Environmental Groups Call on FDA to Revoke Approval of Fluorinated Plastic for Food Contact

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A coalition of environmental and health groups led by the Environmental Defense Fund have petitioned the Food and Drug Administration (FDA) to revoke approval of fluorinated polyethylene as an indirect food additive.  According to the petition, manufacture of fluorinated polyethylene produces PFAS, including harmful perfluoroalkyl carboxylic acids if water or oxygen is present.

FDA approved fluorinated polyethylene as an indirect food additive—a substance that comes into contact with food, but is not intended to be added directly to food—in 1983.  Since then, according to the petition, the dangers of even minimal exposures to PFAS have become clear, and studies have demonstrated that fluorinated polyethylene results in PFAS migration into food.

The petitioners argue that the substance can no longer be considered “safe” as defined at 21 CFR 170.3(i), which requires “reasonable certainty in the minds of competent scientists that the substance is not harmful under the conditions of its intended use.”  The Agency must consider the following factors when determining whether this safety standard is met:

  • The probable consumption of the substance and any substance formed in or on food because of its use.
  • The cumulative effect of the substance in the diet, taking into account any chemically or pharmacologically related substance or substances in the diet.
  • Safety factors which, in the opinion of experts qualified by scientific training and experience to evaluate the safety of food ingredients, are generally recognized as appropriate.

The petitioners also claim that revoking approval for fluorinated polyethylene is the logical consequence of a previous FDA statement on the substance.  In a 2021 public letter to manufacturers, distributors, and users of fluorinated polyethylene food contact articles, the Agency stated that its regulations “[do] not authorize fluorination of polyethylene containers in the presence of water, oxygen, or gases other than nitrogen.”  The petition, however, alleges that all nitrogen gas contains water and oxygen as impurities.  “If FDA is serious about its claim that no oxygen or water may be present in the nitrogen gas, then the agency has effectively determined that the 1983 approval should be revoked,” the petitioners state.

The petition comes after a July 2022 FDA request for information on food contact uses of fluorinated polyethylene due to PFAS concerns.

DOD and FAA Approve Use of a PFAS-Free Fire Suppressant

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This September, the Department of Defense (DOD) announced the approval of the first PFAS-free foam for firefighting activities at military installations.  The approval is an important step in phasing out the use of PFAS-containing aqueous film forming foams (AFFFs), which are used to extinguish liquid fires.

The day after the foam received DOD approval, the Federal Aviation Administration (FAA) notified airports that they could use it.  FAA is not currently requiring exclusive use of the PFAS-free foam, however.

The transition away from PFAS-containing foams is required by section 322 of the 2020 National Defense Authorization Act.  Among other deadlines, the act prohibits DOD from purchasing fire-fighting foams containing more than 1 part per billion PFAS beginning October 1, 2023.

DOD issued a performance specification for PFAS-free (also known as fluorine-free) foams in January of this year.  According to DOD’s announcement, several other fluorine-free foams are currently being tested for conformance with the specifications.

 

 

CPSC Publishes Request for Information Regarding PFAS in Consumer Products

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On September 20, 2023, the Consumer Product Safety Commission (CPSC) published a request for information (RFI) in the Federal Register for information on PFAS in consumer products. The RFI requests information from all stakeholders, including “consumers, manufacturers and importers, government agencies, non-governmental organizations, and researchers.”

The requested information falls into three categories:

  1. Use or potential use of PFAS in consumer products, including information about the definition of PFAS, identification of specific PFAS potentially used or present in consumer products, and information about which PFAS or consumer products CPSC should prioritize in future assessments, among other information;
  2. Potential human exposures to PFAS associated with consumer products use, including information about the potential for exposure and risk from the presence of PFAS in consumer products, among other information; and
  3. Potential adverse human health effects informed by toxicological data, including reports that could inform whether individual PFAS or categories of PFAS have the potential for adverse human health effects, and information on additional data sources that CPSC should consider.

