EPA Publishes ANPRM Seeking Information to Assist in Consideration of Future CERCLA Regulations Regarding PFAS

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On April 13, 2023, EPA published an advance notice of proposed rulemaking (ANPRM) seeking input and data regarding potential future hazardous substance designation under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) of a number of PFAS substances. The ANPRM identifies PFOA, PFOS, seven other PFAS and their salts and structural isomers, precursors to PFOA and PFOS, and several categories of PFAS as candidates for this designation.

EPA is requesting public input to assist in the potential development of future regulations under CERCLA Section 102(a). Section 102(a) authorizes the EPA Administrator to promulgate regulations designating as hazardous substances that, when released into the environment, may present a substantial danger to the public health or welfare or the environment. The seven PFAS for which EPA is requesting input on are:

  • Perfluorobutanesulfonic acid (PFBS), Chemical Abstracts Service Registry Number (“CAS RN”) 375-73-5;
  • Perfluorohexanesulfonic acid (PFHxS), CAS RN 355-46-4;
  • Perfluorononanoic acid (PFNA), CAS RN 375-95-1;
  • Hexafluoropropylene oxide dimer acid (HFPO-DA), CAS RN 13252-13-6 (sometimes called GenX);
  • Perfluorobutanoic acid (PFBA), CAS RN 375-22-4;
  • Perfluorohexanoic acid (PFHxA), CAS RN 307-24-4; and
  • Perfluorodecanoic acid (PFDA), CAS RN 335-76-2.

Regarding these seven PFAS, EPA solicited the following information:

  • Published scientific literature regarding the environmental fate and transport.
  • Information that EPA could consider in preparing an economic analysis of the potential direct and indirect costs and benefits associated with a potential rulemaking designating any of the above-mentioned compounds as hazardous substances.

Regarding information around the PFAS precursors, EPA is requesting the following :

  • Published scientific literature or data regarding the environmental degradation of the precursors to PFOA, PFOS, PFBS, PFHxS, PFNA, HFPO-DA, PFBA, PFHxA, and/or PFDA.
  • Published scientific literature that characterizes the environmental prevalence of these substances.
  • Methods for measuring these substances in environmental samples.

EPA is also requesting information to help inform its decision-making on whether to designate further PFAS groups or categories as hazardous substances under CERCLA. It is requesting information on published scientific literature that can inform whether categories of PFAS could be designated as hazardous substances:

In addition, EPA asked for input on whether there are other PFAS that the Agency could consider designating as hazardous substances in a possible future rulemaking. The ANPRM requests references to published scientific information these on the hazards for substances that commentors identify in response to this request.

Environmental Groups Request EPA Require TRI Reporting for Waste Incinerators

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Public Employees for Environmental Responsibility (“PEER”) and the Energy Justice Network recently filed a with EPA requesting that the Agency require companies to disclose the chemicals discharged from waste incinerators and facilities that recycle plastics (“advanced recycling facilities”). Currently, none of the approximately 400 incinerators and advanced recycling facilities throughout the nation are required to report their facility’s toxic chemical emissions under EPA’s Toxics Release Inventory Program (“TRI”). TRI data provides local communities with information about toxic chemical releases and management activities in their area.

Petitioners argue that waste incinerators are among the largest local air polluters and that the public is entitled to information about these emissions; therefore, they should be TRI data. One particular concern expressed in the petition is that ash generated from the incineration of solid and industrial waste can contain toxic chemicals and heavy metals, including lead and mercury. Additionally, according to petitioners, incineration does not destroy per- and poly-fluoroalkyl substances (“PFAS”). Therefore, petitioners assert that when incinerator ash is placed on top of landfills, as it often is, the contaminants can then travel into communities contaminating local air, water, and soil.

Petitioners have also included advanced recycling facilities in their request for required TRI reporting. Advanced recycling facilities, also called chemical recycling facilities, are categorized by EPA as incinerators. These facilities heat waste, generally plastics, to create a fuel product. While EPA has released a proposed rulemaking to approve the products as renewable fuels, the Agency is also facing litigation for approving a renewable fuel associated with a high cancer risk. Petitioners have the same concerns about emissions from the advanced recycling facilities reaching local communities.

This April’s petition is not the environmental organizations’ first attempt to discuss the matter with EPA; petitioners sent a letter to EPA last October highlighting their health concerns related to incineration.

