Judge Denies Motion to Dismiss in Colgate Toothpaste Greenwashing Case

A suit alleging that the Colgate-Palmolive Company (“Colgate”) misrepresented toothpaste tubes as recyclable will be allowed to proceed, the US 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.

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

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.

Oral Arguments in Case Challenging TSCA Test Order

On December 1, 2023, a panel of the DC Circuit Court heard oral arguments in Vinyl Institute v EPA.  The case marks the first legal challenge of EPA’s authority to administer Toxic Substances Control Act (TSCA) section 4 test orders since Congress granted EPA the authority in the 2016 Lautenberg Amendments.

The case revolves around an avian reproduction study mandated by EPA’s March 2022 test order for 1,1,2-Trichloroethane, a solvent currently undergoing TSCA risk evaluation.  The Vinyl Institute alleges that EPA failed to adequately demonstrate why the study is necessary, while EPA argues that the order met statutory requirements and is supported by substantial evidence.  Also at issue in the case is a TSCA section 19(b) motion filed by the petitioner to make additional submissions to the test order’s administrative record.

Oral arguments focused on the level of detail required in the test order’s statement of need.  The Vinyl Institute’s attorney argued that the statement of need was composed of conclusory statements that did not sufficiently explain EPA’s reasoning.  For example, he said that it is not possible to identify one of the studies cited by EPA in its explanation.  This received pushback from one judge, who said that he seemed to be asking for a level of specificity that may not be required by law.  EPA’s attorney argued that the test order is not statutorily required to be an “exhaustive decisional document,” and said that EPA is not obligated to explain why it believes certain existing studies were inadequate to fill the data need addressed by the order.  In response, one judge implied that the attorneys’ interpretations of the standard for test orders fall on the extreme ends of a spectrum—on one end, EPA would be required to list every piece of information in examined in its decision-making process, and on the other, EPA could simply say “take our word for it”—and said that the standard is probably located between them.

The attorneys also offered competing interpretations of Congress’s intent when it granted EPA the ability to administer test orders.  EPA’s attorney argued that the reason Congress gave EPA the authority to administer test orders was to make it easier for EPA to obtain necessary information, and that requiring high levels of detail in test orders would burden EPA and undermine that intent.  By contrast, the Vinyl Institute’s attorney said that Congress put in place “numerous guardrails to ensure that [EPA’s] test order authority is not abused.”

Because the avian reproduction study is currently in progress, one judge remarked that a ruling in the petitioner’s favor would need to be delivered before summer 2024 to avoid mootness.  Neither attorney had time to address the section 19(b) motion.

A previous Verdant Law blog post on the case, written prior to merits briefing, can be found here.

EPA Proposes to Revise Rules for PBTs DecaDBE and PIP (3:1)

On November 24, 2023, EPA released a proposed rule to revise the final rules for decabromodiphenyl ether (“decaBDE”) and phenol, isopropylated phosphate (3:1) (“PIP (3:1)”), two persistent, bioaccumulative, and toxic substances (PBTs) subject to regulation under section 6 of the Toxic Substances Control Act (TSCA).

Section 6(h) of TSCA (as amended by the Lautenberg Amendments in 2016) required EPA to take expedited action to complete TSCA section 6(a) rules on certain PBTs.  In January 2021, EPA released final rules for decaBDE, PIP (3:1), and three other PBTs.  The final rules for decaBDE and PIP (3:1) generally prohibit their manufacture, processing, and use beginning in March 2021, though the rules contained phased-in prohibitions and exclusions for certain uses; EPA has extended certain phased-in prohibitions for PIP (3:1) multiple times since.

In light of new information and the Agency’s reinterpretation of the directive in TSCA section 6(h)(4) to “reduce exposures to the substance to the extent practicable,” EPA is proposing revisions to the final rules for decaBDE and PIP (3:1).  For decaBDE, the proposed revisions include:

  • Requiring a label on existing plastic shipping pallets containing decaBDE,
  • Requiring use of PPE for certain activities involving decaBDE,
  • Prohibiting releases to water during the manufacturing, processing, and commercial distribution of decaBDE and decaBDE-containing products,
  • Extending the current compliance extension for the processing and distribution in commerce of decaBDE-containing wire and cable insulation for use in nuclear power generation facilities, and
  • Requiring export notification for decaBDE-containing wire and cable for nuclear power generation facilities.