The Federal Register notice also announced the availability of a contract report that CPSC commissioned to characterize the use of PFAS in consumer products, identify PFAS regulations and restrictions, and summarize recent hazard, exposure, and risk assessments on PFAS. The contract report ultimately identified 863 PFAS with reported use or detection in consumer products. The RFI instructs reporting entities to consider information already available to CPSC in the contract report when reporting information.

CPSC does not explicitly state what it plans to do with the collected data in the RFI but states that the contract report “identif[ies] possible next steps.” The next steps identified by the contract report include research (such as developing a consensus on the definition of PFAS), new regulations, and consumer awareness.

The RFI comes after Minnesota, Maine, and other states passed regulations limiting the use of PFAS in consumer products. CPSC will accept the requested information through November 20, 2023.

PFAS Class Action Brought Against Sports Drink Company

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A consumer class action lawsuit has been filed against Biosteel Sports Nutrition, Inc. in the Eastern District of New York, alleging that the company’s BioSteel Blue Raspberry flavored sports drink contains per- and polyfluoroalkyl substances (“PFAS”). Defendant’s products are marketed as healthy sports drinks, using language such as “clean, quality ingredients,” “designed with sustainability in mind,” “no artificial flavors/colors,” and “good for you and the environment.” The product packaging additionally claims that the product is “highly regarded for its premium ingredients and zero sugar formula.”

Plaintiffs claim that based on this language, they believed the product to be a healthy sports drink, but the presence of PFAS directly contradicts Biosteel Sports Nutrition’s marketing claims. The suit alleges violations of the New York General Business Law § 349, et seq., which prohibits deceptive acts and practices in business, violations of New York General Business Law § 350, et seq. prohibiting false advertising, breach of express warranty, fraud, constructive fraud, and unjust enrichment.

On August 4, 2023, the company filed a motion to dismiss, claiming that Plaintiff’s testing of its product was insufficient to demonstrate that PFAS substances are present in its products. The motion claims the testing allegations are “devoid of any details regarding the methodology or sample used.” Additionally, according to Biosteel Sports Nutrition, this information was not within the complaint or the amended complaint.

EPA Requests Information on Addressing PFAS in the Environment for the Superfund Program

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EPA has published a notice of proposed rulemaking, Addressing PFAS in the Environment, asking for public input, which the Agency will use to develop future per- and polyfluoroalkyl substance (PFAS) regulations under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA). The Agency asked for information on the potential future hazardous substance designation of a number of PFAS, categories of PFAS, and several PFAS precursors.

Request for Public Input Regarding Potential Future Hazardous Substance Designation of Seven PFAS

EPA had previously proposed designating PFOA and PFOS and their salts and structural isomers as hazardous substances under CERLA. The present notice requested feedback as to whether the agency should initiate action designating an additional seven PFAS and their salts and structural isomers or a subset thereof as CERCLA hazardous substances as well. The seven PFAS being considered for designation are:

  • Perfluorobutanesulfonic acid (PFBS), CASRN 375–73–5
  • Perfluorohexanesulfonic acid (PFHxS), CASRN 355–46–4
  • Perfluorononanoic acid (PFNA), CASRN 375–95–1
  • Hexafluoropropylene oxide dimer acid (HFPO–DA), CASRN 13252–13–6
  • Perfluorobutanoic acid (PFBA) CASRN 375–22–4
  • Perfluorohexanoic acid (PFHxA) CASRN 307–24–4
  • Perfluorodecanoic acid (PFDA) CASRN 335–76–2

EPA asked interested parties to submit information on whether any of these compounds may present substantial danger to public health or welfare or the environment. Such information could include data on mobility, persistence, and prevalence.

Request for Public Input Regarding Potential Future Hazardous Substance Designation of Precursors to PFOA, PFOS, and PFAS

The Agency is also considering initiating action that would designate certain PFAS precursors as hazardous substances under CERCLA. To make this determination, EPA requested information to help the Agency identify compounds that degrade to these PFAS through environmental processes such as biodegradation and hydrolysis.

