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.

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.

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.

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

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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

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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.

EPA Releases Strategic Plan for Endocrine Disruptor Screening Program

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EPA has released a notice requesting comment on its strategic plan to meet its obligations under the Federal Food, Drug, and Cosmetic Act (FFDCA) to screen for and protect against endocrine-disrupting effects in humans. Endocrine disruptors are chemicals that mimic, block, or disrupt the normal function of endocrine system hormones and can negatively impact biological processes within the endocrine, immune, and nervous systems. Under the new program, the Agency will assess pesticides more quickly and effectively to evaluate their potential to cause endocrine effects in humans. These assessments will be incorporated into pesticide review efforts made under the Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”).

In the Agency’s press release regarding the program, the Deputy Administrator for Pesticide Programs in the Office of Chemical Safety and Pollution, Jake Li, noted that the program is a major milestone. He also stated that “starting with our highest priority chemicals, EPA will communicate more transparently our endocrine findings for humans.”

EPA review of preliminary data has identified 30 high-priority pesticides that these chemicals affect the endocrine system. The Agency requests additional endocrine data for human health for these chemicals in its request for comment. The Agency intends to fill any remaining data gaps by issuing FIFRA human health data requests for these chemicals in early 2024. These chemicals are identified in EPA’s List of Conventional Registration Review Chemicals, for Which an FFDCA Section 408(p)(6) Determination is Needed, which is available in docket EPA–HQ–OPP–2023–0474 on regulations.gov. FFDCA section 408(p)(6) requires EPA to ‘‘as appropriate, take action under such statutory authority as is available to the Administrator, including consideration under other sections of this chapter, as is necessary to ensure the protection of public health’’ for ‘‘any substance that is found, as a result of testing and evaluation under this section, to have an endocrine effect on humans.’’ In addition, in the Federal Register notice, EPA requested that stakeholders submit data on the endocrine effects of these pesticides. Data are requested during the notice’s 60-day comment period. After the assessment of the high-priority pesticides is completed, the Agency will request data on a second group of 126 pesticides.

In the strategic plan, EPA explains that the program will pull from existing data when possible.   and request new data if needed. Existing data has been collected under FIFRA and the FFDCA. EPA has chosen 400 conventional pesticide active ingredients that are being registered for the first time or are undergoing registration review for which, through the implementation of its Strategic Plan, the Agency will assess for endocrine effects and determine if additional protections are needed.

The comment period for this notice began on October 27, 2023, and has been extended to February 26, 2024.

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.

EPA to Consider Revising FIFRA Exemption for Pesticide-Treated Seeds and Paint

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On October 12, 2023, EPA published an advance notice of proposed rulemaking on seeds (“treated seeds”) and paint (“treated paint”) treated with a pesticide that is registered under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) (“treating pesticide”). Treated seeds and treated paints are currently exempted from FIFRA under the “treated articles and substances” exemption at 40 CFR 152.25(a) as long as their use is consistent with the treating pesticide’s label instructions.

EPA’s longstanding position has been that subjecting treated articles to FIFRA requirements would be unnecessary since the treating pesticide would have already been assessed during the pesticide registration process. This position was challenged in 2017 by the Center for Food Safety, which filed a petition requesting that EPA remove the exemption for treated seeds and aggressively enforce FIFRA’s pesticide labeling and registration requirements for seeds treated with systemic insecticide chemicals. EPA denied the petition in 2022 but acknowledged that the use of a treated seed contrary to the treating pesticide’s labeling instructions is generally not enforceable under FIFRA. As a result, EPA noted its intention to issue the current advance notice of proposed rulemaking to collect more information on treated seeds. EPA also included treated paints in the notice because of concerns that painters may be exposed to treated paint without adequate PPE.

The information specifically requested by the notice falls into five main categories:

  1. Effectiveness of instructions on treated seed product labeling to mitigate potential risks. EPA seeks comment on the Agency’s labeling instructions for treated seeds, particularly with regard to whether these instructions are clear, generally achievable, and adequate.
  2. Use, usage, and tracking of treated seed products. EPA seeks comment on the use, usage rates, and volume of imports of treated seeds. EPA also seeks comment on whether tracking treated seed distribution, sale, and/or use would provide any meaningful improvements in the assessments of treating pesticides and whether the treated article exemption should be amended so that manufacturers of treated seeds would be subject to FIFRA section 7 registration and reporting requirements.
  3. Management of spilled or excess treated seed. EPA included additional labeling instructions for the management of spilled and excess treated seed in the registration review proposed interim decisions and interim decisions of several chemicals. EPA seeks comment on whether these instructions are sufficient. EPA also seeks comment on what farmers, distributors, and companies currently do with excess treated seed.
  4. Treated paint. Pesticide labeling requirements for treated paint do not currently exist. EPA seeks comment on whether it should add pesticide labeling requirements and what those requirements should include. EPA also seeks comment on whether it should add specific use instructions or enforceable use requirements for professional painters and whether the treated article exemption should be amended so that manufacturers of treated paints would be subject to FIFRA section 7 registration and reporting requirements.
  5. Administrative action, amendment of the treated article exemption, and/or FIFRA section 3(a) rule. EPA seeks comment on whether action is necessary to prevent unreasonable adverse effects on human health and the environment, considering the concerns raised regarding the enforceability of labeling instructions on treated seeds and paint and whether there are any such examples of the use of treated seed contrary to labeling instructions. If so, EPA requests comments on what the proper action should be and how such an action might impact states.

