a)(6). Therefore, according to PEER and CEH, the original competition date should have been February 2, 2023, and then adjusted to February 16, 2023 after including 10 working days for unusual circumstances.

EPA Proposes to Revoke Approval of PTFE Use in Pesticide Products

On February 28, 2024, EPA released a proposed rule to remove polytetrafluoroethylene (PTFE; CASRN 9002-84-0) from the list of approved inert ingredients for pesticide products.

PTFE, also known by the brand name Teflon, is a PFAS chemical that is currently approved for use in food and nonfood pesticide products.  No currently registered pesticide products use PTFE.  However, if removed from the approved list, any proposed future use of PTFE would need be supported with data provided to and reviewed by EPA.

The proposed rule comes after an EPA review of approved inert ingredients in search of PFAS chemicals.  EPA previously removed twelve PFAS chemicals from the list of approved inerts in December 2022.

Inert ingredients include emulsifiers, solvents, carriers, and any other substance included in a pesticide besides the active ingredient(s).  Comments on the proposed rule are due on March 29, 2024.

Consent Agreement Reached in Ultium Cells and General Motors TSCA Enforcement Action

The U.S. EPA Environmental Appeals Board ratified a consent agreement for EPA’s TSCA enforcement action against Ultium Cells and General Motors Company on November 20, 2023. In February 2023, Ultium Cells and General Motors Company (collectively referred to as Respondents), voluntarily disclosed potential TSCA violations to the Agency under EPA’s Incentives for Self-Policing: Discover, Disclosure, Correction and Prevention of Violations (Audit Policy).  In their disclosure, the companies reported that they may have imported three substances that were not listed on the TSCA Inventory.

The consent agreement identifies the following TSCA violations:

  • Section 5(a)(1). Failure to submit a PMN at least 90 days before manufacturing (importing) new chemical substances for non-exempt commercial purposes.
  • Section 13(a)(1)(B). Failure to submit proper [import] certifications under section 13 of TSCA prior to importing new chemical substances.
  • Section 15(2). Processing and use of new chemical substances that Respondents knew or had reason to know were manufactured, imported, processed, or distributed in commerce in violation of TSCA Section 5.

Following their disclosure, in March 2023, Respondents filed premanufactures notices (PMNs) on the three substances at issue.

EPA assessed civil penalties of more than $650,000.  The companies received Audit Policy credit for the PMN and Import Certification violations, and a substantial portion of the 15(2) counts.  However, penalties were assessed for continued processing and use of the chemical substances during the time after the companies submitted PMNs for the substances, but before the PMNs cleared EPA review.

Under the terms of the consent agreement, the companies were allowed to import, process, use, and distribute the chemical substances at issue while EPA finalizes a TSCA section 5(e) Consent Order for the substances under the condition that they follow the requirements of the Compliance Plan specified by the agreement.  Requirements of the Compliance Plan include no release to water and respiratory protection with an APF of at least 1000.

Oral Arguments in Case Challenging TSCA Test Order

On December 1, 2023, a panel of the DC Circuit Court heard oral arguments in Vinyl Institute v EPA.  The case marks the first legal challenge of EPA’s authority to administer Toxic Substances Control Act (TSCA) section 4 test orders since Congress granted EPA the authority in the 2016 Lautenberg Amendments.

The case revolves around an avian reproduction study mandated by EPA’s March 2022 test order for 1,1,2-Trichloroethane, a solvent currently undergoing TSCA risk evaluation.  The Vinyl Institute alleges that EPA failed to adequately demonstrate why the study is necessary, while EPA argues that the order met statutory requirements and is supported by substantial evidence.  Also at issue in the case is a TSCA section 19(b) motion filed by the petitioner to make additional submissions to the test order’s administrative record.

Oral arguments focused on the level of detail required in the test order’s statement of need.  The Vinyl Institute’s attorney argued that the statement of need was composed of conclusory statements that did not sufficiently explain EPA’s reasoning.  For example, he said that it is not possible to identify one of the studies cited by EPA in its explanation.  This received pushback from one judge, who said that he seemed to be asking for a level of specificity that may not be required by law.  EPA’s attorney argued that the test order is not statutorily required to be an “exhaustive decisional document,” and said that EPA is not obligated to explain why it believes certain existing studies were inadequate to fill the data need addressed by the order.  In response, one judge implied that the attorneys’ interpretations of the standard for test orders fall on the extreme ends of a spectrum—on one end, EPA would be required to list every piece of information in examined in its decision-making process, and on the other, EPA could simply say “take our word for it”—and said that the standard is probably located between them.