Request for Public Input Regarding Potential Designation, or Designations, of Categories of PFAS as Hazardous Substances

Additionally, EPA is considering initiating action that would designate groups or categories of PFAS as CERCLA hazardous substances. These groups or categories would be based on characteristics that determine risk to human health and the environment, such as chemical structure, physical and chemical properties, mode of toxicological action, and precursors or degradants. To inform its decision-making, the Agency solicited the following information:

  • Published scientific literature that can inform whether categories of PFAS could or could not be designated as hazardous substances. This could include findings on the similarities or differences of a specific characteristic among PFAS. Also useful would be data on the relationship between different characteristics, such as the relationship between chemical structure and specific chemical, physical, or toxicological properties.
  • Other information that could inform EPA’s determination of whether to designate one or more categories of PFAS as hazardous substances.
  • Information that would contribute to economic analysis of the potential costs and benefits, including impacts on small entities, associated with a potential rulemaking designating categories of PFAS as hazardous substances. (Although CERCLA section 102(a) precludes EPA from taking cost into account in the designation of a hazardous substance, the Agency is requesting this information to help the Agency understand the potential costs and benefits associated with any potential future regulatory action.)

The deadline for submitting comments was extended from June 12 to August 11, 2023, during which period over 600 comments were submitted. The comments can be reviewed here.

EPA Releases Draft IRIS Assessment of PFHxS and Related Salts

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On July 24, 2023, EPA released a draft IRIS Toxicological Review of Perfluorohexanesulfonic Acid (PFHxS) and Related Salts.  Comments on the draft assessment will be accepted through September 22, 2023.

The IRIS assessment found that, given sufficient exposure conditions, PFHxS is likely to cause thyroid and developmental immune effects in humans.  Other evidence suggests but is insufficient to infer that PFHxS exposure might cause teratological, hepatic, neurodevelopmental, and cardiometabolic effects in humans.  EPA concluded that there is inadequate information to assess whether PFHxS exposure can result in hematopoietic, reproductive, renal, and carcinogenic effects.

PFHxS is one of three PFAS currently undergoing IRIS assessments, along with PFNA and PFDA.  EPA previously published final IRIS assessments for two other PFAS: PFBA in December 2022 and PFHxA in April 2023.

PFAS Action Filed Against The Children’s Place

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In July, a proposed class action lawsuit was filed against the children’s clothing store The Children’s Place, Inc. The complaint states that the company knowingly sells clothing containing per- and polyfluoroalkyl substances (PFAS) despite knowing that these substances are harmful to children’s health. Specifically, the complaint alleges violations of Illinois’ Consumer Fraud and Deceptive Business Practices Act, fraudulent concealment, breach of implied warranty, and unjust enrichment. The allegations are based on the company’s knowledge of the presence of PFAS in their school uniform products and their failure to disclose this fact in its labeling and advertising, knowing parents would not purchase or pay premium prices for the PFAS-containing products.

The Children’s Place products at issue in the case are school uniforms that meet the requirements of Chicago public and private schools. Plaintiff purchased a number of these items for her child. school uniform.  The complaint states that none of the labeling for these items identified the presence of PFAS in the products, and therefore, Plaintiff concluded that PFAS were not present in any of the school uniform items she purchased. However, according to the complaint, independent third-party testing determined many of these school uniform items contained PFAS. Plaintiff additionally claims that the presence of PFAS in these items runs counter to the testing protocols reported in the Children’s Place’s Annual Environment, Social, and Governance Report.  According to the report, the testing protocols help the company avoid unwanted chemical substances in its finished products and provide consumers with confidence that the products they purchase are safe.