EPA also requests comments on whether exposure to treated seeds and paint may be an environmental justice concern and comments regarding potential child health concerns. Comments on the notice will be accepted through December 11, 2023.

DOJ Files Lawsuit Against eBay for Environmental Violations

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On behalf of EPA, the Department of Justice (DOJ) has filed a lawsuit against the online retailer eBay for selling and distributing “hundreds of thousands of products” that allegedly violate the Clean Air Act (CAA), the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and the Toxic Substances Control Act (TSCA).

DOJ first alleges that eBay violated the CAA by selling or causing the sale of over 343,000 automotive aftermarket defeat devices.  These devices, which are often advertised as vehicle power enhancers, “can cause motor vehicles to emit hundreds to thousands of times more pollution than a motor vehicle with properly functioning emission controls,” the complaint says.  DOJ alleges that each aftermarket defeat device sold, offered for sale, or caused to sell by eBay constitutes a violation of CAA section 203(a)(3)(B), which forbids selling or offering to sell a motor vehicle part that bypasses an emission-related element of design.

Second, the complaint alleges that eBay committed a series of FIFRA violations by selling or distributing a minimum of 23,000 unregistered, misbranded, or restricted use pesticide products.  DOJ also alleges 8,074 violations of a Stop Sale, Use, or Removal Order (SSURO) issued by EPA in 2020 (and amended in 2021), which identified some of these allegedly unlawful pesticide products.  Among the products sold in alleged violation of the SSURO was an insecticide containing dichlorvos, which DOJ characterizes as highly dangerous, and a “disinfection card” claiming to protect users from COVID-19 when worn around their neck.

Finally, eBay is being sued under TSCA for violating a 2019 rule prohibiting the manufacture, processing, and distribution of products containing methylene chloride for consumer paint and coating removal.  The TSCA section 6(a) rule was the result of EPA’s determination that those uses pose an unreasonable risk of injury to health due to methylene chloride’s acute human lethality.  According to the complaint, eBay has distributed over 5,600 items in violation of the rule.

The lawsuit seeks injunctive relief to prevent eBay from further selling products violating the CAA, FIFRA, and TSCA.  The complaint additionally requests civil penalties for each of the CAA violations, which could amount to $5,580 per violation.

EPA Faces Lawsuit for Classifying Water Filtration System as a Pesticide Product

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The U.S. District Court for the Northern District of Texas will be tasked with determining whether EPA’s Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) enforcement actions against Berkey, a water filters brand, were arbitrary and capricious in the case Shepherd v. Regan.  The case concerns seven Stop Sale, Use and Removal Orders (SSUROs) issued by EPA against third-party distributors and manufacturers of Berkey water filtration products due to their alleged use of silver as an unregistered antimicrobial pesticide.

The complaint does not deny the presence of silver in Berkey products.  However, the plaintiffs say that they are unaware of any instances where a Berkey-authorized entity claimed that the silver in their products was “used for any purpose other than to protect the filter itself.”  This is significant because articles treated with a FIFRA-registered pesticide for the purpose of protecting the article are exempt from FIFRA under the treated articles exemption at 40 CFR 152.25.

The plaintiffs argue that the orders were the result of an unlawful reinterpretation of a 2007 notice, which clarified EPA’s position that equipment that uses electrodes to emit ions for pesticidal purposes is a “pesticide,” rather than a “device,” under FIFRA.  The complaint alleges that EPA reinterpreted this notice without opportunity for public comment to “now apply to the presence of inert silver in water filters.”

In its response, EPA argues that the plaintiffs—which do not represent Berkey itself—lack standing.  The Agency also characterizes the 2007 notice referenced in the complaint as a “straw man” with no bearing on the case.  EPA does not believe there is any ambiguity regarding the distinction between “pesticides” and “devices,” arguing that EPA has excluded water filters containing pesticidal substances from its interpretation of “devices” since 1975.

EPA focuses on claims made by the SSURO recipients, which allegedly advertised that Berkey filters removed viruses and pathogenic bacteria.  The Agency has long held that such public health claims make a product ineligible for the treated article exemption, EPA says.  Combined with knowledge of the presence of silver in the products, and no pesticide registration, EPA argues that it had “reason to believe” (the requirement for issuance of an SSURO) that the substances were sold in violation of FIFRA.