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 Sued Over Herbicide Registration Renewal

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On June 6, 2023, the Center for Food Safety and two other environmental groups sued EPA over the Agency’s decision to renew registrations for Enlist One and Enlist Duo, two herbicides manufactured by Corteva Agrisciences, LLC.  The case is currently pending before the U.S. District Court for the District of Columbia as Center for Food Safety v. EPA.

The lawsuit alleges that EPA failed to properly evaluate the Enlist products’ risks as required by the Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”) and the Endangered Species Act (“ESA”) when the Agency renewed the herbicides’ registrations until 2027.  According to the plaintiffs, the herbicides cause numerous adverse environmental effects, including harm to crops growing on neighboring properties and drinking water contamination.  The plaintiffs allege that EPA understated these risks in making its decision, while overstating the herbicides’ effectiveness.  In addition, the plaintiffs argue that EPA’s decision harms the survival, growth, and reproduction of exposed plants and animals, including endangered and threatened species.  The plaintiffs ask the court to vacate EPA’s decision and to stop the sale and use of the Enlist products.

In an EPA memorandum supporting the Agency’s decision, EPA stated that it had “evaluated the benefits and risks to human health and the environment from these products’ uses, including potential risk to non-target organisms, and conducted effects determinations for federally listed endangered and threatened species.”  According to EPA, the results of its evaluations and assessments were sufficient for the Agency to conclude that granting the registration renewal met the requirements of FIFRA and ESA.  These requirements include FIFRA section 3(c)(5), which directs EPA to register a pesticide when the Agency finds that the pesticide will not generally cause unreasonable adverse effects on human health or the environment, among other criteria; ESA section 7(a)(2), which requires EPA to consult with the Fish and Wildlife Service to ensure that actions taken by EPA do not jeopardize endangered and threatened species; and ESA section 7(d), which prevents EPA from taking irreversible action during 7(a)(2) consultation that eliminates the implementation of reasonable alternatives.

Enlist Duo has previously been the subject of litigation.  In National Family Farm Coalition, et al., v. U.S. EPA, et al., 966 F.3d 893 (9th Cir., 2020), petitioners challenged EPA’s decisions to register the herbicide in 2014, 2015, and 2017 on FIFRA and ESA grounds.  The panel rejected the petitioners’ ESA claims and the majority of the petitioners’ FIFRA claims, allowing Enlist Duo registration, but agreed with the petitioners that EPA did not properly assess harm to monarch butterflies due to the herbicide’s effects on milkweed.  The panel remanded the registration decision to EPA so the Agency could assess this concern and determine whether it presented an unreasonable adverse effect under FIFRA.

According to EPA, Enlist One and Enlist Duo are registered for use in 34 states for a variety of uses on corn, cotton, and soybeans.  Both herbicides contain the active ingredient 2,4-dichlorophenoxyacetic acid choline salt.  Enlist Duo also contains the active ingredient glyphosate.

Hearing Announced on EPA’s Intent to Cancel Chlorpyrifos Pesticide Registrations

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On June 21, 2023, EPA announced that a public hearing will be held in response to objections and hearing requests following EPA’s issuance of a Notice of Intent to Cancel (“NOIC”) pesticide registrations for three products containing chlorpyrifos. The hearing will begin at 9 a.m. on January 8, 2024, and will continue as necessary through January 11, 2024.

The objections and hearing requests following the NOIC came from a collection of grower groups and a producer of chlorpyrifos products. The petitioners are currently challenging EPA’s 2021 final rule, which revoked all tolerances for chlorpyrifos, in the Eighth Circuit case Red River Valley Sugarbeet Growers Association et al. v. Regan. The petitioners argue that EPA should stay or withdraw the NOIC until the pending case is decided.

EPA’s NOIC was the result of over a decade of efforts to ban chlorpyrifos use. In 2007, two non-profit organizations filed a petition requesting that EPA revoke all tolerances and cancel all registrations for chlorpyrifos, pointing to studies showing neurotoxic, developmental, endocrinal, and carcinogenic effects in humans and animals as a result of exposure. EPA did not take final action on the petition until it denied the petition in 2017, concluding that the science behind the effects of exposure remained unresolved.  In 2021, the Ninth Circuit vacated EPA’s decision in League of United Latin Am. Citizens v. Regan. The court held that EPA had abdicated its statutory duty under the Federal Food, Drug, and Cosmetic Act by failing to update the tolerances for chlorpyrifos despite its inability to conclude, to the statutory standard of reasonable certainty, that present tolerances caused no harm. The court ordered EPA to grant the 2007 petition and modify or revoke the tolerances accordingly. EPA opted to revoke all tolerances in the final rule.

