EPA Releasing Additional Data on the Ongoing Uses of Chrysotile Asbestos

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On March 17, 2023, EPA released additional data for public comment related to the proposed risk management rule for chrysotile asbestos. The proposed rule, introduced in April 2022, aims to prohibit the ongoing use of the only known form of asbestos currently imported into the United States, chrysotile asbestos. The Agency claims that if implemented, the rule will protect people from the unreasonable risk to human health presented by chrysotile asbestos. EPA evaluated human health risks for chrysotile asbestos in Part 1 of the Risk Evaluation for Asbestos; and is currently working on Part 2 of the Risk Evaluation for Asbestos. That document will evaluate legacy uses and associated disposals, including other types of asbestos fibers in addition to chrysotile.

EPA originally proposed that the prohibition on the commercial use of chrysotile asbestos would occur two years after the effective date of the final rule to give facilities time to transition away from asbestos technology. However, after the comment period, EPA received comments and met with stakeholders, including affected industry and other interested groups, about the use of chrysotile asbestos diaphragms in the chlor-alkali industry and chrysotile asbestos-containing sheet gaskets used in chemical production. Raw chrysotile asbestos currently imported into the U.S. is used exclusively by the chlor-alkali industry. It is a main component of systems used for the disinfection of drinking water, but most chlor-alkali plants no longer use asbestos diaphragms, and alternatives are available.

Many commenters argued that the two-year timeline would not provide the chlor-alkali industry with a reasonable transition period and requested additional time to allow the industry to transition away from asbestos-containing diaphragms.  According to EPA, a letter from the Asbestos Disease Awareness Organization (ADAO) provides contrasting information that shows that the chlor-alkali industry has shut down a substantial portion of its asbestos diaphragm production capacity in the last three years and is in the process of transitioning to non-asbestos membrane technology.

EPA is seeking comments on how to consider the additional information received regarding maintaining the prohibition compliance dates, staggering the prohibition compliance dates, or establishing longer deadlines for the prohibition on processing, distribution in commerce, and commercial use of chrysotile asbestos. EPA also seeks comments on the new information provided regarding the practicability of measuring 0.005 fibers per cubic centimeter (f/cc) and 0.0025 f/cc for an eight-hour work shift by existing sampling and analytical protocols. Further, the Agency requests suggestions as to how EPA could effectively implement interim exposure reduction requirements in a way that they are compatible with Occupational Safety and Health Administration (OSHA) requirements and industrial hygiene practices.

EPA states that the Agency plans to use the data it collects during this comment period in the development of the final rule, including the proposed chrysotile asbestos prohibition compliance dates for these uses.

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.

Study Finds Roundup Cancer Risk Isn’t from Active Ingredient Glyphosate

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A newly released study has found that glyphosate, the active ingredient in Roundup, may not be directly responsible for the increased risk of cancer that has been associated with the weedkiller. The study was conducted by a team of federal and private sector researchers who tested glyphosate and herbicide mixtures using glyphosate on human B-lymphoblastoid TK6 cells. The researchers concluded that neither glyphosate nor its metabolite forms damaged DNA, causing cancer. Instead, they found that some other ingredient in weedkillers containing glyphosate may be responsible for the DNA damage attributed to glyphosate. This finding contradicts the 2015 World Health Organization (“WHO”) conclusion that glyphosate was “probably carcinogenic to humans” and genotoxic (meaning it damages DNA). WHO’s conclusion has led to numerous lawsuits against Bayer AG and Monsanto Co., as well as lawsuits against the Environmental Protection Agency for concluding that the herbicide would not cause cancer.

Although the study indicates that DNA damage was caused by other components of the formulations, not glyphosate, it did not rule out the possibility that exposure to glyphosate might cause cancer through other mechanisms, according to the National Toxicology Program. Bayer AG has long maintained that glyphosate does not cause cancer and is not genotoxic, and the company released a statement in response to the study, stating that “the extensive body of research on glyphosate-based herbicides and findings of leading health regulators worldwide support the conclusion that glyphosate does not cause cancer and is not genotoxic.”

Coca-Cola Wins Greenwashing Case

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The DC Superior Court has granted Coca-Cola Company’s motion to dismiss a 2021 lawsuit filed against it for false and deceptive marketing practices. Plaintiffs argued that the company had falsely represented itself as a sustainable and environmentally friendly company. The 2021 Complaint alleged that Coca-Cola’s representations violate the District of Columbia Consumer Protection Procedures Act (“DC CPPA”) because its marketing and advertising “tend to mislead and are deceptive about the true nature and quality of its products and business.”