The proposed revisions to the PBT rule for PIP (3:1) include:

  • Narrowing the exclusion of prohibition for PIP (3:1) use in lubricants and greases to only include use in aerospace and turbine applications,
  • Replacing the exclusion from prohibition for motor and aerospace vehicle parts containing PIP (3:1) with phased-in prohibitions,
  • Excluding from prohibition the processing and commercial distribution of PIP (3:1) and PIP (3:1)-containing products for use in wire harnesses and circuit boards, and
  • Requiring PPE during manufacturing and processing of PIP (3:1).

In the proposed rule, EPA states that the Agency is not reconsidering the final rules for the other three PBTs–2,4,6-TTBP, HCBD, and PCTP–subject to final rules in January 2021.

According to EPA, decaBDE is a flame retardant that is used in textiles, plastics, adhesives, and polyurethane foam, and PIP (3:1) is a flame retardant, a plasticizer, and an anti-compressibility and anti-wear additive used in lubricants, hydraulic fluids, and in the manufacture of other compounds.

EPA Releases Final Guidance for Pesticide Submissions for New Outdoor Uses that Require ESA Reviews

EPA has published the document Final Guidance for Pesticide Submissions for New Outdoor Uses that Require Endangered Species Act (“ESA”) Reviews. In October, the Agency requested public comment on the draft version of this document which was due to the Agency by October 16. In its press release regarding the guidance, EPA stated that the document will fulfill the requirements imposed upon it under the Pesticide Registration Improvement Act of 2022 (“PRIA 5”). Under PRIA 5 EPA must develop and issue guidance to registrants regarding analyses necessary to support the evaluation of potential adverse effects from new outdoor uses of pesticide products on ESA species and designated critical habitats. The draft guidance will apply to the following outdoor uses:

  • new uses of existing conventional pesticides
  • new uses of existing biocides
  • new conventional pesticide active ingredients
  • New uses of biocide active ingredients

The document does not detail any new requirements for applicants. Its purpose is to serve to assist applicants in addressing potential effects on ESA species for the types of new outdoor uses listed above. Many recommended actions include steps that applicants can take voluntarily in developing proposed mitigation efforts. These efforts include:

  • identifying the action area,
  • identifying routes of exposure to potentially affected ESA species,
  • performing initial special overlap analysis to identify where proposed new uses will overlap with critical habitats,
  • identifying mitigation measures (such as decreasing run-off by deploying soil binding agents) and
  • address the risk associated with all active ingredients

The Agency states that “if followed, these recommendations should expedite the review for new outdoor uses of existing conventional pesticides and biopesticide active ingredients under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and improve the efficiency of the overall ESA-FIFRA process.”

EPA Requests Comment on Petition Requiring Proof of Effectiveness for Systemic Insecticides

On November 24, 2023, EPA announced that the Agency is seeking public comment on a petition filed by environmental groups requesting that EPA consider efficacy data when evaluating the registration of neonicotinoids and other systemic insecticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).  Comments will be accepted through January 23, 2024.

In 1980, EPA waived (in most cases) the requirement that registrants provide efficacy data when registering a pesticide under FIFRA (see 40 CFR 158.400(e)(1)).  The petition, filed by the Public Employees for Environmental Responsibility and the American Bird Conservancy, argues that neonicotinoid use is largely ineffective and causes widespread environmental harm.  According to the petition, EPA’s failure to consider neonicotinoids’ lack of efficacy conflicts with the stated purposes of the Agency’s FIFRA registration data requirements to “make regulatory judgments…about the risks and benefits of pesticide products” (40 CFR 158.1(a)) and “ensure that pesticide products will perform as intended” (40 CFR 158.130(c)).

In addition to requiring efficacy data during systemic insecticide registration, the petition asks EPA to mandate that existing systemic insecticide registrants submit efficacy data to EPA within 180 days.  If a proposed or existing systemic insecticide registration “lacks a demonstration that its benefits exceed its environmental and overall costs,” EPA would be required to deny or revoke the registration accordingly.

