EPA Sued Over Delayed Risk Evaluations

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Environmental groups have filed a lawsuit against EPA for failing to complete risk evaluations for 22 substances that may cause harm to humans and the environment.

Under section 6 of the Toxic Substances Control Act, EPA is required to conduct risk evaluations on “high priority” existing substances to determine whether they pose an unreasonable risk to human health or the environment.  Section 6(b)(4)(G) requires EPA to complete risk evaluations “as soon as practicable, but not later than 3 years after” they are initiated, with a one-time six-month extension possible.

According to the complaint, EPA missed this statutory 3.5-year deadline for 22 ongoing risk evaluations which were initiated in 2019 and early 2020.  Plaintiffs allege that this delay harms their members, staff, and children by prolonging their exposure to substances with serious health risks and by depriving them of information about their exposures.

The complaint seeks declaratory and injunctive relief, requesting that the U.S. District Court for the District of Columbia set deadlines for EPA to complete the risk evaluations.

The case is Community In-Power and Development Association v. EPA, No. 1:23‑cv‑02715-DLF.

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.

Minnesota Law Expanding Standards for Compostable Food Packaging

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This May the Minnesota state legislature amended the Standards for Labeling Plastic Bags. The law which previously was limited to plastic bags will now cover food and beverage products and other food packaging. Products subject to the law include any product used to wrap, package, contain, store, prepare or consume a food or beverage.

Additionally, the amendments clarify requirements for compostable claims to reduce misleading product claims and confusion around which product may be labeled as compostable. Beginning in January 2025, products sold in Minnesota labeled as compostable must be

(1) made solely of wood with no additives or coatings;

(2) made solely of paper with no additives or coatings; or

(3) meet the applicable ASTM standard

  1. for plastics designed to be aerobically composted in municipal or industrial composting facilities (ASTM D6400); or
  2. for items that incorporate plastics and polymers as coatings or additives with paper and other substrates designed to be aerobically composted in municipal or industrial facilities (ASTM D6868).

Starting January 1, 2026, all products sold in the state which are labeled compostable must be certified by a nonprofit third party capable of performing the appropriate product analysis. Under the law, products may not be labeled biodegradable until an ASTM standard specification is adopted for measuring biodegradation. *

The law specifically specifies that manufacturers, distributors, and wholesalers are strictly prohibited from selling or offering for sale a covered product with “biodegradable” or “compostable” claims unless the product is certified as meeting the requirements by a third party.  The third party must be a nonprofit that, as its primary focus of operation, promotes the production, use, and appropriate end of life for materials and products that are designed to fully biodegrade.

*It is unclear whether the individuals who drafted the legislation were aware of the existing ASTM standards on measuring biodegradation of plastics in landfills such as the standard for determining anaerobic biodegradation of plastic materials under high-solids anaerobic-digestion conditions (D5511-18).

EPA Proposes SNURs for Flame Retardants

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EPA has proposed significant new use rules (SNURs) for three flame retardants under the Toxic Substances Control Act (TSCA). The three flame retardants are tris(2-chloroethyl) phosphate (TCEP), tetrabromobisphenol A (TBBPA), and triphenyl phosphate (TPP).  All three substances are currently undergoing TSCA risk evaluations.  The proposed significant new uses are manufacture (including import) or processing for any use, except for those uses being considered in the risk evaluations.  In the Federal Register notice, EPA explained that significant new uses would encompass the following categories:

  • Manufacture and processing for uses that have ceased;
  • Manufacture and processing for uses that have not yet ceased but for which all manufacture and processing has ceased; and
  • Manufacture and processing for uses for which EPA has no information demonstrating that the use has previously commenced in the United States.

The Agency sought public comment on its description of the significant new uses for the chemicals identified, including specific documentation of ongoing uses not identified by the Agency in the risk evaluation scope documents.

EPA noted that “The issuance of a SNUR is not a risk determination itself, only a notification requirement for ‘‘significant new uses,’’ so that the Agency has the opportunity to review the [Significant New Use Notification] for the significant new use and make a TSCA section 5(a)(3) risk determination.”  In other words, “Once EPA receives a SNUN, EPA must either determine that the significant new use is not likely to present an unreasonable risk of injury or take such regulatory action as is associated with an alternative determination under TSCA section 5 before the manufacture (including import) or processing for the significant new use can commence.”

In its discussion of the significant new use determination, EPA explained that the Agency considered information about the toxicity or expected toxicity of these substances, likely human exposures and environmental releases associated with possible uses, and the four factors listed in TSCA section 5(a)(2):

  • The projected volume of manufacturing and processing of a chemical substance,
  • The extent to which a use changes the type or form of exposure of human beings or the environment to a chemical substance,
  • The extent to which a use increases the magnitude and duration of exposure of human beings or the environment to a chemical substance and
  • The reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of a chemical substance.

