EPA Proposes to Request Unpublished Studies for 16 Chemicals

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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published a proposed rule that would require manufacturers of sixteen chemical substances to submit a wide breadth of unpublished studies to the Agency.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  Copies of unpublished studies, lists of known unpublished studies not in the submitter’s possession, and lists of ongoing studies would all be required.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

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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.

Judge Denies Motion to Dismiss in Colgate Toothpaste Greenwashing Case

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A suit alleging that the Colgate-Palmolive Company (“Colgate”) misrepresented toothpaste tubes as recyclable will be allowed to proceed, the US District Court for the Northern District of California ruled on February 6, 2024.

The case, Della v. Colgate-Palmolive Company, 2024 WL 457798, concerns recycling claims featured by the company’s Colgate and Tom’s of Maine-branded toothpaste tubes.  Made entirely of plastic, these tubes are theoretically less difficult to recycle than “traditional” toothpaste tubes.  The plaintiffs allege, however, that these claims would mislead a reasonable consumer.  According to the plaintiffs, the tubes are universally rejected by recycling facilities because facilities are unable to distinguish between Colgate’s tubes and traditional tubes and because the tubes cannot be fully emptied of toothpaste, which acts as a contaminant in the recycling process.

Colgate moved to dismiss, arguing that its claims were not misleading because the composition of its toothpaste tubes is compatible with a recycling stream that is available to most Californians.  In other words, the recyclability claims were accurate because the tubes are intrinsically capable of being recycled even if they are not recycled every time they are placed in a recycling bin.  Colgate also pointed to a statement on the packaging inviting consumers to “learn more” on their websites, which provided more comprehensive information about the products’ recyclability.

Magistrate Judge Joseph C. Spero rejected Colgate’s arguments.  Common sense would not lead a consumer to believe that a product labelled as recyclable would not be recyclable anywhere, he said.  He also stated that the invitation for consumers to learn more online would not remedy a misleading statement on the packaging, writing that “courts are generally reluctant to charge a reasonable consumer with the obligation of reviewing product websites or other written product materials before purchasing the product.”

More information on the case can be found in a previous Verdant Law blog post.

EPA Proposes to Revoke Approval of PTFE Use in Pesticide Products

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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

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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.

Summary Judgment Denied in “Krud Kutter” Greenwashing Class Suit

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A class action suit alleging that Rust-Oleum Corporation mislabeled products as “non-toxic” and “Earth friendly” can go to trial, the US District Court for the Northern District of California ruled on January 26, 2024.

The case, Bush v. Rust-Oleum Corp, No. 3:20-cv-03268, concerns the environmental claims made on the labels of Rust-Oleum’s “Krud Kutter” cleaning products.  Plaintiff Anthony Bush alleges that the claims would lead a reasonable consumer to believe that the products do not contain ingredients that are harmful to humans, animals, or the environment.  Bush alleges that these claims are misleading because the products contain multiple ingredients that are known to cause toxic effects.

Rust-Oleum moved for summary judgment, pointing to testimony given by the plaintiff and his expert toxicologist in which they acknowledged that risk can never be fully eliminated; even water can be hazardous in excess.  Rust-Oleum argued that this evidence shows that a reasonable consumer would not believe that the products are completely risk-free.  In addition, Rust-Oleum contended that the labels themselves contradicted the plaintiff’s theory of deception: the phrase “Caution: Eye and Skin Irritant” is included next to the words “Non-Toxic,” and the rear of the products’ labels include a definition of the “Earth friendly” claim.

Judge Laurel Beeler rejected Rust-Oleum’s arguments, saying that “[d]eposition testimony of individuals…is at best anecdotal evidence that isn’t dispositive of how a reasonable consumer interprets the challenged claims.”  Beeler also found that genuine disputes of material fact exist regarding the qualifying language included on the products’ label.  The plaintiff’s expert toxicologist alleges toxic effects besides eye and skin irritation and the defendant’s own surveys show that most customers do not read the small font explanation of the “Earth friendly” claim, she said.

Also at issue in the case are the Federal Trade Commission’s Green Guides, which help marketers avoid making misleading environmental claims.  Bush cited the Green Guides’ commentary on the phrase “non-toxic”—“[a] non-toxic claim likely conveys that a product, package, or service is non-toxic both for humans and for the environment generally”—in his complaint, but Beeler agreed with Rust-Oleum that the Green Guides are not decisive under the reasonable-consumer test.

Oral Arguments in Case Challenging TSCA Test Order

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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)

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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

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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

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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.