EPA Proposes PFAS Drinking Water Standard

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On March 14, EPA released a proposed rule establishing national drinking water standards for PFAS. The proposed rule is part of the Agency’s PFAS Strategic Roadmap. It seeks to regulate PFOA and PFOS as individual contaminants and four additional PFAS (PFNA, PFHxS, PFBS, and GenX chemicals) as mixtures. EPA intends to regulate PFOA and PFOS at the lowest level of which they can be reliably measured, which the Agency has determined to be 4 parts per trillion.

For the additional four PFAS, EPA proposed maximum concentration limits (MCLs) for any mixture containing one or more of these substances. This would require water systems to use an approach called Hazard Index Calculation to determine if the combined levels of these PFAS pose a potential risk. Hazard Indexing is a tool used to evaluate the health risks of simultaneous exposure to mixtures of related chemicals. To determine the Hazard Index for these four PFAS, water systems would  be required to monitor drinking water and compare the amount of each PFAS in the water to its associated Health-Based Water Concentration (HBWC). HBWCs are the levels at which no health effects are expected.

In remarks accompanying the Agency’s press release on the proposed rule, Administrator Michael S. Regan commented, “EPA’s proposal to establish a national standard for PFAS in drinking water is informed by the best available science and would help provide states with the guidance they need to make decisions that best protect their communities. This action has the potential to prevent tens of thousands of PFAS-related illnesses and marks a major step toward safeguarding all our communities from these dangerous contaminants.”

The proposed rule is causing great concern in the wastewater utility and chemicals industries.  They are apprehensive about the logistical and financial hurdles that  implementing the rule would entail. Both the American Chemistry Council and the National Association of Water Companies, a trade group representing investor-owned utilities, have voiced concerns, claiming that compliance with the rule will cost billions of dollars. The Agency is actively working with financial institutions to help utilities in vulnerable communities with limited resources comply with the rule and claims $9 billion is already earmarked for this purpose from bills approved by Congress since 2021.

Additional information can be found in EPA’s Proposal to Limit PFAS in Drinking Water Fact Sheet.

PFAS Class Action Lawsuit Filed Against Colgate-Palmolive and Tom’s of Maine

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A class action lawsuit has been filed against the Colgate-Palmolive Company and Tom’s of Maine after Plaintiffs discovered that Tom’s Wicked Fresh! Mouthwash contains PFAS. (Tom’s of Maine is a majority-owned subsidiary of Colgate-Palmolive.) The complaint alleges that the companies are violating California’s False Advertising Law, California’s Unfair Competition Law, and the Illinois Consumer Fraud and Deceptive Business Practices Act. The complaint also alleges breach of express warranty, fraud, constructive fraud, and unjust enrichment.

Tom’s Wicked Fresh! Mouthwash is marketed as a “natural” mouthwash.  However, the complaint asserts that independent, third-party testing revealed multiple PFAS substances are present at material levels in the product. The complaint argues that the representation of the product as “natural” implies that it is free from unnatural and artificial ingredients. The complaint notes that the presence of PFAS and other synthetic ingredients is not disclosed on the product label. It also argues that consumers are willing to pay a premium for natural products. Plaintiffs assert that the “natural” claims are false statements, misleading representation, and material omissions.  In addition, they argue that customers would not be willing to pay a premium for the product or would not purchase it at all if they knew that the product contained PFAS and artificial ingredients. The complaint asks the court to award restitution on the basis of unjust enrichment.

Verdant Law Presents on Chemical Regulatory Framework and Implications for Product Design

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This month Verdant Law founder Phil Moffat traveled to Orlando, Florida, to present at the International Consumer Product Health and Safety Organization (ICPHSO) 2023 Annual Meeting and Training Symposium. Mr. Moffat’s presentation discussed the implications of chemical regulation for product design.

The presentation outlined recent trends in the chemical regulatory landscape, including EPA’s PFAS reporting rule, state regulations banning PFAS in children’s toys, flame retardants, and other products, and state PFAS labeling and reporting rules. The presentation discussed the risk of regrettable substitutions from both human health and environmental perspectives, as well as from a product efficiency perspective. (An example of decreased product efficiency could be removing PFAS used to waterproof a product may decrease the product’s efficiency if the replacement doesn’t repel water as well.) It also addressed risks associated with introducing multiple versions of the same product into commerce. In addition, Mr. Moffat covered risks of regulatory noncompliance, including penalties, seizures, recall, and market backlash, as well as risks of legal liability. The presentation recognized that the regulatory framework could be incredibly difficult for companies to navigate.