According to the Federal Register Notice, current uses of TCEP are as follows:  TCEP is imported into the United States and processed for commercial use in paints and coatings, for industrial or commercial use in polymers for use in aerospace equipment and products, and for commercial use as a laboratory chemical.

EPA found that TBBPA is currently manufactured (including imported) in the United States. It is processed as a reactant or intermediate to create other flame retardants; incorporated into formulation, mixture, or reaction products; and incorporated into articles. The Agency noted that the predominant uses for TBBPA are as a reactive flame retardant in electrical and electronic products and as an additive flame retardant in electrical and electronic products. In addition, epoxy resin containing TBBPA can be used in adhesives, laminate for aviation and automobile interiors and building/ construction materials.

The Agency reported that TPP is manufactured (including imported) in the United States.  It is processed as a reactant; incorporated into formulation, mixture, or reaction products; and incorporated into articles.  Commercial uses include in plastic and rubber products and in paints and coatings. The chemical is also used in lubricants and greases.  In addition, consumer uses were reported in foam seating and bedding products.

Comments can be viewed in docket EPA–HQ–OPPT–2023–0012 at regulations.gov.

Environmental Group Petitions for Review of EPA’s New Confidential Business Information Rule

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On June 29, 2023, the Environmental Defense Fund (EDF), a non-profit organization, filed a petition in the US Court of Appeals for the District of Columbia requesting a review of EPA’s recently finalized rule Confidential Business Information Claims Under the Toxic Substances Control Act (TSCA) (88 FR 37155).  As described in a previous Verdant Law blog post, the final rule implements new requirements for the assertion and treatment of TSCA confidential business information (CBI) claims in light of the Lautenberg Amendments to TSCA.

In a non-binding statement of issues filed August 21, EDF listed the following as preliminary issues to be raised in the petition: whether the final rule is arbitrary, capricious, an abuse of discretion, or otherwise contrary to law because…

  1. It would allow submitters to assert CBI claims to shield the information from the public that TSCA makes categorically ineligible for CBI protection;
  2. It would not require substantiation or EPA review of a CBI claim that was asserted before a chemical’s commercialization for specific chemical identity once the chemical is commercialized;
  3. It unlawfully adopts a regulatory definition of “health and safety study” that is narrower than the TSCA definition, denying TSCA-mandated public access to important information on chemicals;
  4. The Agency purports to give itself unlawfully broad discretion through its regulations where TSCA imposes a duty upon the Agency; or because
  5. It reduces the transparency previously required under EPA’s CBI review procedures without adequate justification.

Briefs have not yet been filed, and EDF did not file a memorandum detailing its positions, so no additional information on EDF’s positions is currently available.

Clothing Accessories Companies Penalized for False Made in USA Claims

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In August 2023, the Federal Trade Commission (FTC) finalized a complaint and order against Chaucer Accessories, Inc. and two other companies owned by Thomas P. Bates for falsely labeling belts, shoes, and other products as “Made in the USA” (MUSA). The order includes a monetary judgment of $191,481.

According to FTC, the New England-based companies regularly claimed that certain products were MUSA, even though these products were wholly or largely imported. In other instances, the companies claimed that certain belts were “Made in the USA from Global Materials,” when in reality, the companies merely affixed buckles to imported belt straps. FTC alleged three violations of section 5(a) of the Federal Trade Commission Act: one violation for the false MUSA claims, one violation for the false MUSA from global materials claim, and one violation for distributing the false claims to resellers for their use in the resale of the products.

In addition to the monetary judgment, the order places restrictions on the companies and Bates on making unqualified MUSA claims, prohibits them from misrepresenting their products’ country of origin or providing others the means to make misrepresentations and imposes requirements for qualified MUSA claims and assembly claims. The companies must also notify affected customers of the violations and provide FTC with sufficient customer information for the Commission to administer customer redress.

EPA Launches New Interface for the Chemicals and Products Database

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EPA has released a beta version of ChemExpo, a free, publicly available web application that allows users to explore and visualize data on how chemicals are used in commerce.

ChemExpo will serve as a user-friendly interface for EPA’s Chemicals and Products Database (CPDat).  According to EPA, CPDat maps “more than 49,000 chemicals to a set of terms categorizing their usage or function in 16,000 consumer product types (e.g., shampoo, soap) based on what chemicals they contain.”  EPA characterizes this data, which is curated from public documents, as addressing important gaps in the exposure information needed to evaluate chemicals’ safety under the Toxic Substances Control Act.

The ChemExpo team welcomes comments and feedback on the beta, particularly regarding functionality and usability.

Colgate Faces False Advertisement Suit Over Recyclable Claims

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A class action lawsuit has been filed in a California federal court against the Colgate-Palmolive Company (“Colgate”), alleging the company falsely advertises its Colgate and Tom’s of Maine branded toothpaste tubes as recyclable. The complaint alleges that Colgate’s claims are a violation of the Federal Trade Commission’s Green Guides, which prohibits a product from being called recyclable “unless there is an established recycling program, municipal or private, through which the product will be converted into, or used in, another product or package.”