The Complaint stated that the marketing is false and deceptive because the company “portrays itself as ‘sustainable’ and committed to reducing plastic pollution while polluting more than any other beverage company and actively working to prevent effective recycling measures in the U.S.” The Complaint cites numerous examples, including:

  • A statement on the Coca-Cola website stating, “Our planet matters. We act in ways to create a more sustainable and better shared future. To make a difference in people’s lives, communities and our planet by doing business the right way.”
  • A statement on the company website stating, “Make 100% of our packaging recyclable globally by 2025. [And] [u]se at least 50% recycled material in our packaging by 2030.”
  • A statement on the company’s Twitter account stating, “Scaling sustainability solutions and partnering with others is a focus of ours.” “Make 100% of our packaging recyclable globally by 2025. [And] [u]se at least 50% recycled material in our packaging by 2030.”

Coca-Cola filed a motion to dismiss in response. The DC Superior Court found that Coca-Cola’s statements were aspirational in nature and, therefore, not a violation of the DC CPPA. The Court stated that Earth Island Institute had not alleged that any statement made by Coca-Cola was provably false or plausibly misleading or that the company misled consumers as to its products’ characteristics. The Court acknowledged that Coca-Cola may have failed to meet advertised environmental goals in the past, but that does not impede its ability to set future environmental goals publicly.  In addition, the Court held that Coca-Cola’s statements were not tied to a “product or service” as required by DC CPPA. None of the statements were included on the bottle of any product or in the marketing of any product. Furthermore, the Court determined that Coca-Cola’s statements are not sufficient to create a misleading “general impression” or a “mosaic of representations” to a reasonable DC consumer as a matter of law under the DC CPPA.

The Court further stated that the Complaint could not prevail because it was based on how Coca-Cola has branded itself, and the DC CPPA does not have any controlling authority on how a brand cultivates its image. Coca-Cola made no specific environmental commitments, which further made it difficult for the Court to take any action. The Court stated that in other similar cases, companies made claims such as “100% recycled and recyclable bottles,” which is concrete and indicative of a promise to customers, as opposed to vague aspirational statements from Coca-Cola, such as the recyclable packaging by 2025.

EPA Finds TCE as a Whole Chemical Substance an Unreasonable Risk to Human Health

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Earlier this year, EPA announced the final revision to the risk determination for trichloroethylene (TCE) risk evaluation issued under the Toxic Substances Control Act (“TSCA”). EPA found that TCE presents unreasonable risks to the health of workers, occupational non-users, consumers, and bystanders. The risks identified include adverse human health effects unrelated to cancer, such as neurotoxicity and liver effects, from acute and chronic inhalation and dermal exposures to TCE and risks for cancer from chronic inhalation and dermal exposures to TCE. The revised risk determination supersedes the conditions of use (“COU”) specific “no unreasonable risk” determinations that the EPA previously issued in its 2020 TCE risk evaluation.

TCE is a volatile organic compound (“VOC”) used mostly in industrial and commercial processes. Consumer uses include cleaning and furniture care products, arts and crafts, spray coatings, and automotive care products like brake cleaners. EPA determined that 52 of the 54 COUs evaluated drive the unreasonable risk determination.

EPA states that it used the whole chemical risk determination approach for TCE because there are benchmark exceedances for multiple COUs spanning across most aspects of TCE’s life cycle, from manufacturing (including import), processing, commercial use, consumer use, and disposal for health of workers occupational non-users (workers nearby but not in direct contact with this chemical), consumers, and bystanders. EPA holds that this approach is appropriate because the health effects associated with TCE exposures are “severe and potentially irreversible,” including developmental toxicity, reproductive toxicity, liver toxicity, kidney toxicity, immunotoxicity, neurotoxicity, and cancer. EPA notes that the revised risk determination for TCE does not reflect an assumption that workers always and appropriately wear personal protective equipment (PPE). EPA states that as it moves forward with a risk management rulemaking for TCE, it will “strive for consistency with existing OSHA requirements or best industry practices when those measures would address the identified unreasonable risk.

Additionally, EPA stated it is conducting a screening-level approach to assess potential risks from the air and water pathways for several of the first 10 risk evaluation chemicals, including TCE. The goal of the screening approach is to evaluate the surface water, drinking water, and ambient air pathways for TCE that were excluded from the 2020 risk evaluation and to determine if there are risks that were unaccounted for in that risk evaluation. EPA expects to describe its findings regarding the chemical-specific application of this screening-level approach in its proposed risk management rule for TCE.