The attorneys also offered competing interpretations of Congress’s intent when it granted EPA the ability to administer test orders.  EPA’s attorney argued that the reason Congress gave EPA the authority to administer test orders was to make it easier for EPA to obtain necessary information, and that requiring high levels of detail in test orders would burden EPA and undermine that intent.  By contrast, the Vinyl Institute’s attorney said that Congress put in place “numerous guardrails to ensure that [EPA’s] test order authority is not abused.”

Because the avian reproduction study is currently in progress, one judge remarked that a ruling in the petitioner’s favor would need to be delivered before summer 2024 to avoid mootness.  Neither attorney had time to address the section 19(b) motion.

A previous Verdant Law blog post on the case, written prior to merits briefing, can be found here.

EPA Proposes to Revise Rules for PBTs DecaDBE and PIP (3:1)

On November 24, 2023, EPA released a proposed rule to revise the final rules for decabromodiphenyl ether (“decaBDE”) and phenol, isopropylated phosphate (3:1) (“PIP (3:1)”), two persistent, bioaccumulative, and toxic substances (PBTs) subject to regulation under section 6 of the Toxic Substances Control Act (TSCA).

Section 6(h) of TSCA (as amended by the Lautenberg Amendments in 2016) required EPA to take expedited action to complete TSCA section 6(a) rules on certain PBTs.  In January 2021, EPA released final rules for decaBDE, PIP (3:1), and three other PBTs.  The final rules for decaBDE and PIP (3:1) generally prohibit their manufacture, processing, and use beginning in March 2021, though the rules contained phased-in prohibitions and exclusions for certain uses; EPA has extended certain phased-in prohibitions for PIP (3:1) multiple times since.

In light of new information and the Agency’s reinterpretation of the directive in TSCA section 6(h)(4) to “reduce exposures to the substance to the extent practicable,” EPA is proposing revisions to the final rules for decaBDE and PIP (3:1).  For decaBDE, the proposed revisions include:

  • Requiring a label on existing plastic shipping pallets containing decaBDE,
  • Requiring use of PPE for certain activities involving decaBDE,
  • Prohibiting releases to water during the manufacturing, processing, and commercial distribution of decaBDE and decaBDE-containing products,
  • Extending the current compliance extension for the processing and distribution in commerce of decaBDE-containing wire and cable insulation for use in nuclear power generation facilities, and
  • Requiring export notification for decaBDE-containing wire and cable for nuclear power generation facilities.

The proposed revisions to the PBT rule for PIP (3:1) include:

  • Narrowing the exclusion of prohibition for PIP (3:1) use in lubricants and greases to only include use in aerospace and turbine applications,
  • Replacing the exclusion from prohibition for motor and aerospace vehicle parts containing PIP (3:1) with phased-in prohibitions,
  • Excluding from prohibition the processing and commercial distribution of PIP (3:1) and PIP (3:1)-containing products for use in wire harnesses and circuit boards, and
  • Requiring PPE during manufacturing and processing of PIP (3:1).

In the proposed rule, EPA states that the Agency is not reconsidering the final rules for the other three PBTs–2,4,6-TTBP, HCBD, and PCTP–subject to final rules in January 2021.

According to EPA, decaBDE is a flame retardant that is used in textiles, plastics, adhesives, and polyurethane foam, and PIP (3:1) is a flame retardant, a plasticizer, and an anti-compressibility and anti-wear additive used in lubricants, hydraulic fluids, and in the manufacture of other compounds.

EPA Releases Final Guidance for Pesticide Submissions for New Outdoor Uses that Require ESA Reviews

EPA has published the document Final Guidance for Pesticide Submissions for New Outdoor Uses that Require Endangered Species Act (“ESA”) Reviews. In October, the Agency requested public comment on the draft version of this document which was due to the Agency by October 16. In its press release regarding the guidance, EPA stated that the document will fulfill the requirements imposed upon it under the Pesticide Registration Improvement Act of 2022 (“PRIA 5”). Under PRIA 5 EPA must develop and issue guidance to registrants regarding analyses necessary to support the evaluation of potential adverse effects from new outdoor uses of pesticide products on ESA species and designated critical habitats. The draft guidance will apply to the following outdoor uses:

  • new uses of existing conventional pesticides
  • new uses of existing biocides
  • new conventional pesticide active ingredients
  • New uses of biocide active ingredients