If you would like to view the presentation, it can be found here. For questions or assistance with regulatory compliance for consumer and industrial products, please contact Verdant Law.

Maine Proposes Rule to Clarify Reporting Requirements for PFAS in Products

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On February 14, the Maine Department of Environmental Protection (“MDEP”) published a proposed rule clarifying Maine’s PFAS reporting requirement under the state’s “An Act to Stop Perfluoroalkyl and Polyfluoroalkyl Substances Pollution,” which became effective January 1, 2023. Manufacturers of products for sale in the state which contain intentionally added PFAS are required by the statute to submit information to MDEP. Information required under the law includes a description of the product, the purpose for which PFAS are used in the product, and the amount of each PFAS included (identified by its chemical abstract services registry number or CAS number). More than 1,000 companies anticipated compliance difficulties, particularly with the January 1 effective date, and requested that MDEP grant them a six-month extension. MDEP granted the request affording the companies additional time to work with their supply chain partners to determine whether any PFAS are intentionally added to any component of their product.

The February 14 proposed rule provides additional clarification on notification requirements and sales prohibitions under the statute, including providing more thorough definitions than the definitions included within the statute. For example, the statutory definition of “intentionally added PFAS” is PFAS added to a product or one of its product components to provide a specific characteristic, appearance, or quality or to perform a specific function; this also includes degradation by-products of PFAS. The new proposed rule expands on this definition to read as follows:

“”Intentionally added PFAS’ means PFAS added to a product or one of its product components in order to provide a specific characteristic, appearance, or quality or to perform a specific function. Intentionally added PFAS also includes any degradation byproducts of PFAS serving a functional purpose or technical effect within the product or its components. Products containing intentionally added PFAS include products that consist solely of PFAS. Intentionally added PFAS does not include PFAS that is present in the final product as a contaminant.”

The term manufacturer was also significantly expanded upon, with the proposed rule putting forth the following definition:

“’Manufacturer’ means the person that manufactures a product or whose brand name is legally affixed to the product. In the case of a product that is imported into the United States where the person that manufactured or assembled the product or whose brand name is affixed to the product does not have a presence in the United States, manufacturer includes either the importer or the first domestic distributor of the product, whichever is first to sell, offer for sale, or distribute for sale the product in the State of Maine.”

MDEP also noted situations in which the importer is considered to be the manufacturer, stating:

“Certain online retail platforms may allow for purchase of products directly from a producer. When no other person meets the definition of manufacturer under this Chapter, and the product is sold, offered for sale, or distributed for sale in the State of Maine, the Department will consider the importer to be the manufacturer. When it is possible to consider both entities the manufacturer, the Department will consider the party who controls the formulation of the product and its PFAS content to be the manufacturer.”

The proposed rule also discusses prohibitions on the sale of products containing intentionally added PFAS. It reminds manufacturers that the sale of carpets, rugs, or fabrics containing intentionally added PFAS is prohibited as of January 1 of this year. It also reminds manufacturers that a ban on all products containing intentionally added PFAS must be phased out before January 1, 2030.

EPA Issues SNUR for Inactive PFAS

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On January 26, 2023, EPA proposed a significant new use rule (SNUR) for PFAS substances that are currently classified as “inactive” on the TSCA Inventory. A substance is considered inactive on the TSCA Inventory when it has not been manufactured, imported, or processed in the U.S. since 2006. When the rule is finalized, anyone who wants to begin any manufacturing, importing, or processing activity involving any of these PFAS substances would be subject to the SNUR and would be required to obtain permission from EPA via a Significant New Use Notification (SNUN) at least 90 days before commencing the said activity. EPA would then review and make an affirmative determination as to whether the activity detailed in the SNUN presents an unreasonable risk to human health or the environment. EPA proposes some exceptions from the SNUR requirement, including when one of these PFAS are present as an impurity or byproduct and when the substances are imported or processed as part of an article.  Comments on the proposed rule are being accepted until March 27, 2023.

