PEER and CEH Request Court Injunction Against EPA

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On February 15, 2024, the Public Employees for Environmental Responsibility (PEER) and the Center for Environmental Health (CEH) filed a lawsuit against EPA in the U.S. District Court for the District of Columbia stating that EPA failed to comply with a Freedom of Information Act (FOIA) request. The two nonprofit environmental groups said in their claim that they had filed a FOIA request on January 5, 2023, for numerous documents regarding Per-and Polyfluoroalkyl Substances (PFAS), specifically long-chain perfluoroalkyl carboxylate (LCPFAC) substances, created during the fluorination of plastic containers by Inhance Technologies LLC. PEER and CEH claim EPA failed to comply with the FOIA request and are now requesting an injunction for the courts to order EPA to disclose all the documents.

In their complaint, the two groups asserted that a document-by-document review by EPA is inefficient and unnecessary and requested that EPA instead adopt a class determination to expedite disclosure. PEER and CEH acknowledge they have received four interim releases but have yet to receive the full release and “unredacted documents have been produced in accordance with the disclosure requirements of section 14 of TSCA”.

The complaint details the timeline of EPA’s response to the FOIA request.  PEER and CEH note that EPA used an “Unusual Circumstances” exception to the standard time allowed for responding to a FOIA with a new estimated competition date of August 3, 2023. A Continuing Unusual Circumstance letter from EPA pushed the response date back further to December 1, 2023. This is an issue of contention for PEER and CEH, as they state that the FOIA statute allows for 20 working days to comply with FOIA requests and only an additional 10 working days for unusual circumstances. 5 U.S.C. § 552(a)(6). Therefore, according to PEER and CEH, the original competition date should have been February 2, 2023, and then adjusted to February 16, 2023 after including 10 working days for unusual circumstances.

Judge Denies Motion to Dismiss in Colgate Toothpaste Greenwashing Case

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A suit alleging that the Colgate-Palmolive Company (“Colgate”) misrepresented toothpaste tubes as recyclable will be allowed to proceed, the U.S. District Court for the Northern District of California ruled on February 6, 2024.

The case, Della v. Colgate-Palmolive Company, 2024 WL 457798, concerns recycling claims featured by the company’s Colgate and Tom’s of Maine-branded toothpaste tubes.  Made entirely of plastic, these tubes are theoretically less difficult to recycle than “traditional” toothpaste tubes.  The plaintiffs allege, however, that these claims would mislead a reasonable consumer.  According to the plaintiffs, the tubes are universally rejected by recycling facilities because facilities are unable to distinguish between Colgate’s tubes and traditional tubes and because the tubes cannot be fully emptied of toothpaste, which acts as a contaminant in the recycling process.

Colgate moved to dismiss, arguing that its claims were not misleading because the composition of its toothpaste tubes is compatible with a recycling stream that is available to most Californians.  In other words, the recyclability claims were accurate because the tubes are intrinsically capable of being recycled even if they are not recycled every time they are placed in a recycling bin.  Colgate also pointed to a statement on the packaging inviting consumers to “learn more” on their websites, which provided more comprehensive information about the products’ recyclability.

Magistrate Judge Joseph C. Spero rejected Colgate’s arguments.  Common sense would not lead a consumer to believe that a product labelled as recyclable would not be recyclable anywhere, he said.  He also stated that the invitation for consumers to learn more online would not remedy a misleading statement on the packaging, writing that “courts are generally reluctant to charge a reasonable consumer with the obligation of reviewing product websites or other written product materials before purchasing the product.”

More information on the case can be found in a previous Verdant Law blog post.

EPA Proposes to Revoke Approval of PTFE Use in Pesticide Products

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On February 28, 2024, EPA released a proposed rule to remove polytetrafluoroethylene (PTFE; CASRN 9002-84-0) from the list of approved inert ingredients for pesticide products.

PTFE, also known by the brand name Teflon, is a PFAS chemical that is currently approved for use in food and nonfood pesticide products.  No currently registered pesticide products use PTFE.  However, if removed from the approved list, any proposed future use of PTFE would need be supported with data provided to and reviewed by EPA.

The proposed rule comes after an EPA review of approved inert ingredients in search of PFAS chemicals.  EPA previously removed twelve PFAS chemicals from the list of approved inerts in December 2022.

Inert ingredients include emulsifiers, solvents, carriers, and any other substance included in a pesticide besides the active ingredient(s).  Comments on the proposed rule are due on March 29, 2024.