The document does not detail any new requirements for applicants. Its purpose is to serve to assist applicants in addressing potential effects on ESA species for the types of new outdoor uses listed above. Many recommended actions include steps that applicants can take voluntarily in developing proposed mitigation efforts. These efforts include:

  • identifying the action area,
  • identifying routes of exposure to potentially affected ESA species,
  • performing initial special overlap analysis to identify where proposed new uses will overlap with critical habitats,
  • identifying mitigation measures (such as decreasing run-off by deploying soil binding agents) and
  • address the risk associated with all active ingredients

The Agency states that “if followed, these recommendations should expedite the review for new outdoor uses of existing conventional pesticides and biopesticide active ingredients under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and improve the efficiency of the overall ESA-FIFRA process.”

EPA Requests Comment on Petition Requiring Proof of Effectiveness for Systemic Insecticides

On November 24, 2023, EPA announced that the Agency is seeking public comment on a petition filed by environmental groups requesting that EPA consider efficacy data when evaluating the registration of neonicotinoids and other systemic insecticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).  Comments will be accepted through January 23, 2024.

In 1980, EPA waived (in most cases) the requirement that registrants provide efficacy data when registering a pesticide under FIFRA (see 40 CFR 158.400(e)(1)).  The petition, filed by the Public Employees for Environmental Responsibility and the American Bird Conservancy, argues that neonicotinoid use is largely ineffective and causes widespread environmental harm.  According to the petition, EPA’s failure to consider neonicotinoids’ lack of efficacy conflicts with the stated purposes of the Agency’s FIFRA registration data requirements to “make regulatory judgments…about the risks and benefits of pesticide products” (40 CFR 158.1(a)) and “ensure that pesticide products will perform as intended” (40 CFR 158.130(c)).

In addition to requiring efficacy data during systemic insecticide registration, the petition asks EPA to mandate that existing systemic insecticide registrants submit efficacy data to EPA within 180 days.  If a proposed or existing systemic insecticide registration “lacks a demonstration that its benefits exceed its environmental and overall costs,” EPA would be required to deny or revoke the registration accordingly.

Systemic insecticides are most commonly used prophylactically to treat plant seeds.  Treated seeds are currently exempted from FIFRA under the “treated articles and substances” exemption at 40 CFR 152.25(a) if their use is consistent with the treating pesticide’s label instructions.  However, EPA recently signaled that the Agency may revise this exemption.

Systemic insecticides are designed to be absorbed and transported through the target plant.  Neonicotinoids, a class of systemic insecticides that include the active ingredients imidacloprid, thiamethoxam, and clothianidin, are one of the most widely used types of insecticides in the world.

EPA Finalizes TRI PFAS Reporting Rule

On October 31, EPA published its final rule, Changes to Reporting Requirements for PFAS and to Supplier Notifications for Chemicals of Special Concern which modifies the requirements for TRI reporting. These new requirements take effect November 30, 2023, and will apply for the reporting year beginning January 1, 2024; first reports with these requirements will be due July 1, 2025. The rule puts forth two significant changes to the current reporting requirements.

The first change to the reporting requirements is that all PFAS presently subject to TRI reporting will be added to the TRI list of Chemicals of Special Concern (“COSC List”). In addition, in the future, any PFAS added to the TRI list of toxic chemicals will automatically be added to the COSC list without the Agency having to go through a separate rulemaking process as was previously required. Furthermore, all PFAS on the COSC list will be held to the same reporting standard as all other chemicals on the COSC list. This means that all PFAS will be excluded from the de minimis exemption, which had excused quantities of PFAS present in mixtures at less than 1 percent (0.1 for PFOA) from contributing to reporting thresholds. In addition, facilities will no longer be able to report these substances on Form A (the less extensive of the reporting forms) and will not be able to report quantities using ranges. Under the requirements previously in place, Form A could be used for PFAS reporting if each of the following criteria has been met:

  • The reportable chemical substance is not a PBT.
  • The reportable chemical substance was not manufactured, processed, or otherwise used in excess of 1,000,000 lbs.
  • If the total reportable amount of the chemical substance released did not exceed 500 lbs.

Under the new requirements, no one will be able to report PFAS manufacture, processing, use, and releases on Form A. However, Form A can still be used to meet the reporting requirements for PFAS during the 2023 reporting year; beginning in 2024, PFAS will need to be reported using the more extensive Form R.

