European Chemicals Agency Releases Proposal Banning PFAS

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On February 7, The European Chemical Agency (ECHA) proposed a ban on per- and poly-fluoroalkyl substances (PFAS) as part of the European Union’s Registration, Evaluation, Authorization, and Restriction of Chemicals (“REACH”) regulation. The ban, which would include about 10,000 PFAS substances, could greatly impact US companies that export virtually any product to the European Union (“EU”). These companies will need to examine whether their products contain PFAS before exporting products to the EU.

The proposed ban is the EU’s largest-ever chemicals prohibition. It is intended to achieve the EU’s goal of a non-toxic environment by 2050. ECHA proposes banning chemicals, mixtures, and articles with 25 parts per billion (ppb) or more of a particular PFAS or 250 ppb of a combination of PFAS. ECHA defined PFAS as “Any substance that contains at least one fully fluorinated methyl (CF3-) or methylene (-CF2-) carbon atom (without any H/Cl/Br/I attached to it).” According to ECHA, this definition encompasses more than 10,000 PFAS. The proposal explains that this definition is aligned with the definition of PFAS published in 2021 by the OECD. Excluded from the scope of the proposed ban are PFAS substances that are fully degradable as they do not fulfill the underlying concern of high persistence. The ban would begin 18 months following the finalization of the restriction, which is anticipated for some time in 2025.

The initial regulation will include a variety of exemptions with phase-out periods of five or 12 years. Pesticides (referred to as biocides in the EU), along with human and veterinary medicines, would also be exempted from the restriction. PFAS used in specialized fire-fighting suppressants, called aqueous film-forming foam (AFFF), are also exempt as they are being phased out through a separate restriction.

The proposed regulation would supersede existing regulations that allow PFAS in products such as food packaging, pesticides (referred to as biocides in the EU), and human and veterinary medicines. PFAS used in firefighting suppressants (aqueous film-forming foam) used largely by airports, fire departments, and military bases, are being phased out through a separate restriction.

Affected businesses may need to evaluate thousands of products for the presence of PFAS, ranging from camping gear to mobile phones. The ban is likely to have a significant impact on any US company selling products in the EU.

ECHA will accept public comments on the proposal until September 2023. EU companies, working through their trade associations, are already commenting on the proposed ban suggesting a longer phase-out period of 32 months instead of the proposed 18 months and additional exemptions where alternatives are not yet available. The final restriction is expected in 2025.

EPA Report: Pesticide Products Test Negative for PFAS

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EPA has released a summary of its findings from a test of 10 pesticide products that reportedly contained PFAS.  While a previous study in the Journal of Hazardous Materials detected PFAS in over half of these pesticide products, EPA’s laboratory concluded that PFAS substances were not present.

EPA’s study employed two different testing methods.  The first method was the same method used in the previous study, and the second was a newly developed testing method specifically designed to detect the presence of PFAS in pesticide products formulated with surfactants.  According to the Agency, one of the most important differences between the testing methods is that the new testing method eliminates interference from oils and surfactants which can sometimes result in false positive detections.

The previous study discovered PFOS in six of the 10 tested pesticides, which are all insecticides commonly used to treat cotton.  Non-targeted techniques suggested that additional PFAS species were present in seven of the 10.  However, despite testing the same samples tested in the previous study, EPA’s study did not find evidence of PFOS or 28 other types of PFAS above the testing instrument’s background levels.

EPA writes that concern over PFAS contamination in pesticides arose in 2020, when the Agency learned of potential contamination in “a small number of mosquitocide products.”  In 2021, EPA preliminarily determined that the PFAS in those products were most likely formed during their containers’ fluorination process.  In 2022, EPA notified the fluorinated container industry of this concern and later released a study evidencing that PFAS can leach into pesticide products through these plastics.  More information on that study can be found in a previous Verdant Law blog post.

NEWMOA Announces Draft PFAS Prevention Model Act

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In May 2023, the Northeast Waste Management Officials’ Association (NEWMOA) released a draft PFAS Prevention Model Act (Draft Model Act), model legislation for states to use in advancing the reduction of the use of polyfluoroalkyl substance (PFAS). NEWMOA is a non-profit interstate organization composed of the state environmental agency directors of hazardous waste, solid waste, waste site cleanup, emergency response, pollution prevention, and underground storage tank programs in Connecticut, Maine, Massachusetts, New Hampshire, New Jersey, New York, Rhode Island, and Vermont.

NEWMOA seeks to reach the goal of the “virtual elimination of the environmental releases of PFAS into the environment. NEWMOA outlined the following six main goals of this initiative:

  • Reduce/eliminate the use of PFAS in consumer products to the extent feasible.
  • Identify and implement source reduction programs.
  • Ensure that the substitutes for PFAS in products are safer and that there is no regrettable substitution.
  • Coordinate product disclosure, labeling, bans, phase-outs, source reduction, and end-of-life collection on a multi-jurisdiction basis.
  • Help consumers identify products containing PFAS and learn how to properly handle them.
  • Provide regulated entities with regulatory certainty.

To achieve these goals, NEWMOA has put forth what it refers to as a “menu of policy options” that legislators can weigh in their efforts to address PFAS contamination and exposure. By choosing from these options, NEWMOA purports states can adopt more consistent approaches to regulating PFAS-containing products.