The complaint cites to recent studies and reports on the presence of PFAS in children’s school uniforms, stating, “The presence of PFAS in school uniforms is particularly concerning, as uniforms are worn directly on the skin for upwards of eight hours per day, five days per week, by children, who are uniquely vulnerable to harmful chemicals. Due to children’s lower body weight and sensitive development, exposure to PFAS at a young age for prolonged periods of time may result in a greater lifetime threat of adverse health outcomes.” Plaintiff claims that because of the potential harm, she would not have purchased these products for her child had she been aware of the presence of PFAS.

Minnesota Passes Legislation Requiring Reporting on Intentionally Added PFAS

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This June, Minnesota became the latest state to pass legislation that will require manufacturers to report intentionally added PFAS in consumer products. It also bans intentionally added PFAS in certain product categories. The legislation will require manufacturers with intentionally added PFAS in consumer products to report the following information to the Minnesota Pollution Control Agency (“MPCA”):

  • A brief description of the product, including a universal product code (UPC), stock-keeping unit (SKU), or other numeric code assigned to the product.
  • The purpose for which PFAS are used in the product, including in any product components.
  • The amount of each PFAS, identified by its Chemical Abstracts Service Registry Number (CASRN), in the product, reported as an exact quantity determined using commercially available analytical methods or as falling within a range approved for reporting purposes by MPCA.
  • The name and address of the manufacturer and the name, address, and phone number of a contact person for the manufacturer.
  • Any additional information requested by the commissioner as necessary.

Manufacturers will need to submit this information to MPCA on or before January 1, 2026. Furthermore, manufacturers must then receive approval from the Agency before they can sell, offer for sale, or distribute products at issue for sale within the state.

If MPCA does not receive this information and believes a product contains intentionally added PFAS, the Agency can mandate the manufacturer of the product to conduct testing for PFAS. If product testing reveals there are no intentionally added PFAS in the product, the manufacturer must submit a certificate of compliance to MPCA attesting to this fact and including the supporting testing results and any other relevant information. If testing confirms there are intentionally added PFAS in the product, the manufacturer must provide testing results and additional information outlined in the legislation to the Agency.

The legislation bans intentionally added PFAS in a number of products. Such products include:

  • Carpets and rugs
  • Fabric treatments
  • Textile furnishings
  • Upholstered furniture
  • Cleaning products
  • Cookware
  • Cosmetics
  • Dental floss
  • Menstrual products
  • Children’s products
  • Ski wax

The bans on these products will have staggered effective dates between January 1, 2025, and January 1, 2032. The legislation does caveat that MPCA will permit the sale of products with intentionally added PFAS only in instances where the commissioner has determined there is a currently unavoidable use. Product categories that fall under a currently unavoidable use are not detailed in the legislation, but it does specifically state that none of the above product categories are eligible for a currently unavoidable use exemption.

EPA Releases Framework for Addressing New PFAS and New Uses Under TSCA

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EPA has released the Framework for Addressing New PFAS and New Uses of PFAS. This document details the Agency’s planned strategy for evaluating Premanufacture Notices  (“PMNs”) for new PFAS compounds and Significant New Use Notices (“SNUNs”) for “new uses” of existing PFAS to ensure they do not pose harm to human health and the environment.

The Agency states that new PFAS substances present challenges for regulators, as there is frequently limited information available to assess their potential risks accurately. Many PFAS compounds are known to persist in the environment, bioaccumulate, and be toxic (known as “PBT”); the framework aims to qualitatively evaluate PFAS based on how likely they truly are to become PBTs in the body and environment.

The framework distinguishes between PFAS uses that may result in environmental releases and potential exposures and those that don’t. For example, PFAS applications that are deemed to have negligible exposure and minimal environmental release, such as in the closed systems used in the manufacture of electronics. EPA generally anticipates allowing the compounds to enter commerce after exposure data is provided.