The complaint also alleges California Business and Professions Code violations, which make it “unlawful for any person to make untruthful, deceptive, or misleading environmental marketing claims.”

A number of Colgate branded products, including but not limited to its popular products Colgate MaxFresh Toothpaste, Colgate Optic White Toothpaste, and Colgate Sensitive Toothpaste, feature the three-arrow recycling symbol atop the language “Recyclable Tube.” The company’s Tom’s of Maine product packaging advertises its toothpaste tubes as “The First of its Kind Recyclable Tube.” This language is used on over ten of its toothpaste products. None of the packaging of these products, Colgate or Tom’s of Maine, includes language that limits or qualifies the recyclability claims.

Additional recyclability claims are made on the brands’ websites. The Tom’s of Maine website features the following claims, which the Plaintiff alleges are misrepresentations:

  • “Recyclable Tube”
  • “Recycle Me!”
  • “Buy Smart – By reaching for this toothpaste tube you’re actively making a difference.”
  • “Recycle It – Our recyclable tube is not meant for a landfill – it gets turned into useful products.”
  • “As the leaders in the oral care industry, we wanted to create a recyclable alternative.”

While the toothpaste tubes are theoretically recyclable, a consultant at the Association of Plastic Recyclers stated, “[f]or many facilities in the US, the company’s new recyclable tubes are indistinguishable from those made from more common plastics, prompting recyclers to reject them. The old tubes could cause contamination if consumers put them in the recycling bin, so it’s easier for recycling facilities to reject toothpaste tubes across the board.”

In support of its argument, the complaint cites a recent Bloomberg article discussing the accuracy of Colgate’s claims with two solid waste management companies operating in California. (The two companies, Waste Management, Inc. and Republic Services, account for more than 40 percent of recycling services provided to consumers in California and about 25 percent of the recycling services on a national scale.) The companies highlighted that toothpaste tubes “are not in its list of acceptable items” and that there is serious concern about contamination from leftover toothpaste that remains in the tube.

According to the complaint, Colgate is fully aware that its products end up in landfills or are incinerated because recycling facilities do not accept its products. Colgate has even gone so far as to release a video on its website stating as much and explaining that the company is “continu[ing] the work beyond technically recyclable toward acceptance of tubes in recycling centers.” If recycling centers do not accept toothpaste tubes, their recyclability is irrelevant, and labeling and advertising their products as recyclable is false, misleading, and deceptive to consumers and members of the public seeking to make environmentally conscious purchasing decisions.

Plaintiffs seek an injunction on the sale of these products until such time the labeling and advertising language can be modified to remove recyclability language or alternatively to include a qualified claim that accurately states the availability of recycling programs. To be in compliance with the Green Guides’ environmental marketing requirements, a company is only permitted to make unqualified recyclable claims “[w]hen recycling facilities are available to a substantial majority of consumers or communities where the item is sold.” The Guides further clarify a substantial majority to mean at least 60 percent, and that “[w]hen recycling facilities are available to less than a substantial majority of consumers or communities where the item is sold, marketers should qualify all recyclable claims.”

Additionally, Plaintiffs are seeking compensatory and statutory damages.

Canada Requests Input on Proposed CCPSA Requirements for Consumer Chemical Products

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Health Canada has released a notice of intent requesting comments on proposed regulatory requirements for consumer chemical products under the Canada Consumer Product Safety Act (CCPSA).  The Department says it will use the comments and information received to shape a potential regulatory initiative that would mandate information disclosure and other requirements for certain human health hazards of concern (HHHOCs) in consumer products.

The 2001 Consumer Chemicals and Containers Regulations use restrictions on dangerous consumer chemical products, information disclosure requirements, and container requirements to address acute human health and physical hazards, such as acute toxicity and corrosivity.  However, the 2001 regulations do not include requirements to mitigate risks from HHHOCs, which include carcinogenicity, germ cell mutagenicity, reproductive toxicity, specific organ toxicity, and respiratory/skin sensitization.

The initiative would implement hazard classification criteria for HHHOCs consistent with the United Nations Globally Harmonized System (GHS), establish disclosure requirements for HHHOCs based on GHS label elements (including hazard symbols, signal words, hazard statements, precautionary statements, and ingredient disclosure requirements), and institute additional prohibitions, restrictions, or child-resistant container requirements where deemed necessary.

The proposal applies to consumer products within the scope of the CCPSA that are supplied in containers and classified in an HHHOC category or sub-category according to GHS classification criteria.  Health Canada clarified that the initiative would not apply to consumer products that cannot expose the user to any of its hazardous ingredients during reasonably foreseeable use or vaping products covered under the Tabacco and Vaping Products Act.  The comment period ends on October 9, 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.