Third Circuit FIFRA Preemption Ruling Creates Circuit Split

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The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) expressly preempts a Pennsylvania law that allegedly requires Monsanto to include a cancer warning on its “Roundup” weedkillers, the Third Circuit ruled on August 15, 2024.  The decision in Schaffner v. Monsanto Corp. creates a split with the Ninth and Eleventh Circuits, which have found that similar state-level duty to warn laws were not preempted because the state-law labelling requirements were equivalent to a requirement under FIFRA.

Like the Ninth and Eleventh circuits, the Third Circuit applied a “parallel requirements” test outlined by the Supreme Court in Bates v. Dow Agriscience LLC to determine whether the state law diverged from FIFRA requirements.  Those circuits determined that the state laws were not preempted because they were equivalent to FIFRA’s statutory definition of “misbranding.”

But the Third Circuit ruled that those circuits erred when conducting the test by failing to take into account EPA regulations limiting the modification of precautionary statements on labels.  According to the court, these regulations would require Monsanto to seek EPA approval before adding a warning.

“If EPA regulations specifically identify the contents required to be included on a pesticide label, a state-law requirement is preempted unless it is equivalent to that specific regulatory requirement,” the court said.  “The state-law duty cannot survive preemption simply because its standard of liability is equivalent to the broad statutory definition of misbranding.”

The highly technical decision had to contend with the Supreme Court’s holding in Bates, which it acknowledged “plausibly indicates that [FIFRA] does not on its own preempt all state-law duties to include a warning omitted from” its label.  The Third Circuit concluded that there was no discrepancy because the Supreme Court had not considered how regulations would affect preemption under FIFRA section 136v(b), which addresses preemption.

Writing for the panel, Chief Judge Michael A. Chagares rejected arguments that the Third Circuit should be bound to the Ninth Circuit’s decision.  “The complex subject of preemption under FIFRA has not been comprehensively analyzed in prior caselaw, and the Supreme Court has yet to address FIFRA preemption in the specific circumstances presented by this case,” the decision states.

He also noted that the Supreme Court’s recent overruling of Chevron deference did not undermine EPA’s authority to promulgate FIFRA regulations, including those requiring agency preapproval of product labels, because FIFRA explicitly grants EPA authority “to prescribe regulations to carry out the [statute’s] provisions.”

The Supreme Court denied Monsanto’s petition for certiorari in the Ninth Circuit’s case, Hardeman v. Monsanto Co., in 2022.  A blog post on the Eleventh Circuit’s case, Carson v. Monsanto Co., can be found here.

Class Action Targets 3M and Chemours for Suppressing PFAS Risks in Carpeting

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Two Minnesota consumers who own PFAS-treated carpeting have sued 3M and Chemours, alleging that the chemical companies collaborated for decades to suppress information about the health and environmental risks of PFAS.

According to the complaint, the defendants knew that PFAS were dangerous as early as the 1950s but knowingly withheld evidence of their harms from EPA and the public.  The plaintiffs allege that when these companies shifted from using long-chain PFAS like PFOA and PFOS to shorter-chain variants like GenX and PFBS, they baselessly claimed that the shorter-chain variants were safer.  And even after many carpet manufacturers and retailers stopped making and selling carpeting containing PFAS, the complaint states that the defendants “continued to lie about the harms caused by [these] products.”

Products made by the defendants were used to treat carpets to make them stain- and soil-resistant.  However, the suit claims that carpet manufacturers were unaware that these products were dangerous, in part due to false or misleading safety data sheets provided by the defendants.  The proposed class action seeks to represent all persons who had carpeting installed prior to 2020, alleging that the defendants’ PFAS products were applied to “virtually all carpets manufactured in the United States” until that year.

The proposed class action’s claims are partially based on internal company documents released through other litigation, including a 2018 settlement reached between 3M and Minnesota over PFAS contamination in drinking water.  That case unearthed documents allegedly showing that 3M discouraged its scientists from discussing the chemicals in writing and stymied research efforts, despite knowledge that PFAS were severely toxic and widely present in human blood.

