Maine Revises PFAS in Products Legislation

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Maine’s reporting requirements for products containing PFAS will be narrowed, and incremental category-specific bans will be adopted under a new law enacted April 16, 2024.  The law, LD 1537, revises landmark 2021 legislation that implemented a general ban on the sale of products containing intentionally added PFAS starting in 2030 and mandated reporting in the interim.

Narrowed reporting requirements

The new law scraps the old law’s “general notification requirement,” which would have required manufacturers to report information on products containing intentionally added PFAS by January 1, 2023 (later delayed to 2025).  Under LD 1537, reporting will only be required for “currently unavoidable uses” beginning in 2032.

As was the case previously, Maine’s Department of Environmental Protection will be tasked with determining what uses are currently unavoidable.  The department solicited requests for proposals from manufacturers seeking currently unavoidable use determinations beginning in January of this year.  However, in light of the new law, the department says on its website that it anticipates currently unavoidable use determinations to begin in 2025.

New timeline for banned products

LD 1537 pushes back the general sales prohibition for products containing intentionally added PFAS from 2030 to 2032.  However, the new law introduces many product category-specific bans.  Certain categories will now be subject to more aggressive deadlines, and a few will not be banned until 2040.

The new sales bans for products containing intentionally added PFAS are as follows:

  • Effective January 1, 2026: cleaning products, cookware, cosmetics, dental floss, juvenile products, menstruation products, textile articles (excluding outdoor apparel for extreme wet conditions and textiles for watercraft, aircraft, or motor vehicles), ski wax, and upholstered furniture.
  • Effective January 1, 2029: artificial turf and outdoor apparel for severe wet conditions (unless it includes a PFAS disclosure).
  • Effective January 1, 2032: all other products containing intentionally added PFAS except for currently unavoidable uses and those subject to a ban in 2040.
  • Effective January 1, 2040: HVAC equipment, refrigeration equipment, refrigerants, foams, and aerosol propellants.

LD 1537 additionally excludes certain product categories from all requirements, including firefighting foams, medical devices/drugs, veterinary products, motor vehicles/motor vehicle equipment, watercraft, and semiconductors.

Other changes

Under the new law, products that do not contain intentionally added PFAS are still subject to the above bans if they are sold in a container that contains intentionally added PFAS.  Importantly, this includes fluorinated containers.

LD 1537 also increases the minimum number of employees for a manufacturer to be subject to reporting requirements from 26 to 101.

More information on LD 1537 can be found at Maine’s Department of Environmental Protection website.

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 Finalizes Changes to TSCA Risk Evaluation Procedures

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On May 3, 2024, EPA published a final rule amending the procedures for chemical risk evaluations under the Toxic Substances Control Act (TSCA).  The final rule is largely unchanged from the proposed rule, discussed in a previous Verdant Law blog post.

A key change in the final rule is the requirement that risk determinations end in a single risk determination rather than use-by-use determinations.  EPA previously referred to this approach as a “whole chemical” approach.  However, to address concerns that a single determination of unreasonable risk would mislead the public into believing that all uses present an unreasonable risk, EPA will no longer use the term “whole chemical.”  EPA additionally committed to “identify[ing] the conditions of use that significantly contribute” to the single determination.

Another important change reverts an EPA interpretation of TSCA to a previous interpretation.  EPA proposed that risk evaluations consider all conditions of use in 2017, but determined that the agency had discretion over conditions of use in the final regulation.  However, due to the Ninth Circuit’s 2019 decision in Safer Chemicals, Healthy Families v. EPA, the final rule now mandates the inclusion of all conditions of use in risk evaluations.

Other changes include the removal of the definitions of “best available science” and “weight of the scientific evidence” to allow the agency greater “flexibility to quickly adapt to and implement advancing scientific practices”; EPA’s decision to no longer assume use of personal protective equipment when calculating occupational exposure; and identification of “overburdened communities” as a potentially exposed or susceptible subpopulation.

The final rule, effective July 2, 2024, will apply to ongoing risk evaluations “only to the extent practicable.”

EPA Sets Drinking Water Standards for PFAS

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Concentrations of six PFAS substances in drinking water will be regulated for the first time under new drinking water standards published by EPA on April 26, 2024.

The final rule sets individual maximum contaminant levels (MCLs) for PFOA and PFOS at 4 parts per trillion (ppt).  The agency found no evidence that any level of exposure to either substance is safe, setting aspirational maximum contaminant level goals (MCLGs) of 0 ppt for both.