Systemic insecticides are most commonly used prophylactically to treat plant seeds.  Treated seeds are currently exempted from FIFRA under the “treated articles and substances” exemption at 40 CFR 152.25(a) if their use is consistent with the treating pesticide’s label instructions.  However, EPA recently signaled that the Agency may revise this exemption.

Systemic insecticides are designed to be absorbed and transported through the target plant.  Neonicotinoids, a class of systemic insecticides that include the active ingredients imidacloprid, thiamethoxam, and clothianidin, are one of the most widely used types of insecticides in the world.

Federal Court Requests Scientific Information on Diseases Associated with PFAS Exposure

Parties must gather scientific evidence on the human health effects attributable to PFAS exposure in drinking water, the US 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.

California Glyphosate Warning Requirement Ruled Unconstitutional Compelled Speech

California’s requirement that glyphosate-containing products display a carcinogen warning violates the First Amendment, a Ninth Circuit Court of Appeals panel ruled in a 2-1 decision on November 7, 2023. The decision in the case Nat’l Assoc. of Wheat Growers v. Bonta affirmed a district court’s summary judgment and injunction against the requirement.

Proposition 65 (known as “Prop 65”) requires that any product intentionally containing a chemical on California’s list of known carcinogens warn customers of the product’s carcinogenicity. Glyphosate, one of the most widely used herbicides and the active ingredient in the weed killer Roundup, was automatically added to the list of Prop 65 carcinogens following a 2015 determination by the International Agency for Research on Cancer that glyphosate is “probably carcinogenic to humans.” Other organizations, such as EPA, have not found that glyphosate poses a risk to humans, however.

According to the court, compelled commercial speech must pass intermediate scrutiny unless it is “purely factual and uncontroversial information,” in which case a lesser level of scrutiny applies. The panel found that this exemption was not applicable because whether glyphosate is carcinogenic is subject to scientific debate. The panel then determined that the labeling requirement did not survive intermediate scrutiny because “warn[ing] consumers of a potential ‘risk’ never confirmed by any regulatory body” does not directly advance California’s interest in preserving public health.

The warning was previously struck down by a California district court on the grounds that its phrasing would be misleading to customers, it was not purely factual and uncontroversial, and a more equivocal warning would likely not comply with Prop 65. In this case, the panel analyzed three new proposed warning messages from California’s Attorney General and another from California’s Office of Environmental Health Hazard Assessment (OEHHA) but concluded that these warnings were also not purely factual and uncontroversial.

Judge Consuelo M. Callahan wrote for the panel and was joined by Judge Patrick J. Bumatay. Writing in the dissent, Judge Mary M. Schroeder argued that, at minimum, the new OEHHA warning should be remanded to the district court. Schroeder argued that the majority applied inappropriate precedent in determining what makes a statement uncontroversial, failed to examine the actual content of the warning, and ignored the fact that EPA’s most recent determination that glyphosate is unlikely to cause cancer was vacated by the Ninth Circuit in Nat. Res. Def. Council v. U.S. Env’t Prot. Agency (2022) because it was not supported by substantial evidence.

OEHHA Proposes Amendments to Prop 65 Warning Requirements

This October, the California Office of Environmental Health Hazard Assessment (OEHHA) proposed amendments to the “safe harbor” warning requirements under Proposition 65, the California Law that requires businesses with at least ten employees to provide a “clear and reasonable” warning to customers about exposures to chemicals known to the state of California to cause cancer or reproductive toxicity (officially called the Safe Drinking Water and Toxic Enforcement Act of 1986). The proposed amendments to the safe harbor warning requirements for Proposition 65 (known as “Prop 65”) focus on short-form warnings, provisions for internet and catalog purchases, and warnings for motor vehicles and recreational marine vessel parts.

Requirement of chemical identification in short-form warnings

Under regulations adopted in 2016, safe harbor warnings generally require the name of at least one chemical for each health effect covered by the label. However, because small products may not have space for a full-length warning, OEHHA included an optional short-form label that does not require businesses to identify the chemical(s) prompting the warning. However, since the adoption of the regulations, OEHHA has found that many businesses have chosen to use the short-form label regardless of product size. OEHHA also found that some businesses use short-form labels in situations where there is no risk of exposure to a Prop 65 chemical as a litigation avoidance strategy, diluting the impact of legitimate warnings. As a result, OEHHA proposes that short-form labels identify a chemical for each health effect covered by the label beginning two years after the rule’s effective date.

