EPA Grants Petition to Address PFAS Created by Plastic Fluorination

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On July 10, 2024, EPA granted a citizen petition from environmental groups encouraging EPA to take Toxic Substances Control Act (TSCA) section 6 action for three PFAS substances produced during the fluorination of plastic containers.

The petition alleges that the three PFAS—PFOA, PFNA, and PFDA—pose a variety of serious human health hazards, even at extremely low exposures.  The petition cites EPA’s December 2023 response to significant new use notices filed by Inhance Technologies (“Inhance”), a fluorination company, for substances including PFOA, PFNA, and PFDA.  As discussed in a previous blog post, EPA found that Inhance’s production of the three PFAS presents an unreasonable risk and ordered Inhance to stop producing the chemicals under TSCA section 5, which allows EPA to regulate new substances and significant new uses.

Inhance challenged EPA’s order.  In March, the Fifth Circuit ruled that EPA could not regulate Inhance under TSCA section 5 because Inhance’s fluorination process had been in place for decades; a blog post on the verdict can be found here.  However, the court noted that EPA is free to regulate Inhance’s fluorination process under section 6, which allows EPA to restrict existing substances.  Unlike section 5, section 6 requires EPA to conduct a cost-benefit analysis that considers a substance’s benefits and what the economic consequences of regulation would be.

In its letter granting the petition, EPA said that the agency will initiate “an appropriate proceeding under TSCA Section 6 associated with the formation” of the three PFAS during plastic container fluorination.  As part of the proceeding, “EPA intends to request information, including the number, location, and uses of fluorinated containers in the United States; alternatives to the fluorination process that generates PFOA, PFNA, and PFDA; and measures to address risk from PFOA, PFNA, and PFDA formed during the fluorination of plastic containers.”

EPA Proposes to Restrict Use of N-Methylpyrrolidone

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Multiple occupational uses of n-methylpyrrolidone (NMP) would be banned and others would be restricted under a proposed rule published by EPA on June 14, 2024.  The proposed rule follows EPA’s 2020 determination that NMP presents an unreasonable risk to human health due to health effects including fetal death and reduced fertility.

According to the proposed rule, NMP is a widely used solvent with applications in the manufacturing of lithium-ion batteries, “semiconductors, polymers, petrochemical products, paints and coatings, and paint and coating removers.”  2020 Chemical Data Reporting rule data indicates that total annual production ranged from 100–250 million pounds from 2016 to 2019, EPA says.

The proposed rule would ban the manufacture, processing, distribution, and use of NMP for industrial and commercial use in lubricants, anti-freeze products, automotive care products, and cleaning products, among others.  All industrial and commercial uses not prohibited would be subject to a workplace chemical protection program (WCPP) to minimize direct dermal contact with NMP through incorporation of the hierarchy of controls.  Where controls are insufficient, EPA proposes to require implementation of a PPE program.

The proposed rule would also implement prescriptive controls for certain industrial and commercial uses, such as capping the allowed concentration of NMP in industrial and commercial paints and stains at 45%. Similar concentration maximums would apply to a handful of consumer products, including adhesives.

Although no consumer products would be banned, EPA proposes to implement container size limitations and labelling requirements for some consumer uses, including paint removers, paints, automotive care products, and cleaning products.

EPA proposes that the bans take effect under a staggered schedule, varying from one to two years after publication depending on whether an entity is a manufacturer, processor, distributor, or user of NMP.  Private entities subject to WCPP requirements would have one year to establish the program, and consumer product container size limitations and labelling requirements would also take effect after one year.

Comments on the proposed rule are due on July 29, 2024.

OEHHA Proposes Additional Changes to Prop 65 Warning Requirements

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On June 13, 2024, California’s Office of Environmental Health Hazard Assessment (OEHHA) issued a notice proposing changes to Proposition 65’s warning requirements.  The proposed changes revise proposed amendments to Proposition 65 published in October 2023, discussed in a previous blog post.

If implemented, the June 2024 proposal would revise the October 2023 proposal by:

  • Delaying the required use of the new short-form warning content from two years to three years after the amendments take effect.
  • Abandoning many of the proposed changes for internet purchases and catalogues. For example, the June 2024 proposal removes the October 2023 proposal’s requirement that internet retailers provide a warning on the shipped product (in addition to the online warning already required).
  • Including a 60-day grace period for internet retailers to update their online short-form warnings after they are notified that a product will have new warning content.

A document showing the proposed changes to the October 2023 proposal can be found here.  Comments on the proposed changes are due June 28.

Proposition 65, officially known as the as the Safe Drinking Water and Toxic Enforcement Act of 1986, requires businesses in California to warn customers when products contain chemicals known to the state to cause cancer or reproductive harm.

OSHA Revises Hazard Communication Standard

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On May 20, 2024, OSHA published a final rule revising the Agency’s Hazard Communication Standard (HCS), which requires that workers be informed of chemical hazards.  The rule aligns the HCS with Revision 7 (Rev. 7) of the Globally Harmonized System of Classification and Labelling of Chemicals (GHS), which is updated biennially by the United Nations.