More large settlements were reached last year.  But the defendants “have not paid a dime for the grievous harms caused by carpets in homes and day-care centers infused with PFAS,” said the plaintiffs, who are seeking damages to replace contaminated carpeting.  These alleged harms include property damage resulting from PFAS emissions from the carpets, which reportedly continue throughout the carpet’s lifespan.

The suit alleges that the defendants violated the Racketeer Influenced and Corrupt Organizations Act as participants in a scheme to conceal PFAS harms for commercial gain.  The suit’s 127 counts also include a myriad of state law claims, including strict products liability and nuisance claims.

The complaint also includes allegations against PFAS manufacturer Daikin, which is not named as a defendant.

The case is Peterson v. 3M Co. (D. Minn.), No. 0:24-cv-0349.

Court Vacates EPA Test Order, Citing Incomplete Evidence in Public Record

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On August 28, 2024, the D.C. Circuit issued an order in Vinyl Institute v. EPA, a case challenging a Toxic Substances Control Act (TSCA) test order issued in March 2022.  The mandate signals that neither party intends to appeal the court’s July 5 ruling, which found EPA’s justification for the test order inadequate.

The test order, which required an avian reproduction study of 1,1,2-Trichloroethane, was vacated and remanded to EPA.  However, the panel noted several places in which additional EPA materials would have satisfied TSCA’s “substantial evidence” standard if they were included in the public record, suggesting that EPA would not necessarily be required to perform additional analyses to justify future test orders as long as the analyses were included in the record.

For example, the court ruled that EPA’s “conclusory statements” in the public record on why vertebrate testing was necessary were inadequate, but also said that other documents showed that EPA considered new approach methodologies (as required by TSCA).  However, the court ruled that these documents—although covered by EPA’s brief—were not part of the administrative record that was available to the public, and that therefore “they are not part of the record subject to our review.”

According to the decision, not all studies referenced in the statement of need accompanying the test order were explained or even identified.  Nor did EPA publicly explain why those studies’ findings could not be used to fill the data gap, the court said.

“EPA should have explained why it could not extrapolate mammalian chronic exposure data to avian chronic exposure in its Statement of Need description of reasonably available information,” Judge Karen LeCraft Henderson wrote.  “Identifying close but ultimately inapplicable studies and explaining, in the record, why it could not extrapolate other potentially relevant findings could constitute substantial evidence.”

However, the court upheld EPA’s decision to issue a test order rather than pursuing a rule or consent agreement, agreeing with EPA that timeliness in acquiring the data was sufficient justification. EPA initiated the risk evaluation for 1,1,2-Trichloroethane in December 2019 but has yet to issue a report on its findings.

Judge Henderson also agreed that EPA was not required to demonstrate that exposure may exist at potentially toxic levels before issuing a test order.  That would “reverse[]…TSCA’s allocation of burdens,” the decision states.

Judge Henderson was joined in full by Judge Florence Pan and in part by Judge Justin Walker.  A previous blog post on the case, written after the December 2023 oral argument, can be found here.

EPA Issues Seldom-Used Emergency Order to Suspend Registrations of Pesticide DCPA

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For the first time in almost 40 years, EPA has issued an emergency order under section 6(c)(3) of the Federal Insecticide, Fungicide, and Rodenticide Act to suspend the registrations of all pesticide products containing the active ingredient dimethyl tetrachloroterephthalate (DCPA).

The emergency measure is based on DCPA’s thyroid effects in fetuses, which EPA deemed so severe that continued use of DCPA during the time period required to cancel its registrations would pose an imminent hazard.  According to EPA, thyroid hormone perturbations linked to DCPA “can lead to downstream health problems such as low birth weight, impaired brain development, decreased IQ, impaired motor skills, and decreased bone deposition.”

Occupational exposures to DCPA can be over twice as high (as a factor of body weight) as the level at which the thyroid effects were observed in mouse fetuses, and the herbicide’s residues present risks of concern even 30 days after application to crops, EPA said.  DCPA is also registered for non-agricultural uses, including on golf courses and athletic fields.

