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

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

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

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

Maine Proposes Rule to Clarify Reporting Requirements for PFAS in Products

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

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

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

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

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

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

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

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

EPA Issues SNUR for Inactive PFAS

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

EPA to Begin Rulemaking to Regulate PFAS in Effluent Discharges

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

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

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

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

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

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

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

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

 

 

Thinx Settles Lawsuit Over PFAS in Products

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

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

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

EPA Releases PFAS Analytic Tools

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On January 5, EPA released its PFAS Analytic Tools database, a collection of PFAS information the Agency has brought together from internal Agency databases, other federal agencies, and state and tribal agencies. The data will be particularly useful to the Agency when it reviews submissions on  PFAS releases from the Toxics Release Inventory (“TRI”) reporting.  In addition, EPA expects that the database will benefit state, local, and tribal governments in navigating the PFAS-related requirements they are subject to.  The Agency also expects that the database will help communities gain a better understanding of local PFAS releases.

The database has 11 tabs that include:

  • An integrated map,
  • Drinking water contamination, production,
  • Wastewater and/or stormwater discharge monitoring,
  • Superfund sites,
  • Industry sectors in which PFASs were manufactured or used as raw materials, and
  • toxic releases.

In its press release on the database and on the database interface itself, the Agency identifies several data gaps. For example, the drinking water Unregulated Contaminant Monitoring Rule (“UCMR”) data was collected only between 2012 and 2015. EPA notes that state agencies and public water systems may have better data on PFAS levels in drinking water. Additionally, only a few states have set PFAS effluent limits for National Pollutant Discharge Elimination System (“NPDES”) permit holders, causing significant gaps in discharge monitoring. (The Agency has initiated rulemaking to increase monitoring effluent for PFAS.

Each tab identifies relevant data gaps and limitations.

The Agency is taking steps to fill these data gaps, including:

  • Initiating rulemaking to increase monitoring effluent for PFAS;
  • Publishing the fifth Unregulated Contaminant Monitoring Rule, which will significantly increase the number of drinking water samples collected by regulated entities (EPA predicts the number of samples collected will be in the millions);
  • EPA’s proposal to designate PFAS as hazardous substances under CERCLA; and
  • EPA’s recent proposal to change PFAS reporting requirements in the TRI data collection.

EPA recently held a webinar introducing the database and demonstrating its use.  A recording of the webinar is available here. A copy of the Agency’s presentation is available here.

EPA Issues Next Test Order Under National PFAS Testing Strategy — PFAS Used in Plastics at Issue

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EPA has issued its second round of Test Orders under its National PFAS Testing Strategy. The test orders require companies to conduct and submit testing on trifluoro (trifluoromethyl) oxirane (HFPO) (CASRN 428-59-1), a PFAS substance used in making plastics. According to EPA’s Chemical Data Reporting (CDR) database, more than 1,000,000 points of HFPO are manufactured each year. EPA has concluded, using existing hazard and exposure data, that HFPO may present an unreasonable risk of injury to health or the environment, finding that exposure may result in neurotoxicity, reproductive effects, and cancer. The Tier 1 testing will address human health from exposure via inhalation and hydrolysis. Tier 2 testing, if required, will look at reproductive toxicity, developmental neurotoxicity, and carcinogenicity.

The companies that are subject to the test order include The Chemours Company, DuPont De Nemours Inc., E.I. du Pont de Nemours and Company, and 3M Company. These companies are required to submit the results of testing data to EPA within 415 days of the effective date of the order. All data produced from this test order will subsequently be published on EPA’s website.

EPA Publishes Final IRIS Assessment of PFBA

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In December, EPA published the IRIS Toxicological Review of Perfluorobutanoic Acid and Related Salts. The Agency’s assessment addresses potential cancer and noncancer human health effects of exposure to perfluorobutanoic acid (PFBA) and its related salts. The most significant of the IRIS findings is that sufficient oral exposure to PFBA likely causes disruptions to normal thyroid hormone production, liver damage, and developmental effects. The Agency stated there was inadequate evidence to determine whether reproductive effects might represent a potential human health hazard following PFBA exposure.

PFBA and its related salts are members of the PFAS family.  It is a breakdown product of other PFAS that are used in a variety of products, including stain-resistant fabrics, carpets, and paper food packaging. PFBA can also be used in the manufacturing process of photo film and is used as a substitute for a type of PFAS, longer chain perfluoroalkyl carboxylic acids in consumer products. The substance can accumulate in agriculture crops, household dust, soils, food products, and surface, ground, and drinking water. Exposure to PFBA can occur through inhalation of indoor or outdoor air, ingesting contaminated drinking water and food, and dermal contact with PFBA-containing products.