Consent Agreement Reached in Ultium Cells and General Motors TSCA Enforcement Action

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The U.S. EPA Environmental Appeals Board ratified a consent agreement for EPA’s TSCA enforcement action against Ultium Cells and General Motors Company on November 20, 2023. In February 2023, Ultium Cells and General Motors Company (collectively referred to as Respondents), voluntarily disclosed potential TSCA violations to the Agency under EPA’s Incentives for Self-Policing: Discover, Disclosure, Correction and Prevention of Violations (Audit Policy).  In their disclosure, the companies reported that they may have imported three substances that were not listed on the TSCA Inventory.

The consent agreement identifies the following TSCA violations:

  • Section 5(a)(1). Failure to submit a PMN at least 90 days before manufacturing (importing) new chemical substances for non-exempt commercial purposes.
  • Section 13(a)(1)(B). Failure to submit proper [import] certifications under section 13 of TSCA prior to importing new chemical substances.
  • Section 15(2). Processing and use of new chemical substances that Respondents knew or had reason to know were manufactured, imported, processed, or distributed in commerce in violation of TSCA Section 5.

Following their disclosure, in March 2023, Respondents filed premanufactures notices (PMNs) on the three substances at issue.

EPA assessed civil penalties of more than $650,000.  The companies received Audit Policy credit for the PMN and Import Certification violations, and a substantial portion of the 15(2) counts.  However, penalties were assessed for continued processing and use of the chemical substances during the time after the companies submitted PMNs for the substances, but before the PMNs cleared EPA review.

Under the terms of the consent agreement, the companies were allowed to import, process, use, and distribute the chemical substances at issue while EPA finalizes a TSCA section 5(e) Consent Order for the substances under the condition that they follow the requirements of the Compliance Plan specified by the agreement.  Requirements of the Compliance Plan include no release to water and respiratory protection with an APF of at least 1000.

Summary Judgment Denied in “Krud Kutter” Greenwashing Class Suit

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A class action suit alleging that Rust-Oleum Corporation mislabeled products as “non-toxic” and “Earth friendly” can go to trial, the U.S. District Court for the Northern District of California ruled on January 26, 2024.

The case, Bush v. Rust-Oleum Corp., No. 3:20-cv-03268, concerns the environmental claims made on the labels of Rust-Oleum’s “Krud Kutter” cleaning products.  Plaintiff Anthony Bush alleges that the claims would lead a reasonable consumer to believe that the products do not contain ingredients that are harmful to humans, animals, or the environment.  Bush alleges that these claims are misleading because the products contain multiple ingredients that are known to cause toxic effects.

Rust-Oleum moved for summary judgment, pointing to testimony given by the plaintiff and his expert toxicologist in which they acknowledged that risk can never be fully eliminated; even water can be hazardous in excess.  Rust-Oleum argued that this evidence shows that a reasonable consumer would not believe that the products are completely risk-free.  In addition, Rust-Oleum contended that the labels themselves contradicted the plaintiff’s theory of deception: the phrase “Caution: Eye and Skin Irritant” is included next to the words “Non-Toxic,” and the rear of the products’ labels include a definition of the “Earth friendly” claim.

Judge Laurel Beeler rejected Rust-Oleum’s arguments, saying that “[d]eposition testimony of individuals…is at best anecdotal evidence that isn’t dispositive of how a reasonable consumer interprets the challenged claims.”  Beeler also found that genuine disputes of material fact exist regarding the qualifying language included on the products’ label.  The plaintiff’s expert toxicologist alleges toxic effects besides eye and skin irritation and the defendant’s own surveys show that most customers do not read the small font explanation of the “Earth friendly” claim, she said.

Also at issue in the case are the Federal Trade Commission’s Green Guides, which help marketers avoid making misleading environmental claims.  Bush cited the Green Guides’ commentary on the phrase “non-toxic”—“[a] non-toxic claim likely conveys that a product, package, or service is non-toxic both for humans and for the environment generally”—in his complaint, but Beeler agreed with Rust-Oleum that the Green Guides are not decisive under the reasonable-consumer test.

Federal Court Requests Scientific Information on Diseases Associated with PFAS Exposure

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Parties must gather scientific evidence on the human health effects attributable to PFAS exposure in drinking water, the U.S. District Court for the District of South Carolina ordered in the case In Re Aqueous Film-Forming Foams Products Liability Litigation MDL 2873 last week.  The multi-district litigation focuses on the health hazards posed by aqueous film-forming foams (AFFFs), which are used as fire suppressants and allegedly contain PFAS such as PFOA and PFOS.

Plaintiffs allege that AFFF use at military bases, airports, and other locations caused the release of PFAS into local groundwater, which then entered the water supply.  According to Judge Richard Mark Gergel’s order, the litigation now includes over 20,000 cases, the majority of which raise personal injury claims.