The second change to the TRI reporting requirements eliminates the de minimis exemption under the supplier notification requirements for all COSC, including PFAS. This change also goes into effect for the 2024 reporting year. The de minimis exemption for supplier notification meant that raw material suppliers were not required to notify their customers of the presence of PFAS in mixtures below specific concentrations (1 percent for non-carcinogens and 0.1 percent for carcinogens or, in the present case, 1 percent for PFAS and 0.1 percent for PFOA). Eliminating the de minimis exemption for reporting will add notification requirements on suppliers of products containing COSC and include such information on their SDSs. Consequentially, facilities will have more information about their processing, use, and/or release of PFAS, and downstream manufacturers will likely have more information to report to EPA for TRI.

EPA Proposes TCE Ban

EPA has released a proposed rule, which, if implemented, would ban the use of trichloroethylene (“TCE”). The substance has numerous industrial, commercial, and consumer applications, including uses in vapor and aerosol degreasing and as lubricants, greases, adhesives, and sealants. Earlier this year, in its final revision to the TCE risk evaluation conducted under section 6(b) of the Toxic Substances Control Act (“TSCA”), EPA concluded that TCE presents an unreasonable risk of injury to human health due to both its carcinogenic and non-carcinogenic health effects including liver and kidney toxicity, and neurotoxicity. The risk evaluation found these effects resulted from both acute and chronic exposures and through all types of exposures, including inhalation and dermal exposure. TSCA section 6(a) requires EPA to impose restrictions on the manufacture, including import, processing, and distribution of substances that present an unreasonable risk of injury to human health or the environment.

The ban would apply to all manufacturing, import, processing, and distribution in commerce of TCE for all industrial and commercial uses. The rule would go into effect one year following the effective date of the final rule for consumer products and most commercial uses. Some commercial and industrial uses would have longer phaseout timelines and set exemption periods. (The difference between phaseouts and exemptions is that phaseouts are active timelines for the elimination of use, whereas the exemptions do not require current action to eliminate the use of TCE by a certain date; presumably, a determination will be made prior to the exemption period ending that will clarify if the exemption is to be extended or if a phaseout period will be established.)

TSCA section 6(g) allows EPA to grant an exemption from a requirement of a rule banning or restricting a chemical substance for a specific condition of use of a chemical substance if the Administrator finds that the specific condition of use is critical or essential and has no technically and economically feasible safer alternative. The phaseout and exemptions in the proposed rule are narrow in scope. They include the following:

  • An 8.5-year phaseout for the manufacture and processing of TCE as an intermediate in the manufacturing of hydrofluorocarbon134a (HFC-134a). HFC-134a is essential to the operation of refrigeration and air conditioning systems.
  • A 10-year phaseout for the manufacture and use of TCE as a solvent for closed-loop batch vapor degreasing for rayon fabric scouring for end use in the production of rocket booster nozzles. This exemption is limited to production by federal agencies and their contractors.
  • A 10-year TSCA Section 6(g) exemption for the manufacture and processing of TCE as a processing aid for battery separator manufacturing, battery separators are used to prevent short-circuiting in lithium-ion batteries.
  • A 50-year TSCA Section 6(g) exemption for the manufacture, processing, distribution in commerce, and use of TCE as a laboratory chemical for essential laboratory activities such as those associated with ongoing environmental cleanup projects under the CERCLA program and other EPA authorities, and some research and development activities being conducted by U.S. Federal Agencies including NASA.

The rule would also require strict workplace controls for those working with TCE for the uses allowed by the proposed rule.  These workplace controls would be detailed in EPA’s proposed  Workplace Chemical Protection Program (“WCPP”). To further reduce worker risks, the proposed rule would prohibit the disposal of TCE to industrial pre-treatment, industrial treatment, or publicly owned treatment works.

Under this rule, manufacturers, importers, processors, and distributors (excluding retailers) of TCE and TCE-containing products must provide downstream notification of the TCE prohibition. EPA is asking for comments on timeframes for downstream notification and recordkeeping requirements. EPA is proposing a two-month period for manufacturers and a six-month period for processors and distributors to make the required SDS changes. This notification will be provided through Safety Data Sheets (“SDS”). The suggested SDS language is stated within the proposed rule.

Violations of the rule will be subject to TSCA section 16, which permits civil and criminal penalties, including a civil penalty of up to $46,989 per day for each violation of TSCA or TSCA rules. Comments on the proposed rule are due December 15, 2023.