ECOSChem Releases Sustainable Chemistry Report

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The Expert Committee on Sustainable Chemistry (ECOSChem) has released a report, Definition and Criteria for Sustainable Chemistry, which serves to provide a clear and actionable definition and set of criteria for sustainable chemistry. ECOSChem has aspirations that this definition and set of criteria will be adopted and adapted for uses such as policymaking, education, and investment decision-making and to guide chemical, material, process, and product design and implementation.

ECOSChem has defined sustainable chemistry as “the development and application of chemicals, chemical processes, and products that benefit current and future generations without harmful impacts to humans or ecosystems.” The report outlines numerous criteria which should be considered to achieve sustainable chemistry, although the report notes that sector-specific and chemistry-specific metrics and timeframes will need to be developed to make each of the criteria actionable. The criteria are as follows:

Equity and Justice

A sustainable chemical, material, process, product, or service will:

  • Be designed or implemented with authentic community engagement.
  • Be designed or implemented in a manner that does no harm when feasible and prioritizes the remediation of harm to communities that have been disproportionately impacted at any stage in the lifecycle of a chemical process or product.
  • Protect workers, marginalized groups, and vulnerable groups.
  • Be designed or implemented in a way that does not create new problems or shift harm.
  • Be designed or implemented in a way that supports local economies and ensures product access and affordability for marginalized groups.

Transparency

A sustainable chemical, material, process, product, or service will:

  • Make public health, safety, and environmental data an accessible format.
  • Include scientifically defensible and openly accessible verification for sustainability, health, safety, and other claims.
  • When possible, include a chain of custody so that chemicals and materials used in a product can be traceable throughout the lifecycle.

Health and Safety Impacts

A sustainable chemical, material, process, product, or service will:

  • Be without hazards, hazardous components, emissions, and toxic byproducts and breakdowns.
  • Not result in releases, including releases of persistent or bioaccumulative byproducts or breakdown products.

Climate and Ecosystem Impacts

A sustainable chemical, material, process, product, or service will:

  • Utilize renewable, non-toxic chemical building blocks.
  • Have no negative impacts on climate and biodiversity, including impacts on habitat and resource degradation.
  • Be without harmful releases to air, water, and land across its lifecycle, including for transportation and distribution.

Circularity

A sustainable chemical, material, process, product, or service will:

  • Be designed to have a lifetime appropriate to its use and enable safe reuse and non-toxic recycling.
  • Prioritize resource and energy efficiency, conservation, and reclamation, reduced consumption of finite resources, and waste prevention, minimization, and elimination.

There is no indication that this detailed and rigorous definition will be adopted or applied by any federal or state agencies.

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.

EPA Releases Proposed Approach for Considering Cumulative Risks Under TSCA

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EPA recently released two documents regarding cumulative risk assessments under TSCA section 6, Draft Proposed Principles of Cumulative Risk Assessment Under the Toxic Substances Control Act, and Draft Proposed Approach for Cumulative Risk Assessment of High-priority Phthalates and Manufacturer-Requested Phthalate under the Toxic Substances Control Act. The first document details a set of principles for evaluating the cumulative risk of substances under TSCA; the second document presents a proposed approach for applying those principles to the evaluation of the cumulative risk posed by certain phthalate chemicals which are currently undergoing TSCA section 6 risk evaluation.

In the  Draft Proposed Principles of Cumulative Risk Assessment Under TSCA, EPA explained that it plans to alter its approach to individual substance evaluations under TSCA section 6 by taking a cumulative assessment approach when appropriate. Previously, the Agency looked at the risks posed by a single substance under its specific conditions of use. The Agency now intends to implement a new approach to evaluating human health effects, which it believes is more appropriate when considering human exposure to these substances. People are often exposed to many chemical substances with similar effects at the same time, and looking at the combined exposure health risk will paint a more complete picture. The Agency believes that this approach will allow for more effective mitigation of identified unreasonable risks and provide particularly useful information for communities that face higher than normal levels of chemical pollution.

Phthalates will be subjected to a cumulative risk assessment because the group of substances has similar effects on human health and has generally been found concurrently in the human body. The phthalates to be assessed as a group include DEHP, BBP, DBP, DIBP, DCHP, DINP, and DIDP. The chemical group is often used in industrial and consumer products to make plastics more flexible and durable. The draft proposal requests comment and peer review on its assessment that six phthalate substances are toxicologically similar, and the U.S. population is frequently co-exposed to these substances, making a cumulative risk assessment the most appropriate course of review action under TSCA.

The Agency is accepting comments on these documents through April 28, 2023.

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.