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.

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.

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.

EPA Issues SNUR to Keep Inactive PFAS Out of Commerce

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Inactive PFAS chemicals can no longer reenter commerce without EPA approval under a final significant new use rule (SNUR) issued by EPA on January 11, 2024.

The 329 PFAS subject to the SNUR are currently designated as inactive on the Toxic Substances Control Act (TSCA) Inventory and are not subject to an existing SNUR.  (An inactive designation indicates that a substance has not been manufactured, imported, or processed since 2006, with a handful of exceptions addressed below.)  To identify these chemicals, EPA applied the same definition of PFAS the Agency used in its TSCA section 8(a)(7) PFAS reporting rule issued in October 2023, discussed in a previous Verdant Law blog post.

The SNUR requires companies to notify EPA via a significant new use notification at least 90 days before commencing the manufacture, import, or processing of any of these substances.  Upon receiving notification, EPA will assess whether the new use may present an unreasonable risk to human health or the environment and take appropriate action, if necessary, as required under TSCA section 5.

Import and processing of inactive PFAS-containing articles are exempt from the SNUR.  Covered PFAS also fall outside the scope of the SNUR when they are manufactured, imported, or processed:

  • As impurities;
  • As byproducts not for commercial use purposes;
  • In small quantities solely for R&D;
  • For test marketing purposes;
  • For use as a non-isolated intermediate; or
  • Solely for export from the United States.

To establish a significant new use, EPA must determine that the use is not ongoing.  Because the above uses do not result in an active designation on the TSCA Inventory, EPA could not conclude that there are no ongoing uses for these activities.

Federal Court Requests Scientific Information on Diseases Associated with PFAS Exposure

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Parties must gather scientific evidence on the human health effects attributable to PFAS exposure in drinking water, the U.S. District Court for the District of South Carolina ordered in the case In Re Aqueous Film-Forming Foams Products Liability Litigation MDL 2873 last week.  The multi-district litigation focuses on the health hazards posed by aqueous film-forming foams (AFFFs), which are used as fire suppressants and allegedly contain PFAS such as PFOA and PFOS.

Plaintiffs allege that AFFF use at military bases, airports, and other locations caused the release of PFAS into local groundwater, which then entered the water supply.  According to Judge Richard Mark Gergel’s order, the litigation now includes over 20,000 cases, the majority of which raise personal injury claims.

The court adopted a bellwether program for these claims, focusing on alleged connections between exposure and four diseases: kidney cancer, testicular cancer, hypothyroidism/thyroid disease, and ulcerative colitis.  However, Gergel wrote that those diseases only make up a “small minority” of personal injury cases.  To determine which of the other cases have merit, Gergel directed the parties to propose a case management order within 60 days that includes the following:

  • A date by which plaintiffs must identify diseases not addressed in the bellwether program that they allege are the result of exposure to AFFF-contaminated drinking water,
  • A date by which the parties must produce peer-reviewed articles that support or challenge an association between exposure to AFFF-contaminated drinking water and an identified disease,
  • A plan for a science day where the parties can present experts to address those associations and
  • A plan for selecting bellwether cases for those associations.

In a separate order, Gergel stated that the court would select 28 personal injury cases as bellwether cases from a list of proposed bellwether cases submitted jointly by the parties.

EPA Orders Plastic Fluorination Company to Stop Producing PFAS

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Inhance Technologies LLC (“Inhance”) must stop producing PFAS substances created during its fluorination of high-density polyethylene plastic containers, according to two orders issued by EPA on December 1, 2023.

EPA first became aware of PFAS contamination in fluorinated plastic containers in late 2020.  In March 2022, EPA issued a Notice of Violation to Inhance for creating these PFAS in alleged violation of a significant new use rule (SNUR) for long-chain perfluoroalkyl carboxylate (LCPFAC) substances.  The Texas-based company submitted significant new use notices for nine such substances in December 2022 but has continued fluorinating containers nonetheless.

Three of these significant new use notices are addressed in the first order, which was issued under section 5(f) of the Toxic Substances Control Act (TSCA).  EPA determined that these substances—PFOA, PFNA, and PFDA—present an unreasonable risk due to their persistence, bioaccumulation, and toxicity that can only be prevented by prohibiting their manufacture.

The second order, issued under TSCA section 5(e), addresses the six remaining PFAS: PFuDA, PFDoA, PFTrDA, PFTeDA, PFHxDA and PFODA.  EPA determined that these substances may present an unreasonable risk, and the order prohibits their manufacture until certain testing be submitted to and evaluated by the Agency.

In response to the orders, which take effect February 28, 2024, Inhance stated that “the company will pursue all legal options to protect its customers, suppliers, and employees and to ensure the continued operations of this environmentally critical technology.”

The orders are likely to impact ongoing litigation between EPA and Inhance.  In December 2022, EPA sued Inhance for allegedly violating the LCPFAC SNUR.  Inhance has maintained that its fluorination process is legal, arguing that any PFAS present after fluorination are unintended impurities exempt from the SNUR.  More information on that case can be found in a previous Verdant Law blog post.

Fluorination, or the treatment of plastic with fluorine gas, makes containers less permeable.  According to an EPA press release, Inhance fluorinates up to 200 million containers per year.

EPA Finalizes TRI PFAS Reporting Rule

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

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

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

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

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

Environmental Groups Drop Lawsuit Following EPA Finalization of TRI PFAS Reporting Rule

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Environmental and health advocate groups, including the National PFAS Contamination Coalition and Union of Concerned Scientists, have dropped their lawsuit against EPA, challenging two of the Agency’s rules related to PFAS reporting under the Toxics Release Inventory of the Emergency Planning and Community Right-to-Know Act. The 2022 lawsuit alleged that the Agency’s rules Implementing Statutory Addition of Certain Per- and Polyfluoroalkyl Substances; Toxic Chemical Release Reporting and Implementing Statutory Addition of Certain Per- and Polyfluoroalkyl Substances (PFAS) to the Toxics Release Inventory Beginning with Reporting Year 2021, weakened PFAS reporting requirements imposed by the 2020 National Defense Authorization Act (NDAA) by allowing di minimus and alternative threshold exemptions.

The Plaintiffs agree that the issues raised in their 2022 complaint have been sufficiently addressed in EPA’s October 2023 final rule Changes to Reporting Requirements for Per- and Polyfluoroalkyl Substances and to Supplier Notifications for Chemicals of Special Concern; Community Right-to-Know Toxic Chemical Release Reporting which modified the TRI reporting requirements. The amended rule eliminates the di minimus reporting exemption with the purpose of increasing the amount of data on PFAS chemicals released to the environment required to be submitted to the Agency beginning in 2025. More detailed information on the new TRI PFAS reporting requirements can be found here. In both the proposed and final rule, EPA stressed that the two prior rules, the ones at issue in the litigation, resulted in minimal reporting on PFAS releases, and therefore, eliminating exemptions was necessary to achieve the goals of the NDAA.