American Vanguard Corporation (AMVAC), the sole registrant of DCPA, voluntarily canceled all but two of its DCPA products and their use on turf.  It also voluntarily ceased sale and distribution of the only remaining end-use product until EPA approved product labels that would address DCPA’s risks.  However, EPA “determined that there is no combination of practicable mitigations under which DCPA use can continue without presenting an imminent hazard.”

DCPA is currently undergoing registration review, which occurs every 15 years.  EPA assessed DCPA’s health risks in 2023 after AMVAC submitted a study on its thyroid effects and other information requested by the agency.

The agency intends to issue a notice of intent to cancel DCPA registrations within 90 days of the order, which was published on August 7, 2024.

Also known by its trade name Dacthal, DCPA is used on a variety of crops for weed control.  According to EPA, the emergency order will have a negligible impact on produce prices but may impact growers of crops including bok choy, collards, kale, green onions, and leeks.

Update:

On August 28, 2024, EPA announced that it is initiating a voluntary cancellation of DCPA after AMVAC notified the agency of its intent to cancel the remaining pesticide products.  According to EPA, AMVAC also intends to cancel its international registrations.

Court Finds EPA’s Transparency in New Chemicals Disclosures Reviewable

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EPA’s alleged failure to disclose certain information submitted to its New Chemicals Program is subject to judicial review under the Toxic Substances Control Act (TSCA) and the Administrative Procedure Act (APA), the D.C. District Court ruled on August 20, 2024.

In Environmental Defense Fund v. Regan,  No. 1:20-cv-00762-LLA, five environmental organizations allege that EPA engages in a pattern or practice of violating TSCA’s disclosure requirements for premanufacture notices (PMNs) and applications for test marketing exemptions (TMEs).  The suit’s 10 counts include allegations that EPA failed to publish timely and complete notices of receipt of PMNs; failed to make health and safety studies, safety data sheets, and other information contained in PMN submissions available for examination; and failed to disclose information claimed as confidential business information when it facially did not qualify as confidential.

EPA moved for judgment on the pleadings, asserting that the plaintiffs are barred from seeking relief under TSCA for most of their claims.  While TSCA’s citizen suit provisions allow persons to compel the agency to perform nondiscretionary duties, EPA argued that the relevant statutory and regulatory provisions “do not impose a date-certain deadline” on EPA.  The agency also argued that judicial review under the APA would be inappropriate because the claims concern activities that are interlocutory in nature and too minor to meet the APA’s threshold for “agency action.”

The court denied EPA’s motion.  Even in instances where TSCA does not set an explicit deadline, the court said that it is sometimes apparent that activities must be taken in relation to other events.  Three of the plaintiffs’ 10 counts were found to fall in this category.  For example, TSCA directs EPA to provide immediate notice of TME applications for public input and requires EPA to make a determination on each application within 45 days.  Since “[n]otice must precede comment” and “comment must precede the EPA’s decision,” “[t]he only logical conclusion” is that notice is required prior to expiration of the 45-day period, the court held.

For the seven remaining allegations—which all concerned the availability of information submitted with a new chemical notification, and for which a deadline for agency disclosure to interested parties could not be ascertained from the statutory structure—the court was unconvinced by EPA’s argument that the APA could not offer relief.  The APA’s definition of agency action has been interpreted expansively by the courts, and the fact that the challenged activities are merely “interim steps” is not dispositive, the decision states.  Importantly, as part of this analysis, the court held that TSCA section 5(b) creates a “freestanding right to information” submitted as part of a new chemical notification.

Judge Loren L. AliKhan also granted the plaintiffs’ motion to compel the administrative record, rejecting EPA’s arguments that the claims should be understood as “failures to act” rather than actions—meaning that they would not have an administrative record.  However, she did not go so far as to agree with the plaintiffs on the merits.

According to EPA, since the case was filed in 2020, the agency has made “substantial and ongoing improvements to its practices for preparing and publishing public notices and public files as part of its ongoing commitment to improving the administration and transparency” of its New Chemicals Program.

In addition to the Environmental Defense Fund, the plaintiffs include the Center for Environmental Health, the Environmental Health Strategy Center, the Natural Resources Defense Council, and the Sierra Club.