In the ongoing case, Red River Valley Sugarbeet Growers Association et al. v. Regan, the grower groups and the chlorpyrifos producer argue that the final rule was arbitrary and capricious due to EPA’s disregard for safe chlorpyrifos uses. The petitioners observe that shortly before the final rule was published, EPA completed a human health assessment that found that chlorpyrifos use on eleven crops in select regions was safe. By refusing to act on its own evidence, the petitioners assert that EPA disregarded its statutory mandate to review the safety of tolerances using current science.

According to EPA, chlorpyrifos was registered for use in the U.S. beginning in 1965. At the time of the final rule, chlorpyrifos was registered for use on fruit and nut trees, many types of fruits and vegetables, and grain crops.

Oral Arguments in Monsanto “Roundup” Case

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On June 13, 2023, the full Eleventh Circuit heard oral arguments in the case Carson v. Monsanto Co.  The case hinges on whether a Georgia law that requires Monsanto to warn consumers about risks the company knows about or has reason to know about is preempted by the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).

The appellant, John D. Carson Sr., alleges that he developed cancer due to regular use of Roundup, a glyphosate-based pesticide manufactured by Monsanto. Carson claims that Monsanto “has known for decades” that Roundup use can cause cancer and failed to label their products in a way that notified consumers of this risk as required by Georgia law.

FIFRA requires pesticide manufacturers to include warning labels on products that adequately protect consumer health, but EPA has concluded that glyphosate is “not likely to be carcinogenic” to humans.  FIFRA prohibits state labelling laws that are “in addition to or different from” FIFRA requirements (7 U.S.C. § 136v(b)). Monsanto argues that this language expressly preempts the Georgia law, while Carson contends that the Georgia law merely “parallels” FIFRA’s provisions. Carson cites Bates v. Dow AgroSciences LLC, interpreting the ruling to mean that claims “equivalent to” or narrower than FIFRA provisions are not preempted (544 U.S. 431, 447 (2005)).

Also at issue in the case is the question of whether EPA’s actions with regard to Roundup constitute “force of law.” Carson asserts that EPA’s registration of Roundup does not have the force of law necessary to preempt Georgia law.  Monsanto argues that no force-of-law analysis is required because “EPA determinations define the scope of preemption as a matter of statutory construction,” but also argues that EPA’s actions constitute force of law even if such an analysis is undertaken.

During oral arguments the court posed questions to Carson’s attorney regarding whether a force-of-law analysis is necessary and questioned the attorney representing Monsanto on whether the grounds for an impossibility preemption were met. In addition, both attorneys were asked whether the appeal was “collusive” due to the type of settlement the parties reached in the case.

Carson’s suit was initially dismissed by a Georgia court, which held that FIFRA expressly preempted the Georgia law. In July 2022, it was reinstated by a three-judge Eleventh Circuit panel which ruled in favor of Carson. The panel reached the same result in a new opinion in October 2022. Last December, the full Eleventh Circuit vacated the opinion, ordering that the case be heard en banc.

EPA Exempts Categories of Genetically Engineered Plant-Incorporated Protectants from Regulatory Requirements

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On May 31, 2023, EPA published a final rule exempting two categories of plant-incorporated protectants (PIPs) created using genetic engineering from certain Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) registration requirements and from food or feed residue tolerance requirements under the Federal Food, Drug, and Cosmetic Act (FFDCA).  In addition to reducing regulatory burden, EPA stated in a press release that the final rule may result in increased research and development in this sector and provide more pest control options for farmers, ultimately reducing the use of conventional pesticides.

PIPs are defined (in part) at 40 CFR 174.3 as “pesticidal substance[s] that [are] intended to be produced and used in a living plant, or in the produce thereof, and the genetic material necessary for production of such a pesticidal substance.”  In 2001, EPA exempted PIPs derived through conventional plant breeding from FIFRA registration and FFDCA food tolerance requirements, but did not exempt PIPs created using biotechnology.  Because of recent scientific advances, however, EPA writes that PIPs “can now be created through genetic engineering that are virtually indistinguishable from those created through conventional breeding.”  The final rule adds exemptions for the following two categories of genetically engineered PIPs, which EPA states pose no greater risk than PIPs created through conventional breeding:

  1. PIPs in which genetic engineering has been used to insert a gene from a sexually compatible plant or to modify a gene to match a gene found in a sexually compatible plant. This category of PIPs requires EPA confirmation of eligibility for the exemption.
  2. Loss-of-function PIPs, in which a gene is modified through genetic engineering to reduce or eliminate the activity of that gene. The loss of the activity of that gene then results in the pesticidal effect.  For this category of PIP, biotechnology developers can either make a self-determination that their PIP meets the exemption criteria, which requires notification but no EPA review, or request EPA confirmation of eligibility for the exemption.

