EPA Issues Test Order for PFAS 6:2 FTAc

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

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

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

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

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

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

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

EPA Proposes Adding Over 100 PFAS to TRI List

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

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

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

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

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

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

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

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

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

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

Maine Releases Draft Language Clarifying Proposals for Currently Unavoidable PFAS

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This August, the Maine Department of Environmental Protection (DEP) released draft language to implement April 2024 amendments to Maine’s PFAS in products legislation.  The draft language was described by DEP as an “initial, informal outreach process” with the goal of initiating rulemaking this fall.

Under Maine’s PFAS in Products law, DEP has broad authority to determine whether PFAS uses are “currently unavoidable.”  Currently unavoidable uses (CUUs) will be granted a five-year exemption to the amended statute’s incremental sales prohibitions for products containing intentionally added PFAS.

Tight timelines

Under the draft language, CUU proposals would only be accepted 18–36 months prior to the applicable sales prohibition or 12–24 months prior to the expiration of an existing CUU determination.  However, sales prohibitions for cleaning products, cookware, cosmetics, and other products containing intentionally added PFAS take effect in less than 18 months (January 1, 2026).  In an October 1 email, DEP stated that they “recognize the tight timeline with the new statutory prohibitions starting in 2026 and are making efforts to streamline the process as much as possible.”

DEP solicited currently unavoidable use proposals for the 2026 prohibitions earlier this year, before the April amendments forced the department to redraft its rulemaking.  In the email, DEP clarified that they are “still considering” whether they will be able to utilize some of the previously submitted information and that “manufacturers may need to resubmit information” to meet the requirements of the eventual final rule.

Proposal requirements

According to the draft language, proposals for CUU determinations could be submitted by manufacturers individually or collectively.  A separate proposal would be required for each combination of product category and industrial sector.  As part of the proposal, manufacturers would be required to include:

  • An explanation of why use of PFAS in the product is “essential for health, safety or the functioning of society” and “essential to the function of the product”;
  • A description of whether alternatives to the use of PFAS are reasonably available;
  • Information on whether and how other states have regulated the use of PFAS in the product; and
  • Known or reasonably ascertainable information on the product’s health and environmental impacts.

The draft language “strongly recommends that all proposals for currently unavoidable use determinations do not contain claims of confidentiality” because “the Department may determine that there is insufficient publicly available information to justify a rulemaking.”

Other provisions of the draft rulemaking, including the notification requirements for manufacturers of products covered by a currently unavoidable use determination, largely mirror the requirements of the amended statute.  More information on the April 2024 amendments can be found in a previous blog post.

Class Action Targets 3M and Chemours for Suppressing PFAS Risks in Carpeting

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Two Minnesota consumers who own PFAS-treated carpeting have sued 3M and Chemours, alleging that the chemical companies collaborated for decades to suppress information about the health and environmental risks of PFAS.

According to the complaint, the defendants knew that PFAS were dangerous as early as the 1950s but knowingly withheld evidence of their harms from EPA and the public.  The plaintiffs allege that when these companies shifted from using long-chain PFAS like PFOA and PFOS to shorter-chain variants like GenX and PFBS, they baselessly claimed that the shorter-chain variants were safer.  And even after many carpet manufacturers and retailers stopped making and selling carpeting containing PFAS, the complaint states that the defendants “continued to lie about the harms caused by [these] products.”

Products made by the defendants were used to treat carpets to make them stain- and soil-resistant.  However, the suit claims that carpet manufacturers were unaware that these products were dangerous, in part due to false or misleading safety data sheets provided by the defendants.  The proposed class action seeks to represent all persons who had carpeting installed prior to 2020, alleging that the defendants’ PFAS products were applied to “virtually all carpets manufactured in the United States” until that year.

The proposed class action’s claims are partially based on internal company documents released through other litigation, including a 2018 settlement reached between 3M and Minnesota over PFAS contamination in drinking water.  That case unearthed documents allegedly showing that 3M discouraged its scientists from discussing the chemicals in writing and stymied research efforts, despite knowledge that PFAS were severely toxic and widely present in human blood.

More large settlements were reached last year.  But the defendants “have not paid a dime for the grievous harms caused by carpets in homes and day-care centers infused with PFAS,” said the plaintiffs, who are seeking damages to replace contaminated carpeting.  These alleged harms include property damage resulting from PFAS emissions from the carpets, which reportedly continue throughout the carpet’s lifespan.

The suit alleges that the defendants violated the Racketeer Influenced and Corrupt Organizations Act as participants in a scheme to conceal PFAS harms for commercial gain.  The suit’s 127 counts also include a myriad of state law claims, including strict products liability and nuisance claims.

The complaint also includes allegations against PFAS manufacturer Daikin, which is not named as a defendant.

The case is Peterson v. 3M Co. (D. Minn.), No. 0:24-cv-0349.

PFDA IRIS Assessment Finalized Amid Ongoing PFAS Reviews

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This July, EPA released the final Integrated Risk Information System (IRIS) assessment for PFDA.  PFDA’s toxicological review is the third completed IRIS assessment for a PFAS.  Two additional assessments, for PFHxS and PFNA, are still in progress.

Consistent with the draft, the final PFDA assessment concluded that evidence indicates “PFDA exposure is likely to cause liver, immune, developmental, and male and female reproductive effects in humans, given sufficient exposure conditions.”  However, it had a higher maximum acceptable daily dose, known as an oral reference dose (RfD), than the draft assessment.

The draft’s lifetime and subchronic RfD was 4 x 10-10 mg/kg/day.  But the final RfD was 2 x 10-9, partially due to the use of different points of departure (or the dose at which an effect is first observed) for immune and developmental effects.