The final rule also sets individual MCLs (and MCLGs) of 10 ppt for PFHxS, PFNA, and HFPO-DA (known by the trademark GenX).  Mixtures containing two or more of PFHxS, PFNA, HFPO-DA, and PFBS are subject to a hazard index-based limit.

Public water systems are required to conduct initial monitoring by April 2027, be compliant with the MCLs by April 2029, and conduct regular compliance monitoring.  Water systems must include detected PFAS in their annual reports and notify the public if a MCL violation has been detected.

EPA characterizes the regulation as flexible.  The final rule allows reductions in initial monitoring for most small water systems, using previously collected drinking water data to satisfy initial monitoring requirements, and reduced compliance monitoring based on sampling results.  Additionally, the final rule does not dictate how PFAS be removed.

In a press release, EPA said it expects that approximately 6-10% of water systems subject to the final rule may need to take action to meet the standards, reducing PFAS exposure for around 100 million Americans.

A previous Verdant Law blog post on the proposed drinking water standards can be found here.

EPA Publishes Proposed Consent Decrees for Overdue Risk Evaluations

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EPA would be required to complete overdue risk evaluations by new deadlines if two proposed consent decrees, announced by EPA on April 26, 2024, are adopted.

Section 6(b)(4)(G) of the Toxic Substances Control Act (TSCA) requires EPA to complete risk evaluations within three years of initiation, with a six-month extension possible.  EPA has missed this 3.5-year deadline for 22 ongoing risk evaluations.  Twenty of these risk evaluations were initiated in December 2019 as a result of amended TSCA’s requirement that EPA designate 20 existing substances as “high-priority,” which automatically initiated risk evaluations.  The other two, which concern the substances DIDP and DINP, were requested by manufacturers.

The proposed consent decrees would resolve two consolidated lawsuits against the agency.  The first, brought by environmental groups, challenges EPA’s failure to complete all 22 overdue risk evaluations; a previous blog post on that case can be found here.  The American Chemistry Council filed the second, which only concerns the two manufacturer-requested risk evaluations.

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

  • Draft risk evaluations for at least seven of the substances, including 1,3-butadiene, by December 31, 2024;
  • Final risk evaluations for DIDP, DINP, TCEP, formaldehyde, and 1,1-dichloroethane by December 31, 2024;
  • Final risk evaluations for seven of the remaining substances, including 1,3-butadiene, by December 31, 2025; and
  • Final risk evaluations for the remaining 10 substances by December 31, 2026.

Under the proposed decrees, EPA could file a motion to extend a deadline if the agency deems it necessary.  The proposed consent decrees also include a provision automatically extending these deadlines if the agency undergoes a lapse in appropriations.

Since the first lawsuit was filed in September 2023, EPA has completed draft risk evaluations for TCEP (more on that here) and formaldehyde.  However, EPA has yet to release draft risk evaluations for any of the other 22 overdue evaluations.

Comments on the proposed consent decrees are due May 28, 2024.

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.

TSCA Test Order Issued for PFAS NMeFOSE

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On March 20, 2024, EPA issued a test order for a PFAS known as NMeFOSE (CASRN 24448-09-7).  The order, issued under section 4(a) of the Toxic Substances Control Act, requires 3M Co. and Wacker Chemical Corp. to conduct tiered testing on NMeFOSE.

NMeFOSE was selected for testing as a representative of a group of similar PFAS.  Although existing information on NMeFOSE was deemed insufficient, EPA “identified hazards for acute toxicity and specific target organ toxicity.”  NMeFOSE is expected to break down into a highly toxic PFAS known as PFOS, which also drove concerns.

In a press release, EPA stated that NMeFOSE “has been used widely in products, including clothing and carpet treatments as well as furniture coatings.”  The press release also noted that NMeFOSE can accumulate and that the PFAS has been found in the air and in biosolids.  No Chemical Data Reporting manufacturing information is available for the substance.

The first round of tests, which focus on physical and chemical properties, are due 365 to 390 days after the order’s effective date of March 25, 2024.  Subsequent testing will include assessments of NMeFOSE’s environmental fate, in vivo health effects, and reproductive toxicity, with specific testing requirements contingent on earlier results.

The order is the fourth issued under EPA’s National PFAS Testing Strategy.  The most recent prior order was for HFPO-DAF in August 2023.

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 U.S. 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.