EPA Updates Safer Choice and Design for the Environment Standard

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On August 8, 2024, EPA finalized updates to the Safer Choice and Design for the Environment Standard.  The revised standard implements sustainable packaging criteria and introduces a Safer Choice Cleaning Service Certification for cleaning service providers.

Created in 2009, the Safer Choice program allows products such as cleaners and detergents to carry a special label if they meet human and environmental health requirements.  Products must meet both holistic and component-level requirements to be approved for partnership with EPA, which is renewable and lasts three years.  Design for the Environment operates under the same standard and applies specifically to antimicrobial products.

Under the updated standard, primary packaging for certified products can no longer contain intentionally added PFAS.  The revisions also require packages to either be 1) designed to be reused or 2) recyclable and made of a certain percentage of recycled content.

The update also inaugurates a certification program for cleaning services that use certified products “to the maximum extent practicable.”  The agency says that it will consider exceptions on a case-by-case basis, including in situations where limited certified products are available for a certain product class.

Other changes include stricter requirements for pet care products and voluntary criteria aimed at reducing carbon-based energy consumption.  The new standard does not alter the master criteria for ingredients or any of the supplemental requirements for certain product classes.

The update is the first revision to the standard since 2015 and the fourth in its history.  New products must comply with the updated standard immediately.  Existing partnership products must comply within a year after they are notified of the updates.

 

EPA Releases Second Version of Interim Guidance on PFAS Destruction and Disposal

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On April 8, 2024, EPA released the second version of its interim guidance on the destruction and disposal of PFAS and PFAS-containing materials.  The updated interim guidance builds on the initial guidance issued in 2020 by providing new recommendations for the management of PFAS-containing materials.

The updated interim guidance focuses on three categories of large-scale destruction and disposal technologies: underground injection, landfilling, and thermal treatment.  For each category, EPA identifies the technology with a lower potential for environmental release of PFAS when compared to other technologies within their category:

  • Permitted Class I non-hazardous industrial or hazardous waste injection wells (underground injection);
  • Permitted hazardous waste landfills (landfilling); and
  • Permitted hazardous waste combustors (thermal treatment).

However, each technology has drawbacks and is only suitable for certain types of PFAS-containing materials.  For example, EPA notes that new information suggest landfills may release more PFAS into the environment than previously understood, and that transportation logistics may limit the types and amounts of PFAS-containing fluids that can be inserted into Class I wells.

EPA emphasizes the limitations of available data and includes a list of prioritized research needs to inform future guidance.  High-priority research needs include information on releases from landfills and data on releases from thermal treatment units.  EPA describes a new analytical method, OTM-50, that it believes will better characterize the products of incomplete combustion.

In addition, the updated interim guidance presents a new evaluation framework designed to assess emerging technologies and determine their suitability for specific PFAS-containing materials. It also includes an updated list of tools to screen for potentially vulnerable populations living near likely PFAS destruction or disposal sites.

EPA was mandated to publish and triennially update the interim guidance by the FY 2020 National Defense Authorization Act.  More information on the updated interim guidance can be found in an EPA fact sheet.

Comments on the updated interim guidance are due October 15, 2024.

Coca-Cola Asks Judge to Dismiss Simply Juice PFAS Suit

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A proposed class action alleging that Coca-Cola’s Simply-brand juices contain PFAS does not state a plausible claim for relief, Coca-Cola told the Southern District of New York on July 31, 2024.

The plaintiff in Lurenz v. The Coca-Cola Co. alleges that laboratory testing revealed “widespread and uniform” PFAS contamination in Simply juices at levels detrimental to human health.  As a result, the claims made on Simply products—including that the beverages are “All Natural” and “made simply” with “all-natural ingredients”—would mislead a reasonable consumer, the most recent complaint asserts.

The court dismissed the initial complaint for lack of standing in June, but allowed the plaintiff to file a new complaint.  In response, Coca-Cola filed a letter requesting a conference before the company files another motion to dismiss.  The letter argues that the new complaint’s allegations are “even vaguer” than those previously dismissed, making it “impossible to tell” when the plaintiff purchased the contested products.  The plaintiff “still cannot show a concrete economic harm needed to establish Article III standing,” Coca-Cola says.