The court adopted a bellwether program for these claims, focusing on alleged connections between exposure and four diseases: kidney cancer, testicular cancer, hypothyroidism/thyroid disease, and ulcerative colitis.  However, Gergel wrote that those diseases only make up a “small minority” of personal injury cases.  To determine which of the other cases have merit, Gergel directed the parties to propose a case management order within 60 days that includes the following:

  • A date by which plaintiffs must identify diseases not addressed in the bellwether program that they allege are the result of exposure to AFFF-contaminated drinking water,
  • A date by which the parties must produce peer-reviewed articles that support or challenge an association between exposure to AFFF-contaminated drinking water and an identified disease,
  • A plan for a science day where the parties can present experts to address those associations and
  • A plan for selecting bellwether cases for those associations.

In a separate order, Gergel stated that the court would select 28 personal injury cases as bellwether cases from a list of proposed bellwether cases submitted jointly by the parties.

EPA Orders Plastic Fluorination Company to Stop Producing PFAS

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Inhance Technologies LLC (“Inhance”) must stop producing PFAS substances created during its fluorination of high-density polyethylene plastic containers, according to two orders issued by EPA on December 1, 2023.

EPA first became aware of PFAS contamination in fluorinated plastic containers in late 2020.  In March 2022, EPA issued a Notice of Violation to Inhance for creating these PFAS in alleged violation of a significant new use rule (SNUR) for long-chain perfluoroalkyl carboxylate (LCPFAC) substances.  The Texas-based company submitted significant new use notices for nine such substances in December 2022 but has continued fluorinating containers nonetheless.

Three of these significant new use notices are addressed in the first order, which was issued under section 5(f) of the Toxic Substances Control Act (TSCA).  EPA determined that these substances—PFOA, PFNA, and PFDA—present an unreasonable risk due to their persistence, bioaccumulation, and toxicity that can only be prevented by prohibiting their manufacture.

The second order, issued under TSCA section 5(e), addresses the six remaining PFAS: PFuDA, PFDoA, PFTrDA, PFTeDA, PFHxDA and PFODA.  EPA determined that these substances may present an unreasonable risk, and the order prohibits their manufacture until certain testing be submitted to and evaluated by the Agency.

In response to the orders, which take effect February 28, 2024, Inhance stated that “the company will pursue all legal options to protect its customers, suppliers, and employees and to ensure the continued operations of this environmentally critical technology.”

The orders are likely to impact ongoing litigation between EPA and Inhance.  In December 2022, EPA sued Inhance for allegedly violating the LCPFAC SNUR.  Inhance has maintained that its fluorination process is legal, arguing that any PFAS present after fluorination are unintended impurities exempt from the SNUR.  More information on that case can be found in a previous Verdant Law blog post.

Fluorination, or the treatment of plastic with fluorine gas, makes containers less permeable.  According to an EPA press release, Inhance fluorinates up to 200 million containers per year.

Eight Circuit Vacates Chlorpyrifos Ban

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EPA’s ban on the pesticide chlorpyrifos was arbitrary and capricious because the Agency failed to adequately consider other options, the Eighth Circuit Court of Appeals ruled on November 2, 2023, in the case Red River Valley Sugarbeet Growers Ass’n v. Regan.

EPA’s 2021 revocation of all chlorpyrifos tolerances was the result of a Ninth Circuit decision ordering EPA to either modify chlorpyrifos tolerances to ensure they are safe for children or revoke them entirely.  EPA had previously determined that 11 “high-benefit” uses were likely to be safe if other uses were revoked.  But with only 60 days to make a decision and under a court directive not to “engage in additional fact-finding,” EPA opted to revoke all tolerances, effectively banning use of chlorpyrifos on all food and animal feed.

The Eighth Circuit characterized EPA’s decision to revoke all tolerances, despite evidence that some uses could be considered safe, as “g[iving] up” in the face of a “tight deadline.”  “EPA should not have reflexively rejected an approach it had the power to adopt, even if it would have required more work,” the court said.

Under the Federal Food, Drug, and Cosmetic Act, EPA can only leave in place tolerances that the Agency has determined to be safe after consideration of aggregate exposure, “including all anticipated dietary exposures.”  In a 2022 order denying objections to the 2021 revocation, EPA argued that it would not be reasonable to consider exposures solely from the 11 high-benefit uses as “anticipated” because EPA did not have reason to believe they would reflect real-world exposures.  EPA is required to determine whether tolerances are safe, not whether they will be safe “at some unspecified future time,” the Agency said.