Exempted PIPs are still subject to the adverse effects reporting requirements at 40 CFR 174.71 and recordkeeping requirements.

In the preamble to the final rule, EPA established that the Agency is open to considering additional PIP category exemptions and expanding the categories of PIPs that are allowed to self-determine without EPA confirmation of their eligibility exemption.

Study Finds Roundup Cancer Risk Isn’t from Active Ingredient Glyphosate

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A newly released study has found that glyphosate, the active ingredient in Roundup, may not be directly responsible for the increased risk of cancer that has been associated with the weedkiller. The study was conducted by a team of federal and private sector researchers who tested glyphosate and herbicide mixtures using glyphosate on human B-lymphoblastoid TK6 cells. The researchers concluded that neither glyphosate nor its metabolite forms damaged DNA, causing cancer. Instead, they found that some other ingredient in weedkillers containing glyphosate may be responsible for the DNA damage attributed to glyphosate. This finding contradicts the 2015 World Health Organization (“WHO”) conclusion that glyphosate was “probably carcinogenic to humans” and genotoxic (meaning it damages DNA). WHO’s conclusion has led to numerous lawsuits against Bayer AG and Monsanto Co., as well as lawsuits against the Environmental Protection Agency for concluding that the herbicide would not cause cancer.

Although the study indicates that DNA damage was caused by other components of the formulations, not glyphosate, it did not rule out the possibility that exposure to glyphosate might cause cancer through other mechanisms, according to the National Toxicology Program. Bayer AG has long maintained that glyphosate does not cause cancer and is not genotoxic, and the company released a statement in response to the study, stating that “the extensive body of research on glyphosate-based herbicides and findings of leading health regulators worldwide support the conclusion that glyphosate does not cause cancer and is not genotoxic.”

EPA Revokes Interim Approval of Glyphosate

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EPA recently withdrew its 2020 Interim Approval of glyphosate, often referred to by its trade name Roundup. Interim approvals are part of a conditional registration process used by the Agency to allow new active ingredients to enter the market for an unspecified period of time while the registrant generates missing data required by the Agency for the formal registration process.  Although the Interim Approval was revoked, EPA maintains that the chemical is not carcinogenic, and the product will remain on the market as the Agency completes its periodic review as required by law. In its registration review of glyphosate, the Agency will attempt to elaborate on its evaluation of the carcinogenic potential of glyphosate. EPA will also consider whether a better explanation is needed for its findings on other aspects of the human health analysis. EPA expects to complete the review of glyphosate in 2026.

The 2020 Interim Approval was challenged in the U.S. Court of Appeals for the Ninth Circuit. Petitioners made two main allegations, first that EPA’s analysis of human health, particularly related to cancer analysis, was faulty. Second, the Agency violated the Endangered Species Act (ESA) which requires the weighing of such risks against the benefits of glyphosate and the interim risk mitigation measures.

In June 2022, the Court vacated the human health portion of the glyphosate interim review decision and held that EPA’s registration review decision under FIFRA triggered ESA obligations. It also granted EPA’s request for voluntary remand, without vacatur, of the ecological portion of the interim registration review decision but imposed a deadline for EPA to issue a new ecological potion.

While the EPA has made this withdrawal decision, it is unable to finalize the new ecological portion in a registration review decision as mandated by the Court decision. The Agency states the delay is necessary to appropriately address the issues EPA sought to remedy in the ecological potion and satisfy the ESA requirements. EPA is currently working on a consultation with the U.S. Fish and Wildlife Service and the National Marine Fisheries Services. Any proposed decisions will require a 60-day comment period and an assessment of comments received. You can read EPA’s full release on its withdrawal decision here.

EPA Advances Early Pesticides Protections for Endangered Species

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On November 16, 2022, the Environmental Protection Agency (EPA) released an update to its Endangered Species Act (ESA) Workplan that outlines steps to increase protections for wildlife while also providing regulatory certainty for pesticide users. The update, which follows the EPA’s April 2022 ESA Workplan, aims to address the complexity of meeting the Agency’s obligations under the ESA under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). When registering or reevaluating a pesticide, EPA has an obligation under FIFRA to determine whether the pesticide presents unreasonable adverse effects on human health or the environment.   EPA is also obligated under the ESA to ensure pesticide registrations do not imperil the continued existence of ESA-listed species or adversely impact their respective critical habitats.