As part of its PFAS Strategic Roadmap, EPA has been actively working on IRIS assessments for five PFAS: PFBA, PFHxA, PFHxS, PFNA, and PFDA. The PFBA IRIS is the first in this series to be released.

EPA Releases Initial Regulatory Flexibility Analysis for the Proposed PFAS Reporting Rule

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On November 25, 2022, EPA released an Initial Regulatory Flexibility Analysis (IRFA) for public comment as part of its development of a rule to collect information about PFAS. The IRFA follows the Agency’s June 2021 proposed rule, which would require all manufacturers and importers of PFAS in any year since 2011 to report information related to chemical identity, categories of use, volumes manufactured and processed, byproducts, environmental and health effects, worker exposure, and disposal. In the proposed rule, EPA certified that the rule would not have a significant impact on a substantial number of small entities under the Regulatory Flexibility Act (RFA). In response to public comments from the June 2021 proposed rule and additional data sources on PFAS-containing imports, EPA convened a Small Business Advocacy Review Panel and prepared the IRFA to investigate further the burdens the proposed rule would place on small businesses.

EPA significantly increased its cost estimates for the proposed rule, stating social costs would be approximately $875 million, from the original $10.8 million estimate, and Agency costs would be approximately $1.5M,  from the originally estimated $948,078.  The IRFA anticipates that in order to report years of production and importation data, small businesses would be expected to pay the lion’s share of these costs, $863.5 million, not the originally anticipated $1.8 million. Additionally, the IRFA details the percentage of small firms that will be impacted by the rule, finding that approximately 93% of manufacturers and 97.3% of article importers affected by the proposed rule are small businesses. The total number of small businesses expected to be impacted is 127,794.

In the IRFA, EPA proposed and requested comment on a variety of regulatory flexibility alternatives, including:

  • Exemptions for businesses with less than $12 million in sales.
  • Exemptions for businesses with less than $6 million in sales.
  • Exemptions for article importers with less than $6 million in sales.
  • Exemptions for article importers with less than $2 million in sales.
  • Limiting the scope of PFAS subject to the rule to a finite list of PFAS, removing the structural definition. (Although EPA expressed concern over the Agency’s inability to list substance identities based on CBI claims.)
  • Exemption for reporting thresholds of either 2,500 lbs. per year or 25,000 lbs. per year.
  • Allow for small businesses, providing a six-month deferral of data submission.
  • Simplified reporting forms for R&D substances manufactured in volumes less than 10 kg. per year — including limiting reporting to company information, generic chemical name, and production volume.
  • Simplified reporting forms for article importers– excluding requiring information on existing environmental and health effects data, environmental release and disposal data, or occupational exposure data.
  • Exemptions for R&D substances, byproducts, impurities, recyclers, and intermediates. (However, EPA stated that these exemptions would limit the Agency’s ability to achieve its goal of better understanding the entire scope of existing information on PFAS.)

The Agency also requested information and comment on items pertaining to CBI, including treatment of chemical identity claims, notice prior to publication on the public TSCA Inventory, and the generic naming of PFAS. These issues were not included in the IRFA and the Updated Economic Analysis. Regarding the treatment of CBI claims, EPA sought to clarify language related to an entity’s knowledge of a specific chemical identity stating:

[A]n entity that does not have knowledge of a specific chemical identity must initiate a joint submission with its supplier or other manufacturer. In these cases, the secondary submitter would be responsible for providing the specific chemical identity and for asserting and substantiating any CBI claims concerning the specific chemical identity. See, e.g.,40 CFR 711.15(b)(3); 711.30(c).

Regarding notice prior to publication on the public TSCA Inventory, EPA sought to clarify that if a submitter reports a PFAS substance by a specific chemical identity and does not assert CBI, that chemical identity will be published on the public Inventory without notice to the submitter. Importantly, EPA requested comment on aligning this provision with the language in the proposed CBI Procedures rule indicating that persons who previously made a CBI claim for the same specific chemical identity will not receive prior notice before the specific chemical identity is moved to the public Inventory. Lastly, EPA clarified that generic names must sufficiently identify the chemical as a PFAS; for example, under TSCA Section 14(c)(1)(C), a generic name for a PFAS that does not contain “fluor” would be rejected as insufficient.