The Draft Model Act contains 18 sections, beginning with relevant definitions developed by adapting definitions provided in the Toxics in Packaging Clearinghouse’s model legislation and existing PFAS laws.

The most unique aspect of the Draft Model Act is Section 4, which proposes the creation and implementation of a multijurisdictional clearing house. The role of the clearing house would be to “assist in carrying out the requirements of this Act and to help coordinate collection and reviews of the manufacturers’ notifications regarding PFAS-added products, applications for phase-out exemptions, the collection system plans, applications for alternative labeling/notification systems, education and outreach activities, and other related functions.” The clearinghouse would additionally be responsible for maintaining a database of “all products containing PFAS, including PFAS-added products; a file on all exemptions granted by the participating jurisdictions; a file on alternative labeling plans; and a file of all the manufacturers’ reports on the effectiveness of their collection systems.”

Additional notable provisions include:

  • Requiring PFAS-product manufacturers to provide notice to the relevant agency before the sale of the product in the relevant jurisdiction; if products are sold without the notification, a ban will be placed on the product.
  • Banning the sale of PFAS-added products in the relevant jurisdiction unless the relevant agency has determined that the use of the product is “currently unavoidable” (defined as whether the product is determined to be beneficial to the environment or protective of public health or protective of public safety; there is no technically feasible alternative that has less risk to human health or the environment to use of PFAS in the product; and there is no comparable non-PFAS-added product available at a reasonable cost”).
  • PFAS-added products that qualify for sale under a “currently unavoidable” use must have a label stating that the product contains PFAS.
  • Manufacturers must have an extended producer responsibility plan for a PFAS-containing product collection system, which will require approval from the relevant agency.

NEWMOA has accepted written public comment on the Draft Model Act and aims to finalize the model legislation by the end of summer 2023.

EPA’s SBIR Program Showcases Small Businesses Developing Technologies to Test and Treat PFAS

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This April, EPA’s Small Business Innovation Research (SBIR) Program highlighted eight companies supported by the program that are developing technologies to detect, assess, and treat PFAS in the environment.

Of the eight companies, seven are pioneering technologies to remove PFAS from water, wastewater, and/or other liquids.  They utilize a variety of technological methods: Onvector LLC developed a plasma vortex reactor-based system; Claros Technologies, Inc. uses a photochemical method; and OxByEl Technologies, Inc.’s treatment relies on an electrochemical process.  One company, RemWell Inc., is working on a sonolysis reactor that will remediate PFAS in groundwater when placed in a horizontal well.  Another, BioLargo, Inc., uses an aqueous electrostatic concentrator to capture PFAS in a membrane for further treatment or disposal.

The only highlighted company that does not specialize in PFAS water treatment, Accurate Environmental Laboratories, developed a passive sampling method that determines levels of PFAS contamination in soils and sediments using diffusion.

Many of the small businesses report impressive efficacy, and some of their technologies are being applied in real-world situations.  Aquagga’s hydrothermal alkaline groundwater treatment process will soon be used for remediation projects at airports and air force bases.  Meanwhile, Cyclopure, Inc. is in the process of constructing full-scale regeneration and PFAS destruction facilities to administer its adsorbent-based PFAS water treatment.

Every year, EPA’s SBIR Program solicits technological proposals that address specific environmental topics.  Winning proposals are awarded contracts for “proof of concept” of the proposed technology and are eligible to apply for additional funding to further develop and commercialize the technology.  In five of the last six years, the program has included a PFAS-related topic in its batch of solicitations.

EPA Hosts CERCLA PFAS Enforcement Listening Sessions

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In March, EPA hosted two public listening sessions requesting individual feedback regarding concerns about PFAS liability under CERCLA. The listening sessions follow the Agency’s August 2022 proposed rule, which would designate two of the most widely used PFAS as hazardous substances under the Comprehensive Environmental Response, Compensation, and Liability Act (“CERCLA”). EPA  has stated that the information gathered during these sessions and any written comments submitted on the topic will be reviewed and considered in drafting its enforcement and discretion policy.

The webinars each began with presentations summarizing CERCLA, detailing the potential harms of PFAS substances, and describing EPA’s plan to issue an enforcement discretion and settlement policy. In addition to comments voiced during the webinars, EPA is reviewing written comments received on the proposed rule. The Agency stated it intends to focus enforcement efforts on manufacturers, federal facilities, and other industrial parties whose actions result in the release of significant amounts of PFAS. EPA clarified that parties that resolve their liability with EPA through settlement would not be liable for third-party claims. Therefore, settlements may provide CERCLA contribution protection to some parties. The Agency’s enforcement discretion policy will be contingent on a party’s cooperation, and it retains the ability to address any situations which present imminent and substantial endangerment.

The Agency also commented on parties against which it does not intend to pursue CERCLA enforcement for PFAS contamination, including:

  • Water utilities and publicly owned treatment works;
  • Publicly owned and/or operated municipal solid waste landfills;
  • Farms that apply biosolids; and
  • Certain airports and fire departments.

EPA further commented that enforcement discretion under this policy would be limited to CERCLA and not impact EPA enforcement actions under any other applicable statute.

EPA has posted the recordings of the sessions, which can be viewed here.

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 petition 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.