The court rejected this interpretation of the statute, which was central to EPA’s decision not to implement a partial ban.  The Agency has an “obligation to ‘anticipate[]’ the effects of its own actions,” Chief Judge Lavenski Smith wrote for the three-judge panel.  If EPA proposed to “keep a set of high-benefit uses in place,” it could certainly “anticipate what would happen under its own proposal.”

The court vacated both the 2021 revocation and the 2022 denial order, remanding to EPA.  The Agency will have 45 days from the date of the ruling to petition for rehearing or rehearing en banc.

More information on the legal battles over chlorpyrifos tolerances can be found in a previous Verdant Law blog post.

Irene Hantman Presents on EPA’s Audit Policy and TSCA Audits at PSX 2023

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Verdant Law is pleased to report that Irene Hantman gave a presentation on EPA’s Audit Policy and Toxic Substances Control Act (TSCA) audits on October 18 in Boston at PSX 2023.  PSX is the Product Stewardship Society’s annual conference, and its website can be found here.  Ms. Hantman serves on the Conference Planning Committee for PSX and looks forward to next year’s conference in Denver.

The presentation covered the incentives for the self-disclosure of violations provided by EPA’s audit policy, the conditions that must be met to qualify for audit policy penalty mitigation, and the benefits and risks of TSCA audits.  Ms. Hantman discussed important considerations for companies conducting audits, such as compliance with the 21-day self-disclosure deadline and understanding the 5-year statute of limitations that applies to most TSCA violations.  Ms. Hantman also highlighted the role of negotiations with EPA during an audit, for example, to avoid triggering penalties for repeat violations.

Particular attention was given to the New Owner Audit Policy, which allows new owners to get a clean baseline following the purchase of a facility.  Ms. Hantman covered the additional benefits to new owners of conducting TSCA audits, which include the opportunity to seek indemnification from the seller for breach of reps and warranties, the opportunity to submit an insurance claim if the new owner purchased deal insurance, and further reduced economic penalties under the New Owner Audit Policy.

Also presenting was Ashish P. Deshmukh, PhD, Principal at Ramboll, who spoke about the particulars of audit processes and how product stewards can prepare for TSCA audits.  The presentation was moderated by Robert DeMott, PhD, Principal Toxicologist at Ramboll.

If you have questions about the topics of the presentation, please contact Ms. Hantman.

EPA Updates Safer Chemicals Ingredients List

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On September 23, 2023, EPA announced that it is adding 10 chemicals to the Safer Chemicals Ingredients List (SCIL), a list of chemicals which have been reviewed by EPA’s Safer Choice Program and meet its Safer Choice Criteria.  The chemicals on the list are considered to be among the safest chemicals for their functional use class (such as surfactants, solvents, or chelating agents), allowing manufacturers to choose the safest available chemicals for each type of ingredient in a product.

Manufacturers can apply to have chemicals added to the SCIL.  During the application process, a third-party profiles the substance and the Safer Choice Program assesses whether it meets Safer Choice criteria, which includes toxicity and fate standards.  Products containing chemicals that meet Safer Choice criteria may be eligible to enter into partnership with the program, which grants use of a Safer Choice product label.

According to EPA, the updated SCIL includes 1,071 substances.  The 10 chemicals added to the list in September 2023 are shown below.

List Name CAS Registry Number Functional Use Class
Fats and Glyceridic oils, vegetable, hydrogenated 68334-28-1 Emollients
Tocopherols 1406-66-2 Preservatives and Antioxidants
Sulfuric acid, dimethyl ester, compd. with .alpha.,.alpha.’,.alpha.”,.alpha.”’-[1,6-hexanediylbis(nitrilodi-2,1-ethanediyl)]tetrakis[.omega.-hydroxypoly(oxy-1,2-ethanediyl)] 247074-09-5 Polymers
Glycolipids, sophorose-contg., Candida bombicola-fermented, from D-glucose and mahua Madhuca longifolia fats and glyceridic oils 1573124-58-9 Surfactants
1,4-Benzenedicarboxylic acid, 1,4-dimethyl ester, polymer with 1,2-ethanediol, .alpha.-hydro-.omega.-hydroxypoly(oxy-1,2-ethanediyl) and 1,2-propanediol, ester with .alpha.-methyl-.omega.-hydroxypoly(oxy-1,2-ethanediyl) 152442-40-5 Polymers
Dodecanoic acid, ester with 1,2-propanediol 37321-62-3 Solvents
Diisopropyl succinate 924-88-9 Solvents
Diisopropyl sebacate 7491-02-3 Solvents
Methyl propanediol 2163-42-0 Solvents
Methyl ethyl ketone 78-93-3 Solvents