The 318-page final rule includes special labelling provisions for small containers and mandates use of prescribed concentration ranges in safety data sheets (SDSs) when a chemical concentration is claimed as confidential.  The final rule also revises the definitions and classification considerations for various health hazards, adds a new hazard class (desensitized explosives) and three new hazard categories, and makes a number of modifications to the formatting and language that must be used on labels and SDSs.

Though the rule was largely finalized as proposed, OSHA amended one provision in response to industry pushback.  In the proposed rule, OSHA included language requiring that chemical manufacturers and importers evaluate chemical hazards “under normal conditions of use and foreseeable emergencies.”  Many commenters argued that the provision would be overly burdensome, requiring manufacturers to anticipate all possible downstream uses.  In response, OSHA eliminated the language, instead mandating that hazard classifications include “any hazards associated with the chemical’s intrinsic properties,” such as changes to the chemical’s physical form or chemical reaction products associated with reasonably anticipated uses.

The final rule is effective July 19, 2024, and contains staggered compliance deadlines.  Chemical manufacturers, importers, and distributors evaluating substances must update labels and SDSs within 18 months and must make any necessary updates to alternative workplace labelling, hazard communication programs, and trainings within 24 months.  The corresponding compliance dates for mixtures are 36 months and 42 months, respectively.  However, OSHA is not requiring chemicals that have been released for shipment to be relabeled.

GHS Rev. 7 was published in 2017.  Though GHS Rev. 8 was published before OSHA released the proposed rule, OSHA opted to align the HCS with Rev. 7 in large part because major trading partners (including Canada, Europe, and Australia) have adopted or are planning to adopt Rev. 7.  However, OSHA integrated some elements of Rev. 8 that the Agency believes will better protect workers, such as an updated method of classifying skin corrosion/irritation that expands use of non-animal test methods.

The final rule marks the first major update to the HCS since 2012, when the Agency adopted GHS Rev. 3.  A previous Verdant Law blog post on the proposed rule can be found here.

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 (underlined 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.

Fifth Circuit TSCA Ruling: Established Process Not a “New Use”

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A decades-old manufacturing process cannot constitute a significant new use under TSCA, the US Court of Appeals for the Fifth Circuit ruled on March 21, 2024, in the case Inhance Techs. v. EPA.

Inhance Technologies LLC (“Inhance”) has strengthened plastic containers using the same fluorination process since 1983.  Unbeknownst to Inhance and EPA until March 2022, the fluorination process resulted in the creation of multiple PFAS chemicals that were included in a significant new use rule (SNUR) for long-chain perfluoroalkyl carboxylate substances, which took effect in September 2020.

When EPA detected PFAS in a container manufactured by Inhance, it issued the Texas-based company a notice of violation of the SNUR because Inhance had not filed significant new use notices (SNUNs) for the PFAS created during the fluorination process.  EPA instructed Inhance to stop or change the fluorination process so that it no longer created PFAS.  Inhance filed two SNUNs in December 2022 but continued fluorinating plastic containers using the same process.  Following review of the SNUNs, in December 2023, EPA issued two orders under TSCA sections 5(e) and 5(f) prohibiting Inhance from manufacturing or processing PFAS through their fluorination process.  In response, Inhance successfully petitioned the Fifth Circuit for expedited review and a stay pending appeal, stating that the company would be forced to shut down if the orders were put into effect.

Inhance argued that EPA’s orders were unlawful for three reasons.  First, Inhance argued that its fluorination technology could not be understood as a “new” use under TSCA because it had been ongoing for over thirty years before EPA finalized the SNUR.  Second, Inhance argued that the PFAS created during the fluorination process constituted impurities, which are exempted from the scope of the SNUR.  Finally, Inhance argued that EPA’s interpretation of the SNUR as applying to all industries is a “reinterpretation” for which Inhance had not received fair notice.

In the end, the court did not address Inhance’s second and third points, finding the first argument sufficient to vacate EPA’s orders.  Though the statute does not define “new,” the court found Inhance’s interpretation, “not previously existing,” more compelling than EPA’s interpretation, “not previously known to the EPA,” for multiple reasons.  But ultimately, the court just did not think EPA’s interpretation was sensible, stating that it “lacks intuitive force.”  Inhance could not have been expected to submit its fluorination process as an ongoing use during the rulemaking process for the SNUR because it did not know that it created PFAS at that time, the court said.

Writing on behalf of the three-judge panel, Judge Cory T. Wilson concluded by stating that EPA is not powerless to regulate Inhance’s fluorination process.  TSCA section 6 allows for regulation of all chemical substances, unlike section 5, which only applies to new substances and significant new uses.  However, unlike section 5 rulemaking, section 6 requires EPA to conduct a cost-benefit analysis, which takes into account the substance’s benefits and economic considerations.  The court stressed that this requirement indicates that Congress wanted EPA to give more thoughtful consideration to the impact of its regulations on preexisting manufacturing processes.

Judge Wilson was joined by Chief Judge Priscilla Richman and Judge James E. Graves Jr., who concurred in the judgment only.

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.