To better fulfill the Agency’s obligations under the ESA, the Workplan update stresses the need for pesticide registration review and other FIFRA actions to provide protections for nontarget species, including endangered and threatened species, earlier in the review process. As well as resulting in better ESA compliance, these changes could provide farmers with more predictable access to pesticides.

  1. Describes EPA’s overall approach to mitigating ecological risks in registration review, which includes prioritization of registration review cases based on opportunities to reduce a pesticide’s risk to human health or the environment.
  2. Proposes a menu of FIFRA Interim Ecological Mitigation measures that EPA will draw from for future conventional and biological pesticide registration and registration review actions to protect non-target species
  3. Proposes label language to expand the use of online endangered species protection bulletins to implement geographically specific mitigation measures for individual listed species. These measures are designed to focus protections only in specific needed areas, thus minimizing impacts to agriculture..
  4. Describes current and future programmatic initiatives with other federal agencies to prioritize mitigation for listed species that are particularly vulnerable to pesticides and to improve the efficiency and timeliness of the ESA-FIFRA process.

The FIFRA Interim Ecological Mitigation measures will focus on reducing pesticide spray drift and runoff. and will be applied on a case-by-case basis, depending on the level of risk that a particular pesticide presents to species and the exposure route. This approach is intended to more efficiently protect nontarget species, including listed species, and to standardize protections across similar pesticides, rather than addressing risks on a pesticide or species-specific basis as the EPA has done in the past.

Additionally, the Agency plans to work with registrants of pesticides to add language to pesticide labels that direct users to reference Bulletins Live! Two, a website containing endangered species protection bulletins. These bulletins contain use limitations to protect threatened and endangered species and their designated critical habitat in specific geographic areas. The EPA expects that adding the reference to Bulletins Live! Two, to pesticide labels in advance of consultation with the US Fish and Wildlife Service and the National Marine Fisheries Service, will save time and resources by reducing the number of amendments to labels. It further plans to add language on pesticide incident reporting and advisory language to protect insect pollinators to protect listed and other non-target species better.

EPA Takes Enforcement Action Against Companies for Misbranded Pesticide

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On September 21, 2022, EPA announced settlements with two New Jersey companies for the sale and distribution of the pesticide Zoono Microbe Shield. The companies made false and misleading claims that the registered pesticide was suitable for use as a disinfectant or sanitizer against the virus which causes COVID-19. The companies’ claims were a violation of the Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”) which prohibits false and misleading claims of registered pesticide products.

The two companies, Zoono USA and Zoono Holdings, advertised and sold the Zoono Micro Shield product on their companies’ websites as well as on Amazon. The product’s labeling contained public health claims that EPA found to differ substantially from statements approved by the Agency in its review of the product label. The approved label allows only for statements regarding the product’s effectiveness against odor-causing bacteria, bacteria that cause staining and discoloration, fungi, and algae.  EPA did not approve the use of the product as a disinfectant or sanitizer or make any public health claims. The settlements included civil penalties in the amounts of $205,000 and $120,000.

EPA Issues Stop Sale, Use, or Removal Orders to Amazon

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In February 2021, EPA announced that the Agency issued a “stop sale” order to Amazon in relation to unregistered pesticides and disinfectants.  This is the third stop sale order Amazon has been issued by EPA and brings the list of products in the stop sale order from 30 to 70.  The first stop sale order for unregistered pesticide products was on August 12, 2015.  The second stop sale order for unregistered pesticide products was on January 29, 2016.  For the current stop sale order, a majority of the products at issue make antimicrobial, antibacterial, or antiviral claims.  A few examples include Antimicrobial Pure Copper Therapy Ring, Replaceable Wipes Made of Sterile Non-Woven Fabric, and Antibacterial Sanitizing Disinfecting Alcohol Wipes.  EPA states that consumers wishing to purchase products to kill the coronavirus SARS-CoV-2 (COVID-19) should refer to the Agency’s list of disinfectants, instead of purchasing unregistered pesticides, because unregistered pesticides have not been evaluated for safety and efficacy by EPA.

In its announcement, EPA reminded the public that unregistered pesticides pose health risks to consumers, children, pets, and others who are exposed to the products.  Additionally, EPA advised consumers to dispose of the unregistered pesticides and disinfectants in accordance with local, state, and federal laws.  The announcement noted that pesticides and disinfectants intended for sale in the U.S. must be evaluated by EPA and have approved labeling with an EPA registration number according the requirements of the Federal Insecticide Fungicide and Rodenticide Act.