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.

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.

Shell Company Greenwashing Complaint Filed with SEC

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On February 1, 2023, Global Witness, an environmental justice-focused non-profit organization and a Shell shareholder, filed a complaint with the SEC’s Climate and ESG Task Force requesting the Agency investigate claims Shell has made regarding its renewable energy sources. The complaint alleges that Shell has materially misstated its financial commitment to renewable resources of energy by inflating the content of its new report,  “Renewables and Energy Solutions” (“RES”), reporting segment regarding fossil fuel activities.

Global Witness believes statements in the RES exaggerate the extent to which Shell is reducing its reliance on fossil fuels and investing in renewable energy sources. The non-profit states that while Shell claims to spend 12% ($2.4 billion) of its annual expenditure ($19.7 billion) on “Renewables and Energy Solutions,” actually, the company spends only 1.5% ($288 million) of its annual expenditure on true renewables (e.g., solar and wind power generation).  The complaint asserts that much of the RES designation is actually being diverted to investments in natural gas, which is neither renewable nor an energy solution.

In its complaint, Global Witness requests an SEC investigation into the following:

  • Whether the activities included in the RES segment have been properly reported under relevant accounting standards.
  • Whether including natural gas in RES without reporting how much spending Shell directs to gas has caused Shell to omit material facts necessary to its investors’ clear understanding of Shell’s purported energy transition.
  • Whether Shell’s reported capex on RES includes so much natural gas spending that labeling the segment “Renewables and Energy Solutions” constitutes a materially misleading misstatement.
  • Whether Shell is adequately disclosing its renewable energy investments in accordance with Section 10(b) of the Exchange Act and Rule 10b-5 thereunder, which make it unlawful to issue materially misleading statements or omissions in connection with the purchase or sale of any security.

Global Witness further requests that if SEC finds that Shell is misstating or omitting material facts in its financial filings, the Commission issue appropriate enforcement action to ensure that Shell’s investors have access to the clear and comprehensive information they rely upon to inform their investment decisions.

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.