In addition, Coca-Cola argues that the new complaint still provides insufficient factual detail about the testing that revealed PFAS contamination, which was a factor in the earlier dismissal.  Even if the testing allegations are deemed sufficient, Coca-Cola asserts that the all-natural claims are not misleading.  “[N]o reasonable consumer would understand PFAS—a substance that is not intentionally added to the [juices]—to be an ingredient,” the letter states.

The case is similar to an ongoing suit against L’Oréal, the cosmetics company, for alleged PFAS contamination.  A blog post on that case, written after a dismissal due to standing issues, can be found here.

Kansas City Grocers Ordered to Stop Selling Illegally-Imported Disinfectants

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On May 6, 2024, EPA Region 7 announced that 17 grocery stores in the Kansas City area had been ordered to stop the sale and use of certain Fabuloso-brand cleaners and other disinfectants because of potential health risks.  The orders, issued by the Kansas and Missouri Departments of Agriculture in partnership with EPA, require the stores to immediately remove the illegal products from their shelves.

According to EPA’s press release, the products contain glutaraldehyde, an active ingredient not approved for household disinfectant use in the U.S. due to its potential health risks. These risks include “throat and lung irritation, asthma and difficulty breathing, dermatitis, nasal irritation, sneezing, wheezing, burning eyes, and conjunctivitis.”

EPA says that the products were illegally imported.  The press release states that their labels are primarily in Spanish and that the affected grocers “serve Hispanic communities.”

It is important to note that not all Fabuloso products are unsafe.  There is also an EPA approved US version of Fabuloso which does not contain glutaraldehyde.  According to the press release, some stores subject to the orders sold both the illegal and the approved US versions of the disinfectants.

Class Action Against Coca-Cola for “100% Recyclable” Claims Advances

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A proposed class action against Coca-Cola and other companies selling bottled water can proceed after the plaintiffs provided survey results indicating that consumers may be misled by Coca-Cola’s recyclability claims, the Northern District of California ruled in the case Swartz v. The Coca-Cola Co., No. 3:21-cv-04643.

Crucial to the case are the Federal Trade Commission’s Green Guides, which provide guidance for environmental marketing claims and are codified into California law.  The Green Guides allow marketers to make unqualified recyclable claims “if the entire product or package, excluding minor incidental components, is recyclable” by facilities available to “at least 60 percent” of Californians.

The plaintiffs initially alleged that the defendants’ “100% Recyclable” claims are false and misleading because most of the bottles are not recycled in practice.  The judge rejected that argument, stating that reasonable consumers would not understand the claims “to mean that the entire product will always be recycled.”  The plaintiff’s next complaint placed greater emphasis on the bottles’ caps and labels, which are allegedly not recyclable.  However, the court found inadequate factual support for their claims, which were also undermined because bottle caps and labels constitute minor components under the Green Guides.

The plaintiffs’ newest complaint overcomes those shortfalls, Judge James Donato ruled on April 8, 2024.  The survey results indicate that consumers understand the defendant’s claims to mean the entire bottle (including bottle caps and labels) are recyclable, and the defendants “expressly qualify” their recyclability as “100%.”  As a result, the plaintiffs can plausibly allege that “these representations to consumers are different from” unqualified claims protected by the Green Guides, he said.

The court also determined that there was sufficient factual support for the plaintiffs’ deception claims to move forward.  Because the defendant’s product labels are “disposed of as refuse” by facilities responsible for over 40% of the relevant type of bottle recycling in California, it is plausible that the “defendant’s products are not capable of being ‘100%’ recycled by plants in California,” the court ruled.

The lawsuit consolidates actions brought separately by consumers and the Sierra Club.  In addition to Coca-Cola, the suit names BlueTriton Brands and Niagara Bottling as defendants.  Between the three companies, water bottles are sold under the brand labels Dasani, Deer Park, Poland Spring, Niagara, Kirkland Signature, and others.