Provisions for internet and catalog purchases

OEHHA is aware of confusion among businesses about how to provide warnings for products purchased online. For example, some businesses have expressed confusion as to whether an online warning is necessary if the product has a warning on its label and vice versa. To clarify, OEHHA proposes that warnings be required both online and on the product label, or in the case of a catalog, both in the catalog and on the product. OEHHA additionally clarifies the requirements for online warnings; a business must include either a warning on the product display page, a hyperlink on the product display page using the word “WARNING” that links to the warning, or an otherwise prominently displayed warning made to the purchaser prior to completing the purchase.

Warnings for motor vehicles and recreational marine vessel parts

OEHHA states that passenger and off-highway motor vehicles and recreational marine vessel parts present a unique challenge because parts are often too small to comfortably fit full-length warnings and because consumer exposure varies substantially from person to person. To address these concerns, OEHHA proposes that businesses selling these parts can choose to provide a general exposure warning (either at each retail point of sale or point of display) in lieu of a warning on the product label.

Other proposed revisions include explicitly allowing the use of short-form warnings on food products, allowing warnings to begin with “CA” or “CALIFORNIA WARNING” instead of just “WARNING,” allowing more flexibility for warning font sizes and adding additional language to clarify that warnings be placed conspicuously.

The proposed amendments are similar to amendments proposed by OEHHA in January 2021. OEHHA was unable to complete that rulemaking within the regulatory time limit. The current proposal is the first on safe harbor warning requirements since that time.

Comments on the proposed amendments are due December 20, 2023. In addition, OEHHA will hold a hybrid public hearing on the proposed amendments on December 13, 2023, at 10:00 AM PST.

EPA Finalizes TRI PFAS Reporting Rule

On October 31, EPA published its final rule, Changes to Reporting Requirements for PFAS and to Supplier Notifications for Chemicals of Special Concern which modifies the requirements for TRI reporting. These new requirements take effect November 30, 2023, and will apply for the reporting year beginning January 1, 2024; first reports with these requirements will be due July 1, 2025. The rule puts forth two significant changes to the current reporting requirements.

The first change to the reporting requirements is that all PFAS presently subject to TRI reporting will be added to the TRI list of Chemicals of Special Concern (“COSC List”). In addition, in the future, any PFAS added to the TRI list of toxic chemicals will automatically be added to the COSC list without the Agency having to go through a separate rulemaking process as was previously required. Furthermore, all PFAS on the COSC list will be held to the same reporting standard as all other chemicals on the COSC list. This means that all PFAS will be excluded from the de minimis exemption, which had excused quantities of PFAS present in mixtures at less than 1 percent (0.1 for PFOA) from contributing to reporting thresholds. In addition, facilities will no longer be able to report these substances on Form A (the less extensive of the reporting forms) and will not be able to report quantities using ranges. Under the requirements previously in place, Form A could be used for PFAS reporting if each of the following criteria has been met:

  • The reportable chemical substance is not a PBT.
  • The reportable chemical substance was not manufactured, processed, or otherwise used in excess of 1,000,000 lbs.
  • If the total reportable amount of the chemical substance released did not exceed 500 lbs.

Under the new requirements, no one will be able to report PFAS manufacture, processing, use, and releases on Form A. However, Form A can still be used to meet the reporting requirements for PFAS during the 2023 reporting year; beginning in 2024, PFAS will need to be reported using the more extensive Form R.

The second change to the TRI reporting requirements eliminates the de minimis exemption under the supplier notification requirements for all COSC, including PFAS. This change also goes into effect for the 2024 reporting year. The de minimis exemption for supplier notification meant that raw material suppliers were not required to notify their customers of the presence of PFAS in mixtures below specific concentrations (1 percent for non-carcinogens and 0.1 percent for carcinogens or, in the present case, 1 percent for PFAS and 0.1 percent for PFOA). Eliminating the de minimis exemption for reporting will add notification requirements on suppliers of products containing COSC and include such information on their SDSs. Consequentially, facilities will have more information about their processing, use, and/or release of PFAS, and downstream manufacturers will likely have more information to report to EPA for TRI.