July also saw the release of the external peer review report for the PFHxS draft IRIS assessment, and external peer review meetings for the draft PFNA assessment took place from July 30 to August 1.  The most recent update to the IRIS Program Outlook, released in June, did not include expected release dates for the final PFHxS or PFNA assessments.

Following external peer review, EPA revises the assessment, conducts a final agency review, and holds a interagency science discussion before releasing the final version.  It took nine months for EPA to finalize the assessment for PFDA after releasing the external peer review report.

EPA finalized drinking water standards for PFAS including PFHxS and PFNA in May; more on that can be found here.  Additional information on the draft IRIS assessment for PFHxS is available in a previous blog post.

EPA Releases Second Version of Interim Guidance on PFAS Destruction and Disposal

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On April 8, 2024, EPA released the second version of its interim guidance on the destruction and disposal of PFAS and PFAS-containing materials.  The updated interim guidance builds on the initial guidance issued in 2020 by providing new recommendations for the management of PFAS-containing materials.

The updated interim guidance focuses on three categories of large-scale destruction and disposal technologies: underground injection, landfilling, and thermal treatment.  For each category, EPA identifies the technology with a lower potential for environmental release of PFAS when compared to other technologies within their category:

  • Permitted Class I non-hazardous industrial or hazardous waste injection wells (underground injection);
  • Permitted hazardous waste landfills (landfilling); and
  • Permitted hazardous waste combustors (thermal treatment).

However, each technology has drawbacks and is only suitable for certain types of PFAS-containing materials.  For example, EPA notes that new information suggest landfills may release more PFAS into the environment than previously understood, and that transportation logistics may limit the types and amounts of PFAS-containing fluids that can be inserted into Class I wells.

EPA emphasizes the limitations of available data and includes a list of prioritized research needs to inform future guidance.  High-priority research needs include information on releases from landfills and data on releases from thermal treatment units.  EPA describes a new analytical method, OTM-50, that it believes will better characterize the products of incomplete combustion.

In addition, the updated interim guidance presents a new evaluation framework designed to assess emerging technologies and determine their suitability for specific PFAS-containing materials. It also includes an updated list of tools to screen for potentially vulnerable populations living near likely PFAS destruction or disposal sites.

EPA was mandated to publish and triennially update the interim guidance by the FY 2020 National Defense Authorization Act.  More information on the updated interim guidance can be found in an EPA fact sheet.

Comments on the updated interim guidance are due October 15, 2024.

Coca-Cola Asks Judge to Dismiss Simply Juice PFAS Suit

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A proposed class action alleging that Coca-Cola’s Simply-brand juices contain PFAS does not state a plausible claim for relief, Coca-Cola told the Southern District of New York on July 31, 2024.

The plaintiff in Lurenz v. The Coca-Cola Co. alleges that laboratory testing revealed “widespread and uniform” PFAS contamination in Simply juices at levels detrimental to human health.  As a result, the claims made on Simply products—including that the beverages are “All Natural” and “made simply” with “all-natural ingredients”—would mislead a reasonable consumer, the most recent complaint asserts.

The court dismissed the initial complaint for lack of standing in June, but allowed the plaintiff to file a new complaint.  In response, Coca-Cola filed a letter requesting a conference before the company files another motion to dismiss.  The letter argues that the new complaint’s allegations are “even vaguer” than those previously dismissed, making it “impossible to tell” when the plaintiff purchased the contested products.  The plaintiff “still cannot show a concrete economic harm needed to establish Article III standing,” Coca-Cola says.

In addition, Coca-Cola argues that the new complaint still provides insufficient factual detail about the testing that revealed PFAS contamination, which was a factor in the earlier dismissal.  Even if the testing allegations are deemed sufficient, Coca-Cola asserts that the all-natural claims are not misleading.  “[N]o reasonable consumer would understand PFAS—a substance that is not intentionally added to the [juices]—to be an ingredient,” the letter states.

The case is similar to an ongoing suit against L’Oréal, the cosmetics company, for alleged PFAS contamination.  A blog post on that case, written after a dismissal due to standing issues, can be found here.

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 decision 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.”

Maine PFAS Law Triggers Class Action Against BIC in California

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Customers in California have filed a class action lawsuit against BIC USA, Inc. (“BIC”), a razor manufacturer, over allegations of PFAS use discovered through BIC’s compliance with a Maine PFAS reporting law.

In 2021, Maine enacted legislation requiring companies to disclose whether their products contain intentionally added PFAS by January 1, 2023.  Although a subsequent law extended this deadline to 2025, some companies had already submitted PFAS information to Maine’s Department of Environmental Protection.  According to the complaint, a Freedom of Access Act request by a public advocacy group revealed that BIC had disclosed the use of PFAS as a lubricant in its razor blades.

The plaintiffs argue that they would not have purchased BIC razors for the price they paid had they known they contained PFAS.  Without a disclosure to the contrary, the complaint asserts that “[n]o reasonable customer would expect that shaving razors would contain dangerous PFAS, which are indisputably linked to harmful health effects in humans.”

The lawsuit alleges violations of California’s Unfair Competition Law and False Advertising Law, among other claims.  The plaintiffs seek injunctive relief, compensatory damages, and punitive damages.

The Maine legislature substantially revised the state’s PFAS reporting requirements in April, discussed in a previous blog post.  Under the amended law, reporting requirements will only apply to “currently unavoidable uses” starting in 2032.

The case is Butler v. BIC USA Inc., N.D. Cal., No. 4:24-cv-02955, filed May 15.

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.