The framework calls for more comprehensive testing, including toxicokinetic data, for PBT PFAS compounds that are expected to have a low but greater than negligible potential for environmental release and exposure. If initial testing raises concerns about exposure levels and risks, EPA will mandate further testing and risk mitigation before permitting manufacturing. This comprehensive testing would encompass physical-chemical properties, toxicity, and fate analysis. For example, uses of PFAS in spray-applied stain guards inherently involve releases into the environment. If required testing finds potential hazards, EPA has the authority under TSCA section 5 to demand additional testing and risk mitigation strategies or prohibit manufacturing entirely.

If EPA determines a new chemical substance poses an unreasonable risk, lacks sufficient risk information, or involves substantial production with potential exposure, it must issue a section 5(e) order for human health and environmental protection, which may include testing requirements. If PFAS data suggests it’s a PBT chemical and EPA anticipates exposures, the substance or significant new use could be deemed to present an unreasonable risk, therefore requiring either a section 5(f) order or an immediately effective proposed rule under TSCA section 6(a). The section 5(f) order applies to the submitter, while the 6(a) rule covers all users. For a SNUN, the 6(a) rule typically targets the specified new use. The chart below further details the possible EPA determinations and related actions following their review.

Determination Related Action
In the absence of sufficient information to permit a reasoned evaluation of risk from the substance or significant new use, the substance or significant new use may present an unreasonable risk. EPA must issue an order under TSCA section 5(e).
There is insufficient information to permit a reasoned evaluation of risk from the substance or new use. EPA must issue an order under TSCA section 5(e).
The substance or significant new use presents an unreasonable risk. EPA must take action under TSCA section 5(f).
The substance is or will be produced in substantial quantities, and there may be significant or substantial human and/or environmental exposure (exposure-based). EPA must issue an order under TSCA section 5(e).
The substance or significant new use is not likely to present an unreasonable risk. EPA notifies the submitter of its decision and publishes its findings in the Federal Register.

 

New Jersey Reaches Historic Settlement with Solvay Polymers over PFAS Contamination

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On June 28, 2023, New Jersey’s Department of Environmental Protection (NJDEP) announced a proposed settlement with Solvay Specialty Polymers USA, LLC (“Solvay”) over the company’s discharge of PFAS and other hazardous substances from its West Deptford facility.  According to a press release from New Jersey’s Office of Attorney General (NJOAG), the $392.7 million proposed settlement is the “largest single-site natural resource damages and remediation case in New Jersey history.”

In the 2020 complaint that led to the proposed settlement, NJDEP alleged that PFAS discharges and emissions from Solvay’s West Deptford facility had caused “widespread soil, sediment, groundwater, and surface water contamination.”  In particular, NJDEP asserted that levels of PFNA­—a type of PFAS—detected in surface water and public drinking water near the facility were higher than levels reported “anywhere else in the world.”  According to NJDEP, Solvay and the facility’s previous owner knew or should have known about the dangers posed by PFAS but “failed to disclose the impact of their use and releases of PFAS into the environment to the Department and the surrounding community.”

Under the terms of the proposed settlement, Solvay would be required to reimburse NJDEP for previous remediation efforts, pay claims for natural resource damages, and fund additional remedial activities to be undertaken by NJDEP and the company.  Solvay would be responsible for identifying and remediating contaminated natural resources and wells and providing regular reports of its remedial activities to NJDEP.  Funds allocated to NJDEP would primarily be used to address PFAS in drinking water systems.

The settlement comes after a 2019 NJDEP directive for Solvay and four other chemical manufacturers responsible for “significant contamination of New Jersey’s natural resources” to provide financial compensation for PFAS-related contamination and information on their PFAS use and emissions.  NJDEP’s 2020 complaint argued that Solvay did not fully comply with the directive.  According to NJOAG, Solvay is the first company identified by the directive to reach a proposed settlement with NJDEP.

A formal notice of the proposed settlement was published in the New Jersey Register on August 7, 2023.  Public comments on the proposal will be accepted through October 6, 2023.