EPA to Begin Rulemaking to Regulate PFAS in Effluent Discharges

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EPA has announced that it will begin a rulemaking to regulate PFAS in landfill leachate discharges. Pursuant to the 2021 Preliminary Effluent Guidelines Program Plan, EPA has been collecting data on wastewater discharges from the Landfills Point Source Category (40 CFR part 445), with a focus on PFAS discharges. EPA refers to this data collection as the Landfill Leachate Detailed Study. The goals of the study were to understand the total number and location of landfills discharging leachate, characterize PFAS leachate effluent from regulated landfills, and identify current wastewater treatment technologies and management practices at these landfills.

Study results on effluent from 200 landfills revealed that 95 percent of the facilities discharged PFAS. The detections included 63 different PFAS with average concentrations for an individual compound as high as 14,000 part-per-trillion (ppt). This announcement was included in the Agency’s Effluent Guidelines Program Plan, which was released last month. The Effluent Guidelines Program Plan explains that

The details of the pending rulemaking and how the proposed rule could impact daily landfill operations are limited, but EPA commented that landfill operators are likely able to treat PFAS with technologies onsite. These technologies could include granular active carbon, ion exchange, and reverse osmosis. Further, the timing of the rule is uncertain as the Agency awaits other PFAS decisions, such as the anticipated regulation of PFAS designation as hazardous substances under RCRA and CERCLA.

Through the Effluent Guidelines Program Plan, the Agency is pursuing additional PFAS-related actions as well, including:

  • Data gathering on textile mills’ use and treatment of PFAS in the industry and associated PFAS discharges.
  • Initiation of a Publicly Owned Treatment Works (POTWs) Influent Study on PFAS, which will focus on gathering nationwide data on industrial discharges of PFAS to POTWs. The focus of the study will be to verify current sources of PFAS wastewater and document new PFAS water sources.
  • Continuing monitoring PFAS use and discharges from the Pulp, Paper, and Paperboard Category (40 CFR part 430).
  • Continuing monitoring of PFAS use and discharge at airports.

Kraft Heinz Sued Over PFAS in Capri Sun Strawberry Kiwi Juice Drink

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A class action lawsuit has been filed against Kraft Heinz, alleging that the company’s “all natural” Capri Sun Strawberry Kiwi juice drink contains PFAS chemicals. The lawsuit alleges violations of New York Business laws against misleading business practices and false advertising, as well as breach of express warranty, fraud, constructive fraud, and unjust enrichment. It asserts that Kraft Heinz has engaged in false and misleading marketing by claiming that the drink is always made from “all natural ingredients,” “every ingredient in Capri Sun® is All Natural” and is a healthy choice for kids while failing to disclose the presence of PFAS.

The complaint alleges that Kraft Heinz is aware that consumers are willing to pay a premium for all-natural foods and that disclosing the presence of PFAS in its product would damage place in the market. Capri Sun ranks as one of the top products in the $1.5 billion juice box market, with the company touting its product as the “#1 Kids’ Favorite Juice Drink”. The lawsuit seeks to cover all persons in the United States who purchased the drink for personal use during the period allowed by law.

 

 

Thinx Settles Lawsuit Over PFAS in Products

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Thinx, a New York-based period underwear company, has reached a settlement in a class action lawsuit related to the presence of PFAS in its products. The company was sued for marketing misrepresentations under the Florida Deceptive and Unfair Practices Act, on behalf of the Florida class, and breach of express warranty, unjust enrichment, negligent misrepresentation, and fraud, on behalf of the nationwide class. Plaintiffs alleged that third-party testing revealed the presence of PFAS in Thinx products despite claims by the company that its products, collectively referred to as “Thinx Underwear,” are a safe, healthy and sustainable choice. For example, multiple pages on its website state that the underwear is free of harmful chemicals.

The complaint asserted that customers are willing to pay a premium for Thinx Underwear as opposed to using less expensive traditional feminine hygiene products because traditional products are known to contain a variety of chemicals, including VOCs.

Thinx has continued to insist that it has never intentionally added PFAS to any of its Thinx Underwear. But the settlement agreement requires the company to take a number of steps to ensure PFAS are not intentionally added to its underwear at any stage of production. The company must also modify marketing materials to disclose the use of anti-microbial treatments, and it may not refer to the anti-microbial components as “non-migratory.” In addition, the settlement agreement requires Thinx to enter into a raw materials code of conduct with its suppliers, which requires suppliers to attest that PFAS are not intentionally added to Thinx period underwear.